How to Solve the Opioid Epidemic

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 Challenges of Opioid Litigation

Lawsuits against opioid manufacturers such as Purdue Pharma (maker of OxyContin) have been an uphill battle.

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.

Individual Lawsuits

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.

State Lawsuits

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.

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How Does the FDA Approve New Drugs?

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 trials take 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.

Source: BMJ

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.”

When he spoke with pharmaceutical CEOs in January, the president mentioned eliminating 75-80 percent of all FDA regulations.

“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.

Reciprocal Approval

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.”

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Fairness in Class Action Act Threatens Civil Justice

This week, the House of Representatives passed a bill that may eliminate your right to join a class action lawsuit.

The Fairness in Class Action Litigation Act of 2017, or H.R. 985, proposes to “assure fairer, more efficient outcomes for claimants and defendants.” According to 120 civil rights groups, though, H.R. 985 would only help corporations.

We spoke with Amanda Werner, an economic justice advocate who works on behalf of Public Citizen and Americans for Financial Reform, to better understand how the bill would affect the legal rights of millions of American consumers. Werner also shared how arbitration, or the “ripoff clause,” is similarly taking away our right to join class action lawsuits.

What is H.R. 985 and why should Americans be concerned about it?  

amanda werner
Amanda Werner

H.R. 985 is one of the biggest threats to civil justice that we’ve seen in recent years. It would essentially destroy the class action mechanism as a means of achieving justice.

That would mean that a lot of corporate wrongdoing would go completely unaddressed; corporations would be able to steal from consumers, pollute the environment, abuse their workers, and people would have absolutely no ability to bring them to court. So, it’s a huge deal, especially in a time where the courts seem to be our last line of defense to enforce our rights.

Why in particular is our right to join a class action lawsuit important?

Class actions are particularly important for illegal behavior that hurts many people but might involve small amounts of money per person. For instance, there are many cases where a bank might overcharge each of its consumers by $20, which is small enough that the consumer may not notice. But multiply that over one million customers, and the bank has just stolen a huge amount of money. Without class actions, they would get away with it and in fact be at a competitive advantage for ripping off their customers.

So we really need class actions to not only alert the public to fraud but also sometimes to alert the customers themselves. Take Wells Fargo’s fake accounts scandal, for example—many people didn’t realize that they had multiple credit cards or bank accounts open in their name until they heard about these lawsuits. And even when a consumer finds out, without class actions, they can’t do anything about it because suing a bank over $20 by yourself just isn’t cost effective.

Supporters argue that H.R. 985 will help class members receive higher awards. What is your response to that?

“If these claims aren’t able to be brought, consumers aren’t going to be able to recover at all, let alone recover higher sums.”

It is completely unfounded. This bill is opposed by every major civil justice, civil rights, and consumer group, all across the board.

How can you make a class action much harder to bring and then also claim that it’s somehow going to benefit people more? If these claims aren’t able to be brought, consumers aren’t going to be able to recover at all, let alone recover higher sums.

The bill would require that plaintiffs share the same injury. Why is this a problem?

It’s a solution for a problem that doesn’t exist. There are already strict standards in place—standards which have gotten much higher in the past few years as it is—to ensure that members of a class have a similar type of injury. When you heighten those standards even more and make them so specific, it destroys consumers’ ability to bring a claim. That is the real purpose here.

“It essentially requires everyone to bring their own case, which is not only very inefficient but the opposite of the purpose of class actions.”

One thing the bill does is it requires that people all have the same scope of injury. Going back to the Wells Fargo scandal, one customer may have lost $150 because they opened up a fake account and started charging them fees, and someone else may have lost $35. Those slightly different amounts of money could make for a different scope of injury, even though the actual harm they suffered is very similar. Under this bill, they would likely not be able to certify that class and thus will have a lot more trouble bringing suit.

At some point, these injury requirements get so specific that it essentially requires everyone to bring their own case, which is not only very inefficient but the opposite of the purpose of class actions.

A similar threat to our legal rights is forced arbitration, or the “ripoff clause.” Could you explain this?

What we call the ripoff clause is fine print that corporations sneak into their consumer contracts—think of something like the terms and conditions of an iTunes agreement—that says if you have a dispute with the company, you aren’t able to go to court, and you aren’t able to join a class action. Instead, you have to go after the company by yourself in forced arbitration.

Arbitration is a private system where the corporation gets to choose the firm who decides the case, what rules apply, sometimes even where the arbitration takes place.

The arbitrators have an incentive to rule for the company who is going to rehire them, so there’s also a built-in bias to the system. The most comprehensive federal study showed that companies generally win in arbitration 93% of the time. Consumers, even in the small percentage of the times that they do win, only win twelve cents on the dollar compared to corporations, which average ninety-eight cents on the dollar.

“Consumers only win twelve cents on the dollar compared to corporations, which average ninety-eight cents on the dollar.”

But even more important than the bias in arbitration is that ripoff clauses often mean that people simply don’t bring claims at all. The Consumer Financial Protection Bureau found that there were about 400 arbitration cases brought per year against banks and lenders—compare that to class actions which benefit millions and millions of Americans every year.

(For more on ripoff clauses, check out this consumer’s negative arbitration experience with Citibank).

The Arbitration Fairness Act seeks to eliminate ripoff clauses. What will it take for the bill to be passed?

We have seen the Arbitration Fairness Act introduced the past few Congresses, and in that time we have seen increasing public interest in of this issue.

I think our biggest hurdle has been the lack of public knowledge. Part of the reason for that is because it’s a pretty new phenomenon. Businesses have been using arbitration to decide disputes between companies for many years, but it’s really only recently that arbitration—especially class actions bans—have been used on consumers, students, and other groups with no bargaining power.

I’m unfortunately not very optimistic that these bills will move this Congress, especially because we are seeing major assaults on civil justice in the form of H.R. 985 and some other House bills. But I hope that once people show that we are paying attention, that we support the right of class actions, that we want the ability to enforce our rights in court, then the tide will start to change.

What can Americans do to protect their right to join a class action?

“Many of us take the right to a day in court for granted… But most people don’t realize that they’ve unintentionally or against their will had to sign it away.”

The good thing is there are actually things happening on these issues now. There are seven bills that restrict the use of forced arbitration introduced this week, and there’s the class action bill that we want people to vote against coming up this week as well. If you call your senator or representative, there’s a lot of things they are going to be paying attention to.

But also, people should tell their friends and family about the importance of class actions and the abuses of forced arbitration. So many people don’t know that their rights are threatened in this way.

I think many of us take the right to a day in court for granted because it is a Seventh Amendment right—it’s very, very basic. But most people don’t realize that they’ve had to sign it away just by participating in the marketplace: by having a cell phone, by having a bank account, any of these basic things that we do every day.

A huge part of it is education and just making sure people know about these things.

For the latest on forced arbitration, follow #RipoffClause on Twitter. You can also follow Amanda Werner: @wamandajd.

Is Congress Trying to Outlaw Class Action Lawsuits?

(Above: Rep. Bob Goodlatte; photo credit: Gage Skidmore)

According to more than 120 civil rights groups, that’s exactly what they’re doing.

On February 9, 2017, Representative Bob Goodlatte (R – VA) proposed the Fairness in Class Action Litigation Act of 2017, “To amend the procedures used in Federal court class actions and multidistrict litigation proceedings to assure fairer, more efficient outcomes for claimants and defendants.”

On February 15, the House Judiciary Committee passed the bill, H.R. 985, by a vote of 19 to 12. On March 9, the bill passed the House of Representatives by a vote of 220-201. It will now move to the Senate for consideration.

If passed, this bill could eliminate cases that have already been filed and pending in an MDL for years.

ClassAction.com attorney Laura Yaeger says that the bill “seeks to essentially eliminate the rights of all Americans to seek redress in our court system through class actions or multidistrict litigation efforts, which are often the only viable options for injured patients and consumers to level the playing field and seek compensation when they have been harmed by large corporations.”

Ms. Yaeger adds, “This bill seeks to have retroactive application, which means that, if passed, it could eliminate cases that have already been filed and pending in an MDL for years.”

She encourages every consumer to visit Congress.gov to contact his or her representative and urge them to stand up for the rights of all Americans to hold corporations accountable, and to vote no on H.R. 985.

