Top Mass Torts of 2022
In March 2019, a federal jury found that Monsanto’s weedkiller Roundup caused Edwin Hardeman’s cancer and returned a verdict of $80 million, $75 million of which represented punitive damages aimed at Monsanto’s reprehensible conduct. Monsanto appealed, first unsuccessfully to the U.S. Court of Appeals for the Ninth Circuit, and then to the U.S. Supreme Court, arguing (among other things) that the EPA’s approval of Roundup labeling preempted state failure-to-warn claims.
Despite the fact that the same issue was previously decided against the manufacturer in the 2005 case of Bates v. Dow Agrosciences LLC, 544 U.S. 431, the Supreme Court sought the input of the U.S. Solicitor General on the case, suggesting it was at least considering taking the case up for review.
While this appeal was pending, the U.S. Environmental Protection Agency sent a letter to the State of California stating that the EPA would allow warning language California had proposed on Roundup bottles sold in California. This development significantly undercut Monsanto’s argument that it would be impossible for it to comply with both the EPA-mandated labeling requirements and the warning standard the Hardeman and other plaintiffs would hold it to.
Ultimately, the U.S. Supreme Court denied Monsanto’s appeal, leaving both the Hardeman decision and, more importantly, the availability of common law causes of action against pesticide manufacturers intact.
Bayer, the parent company of Monsanto, previously set aside an additional $4.5 billion beyond what had already been allocated to pay Roundup claims. With individual continuing to develop Non-Hodgkin’s lymphoma and related diseases due to exposure to Roundup, this litigation remains viable in 2022.
- Talcum Powder
In 2021, the shot heard ‘round the world—at least in the world of mass torts—was the Johnson & Johnson talc-specific bankruptcy. The situation was unprecedented. A company valued at half a trillion dollars, with the highest possible credit rating (a feat shared by only one other company, Microsoft), created a shell company, assigned it all Johnson & Johnson’s talc-related liabilities, then promptly declared that shell company was bankrupt.
Perhaps even more surprising was that the federal bankruptcy judge overseeing the challenge to this settlement-by-fiat strategy upheld it in February 2022, writing that “justice will best be served by expeditiously providing critical compensation through a court-supervised, fair, and less-costly settlement trust arrangement.”
Nevertheless, the judge allowed an expedited appeal of his ruling to the U.S. Court of Appeals for the Third Circuit, and the Third Circuit has accepted the case.
Needless to say, the case has drawn the attention of both sides of the mass tort bar, and it remains to be seen whether this bankruptcy strategy will be used in other cases (the most obvious candidate being 3M, which faces substantial liability in both the combat arms earplug litigation and the PFAS—per- and polyfluoroalkyl substances—litigation.
With all this uncertainty, why does talcum powder remain a top tort of 2022? Whether Johnson & Johnson’s bankruptcy is dismissed or not, ovarian cancer cases caused by talcum powder are likely to result in compensation. Either the bankruptcy strategy will be upheld, resulting in compensation through a claims-submission process, or it will be dismissed, resulting in a settlement negotiation process outside of bankruptcy. Both scenarios suggest the litigation will be substantially resolved within a year or two. As with Roundup, we can expect cases to continue to appear as women develop ovarian cancer as a result of using talcum powder.
- Camp Lejeune
Between at least 1953 and 1987, people who lived and worked at the Camp Lejeune military base in North Carolina were exposed to contaminated water containing a number of dangerous chemicals, including trichloroethylene (“TCE”), perchloroethylene (“PCE”), benzene, vinyl chloride, and other volatile organic compounds. Exposure to these chemicals causes a host of diseases and medical problems, including cancers, miscarriages, infertility, birth defects, Parkinson’s disease, blood disorders. Due to the amount of time involved, it is believed that as many as a million people may have been affected.
Previous attempts to obtain compensation for veterans and their family members who got sick because of Camp Lejeune’s contaminated water were largely unsuccessful. Although there was multidistrict litigation, it was ultimately unsuccessful for a number of reasons. First, the Feres doctrine barred claims by veterans against the U.S. government for injuries caused by exposures that occurred while on active duty. Second, the court overseeing the litigation ruled that (1) North Carolina law applied to the cases and (2) North Carolina’s ten-year statute of repose barred most of the claims.
For the past several years, veterans and members of Congress have been working on a legislative fix, which culminated in the Honoring Our Pact Act of 2022. Among other things, the Act creates a federal cause of action for individuals who were exposed to contaminated water at Camp Lejeune between August 1, 1953, and ending on December 31, 1987. The Act also specifically provides that the statutes of limitations and repose that previously doomed the litigation do not apply, and although new limitations periods are imposed under the Act, they are sufficient to allow claims to be brought against the United States after the passage of the Act.
