Trial Magazine

Pharmaceutical and medical device companies develop products to address health issues—whether treating or curing diseases or stemming infectious disease outbreaks. However, along with the benefits come risks. When manufacturers ignore or cover up these risks, the negative health consequences can be devastating. And these injuries are not limited to an individual; they are by nature mass torts affecting the thousands or millions of patients who use the product. Trial lawyers are key to ensuring that manufacturers are held accountable, which often reveals dangers previously unknown to regulators, health care professionals, and consumers.

The first drug mass tort suit involved MER-29 (triparanol), approved by the FDA in 1960 to lower cholesterol. In December 1961, after approximately 400,000 people had used MER-29, manufacturer Richardson-Merrell finally issued a warning to physicians that the drug caused cataracts, baldness, and severe dermatitis. The company withdrew the drug from the market in April 1962, but approximately 5,000 people already had been injured. At first, patients filed largely unsuccessful individual suits, but by 1963, attorneys had formed a group to coordinate MER-29 claims—through the products liability exchange maintained by AAJ (then known as the National Association of Claimants’ Compensation Attorneys)—helping patients finally get justice.

To hold Big Pharma responsible for injuries from dangerous or defective drugs and devices, plaintiff attorneys have expanded on lessons learned from early litigation such as MER-29. Their efforts have led to increased safety warnings and FDA action to remove unsafe products from the market.

Common Claims

When a patient has been injured by a drug or device, the claims will vary, depending on the circumstances surrounding the injury.

Improper marketing. Drugmakers may not make false or misleading statements about a drug’s risks and benefits. This was a key issue in the Vioxx litigation, resulting in one of the largest drug marketing settlements of its time. Promoted as a safer pain medication causing fewer gastrointestinal problems than older medications, the FDA approved Vioxx in 1999. However, by the end of that year, data revealed that Vioxx users had twice the risk of heart problems as patients using an alternative naproxen painkiller. In 2001, the FDA sent drugmaker Merck a warning letter about its promotional campaign for Vioxx and how it minimized the potential for serious cardiovascular side effects. But by the time Merck finally withdrew the drug from the market in 2004, 20 million Americans had taken it—resulting in an estimated 88,000 heart attacks and 38,000 deaths. Merck agreed to pay $4.85 billion to settle approximately 47,000 personal injury suits and 265 class actions.

Another common claim is that a manufacturer improperly marketed a drug for “off-label” uses—those unapproved by the FDA. Manufacturers seeking FDA approval must conduct trials before they can market and sell a drug for a specific use, and the agency has long taken the position that promoting a drug for a use other than that supported by trial data is prohibited under the Federal Food, Drug, and Cosmetic Act (FDCA). While doctors are permitted to prescribe drugs off-label, manufacturers’ marketing materials cannot promote drugs for off-label indications or populations, absent certain circumstances. For example, unless a drug has been approved for use in children, promotional materials cannot imply that it’s safe for children.

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In off-label marketing claims, trial lawyers have successfully argued that drugmakers downplayed products’ risks while promoting them for uses the FDA never approved.

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Several drugmakers have been held accountable for off-label promotion claims. In 2013, Johnson & Johnson (J&J) paid $2.2 billion to settle claims that it improperly marketed its drugs, including the schizophrenia drug Risperdal, for unapproved uses. Later, a Philadelphia jury ordered J&J to pay $8 billion in punitive damages in a case accusing the drugmaker of marketing Risperdal for treatment of certain mental health disorders in children and downplaying its risks, such as breast growth in males.

In 2012, Abbott Labs agreed to pay $1.5 billion in penalties to settle claims regarding its promotion of Depakote—approved only for patients with epileptic seizures, bipolar mania, and migraines—as treatment for schizophrenia and for agitation and aggression in elderly dementia patients. Lawsuits followed, claiming the drugmaker failed to disclose the drug’s risks when used during pregnancy.

GlaxoSmithKline (GSK) reached a settlement the same year with the U.S. Department of Justice for promoting off-label uses of three of its drugs, including Paxil—which it promoted for use in children and adolescents to treat depression, despite the lack of efficacy data and the known risks. That $3 billion settlement was the largest health care fraud settlement in U.S. history.

Plaintiffs have also successfully brought off-label marketing claims in hormone replacement therapy and testosterone litigation, arguing that drugmakers downplayed risks while promoting products they claimed prevented everything from cardiovascular disease to Alzheimer’s disease to fatigue to sexual dysfunction—uses the FDA never approved.