H.R. 985 in a Nutshell

The Fairness in Class Action Litigation Act would make sweeping changes in the way class action lawsuits are formed, tried, and awarded. Here are some of the many provisions put forth in H.R. 985:

  • Classes will only be certified if every member of the class has “suffered the same type and scope of injury as the named class representative.” Though the terminology is vague (more on this later), in short the bill wants to prohibit class action lawsuits in which class members have suffered varying degrees of losses—or no losses at all.
  • The bill aims to rein in attorneys’ fees, which it says must be “limited to a reasonable percentage of any payments directly distributed to and received by class members.” Moreover, H.R. 985 says that attorneys’ fees must never “exceed the total amount… received by all class members.”
  • The bill also seeks more transparency and accountability in terms of attorneys’ fees. Prior to the payout of attorneys’ fees, the bill demands reporting of all funds paid to counsel by the defendant, as well as every payment made to class members, the number of class members, average amount paid, etc.
  • Attorneys may not represent relatives or any client they have previously represented in a class action. They also may not have any business ties to their clients outside of the class action lawsuit. (This provision seeks to cut down on conflicts of interest, especially attorneys’ friends and family serving as class representatives.)
  • Plaintiff lawyers must supply a “reliable and administratively feasible mechanism” with which they can identify and distribute money to their clients. The question of who exactly is a member of a class is called ascertainability, and this measure aims to clarify and tighten ascertainability.
  • The bill would also reform the procedures for multi-district litigation (MDL), requiring plaintiffs to provide evidence of injury prior to acceptance into the MDL. Cases that don’t meet this requirement will be dismissed within a month.
  • It also requires 80 percent of MDL settlement money to go to clients (versus attorneys).

Critics Say Bill Will “Obliterate” Class Action Lawsuits

“If this bill were enacted into law, it would obliterate class actions in America.”

H.R. 985 prompted swift outrage from civil rights, labor, and environmental groups, 70 of which signed a letter condemning the bill. Among the dozens of organizations that signed are the AFL-CIO, the Center for Biological Diversity, the Farmworker Association of Florida, the National Disability Rights Network, the National Employment Lawyers Association (NELA), Public Citizen, the Southern Poverty Law Center (SPLC), and the Workers’ Rights Center.

The letter states, “If this bill were enacted into law, it would obliterate class actions in America… The fact that the Committee would even consider such a sweeping, reckless legislation without holding a single hearing is an outrage.”

It goes on to say that requiring every member of a class action to have an injury of the same type and scope

…would sound the death knell for most class actions. Classes inherently include a range of affected individuals, and virtually never does every member of the class suffer the same “scope” of injury from the same wrongdoing. Certainly, many civil rights, discrimination and employment class actions, including cases involving refusals by companies to properly pay workers, would not satisfy these criteria.

A second letter, signed by 121 civil rights groups—including the American Civil Liberties Union (ACLU), the Equal Justice Center, Farmworker Justice, NELA, and SPLC—highlighted “the most egregious of [the bill’s] many harms.”

The letter emphasizes that “class actions are critical for the enforcement of laws prohibiting discrimination in employment, housing, education, and access to public areas and services.” For this reason, these groups feel strongly that H.R. 985 presents a grave threat to American civil rights.

Subtler Aspects of Bill Could Be More Troubling

Defendants of H.R. 985 say that the sky-is-falling rhetoric of critics is overblown and misleading. Daniel Fisher of Forbes writes, “It wouldn’t close the courthouse door to consumers, as critics are sure to say… What it would do is discourage lawyer-driven litigation, where plaintiff attorneys target a company… knowing full well the bulk of their clients will never learn of the lawsuit or seek to claim their piece of the settlement.”

H.R. 985 “will create a lot of unnecessary litigation over what the bill really means.”

Transparency and accountability are good things, proponents argue. They say that cutting down on frivolous lawsuits that endeavor only to fatten the pockets of attorneys is a step in the right direction.

Jay Edelson, a prominent plaintiffs attorney in Chicago, considers the bill problematic—but not for the reasons people think. He doesn’t feel it will “obliterate” class actions, and he is in favor of transparency, accountability, and making sure attorneys’ fees don’t soar out of control (especially if their clients only take home a few bucks apiece).

But Mr. Edelson also says that H.R. 985 “will create a lot of unnecessary litigation over what the bill really means.” He says that the similar-type-and-scope-of-harm wording is “unbelievably unclear,” and will inevitably cause delays as the Courts hash out just what that means.

He also feels that a less notorious aspect of the bill is worrisome and even potentially unconstitutional:

You can’t have a class rep who’s a family member, someone who works with you. That’s fine. But then they go further and say you can’t have them be a class rep if you’ve ever represented them before in any case. And that’s crazy. Congress coming in and telling people, “no, you can’t use your attorney, you have to find someone you don’t know at all,” is really shocking and should be offensive to all attorneys. I think it would face constitutional challenges. People have a right to choose their lawyer.

One thing everyone seems to agree on is that this bill would make class action lawsuits vastly more difficult.

Wage and Hour Awards Skyrocketed in 2016

Class action lawsuits against employers for alleged violations of minimum wage, overtime, and other wage and hour protections decreased slightly in 2016. But they remain on track for long-term growth under a more business-friendly Trump administration, according to a new report.

Wage and hour class action filings were down in 2016, but settlement values were up.

That said, Supreme Court nominee Neil Gorsuch has sided with businesses on past labor issues and could provide the deciding vote in an upcoming high court review that could curb workers’ ability to file class action lawsuits.

If your employer violated wage and hour laws, you may be eligible for a lawsuit. Learn more during a free case review from ClassAction.com.

Contact an Employment Lawyer

Wage and Hour Lawsuits Soared in Value

Corporate defense firm Seyfarth Shaw issues an annual report on workplace class action litigation that covers employment lawsuit trends from the previous year and offers analysis of what to expect in the year ahead.

More than 70% of all employers violate federal wage and hour laws.

Wage and hour lawsuit filings have increased by more than 450% over the last 15 years, reports Seyfarth Shaw, which notes that these lawsuits cause the most concern for employers. That’s because more than 70% of all employers violate federal wage and hour laws, according to the Department of Labor (DOL). Such cases also tend to be high stakes lawsuits from an employer’s perspective, since many result in large settlements.

Key wage and hour litigation insights from the 2017 report include:

  • One hundred and ninety-five wage and hour class actions were allowed to proceed in 2016, compared to 175 certifications in 2015. Wage and hour cases were certified at a higher rate than any other employment class action type in 2016.
  • Although the number of wage and hour cases filed in 2016 decreased for the first time in more than a decade, the value of the top ten wage and hour lawsuits increased significantly, to $695.5 million—nearly quadrupling in value compared to 2014.
  • The top two wage and hour settlements of 2016—both involving FedEx—were valued at $240 million and $226 million. Both cases settled claims that FedEx employees had been misclassified as independent contractors.
  • Wage and hour litigation is expected to continue its overall growth in 2017 and beyond based on new federal overtime regulations, local minimum wage laws, independent contractor misclassification lawsuits, and increased public awareness of employees’ rights.

How Trump Could Impact Wage and Hour Cases

Not all wage and hour disputes are taken up as class action lawsuits. Through the Department of Labor, the federal government also files lawsuits against employers that violate wage and hour laws and obtains settlements on workers’ behalf.

DOL enforcement lawsuits are typically pursued far more aggressively under Democratic administrations than under Republican administrations. The DOL aggressively sued employers for wage and hour violations during the Obama years. Since 2009, the DOL’s Wage and Hour Division closed 200,000 cases and recovered more than $1.8 billion in back pay for more than two million workers.

Sixty percent of CKE restaurants investigated by the DOL were caught violating labor laws.

While the scope of labor enforcement policies in the Trump administration remains to be seen, if the new Administration’s Department of Labor does back off wage and hour enforcement, plaintiffs’ attorneys would likely pick up the slack by filing more private wage and hour employment lawsuits.

Critics of Mr. Trump’s pick for labor secretary, CKE Restaurant Holdings Inc. CEO Andy Puzder, claim CKE chains such as Carl’s Jr. and Hardees are some of the nation’s worst labor law violators.

A fast food worker advocacy group called Fight for $15 says that 60% of CKE restaurants investigated by the DOL since 2009 were caught violating labor laws.

Neil Gorsuch Could Curb “Frivolous” Lawsuits

Perhaps the biggest wage and hour wildcard of the Trump Administration is how his Supreme Court Justice will shape labor law outcomes. Of particular importance to wage and hour cases is an upcoming review that will decide whether employers can use arbitration agreements that prohibit workers from filing class action lawsuits.

Mr. Trump has nominated conservative justice Neil Gorsuch to fill the void left by the late Antonin Scalia. As a federal appeals court judge, Mr. Gorsuch opined against what he perceived as government agency overreach. In his private legal career, Mr. Gorsuch supported curbs on what he deemed “frivolous” class action lawsuits.

The court is expected to hear the class action waiver case in the 2017 term, which begins in October. Judge Gorsuch should sit on the bench by then, barring a refusal by Senate Democrats to confirm him.

Gerald Maatman, lead author of the Seyfarth Shaw report, told The Chicago Tribune, “I think employers have a supporter with [Mr. Gorsuch], who is unwilling to go along with agencies just because they interpret the law in a certain way.”

“If you think that workers need more protection, then he’s probably not your guy.”

Richard Trumka, President of The American Federation of Labor and Congress of Industrial Organizations (AFL-CIO), also sees an employer ally in Gorsuch.

