An outbreak of Burkholderia cepacia, a bacteria resistant to common antibiotics, affected 60 people across eight states last year. The culprit? Diocto Liquid, an over-the-counter laxative commonly used to treat constipation.
After the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and the Department of Health and Human Services investigated the outbreak, they determined that it was caused by contaminated water at PharmaTech’s manufacturing facility in Davie, Florida.
ClassAction.com is now filing lawsuits against PharmaTech and its distributors on behalf of individuals who fell gravely ill from B. cepacia-contaminated Diocto Liquid.
Burkholderia cepacia is a group of bacteria found in soil, water, and other moist environments.
While the bacteria is generally harmless to healthy individuals, it can cause life-threatening infections in those with weakened immune systems. It is most commonly found in medicine and medical devices, making it doubly dangerous for hospital patients. People with chronic lung infections, like cystic fibrosis, are also vulnerable to B. cepacia.
“Recent outbreaks involving contaminated medicines and medical devices are particularly dangerous and have caused serious permanent injuries and, in some cases, death.”
B. cepacia is resistant to common antibiotics, complicating patient treatment.
“B. cepacia is a scary bacteria,” said Michael Goetz, an attorney who leads ClassAction.com’s mass tort section.
“Recent outbreaks involving contaminated medicines and medical devices are particularly dangerous and have caused serious permanent injuries and, in some cases, death. Other products, such as baby wipes and mouthwash have previously been the subject of B. cepacia outbreaks.”
PharmaTech was the subject of multiple investigations last year when their Docusate sodium solution was linked to B. cepacia infections in eight different states.
The FDA, CDC, and Department of Health and Services investigations found multiple gaps in quality control processes at PharmaTech’s Davie, Florida manufacturing facility. These included a failure to monitor water quality or conduct final product testing for potential contamination.
The FDA found B. cepacia in 10 Diocto Liquid lots manufactured between 2015 and 2016. The source, they believe, was PharmaTech’s water supply which also tested positive for the bacteria. They later confirmed that the contaminated water was the source of the multistate outbreak.
On July 16, 2016, the FDA announced a recall of all non-expired Diocto Liquid distributed by Rugby Laboratories for B. cepacia contamination. By August, they expanded the recall to include all liquid products made by PharmaTech.
PharmaTech Sued After Infant Contracts Life-Altering Illness
Anderson Moreno, an infant living in Michigan, took Diocto Liquid as recommended and directed by his physician while awaiting a heart transplant. The solution was contaminated with B. cepacia and Anderson subsequently fell gravely ill with a bacterial infection.
The infection weakened Anderson’s heart, which necessitated a left ventricular assist device. It also resulted in a delay of his heart transplant and permanent kidney damage, requiring lifelong dialysis.
ClassAction.com filed a lawsuit against PharmaTech, Harvard Drug Group, Rugby Laboratories, and Cardinal Health on behalf of Anderson and his parents, Alicia and Andrew Moreno.
“Because the source of infection may not be readily apparent, anyone who has been infected by the B. cepacia bacteria should seek legal advice.”
In the complaint, they allege that the defendants negligently designed, manufactured, tested, advertised, promoted, marketed, sold, and/or distributed Diocto Liquid. These actions, they allege, allowed the solution to become contaminated with B. cepacia, and later sold and distributed in its defective condition.
The Moreno family requests past and future compensatory damages for pain and suffering, loss of enjoyment of life, emotional distress, medical expenses, and lost earnings.
Though the source of PharmaTech’s B. cepacia outbreak is now confirmed, in many cases it can be difficult to track.
“Because the source of infection may not be readily apparent, anyone who has been infected by the B. cepacia bacteria should seek legal advice,” said Attorney Goetz.
Infected with Burkholderia Cepacia? We Can Help
If you or a loved one were infected with B. cepacia, you may be eligible for a lawsuit against the manufacturer, distributor, and other responsible parties.
ClassAction.com’s attorneys have recovered more than $5 billion for its clients against negligent corporations, including big pharmaceutical companies like PharmaTech. With more than 350 attorneys across 40 offices, our firm has the resources and experience to tackle Big Pharma. Contact us today for a free, no-obligation legal review.
Drug injuries have increased twofold in the last decade, according to the Food and Drug Administration’s adverse event database. Out of the more than one million adverse events reported to the FDA just last year, patients complained of their blood thinners the most.
The Institute for Safe Medication Practices (ISMP), a nonprofit organization, provided a breakdown of the pharmaceutical drugs that received the most injury and adverse event reports in their recently released 2016 annual report. Blood thinners, or anticoagulants, were connected to 21,996 adverse events and 3,018 deaths.
This group of pharmaceutical drugs includes Xarelto, Pradaxa, Eliquis, Warfarin, Coumadin, and Savaysa. Xarelto, a drug which is linked to thousands of lawsuits, was responsible for the bulk of adverse event reports.
Blood Thinner Risks Are “Unacceptably High”
Patients who are at risk of developing blood clots—which can potentially stop blood flow to vital organs—are often prescribed anticoagulants. Each blood thinner targets a particular blood clotting factor to prevent or reduce the formation of blood clots.
Blood clotting isn’t always bad though; in fact, in most cases, it’s vital in preventing small bumps and cuts from turning into severe bleeding events. By preventing this natural healing process from occurring, especially when the drug’s concentration is too strong, some patients may suffer from uncontrollable bleeding.
In 2016, internal hemorrhages made up the bulk of blood thinner injuries reported to the FDA:
17,218 reported anticoagulant-related hemorrhages
8,495 reported gastrointestinal hemorrhages
1,019 reported cerebral hemorrhages
Some of these events were serious enough to require an emergency room visit. Overall, the ISMP authors warn, 6.3% of patients on blood thinners will require an E.R. visit, and half of those visits will require hospitalizations.
These numbers surpass any other type of drug. Altogether, anticoagulants were responsible for 17.6% of all FDA-reported hospitalizations.
“The manufacturer has created an unacceptably high safety risk for many patient’s prescribed this drug.”
It’s a statistic that should raise alarms in the medical community. Patients on blood thinners were 2.4 times more likely to require an E.R. visit than patients who were prescribed opioids—a drug type currently responsible for the nation’s worst drug epidemic.
ClassAction.com attorney Michael Goetz is part of the Plaintiffs’ Steering Committee for the Xarelto multidistrict litigation (MDL), filed in the federal Eastern District of Louisiana. The MDL includes thousands of claims alleging injuries caused by Xarelto.
“These new results are not surprising and confirm what we’ve said from the beginning: that certain members of the patient population are at heightened risk for major bleeding events while on Xarelto,” he told us. “In the absence of stronger warnings or a way to monitor a patient’s Xarelto concentration level or an antidote, the manufacturer has created an unacceptably high safety risk for many patient’s prescribed this drug.”
Xarelto’s Once-Daily Dosage Problem
Monitoring blood thinner concentration level is important in that the medication can create “peaks and troughs” in the drug’s severity for some patients.
It’s a particular problem for Xarelto’s once-daily dosing, which has been marketed as a more convenient alternative to the generic warfarin, which requires twice-daily dosing.
But while a once-daily dosing may seem easier for the patient, it may leave them more vulnerable to strokes or bleeding events. Taking anticoagulants only once a day can create inconsistencies in the drug’s concentration—too weak at times (presenting a stroke risk) and too strong at others (making patients vulnerable to bleeding).
Xarelto also poses potentially greater health risks than Warfarin in that it does not require regular patient monitoring. Regular medical visits could help ensure patients receive an accurate dosage, one that prevents dangerous fluctuations in the blood thinner’s concentration. According to a 2017 Mayo Clinic study, one in six patients on newer blood thinners may be prescribed the wrong dosage.
Xarelto Still Lacks an Antidote
Of the 17,000-plus patients who suffered a blood thinner-related hemorrhage last year, those who were on Xarelto (rivaroxaban) did not have access to an antidote to help stop the bleeding. Without a reversal agent to stop blood flow, these events could quickly become life-threatening.
Pradaxa allegedly caused 1,000 deaths.
An antidote for Pradaxa (dabigatran) was only recently approved in 2015. Unfortunately, this was not soon enough to prevent the more than 1,000 casualties allegedly caused by the blood thinner.
An antidote, ISMP researchers stated, could reduce the amount of fatalities and serious injuries in patients significantly. Warfarin has had a simple vitamin K antidote available for years, but despite this major difference, Xarelto and Pradaxa were marketed as superior alternatives.
Thousands File Lawsuits Against Xarelto, Pradaxa
This dangerous risk of bleeding, combined with misleading advertising and an absence of warnings and antidotes, has resulted in thousands of lawsuits against Xarelto and Pradaxa manufacturers.
There are currently 14,000 Xarelto lawsuits consolidated in New Orleans. Thousands more have been filed in state courts against manufacturer Bayer and Janssen, the Johnson & Johnson subsidiary who markets the drug in the U.S.
In 2014, Boehringer Ingelheim (Pradaxa’s manufacturer) settled 4,000 of its lawsuits for $650 million. This was before an antidote was available, though, so some patients were still suffering from Pradaxa-related injuries. Because of this, litigation is likely far from over for Boehringer Ingelheim.
Blood Thinner Injury? We Can Help
ClassAction.com attorneys are filing lawsuits against Xarelto and Pradaxa manufacturers. If you or a loved one suffered uncontrollable bleeding while taking either blood thinner, contact us today for a no-obligation case evaluation. It costs nothing unless we win a jury award or settlement for you.
(NOTE: As of August 28, 2017, Donald Trump has not formally declared the opioid crisis a national emergency, despite his announcing his intention to do so on August 10.)
In a seeming reversal from his previous stance, Donald Trump said yesterday that he was declaring the nation’s opioid crisis an emergency.
“I’m saying officially right now—it is an emergency. It’s a national emergency,” Trump said from his golf club in Bedminster, New Jersey. “We’re going to spend a lot of time, a lot of effort and a lot of money on the opioid crisis.”
“I’m saying officially right now—it is an emergency.”
Prior to that announcement, Health and Human Services Secretary Tom Price had said that an emergency declaration was unnecessary. This surprised many after Chris Christie’s Commission on Combating Drug Addiction and the Opioid Crisis recommended the declaration to unlock government funding to combat the crisis.
Vox examined what the emergency announcement could mean in terms of actual policy, emphasizing that this is a nebulous issue. The declaration could free up funding and other support to help tackle the crisis, but experts agree that for it to be effective, it must be part of a large, comprehensive effort.
Tom Frieden, former head of the Centers for Disease Control and Prevention (CDC), tells Vox, “[I]t could help in the right context, as part of a comprehensive response, and if it encourages both funding and better collaboration between public health and law enforcement.”
But Frieden added, “If it’s just a political statement not backed by money or commitment to more action, and if it’s a way to propagate the criminalization of addiction, then it would be counterproductive.”
Six Thousand More Opioid Deaths Discovered
Trump’s declaration of a state of emergency came just days after a new study published in the American Journal of Preventative Medicinefound that opioid deaths in 2014 were underestimated by 24 percent. If true, the total would rise from 29,000 to 35,000.
Opioid deaths in 2014 were underestimated by 24 percent.
The study, helmed by University of Virginia researcher Christopher Ruhm, also found that certain states were particularly guilty of underreporting opioid fatalities. In Alabama, Indiana, Louisiana, Mississippi, and Pennsylvania, the final tally was more than double the original number. (In New England, on the other hand, the original reports were largely accurate.)
For the study, Ruhm examined more than 47,000 death certificates from 2014 for which the cause of death was marked as a drug overdose. In thousands of these cases, he found that an opioid overdose was the cause of death but that the local medical examiner had not marked the certificate as such.
There is no official standard for or definition of an opioid overdose, which helps account for the underreporting in several pockets of the country. In many cases, no drug was specified.
Ruhm’s study concludes that his corrections “supply important information to policymakers attempting to reduce or slow the increase in fatal drug overdoses.”
Research such as this could prove vital as the Trump administration tries to quell the opioid epidemic.
ClassAction.com Files Lawsuits Against Drug Distributors
To effect real change and hold the powerful accountable, ClassAction.com attorneys John Yanchunis, James Young, and Patrick Barthle have filed several lawsuits on behalf of towns and counties in West Virginia.
McDowell County’s fatal drug overdose rate is three times higher than West Virginia’s.
These complaints were filed against major drug distributors, pharmacies, pill mills, and physicians. They accuse the defendants of public nuisance, negligence, code violations, and unjust enrichment.
A lawsuit filed on behalf of McDowell County claims that claims that, in addition to spreading “addiction and destruction,” drug companies drained McDowell County’s finances:
Defendants have caused and will continue to cause McDowell County to expand substantial sums of public funds to deal with the significant consequences of the opioid epidemic that was fueled by defendants’ illegal, reckless and malicious actions…
ClassAction.com attorney John Yanchunis said: “McDowell County was once a thriving community, now laid to waste by drug addictions which have destroyed lives, broken up families and caused a dramatic increase in crime, addiction-related social and health issues, overdose and even death.”
McDowell County’s fatality rate from drug overdoses is nearly three times higher than West Virginia’s.
ClassAction.com attorneys are also exploring lawsuits on behalf of other states and counties, and on behalf of opioid victims. If you or a loved one became addicted to prescription painkillers, please contact us today to learn your rights. You may be owed money for damages caused by your addiction.
More than 400 arrests were announced last week in the Department of Justice’s largest-ever healthcare fraud takedown. The federal sweep involved crimes totaling more than $1.3 billion in fraudulent healthcare charges.
Defendants were charged with crimes ranging from fraudulent insurance charges (billing Medicare and Medicaid for services and treatments that were never provided), illegal drug prescriptions (particularly for opioids), and kickbacks for patient referrals and prescriptions.
“Too many trusted medical professionals, like doctors, nurses, and pharmacists, have chosen to violate their oaths and put greed ahead of their patients,” Attorney General Jeff Sessions said. “Their actions not only enrich themselves often at the expense of taxpayers but also feed addictions and cause addictions to start.”
120 Defendants Charged with Opioid-Related Crimes
The Justice Department’s recent crackdown is the largest federal effort to date in fighting the opioid crisis: 120 of the defendants were charged with opioid-related crimes.
Among the opioid-related crimes that the DOJ reported were fake rehabilitation centers. One center in Florida was accused of defrauding the government of $58 million for rehabilitation services that they failed to provide. The center allegedly lured patients who were struggling with opioid addictions by offering gift cards and strip club visits.
The roundup also targeted health care workers who illegally prescribed opioids for money and other kickbacks.
One doctor in Connecticut was accused of selling opioid prescriptions to drug dealers, which allegedly earned him $50,000 in one year. A Houston doctor allegedly prescribed 12,000 prescriptions for 2 million opioid doses in return for cash payments.
These crimes represent more than just stolen government money. For patients who are prescribed opioids like oxycodone, hydrocodone, methadone, or fentanyl for pain relief, they may be susceptible to developing a drug dependency. Tom Frieden, the director of the Centers for Disease Control, once told the Washington Post that “prescription opiates are as addictive as heroin.”
While the DOJ takedown is historic and a positive step in fighting the opioid crisis, the fight is far from over. Experts now worry that we may see a spike in drug overdoses if there isn’t a similar investment in rehabilitation.