Contamination. When an unintended product or ingredient ends up in a drug, it is considered to be adulterated or contaminated. Contamination may occur when manufacturers do not ensure their operations are free from impurities such as microorganisms. In 2010, GSK agreed to pay $600 million to settle civil claims stemming from known contamination issues at its Puerto Rico manufacturing plant. 

Recent adulterated drug suits have focused on contamination resulting from a byproduct of the manufacturing process itself. This is particularly common for generic drugs whose manufacturers may alter the manufacturing process.

For example, in 2018, the FDA began recalling batches of the generic hypertension drug valsartan that were contaminated with carcinogens N-nitrosodimethylamine and N-nitrosodiethylamine. The recall has since expanded and now involves multiple drug manufacturers. In the resulting valsartan multidistrict litigation, patients exposed to these carcinogens argued that the drug was adulterated, defectively manufactured, and misbranded because it contained ingredients (the contaminants) not on the label.

Defective design. Some drugs and devices, even if manufactured according to plan, are defective by design. This may be because the product design is faulty or—especially in devices—the materials called for are inadequate for the intended purpose.

Tens of thousands of patients implanted with hernia and transvaginal mesh have filed claims alleging design defect after their mesh implants failed and caused severe injuries—often requiring revision surgery. Whereas mesh has been used to repair abdominal hernias since the 1950s, it was first used for transvaginal repair of pelvic organ prolapse in the 1990s, and the FDA cleared it for this use in 2002.

But patients claimed that the mesh eroded, shrank, and promoted bacteria growth and that the products were defectively designed when sold and unreasonably dangerous considering their uses and risks. After several courtroom victories for plaintiffs, in 2019 the FDA ordered manufacturers to stop selling and distributing transvaginal mesh, noting safety and efficacy concerns.

Another device that was defectively designed was metal-on-metal hips—reintroduced in the 1990s as an alternative to conventional implants for active patients. But by 2010, after being used in over 80,000 hip replacements, patients and their doctors raised concerns that the devices caused tissue and bone damage, as well as elevated cobalt and chromium levels. Thousands of patients received defective hip implants, and the FDA has since placed metal-on-metal hips in the strictest regulatory category for devices—currently, there is no FDA-approved metal-on-metal total hip replacement device.

Strict products liability. Some products are so dangerous that manufacturers may be held accountable whether or not they were aware of or took actions to remedy issues with the product. In 2013, a jury awarded over $8 million to a man whose metal-on-metal hip implant had caused him years of severe pain and loss of mobility. The jurors found that device maker DePuy Orthopaedics was strictly liable for selling a product with a defective design, and a state appellate court affirmed.

Defenses and Counterarguments

Patients injured by drugs and devices face many roadblocks when they sue Big Pharma. For years, drug and device companies have been working to create immunities and restrict or minimize liability for their misconduct. And while the defenses that trial lawyers and plaintiffs confront every day are numerous, here are some of the most common ones they have faced down.

Preemption. This spans many practice areas but has a particularly colorful history in the drugs and devices sphere. Device manufacturers often argue they cannot be liable because the FDA approved and regulated the device. In Riegel v. Medtronic, Inc., the U.S. Supreme Court agreed with this argument, holding that a patient injured during surgery by an FDA-approved catheter could not bring claims challenging the safety or effectiveness of that device in the form approved by the agency.

But the preemption analysis differs for plaintiffs injured by drugs. Defendants often argue that so-called “impossibility preemption” applies—that they cannot comply with both federal and state law and therefore federal law overrides potentially stronger state law requirements. In these cases, plaintiff attorneys have made headway when they can show that drug manufacturers could have added an adequate warning and complied with both the FDA’s labeling requirements and state law warning requirements.

The Supreme Court found this to be true in Wyeth v. Levine, which involved a patient who contracted gangrene and required amputation after she received an antinausea drug via IV-push. The drug’s risk would have been almost entirely eliminated if administered by IV-drip instead, but its label contained no such warning. The Court held that Wyeth could have added a warning via the changes being effected process and that there was no “clear evidence” the FDA would have rejected this label change. The Court also rejected Wyeth’s argument that the FDCA preempts state law failure-to-warn claims.