“He’s been a very, very strong advocate for corporations at the expense of working people,” said Mr. Trumka. “If you think that workers need more protection and corporations need less protection, then he’s probably not your guy.”

Can Employers Ban Class Actions? Supreme Court to Decide

“Class action waivers may be one of the most important issues facing workers today.”

The Supreme Court announced on Friday that it will review whether or not class action waivers violate national labor laws. Companies frequently include these waivers in arbitration agreements to prohibit employees from forming class action lawsuits. For years though, district and appellate courts have disagreed on whether or not the practice is legal.

“Class action waivers may be one of the most important issues facing workers today, and many are unaware it is such an issue,” said attorney C. Ryan Morgan, co-chair of Morgan & Morgan’s Employee Rights Group. “Class action waivers are detrimental to the vast, vast majority of workers and hinder workers from having knowledge of their rights.”

40% of Employers Use Class Action Waivers

“Most workers would be shocked if they knew that many employers force workers to sign these agreements.”

Arbitration agreements and class action waiverswhich are usually buried deep within an employer’s contractrequire employees to handle their legal disputes in private arbitration, without a judge or jury. Employers prefer arbitration because proceedings are faster and are less costly than typical lawsuits. And, companies are more likely to win.

In arbitration, companies set the rules of proceedings and hire the arbitrator. A Cornell University study found that out of nearly 4,000 workplace arbitration cases filed between 2003 and 2007, only 21% were awarded in favor of employees. And, on average, employee litigation awards were 5 to 10 times greater than arbitration awards.

Employees are usually unable to opt out, and some courts, like the Sixth Circuit, have ruled that by simply showing up to work, an employee has agreed to the arbitration terms.

Favorable court decisions have only encouraged the practice. In 2015, about 40% of employers used class action waivers in their arbitration agreements.

“Most workers would be shocked if they knew that many employers force workers to sign these agreements and certain courts enforce the agreements,” said Carlos Leach, an employee rights attorney for Morgan & Morgan.

Class Action Waivers May Violate the National Labor Relations Act

Stephanie Sutherland was told that pursuing her case in arbitration would cost her $200,000.

Agencies like the National Labor Relations Board (NLRB) argue that class action waivers violate the National Labor Relations Act (NLRA) because they strip away employees’ rights to collective action. Employers, however, often argue that the Federal Arbitration Act, which permits class action waivers, trumps the NLRA.

The Supreme Court will decide whether or not the NLRB’s interpretation is correct by reviewing three cases involving Murphy Oil, Epic Systems, and Ernst & Young.

Epic Systems and Ernst & Young are appealing decisions made by the Seventh and Ninth Circuits respectively that declared their class action waivers were illegal. The Chicago and San Francisco-based appellate courts were the first to rule against class action waivers in 2016.

For smaller disputes, a class action lawsuit is usually the most cost-effective legal method since plaintiffs can share legal costs. Stephen Morris and Kelly McDaniel are fighting for their right to form a class action lawsuit against Ernst & Young, whom they allege withheld overtime pay from employees. 

In a similar case filed by another former Ernst & Young employee, Stephanie Sutherland was told that pursuing her case in arbitration would cost her $200,000. Though a New York federal court overrode the class action waiver since arbitration fees would prevent her access to the courts, it was later reversed by the Second Circuit Court of Appeals.

Employee Rights Advocates Are “Cautiously Optimistic”

“I am cautiously optimistic that the [Supreme Court] will do the right thing and side with the NLRB.”

Experts caution that the possibility of a 4-4 split and the looming justice vacancy far from guarantees a decision in favor of class action rights.

However, the Supreme Court announcement comes on the heels of President Obama’s Fair Pay and Safe Workplaces executive order, which rules that companies with federal contracts of $1 million or greater cannot require employees to sign arbitration agreements. And, last year, the Senate introduced the Restoring Statutory Rights Act, which would prohibit arbitration agreements that violate employee discrimination laws.

“As an attorney who constantly fights against these agreements on behalf of employees, I am cautiously optimistic that the [Supreme Court] will do the right thing and side with the NLRB’s position that class action waivers violate workers’ fundamental rights to join together versus their employer,” said Carlos Leach.

Opening briefs are scheduled to begin in February; a decision will likely be made sometime this summer.

 

The Regulatory Battles Uber Faces in 2017

In 2016, Uber unleashed a host of innovations: self-driving cars, UberFreight, and more. But with innovation comes new regulations—something Uber consistently demonstrates it doesn’t have the patience for.

Some cities and states believe that by siding with Uber, they are standing for innovation, while others are taking a more cautious approach and are trying to rein in the company. It has created a complicated legal landscape that is still trying to catch up with the new technology.

Here are some of the major legal issues we think Uber will wrestle with in 2017.

State Battles Over Self-Driving Legislation

In November 2016, the Department of Transportation created the first Federal Automated Vehicles Policy, leaving the manufacturing of self-driving cars to companies, and the development of laws and regulations to the states.

Though the document warns against states creating inconsistent legislation, it also says that “states may wish to experiment with different policies and approaches.”

These “experiments” have already been tested during Uber’s self-driving car pilots. In Pittsburgh, the pilot has been relatively uneventful, compared to San Francisco, where the company received a cease-and-desist letter from the Attorney General within two days of the pilot’s launch.

Uber refused to obtain an autonomous vehicle testing permit from the state—which only costs $150.

Uber refused to obtain an autonomous vehicle testing permit from the state—which only costs $150—arguing that their vehicles still required human drivers and therefore did not fit within California’s definition of self-driving. Making matters worse, cameras captured their autonomous cars running red lights and making unsafe turns in bike lanes.

Though Uber dismissed traffic violations as human error from their operators, in the end they shipped their cars to Arizona.

Arizona Governor Doug Ducey welcomed the company, saying, “While California puts the brakes on innovation and change with more bureaucracy and more regulation, Arizona is paving the way for new technology and new businesses.”

In addition to Arizona, Uber may also test their autonomous vehicle technology in Michigan this year. Though there haven’t been any announcements, the state just legalized self-driving cars without licensed drivers, steering wheels or brakes.

Without clear, consistent oversight, though, the legal skirmishes and unsafe driving that we saw in California will likely continue. Increased federal regulation is likely to come, but it may favor Uber and other autonomous vehicle manufacturers: Uber CEO Travis Kalanick and Elon Musk are both on the President-elect’s Strategic and Policy Forum.

Transit Partnerships Demand Greater Transparency

In 2016, some city officials cut back on public transit spending and began offering residents vouchers for Uber rides instead. These programs are often referred to as “First Mile Last Mile” since they replace the first and last few stops of a route where there are the fewest passengers.

Is it wise to give Uber even more power?

For a city’s budget, it often makes financial sense to replace low-traffic bus routes with subsidized Uber rides. Florida cities like Pinellas Park and Altamonte Springs (which pays 20% for all Uber rides within city limits) have done this and claim it’s a success.

It’s a worrisome trend, though, and may negatively affect citizens who rely on public transportation the most. Citizens who don’t own smartphones or credit cards can’t order a ride. And the disabled would likely have a harder time getting around, as it’s still difficult for passengers to find Uber drivers who can accommodate wheelchairs and guide dogs.

Swapping out bus routes for Uber rides also shifts the power away from local authorities to a private company. In addition to replacing public sector jobs with poor contract jobs (see below), it also limits government access to ridership data, which Uber considers confidential information.

New York City is currently battling this issue. The city requires drivers to report pick-up locations and times, but they want to extend this to include drop-off locations and times. Officials argue the data would be used to identify incidents of driver fatigue, but Uber thinks it’s an invasion of privacy.

At the moment Uber and Lyft are subsidizing U.S. ridership, and one day they’re going to start profiting from it.”

While New York City’s argument certainly has some holes, Uber hasn’t proven to be the best privacy protector: Former employees revealed last year that workers tracked the locations of ex-partners and celebrities.

More importantly, is it wise to give Uber even more power? What happens if Uber decides to end these partnerships and local cities are left without efficient bus or train routes?

And, as Slate author Henry Grabar points out, “At the moment Uber and Lyft are subsidizing U.S. ridership, and one day they’re going to start profiting from it.”

Drivers Push to Be Employees, Not Contractors

Will 2017 finally settle Uber’s longest fight, over whether drivers are employees or contractors?

The company has maintained that by classifying drivers as contractors they are providing them with the flexibility drivers desire. “Flexibility” is a common term the company uses to defend why they deny drivers basic employee rights, like informing them when fares are reduced or ensuring that drivers are paid at least the minimum wage.

Two pending class action lawsuits representing drivers in California and Massachusetts will lend weight to the classification debate.

U.S. District Judge Edward Chen rejected the $100 million settlement, saying that it was unfair to drivers.

In April 2016, Uber proposed a $100 million settlement that, if accepted, would have maintained drivers’ contractor status. But U.S. District Judge Edward Chen rejected the settlement, saying that it was unfair to drivers. (The two parties have since resumed negotiations.)