An Investment in Rehabilitation Must Come Next
For many long-term opioid users, simply stopping their prescription isn’t an option. Withdrawal symptoms can be severe and can include anxiety, vomiting, abdominal pain, difficulty sleeping, and drug cravings.
Because of this, doctors must exercise caution when prescribing these powerful painkillers.
“I think doctors can play a central role in fighting the opioid crisis in several ways,” Dr. Michael Barnett, an assistant professor at the Harvard T. H. Chan School of Public Health, told us. “They are the front line of prescribing, and bear the responsibility of safely prescribing opioids when the benefit (pain relief) outweighs the risks (dependence and other side effects).”
In that study, one out of 48 Medicare patients prescribed opioids in the emergency room became long-term users (someone who uses opioids for 180 days or more within the first 12 months of an emergency room visit). If patients saw a doctor who was a “high-intensity prescriber”—someone who prescribes opioids in 25% of their patients—they were 30 percent more likely than patients who were treated by “low-intensity” prescribers to use opioids in the long term.
“We should have a culture of transparency and accountability around opioid prescribing—we are all in this together.”
But, as more and more healthcare providers are cracking down on the number of opioid prescriptions, some long-term opioid users may seek other sources of relief if they aren’t properly treated for withdrawal symptoms. Some have turned to illegal opioid suppliers like drug dealers or pill mills, while others have turned to stronger drugs entirely. Heroin, for example, produces a similar effect to opioids and has seen a spike in usage.
Fighting the opioid crisis then requires a two-pronged approach: We must address the effects of addiction in addition to restricting opioid access. This is another area where Dr. Barnett feels doctors can make a difference.
“Doctors can play a key role in safely transitioning long-term opioid users off of the medications to alternative therapies as they are able, and to promote and prescribe medication assisted therapy for those with dependence,” said Dr. Barnett. “Above all, we should have a culture of transparency and accountability around opioid prescribing—we are all in this together.”
Attacking the Root of the Crisis: Pharmaceutical Companies
We can’t educate doctors and patients on the effects of opioids without addressing the source of the problem: the pharmaceutical companies.
“Drug companies such as KVK-Tech that manufacture opioids have an obligation to ensure their product is not diverted illegally and are safe to use,” John Mack, owner of Pharma Marketing News, told us.
“Drug companies that manufacture opioids have an obligation to ensure their product is not diverted illegally and are safe to use.”
He explained that companies like KVK-Tech are not only failing to do all that they can to prevent abuse, but they may have even known that their opioids were going straight to illegal pill mills or pain clinics.
He points to a 2014 Drug Enforcement Administration case involving Masters Pharmaceutical. KVK’s representatives stated that the “majority of the oxycodone they manufactured was sold in Florida due to the demographics of the population, the prescribing patterns of Florida physicians, the prevalence of pain clinics, and laws which [then] allowed physicians to dispense controlled substances.”
“This verges on knowing that much of its opioids may have been diverted by pain clinics operating illegally since federal authorities have long focused on Florida pain clinics as bad players in this crisis,” Mack explained.
“Aside from ensuring the safe and legal use of these products, opioid-producing drug companies should, in my opinion, fund local and national efforts to combat addiction to these drugs. In my community, for example, I urge KVK-Tech to fund a 24/7 drug drop-off box so residents can safely dispose of their unused drugs, including opioids.”
If we have any hope of fighting America’s opioid crisis, the federal government, medical community, and pharmaceutical companies must continue to hold themselves accountable for their roles in the epidemic.
Roche’s rheumatoid arthritis medication Actemra has been linked to more than 1,100 deaths, prompting questions about why the drug does not have warning labels about potentially fatal side effects.
Evidence links Actemra to cardiovascular, lung, gastrointestinal, and pancreatic side effects.
Actemra (tocilizumab) competes with arthritis medications that include Humira, Remicade, and Enbrel. But unlike its competitors, Actemra does not warn about potential injuries and deaths from heart attacks, heart failure, strokes, lung disease, pancreatitis, and gastrointestinal perforation—even though there is evidence that the risks of these side effects are as high or higher for patients treated with Actemra than for patients who take competing drugs.
ClassAction.com is closely monitoring the emerging reports about deaths and injuries associated with Actemra. If you have experienced dangerous Actemra side effects that the labels do not warn about, please contact us and share your story.
13,500 Adverse Event Reports Involve Actemra
Actemra was introduced to the U.S. market in 2010 to treat the disabling disease rheumatoid arthritis. Its introduction was met with enthusiasm since Actemra ostensibly was not associated with the potentially deadly cardiovascular and lung complications that its competitors are.
But according to a new report from STAT, Actemra is not as safe as the U.S. Food and Drug Administration (FDA) and Roche would lead consumers to believe. In fact, the STAT report suggests that Actemra is at least as dangerous as its competitors—if not more dangerous.
STAT analyzed more than 500,000 adverse event reports about several rheumatoid arthritis drugs, including over 13,500 reports involving Actemra, and uncovered 1,128 reports of Actemra patients who died while taking the medication. Many of these patients died from unwarned against cardiovascular and pulmonary side effects.
Highlights from the report reveal worrying trends for Actemra users:
More than 1,000 people died while on Actemra.
Actemra had similar rates of serious side effects compared to competitor drugs such as Humira and Remicade—despite the fact that Humira and Remicade have significantly more users.
Actemra users and Humira users have reported a similar number of cases of interstitial lung disease, while many more cases of lung disease were reported with Actemra than with Remicade. Actemra, unlike Humira and Remicade, does not warn about lung disease.
Similar results were found for heart attacks, strokes, and heart failure—conditions that Humira and Remicade warn about but Actemra does not.
Pancreatitis was reported in 132 Actemra patients. Twenty-six of these patients died. Pancreatitis can kill up to 50 percent of patients in its acute form.
STAT recruited experts to examine the data, and the experts said the FDA should immediately consider Actemra warnings for heart failure and pancreatitis. They also said that the possible link between Actemra and increased risk of heart attacks, strokes, and interstitial lung disease should be further investigated.
STAT points out that adverse event reports are not proof of causation between Actemra and the reported deaths. But it also notes that patient deaths could be higher because these voluntary reports only capture an estimated ten percent of adverse patient experiences.
“There Were Some Red Flags”
The STAT report on Actemra is not the first to raise concerns about the drug’s side effects.
Across five Actemra clinical trials, 72 percent of patients had an adverse side effect. One or more serious side effects occurred in 6 percent of patients. Four patients died of heart attacks, one from heart failure, and four from infections during clinical testing.
Nine patients died during Actemra clinical testing.
Infections, gastrointestinal perforations, cardiovascular complications, and other serious side effects prompted serious discussion during a meeting of the FDA’s advisory panel in 2008.
The panel voted ten-to-one to recommend approval of Actemra. The sole dissenter was consumer representative Diane Aronson.
Ms. Aronson said, “As a ‘no’ voter, I felt there wasn’t enough data; it was too short-term. There were some red flags.”
She added that ‘yes’ voters felt that “long-term studies will be acted upon” and warning labels adjusted if necessary. “That’s why they voted ‘yes,’” Ms. Aronson said.
FDA’s Ties to Roche Raise Questions
Roche received approval for Actemra on the condition that it would perform Phase IV clinical trials, or post-marketing trials. The FDA may recommend these additional safety studies when there is inconclusive evidence about a drug’s long-term safety.
Results from a phase IV trial of Actemra were presented at the 2016 American College of Rheumatology. Actemra patients were compared to patients taking competitor drug Enbrel. Actemra patients were found to have a 1.5 times higher rate of stroke and heart failure.
While the increase is not a statistically significant amount, this does not explain why Enbrel labels warn against prescribing the drug to patients with cardiovascular disease, but equivalent labels have not been added to Actemra.
All 11 authors of the Actemra Phase IV study disclosed financial ties to Roche or Genetech.
Since its 2010 approval, the FDA has scrutinized Actemra several times. A 2012 FDA investigation of Actemra data from several sources found 258 cases of pancreatitis and 185 cases of interstitial lung disease among users. Under pressure from Roche, the FDA declined to push forward with warning labels for these side effects.
The STAT article describes the possible conflicts-of-interest between FDA and Roche, including a former FDA manager who helped oversee Actemra’s approval and shortly after left for Roche, where he now works with the FDA to gain approval for new uses of the drug. And all eleven authors of the phase IV study published in 2016—which found an insignificant cardiovascular risk difference between Actemra and Enbrel—disclosed financial ties to Roche or its subsidiary Genentech.
In a 2013 safety review of Actemra, the FDA found 118 deaths associated with the drug, including 42 deaths from heart attack or heart failure. But once again, the agency failed to update the medication’s labeling, citing an inconclusive show of causality.
In May 2017, the FDA approved Actemra for use in patients suffering from giant cell arteritis, a move that expands the user base for one of Roche’s best-selling drugs. The agency, however, has yet to expand Actemra’s safety labeling.
Which raises the question: How many deaths and injuries will it take before the FDA and Roche do take action?
This editorial was written by James Young, a ClassAction.com attorney who is nationally known in the areas of pharmaceutical litigation, health fraud, and consumer protection. Mr. Young has served in leadership positions in numerous multi-state Attorney General investigations, including starting and co-leading the largest consumer protection drug settlement to date, In Re Risperdal. He was appointed co-lead of the government plaintiffs group in the Vioxx Multi-District Litigation and served as lead of several litigation subcommittees. Along with John Yanchunis, he is now in the process of filing several lawsuits against opioid distributors, doctors, and state Boards of Pharmacy.
Last week the U.S. Food and Drug Administration (FDA) politely asked a drug company to take its blockbuster opioid medication off the market.
The drug, Opana ER, is an extended release form of the painkiller oxymorphone hydrochloride made by Endo. Patients have heavily abused the drug by crushing it up and snorting it, bypassing the extended release mechanism. (Note: This is a drug that the FDA has already approved as safe and effective; the FDA’s request pertains to the abuse and misuse of the drug.)
The FDA action is limited to a request, to which Endo has said it would evaluate misuse of the drug—not pull it from the market (not yet, anyway). In light of this refusal, the FDA could withdraw its approval of the drug, but such a move might be fraught with significant legal challenges.
The FDA’s request is a refreshing shift from an otherwise toothless watchdog.
Still, this latest move by the FDA is a refreshing shift from an otherwise toothless watchdog. Perhaps the most notable takeaway from the request is that, according to Commissioner Scott Gottlieb, the FDA is considering similar action against similar products. After decades of watching the FDA sit on its hands while opioids ravage the country, it’s a start.
In my opinion, though, this is a case of trying to chase one of the many horses back into the barn while the others roam free.
The full range of actors behind the opioid epidemic are researchers, manufacturers, state and federal regulators, drug distributors, pharmacies, providers, patients, and even street criminals. These drugs make billions of dollars for manufacturers and distributors, yet they wash their hands once they get the FDA’s blessing.
A cursory examination of their respective liability reveals no single entity serves as the gatekeeper or watchdog once a drug is approved. That raises the question: Aside from the FDA, which group among these players is or should be responsible for ensuring that these dangerous drugs don’t end up in the hands of the wrong people?
These drugs make billions of dollars for manufacturers, yet they wash their hands once they get the FDA’s blessing.
The drug industry has deftly created a host of “get out of jail” defenses by selectively and strategically picking their battles. For example: agency preemption, rejection of fraud on the FDA, commercial speech, and the “learned intermediary” theory.
Then Big Pharma’s lobbyists cook up bills like the 21st Century Cures Act, CAFA, FICALA, etc. Meanwhile, plaintiffs swing and miss in a disorganized confederation focused more on monetary recovery than changing practices. They also have to play defense in trying to fight the onslaught of conservative legislation.
When considering liability for the harm caused by prescription drugs, a defense theory exists called the learned intermediary theory. The basic premise is that manufacturers and distributors cannot be held accountable for damages caused by drugs since the drugs require a “learned intermediary” (the physician) to render an objective professional opinion that the patient needs the drug, thereby breaking the chain of causation. The logical conclusion, then, is to look to these learned intermediaries to stave off the epidemic.
Physicians will quickly point out that the patients who come to them—many of whom are solely seeking the pills, not actual relief of symptoms—must also be held accountable for misrepresenting their symptoms or lying about existing prescriptions. This is akin to a bartender defending a charge of over-serving by arguing that the customer said they were thirsty.
Pharmacies are keenly aware of how to navigate the regulatory morass to avoid being held accountable.
The liability of pharmacies is fairly limited once an actual prescription is presented, thus the buck is passed again. We could next look to the state and federal regulators like the Drug Enforcement Agency (DEA) and state Boards of Pharmacy and Medicine. To their credit, there seems to have been an increase in Board actions, but their regulatory framework limits what they can do. Physicians and pharmacies are keenly aware of how best to navigate through the regulatory morass to avoid being caught or held accountable.
If we go back to the beginning of a drug’s approval, particularly when considering opioids like Oxycontin, we find a collection of flimsy clinical support largely organized by the manufacturers themselves. In this modern era, it is hard to fathom that an agency like the FDA could be duped by false front organizations created by manufacturers, yet it happens.
There are numerous lawsuits pending or about to be filed against all of the above players, but these lawsuits largely seek money damages. In my experience, the seemingly large amounts recovered in such litigation pale in comparison to the actual profits for each of the players.
Who, then, is best suited to serve as a watchdog of the vulnerable population of current or future opioid addicts? The practical fix is to break down the barriers of regulatory accountability for every player in the chain, beginning with researchers and ending with pharmacists and providers.
If a physician chooses to open a pill mill, he or she should face quick but fair oversight by regulators.
If a physician chooses to open a pill mill, or a pharmacy wishes to dispense to known addicts, they should face quick but fair oversight by regulators. When appropriate, these players should permanently lose their ability to operate such practices. If a manufacturer creates phony support for its drug approvals, or withholds material information from the FDA, the drug should be pulled from the market.
Of course, the current climate in Washington, D.C. will never expand legal liabilities for these players or reinforce regulatory oversight. When we reduce legal liability and reduce regulations and appoint industry shills to lead government agencies, as this Congress has, it is a recipe for disaster.
The buck has been passed, and we the people are left to pick up the pieces in the aftermath.
Given that Risperdal labels initially described gynecomastia as a “rare” side effect, there sure are a lot of lawsuits stemming from the condition.
In its annual report at the end of February, Johnson & Johnson (the parent company of drug maker Janssen) announced that it faced 18,500 Risperdal lawsuits in the United States and Canada.
Plaintiffs filed more than 3,000 Risperdal lawsuits in Philadelphia in the first quarter of 2017.
Since that report, at least 500 Risperdal lawsuits have been filed in Philadelphia alone, bringing the total to at least 19,000 and perhaps as many as 20,000 across America and Canada.
Plaintiffs filed more than 3,000 such lawsuits in Philadelphia in the first quarter of 2017. An additional 310 lawsuits have been filed there in the past two months, for a total of 5,815 as of this writing.
Those numbers are staggering, but so are the side effects—and the jury awards.
Gynecomastia Risk Was 23x What Label Said
Risperdal is an antipsychotic medication used to treat attention deficit disorder (ADD), bipolar disorder, and other mental health issues. Studies show that the drug can cause young boys to develop female breast tissue—a condition known as gynecomastia.