Ten years later, the Court revisited the boundaries of impossibility preemption for drug cases in Merck Sharp & Dohme Corp. v. Albrecht, which involved an osteoporosis drug linked to atypical femoral fractures. Here, the Court clarified that the clear evidence standard is met only if the drug manufacturer “fully informed” the FDA of the justifications for a warning and, in turn, the FDA informed the manufacturer that it would not approve a change to the drug’s label to include that warning. The Court also found that judges, not juries, should determine whether a warning is preempted.

Recently, in In re Zofran (Ondansetron) Products Liability Litigation, a Massachusetts federal district court applied the clear evidence standard from Albrecht and granted the defendant’s summary judgment motion based on preemption. The district court found that the FDA was fully informed of the justifications for a birth defect warning on the antinausea drug’s label but had rejected the plaintiffs’ proposed label changes. This case has been appealed to the First Circuit.

When raised by generic drug manufacturers, the preemption defense has had more sticking power. In PLIVA, Inc. v. Mensing, patients sought relief after being injured by generic metoclopramide, a drug treating digestive tract problems that has been linked to tardive dyskinesia—a condition causing repetitive, involuntary movements such as grimacing. The Supreme Court held that the generic manufacturers could not have independently changed the drug label to warn of the risks because doing so would have violated federal law requiring generic drug labels to correspond to brand-name labels.

Learned intermediary doctrine. When patients claim they were not adequately warned of the risks of a drug or device, one common response from manufacturers is that the plaintiffs’ doctors were warned and were in the best position to assess the risks and benefits. A manufacturer’s obligation to warn applies only to the physician—not to the patient. If a manufacturer warns the physician of the risk, its duty to warn is discharged.

This line of defense dates back to a 1948 decision in Marcus v. Specific Pharmaceuticals, Inc., when the drugmaker was sued after a child’s overdose from too large an amount of a suppository. The court reasoned that because the drug was available by prescription only, the drugmaker could not be liable for failing to warn the child’s parents about the correct dosage amount.

The defense was adopted in some form by more and more jurisdictions—at least 37 state high courts—but has faced criticism that it is based on an outdated view of the doctor-patient relationship and the American health care system. Plaintiff attorneys have pointed to drugmakers’ massive direct-to-consumer advertising campaigns, and some courts have agreed that these have changed the duty to warn.

Protecting Patient Groups

Historically, some patient groups have been particularly vulnerable to health care product-related injuries. Pharmaceutical and medical device makers have much too frequently introduced women’s health products without adequate safety and efficacy data. They’ve also marketed unsafe health care products specifically to minority populations. Trial lawyers have been leading the fight to bring these safety issues to light, often resulting in increased warnings or even recalls, while also helping those who have been injured.

Women’s health products. An early case involved the Dalkon Shield, marketed in 1971 as “a superior modern contraceptive” by device maker A.H. Robins. However, after approximately 2.8 million devices were sold around the country, they were linked to serious pelvic infections—leading to sterility, hysterectomies, and even death. More than 400,000 claims against the device maker were resolved, and more than $3 billion was paid to plaintiffs. The device was taken off the market in 1974 but was not officially recalled until 1980.

And as device makers keep introducing unsafe contraceptives to the market, plaintiff attorneys continue their fight. More recently, women injured by Essure devices that broke and migrated in their bodies sued device maker Bayer, alleging it failed to report mounting adverse events of the device’s serious side effects. After approving Essure in 2002, the FDA received more than 26,000 adverse event reports by the beginning of 2018. Bayer stopped selling the product later that year. In August 2020, Bayer agreed to pay $1.6 billion to resolve about 90% of the approximately 39,000 claims against it.

Used to treat menopause symptoms, hormone replacement therapy (HRT) drugs like Prempro have been linked to an increased risk of cardiovascular disease, stroke, and breast cancer. When a 2002 Women’s Health Initiative study revealed these risks, an estimated 15 million postmenopausal women in the United States had been prescribed HRT. Plaintiff attorneys took the lead to help the thousands of women injured by the drugs. They also compelled the release of internal company documents to the public, which significantly increased awareness of the danger and the companies’ cover-up.

Another battle has been over the power morcellator, first introduced in 1995 and used primarily in laparoscopic surgeries to remove uterine fibroids and to perform hysterectomies. However, in women with undiagnosed uterine cancer, the device can shred cancerous tissue and spread it, making the cancer much more difficult to treat. The FDA issued warnings in 2014, and injured women and their families began filing suit—these actions caused one of the highest-profile makers of the device, J&J subsidiary Ethicon, to pull its device off the market.

