House Approves Controversial 21st Century Cures Act

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.

A letter to Congressional leaders from Public Citizen and a dozen other organizations singles out the legislation’s failure to relieve high prescription drug costs.

“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.

Help hold drug and device companies accountable. Report problems to ClassAction.com.

FDA Approves New Power Morcellator Despite Cancer Risks

The U.S. Food and Drug Administration (FDA) has approved a new surgical tool used in minimally invasive gynecological procedures months after it discouraged use of the device over cancer concerns.

Power morcellation has been shown to spread undetected cancer in patients.

Olympus America Inc.’s Contained Tissue Extraction System, a type of laparoscopic power morcellator, was cleared through FDA’s controversial 510(k) program, which requires no testing on human subjects.

Olympus received clearance from the FDA on November 16 for the company’s next-generation laparoscopic PK Morcellator, even though power morcellation has been shown to spread undetected cancer in patients.

Power Morcellation Can Spread Cancerous Tissue

Laparoscopic power morcellation is a surgical procedure for the removal of the uterus (hysterectomy) or uterine fibroids (myomectomy). During the procedure, a power morcellator–a device resembling a handheld drill–is inserted through a small incision. It then grinds up tissue into small pieces for removal.

Hysterectomies and myomectomies via power morcellation are associated with fewer complications than the same procedures performed via surgical incision into the abdominal cavity.

But there’s a catch: power morcellation has been shown to spread undetected cancer (uterine sarcoma) in patients. This has led to hundreds of lawsuits filed by affected patients.

Most women will develop uterine fibroids at some point in their lives. While many fibroids are benign, approximately 1 in 350 women have unsuspected uterine sarcoma hidden within fibroids. Power morcellation has the potential to disperse cancerous tissue beyond the uterus, substantially worsening the patient’s long-term survival outlook.

FDA Discourages Power Morcellation for Hysterectomies

In April 2014, the FDA issued a safety communication discouraging use of laparoscopic power morcellation for removal of the uterus or uterine fibroids.

“There is no reliable way to determine if a uterine fibroid is cancerous prior to removal,” said Chief Scientist William Maisel. “Patients should know that the FDA is discouraging the use of laparoscopic power morcellation for hysterectomy or myomectomy, and they should discuss the risks and benefits of the available treatment options with their health care professionals.”

Since the safety communication was issued, rates of power morcellation use for hysterectomy and myomectomy have decreased significantly.

According to a study in the Journal of the American Medical Association (JAMA), the percentage of women undergoing hysterectomy via power morcellation decreased from 13.7% in the fourth quarter of 2013 to 2.8% in the first quarter of 2015. A study reported at the American Society for Reproductive Medicine 2016 Scientific Congress found a 63.9% drop in all myomectomies (both laparoscopic and abdominal) following FDA’s warning.

“Many of the existing studies evaluating the impact of the FDA warning against power morcellation have shown a decrease in use of power morcellation,” Dr. Deirdre Lum told Medscape Medical News.

Dr. Lum suggested that the FDA’s warning may have raised fears about tissue disruption in general, steering patients and their doctors towards other fibroid treatment options.

Olympus Morcellator Cleared Based on “Substantial Equivalence”

The Olympus PK Morcellator is designed for the very same surgeries that the FDA warned against. But whether the PK Morcellator poses equivalent cancer-spreading risk is difficult to determine, because the device did not undergo human testing.

The FDA approved Olympus’ morcellator under its 510(k) program, which allows device makers to forego human testing if the new product is “substantially equivalent” to already-approved devices (so-called “predicate devices”).

FDA documents show few design differences between the PK Morcellator and its predecessor. For example, the PK and its predecessor have the same dimensions, mode of tissue dissection, and sterilization.

New for the PK is a “peeling” method of tissue morcellation, compared to a “coring” morcellation technique used in the predicate. The PK also is designed to be used with the “first of its kind” PneumoLiner containment bag—a device designed to contain morcellated tissue

The FDA, however, acknowledges that “the PneumoLiner device has not been proven to reduce the spread of potentially cancerous tissue during power morcellation.”

PneumoLiner was cleared through FDA’s de novo classification process. Although different than the 510(k) process, de novo classification similarly allows devices to escape the much more rigorous premarket approval process.

Neither the PK Morcellator nor its containment bag underwent human testing.