Risperdal plaintiffs allege that Janssen understood the full extent of the gynecomastia risk but failed to adequately warn patients. Originally Risperdal labels claimed that gynecomastia occurred in fewer than one in 1,000 patients.
But after 13 years on the market (1993-2006), Janssen updated the labels to state that 2.3 percent of patients—more than 20 times the original rate—would suffer this severe side effect.
Originally Risperdal labels claimed that gynecomastia occurred in fewer than one in 1,000 patients.
As a result of Janssen’s failure to warn, lawsuits allege, these boys’ bodies transformed in a way that rendered them confused and ashamed.
Many of these boys are now men who have had to undergo surgery to remove their breasts. Adding insult to injury, many also gained a substantial amount of weight (allegedly from Risperdal) and had to shed those extra pounds before going under the knife.
But after years of being bullied for their bodies, they are fighting back.
“Risperdal Boys” Photo Series Brings Trauma to Light
Besides filling lawsuits to hold Janssen accountable, another way Risperdal victims can take action is by raising awareness of the gynecomastia side effect. This could ramp the pressure up on Janssen to make the situation right. But more importantly, it lets other victims know that they’re not the only ones suffering from this condition.
“They wanted the world to know what happened to them.”
With this in mind, a photographer named Richard Johnson recently published a series of photos called “Risperdal Boys.” This project presents three photos each of six boys (now men) who allegedly grew breasts after taking Risperdal. (There were going to be ten Risperdal Boys, but four of them ultimately decided that they did not want their photos to go public.)
Of the six who did participate, Mr. Johnson tells PetaPixel, “…it was because they wanted the world to know what happened to them. Most of the young men in the project suffered alone; they’ve never met someone else with their condition.”
Thanks to the Risperdal Boys’ bravery, dozens if not hundreds more boys will know that they’re not alone.
Juries Side with Plaintiffs, Awarding Them Millions
Juries have not taken lightly the suffering of Risperdal plaintiffs. Last year J&J lost four individual Risperdal lawsuits that went to trial. The awards in the first three cases totaled nearly $5 million, with Austin Pledger alone receiving $2.5 million.
But even those numbers pale in comparison to Andrew Yount, who was awarded $70 million by a Philadelphia jury in July 2016. They ruled that J&J had not only failed to warn Mr. Yount about taking Risperdal, but had destroyed evidence related to the case.
By that point, Johnson & Johnson had already racked up $30 billion in Risperdal sales.
The U.S. government has aimed to punish Janssen for its handling of Risperdal. In 2013, the Department of Justice fined the company $2.2 billion for its off-label marketing of the drug.
By that point, Johnson & Johnson had already racked up $30 billion in Risperdal sales. Last year alone, the drug generated $800 million.
Keep that in mind if—or, more likely, when—J&J settles these thousands of lawsuits.
The company still faces thousands of talc and Xarelto lawsuits, and hundreds for transvaginal mesh.
Johnson & Johnson has been on a litigation rollercoaster after receiving major verdicts for talcum powder, transvaginal mesh, and Xarelto.
While the latest talc and transvaginal mesh verdicts were favorable for plaintiffs, Johnson & Johnson’s subsidiary Janssen Pharmaceuticals was cleared of allegations in the first Xarelto bellwether.
Despite the outcomes of these verdicts, Johnson & Johnson still has a long road ahead of them before they are free from litigation. The company still faces thousands of pending talc and Xarelto lawsuits, and hundreds for transvaginal mesh.
Laura Yaeger, an attorney who specializes in complex litigation for defective drugs and medical devices, warns that large verdicts aren’t necessarily a clear indicator of future settlements or trial wins when you are talking about a defendant like Johnson & Johnson.
“Johnson & Johnson is known to fight hard in litigation despite verdicts,” she told us.
$110M Talcum Powder Verdict is the Highest Yet
On May 4, Johnson & Johnson was hit with its highest verdict yet for talcum powder: $110 million, including $5.4 million in compensatory damages and $105 million in punitive damages. A St. Louis jury sided with Lois Slemp, who alleged her ovarian cancer was caused by using Johnson & Johnson’s baby powder and shower-to-shower powder products for four decades.
Ms. Slemp’s attorneys presented studies linking ovarian cancer to talcum powder use, and alleged that Johnson & Johnson’s executives were aware of the risks.
“They chose to put profits over people, spending millions in efforts to manipulate scientific and regulatory scrutiny,” said Ted Meadows, co-lead counsel for Ms. Slemp. “I hope this verdict prompts J&J to acknowledge the facts and help educate the medical community and the public about the proper use of their products.”
The verdict comes after a string of major talc losses for Johnson & Johnson, including three substantial verdicts last year: $72 million in February, $55 million in May, and $70 million last October. These lawsuits similarly alleged that executives knew of talc’s cancer risk but failed to warn the public and medical community.
The company still has 2,500 cases to battle in the Missouri multidistrict litigation (MDL), and have already said they will appeal the $110 million verdict.
J&J Subsidiary Hit with $20M Mesh Verdict
Just days before the record-breaking talc verdict, Johnson & Johnson’s subsidiary Ethicon was hit with its third multi-million dollar verdict for its TVT-Secur device, a type of transvaginal mesh.
A jury in the Philadelphia mass tort awarded Peggy Engleman $20 million ($2.5 million in compensatory damages and $17.5 million in punitive damages) for the ongoing complications she still suffers from the device, including chronic vaginal pain, permanent urinary dysfunction, and pelvic floor spasms.
“While verdicts are important to the litigation, there is still work to be done.”
Ms. Engleman received the device in 2007 for stress urinary incontinence. But within a month, she alleged the device failed and began to erode in her body. She underwent three surgeries to remove the device, but physicians were unable to remove it in its entirety.
It’s a story that is sadly too common among plaintiffs, and it’s not the first time Johnson & Johnson has shelled out millions for the mesh. They were hit with a $12.5 million verdict in 2015 and a $13.5 million verdict in 2016.
“While verdicts are important to the litigation, there is still work to be done,” said Yaeger. “I expect J&J to appeal the transvaginal mesh verdict and continue their hard press to litigate the cases.”
Plaintiffs Attorneys Still Hopeful After First Xarelto Trial
Amid the headlining verdicts came a somewhat rare victory for Johnson & Johnson when they won the first Xarelto bellwether on May 3.
Xarelto is manufactured by Bayer but marketed by Janssen Pharmaceuticals, a Johnson & Johnson subsidiary. The blood thinner has been linked to reports of uncontrollable bleeding in patients, for which there is no antidote.
14,000 of the nearly 18,000 Xarelto lawsuits are consolidated in a federal court in New Orleans under the jurisdiction of Judge Eldon Fallon. The other cases are consolidated in Pennsylvania and Delaware state courts.
The first bellwether in the New Orleans MDL was filed by Joseph Boudreaux who suffered gastrointestinal bleeding after taking Xarelto for irregular heartbeats and a high risk of stroke. The internal bleeding was so serious that it resulted in a week-long stay in the ICU and required blood transfusions and multiple heart procedures.
Boudreaux’s suit rested on one allegation: That his cardiologist didn’t receive proper safety information for prescribing Xarelto. Specifically, the lawsuit alleged, Bayer and Janssen should have instructed physicians to perform tests to assess the bleeding risk of patients. However, the jury did not find Bayer and Janssen liable for these failure to warn claims.
The narrow scope of Boudreaux’s claims make it hard to predict the outcomes of the remaining three bellwethers, some attorneys point out.
“As plaintiffs lawyers, we wonder what it looks like if the full set of claims were there—here, it ended up being very limited to just this additional testing issue,” plaintiffs attorney Max Kennerly told Law360.
The next bellwether is scheduled for the end of May. The lawsuit was filed by Joseph Orr who alleges his wife died from a brain hemorrhage caused by taking Xarelto. In addition to accusing the company of failure to warn, the suit also claims the medication lacked a reversal agent for fatal bleeding incidents.
Johnson & Johnson may have pledged to keep fighting, but so have our attorneys. If you or a loved one suffered injuries from a medication or medical device, contact us for a free, no-obligation legal review.
The worst drug overdose crisis in American history shows no sign of slowing, despite growing public awareness.
More than 50,000 Americans died from drug overdoses in 2015—the most ever. Nearly two-thirds of the deaths were linked to opioids such as OxyContin, Percocet, heroin, and fentanyl.
Drug overdoses are now killing more people than during past heroin, cocaine, and methamphetamine epidemics. The 33,091 opioid related deaths in 2015 represents a fourfold increase since 1999. Nearly half of those deaths involved a prescription opioid.
Efforts are underway that could finally produce a breakthrough in the crisis.
Every day, news headlines speak to the deepening opioid crisis. In Eerie County, New York, there were ten opioid deaths during a single week in April. Fifty people recently died in a single day from a batch of heroin in Philadelphia, where 900 people are projected to die from opioids this year. Hennepin County, Minnesota experienced a nearly 60 percent jump in opioid deaths from 2015 to 2016. In Palm Beach County, Florida, opioid overdose deaths nearly doubled in 2016. Colorado saw 56 homicides in 2016, compared to 442 opioid-related deaths.
Our country desperately needs new solutions for this unprecedented public health crisis. Initiatives such as more drug treatment and increasing access to overdose antidotes—while helpful—ignore the role of Big Pharma, which every year floods the market with enough painkillers to provide every U.S. adult with a bottleful. They also ignore the role of prescribing patterns on chronic opioid use.
Many experts believe that a three-pronged approach involving opioid addiction prevention and treatment—as well as pain pill supply control—is needed.
Efforts on the local, state, and national levels are currently underway that could finally produce a breakthrough in the crisis. They include lawsuits against prescription opioid manufacturers and distributors, a special opioid commission created by President Donald Trump, a congressional investigation, and new state laws.
The U.S. opioids market is expected to reach $17.7 billion by 2021.
Big Pharma’s deep pockets and cozy relationship with government make it a powerful adversary. The U.S. market for opioids is worth more than $11 billion and is expected to reach $17.7 billion by 2021. Opioid makers’ huge profits have allowed them to stack the regulatory deck in their favor and hire high-powered legal teams that include former government insiders.
And even though the actions of opioid makers seem indefensible, pharmaceutical companies have successfully invoked sound legal defenses in many of cases they’ve faced. The stigma surrounding opioid addiction is yet another factor working in drugmakers’ favor.
Arguing before the Philadelphia Court of Common Pleas in February, Judge Frederica Massiah-Jackson told an attorney (who was trying to convince her that the opioid industry was responsible for his client’s overdose death), “I’m not as sympathetic to this whole opiate thing. When it was cocaine and heroin there wasn’t all of this.”
Judge Massiah-Jackson added, “Find some legal arguments for me.”
Unfortunately, the legal arguments often favor opioid manufacturers. A review of cases against Purdue Pharma published in the West Virginia Law Review found that Purdue won most individual plaintiff lawsuits at the summary judgment level by claiming lack of causation, misuse, wrongful conduct, or expiration of the statute of limitations.
Product liability law is the typical recourse for pharmaceutical-related harm. But arguments that OxyContin and other opioid medications are defectively manufactured, defectively designed, or defectively marketed are a tough sell.
Manufacturing defect means that the product is not made to specification. While such opioid cases have succeeded, they’re usually limited to a particular opioid product or batch that doesn’t work the way it’s supposed to.
Design defect claims—in particular, arguments related to higher strength opioid pills having an excessive drug dose, lack of antagonistic (euphoria-suppressing) formulations, and the ability of users to bypass time-release mechanisms (by, for example, crushing the drugs and snorting or injecting them)—are more feasible. However, when opioid patients misuse or alter the drugs, which commonly occurs among patients who’ve become opioid addicts, manufacturers can use patients’ behavior as a defense.
Failure to warn claims have been mostly unsuccessful because many opioid pill inserts warn about the drugs’ potential toxicity, addictiveness, and potential for abuse. In addition, the “learned intermediary” doctrine followed in many states—whereby the physician serves as the gatekeeper between drugmaker and patient—breaks the chain of causation and provides legal cover for manufacturers.
Drugmakers’ aggressive marketing allowed them to alter prescribing patterns and turn drugs like OxyContin into blockbusters.
Also instrumental to opioid makers’ legal successes is that they’ve done relatively little direct-to-consumer advertising, instead targeting physicians in an attempt to alter their prescribing habits. Purdue, in fact, engaged in no direct-to-consumer advertising. This strengthens the physician’s role as a learned intermediary and shields drugmakers from failure to warn and other marketing claims.
But while manufacturers’ aggressive (and, many argue, false and misleading) marketing allowed them to fundamentally alter opioid prescribing patterns and turn drugs like OxyContin into blockbusters, their tactics have produced legal consequences.
Opioid Class Actions
Class action lawsuits brought by opioid users against drug companies remain a possibility, but they too have failed to gain traction.
Class action lawsuits must receive certification before they can proceed. Certification is based on several requirements; failure to meet any of the requirements results in the case not being certified.
Perhaps most troublesome has been the “commonality” requirement that says there must be a legal or factual question common to all class members. Courts have supported drugmakers’ assertion that questions regarding class members’ medical histories, the factual circumstances of their addiction, and whether drug companies misrepresented opioids or inappropriately promoted them could only be determined on an individual—not a class-wide—basis.
Government legal action against opioid manufacturers has been much more successful than individual and class action lawsuits, although some of the settlements reached are seen as disappointments.
Parens patriae lawsuits—cases in which the state asserts its standing to sue to protect its “quasi-sovereign” interests, such as its interests in the wellbeing of its residents—have effectively allowed state officials to bypass the individual claims requirements that have hampered other lawsuits by naming the state itself as the injured party and seeking damages that can replenish welfare, healthcare, justice, and other social systems stressed by rampant opioid addiction.
Kentucky settled with Purdue Pharma in 2015 for $24 million.
Liability theories also differ in parens patriae cases. For example, they often include public nuisance claims. Public nuisance laws were originally designed to allow the demolition of run-down buildings that threatened the community’s safety.
The state of West Virginia and Pike County, Kentucky settled parens patriae cases with Purdue Pharma for $10 million (2004) and $4 million (2013), respectively. Pike County used the settlement money to expand a drug rehabilitation facility.
Non-parens patriae state lawsuits have made inroads against opioid makers as well.
In 2007, Purdue Pharma settled with 26 states and the District of Columbia for $20 million for unlawfully marketing OxyContin. The multi-state class action lawsuit was inspired by the West Virginia settlement and alleged that Purdue misbranded OxyContin as “less addictive, less subject to abuse and diversion, and less likely to cause tolerance and withdrawal than other pain medications.”
While a $20 million settlement might seem like a big win, an assistant attorney general in the case expressed “tremendous buyer’s remorse” that the case did not settle for more money or lead to substantive changes in opioid prescribing patterns. Indeed, the opioid epidemic has only deepened over the last decade.
Kentucky refused a $500,000 offer in the case, fought for more money, and in 2015 settled with Purdue for $24 million. Former Kentucky Attorney General Greg Stumbo, who filed the 2007 lawsuit, believes the case could be worth $1 billion if it ever reached a jury. But accepting the settlement suggests that the Attorney General’s lawyers had doubts about a win at trial.