A new thorn for drivers is the Ninth Circuit Court of Appeal’s decision to uphold Uber’s arbitration agreements—an agreement that Judge Chen declared was “unconscionable.” The September 2016 decision ruled that drivers who joined Uber in 2013 and 2014 must settle their disputes in private arbitration, rather than class action lawsuits. This decision will likely disqualify thousands of drivers who were originally in Massachusetts and California’s employee misclassification suit.

ClassAction.com will continue to follow this debate to provide Uber drivers with the latest information on their worker classification and legal rights. If you are an Uber driver, contact us today with your legal questions.

Time Running Out for Victims of Priests’ Sexual Abuse

(Above: Cardinal Timothy Dolan, Archbishop of New York)

In October 2016, the Roman Catholic Archdiocese of New York announced that it had established a fund to compensate victims of sexual abuse at the hands of Catholic priests: the Independent Reconciliation and Compensation Program, or IRCP.

The IRCP is headed up by mediator Kenneth Feinberg, who has also handled compensation funds for victims of 9/11, the Boston Marathon bombing, and the shooting at the Pulse nightclub in Orlando.

According to Cardinal Timothy Dolan, the Archbishop of New York, the roughly 200 victims who have already come forward have until January 31, 2017 to enroll in the compensation program. Starting February 1, new victims may enroll.

That January 31 deadline is now less than four weeks away. Because of New York’s stiff statute of limitation (SOL) laws, this could be the last chance for some victims of abuse to obtain a measure of justice for their suffering.

If you or a loved one experienced abuse by a Catholic priest or deacon in the Archdiocese of New York, contact us today to learn how you can hold the Archdiocese accountable.

Hold the Church Accountable

Only 30 of 200 Victims Have Received Compensation

Though Cardinal Timothy Dolan, the archbishop of New York, said that roughly 200 victims had come forward, only 30 of them have received compensation as of this writing.

“How can you look the survivors in the eye?”

That is in part due to New York’s notoriously harsh statute of limitation laws, which require child victims of sexual abuse to file charges (criminal or civil) by the time they turn 23. Some states have no statute of limitations at all for these cases.

The Child Victims Act—a law proposed by Assemblywoman Margaret Markey (D-Queens) that would have eliminated or extended New York’s SOL—failed to reach the state legislature’s floor for a vote last summer.

Senator Brad Hoylman (D-Manhattan), who sponsored the act, said, “How can you look the survivors in the eye?”

The archdiocese opposed the act. Critics of the Church’s compensation fund say it is just a way for the Archdiocese to keep from disclosing its private records about the abuse in future litigation. (Victims who enroll in the compensation program may not file lawsuits thereafter.)

Meanwhile, a new legislative session in the state will bring a new push to pass some version of the Child Victims Act. There is no guarantee it will pass, though, so some victims may consider the IRCP their best bet for relief.

New Victims May Enroll in IRCP Starting Feb. 1

While the 200 or so victims who have already approached the Archdiocese with claims of abuse have just a few more weeks to enroll in the IRCP, victims who have not yet come forward may join the program starting February 1.

These victims may have been abused recently or as far back as 50 years ago.

These victims may have been abused recently or as far back as 50 years ago. While New York’s statute of limitations has prohibited many lawsuits, the IRCP does not discriminate with regard to the date of the abuse.

According to the archdiocese, 40 priests in the state have been linked to abuse. But that number could rise if or when new victims come forward next month.

In announcing the program, Cardinal Dolan said, “I wish I would have done this quite a while ago. I just finally thought: ‘Darn it, let’s do it. I’m tired of putting it off.’”

Many victims of the archdiocese’s abuse don’t have the luxury of putting off justice—they have just a few weeks left to pursue it.

Why a Bayer-Monsanto Merger Could Spell Disaster for Our Food Supply

Combined with Monsanto, Bayer would control a quarter of the world’s seeds and pesticides, potentially affecting the world’s food supply, ecosystem, and supermarket prices.

A merger between Monsanto (the company behind GMOs and the herbicide Roundup) and Bayer (the pharmaceutical company that manufacturers pesticides and seeds under Bayer CropScience) is gathering momentum. Earlier this week, Monsanto shareholders approved Bayer’s $66 billion offer to acquire the company: the largest all-cash offer in history.

What makes this potential merger so important—and scary—is just how powerful it would make Bayer. Combined with Monsanto, they would control a quarter of the seeds and pesticides market worldwide, potentially affecting the world’s food supply, ecosystem, and supermarket prices.

Small farmers, consumers, scientists, and politicians alike hope that the merger will be rejected by antitrust regulators. But with shareholders on board and a new administration on the horizon, the merger may be approved.

Merger Raises Red Flags for Antitrust Regulators 

If the merger is approved, Bayer would own 29% of seeds and 28% of pesticides worldwide. The sheer size of the new company, combined with the similarity of Monsanto and Bayer’s businesses, raises antitrust red flags.

The century-old Sherman Antitrust Act and Clayton Antitrust Act help prevent mergers and acquisitions of this size. Primarily, regulators are concerned about reduced competition which can inhibit innovation, result in price fixing, and leave consumers and employees vulnerable to abusive business practices.

As a preventative measure, large mergers and acquisitions must be reviewed by the Federal Trade Commission and the Department of Justice. This is where Bayer may stumble. The current administration has strictly opposed large mergers, like Staples and Office Depot, among others.

But Bayer may benefit from a change in administration. The company is so optimistic that it promised Monsanto shareholders a $2 billion termination fee if blocked.

“A Marriage Made in Hell” 

If approved, environmental experts warn the merger would be a “marriage made in hell.” After examining the harmful track record of their products, this description may not be far off.

Monsanto is known for a long list of dangerous and controversial biotechnology, including Agent Orange, PCBs, GMOs, and the carcinogenic pesticide RoundUp.

Like Monsanto, Bayer also has a line of genetically engineered (GE) seeds and herbicides and pesticides. Most dangerous are Bayer’s neonicotinoids—pesticides that are the primary cause of the destruction of bee colonies.

Bayer argues that acquiring Monsanto will help the company better address greater demands on the world’s food supply, primarily by selling GE seeds. GE seed cells are modified so that they are resistant to the powerful herbicides and insecticides Monsanto and Bayer sell. By planting GE crops, the companies argue, farmers are able to produce greater crop yields and decrease the overall amount of herbicides and pesticides they spray. 

Farmers Will Pay Higher Seed Prices

What does a Bayer-Monsanto merger mean for the average farmer and consumer? Farmers will first notice higher seed prices and few non-GE alternatives—a cost eventually felt by consumers in the supermarket. 

GE seeds are particularly pricey because they are registered as intellectual property. This prevents farmers from reusing their seeds, a millennia-old farming practice. 

Corn and soy seed prices have increased more than 300 percent since 1995.

Since the introduction of GMOs 20 years ago, seed prices have only gone up. According to Farm Aid’s Alicia Harvie, corn and soy seed prices have increased more than 300 percent since 1995.

Farmers looking for alternatives to genetically engineered seeds are having a harder time finding them. Charles Benbrook, a research professor at Washington State University, found that between 2000 and 2010, non-GE corn seed varieties decreased by 67 percent. Similar trends were found for other plants, including sugar beets, for which Monsanto owns 95% of the seeds.

More Herbicide Will Be Sprayed

Credit: www.justlabelit.org
Credit: www.justlabelit.org

In addition to pricier seeds, farmers are also faced with having to spend more on the seeds’ accompanying herbicides.

After years of spraying, weeds eventually adapt to the herbicides and become resistant to it. This leaves farmers with “super weeds,” requiring them to spray greater quantities of stronger chemicals. 

A study by The New York Times found that since genetically engineered seeds were introduced, herbicide use increased by one-fifth in the U.S. and Canada—countries reliant on GE seeds. In France, a country that is GMO-free, herbicide usage dropped by one-third.

Aside from the costs to farmers, higher quantities of herbicides is also bad news for the health of consumers and the environment. Monsanto’s Roundup is a carcinogen that puts farmers and gardeners that use the spray at a greater risk of developing non-Hodgkin’s lymphoma.

Lingering herbicide residue left on food is also linked to a rise in food allergies, especially gluten intolerance like celiac disease.

Hold Monsanto Accountable

A Potential Disaster for Bees and Biodiversity

Bayer and Monsanto argue that their merger would help to feed a growing world population, but it may actually lead to more food shortages.

The New York Times discovered that over GMOs’ 20-year history, they have not resulted in an increased food supply. What Monsanto and Bayer have managed to do, though, is severely damage the ecosystem—a trend that is likely to result in major food crises in the future.