Research published in The Journal of Minimally Invasive Gynecology found that approximately 1 in 10 morcellation containment bags leaked and spread tissue.

There have been calls for power morcellators to be pulled from the market, or at the very least, classified as high-risk devices, which would necessitate premarket approval testing.

Johnson & Johnson’s Ethicon unit withdrew its morcellators from the market following the FDA’s warning. In March 2016, J&J settled the majority of the morcellator lawsuits it is facing for $100,000 to $1 million per case.

Lawsuits against other morcellator manufacturers are ongoing. Please contact us if you or a loved one had cancer spread throughout your body by a power morcellator.

Johnson & Johnson Can’t Win in Court

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.

Hold J&J Accountable

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.

That is one of dozens of Risperdal cases that J&J has opted to settle out of court.

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

The most expensive legal battle of all, though, keys on Johnson & Johnson’s defective hip implants. In 2013, J&J settled thousands of claims about its Depuy ASR implants for an estimated $4 billion.

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.

The Trouble with Stryker Hip Implants

Stryker Orthopaedics recently issued a hazard alert warning doctors and patients of potential side effects that may be caused by seven models of Stryker V40 femoral heads, which are used in metal-on-metal (MoM) hip replacement procedures.

These types of procedures have generated many such alerts from health organizations. They have also spawned thousands of lawsuits filed by patients who exhibited severe side effects and/or had to undergo revision surgery as a result of MoM complications.

Hold Stryker Accountable

The side effects cited in the most recent Stryker alert include the following:

  • Loss of mobility
  • Pain
  • Inflammation
  • Adverse tissue reaction
  • Dislocation
  • Joint instability
  • Broken bones
  • Leg length discrepancy
  • Need for revision surgery

Though the alert is not technically a recall, it could certainly discourage surgeons and patients from pursuing total hip replacements that include a Stryker V40 femoral head.

Many companies have ceased producing MoM hip replacements altogether because of the kinds of risks outlined in the alert. When the metal head rubs against the metal socket, metal particles can be released into the bloodstream, leading to cobalt chromium poisoning.

As a result, drug and health agencies worldwide have issued warnings about MoM replacements since as early as 2010.

FDA, Other Agencies Warn of “Unique Risks”

“Metal-on-metal (MoM) hip implants have unique risks in addition to the general risks of all hip implants.”

In the spring of 2010, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) issued a warning about MoM hip replacements. In this alert the MHRA advised patients to get blood tests and imaging to ensure they didn’t have metal poisoning. Two years later, the MHRA issued a follow-up with guidelines on monitoring and caring for MoM hip patients.

In 2012, Health Canada issued an alert containing important safety information for MoM hip replacement surgeons and patients. This alert noted:

In recent years, there has been an increase in awareness of pain, implant loosening and significant soft tissue reactions thought to be the result of increased levels of metal (cobalt and chromium) ions in the surrounding joint tissue. Soft tissue reactions can range from fluid collection to more extensive necrotic and “pseudotumor” reactions and can necessitate device revision.

Health Canada also reported that “14.2% of revised MoM hip implants exhibited soft tissue reactions.”

Furthermore, the U.S. Food and Drug Administration (FDA) states on the Metal-on-Metal Hip Implants section of its website, “Metal-on-metal (MoM) hip implants have unique risks in addition to the general risks of all hip implants.”

The FDA advocates the following measures for any patient experiencing symptoms that suggest their implant is not functioning as it should:

  • Joint aspiration (removing fluid from around the joint)
  • Soft tissue imaging
  • Blood tests, including checking metal ion levels

The FDA adds that MoM patients should be extra-aware of their general health, as some medical literature suggests MoM hip implants can lead to systemic reactions elsewhere in the body.

Among these potential reactions are skin rash and hypersensitivity, cardiomyopathy, neurological changes, renal function impairment, depression or cognitive impairment, and thyroid dysfunction.

Stryker Hip Implants Lead to $1.4 Billion Settlement

Given the startling health risks laid out by the FDA, MHRA, Health Canada, and Stryker itself, it should come as no surprise that a Rhode Island judge recently denied Stryker’s motion to dismiss a lawsuit pertaining to its Trident hip replacement system.

In fact, the corporation is no stranger to litigation. In the fall of 2014, Stryker agreed to pay $1.43 billion to settle thousands of lawsuits concerning its ABG II and Rejuvenate hip stems. Under the settlement, each plaintiff could receive as much as $600,000 in damages.