The U.S. is only one of two countries in the world that allows direct-to-consumer drug advertising, and we may be paying a heavy price for it.
It’s difficult to watch television without hearing “ask your doctor” blaring from the latest pharmaceutical commercial.
Yet, these commercials that are so commonplace in the U.S.—80 air every hour, according to Nielsen—are a unique phenomenon. In fact, the only other country where direct-to-consumer drug advertising is legal is New Zealand.
In 2016, direct-to-consumer drug advertising was the sixth largest advertising category in the U.S., and it continues to grow.
Now, leading groups like the American Medical Association are calling for a ban on consumer drug advertising, voicing what many Americans are already thinking. In a poll conducted by STAT and Harvard School of Public Health last year, 57% of respondents said they supported a ban on drug commercials.
These commercials do more than just take up advertising air space. Big Pharma’s billion-dollar advertising budget can cause a host of problems, including high drug costs and adverse drug events.
The Evolution of Big Pharma Advertising
The following events were pivotal in shaping Big Pharma into the advertising giant that it is today.
1969: FDA Allows Direct-to-Consumer Advertising
The FDA permits consumer advertising to encourage price competition. Advertisements must include a brief summary of every known health risk of the medication. This requirement makes print the only feasible option for advertising since the health risks can be spread across multiple pages.
1983: FDA Pulls First Pharmaceutical Drug Commercial
Boots Pharmaceuticals runs the first commercial for their ibuprofen, rufen. The company only advertises the price of the medication, believing that if it doesn’t make any medical claims, it doesn’t have to share the risks. But within 48 hours, the FDA orders them to pull the commercial.
1996: Claritin Finds a Loophole
A Claritin commercialexploits a regulations loophole by not specifying what the medication is for, instead telling viewers to ask their doctors for details. By doing so, they don’t have to list the drug’s risks.
1997: FDA Trims Advertising Regulations
Pressured by lobbyists and politicians, the FDA loosens advertising regulations by only requiring companies to share a medication’s major health risks in advertisements. Companies can now direct consumers to another source (a phone number, website, etc.) for more information.
Drug Advertising Encourages Pricey Prescriptions
Nine out of ten pharmaceutical companies spend more money on advertising than they do on research and development.
Though companies have to disclose the major risks in their ads, they don’t have to share data on the effectiveness of the medication or whether or not it is superior to a generic version. Drug companies heavily advertise their premium medications, often leading Americans to ask their doctors for expensive medications over generic versions.
“Looking at all the evidence about direct-to-consumer advertising, any reasonable person would support a ban on this dangerous form of marketing.”
The American Medical Association (AMA) noted this discrepancy when they asked for a complete ban on direct-to-consumer drug advertising in 2015. The AMA said that direct-to-consumer advertising “inflates demand for new and more expensive drugs, even when these drugs may not be appropriate.”
We asked Dr. Ray Moynihan, Senior Research Fellow at Bond University and author of Selling Sickness, for his thoughts on banning drug advertisements altogether.
“Looking at all the evidence about direct-to-consumer advertising, any reasonable person—acting independently of the pharmaceutical industry influence—would support a ban on this dangerous form of marketing. [This] would inevitably bring improvements in health and health system sustainability,” Dr. Moynihan said.
Drug Advertisements Understate Side Effects
In an FDA study, participants were less likely to remember the drug risks listed in a commercial if they were played alongside distracting visuals or music.
Drug companies are required to list the side effects of their medications in commercials, but whether or not viewers can remember that information is another story. There are no restrictions against using visuals, music, and other design elements to understate harmful risks.
In 2016, the FDA conducted a study on viewer distraction during drug commercials. The agency discovered that viewers were less likely to remember the drug risks if they were played alongside distracting visuals or music. Instead, what viewers often remember are the images of happy and healthy people and the drug’s benefits.
In 2008, the FDA accused popular birth control YAZ of downplaying the risks of the contraceptive in their commercials. YAZ patients, the FDA reported, had a 74% increased risk of blood clots compared with patients on other oral contraceptives. The company was also accused of overstating the contraceptive’s benefits by claiming it could help other conditions like acne.
The FDA sent YAZ manufacturer Bayer a warning letter in 2008 that said:
The[se] complex presentations distract from and make it difficult for viewers to process and comprehend the important risks being conveyed… The overall effect … is to undermine the communication of important risk information, minimizing these risks and misleadingly suggesting that YAZ is safer than has been demonstrated by substantial evidence or substantial clinical experience.
As part of a $20 million settlement with the FDA, Bayer aired a follow-up commercial that clarified the contraceptive was not approved for moderate acne or premenstrual syndrome.
During his first address to a joint session of Congress, President Donald Trump vowed to “slash the restraints” on the “slow and burdensome approval process” at the U.S. Food and Drug Administration (FDA) that “keeps too many advances… from reaching those in need.”
Mr. Trump did not provide concrete reform proposals, but his comments echoed those he made about the agency on the campaign trail and are consistent with conservatives’ desire to slash what they see as excessive FDA red tape.
Mr. Trump’s posture suggests a significant shakeup of the FDA.
While many were quick to point out that the FDA not only approves new drugs about as fast as any regulatory agency in the world, but has also in recent years streamlined how it approves many new drugs. But focusing only on the “approval process,” while leaving out a discussion of clinical drug development—which can take 12 years or more—paints an incomplete pictur
FDA critics claim that the agency as it currently operates is not flexible enough to efficiently oversee a world of accelerating medical advancements and personalized medicine. Some have proposed, among other measures, a market-based solution that they argue would break the FDA’s monopoly on drug access and make new drugs available up to seven years earlier than they are at present.
The FDA’s future under President Trump should gain clarity when he finally announces his pick to lead the agency. However, Mr. Trump’s leading FDA chief candidates and his early comments to the pharmaceutical industry suggest significant FDA reforms.
How a New Drug Gets Approved
Before addressing FDA modernization, it’s important to understand the journey new drugs take from the laboratory to pharmacy shelves.
FDA approval is the final phase of a larger process known as the “new drug development process.” Although the FDA does not conduct its own new drug testing (this would be prohibitively expensive), it is actively engaged in all phases of the new drug development process.
For example, the FDA determines what evidence is needed to prove that a new drug is safe and effective, approves and monitors clinical trials, and at the end of the process, evaluates a company’s New Drug Application (NDA). A drug cannot be marketed to the public until the FDA approves its NDA.
This entire process takes an average of 12 years. Here’s how it breaks down:
Preclinical research: New drug research starts in the lab. Researchers identify a compound they believe has a clinical effect on a specific disease and then test it on cell cultures and eventually, on living animals. If lab results justify further testing on human subjects—a determination the FDA makes based on a lengthy application—the drug proceeds to clinical trials. The preclinical research phase can take up to 3.5 years.
Phase I trials: The first stage of clinical trials, Phase I studies involve 20-100 people with the disease/condition the drug intends to treat. Meant to establish the drug’s basic properties and human safety, Phase 1 studies last 1-2 years. About 70% of drugs clear this stage.
Phase II trials: Phase II clinical trials ascertain a drug’s efficacy and side effects. They use several hundred people with the disease being studied and take several months to 2 years. Approximately two-thirds of drugs move on to phase III trials.
Phase III trials: Phase III clinical trials are typically the most extensive and expensive phase of drug development. This phase involves testing the drug on 300-3,000 patients to confirm safety, effectiveness, and dosing. These trialstake 2-4 years. About 10% of medicines fail in phase III trials.
New Drug Application: A drug that successfully completes all three clinical trial phases is eligible for a New Drug Application (NDA) with the FDA. It usually takes 1-2 years between the completion of a phase III trial and drug approval, including 6-10 months for the NDA review.
If the FDA approves the drug, physicians may then prescribe it to patients. In some cases, including Xarelto, the FDA orders phase IV (“post-marketing”) studies to evaluate long-term safety and efficacy.
Only one out of every 5,000-10,000 compounds that begin in preclinical testing is approved for marketing.
Expedited Drug Approval Programs
The multi-stage drug development and review process is intended to keep unsafe and/or ineffective drugs from reaching the public. However, because it takes so long, the process can be problematic for patients who have conditions that currently lack good treatment options.
This issue came to the fore during the AIDS crisis of the 1980s and 1990s, spawning FDA programs that expedite the approval of new therapies intended to treat unmet medical needs.
Orphan drug: The 1983 Organ Drug Act incentivizes new drugs that treat diseases affecting fewer than 200,000 patients per year by creating tax breaks and market exclusivity periods. Orphan drugs are often approved on the basis of less-rigorous clinical trials.
Fast track: The FDA’s “fast track” approval designation of 1988 allows drugs that treat life-threatening or debilitating diseases to be approved after a single phase II clinical study.
Accelerated approval: Implemented in 1992, the FDA’s “accelerated approval” pathway alters evidentiary standards for drugs that treat serious or life-threatening diseases.
Priority review: In 1992 the FDA formalized a 1975 program guaranteeing FDA review within six months of drugs offering a therapeutic advance over available treatment.
Breakthrough therapy: Since 2012, the FDA may designate a new drug a “breakthrough therapy” if it treats a serious or life-threatening disease and demonstrates substantial improvement over existing therapies. Designated breakthroughs receive expedited development and review.
How effective have these programs been at bringing new drugs to needy patients? A 2015 BMJ study suggests the programs aren’t exactly being used as they’re intended.
BMJ looked at nearly 800 drugs approved by the FDA through expedited development and review pathways between 1997 and 2014. It found that, “over time… a greater proportion of programs were being applied to drugs that were not the first in their class. Such drugs are more likely to be only incrementally innovative and many not represent a clinical advance.”
While such drugs may still have value, using the expedited programs for less innovative products can divert limited FDA resources, says BMJ.
How Trump Could Shake Up the FDA
Megan Crowley, a guest of first lady Melania Trump at the president’s congressional address, was held up as a “miracle” of drug innovation.
Megan is a 20-year-old college student who suffers from Pompe disease, a potentially fatal neuromuscular disease. She was not expected to live past age five, but her father founded a medical company that developed the enzyme replacement drug which helped save Megan’s life.
The drug, Myozyme, was approved in 2006 based on trials featuring only a few dozen patients and an expedited review.
“If we slash the restraints, not just at the FDA but across our government, then we will be blessed with far more miracles like Megan,” said Mr. Trump.
His comments to Congress on the FDA were very similar to those he made on the campaign trail, where he said he wanted to “speed the approval of life-saving medications” and mentioned “cutting the red tape at the FDA.”
“We’re going to get the approval process much faster,” Mr. Trump told the pharma heads.
“Right to Try” Law
Mr. Trump has also signaled support for a national “right to try” law giving terminally ill patients the right to take drugs that are still in development. Thirty-three states have right-to-try laws on the books, and the FDA has a similar “compassionate use” program.
The FDA has denied only 39 of the 7,291 compassionate use requests made by physicians since 2009, making a national right-to-try law somewhat redundant, but it cannot make companies comply with physician requests for experimental drug access for their terminal patients. A national right-to-try law in theory could compel pharmaceutical and insurance companies to provide and pay for experimental drugs.
Another FDA reform President Trump could champion is “reciprocal approval” legislation, or a law that would allow new drugs approved in other countries with drug safety standards similar to the U.S. to be sold stateside.
On the campaign trail Mr. Trump said he would “remove barriers to entry” of “imported and safe dependable drugs from overseas.”
While reciprocal legislation might help fill drug gaps and lower drug prices by introducing greater competition, a BMJ study concluded that the legislation “would most likely benefit only a small number of US patients receiving treatment for rare diseases, and the benefit may be somewhat mitigated by an increased exposure to harms.”
It’s an all-too-common story in the nation’s opioid epidemic: a single prescription of the powerful painkillers leads to dependence, escalating doses, and in many cases, fatal overdoses.
Patients whose doctors prescribed opioids were more likely to become chronic users.
Thanks to new research, this familiar pattern has gone from anecdotal to empirical, with a study suggesting that patients treated by emergency room doctors who prescribe opioids at higher rates are at greater risk for chronic opioid use.
“This is the analysis we have been looking for to show the risk of a single exposure of a patient in an emergency room to an opioid,” said Dr. Lewis S. Nelson, Rutgers New Jersey Medical School and University Hospital.
Although the study is limited in its scope, it contributes to a broader understanding of the role of physicians in an opioid overdose crisis that claims 91 American lives per day.
NEJM Study Compares High-Intensity, Low-Intensity Prescribers
Approximately one out of 48 Medicare patients prescribed an opioid in the emergency room ends up using opioids long-term, according to a New England Journal of Medicine study published on February 16, 2017.
But a doctor’s prescribing trends play a crucial role in a patient’s risk of chronic use. Patients who saw a doctor identified in the study as “high-intensity prescriber”—one who gave one in four patients opioids—were 30 percent more likely to become long-term opioid users, compared to patients treated by a “low-intensity” prescriber, who gave just one in 14 patients opioids.
Lead author Dr. Michael Barnett told The New York Times that the study’s conclusion was “not that high-intensity prescribers are necessarily irresponsible in prescribing opioids to certain patients.” Rather, says Dr. Barnett, “Their patients have worse outcomes that we weren’t aware of before.”
The primary study outcome was long-term opioid use, defined as 180 days or more of opioids supplied in the 12 months after an emergency department visit. Secondary outcomes were hospitalizations and emergency department visits—including those possibly linked to adverse opioid effects and opioid-influenced medical conditions—over the subsequent 12 months.
A doctor’s prescribing trends play a crucial role in a patient’s risk of chronic use.
Opioid use among older patients is associated with falls, fractures, worsened kidney and blood pressure problems, constipation, respiratory failure, and opioid poisoning.
Because the study focused on Medicare patients and emergency department visits, the authors cautioned that the results may not be applicable to other patient groups. However, they added that rising opioid misuse among the elderly makes the study’s findings significant.
“Clinical Inertia” Could Stem From Initial Prescription
The study authors also mentioned how an initial opioid prescription could—through continued, non-emergency room doctor prescribing—fuel patient dependence.
As the opioid dose increases, so does the risk of a fatal overdose.
“Clinical conversion to long-term use may be driven partly by clinical ‘inertia’ leading outpatient clinicians to continue providing previous prescriptions,” the authors wrote.
This point suggests the need for emergency room doctors to think more carefully about prescribing opioids.
While physical dependence and addiction aren’t identical, both can result in accidental opioid overdoses as patients develop drug tolerance and require higher and higher doses to achieve the same pharmacological effects. As doses escalate, it increases the risk of an overdose that causes respiratory depression and death.
Many opioid-addicted patients end up buying black market pain pills to feed their growing habit. Others begin using the illicit opioid heroin. The CDC reports that 80 percent of heroin addicts started out as prescription opioid addicts.
Some doctors have been named alongside pharmacies and wholesalers in opioid lawsuits as pill-pushing accomplices in a legal drug trade.
On the whole, opioid prescribers are well-meaning; they simply want to help their patients manage pain. And many are handcuffed by an insurance system that offers poor reimbursements for alternative pain treatments like massage therapy and acupuncture.
But if the study has one major takeaway, it’s that opioid prescribing should not be taken lightly, since the decision to prescribe—even once—can have long-lasting risks.