Pesticides like Bayer’s neonicotinoids have decimated the world’s populations of natural pollinators. Ninety percent of the monarch butterfly population has died over the last 20 years, and between 2006 and 2012, the USDA reported that 10 million beehives were lost

Environmental experts estimate that the work of pollinators equates to $15 billion in agricultural labor. Because of the severity of the crisis, the EPA is  taking steps to regulate neonicotinoids

But Bayer’s pesticides aren’t the only threat to the environment. By using identical genetically modified seeds, companies like Bayer and Monsanto destroy biological diversity. Biodiversity is important because it helps reduce the spread of crop diseases. If every crop has the same genetic makeup, a disease has the potential to wipe out a huge portion of our food supply.

Giving so much control to one company—especially one that is hurting farmers, the ecosystem, and our health—may spell disaster for our food supply.

FDA Chief’s Conflicts of Interest and the “Revolving Door” Problem

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.

Lobbying-ROI-1024x461
Credit: UnitedRepublic.org/Represent.us

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.

How Hidden Arbitration Clauses Are Taking Away Your Legal Rights

Arbitration clauses are buried deep within consumer and employer contracts, causing many Americans to unknowingly sign away their rights to a trial by jury.

Arbitration is changing the legal landscape, popping up everywhere from employer agreements to your favorite app’s terms of service. But what is it?

Arbitration agreements require that legal disputes are resolved in private arbitration, rather than in court. Arbitration does not involve a jury; instead, decisions are made by a third-party arbitrator or tribunal. The intent is that if decided outside of court, disputes will be resolved more efficiently.

Initially, arbitration was used between companies. But when employees and consumers were first presented with these agreements, an important shift happened: No longer were the terms agreed to voluntarily and knowingly, but often, without the knowledge of the other party.

These clauses are often buried deep within a contract and use confusing and dense terminology. As a result, many employees and consumers agree to them without understanding that they are signing away their rights to a trial by jury, including class action lawsuits. (Remember that “terms of service” box you clicked in a rush?)

A Timeline of Arbitration’s Rise in Popularity

Arbitration agreements have been around since the 1920’s. But, between 1985 and 2015, 14 Supreme Court decisions made arbitration an industry standard. Here are some key moments in its history.

1925: Federal Arbitration Act

Legalizes arbitration. Initially created to offer an alternative legal procedure for disputes between companies.

1991: Gilmer v. Interstate / Johnson Lane Corp.

Ruled that a non-union employee who was under an arbitration agreement couldn’t settle their workplace discrimination complaint in court. More employers begin to use arbitration agreements.

1999: Meeting of the “Arbitration Coalition”

Corporate attorney Alan Kaplinsky gathers major banks and financial institutions to discuss arbitration clauses. Arbitration becomes increasingly common in the financial sector.

2011: AT&T Mobility v. Concepcion

Plaintiffs fight to file a class action lawsuit against AT&T. The Court rules in favor of AT&T’s class action waiver, causing other companies to adopt similar waivers.

2013: Italian Colors v. American Express

Plaintiff uses the Sherman Actwhich allows citizens to take on monopolistic entitiesto argue their right to form a class action lawsuit against American Express. Court rules in favor of American Express.

The Problems With Arbitration

Arbitration Agreements Are Everywhere

banking-on-arbitration-big-banks-consumers-and-checking-account-dispute-resolution_50b664bb9878f
Credit: The PEW Charitable Trusts

In most cases, you are unable to opt out of arbitration agreements. You either agree to the terms and work for the company or purchase the particular product, or you do not.

In 2010, the National Employment Lawyers Association estimated that one-third of the nonunion workforce in America was forced to sign arbitration agreements.

They’re even more common in the financial sector: In 2016, PEW discovered that 70% of major banks had mandatory arbitration agreements, and 73% used class action waivers.

Though banks argue that their customers willingly signed their rights away, PEW found that 95% of respondents wanted the right to a trial in the event of a dispute with their bank.

James Young, an attorney for ClassAction.com, shared with us just how widespread arbitration has become.

“These clauses have enabled big businesses to force both customers and employees into a seemingly rigged arbitration system for almost every type of legal dispute: consumer fraud, unsafe products, employment discrimination, nonpayment of wages, and countless other state and federal laws intended to protect citizens against corporate wrongdoing.”

Even if You Don’t Sign an Agreement, You Can Still Be Bound by Its Terms

In some cases when individuals have refused to sign arbitration agreements, they were still prohibited from going to court.

Mother Jones reported that even though Fonza Luke refused to sign her employer’s arbitration agreement, when she needed to file a workplace discrimination lawsuit she was told it had to be settled in arbitration. By showing up to work, her employer argued, she had agreed to their terms.

General Mills argued that if you “liked” the company on Facebook, you accepted their arbitration agreement.

A similar decision was made this year by the Sixth Circuit. Former University of Phoenix employees tried to form a class action lawsuit against the school, arguing that they never signed an arbitration agreement. Using Kentucky law, the court ruled that continued employment indicated acceptance of the employer’s terms.

This interpretation is found in consumer agreements as well. By purchasing a product, for example, you have agreed to a company’s terms—whether or not you know what those terms are. In one extremely farfetched incident, General Mills argued that if you “liked” the company on Facebook, you accepted their arbitration agreement.

Mandatory Arbitration Violates the Constitution

The most problematic aspect of forced arbitration is that it strips away the legal rights of employees and consumers.

“By inserting such clauses in every possible contract, businesses effectively moot the judicial system.”

“Mandatory arbitration is a limitation on your right to seek relief,” said James Young. “By inserting such clauses in every possible contract, businesses effectively moot the judicial system. The result is anathema to the founding fathers’ intentions as outlined in our Constitution.”

The Second Circuit recently protected the right to a trial by jury when they ruled that Uber could not force a class action lawsuit into arbitration. The small print of the app’s online agreement, they ruled, did not sufficiently warn customers they were waiving this right.

Explaining the verdict, U.S. District Judge Jed Rakoff said that a trial by jury “can be waived only if the waiver is knowing and voluntary.”

The importance of knowingly signing away your rights is currently playing out in many nursing homes. Facilities argue their patients consented to arbitration terms upon their arrival, but families argue their loved ones did not understand what they were signing. When families try to sue nursing homes for neglect or mistreatment, they find their legal rights barred.

The Centers for Medicare and Medicaid tried to stop this by passing a rule restricting arbitration agreements in nursing homes. However, this was blocked in November 2016 (within days of the rule taking effect) by a Mississippi federal judge.

Mandatory Arbitration Violates National Labor Laws

By prohibiting class action lawsuits, employers are also at risk of violating labor laws. In particular, the National Labor Relations Act (NLRA) permits employees to organize against employers by forming unions or through collective action.

Employers often argue that the Federal Arbitration Act trumps the NLRAan idea that many courts have sadly supported. As it stands, the legality of mandatory employee arbitration agreements depends on which judicial district is reviewing the case.

This inconsistency has necessitated Supreme Court review. Among the many cases awaiting trial is a case between the National Labor Relations Board (NLRB) and Murphy Oil USA.

The NLRB, which enforces labor laws, is appealing the Fifth Circuit Court of Appeals’ ruling that Murphy Oil can use mandatory arbitration agreements to prohibit their workers from filing class action lawsuits. They argue it violates the NLRA.

(Click below for Part 2.)

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.

Former FBI Investigator Lee Walters on What’s Next for 9/11 Lawsuits

With the passage of the Justice Against Sponsors of Terrorism Act (JASTA)—allowing victims of terror to sue the foreign governments responsible—came a tidal wave of questions and predictions about what could happen if Americans filed lawsuits against Saudi Arabia for 9/11.

To better understand the potential implications of the bill and the ins and outs of investigating foreign governments, we spoke with Lee Walters, a legal investigator for Morgan & Morgan’s Whistleblower team. Working alongside qui tam attorneys like James Young, along with government prosecutors, his experience developing evidence and extracting details from witnesses helps whistleblowers recover taxpayer money.

Previously, Lee was a Supervisory Special Agent for the FBI, making him uniquely qualified to comment on and tackle complex investigations like those associated with JASTA. Throughout his 24 years with the agency, he investigated healthcare and bank fraud, public corruption, and violations of the Foreign Corrupt Practices Act.

JASTA allows civilians to sue foreign governments for acts of terrorism that occur on U.S. soil. Is there any precedent for cases like these?

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Lee Walters

Yes, there is. One example is the bombing of Pan Am Flight 103 by agents working on behalf of Libya. Bruce Smith, a Pan Am pilot who lost his wife on the flight, filed suit against the country of Libya under the Foreign Sovereign Immunities Act.

The lawsuit, filed in federal court, was initially dismissed on the grounds that Libya was a sovereign state and had immunity under federal law. After lobbying Congress to change the law, the lawsuit was allowed to go forward and the country of Libya ultimately paid a $2.7 billion settlement to the victims of this terrorist act.

How is investigating a foreign government different than any other defendant?

Investigating a foreign government can be tricky for an investigator as it can be challenging to get access to the kinds of evidence normally sought. A foreign government can put up roadblocks to an investigator looking for evidence such as banking information, electronic communications, and internal written documentation.