Both the House of Representatives and the Senate have passed versions of the Honoring Our Pact Act, and the Senate’s version is currently awaiting passage by the House, which is expected sometime in July 2022. Thereafter, it is expected to be signed by President Biden.
Camp Lejeune lawsuits made under the Act may only be filed in the U.S. District Court for the Eastern District of North Carolina. Under the Act (as well as the Federal Tort Claims Act), however, a suit cannot be filed until an administrative claim has been filed and denied. This requires the submission of a claim using Standard Form 95 to the Department of the Navy. Although Camp Lejeune is a Marine Corps base, the Department of the Navy has jurisdiction despite the Marine Corp being a separate service branch. If the administrative claim has not been accepted or denied within six months of submission, it is presumed denied. As such, expect litigation to begin in earnest six months after the passage of the Act.
Philips, previously the largest supplier of continuous positive airway pressure (“CPAP”) devices in the United States, issued a massive recall of its devices in June 2021. Before the recall, Philips controlled around 70% of the market for CPAPs and related devices; four million devices have been recalled so far. The recall stems from problems with the polyester-based polyurethane (“PE-PUR”) foam used to reduce sound and vibration, which was discovered to be degrading in the devices during use. Not only did the breakdown lead to inhalation of particles of the foam itself, but the chemical breakdown of the foam caused inhalation of dangerous chemicals that were emitted when the foam degraded. In addition to lung issues like asthma, the foam and the off-gassed chemicals cause cancer in the lungs, kidneys, and liver.
As expected, the recall, the FDA’s investigations—which revealed Philips was aware of issues with the foam going back to at least 2016—and the resultant injuries have led to largescale litigation against Philips. In October 2021, the Judicial Panel on Multidistrict Litigation transferred all pending federal actions to Judge Joy Conti in the Western District of Pennsylvania, which district encompasses one of the Philips facilities involved in manufacturing the subject foam. The CPAP litigation is somewhat unusual in that there are both large class actions and large numbers of personal injury actions consolidated into the same MDL, and it is expected that the litigation will proceed on parallel tracks within the MDL.
The CPAP litigation also proceeds in tandem with an investigation by the U.S. Department of Justice, which is investigating the recall.
Zantac (ranitidine) was once one of the most commonly used prescription and over-the-counter drugs. Unfortunately, it has become clear that Zantac is often contaminated by N-Nitrosodimethylamine (“NDMA”), classified as a probable human carcinogen, through a convergence of factors. When ranitidine—the active ingredient in Zantac—is exposed to heat, it degrades into NDMA. This process occurs in two ways. First, due to how and where Zantac was manufactured and shipped to U.S. consumers, it was regularly exposed to high heat, resulting in high levels of NDMA in Zantac before it was consumed. Second, exposure to the body’s own heat caused ranitidine to degrade into NDMA, leading to even higher exposures after consumption. The FDA therefore requested in April 2020 that all Zantac and ranitidine products be withdrawn from the U.S. market. While the brand “Zantac” is still available for purchase, it no longer contains ranitidine.
Individuals with a history of taking Zantac alleged it caused a number of cancers, and a large federal Zantac MDL has been pending in the Southern District of Florida before Judge Robin Rosenberg since February 2020. Significantly, the court ruled that claims against the generic manufacturers were preempted by operation of three cases: Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001); PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011); and Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013). The lead plaintiffs’ counsel later informed the court that of the myriad cancers alleged to be caused by Zantac, they would only provide expert evidence for bladder, esophageal, gastric, liver, and pancreatic cancers. The first federal trials are expected sometime in 2023.
At the same time, consolidated litigation in California state court is proceeding as well, and the first California trial is currently scheduled to begin February 13, 2023.
Exactech manufactures hip, knee, and ankle implants. In February 2022, it sent urgent letters to doctors and hospitals recalling almost 150,000 joint implants due to substandard packaging in its Optetrak, Truliant, and Vantage products going back to 2004. According to Exactech, substandard packaging exposed the implant components to oxygen, which in turn leads to premature wear and failure of the implants. In addition, it has been alleged that the plastic itself is deficient, apart from any effects of oxidation caused by bad packaging.
State-court litigation against Exactech—a Florida company—has been developing for some time, and the parties are well into discovery in those cases. At the same time, several federal suits have been filed, and a motion to consolidate the federal suits was filed in June 2022. The Judicial Panel on Multidistrict Litigation is expected to hear the motion in late September 2022 and will likely create an MDL.
Since it can take years for the implants to cause symptoms or fail, we can expect to see new cases to arise for several years to come.