There’s no shortage of blame to go around for an opioid addiction crisis that is wreaking havoc on communities across the United States.
Drug overdoses now kill more Americans than car crashes. More than 60 percent of overdose deaths involve either prescription opioids or heroin, and half of opioid deaths involve a prescription painkiller such as methadone, hydrocodone, or oxycodone.
Drug overdoses now kill more Americans than car crashes.
Prescription opioid sales have quadrupled since 1999. This legal drug trade is made possible by a nexus of manufacturers, wholesalers, doctors, and pharmacies that have put into circulation enough opioid pills to provide every American adult with a bottleful. Many of these pills end up on the black market, where they enrich criminals and create more addicts.
Communities devastated by the addiction scourge are fighting back with legal action against the people who have facilitated the epidemic.
As several recent opioid lawsuits show, there are different legal approaches to address this multi-pronged problem.
West Virginia is at the epicenter of the opioid overdose crisis. Over the last six years, more than 1,700 West Virginians suffered fatal opioid overdoses, as the equivalent of 433 pain pills for every man, woman, and child poured into the state.
A lawsuit filed by the City of Huntington takes aim at three drug distributors—AmerisourceBergen Drug Corporation, Cardinal Health, and McKesson Corporation—whom the city blames for the pain pill deluge. The lawsuit also names a physician who allegedly wrote opioid prescriptions to city residents. (The doctor has admitted to fraudulently prescribing oxycodone pills.)
As the Huntington lawsuit notes, no single act—or actor—could sufficiently create the opioid epidemic. The current situation results from joint negligence by medical providers, pharmacies, and distributors.
“The citizens in our city, our region and our state are living in a nightmare that was avoidable,” said Huntington Mayor Steve Williams. “Profits have been pocketed while our community has been left with the fallout and stigma of the opioid epidemic.”
Washington Community Files Lawsuit Against OxyContin Maker
Across the country, some 2,500 miles from Huntington, the small city of Everett, Washington has filed a first-of-its-kind lawsuit against OxyContin maker Purdue Pharma for its alleged contribution to illegal pain pill trafficking.
Purdue is no stranger to lawsuits; the drugmaker has been sued hundreds of times for its role in the opioid crisis. But this suit, prompted by a Los Angeles Times investigation, is substantively different. It claims that Purdue knew about corrupt doctors and pharmacies providing drug dealers and addicts with OxyContin, but failed to stem the drug flow or alert law enforcement.
“We know this is a bold action we are taking, but it is the right thing to do.”
Everett officials say OxyContin is a major contributor to crime and a related heroin epidemic. According to the CDC, four out of five heroin addicts were originally addicted to prescription opioids.
Everett and the surrounding area has experienced a surge in opioid addiction, overdose deaths, crime, homelessness, and government resources spent addressing the crisis.
Purdue is accused of “intentional, reckless, and/or negligent misconduct” that has caused “substantial damages to Everett,” say lawyers for the city.
Everett Mayor Ray Stephenson says, “We know this is a bold action we are taking, but it is the right thing to do.”
The New Hampshire attorney general may be considering similar legal action against Purdue, but the company has so far succeeded in blocking requests for information on criminal opioid trafficking in the state.
McKesson Corp. Pays $150M Settlement Over Suspicious Pill Sales
Wholesaler McKesson Corporation—which agreed in 2008 to set up a system for detecting and reporting suspicious orders of oxycodone and hydrocodone—will pay federal authorities $150 million for its alleged failure to follow through on that agreement.
In Colorado, for example, McKesson processed more than 1.6 million drug orders from June 2008 to May 2013, but only reported 16 as suspicious (1 out of 100,000 orders)—all from a single customer.
“Given a chance to implement a more robust system for monitoring the distribution of these products, the company instead chose to ignore its own compliance regime in favor of a bigger bottom-line,” said U.S. Attorney Paul. J. Fishman.
McKesson—the nation’s largest drug distributor—has been a frequent opioid lawsuit target. Last year West Virginia filed suit against McKesson for allegedly delivering 100 million doses of hydrocodone and oxycodone to the state over a five-year period.
Are You a Victim of the Opioid Trade?
While some companies and individuals have profited from the opioids flooding our communities, many more lives have been ruined by addiction.
If you became addicted to prescription painkillers, ClassAction.com wants to hear from you. Get in touch with us to learn your rights and receive updates about the opioid epidemic and related lawsuits.
The high cost of drugs is one of the few issues able to muster bipartisan support on Capitol Hill.
President-elect Donald Trump took aim at the pharmaceutical industry during a January 11 press conference when he said that “[drug companies] are getting away with murder—pharma has a lot of lobbyists and a lot of power. There’s very little bidding on drugs; we’re the largest buyer of drugs in the world and yet we don’t bid properly.”
“Drug companies are getting away with murder.”
That same day, across the political aisle, Senator Bernie Sanders railed against the industry from the Senate floor, saying, “The American people pay the highest prices in the world for prescription drugs, millions cannot afford the medicine they desperately need, but at the same time the drug companies make out like bandits and their CEOs earn exorbitant compensation packages.”
In the past year, Mr. Trump, Mr. Sanders, and Hillary Clinton have all proposed a simple fix to lowering drug prices: allowing federally run Medicare to negotiate drug prices directly with manufacturers. It’s an idea that 93 percent of Democrats and 74 percent of Republicans support.
Contempt for Big Pharma could be the villain that brings together populist factions on the left and the right. But lowering drug prices is, unfortunately, not as simple as allowing Medicare price negotiations, for several reasons.
Drug Prices by the Numbers
Just how expensive are U.S. prescription drugs? The numbers below help bring into focus an issue causing widespread outrage:
Drug prices increased by double-digit increments from 2013-2015 and by nearly 10 percent from May 2015 to May 2016. To put this in perspective, the overall U.S. inflation rate is around 1 percent per year.
U.S. healthcare spending on drugs increased from around 7 percent in the 1990s to nearly 17 percent in 2015.
Some drug prices are seeing astronomical rises. For example, prices for more than 60 prescription drugs more than doubled from 2014-2016. EpiPen prices have increased 450 percent since 2007; HIV drug Daraprim went from $13.50 to $750 per pill overnight in August 2015; and the cost of topical gel Alcortin A increased 20-fold over two years.
About 2 in 10 Americans went without prescription drugs in 2015 because they couldn’t afford them.
A March 2016 Consumer Reports survey found that about 30 percent of Americans experienced higher out-of-pocket drug expenses in the last year, often resulting in household budget crunches.
In 2015, the industry spent $231 million attempting to influence lawmakers. There are more Washington, D.C. lobbyists working for drug manufacturers than there are members of Congress—in 2015, drug company lobbyists outnumbered Congress members 894-535.
Many drug company lobbyists are so-called “revolvers” who previously held government positions. Over the last 13 years, Mother Jones reports, more than 60 percent of the drug industry’s lobbyists passed through the revolving door from government to lobbying.
The drug industry is also among the leaders in federal political campaign contributions. Pharmaceutical manufacturers have been top House and Senate campaign contributors for years. In 2016, drug companies contributed more than $19.5 million to Congressional campaigns.
Industry spending increased in the years leading up to the 2003 passage of a Medicare prescription drug benefit known as Medicare Part D, which subsidizes prescription drug costs for Medicare beneficiaries. The program, however, contains an odd restriction: under the Part D law, the federal government is banned from negotiating drug prices with manufacturers.
Lifting this restriction and allowing Medicare to set (and theoretically, lower) drug prices is what Mr. Trump, Mr. Sanders, and others have proposed.
It’s common sense, considering that the U.S. government has significant bargaining power as the nation’s (and the world’s) single-largest pharmaceutical drug purchaser.
There are more lobbyists in DC working for drug manufacturers than there are members of Congress.
So why have numerous bills introduced over the last 13 years that would allow such negotiations failed? For the same reason that the Part D restriction was added in the first place: the drug industry lobbying machine.
“It’s Exhibit A in how crony capitalism works,” says Rep. Peter Welch (D-VT). “I mean, how in the world can one explain that the government actually passed a law saying that you can’t negotiate prices? Well, campaign contributions and lobbying obviously had a big part in making that upside-down outcome occur.”
Medicare Negotiations Not a Cure-All
Allowing Medicare to negotiate drug prices is a popular reform idea, but critics contend that removing the Part D negotiation ban wouldn’t necessarily produce the desired cost-reduction effect.
Medicare Part D covers six “protected classes” of medications associated with complicated diseases such as HIV, cancer, and epilepsy. Part D allows patient access to “all or substantially all” medications within these classes. In other words, the government has less bargaining power for protected drugs because it doesn’t have the option to refuse coverage for them.
A similar requirement is found in private health care insurance laws that “force insurers to include essentially all expensive drugs in their policies, and a philosophy that demands that every new health care product be available to everyone, no matter how little it helps or how much it costs,” according to Peter B. Bach of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center.
Europeans pay half as much as Americans for prescription drugs.
Letting insurance companies say “no” to even a handful of drugs each year—a policy employed by many European countries—could substantially lower drug prices. Europeans pay about half as much as Americans for prescription drugs.
The U.S. Department of Veterans Affairs (VA) has more leeway to set its own formulary than Medicare does. The VA only covers about 59 percent of the 200 most popular drugs, compared to 85 percent for Medicare and 93 percent for some private firms. By one estimate, the VA pays 40 percent less than Medicare for drugs.
Narrowing consumer choice, however, is a politically salient issue. In 2014, when the Obama administration proposed removing some categories of drugs from the Part D protected list—at an annual savings of $1.3 billion—strong patient backlash squashed the plan.
By one estimate, the VA pays 40 percent less than Medicare for drugs.
There’s also a downside to price controls. If Medicare received the same discounts as the VA, it could save $155 billion over ten years. But since drug companies spend about one-quarter of revenues on research and development, this savings would take away about $36 billion from new drug development over a ten-year span.
Not All Drugs Are Created Equal
Grouping all medications together in the drug price discussion oversimplifies a complex issue.
Turing Pharmaceuticals raised the price of Daraprim by 5,000%—overnight.
Some drugs, they argue, such as Hepatitis C treatment Sovaldi (cost: $1,000 per pill) are cost-effective despite being extremely expensive because they cure diseases with serious consequences and poor treatments and thus provide a net societal benefit.
Other drugs, however, are new and expensive but not very effective. Their low value does not equate to an overall positive cost-benefit ratio.
Complicating matters further is the so-called “moral hazard” of insurance, or the idea that health insurance causes people to use more—and more costly—medical products and services, leading to spending increases and inefficiencies. From this standpoint, greater consumer information about drug costs and benefits, in particular regarding marginally effective drugs, can help reduce insurance’s moral hazard.
Yet another piece of the drug price puzzle is limited generic competition stemming from the FDA’s slow drug review process. There’s been a recent trend of companies acquiring formerly inexpensive generic drugs and drastically raising prices—such as the notorious Daraprim, which Turing Pharmaceuticals marked up 5,000% overnight.
Huge price spikes like this should in theory prompt more competition and lower prices, but the FDA’s three-year wait for generic drug applications discourages market competition, say Drs. Friedman and Weiner.
These distinct storylines show there is no one-size-fits-all solution for lowering drug prices. They also suggest that a well-intentioned health care policy—such as FDA oversight—can create unintended pricing consequences.
Big Pharma Blames Drug Development Prices
Pharmaceutical companies blame high drug prices on a steep rise in development costs.
The cost of developing a drug is estimated at $2.6 billion.
That $2.6 billion figure includes both direct costs, such as testing and development, as well as indirect opportunity costs—the money the company could have made had it invested in something other than drug development.
Assuming these calculations are accurate, they still don’t account for the 164 percent drug price increase seen since just 2008. What’s more, one can poke numerous holes in the cost estimate.
For starters, the Tufts report is largely funded by the pharmaceutical industry, which has a vested interest in promulgating a high drug cost narrative.
The report also only takes into account new molecular entities—the most expensive type of drugs that companies develop. In addition, the estimate doesn’t reflect taxpayer funding of new drugs through the National Institutes of Health and other groups. Drug research costs are tax-deductible as well, meaning the public bears part of the expense.
Finally, the report conveniently fails to mention that drug companies spend twice as much on marketing and promoting their products as they do on research and development.
None of this is to say that developing new drugs isn’t expensive, or important for the next generation of treatments.
It’s not as if Americans are begrudging Big Pharma for making a profit. Our free-market system is built on a quid pro quo arrangement that sees innovators get rich from making publicly useful products.
High drug prices are fundamentally about fairness. Drug companies aren’t subject to the same rules as other markets, where exorbitant prices reduce customer demand.
“A drug company can increase the price of a product many times over, and people will still buy it because they need it,” says Dr. Kevin Riggs of Johns Hopkins University. “At the end of the day, they largely charge whatever the market will bear—and with lifesaving medication, that’s a lot.”
Consumers can do their part to lower drug prices by asking for generics whenever possible.
Most Americans believe the government needs to take action on drug prices and keep Big Pharma from “getting away with murder.”
Only half of all clinical trial results are published. Favorable results are twice as likely to be released.
Your doctor only knows half of the research on the medication they just prescribed to you. Scary, right? That’s not all: Governments, regulators, and scientists are similarly left with limited data.
A study published in the New England Journal of Medicine estimates that only half of all clinical trial results are published. Results that are published are twice as likely to favor the medical treatment.
Similarly, a PLOS Medicine study found that half of the research on new medical treatments under reports adverse events. Though 95% of research contains adverse effects, only 46% of published documents include them.
So, what does this mean? It means that drugs are approved, regulated, and prescribed based on skewed data. It means that taxpayer dollars are wasted by scientists unknowingly repeating the same clinical trials over and over again. And it means that patients receive medications that may do them more harm than good.
A “Cancer” at the Heart of Medical Research
It’s easy to understand why drug companies are more likely to hide negative clinical trial results. But universities and non-industry sponsored researchers are even more susceptible to leaving out data.
Starting in 2007, the FDA required that all clinical trials are registered and their results published within one year of completion on ClinicalTrials.gov.
However, the New England Journal of Medicine study discovered that of the clinical trials registered, only 13.4% of trials reported their results within the one-year time frame. While 17% of industry trials were published, only 8.1% of NIH-funded trials were, and a mere 5.7% of university and other government-sponsored trials were released. Five years on, still less than half of clinical trial results were published.
“If I conducted one study and I withheld half of the data points from that one study, you would rightly accuse me, essentially, of research fraud,” said Ben Goldacre, creator ofthe AllTrials campaign, in his popular TED Talk. “And yet, for some reason, if somebody conducts 10 studies but only publishes the five that give the result that they want, we don’t consider that to be research misconduct.”
The problem is more complex than protecting profits. Medical journals have to change their publishing incentives, Goldacre says. Studies that flop rarely get accepted for publication.
Doctors Rely on Distorted Information
With only half of the information, doctors can’t know all the possible side effects of a medication, if its benefits outweigh the risks, or whether or not it is better than cheaper alternatives.
“You want to do the best for the patient, but if you can access only half the information, then a decision on choosing a particular drug or device might not be as reliable as you’d like,” said Yoon Loke, one of the PLOSMedicine study researchers.