If you have experienced metal poisoning, dislocations, pain, inflammation, or broken bones, and you require(d) revision surgery as a result, please contact us today to learn your rights. You may qualify for a lawsuit that could help you pay medical bills and other expenses related to your device’s unforeseen side effects.

Northwestern Medicine Study Highlights Flaws in FDA Device Regulation

Most women probably assume that medical devices used in obstetrics and gynecology are thoroughly tested before introduction to mainstream medicine. However, a new study out of Northwestern Medicine shows why faith in the regulatory process is misplaced and demonstrates how dangerous devices can make their way onto the market and into women’s bodies.

“Despite the fact that we’ve had multiple safety issues connected to OB-GYN devices affecting millions of women worldwide, the evidence leading to approval has a lot of weaknesses.”

Several obstetrics and gynecology medical devices—including Essure permanent birth control, laparoscopic power morcellators, and transvaginal mesh—have been the subject of recent controversy (as well as lawsuits) due to high rates of complications. These devices have a common link, according to researchers at Northwestern University: they were approved by the FDA based on flawed data.

The researchers looked at 18 high-risk OB/GYN medical devices approved from 2000 to 2015 and found that:

  • Four devices were approved despite failure to demonstrate efficacy in clinical trials.
  • Six devices were not required to undergo postmarketing surveillance to measure ongoing safety.
  • Nearly half of the devices were approved based on nonrandomized controlled trials (the randomized controlled trial is considered the “gold standard” of clinical trials).
  • Three devices were withdrawn from the market; of these, two were not reviewed by experts on the FDAs obstetrics and gynecology advisory committee, and the other was reviewed by the panel but not recommended for approval.

“We looked at the class of devices with the highest potential risk to patients—the devices that had to go through the most rigorous pre-market approval process,” said Dr. Steve Xu, the study’s senior author. “Despite this being the most stringent pathway, and despite the fact that we’ve had multiple safety issues connected to OB-GYN devices affecting millions of women worldwide, the evidence leading to approval has a lot of weaknesses.”

Researchers Point to Failings of Essure

The researchers used Bayer’s Essure permanent birth control as an example of how weaknesses in the FDA medical device approval process can lead to patient harm.

Essure was approved in 2002 based on short-term evidence and inadequate post-market follow-up, the study authors said. It has been linked to more than 10,000 injuries, including severe pain, organ damage, and unintended pregnancy.

“There are no explicit requirements about conducting randomized-controlled trials or post-market surveillance for medical devices.”

In one premarket study used to approve Essure, 9% of women reported adverse events, but the device was approved based on the fact that no pregnancies were reported during testing. Although the FDA ordered post-approval studies for Essure, these studies were found by the New England Journal of Medicine to have serious limitations, such as short follow-up periods, the exclusion of key data, and a lack of a comparison group (i.e. a controlled study).

Independent, controlled testing has found that Bayer’s Essure device has a much higher failure rate than pre and post-marketing data indicate.

FDA ordered in March 2016 that a “black box” warning be added to Essure and additionally called for Bayer to conduct new studies of the device.

“There are no explicit requirements about conducting randomized-controlled trials or post-market surveillance for medical devices,” said Dr. Xu. There are much higher standards for the approval of new drugs. The important question to ask is: should we really be holding high-risk medical devices to a lower standard of evidence than drugs?”

File an Essure Lawsuit

More Stringent Device Regulation Needed

The research team emphasized the need for greater scrutiny of medical devices, even as legislation opposed to this is making its way through Congress.

The 21st Century Cures Act, an industry-friendly bill that contains a broader definition of “valid scientific evidence,” passed the House of Representatives in May 2015 and is currently before the Senate.

“Our concern,” said study author Jessica Walter, “is that this would lead to more devices getting approved with even less clinical evidence that they are both safe and effective.”

Walter and Xu suggested that both physicians and the FDA have a role to play when it comes to bringing higher quality studies into the device approval process. They added that evidence shows more regulation doesn’t necessarily mean less innovation.

“Medical Device Approvals Through the Premarket Approval Pathway in Obstetrics and Gynecology From 2000 to 2015: Process and Problems” is published in the June 2016 edition of Obstetrics and Gynecology.