The key to success in these investigations, as is the case with any investigation, is developing relationships with individuals who can provide access to the information sought.

Do you think Saudi Arabia’s relationship with the U.S. will affect legal proceedings in any way?

I don’t. JASTA does not specifically mention Saudi Arabia anywhere in the law. And, soon after the president’s veto was overridden with overwhelming bipartisan support, Congress agreed to a $1.15 billion sale of arms to Saudi Arabia as a show of goodwill.

“[Saudi Arabia] will need to cooperate, to some degree, in any lawsuits that are brought under JASTA.”

Politically, Saudi Arabia has to speak out; but, to maintain the kind of relationship with the U.S. necessary for the continuation of the monarchy, they will need to cooperate, to some degree, in any lawsuits that are brought under JASTA.

Is there enough declassified information to form a case against Saudi Arabia?

I think the 28 pages released by the House Intelligence Committee in July of this year regarding Saudi Arabia’s involvement in the 9/11 attacks is pretty damning and a great start.

The report found that Omar al-Bayoumi, who some in the report theorized was a Saudi intelligence officer, received large sums of money from the Saudi government and provided substantial support to two of the hijackers while they were living in San Diego.

It also identified two Saudi citizens, Mohammed al-Qudhaeein and Hamdan al-Shalawi, as conducting a dry run for the 9/11 attack in 1999 on a flight from Phoenix to Washington, D.C., which ultimately made an emergency landing after al-Qudhaeein twice tried to enter the cockpit. Both men told the FBI the Saudi embassy in D.C paid for their flights.

This is just one piece of declassified information that is available and I suspect more will be forthcoming.

Hold Them Accountable

Is the U.S. government likely to cooperate during the discovery process for the 9/11 lawsuits? Do these cases hinge on the government’s participation?

I think the government will cooperate to an extent. I say this because both political parties were behind JASTA and no one in either party wants to be seen as soft on terrorism.

The U.S. government, of course, is not going to release methods and techniques as part of the discovery process, but can release information that is redacted enough to protect that information while revealing the types of information necessary to prevail in a civil lawsuit.

These cases will not totally hinge on the government’s participation, but it will make the chance of success much greater if the government does participate. Information can be developed that does not require the government’s participation, but the quality of that information will lie on the ability of an investigator to develop relationships with human sources that have access.

How do you think JASTA will affect future litigation?

Opponents of JASTA argued that the law would provoke retaliatory lawsuits against U.S. citizens by other countries, which remains to be seen.

“The passing of JASTA allows for some legal recourse and ultimately closure.”

I think JASTA provides a framework for aggressive law firms, such as Morgan & Morgan, to work on behalf of the many victims of state sponsored terrorism, which is a problem that doesn’t appear to have an end in sight. I imagine there is nothing worse than losing a loved one to an act of state sponsored terrorism and feeling like you have no recourse. Fortunately the passing of JASTA allows for some legal recourse and ultimately closure.

Self-Driving Cars and the Future of Auto Accident Liability

Self-driving cars are no longer a dream of the future. Although still in its infancy, on-road vehicle automation technology grows by leaps and bounds each year, and governments and private companies agree that the eventual transition to cars without human drivers is all but inevitable.

“Self-driving cars have gone from sci-fi fantasy to an emerging reality.”

That doesn’t mean the shift to driverless cars will be seamless. Automated vehicles from multiple companies have been involved in accidents, including a deadly Tesla crash in May. There are also numerous questions about privacy, regulation, insurance underwriting, and liability.

A future where software and hardware make more driving decisions could let people off the hook for crashes. But will automakers step up and pay for damages—or will they try and pass the blame to another party?

These are some of the issues ClassAction.com will be keeping a close eye on in the months and years to come as we aim to keep people in the know.

Have a question or complaint about a self-driving vehicle? Please let us know.

The Driverless Future is Now

President Obama recently wrote in a Pittsburgh Post-Gazette op-ed that, “self-driving cars have gone from sci-fi fantasy to an emerging reality.”

That reality is seen in the efforts of automakers such as Ford, Volvo, and Tesla—as well as tech companies like Google, Apple, and Uber—to roll out fleets of self-driving cars as soon as 2021.

In the same editorial, Obama announced a White House conference on October 13 in the Steel City to discuss new technologies and innovations. His administration has published a 15-point safety checklist it hopes automakers and tech companies will adopt before self-driving cars hit the road.

The incoming administration could have different policy goals for self-driving cars, but politics aside, the rising tide of autonomous vehicle technology makes it an issue that regulators can’t escape.

A Rush to Market?

Google, the leader in self-driving technology, has been working on autonomous cars since 2009. The company’s car program has already put nearly sixty self-driving vehicles on roads in four states and logged two million miles. Apple is also rumored to be working on its own self-driving car, while Uber and Lyft have plans to introduce driverless taxis. Lyft CEO John Zimmer boldly predicted, “By 2025, private car ownership will all but end in major U.S. cities.”

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Ford and Volvo plan to mass-produce fully autonomous vehicles by 2021. Cars from Audi, BMW, Mercedes-Benz, Tesla, and other makers already feature sophisticated automation systems that can parallel park, follow a lead vehicle at a safe distance, and break to avoid collisions, among other features.

ClassAction.com attorney Mike Morgan, however, cautions that, in their zeal to become self-driving car market leaders, companies may not be focusing enough on big picture safety.

“The most dangerous part of self-driving cars is the rush to market,” said Morgan. “Everyone wants to be first to sell the most cars but the truth is the technology they are using is going to lead to catastrophic results.”

Degrees of Automation

In terms of legal repercussions, the distinction between fully autonomous and semi-autonomous technology is a significant one.

In the former, an automated driving system performs all driving tasks under all conditions. Such vehicles—which are still years away—would not even have a steering wheel.

Semi-autonomous vehicles, on the other hand, require some level of driver engagement, depending on the system capabilities. Tesla Motors Inc.’s Autopilot is a semi-autonomous feature that can control the car in certain conditions. Similar systems are planned for 2017 General Motors and Volvo vehicles as luxury options.

The Society of Automotive Engineers (SAE) developed standards for driving automation levels, ranging from 0 (no automation) to 5 (full automation). Tesla’s Autopilot—blamed for a deadly crash earlier this year—is officially Level 2.

Countdown to the Driverless Future

Experts disagree on when autonomous vehicles will become mainstream. The Insurance Institute for Highway Safety (IIHS) estimates that there will be 3.5 million self-driving vehicles by 2025, and 4.5 million by 2030, although it cautions that the vehicles will not be fully autonomous.

A majority of autonomous vehicle experts surveyed by technical professional organization IEEE said they expect mass-produced cars to lack steering wheels and gas/brake pedals by 2035.

While a future of self-driving cars seems certain, there are roadblocks to their widespread adoption. The same IIEE survey that asked experts when autonomous cars might be widespread also asked about potential obstacles. Leading responses included legal liability, policymakers, and consumer acceptance.

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Tesla Autopilot Mishap Could Spell Legal Trouble

A lawsuit over the deadly Tesla accident in May, in which a man’s autopilot did not recognize a tractor trailer turning in front of his Model S and his car smashed into it, is a strong possibility.

Tesla maintains, “Autopilot is an assist feature. You need to maintain control and responsibility of your vehicle.” But ClassAction.com attorney Andrew Felix counters, “Even the term ‘autopilot’ was used to coerce customers into a false sense of confidence and safety while this technology is still in its infantile stages.”

Tesla has not gone so far as to blame the man for the deadly crash. Should Tesla do so in the context of litigation, several legal arguments would be available to his family. But how they’d apply under the circumstances remains unknown.

“This is all new territory technologically and legally as well,” said Harvard Law School professor John C.P. Goldberg. “There are well established rules of law but how they apply to the scenario and technology will have to be seen.”

Volvo Promises to Assume Accident Liability. Will Others Follow Suit?

In the Tesla example, liability could come down to onboard vehicle log data. But semi-autonomous cars, which need some driver input, are very different from fully autonomous cars that assume little or no driver responsibility.

“Existing liability frameworks are well positioned to address the questions that will arise with autonomous cars.”

Legal experts generally agree that carmakers will assume blame for crashes when a computerized driver completely replaces a human one. For its part, Volvo has promised to assume full accident liability whenever its cars are in autonomous mode.

John Villasenor, a professor at UCLA and author of the paper, “Products Liability and Driverless Cars,” is confident that minor, sensible tweaks to current laws—not broad new liability statutes—will ensure that manufacturers are held accountable. “Existing liability frameworks are well positioned to address the questions that will arise with autonomous cars,” he told IEEE Spectrum.

A Bigger Slice of a Smaller Pie

Although this framework would seem to spawn a mountain of litigation for carmakers, the upshot is that automated technology is expected to drastically decrease accidents, the vast majority of which are caused by human error. After all, automation has already made cars safer. Electronic stability control systems, for example, have saved thousands of lives.