Even with the journal results they do have access to, psychiatrist Erick Turner told LiveScience that most physicians lack the statistical knowledge to understand how reports can distort results.
“If the average physician believes that every trial done on a drug is positive, they’re going to have a very rosy impression and perhaps pooh-pooh [other] treatments that might also be effective,” said Turner.
An Unpublished Study Costs 100,000 Lives
If researchers had released the results earlier, they “might have provided an early warning of trouble ahead.”
Lorcainide offers a classic example of the importance of publishing failed trials. Created in the 1960s, it was an antiarrhythmic medication that helped restore regular heartbeats in patients.
Its 1980 clinical trial was a failure: Nine of the 49 participants on Lorcainide died, while only one of the 46 who received a placebo died. The company didn’t release the results.
Without knowing the outcomes of the trial and its deadly consequences, other manufacturers pursued their own antiarrhythmic medications. It’s estimated that more than 100,000 people died because of it.
The researchers finally published Lorcainide’s clinical trial results in 1993, and wrote that if they had released them earlier, they “might have provided an early warning of trouble ahead.”
Billions of Government Money Wasted on Tamiflu
After five years, Roche released the results of all 70 clinical trials, showing that Tamiflu was largely ineffective.
Even if a drug is relatively harmless, withholding results can result in a waste of money if a medication isn’t as effective as its data claims it is.
Tamiflu, an anti-influenza drug made by Roche, didn’t publish the results of 70 clinical trials. The results they did release presented Tamiflu as more effective than comparable drugs for preventing flu complications and reducing symptoms.
Governments around the world stocked up on the drug in preparation for the next flu outbreak. Britain spent £473 million and the U.S. spent $1.3 billion on Tamiflu and other anti-viral medications.
After five years, the Cochrane Collaboration, a nonprofit in Britain, was able to persuade Roche to release all 70 trials. They discovered that Tamiflu didn’t prevent hospitalizations or flu complications. At best, it just reduced symptoms by one day.
These weak benefits didn’t outweigh the risks for many patients. At least 70 people committed suicide while on Tamiflu, and many others suffered from temporary bipolar disorder, schizophrenia, and other psychotic episodes.
New Rules Ignore Problems From the Past
“Selective reporting…leads to an incomplete and potentially biased view of the trial and its results.”
Regulators and companies like Roche have committed to greater transparency, offering some hope for the future. In 2015, the World Health Organization (WHO) warned that, “Selective reporting, regardless of the reason for it, leads to an incomplete and potentially biased view of the trial and its results.”
Perhaps recognizing that the FDA’s existing rule is ineffective, the U.S. Department of Human Health and Services published a final rule on clinical trial reporting in September 2016, which goes into effect later this month. The rule has been expanded to include trials that have yet to be regulated by the FDA, ensuring that all results—regardless of whether a medication is eventually sold—are released.
However, even if every trial is published going forward, we’re still saddled with erroneous decisions from the past. In order for doctors and scientists to get a complete understanding of every medication that is currently prescribed, we have to publish historic data.
Are You Suffering From Adverse Effects?
With this pervasive cover-up culture, it’s no wonder that we frequently hear of harmful medical treatments. If you are suffering from complications caused by your medications, you may be entitled to compensation. Contact ClassAction.com today for a free, no-obligation legal review.
A drug overdose epidemic is sweeping America, led by a dramatic surge in deaths from opioids—a powerful, highly-addictive class of drugs that includes natural and synthetic analgesics such as morphine, oxycodone, hydrocodone, methadone, and fentanyl, as well as heroin.
Those responsible for America’s opioid epidemic have largely escaped legal consequences, but people from the hardest-hit states are starting to fight back.
Heroin is the product of an underground drug trade pushed in back alley deals. Prescription opioids are shipped from warehouses, prescribed in doctor’s offices, and picked up at pharmacies.
One drug cartel operates on the black market, the other in white lab coats. But their products are nearly identical, both in their chemical composition and their ability to destroy lives.
Indeed, a patient who begins a painkiller regimen at a clinic very often ends up buying drugs on the street. And all too often, that same patient ends up dead.
Protected by powerful interests, those responsible for America’s opioid epidemic have largely escaped legal consequences. People from the hardest-hit states, however, are beginning to fight back.
Last year the U.S. death rate increased for the first time in a decade, and overall life expectancy dropped for the first time since 1993.
Since 1999, the number of prescription opioids sold has almost quadrupled.
These sobering statistics coincide with 33,091 deaths from illegal and legal opioids in 2015—an increase of more than 200% since 2000—including more than 15,000 from overdoses involving prescription opioids.
More than six out of ten overdose deaths involve an opioid. Every day, 91 Americans die from an opioid overdose. Nearly half of all opioid deaths involve a prescription opioid.
Heroin overdose deaths, which have more than tripled in the past four years, are closely correlated with prescription opioids. The CDC reports that past prescription opioids misuse is the strongest risk factor for heroin use. Four out of five heroin addicts were initially addicted to prescription opioids.
Since 1999, the amount of prescription opioids sold has almost quadrupled. Over the same period, prescription opioid deaths have more than quadrupled.
But the amount of pain Americans report has not changed. There is also a lack of evidence to support opioids’ long-term effectiveness for managing chronic pain.
This could help explain why prescription opioid users frequently require higher medication doses to achieve the same pain relief. Higher opioid doses make it more likely that a patient will become addicted.
As the dose increases, so does the overdose risk. Overdosing on opioids can stop a person’s breathing, causing permanent brain damage or death.
Drug Companies Capitalize on Expanded Indications
Before the 1980s, prescription opioids were primarily prescribed for short-term pain and chronic pain associated with cancer and the end of life.
The medical community’s fundamental rethinking of pain in the mid-80s—from a symptom that should be tolerated to a vital sign that doctors could measure and treat—paved the way for prescription narcotics’ emergence.
Drug companies, seizing on expanded pain pill uses, began introducing new drugs and aggressively marketing them.
One company in particular, Purdue Pharma, maker of OxyContin, exemplified the industry’s focus on chronic non-cancer pain.
OxyContin was approved in 1995. From 1996 to 2002, OxyContin sales increased from 300,000 prescriptions ($44 million) to 7.2 million prescriptions ($1.5 billion). Over this period the number of Purdue sales representatives more than doubled.
In 2001 alone, Purdue spent $200 million on OxyContin marketing. Sales representatives received six-figure bonuses.
In 2001 alone, Purdue spent $200 million on OxyContin marketing.
High-prescribing doctors were compiled in a company database and targeted. Branded promotional materials—including hats, plush toys, coffee mugs, and coupons for free OxyContin prescriptions—were distributed to practitioners.
But the marketing frenzy was based on a fundamental lie. Purdue claimed that OxyContin’s patented time-release formula posed an addiction risk of less than 1 percent. Sales reps told some doctors that the drug didn’t even cause a buzz. Meanwhile, Purdue rolled out stronger pills with even higher addiction and abuse risks.
In this way, a supposedly non-addictive, heroin-like drug was prescribed to millions of patients who in years past would have been given an over-the-counter drug.
Distributors, Doctors, and Pharmacies Get in on the Game
Drug companies like Purdue Pharma bear outsize blame for America’s opioid epidemic, but they’re not the only ones responsible for flooding communities with narcotic pain pills.
West Virginia—one of the states hit hardest by the epidemic—shows a multi-pronged conspiracy.
Over six years, according to the Charleston Gazette-Mail, 1,728 West Virginians suffered fatal opioid overdoses as drug wholesalers poured 780 million hydrocodone and oxycodone pills into the state—an amount equal to 433 pain pills per resident.
Just three wholesalers supplied more than half of the pills. The companies have total revenues exceeding $400 billion. Their top executives pulled in more than $450 in compensation over the past four years as the West Virginia opioid death toll climbed.
The middlemen, however, had help from pharmacies and doctors.
For example, the Gazette-Mail reports that some small, independent drugstores and pharmacies ordered 1.1 million to 4.7 million opioid pills per year.
A report in The Guardian describes one “pill mill” pharmacy in Williamson, West Virginia that filled up to 200 opioid prescriptions per day.
Some doctors and clinics are willing pill mill accomplices.
Opioid-addicted patients, many of whom get hooked after an initial prescription for pain, “doctor shop” among numerous providers. Some doctors and clinics, however, are willing pill mill accomplices.
One Williamson clinic with a reputation for no-questions-asked prescriptions made $4.5 million per year. The doctors—including a Pennsylvania physician who sent blank, pre-signed prescriptions to the clinic—often did not even see the patients for whom they were prescribing pills.
Lawsuits Seek Accountability
In 2006, as the opioid epidemic gained attention, the Drug Enforcement Agency (DEA) began cracking down on the drug distribution chain.
A groundbreaking West Virginia lawsuit seeks damages from doctors, pharmacies, and distributors that formed a “veritable rogue’s gallery of pill-pushing.”
Civil cases against manufacturers, distributors, pharmacies, and doctors reached 131 in 2011 but dropped to 40 in 2014, reports TheWashington Post.
The reason for the decline was industry pushback. Drug companies hired former DEA and Justice Department officials to lobby against industry prosecution. Soon after, DEA officials began delaying and blocking enforcement actions.
At the state level as well, drug-makers have blocked measures aimed at curbing prescription opioid distribution. Using lobbyists and campaign contributions, drug companies have outspent anti-opioid activists by more than 200 times, according to the Associated Press.
The state of New Hampshire, which had the third highest rate of drug overdose deaths in 2014, has filed subpoenas against drug companies seeking information about how prescription painkiller are marketed in the state. The state has three attorneys on the case. The pharmaceutical companies have 19. So far, the investigation hasn’t produced a single document.
But not all legal efforts against the prescription opioid racket have fallen flat.
In 2007, Purdue Pharma pleaded guilty to misleading doctors and patients about the addictive potential of OxyContin and misbranding the drug as “abuse resistant.” And in 2015, after a nine-year legal battle, Purdue agreed to a $24 million settlement with the state of Kentucky for alleged Medicaid fraud involving OxyContin.
A groundbreaking West Virginia lawsuit filed by 29 plaintiffs who survived opioid addiction or lost a loved one to painkiller addiction seeks damages from doctors, pharmacies, and distributors that formed a “veritable rogue’s gallery of pill-pushing.”
West Virginia’s highest court rejected claims by the defense that admitted drug abusers should not be able to sue, citing the legal principle of comparative fault.
“What is it going to take before we as a nation accept that we are the victims for the most part and the doctor, the pharmacist and pharmacies are the perpetrators feeding off the lives of others?” said plaintiff and former opioid addict Wilbert Hatcher.
America’s opioid epidemic is an unprecedented public health crisis. Holding the responsible parties accountable may just require unprecedented litigation.
Plaintiffs alleging harm from Invokana and Invokamet in September requested that the U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidate 55 individual lawsuits in Jew Jersey federal court, citing enhanced efficiency.
On December 7 the JMPL agreed and issued an order transferring lawsuits from California, Georgia, Illinois, Kentucky, Louisiana, and Minnesota to the District of New Jersey under Judge Brian R. Martinotti.
“We find that the Invokana/Invokamet actions involve common questions of fact, and that centralization of these cases will serve the convenience of the parties and witnesses and promote the just and efficient conduct of this litigation,” the Panel wrote. “The actions share factual questions arising from allegations that taking Invokana or Invokamet may result in patients suffering various injuries, including diabetic ketoacidosis and kidney damage.”
Plaintiffs claimed in their consolidation request that J&J knew about kidney damage and ketoacidosis caused by Invokana/Invokamet, but did not warn patients while continuing to promote the drug. Plaintiffs also allege that Invokana and Invokamet are defectively designed and were not adequately tested.
Multidistrict litigation centralizes similar cases for pretrial proceedings, making it easier for lawyers to coordinate their activities. Individual cases are tried in the jurisdictions where they were originally filed.
Several MDL cases, known as bellwether cases, are typically singled out and tried first.
The Panel says it is aware of 44 additional related federal lawsuits.
New—but Not Necessarily Improved—Diabetes Drug
Invokana (canagliflozin) was approved in 2013 to treat Type 2 diabetes. It belongs to a new class of diabetic drugs known as sodium-glucose co-transporter 2 (SGLT2) inhibitors. Invokana works differently than older diabetes drugs, and poses new risks.
Invokana works differently than older diabetes drugs, and poses new risks.
Diabetic patients do not produce enough insulin, causing dangerous blood sugar spikes that damage the body over time.
Older diabetes drugs increase insulin levels, but SGLT2 inhibitors are different. They reduce the amount of blood sugar the kidneys reabsorb into the body by expelling some sugar through urination.
This mechanism of action is associated with an increased risk of acute kidney damage. The FDA strengthened existing kidney damage warnings for Invokana and other SGLT2 inhibitors in June 2016, but some say this was too little, too late.
Invokana is also linked to potentially-fatal excessive blood acids (ketoacidosis), increased bone fracture risk, cardiovascular side effects, and amputations.
J&J Spent Millions on Invokana Doctor Payments
In 2015, Invokana’s second full year on the market, sales surged 123% to $1.3 billion.
That same year, public records show, J&J spent $20.9 million promoting Invokana to physicians. Only two brands—Xarelto and Humira—were associated with higher doctor spending. Other top-spending brands for 2015 were Viekira, Eliquis, and Androgel.
These figures come from ProPublica’s Dollars for Docs, which is based on disclosures required under the Physicians Payments Sunshine Act, part of the 2010 Affordable Care Act.
Included in the payments data is money for speaking, consulting, meals, travel, gifts, and royalties. Although doctors who receive drug company money are not formally obligated to prescribe certain products, research shows that doctors receiving payments tend to prescribe more brand-name drugs than those not receiving payments.
Invokana spending reflects increased SGLT2 competition in a growing diabetes treatment market.
Contact us to report an Invokana complication and learn your legal rights.
When a government official holds or has held a professional position in the same industry that he or she is charged with regulating, it raises questions about whether public or private interests are being served.
The “revolving door” between the public and private sectors is a major impediment to responsible democratic governance.
The current U.S. Food and Drug Administration (FDA) commissioner, Dr. Robert M. Califf, has extensive pharmaceutical industry ties and has been accused of undermining public health and safety.
With President-elect Donald Trump set to choose a new FDA chief, ClassAction.com looks at how an official’s non-government experience can muddy the regulatory waters.
What Is the Revolving Door?
The revolving door refers to the practice of switching back and forth between public and private employment.
This phenomenon is commonly observed among members of Congress who leave the federal government and become lobbyists, although it can occur whenever someone with government experience gains employment in a private sector job where they can influence public policy decisions, or vice versa.
Lobbying’s return on investment bears out its effectiveness.
Although generally seen as negative, the revolving door has a practical upside. Namely, corporate experience gives regulators and policymakers a deeper understanding of complex issues that, in a capitalist system, cannot be divorced entirely from private interests.
However, the opposite also holds true: once a public official leaves office, he or she can leverage knowledge about the workings of government into lucrative private sector compensation.
Lobbying’s return on investment bears out its effectiveness. Research conducted by the Sunlight Foundation found that from 2007-2012, 200 corporations spent $5.8 billion on federal lobbying and campaign contributions and got back $4.4 trillion in federal business and support.
In other words, for every dollar these corporations spent on influencing politics, they received $760 from the government.