Minority patients. Cosmetic products, in particular, have been marketed to people of color despite safety risks. In the talc cases against J&J, for example, internal company documents revealed that after the World Health Organization classified cosmetic talc as a possible carcinogen in 2006, the company focused its marketing efforts on “underdeveloped geographical areas with hot weather, and higher [African American] population.” The drugmaker faced more than 34,000 federal talcum powder lawsuits, as well as hundreds of suits in state courts, alleging its powder caused ovarian cancer and mesothelioma. After years of litigation and multiple plaintiff verdicts, in May 2020 J&J announced it would stop selling talcum powder products in the United States and Canada.

With recent studies showing that women of color are disproportionately at risk of exposure to toxic cosmetic products—including skin lightening creams, hair straightening and relaxing treatments, and feminine hygiene products—it’s likely the talc litigation is the tip of the iceberg.

And people of color constitute nearly 40% of the U.S. population but less than 20% of clinical trial participants. Diversity in clinical trials is crucial to ensure drugs and devices are safe and effective for all.

Plaintiff attorneys play a key role in spurring manufacturers to remove dangerous drugs and devices from the market or to add more specific warnings. By raising awareness of the risks of these products and pushing regulators to act, they have been indispensable in ensuring that the injured get some measure of justice.

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The Endless Battle Against Big Tobacco

After countless cancer diagnoses and deaths, trial lawyers representing former smokers and their families faced many challenges in holding the massive and well-funded tobacco industry accountable—a battle echoed today in litigation against e-cigarette manufacturers. Scientific studies dating back to the 1950s (and some say even earlier) show the dangers of tobacco smoking, but for years, plaintiffs’ claims against tobacco companies were unsuccessful—and manufacturers continued to promote cigarettes while downplaying any health risks. And after Congress passed legislation in the 1960s requiring a surgeon general’s warning on packs of cigarettes and banning cigarette advertisements on television and radio, the tobacco industry’s winning argument was that former smokers were preempted from bringing personal injury claims due to these warnings.

That changed with Cipollone v. Liggett, a case involving a woman who died of lung cancer at 58 after smoking for 42 years. After a 1984 success for the Cipollone family in New Jersey federal district court on the preemption issue and a jury verdict four years later, the U.S. Supreme Court in 1992 largely affirmed the district court’s findings. While failure-to-warn claims alone were not viable, the Court concluded, plaintiffs could bring claims that tobacco companies made fraudulent or inaccurate statements in advertisements or that they conspired to mislead smokers about health hazards.

Successes for plaintiffs followed, and in 1998, the four largest cigarette companies and 46 states, five territories, and the District of Columbia entered a settlement agreement requiring the companies to pay billions annually in perpetuity while imposing significant restrictions on marketing, including forbidding youth-targeted ads, transit and most outdoor ads, and most sponsorships.

Individual plaintiffs too saw successes in the 1990s and early 2000s, including a record-breaking $51.5 million California jury verdict against Philip Morris for a woman with inoperable lung cancer and, just a month later, an $81 million Oregon jury verdict against Philip Morris for the family of a man who died of lung cancer after smoking Marlboro cigarettes for four decades.

These verdicts signaled a willingness of jurors to hold tobacco companies accountable for years of deception. And while a Florida class action in Engle v. R.J. Reynolds Tobacco Co. resulted in billions in punitive damages for smokers and their families, a state appellate court found the group to be too disparate to be certified as a class. But the Florida Supreme Court allowed each of the former class members’ claims to proceed individually in Engle progeny suits—cases that are still heard today.

In 2008, the Supreme Court again found in favor of plaintiffs in Altria Group, Inc. v. Good. It reached back to its reasoning in Cipollone to find that manufacturers’ promotion of cigarettes as “light” fraudulently conveyed the message that these cigarettes contained “lowered tar and nicotine” and therefore were safer. This constituted a violation of Maine’s Unfair Trade Practices Act and was not preempted by federal law on cigarette advertising.

Recently, history repeated itself with e-cigarette companies’ tactics of marketing their sleek vaping devices and fun-flavored pods to young people on social media and billboards. Entering the U.S. market in 2007, e-cigarettes were touted as a safer alternative to traditional cigarettes and as an aid to help people stop smoking. But by 2020, one in five high school students had used e-cigarettes, despite the fact that many had never smoked a traditional cigarette—and many did not know that e-cigarettes contained nicotine, as well as potentially harmful ingredients and additives. Reports of vaping-related illnesses, particularly those affecting the lungs, grew, resulting in almost 3,000 hospitalizations by early 2020.