“From the manufacturer’s perspective,” according to tech policy expert and USC professor Bryant Walker Smith, “what they may be looking at is a bigger slice of what we all hope will be a much smaller [liability] pie.”

But what if the driverless technology is forced to make a decision between, say, crashing into a barrier and killing the car’s only occupant, or running over a pedestrian to avoid a crash?

New Age, Age-Old Dilemma

This is the type of scenario a game developed at MIT asks in a variation of the classic “trolley problem” thought experiment, which poses the following moral quandary: a runaway trolley is heading towards five unsuspecting workers. Do you pull a lever, sending the trolley down a different track where there’s only one worker, or do you do nothing and let it kill five?

MIT, in its “Moral Machine” game, presents people with a self-driving car with failed brakes and asks them to make a choice: swerve or stay straight; hit legal pedestrians vs. jaywalkers; hit a boy or an elderly man; etc.

That an autonomous car algorithm might have to make such a life and death decision shows how technology’s intersection with humanity is never black and white—or certain.

Lawmakers Forced to Play Catch-Up

Technology moves faster than the law and ethics.

In the first decades of the 20th century, when the number of cars on roadways exploded, there were no traffic laws, traffic signs, lane lines, or licensing requirements. The speeding vehicles terrified horses and ran over thousands of unaccustomed pedestrians, leading the state of Georgia to classify automobiles as “ferocious animals.”

Slowly, though, as the automobile became a staple of American life, governments figured out sensible legal solutions to the hazards cars were creating. A similar trajectory seems likely in response to whatever unintended consequences self-driving cars bring.

With the speed of technological change these days, the time may not be far off when human-driven cars are as quaint a concept as horse-driven carriages are today. Indeed, given the breakneck pace of innovation, the ink may not be dry on self-driving car legislation before lawmakers are grappling with flying cars.

Through all the changes, count on ClassAction.com to keep you up to speed.

5 FAQs About the New 9/11 Lawsuits

1. What is JASTA?

 The Justice Against Sponsors of Terrorism Act, or JASTA, allows victims of terrorist acts committed on American soil to file lawsuits against foreign governments who helped carry out the attacks. It creates an exemption to the foreign sovereign immunity that typically protects countries in these kinds of incidents.

Senator John Cornyn (R – TX) introduced the bill in September 2015. A year later, President Obama vetoed the bill, citing national security and diplomatic concerns. But days later, he was overridden by Congress via a 97-to-1 vote in the Senate and a 348-to-77 vote in the House.

JASTA was enacted on September 28, 2016. People who suffered physical, financial, or property damage as a result of the 9/11 attacks can now seek relief from foreign governments that they feel played a role in the attacks.

Stephanie DeSimone—the wife of Navy Commander Patrick Dunn, who died at the Pentagon on September 11—filed a 9/11 lawsuit against Saudi Arabia shortly after JASTA’s passing.

2. Why did Obama try to veto JASTA?

The main reason Obama vetoed JASTA (only to be overridden by Congress) is because the law could open up the U.S. to litigation over its military actions abroad (drone strikes, civilian casualties, etc.). Even if the U.S. was not convicted of wrongdoing, Obama argued, the evidence it would have to supply in the discovery phase of trial could jeopardize national security.

In his statement to Congress, President Obama said, “Enacting [this legislation] into law… would neither protect Americans from terrorist attacks nor improve the effectiveness of our response to such attacks.”

Of course, the point of the law is not protection or retaliation but relief for victims of 9/11 and accountability for its perpetrators.

Hold Them Accountable

3. Did the Saudi government play a role in 9/11?

Maybe. Fifteen of the 19 hijackers on 9/11 were Saudi citizens (the other four were from the United Arab Emirates, Egypt, and Lebanon).

Though the 9/11 Commission Report “found no evidence that the Saudi government as an institution or senior Saudi officials individually funded the organization,” it also noted, “Saudi Arabia has long been considered the primary source of al Qaeda funding.” Al Qaeda’s Osama bin Laden, of course, claimed responsibility for orchestrating the 9/11 attacks.

Also of note: Saudi Arabia spent more than $3 million dollars to lobby against JASTA, which also raised some eyebrows. If they don’t bear any responsibility for the 9/11 attacks, why did they try so hard to kill the bill?

As Senator Charles Schumer (D – NY) put it, “If the Saudis did nothing wrong, they should not fear this legislation.”

4. Who qualifies for a 9/11 lawsuit?

Anyone who suffered physical, financial, or property damage from the 9/11 attacks is now eligible to seek redress from foreign governments like Saudi Arabia’s, assuming they can prove liability on the part of that government.

Importantly, eligible parties may have filed domestic 9/11-related lawsuits in the past. For example, a potential client may have been denied redress in an earlier case because he was working at the time of his or her injury and awarded worker’s compensation. Whether a past lawsuit was successful has no bearing on the new 9/11 lawsuits that will be filed against foreign governments.

Qualifying parties may include:

  • Business owners in Lower Manhattan/the Financial District
  • First responders (police, firefighters, etc.) on 9/11
  • Spouses and family members of 9/11 casualties
  • People working in the Pentagon or at Ground Zero on 9/11
  • Cleanup workers at the attack sites

5. What types of relief do people seek in a 9/11 lawsuit?

Depending on the circumstances of the case, plaintiffs may seek relief in a 9/11 lawsuit for the following:

  • Property damage
  • Loss of business/wages
  • Medical bills
  • Pain and suffering
  • Funeral expenses
  • Punitive damages
  • Attorney fees

Our attorneys have extensive experience with complex litigation. As one of the largest consumer protection firms in the country—with 300+ attorneys and a support staff of more than 1,500—we are one of the few with the resources to take on a foreign government like Saudi Arabia. To date, we have won $2 billion for 200,000 clients.

If you or a loved one suffered losses as a result of these horrific attacks, the Saudi government may be partially to blame, and you could be owed compensation. For a free, no-obligation case review, contact us today or call 888-522-5237.

What You Need to Know About the 9/11 Lawsuit Bill

Congress has almost unanimously voted to pass the Justice Against Sponsors of Terrorism Act (JASTA), overriding a veto from President Obama. The bill, first introduced by Senator John Cornyn in September 2015, makes it easier for victims of terrorism to file lawsuits against foreign governments.

The Senate voted 97-to-1 in favor of the bill—a rare bipartisan victory. (Only Harry Reid of Nevada voted against.) The House voted 348-to-77 in favor. This marks the first override of a veto during Obama’s presidency.

Prior to the House vote, Representative Ted Poe (R—TX) said, “We as a people should be more concerned about these victims of terror than we are about democratic niceties… Justice has been waiting too long.”

JASTA Allows Families of 9/11 Victims to Sue Saudis

Capitol_hillHistorically, international law has largely protected governments from being sued under the Foreign Sovereign Immunities Act. However, the JASTA bill creates an exception and allows civil claims to be filed against foreign governments for acts of violence and terrorism that occur on U.S. soil.

Specifically, the bill states that the plotting and planning of acts of violence do not have to happen on U.S. soil. It also holds foreign governments accountable for aiding and abetting acts of violence, whether or not they performed the acts themselves.

These clarifications make it easier for 9/11 victims (including families of the deceased and businesses that sustained economic losses) to file lawsuits against the Saudi government for their alleged involvement in the terrorist attacks.

Though an independent commission did not find evidence that the government or a senior official officially supported the 9/11 terrorist attacks, recently declassified information indirectly connects Saudi Ambassador Prince Bandar bin Sultan to al Qaeda.

“We want accountability.”

Families of 9/11 victims say they want answers concerning the horrible acts that claimed the lives of their loved ones. “We want accountability,” said Terry Strada, whose husband died in the World Trade Center. “I think the truth would be the first thing, our mission.”

Opponents Fear Foreign Backlash

Justice and answers are not enough though to sway opponents of the new legislation, who argue that it could damage foreign relations.

Opponents fear that the bill will result in foreign governments pulling their assets out of the United States. Saudi Arabia allegedly threatened to liquidate $750 billion in U.S. assets should the bill pass, though some believe this to be an empty threat.

The Obama administration also argues that the act could set legal precedent and result in future lawsuits against the U.S. government and military personnel. They point to the U.S. military’s actions in the Middle East as easy targets for potential lawsuits.

However, supporters argue that because of the bill’s narrow scope, it is unlikely to trigger a significant uptick in litigation. JASTA only implicates countries who support terrorism—acts for which foreign governments should be held accountable.

Senator Chuck Schumer told The New York Times, “If the Saudis did nothing wrong, they should not fear this legislation.”

Saudi Arabia Enlisted Help from Lobbyists, Corporations

Saudi Arabia hired two lobbying firms and spent more than $3 million to try to kill the legislation.

Though Saudi Arabia continues to claim they are innocent of any involvement in the 9/11 attacks, they hired two lobbying firms and spent more than $3 million to try to kill the legislation.