Robert Califf, Big Pharma, and the FDA
Current FDA commissioner Robert Califf, a cardiologist and clinical researcher tapped by President Obama to run the nation’s drug regulatory agency, was criticized at the time of his nomination for his drug company connections.
The New York Times reported that Dr. Califf “has deeper ties to the pharmaceutical industry than any FDA commissioner in recent memory, and some public health advocates question whether his background could tilt him in the direction of an industry he would be in charge of supervising.”
Dr. Califf’s disclosed industry ties include financial support from Johnson & Johnson, Lilly, Merck, Bayer, Boehringer Ingelheim, GlaxoSmithKline, Medtronic, and Bayer. He also has financial links to Gambro, Regeneron, Gilead, AstraZeneca, Roche, Genetech, Medscape LLC, Portola Pharmaceuticals, and other companies.
Dr. Califf first joined the FDA as deputy commissioner for medical products and tobacco. Before his government tenure, he ran a multimillion-dollar clinical research center at Duke University that was a major contractor to the pharmaceutical industry. The center was more than 60% industry-funded.
Califf Ran Troubled Xarelto Trial
While at Duke, Johnson & Johnson paid Dr. Califf to conduct an important clinical study of the blood-thinner Xarelto. That study was criticized for being biased in the drug’s favor.
Although the FDA approved the anticoagulant Xarelto, FDA scientists expressed misgivings about its safety and effectiveness, warning that it could pose greater stroke and/or bleeding risks than its predecessor, warfarin.
Xarelto is a blockbuster drug for Johnson & Johnson but it has also been the target of thousands of lawsuits alleging the drug caused serious bleeding events and deaths. Unlike warfarin, Xarelto does not have an antidote to stop internal bleeding.
Some Question Califf’s Involvement in 21st Century Cures Act
Congress recently passed the 21st Century Cures Act, a sweeping health bill some say is too friendly to drug and device companies.
“It should be unimaginable that the most senior [FDA] officials would collude with the lead medical device trade association.”
Leading the legislation’s criticism was Ralph Nader’s Public Citizen. In 2015, when an earlier version of the bill was being considered and Dr. Califf was awaiting confirmation as FDA chief, Public Citizen criticized him for participating in at least one high-level strategy meeting with the industry about the bill.
“It should be unimaginable that the most senior Food and Drug Administration officials would collude with the lead medical device trade association to write legislation to weaken the agency’s regulatory oversight and approval standards for medical devices. But that is exactly what appears to have happened,” said Public Citizen’s Dr. Michael Carmone in a statement.
New Nomination, New Questions
The incoming Trump administration hasn’t officially nominated an FDA commissioner, but rumored picks are drawing scrutiny.
Leading candidates to run Trump’s FDA include Jim O’Neill and Dr. Scott Gottlieb.
Potential nominee Jim O’Neill, a self-described libertarian, served as principal associate secretary of health and human services under George W. Bush and is a managing director at Peter Thiel’s Mithril Capital Management.
While Mr. O’Neill doesn’t have a medical background, perhaps more worrying is his endorsement of what he calls “progressive approval,” which would allow drugs proven safe—but not necessarily effective—by the FDA to be marketed.
Another potential Trump FDA pick, Dr. Scott Gottlieb, has medical credentials as well as government experience, having served as a senior adviser to the FDA commissioner in 2003-2004, senior adviser to the Centers for Medicare and Medicaid Services in 2004, and FDA deputy commissioner for medical and scientific affairs from 2005-2007. But Dr. Gottlieb also has deep pharmaceutical industry ties, reports Reuters.
Trump’s eventual nominee requires Senate approval. But despite a divided government, the revolving door between government and industry has bipartisan support: after all, Robert Califf was confirmed in an 89-4 vote.
The 21st Century Cures Act—a nearly 1,000-page omnibus healthcare spending bill—has been approved by the House and is now under Senate review.
Supporters say the bipartisan bill will accelerate medicinal and medical device innovation. Detractors claim it makes industry concessions that weaken regulatory oversight and undermine public health.
If Senators approve the legislation as expected, President Obama could sign it into law before the end of the year.
Act Will Streamline FDA Approval Process
A lot is covered in the sprawling, 996-page bill, from foster care to mental health to stem-cell therapies and Medicare.
Changes primarily revolve around the National Institutes of Health (NIH), which provides federal funding for healthcare research, and the Food and Drug Administration, the agency responsible for pharmaceutical and medical device safety and efficacy.
Major provisions include:
Increased NIH funding: NIH will receive $4.8 billion in new funding over ten years, including money for brain, cancer, and precision medicine research, as well as $1 billion for the nation’s opioid crisis. A top priority is Vice President Biden’s “Cancer Moonshot,” a plan that aims to accomplish 10 years of cancer research in half the time. Additional support for young emerging scientists would be created through a loan repayment program.
Faster action on new drugs and devices: The FDA has been criticized for a slow approval process that prevents faster adoption of healthcare breakthroughs. Proposals in the 21st Century Act aim to streamline the drug and device approval process. Specific initiatives include an accelerated approval pathway for regenerative medicines, using “real world evidence” (such as observational studies and registries) to support new indications for approved drugs, and broader categorization of “breakthrough” devices.
The bill also places new requirements on the Centers for Disease Control and Prevention (to expand neurological disease surveillance) and the Department of Health and Human Services (to revise health information privacy rules).
“A Grab Bag of Goodies for Big Pharma”?
Critics have voiced concerns about what’s in the legislation, as well as what’s not in it.
“The bill has been sold erroneously as a commonsense, bipartisan compromise that enables scientific breakthroughs for America.”
Public Citizen says the Senate should reject 21st Century Cures, calling it a corporate giveaway disguised as reform.
“The bill has been sold erroneously as a commonsense, bipartisan compromise that enables scientific breakthroughs for America. But in reality, the legislation includes a grab bag of goodies for Big Pharma and medical devices companies that would undermine requirements for ensuring safe and effective drugs and medical devices,” said Public Citizen’s Dr. Michael Carmone in a statement.
Public Citizen further notes the new NIH money must be reauthorized each year, making its programs non-guaranteed.
“There is no justification for moving forward with legislation that provides substantial benefits to the drug industry without asking for something in return,” the letter states.
Critics blame what they consider already-lax FDA oversight for failed medical devices such as the Essure permanent birth control. Essure received fast-track FDA approval in 2002 and has since been linked to thousands of injuries, several deaths, and an unacceptably high pregnancy rate. As a result, the FDA recently slapped Essure with a black box warning.
1,500 Lobbyists Fought for the Act
The 21st Century Cures Act passed the House last year but died in the Senate. Republican lawmakers unveiled a revised version during the Thanksgiving holiday weekend and it passed 392-26 during the lame-duck session.
Now under Senate consideration, the Act enjoys bipartisan support but has drawn disparate comments along partisan lines.
“It really is a David and Goliath issue of where the money is.”
Senate Majority Leader Mitch McConnell (R-KY) called the bill “the most important legislation Congress will consider this year.”
Elizabeth Warren (D-MA) said, “I cannot vote for this bill,” and described the Act as “a tiny fig leaf” covering “huge giveaways to giant drug companies.”
So who actually benefits from the 21st Century Act? The money trail provides answers.
According to Kaiser Health News, nearly 1,500 lobbyists representing 400 organizations petitioned Congress regarding the Act. That’s the fourth-most lobbying activity for any bill this congressional cycle.
Major lobbying efforts were made by:
Pharmaceutical, device, and biotech companies: $192 million
Medical schools, hospitals, and doctors: $120 million
Chamber of Commerce: $87.1 million
Health information technology and software companies: $35 million
Patient groups (funded by drug and device companies): $6.4 million
Mental health, psychology, and psychiatry groups: $1.8 million
In contrast, opposition generally comes from nonprofit patient advocacy and research groups.
“It really is a David and Goliath issue of where the money is,” said Diana Zuckerman of the nonprofit National Center for Health Research, which is running a campaign against the bill.
The hits keep coming for pharmaceutical titan Johnson & Johnson, which has suffered a series of huge legal and financial blows in 2016. A slew of jury awards and settlements have cost the company hundreds of millions of dollars and severely damaged its credibility in the court of public opinion.
J&J is struggling to fight three mammoth legal battles at once, and the strain is showing both in its courtroom performances and in its bank account.
J&J Will Try—Again—to Move Talc Cases Out of St. Louis
After three massive awards for plaintiffs who claimed they contracted ovarian cancer from using Johnson & Johnson’s talc-based products, J&J will attempt to move future talc cases out of Missouri. They tried this once before, last August, arguing that the company and plaintiffs had no ties to St. Louis. The judge dismissed the motion.
The most recent jury award, in October, was $70 million to Deborah Giannecchini. Five months prior, a Missouri jury awarded Gloria Ristesund $55 million.
The first big win for plaintiffs, in February 2016, went to the family of Jacqueline Fox, a woman who passed away from ovarian cancer after a lifetime of using Johnson & Johnson’s Baby Powder for feminine hygiene. Ms. Fox’s family received $72 million.
There are more than 1,000 talcum powder lawsuits pending in St. Louis, and 200 more awaiting their day in New Jersey courts.
Attorney Jere Beasley, whose firm filed the three Missouri cases and hundreds of others, told Fortune, “If I were representing them [Johnson & Johnson], I would say, folks, we need to sit down and regroup and start trying to settle these cases.”
But as of this writing, J&J seems more concerned with upholding its image as a wholesome family company than admitting wrongdoing and reimbursing the hundreds of women who say they have contracted ovarian cancer from using talc products.
J&J Settles Another Risperdal Lawsuit, Avoiding Trial
Talcum powders aren’t the only Johnson & Johnson products that have spawned a mountain of litigation. The antipsychotic drug Risperdal has allegedly caused many young boys to grow breasts, a condition known as gynecomastia. Hundreds of these boys have filed Risperdal lawsuits against J&J, and so far, they have been very successful in obtaining relief.
In July, a Philadelphia jury awarded Andrew Yount a staggering $70 million,ruling not only that J&J had failed to warn Mr. Yount of the risks in taking Risperdal, but that the company had concealed or destroyed evidence related to the case. Mr. Yount, of Tennessee, started taking Risperdal when he was just five years old.
A Philadelphia jury found that J&J had concealed or destroyed evidence related to the Andrew Yount case.
Mr. Yount’s award was the latest in a string of wins for Risperdal plaintiffs. Nicholas Murray was awarded $1.75 million in November 2015, and Austin Pledger was awarded $2.5 million in February 2015.
Perhaps still smarting from all of those losses, earlier this month Johnson & Johnson reached an undisclosed settlement to end a Risperdal case filed by a man who started taking the drug at age seven to manage symptoms brought on by his Asperger’s syndrome. According to court documents, the plaintiff developed permanent gynecomastia.
In November 2013, Johnson & Johnson paid a $2.2 billion fine to settle a Justice Department investigation into its promotion and marketing of Risperdal.This was one of the largest such fines in American pharmaceutical history.
There are 1,500 Risperdal lawsuits still pending in U.S. courts.
Hip Replacement Cases Cost $4.15 Billion and Counting
That model is not the only one creating pains for patients and headaches for J&J, though. Johnson & Johnson’s Pinnacle hip implant has generated 8,400 lawsuits, the vast majority of which are currently pending in multi-district litigation (MDL).
A bellwether Pinnacle case recently made it to trial, where a jury awarded plaintiffs $500 million in damages.
One bellwether case, though, recently made it to trial, where a jury awarded five plaintiffs $500 million in damages. (A Texas judge later cut that award to $151 million.) Another bellwether Pinnacle trial went to court in September; there has been no word yet on a verdict. Legal experts feel that another loss for J&J could prompt the company to settle the remaining 8,400 suits.
If you or a loved one have suffered unforeseen physical or financial harm because of Johnson & Johnson hip implants, talc products, or its drug Risperdal, please contact us today to explore your options. Don’t wait; you could qualify for compensation.
Although the legal strategy of Xarelto plaintiff attorneys won’t become clear until the first trials begin in early 2017, it appears that the quality—or seeming lack thereof—of clinical trials used to approve Xarelto (rivaroxaban) will be a key issue. One particular point of emphasis could be a lack of quality data supporting once-daily Xarelto dosing, something drugmakers Bayer/Janssen claim makes Xarelto more convenient but could cause life-threatening side effects.
Xarelto’s once-daily dosing makes the blood thinner more convenient, but could also make it more dangerous.
Xarelto and other so-called “novel anticoagulants” are vying to replace the older blood thinner Coumadin (warfarin) largely on the grounds that they are easier to use than warfarin. Blood thinners are prescribed to patients at risk for developing blood clots and suffering related complications such as stroke and deep vein thrombosis.
Xarelto does not require medical monitoring to ensure patient safety, whereas warfarin patients must be monitored once or twice per month for blood clot risks and have their dosage adjusted accordingly. Another purported benefit of Xarelto over warfarin is its once-daily dosing, something that makes Xarelto more user-friendly—and thus more marketable—but according to some critics makes the drug more dangerous.
Xarelto’s Short Half-Life
The dosing problem has to do with Xarelto’s relatively short half-life of 5-9 hours. Other new coagulants such as Pradaxa and Eliquis have a half-life of 12-17 hours, while warfarin has a half-life of 20-60 hours.
A short half-life means that a drug’s concentration in the body diminishes rather quickly. This leads to drug “peaks” (high drug concentrations) and “troughs” (low drug concentrations). Fluctuations in drug concentration present a twofold risk: of bleeding (when concentrations are high), and of lower blood clot prevention efficacy (when concentrations are low).
According to one study, at its peak the amount of Xarelto measured in the blood was 16.9 times higher than at its trough. For Eliquis (abixaban), which is administered twice per day, the peak was 4.7 times higher than the trough.
FDA staff clearly identified this issue during the approval process but decided to clear Xarelto for sale because clinical trial data indicated it had a safety profile that was no worse than warfarin.
But while the overall safety of the drugs was comparable in premarketing studies, postmarketing adverse event data shows what would be expected of a drug with a short half-life and once-daily dosing. According to data provided by the Institute for Safe Medication Practices (ISMP), compared to other blood thinners, Xarelto has a significantly higher frequency of treatment failure events (embolic-thrombotic events, or blood clot events), an apparent outcome of a “trough.”
Potential side effects of rivaroxaban “peaks,” which may lead to excessive levels of the drug in some patients’ bodies, are especially concerning when considered alongside Xarelto’s lack of a reversal agent. Plaintiffs in Xarelto lawsuits commonly claim that they were not properly warned about the lack of a Xarelto bleeding antidote. If serious bleeding occurs with warfarin, the drug’s effect is easily reversible.
Bad Dosing Data
FDA reviewers noted that the “the clinical relevance was uncertain” in regards to the safety profile of Xarelto 10 mg twice daily versus Xarelto 20 mg once daily. The reason for their uncertainty? In the pivotal trial (ROCKET AF study) used to support Xarelto’s approval, only the once-a-day regimen was tested.
One study did compare once daily dosing with twice daily dosing, but according to an attorney representing Xarelto lawsuit plaintiffs, the study was on par with “an elementary school science fair project” due to numerous shortcomings, including missing data.