Trial attorneys once again took action to hold manufacturers accountable, filing more than 2,000 cases against Juul and Altria Group that have been consolidated into multidistrict litigation (MDL). The plaintiffs allege the defendants intentionally designed their products to increase the risk of nicotine addiction and to appeal to young people. The MDL is pending, but this year Juul agreed to a $40 million settlement with North Carolina—its first with a state—rather than face the state’s claims in court that it designed, marketed, and sold its e-cigarettes to attract young people and misrepresented the potency and danger of nicotine in its products. The settlement requires the company to make payments to the state over six years, stop targeting young people through advertisements, and maintain a secret shopper program to ensure products are not sold to underage consumers, among other things.

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Fighting an Epidemic

70,630 died due to opioids in 2019 and more than 93,000 died in 2020. 10.1 million people had misused prescription opioids in the past year as of 2019—and 1.6 million had an opioid use disorder. How did we get here?

The risks of opioids have been long-recognized—international agreements were reached as early as 1912 in an attempt to control opiates and prevent nonmedicinal uses. However, by the end of the 20th century, the drug industry had convinced the public that synthetic opioids were safe for widespread use to manage pain. Opioid prescriptions nearly quadrupled from 1999 to 2014, though no corresponding increase in pain was reported by patients.

State attorneys general and trial lawyers have filed thousands of lawsuits seeking to hold opioid manufacturers, distributors, and dispensers accountable for their role in the opioid epidemic. In federal court, the opioid multidistrict litigation includes approximately 2,500 cities, counties, tribes, labor unions, and other entities. And state attorneys general and other entities, such as hospitals, are pursuing similar claims in state courts.

The theories of liability vary: Many suits allege that manufacturers, beginning in the 1990s, engaged in misleading marketing that downplayed the risks of opioid painkillers while overstating their benefits. Distributor and dispenser suits allege these entities supplied prescription opioid medications even though they knew or should have known, based on local population sizes, that too many pills were flooding the market. CDC data shows that in 2019, in 5% of U.S. counties, there were enough opioid prescriptions dispensed to cover every person in the county.

In the first ruling to hold a drugmaker liable for its role in the opioid crisis, in 2019, an Oklahoma judge ordered Johnson & Johnson to pay $572 million to the state after more than 6,000 Oklahoma residents died. Several drug manufacturers have settled rather than face trial. For example, J&J agreed to a $20.4 million settlement with two Ohio counties in 2019 to avoid what would have been the first federal trial. And generics manufacturer Mallinckrodt Pharmaceuticals agreed to pay $24 million to those counties, as well as provide $6 million in drugs, including addiction treatment medications.

Many companies have filed for bankruptcy in the wake of the litigation, and trial lawyers are working to ensure these companies don’t escape accountability to the people they’ve injured. Purdue Pharma’s pending settlement, recently approved by a bankruptcy court but under appeal, would provide billions to states, localities, tribes, and more—however, with a controversial catch: It would absolve the company’s owners, the Sacklers, of any future liability related to the opioid epidemic.

Suits to hold distributors liable for their part in the opioid epidemic also have moved forward. In 2019, the “big three” distributors—AmerisourceBergen, Cardinal Health, and McKesson—and drugmaker Teva agreed to pay two Ohio counties roughly $260 million for their role in the opioid crisis just hours before trial.

This past summer saw a landmark federal trial in West Virginia. Plaintiff lawyers in that case argued on behalf of a West Virginia town and county that it was unreasonable for distributors to ship approximately 81 million opioid pills over eight years to a small community of about 100,000. That case is pending. And in September, the Cherokee Nation—the first Native American tribe to sue opioid distributors and pharmacies—reached a $75 million settlement with the big three distributors. The settlement proceeds will fund mental health and recovery treatment.

But this July brought one of the broadest successes—manufacturer J&J and the big three distributors agreed to a $26 billion multistate opioid settlement that would cover states and localities. In addition to monetary relief—much of which would be used for opioid abatement—the settlement would bar J&J from manufacturing, selling, and promoting opioids for 10 years. It also would establish a clearinghouse to track the three distributors’ opioid shipments. Forty-two states, five territories, and the District of Columbia signed on to the settlement, and localities have until Jan. 2, 2022 to join.