The kingdom also used the Saudi Arabian assets of some Fortune 100 companies to their advantage. Companies like General Electric, Chevron, Boeing, and Dow Chemical all quietly opposed the bill, fearing the security of their assets abroad.

ClassAction.com Attorneys Are Investigating

ClassAction.com attorneys are keeping a close eye on the new 9/11 lawsuit legislation. We currently have former FBI investigators looking into possible connections to Saudi Arabia in the 9/11 terrorist attacks, and will keep you up to date on our findings.

Essure Lawsuits Explained in the Context of Federal Preemption

Since it was approved in 2002 about 900,000 women have been implanted with the Essure permanent contraception device. Manufacturer Bayer has acknowledged receiving over 30,000 reports of Essure adverse events, while the FDA has received around 10,000 Essure complaints. A Facebook support group for women suffering from Essure-related health problems—which asks “Has your life become a living hell since having the Essure procedure done?”—has more than 30,000 members.

Federal preemption, Bayer claims, makes it immune to injury lawsuits. But this isn’t necessarily the case.

To date, however, only about 1,000 women have stepped forward and filed Essure personal injury lawsuits.

Clearly, the number of reported Essure problems doesn’t correlate well with the number of Essure lawsuits. A big reason for this is something called “federal preemption” that, according to Bayer, makes it immune from Essure injury claims.

But recently, and in opposition to Bayer’s legal arguments, judges have allowed certain Essure claims to proceed. ClassAction.com takes a look at what federal preemption means for women seeking redress for alleged Essure injuries, why some claims have been allowed to proceed, and why Essure may serve as a springboard for a broader preemption discussion.

Federal Preemption

Federal preemption is a legal concept rooted in the U.S. Constitution’s Supremacy Clause (Article VI, Paragraph 2), which establishes that the federal constitution (and federal laws in general) are the supreme law of the land. In other words, where state and federal statutes, regulations, and common law civil actions come into conflict, federal law takes precedence.

There are two types of federal preemption: explicit and implicit. Explicit preemption occurs when a federal statute expressly reserves to the federal government an area of legislation. Federal law can also preempt state law implicitly, even if it does not do so explicitly, if the enforcement of state law interferes with federal purposes.

Lawmakers don’t have perfect foresight. New legislation as well as societal changes (particularly technological ones) make it necessary at times for courts to interpret whether there is a genuine conflict between a state law and a federal law on the same subject. These interpretations create precedents that come to bear on relevant future questions of federal preemption.

Hold Bayer Accountable

FDA Authority

The Federal Food, Drug, and Cosmetics Act (FDCA), passed in 1938, authorized the Food & Drug Administration (FDA) to oversee food, drug, and cosmetics safety. Its passage, prompted by the poisoning death of 107 people from a legally marketed toxic elixir, gave the FDA authority to demand safety evidence for new drugs.

Congress added the requirement in 1962, through the Kefauver-Harris Amendments, that FDA demand evidence of product effectiveness, in addition to evidence of safety. The 1976 passage of the Medical Device Amendments (MDA), which followed a Senate finding that faulty medical devices were responsible for more than 700 death and 10,000 injuries, extended safety and effectiveness standards to new medical devices.

MDA also contains an express preemption clause (21 U.S.C. §360k) that says state device requirements for safety and effectiveness cannot trump federal (FDA) requirements. Importantly, however, the clause does not prohibit states from imposing standards that run parallel to federal law, does not expressly prohibit medical device lawsuits based on state tort claims, and only applies to Class III medical devices (the highest-risk medical devices, subject to the highest level of regulatory control).

Riegel v. Medtronic

A Supreme Court ruling in a 2008 case involving the question of federal preemption created the precedent that is currently making it difficult for women harmed by Essure to file personal injury lawsuits.

Courts cannot enforce state laws on medical devices with Premarket Approval, unless the regulations are the same as corresponding FDA regulations.

In Riegel v. Medtronic, Charles Riegel brought suit under New York law against device manufacturer Medtronic after a catheter—an FDA-approved Class III medical device—burst in his coronary artery during surgery. Medtronic argued that because the device was subjected to FDA approval requirements, letting the case proceed would impose state requirements and undermine FDA power.

The court agreed but Riegel challenged the ruling. Eventually the issue was put before the Supreme Court, which upheld the decision. Riegel v. Medtronic thus established that federal preemption applies to devices determined to be safe and effective by the FDA through its rigorous premarket approval (PMA) process (although devices approved through the less-stringent 510(k) process are a different story).

As a result, courts cannot enforce state regulations on medical devices with PMA, unless the restrictions are the same as corresponding FDA restrictions. This caveat provides a small window of opportunity for plaintiffs to bring state law medical device claims against PMA-approved devices.

Essure Lawsuits

A recent California state judge ruling has given some hope to women with Essure injury claims.

On August 2 Alameda County Judge Winifred Smith ruled that a narrowed set of claims from 14 women could proceed against Bayer because they sought to impose a parallel standard (rather than a different or tougher standard).

Smith said that the women’s failure to warn claims, which allege that Bayer did not report more than 32,000 Essure complaints to the FDA, were not preempted under California law. Also not preempted were breach of warranty, fraud, and negligent misrepresentation claims over advertising and promotional materials not subject to FDA approval. Plaintiff claims for manufacturing defect and negligent training of physicians, however, are preempted, Smith ruled.

A Pennsylvania federal judge similarly ruled earlier this year that a narrow set of claims, including those for negligent misrepresentation and negligent failure to warn, could proceed. But a different California judge ruled in February that an Essure lawsuit could not proceed due to federal preemption. These different outcomes reveal the significance of state law, as well as the importance of judicial interpretation of those laws, when it comes to preemption.

Bills Seek to Undo Preemption

The 1976 Medical Device Amendments was not intended to grant manufacturers of defective medical devices immunity from personal injury lawsuits. Yet thanks to the Supreme Court’s ruling in Riegel v. Medtronic, that is precisely what has happened.

Rep. Mike Fitzpatrick has introduced two bills that would make Essure lawsuits easier.

In 2012 the Supreme Court declined a petition to review a case (Walker v. Medtronic) decided by the U.S. Court of Appeals which had confirmed MDA preemption as interpreted in Riegel v. Medtronic. The Supreme Court’s refusal to review the decision preserves the current preemption analysis being implemented by the federal courts. This has led to legislative efforts aimed at stripping device makers of the preemption defense.

Rep. Mike Fitzpatrick (R-PA), working closely with Essure victims, introduced in November 15 the “E-Free Act” (aka H.R. 3920). If passed, the Act would withdrawal FDA approval of Essure, thereby making the federal preemption argument irrelevant.

Fitzpatrick also introduced H.R. 5403 (Ariel Grace’s Law), a bill that would amend section 360k of the Food, Drug, and Cosmetics Act so that “Nothing in this section shall be construed to modify or otherwise affect any action for damages or the liability of any person under the law of any State.”

Both of Fitzpatrick’s bills were sent to committee in June 2016.

FDA Medical Device Standards Fail to Protect Public

Giving the FDA the last word on medical device safety may not be the wisest idea, considering the agency’s track record of approving devices based on questionable evidence.

Essure is a textbook example of FDA approval shortcomings. A Northwestern University study published in 2016 looked at 18 Class III devices approved by the FDA from 2000 to 2015 and found that 22% were given market clearance despite a failure to show effectiveness during clinical trials. The study authors noted that Essure approval was based on short-term evidence and insufficient post-market follow-up.

Of the PMA process in general, the study’s lead author said, “Despite this being the most stringent pathway, and despite the fact that we’ve had multiple safety issues connected to OB-GYN devices affection millions of women worldwide, the evidence leading up to approval has a lot of weaknesses.”

FDA did finally order Bayer to conduct a postmarket surveillance study about Essure’s benefits and risks—more than 14 years after it was initially approved, and only after tens of thousands of women filed adverse event reports. FDA additionally ordered a “black box” warning be added to Essure based on concerns over serious complications such as abnormal bleeding, autoimmune reaction, and tearing of the uterus or fallopian tube. Again, this move was too little too late for women who would have benefited from a stronger warning in the first place.

If the FDA cannot ensure the safety and effectiveness of medical devices, then injured patients at the very least need a clear path to personal injury lawsuits. Absent corrective legislation, medical device users will continue to be at the mercy of an organization that has shown it is incapable of protecting the public health.

Attorney Choice Matters in Essure Lawsuits

Courts’ interpretation of medical device preemption laws make it very difficult—but not impossible—to successfully bring Essure lawsuits.

Plaintiffs have a narrow window through which to assert their Essure injury claims. Their arguments and the evidence used to support them must be extremely solid. For these reasons, it is of the utmost importance to work with an experienced, knowledgeable personal injury attorney who can craft a legal strategy that survives Bayer’s dismissal efforts.

To learn more, schedule a free case review with ClassAction.com.

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