One attorney compared Xarelto clinical trials to “an elementary school science fair project.”
An article published in the Journal of the American College of Cardiology reviewed the trial-in-question (the ATLAS ACS 2–TIMI 51 Trial) and found that “an unanticipated high rate of missing data, particularly the vital status of patients, precludes reliable and valid information.” The article also found that “there was a lack of an expected dose response—the 5-mg dose did not have greater efficacy compared with the 2.5-mg dose of rivaroxaban.”
So why, in spite of inadequate safety and efficacy data, is Xarelto recommended for once-daily dosing? It could simply be a marketing ploy. Once-a-day dosing helps to sell the idea that Xarelto is more convenient than competitors.
If plaintiff attorneys are able to poke holes in Xarelto clinical trials and show that Bayer/Janssen should have provided stronger warnings about the potential side effects associated with once-daily dosing, they may have success in the initial Xarelto trials that are scheduled for February and March 2017.
Questions about Xarelto litigation? Interested in filing a claim? Get in touch with ClassAction.com and learn your legal options.
New research is confirming what many have long suspected: doctors who take money from BigPharma tend to prescribe brand name drugs at higher rates than doctors who do not accept drug company payments.
“You want your doctors to be objective rather than doing something because there is a financial gain, be it subconscious or conscious.”
Improved transparency laws are shedding light on physician-industry relationships and igniting debate about the propriety of these ties. While not illegal, industry payments can lead to decreased patient trust, increased drug costs, and other negative health care outcomes. There’s also no evidence that branded drugs work better than generic equivalents or produce greater patient satisfaction.
While a Harvard study suggests there is a positive correlation between the amount of industry money received and the rate of brand name prescribing, a study out of the University of California shows that even a single meal can make a difference. Both studies confirm a first-of-its-kind analysis performed by ProPublica.
Harvard Study Associates Industry Payments With Branded Statin Prescriptions
Dr. James S. Yeh and colleagues from Harvard Medical School set out to determine the association between drug company payments to physicians and the prescribing of brand name vs. generic statin drugs by analyzing Massachusetts Part D Medicare prescriptions claims data and the state’s physicians payment database.
They found that doctors’ rate of prescribing brand name statins increased 0.1% for every $1,000 in industry money received. Payments for educational training were associated with a 4.8% uptick in brand name prescribing rates. The researchers called their findings, published in JAMA Internal Medicine, “concerning.”
“You want your doctors to be objective rather than doing something because there is a financial gain, be it subconscious or conscious,” Dr. Yeh told ProPublica.
Not only are prescription drugs significantly more expensive than generics, but patients are also less likely to continue taking costlier drugs, which can lead to worse patient health outcomes.
Yeh and ProPublica caution that the study results don’t necessarily show a causal relationship between doctor payments and brand name prescribing, because the data alone can’t account for factors such as why a doctor chose a particular drug, or whether pharmaceutical companies target doctors who already prescribe brand name drugs in higher numbers.
UCSF Study: Meals Lead to Promoted Drug Prescriptions
Most industry payments to doctors are not supplied in the form of cold hard cash. Instead, payments tend to be provided as speaking fees, consulting compensation, travel and lodging for company-sponsored training events, tickets to shows, charitable contributions, and meals.
A meal might not seem like enough to sway a doctor’s prescribing patterns, but according to a new study out of the University of California San Francisco, a single drug company lunch worth less than $20 could convince a doctor to prescribe a promoted drug over competitors.
Published in JAMA Internal Medicine, the study analyzed 2013 data from the federal Open Payments Program and Medicare Part D associated with three brand name cardiovascular drugs (Crestor, Pristiq, and Benicar) and one brand name anti-depressant (Pristiq). It concluded that doctors treated to a single industry-sponsored meal promoting the drug of interest were significantly more likely to prescribe that drug. The more meals doctors received, the more likely they were to prescribe the promoted drug. Each of the drugs had lower-cost generic alternatives.
“I don’t think there is a doctor out there who thinks, ‘I can be bought for a hero or a slice of pizza.’”
Physicians receiving just one meal promoting the drug of interest were 18% more likely to prescribe AstraZaneca’s Crestor over an alternative, 52% more likely to prescribe Daiichi Sankyo’s Benicar, 70% more likely to prescribe Allergan’s Bystolic, and 118% more likely to prescribe Pfizer’s Pristiq.
According to the study authors, industry-sponsored meals account for about 80% of the total number of industry payments to physicians. The findings are important because they suggest that it doesn’t require hefty consulting fees or lavish entertainment to influence doctor prescribing trends. A single lunch appears sufficient to provide a big payoff for drug companies.
Lead author R. Adams Dudley told the Wall Street Journal, “I don’t think there is a doctor out there who thinks, ‘I can be bought for a hero or a slice of pizza.’” But Dr. Dudley added that it is human nature for a doctor to listen to the pitch of a sales representative who provides a free meal, and this can affect prescribing patterns.
The authors stress the findings represent an association, not cause-and-effect, but in an accompanying editorial, JAMA Internal Medicine editor-at-large Robert Steinbrook said that proving a causal relationship may not be necessary.
“There are inherent tensions between the profits of health care companies, the independence of physicians and the integrity of our work, and the affordability of medical care,” wrote Mr. Steinbrook. “If drug and device manufacturers were to stop sending money to physicians for promotional speaking, meals, and other activities without clear medical justifications and invest more in independent bona fide research on safety, effectiveness, and affordability, our patients and the health care system would be better off.”
ProPublica Analysis Confirmed
It may seem obvious that drug company payments affect doctor prescribing patterns, but until this year, proof for the trend had been lacking.
Doctors who received industry payments were two-to-three times more likely to prescribe brand name drugs at very high rates.
According to the analysis, which looked at doctors across five common specialties who wrote at least 1,000 prescriptions in Medicare’s Part D drug program, doctors who received more industry money tended to prescribe brand name drugs at a higher rate. The highest percentages of brand name prescribing were associated with payments of $5,000 or more, but even a single meal was correlated with a higher brand name prescribing rate. Overall, doctors who received industry payments were two to three times more likely to prescribe brand name drugs at very high rates as other doctors in the same field, the analysis shows.
ProPublica’s research “confirms the prevailing wisdom… that there is a relationship between payments and brand name prescribing,” said Dr. Aaron Kesselheim of Harvard Medical School. “This feeds into the ongoing conversation about the propriety of these sorts of relationships. Hopefully we’re getting past the point where people will say, ‘Oh, there’s no evidence that these relationships change physicians’ prescribing practices.’”
Although the analysis does not prove that industry payments cause doctors to prescribe specific drugs or a specific drug company’s products, it shows that doctor payments in general benefit Big Pharma’s profits.
“There is a very good reason why drug companies spend billions of dollars on their sales and promotional efforts: the strategy works,” said James D. Young, an attorney for ClassAction.com.
Branded Drugs Not More Effective Than Generics
Despite their higher price tag, name brand drugs do not work any better than generics, according to research. There also isn’t much difference between name brand and generic drugs in terms of patient satisfaction.
Generic drugs, furthermore, may have a better-understood safety profile. In order to be sold as generics, drugs must be on the market for many years, and this real world use is very effective at picking up on potential side effects. The safety of newer drugs, on the other hand, is largely based on clinical trials with smaller population sizes that may underrepresent poor patient outcomes in the real world.
“Next time your doctor writes a prescription for a brand drug, ask her why she chose that drug over generics or competitors.”
Another potential benefit of generic drugs is lower health care spending. The multi-million dollar direct-to-consumer ad campaigns that promote brand name drugs over less expensive treatments are blamed in part for rising prescription drug prices. For example, in 2015, brand name drug costs increased 15.8%, compared to a 6.6% increase in generic drug costs. Generic drugs cost on average 15 to 60 percent less than brand name drugs.
Finally, studies show that the mere belief that physicians are receiving industry money can undermine a patient’s faith in their doctor. A 2012 study, for instance, found that more than half of patients surveyed said they would have less trust in their physician if they found out he or she accepted gifts, went on industry-sponsored trips, or received sporting event tickets.
So what can you do if you want to know more about your doctor’s industry ties? James Young of Morgan & Morgan encourages patients to challenge their doctor’s prescribing habits.
“Next time your doctor writes a prescription for a brand drug, ask her why she chose that drug over generics or competitors,” says James Young.
Patients can also check the government’s Open Payments Database to find out how much drug companies are paying their doctor. ProPublica offers a similar tool through their Dollars for Docs project.
For five years, Shaquil Byrd had to protect himself from bullies. Now he’s going after the source of his torment: Johnson & Johnson.
At the age of nine, Mr. Byrd (now 24 and living in Albany, New York) was prescribed Risperdal to treat his mental health issues: depression, ADHD, and bipolar disorder. Soon after he started taking the drug, Mr. Byrd grew breasts—a condition known as gynecomastia.
Though J&J knew Risperdal could have this side effect, they did not add a warning to its label until 2006. By that point, the drug had been prescribed to hundreds if not thousands of young men.
At times, Mr. Byrd’s breasts would lactate. For five years—from 2002 until he stopped taking Risperdal in 2007—Mr. Byrd was mocked and harassed by classmates. His confidence wilted, and his self-image became warped.
“He did a lot of crying,” Mr. Byrd’s mother, Eugenia Jordan, told WNYT. “He was very uncomfortable around other people.”
Byrd Fights Back
In 2014, Mr. Byrd had his breasts surgically removed: a big step forward in his recovery from this trauma. He also filed a lawsuit against Johnson & Johnson—one of roughly 1,600 the company has faced in the wake of Risperdal’s traumatic side effects.
Incredibly—despite their own research and others’, the evidence in this case, and the scores of similar cases—J&J denies all wrongdoing, stating
We believe there is no evidence that RISPERDAL® caused any harm to this patient, who stopped taking the medication eight years before receiving a diagnosis of gynecomastia. We will continue to defend ourselves in this litigation.
Johnson & Johnson claims Mr. Byrd received a gynecomastia diagnosis eight years after he stopped taking Risperdal—which would be 2015, a year after he’d had his breasts surgically removed.
In 2000, Johnson & Johnson learned that 5.5% of boys taking Risperdal long-term eventually developed breasts. But the Risperdal label said that this occurred in 0.1% of boys. By 2000, more than one-fifth of Risperdal users were children and adolescents.
Risperdal wasn’t FDA-approved for children in 2002, when a doctor prescribed it to Shaquil Byrd. (Off-label prescriptions are legal; off-label promotions by drug makers are not.) But that didn’t stop J&J from marketing it to kids, a significant chunk of whom would contract gynecomastia. This callous disregard would wind up costing the company billions.
By 2000, more than one-fifth of Risperdal users were children and adolescents.
In 2013, J&J settled 77 lawsuits filed by men who had taken Risperdal and experienced unwanted (and undisclosed) side effects. Later that year, Johnson & Johnson settled a Justice Department investigation into its promotion and marketing of Risperdal by paying a $2.2 billion fine—one of the largest in American pharmaceutical history.
The name of the article: “America’s Most Admired Lawbreaker.”
Alabama Man Awarded $2.5 Million
Johnson & Johnson probably wishes it had settled Austin Pledger’s lawsuit.
Like Shaquil Byrd, Mr. Pledger—an autistic young man from Alabama—grew breasts after taking Risperdal as a child, in 2002. Like Mr. Byrd, he was ridiculed by his peers for his breasts, which eventually grew to be size 46DD.
Mr. Pledger’s breasts grew to size 46DD.
And like Mr. Byrd, Mr. Pledger filed a lawsuit against J&J to hold them accountable for their egregious disregard and concealment of Risperdal’s potential side effects.
Mr. Pledger may have won the trial, but he still hates his body. He idolizes his father, but when he looks in the mirror, he sees his mother. As Mr. Byrd did, Mr. Pledger will likely have to undergo a mastectomy in the near future.
No amount of money can give him his body back, or take away the years of bullying and self-loathing he has suffered.
Thousands of Risperdal Cases Still Pending
Austin Pledger’s case was one of thousands that now await trial in Philadelphia. The sheer volume of plaintiffs serves as a powerful indictment of Johnson & Johnson—as does J&J’s internal handling of the Risperdal issue.
The man responsible for Risperdal’s unlawful marketing was Alex Gorsky. Instead of punishing or firing Mr. Gorsky for the damage he inflicted on hundreds of young boys (and the elderly, who are vulnerable to strokes if they take Risperdal), Johnson & Johnson promoted him to CEO.
Today, Mr. Gorsky is still CEO. While victims like Shaquil Byrd and Austin Pledger have to hire lawyers, go to court, and fight to win compensation for medical bills and psychological trauma, Mr. Gorsky happily takes home more than $25 million a year.
Our law firm, Morgan & Morgan, doesn’t think that’s right. We are one of the largest personal injury firms in the country, and we aim to hold Johnson & Johnson accountable for their actions.
If you or a loved one has suffered side effects after taking Risperdal, please contact us. Don’t wait; these cases are time-sensitive, and you may be owed money.
Nestled within the 20,000+ pages of the Affordable Care Act (aka “Obamacare”) is something known as the Physician Payments Sunshine Act.
The Sunshine Act mandates that manufacturers of drugs and medical devices disclose payments to physicians of more than $10. It also requires that drug and device maker payment data be posted on a publicly accessible website administered by the Centers for Medicare and Medicaid Services (CMS). These provisions are intended to help patients make better-informed healthcare decisions and to discourage financial ties that could increase health care costs.
As the New England Journal of Medicine (NEJM) explains, patients who find out that their doctor is involved with industry might trust the doctor less and be less inclined to accept treatment recommendations or care from them. “Given the evidence that greater physician financial involvement with manufacturers is associated with higher utilization of expensive, brand-name products, such dynamics could reduce costs,” writes NEJM.
With U.S. healthcare costs skyrocketing, and with high brand name drug costs a major culprit, the cost-lowering aspect of transparency is certainly important. But beyond that, patients simply have a right to know whether their doctor is taking medical industry money. What they do with that information is up to them. Without adequate knowledge, however, transparency is impossible.
Here’s how to find out if your doctor is taking money from Big Pharma:
ProPublica, using data obtained through the CMS Open Payments tool, recently published an analysis that shows the more money doctors receive from the medical industry, the more they prescribe brand name medications.
While this may not seem like an earth-shattering finding, the evidence for it up until now has been piecemeal. Prior to the Sunshine Act, there was no centralized mechanism for tracking physician payments from drug and device companies.
According to ProPublica, from August 2013 to December 2014 alone, pharmaceutical and medical device companies made $3.49 billion in payments to more than 680,000 doctors.
Doctors tend to deny that financial influences have any bearing on what they recommend to patients. ProPublica says their analysis doesn’t prove industry payments sway physicians to prescribe certain drugs or a particular company’s drugs, but that overall, payments benefit drug companies’ bottom line.
In a health care system that should be serving the people, not the powerful, this is reason enough to discourage financial ties between the medical industry and doctors.
“There is a very good reason why drug companies spend billions of dollars on their sales and promotional efforts: the strategy works,” says James Young, an attorney for ClassAction.com who is nationally recognized for his work in pharmaceutical litigation.
Mr. Young adds, “The next time your doctor writes a prescription for a brand drug, ask her why she chose that drug over generics or competitors.”