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. Next it will move to the House of Representatives for a vote.

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 more difficult. But whether that’s a good thing—and whether or not H.R. 985 will pass—remains to be seen.

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.

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

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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.)

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.

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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