- Similac Infant Formula Recall
In February 2022, Abbott Laboratories, the maker of Similac, Alimentum, and EleCare infant formulas, issued a recall due to suspected cases of Cronobacter sakazakii and Salmonella linked to contaminated formula manufactured at Abbott’s Sturgis, Michigan facility. FDA investigations of the facility showed both the FDA and Abbott itself found Cronobacter in the facility and in finished infant formula products.
Additionally, Abbott failed to test formula in violation of federal law.
We then learned in early May 2022 that a whistleblower who worked in quality control at the Sturgis facility that manufactured the formula sent a 34-page letter to the FDA in October 2021 detailing extensive food-safety-related deficiencies, as well as a culture of silence and retaliation. These allegations are consistent with the FDA’s findings going back to at least September 2019.
Additionally, the U.S. Department of Justice and Abbott recently entered into a consent decree relating to the Sturgis facility. The Department of Justice had been investigating the unsanitary conditions at the facility.
Finally, both the FDA and an executive for Abbott have testified before Congress about the recall and the facility. The FDA commissioner, Robert Califf, testified that “[f]rankly, the inspection results were shocking.
All these developments bode well for the litigation. Currently, there is a motion to consolidate both the class actions on behalf of consumers and the actions on behalf of children who became ill after consuming the tainted formula currently pending before the Judicial Panel on Multidistrict Litigation, which will hear arguments on the motion at the end of July 2022.
- Infant Formula – Necrotizing Enterocolitis
There is substantial evidence that premature infants fed cow’s-milk-based infant formula have a substantially increased risk of developing necrotizing enterocolitis (“NEC”), a devastating and deadly intestinal condition. For over 30 years, Abbott Laboratories and Mead Johnson, the manufacturers of Similac and Enfamil, respectively, and prominent public health organizations like the American Academy of Pediatrics have warned for years against feeding newborns cow’s-milk-based infant formulas.
Multiple centers of litigation against Abbott and Mead Johnson have developed over the past 18 months related to this formula. First, there is Illinois state court litigation in both Madison and Cook Counties. Mead Johnson has challenged fought being sued in state court, arguing that it is now an Indiana company and should therefore be allowed to remove to federal court. Other litigation had been brought in Connecticut and later other federal courts against these companies, and these suits were recently consolidated for pretrial purposes before Chief Judge Rebecca Pallmeyer in the Northern District of Illinois. At the end of May 2022, Judge Pallmeyer appointed 26 lawyers to the plaintiffs’ steering committee, and the consolidated federal litigation is still in its early states.
This litigation will proceed on parallel tracks in state and federal court. Since the state actions were filed much earlier, however, they can be expected to reach trial much sooner, which may ultimately drive Abbott and Mead Johnson to the bargaining table earlier than might otherwise be expected.
- Baby Food – Heavy Metal Poisoning
A 2019 study showed that 95% of baby foods tested contained dangerous levels of heavy metals like arsenic, lead, cadmium, and mercury. This in turn led to Congressional investigations, and in February 2021, the Subcommittee on Economic and Consumer Policy Committee on Oversight and Reform of the U.S. House of Representatives issued a report confirming these findings. These heavy metals were found in well-known brands such as Gerber, HappyBABY, Earth’s Best Organic, and Beech-Nut. Notably, Walmart, Sprout, and Campbell’s Soup refused Congress’s request for information. The Report also found that in 2019, the FDA ignored a presentation they had received by the industry in secret showing the risks of heavy metals in baby food.
Compared with other litigation, relatively few firms are involved in litigation relating to baby food containing heavy metals, and there are several reasons for this. There is a feeling that autism and ADHD are relatively ubiquitous parts of modern life. At the same time, neither conditions are well understood when compared with diseases such as mesothelioma or pigmentary maculopathy, both of which are easily diagnosable and strongly associated with particular product exposures. Finally, because there are many different manufacturers involved, and a parent may have fed their baby several types of baby food, it can be difficult to attribute a child’s autism or ADHD to a particular manufacturer’s product. All of these make case intake a difficult proposition.
This litigation gained significant support in May 2022, when a California state court ruled that a plaintiff’s expert could testify that his autism and ADHD was caused by consuming the heavy metals contained in the defendants’ baby foods. The ruling clears the way for the first trial to occur sometime in summer of fall 2022.
Since the 1960s, paraquat has been used as a weed killer (among other applications) in commercial farming, forestry, road maintenance, and commercial landscaping. While the acute effects of paraquat exposure are well known—even a thimbleful can be deadly—there has been less public awareness of the long-term effects of repeated, low-dose exposure. Recently, more and more scientific literature has identified the link between paraquat exposure and Parkinson’s disease, a neurodegenerative brain disorder. The science has also identified how paraquat causes Parkinson’s disease at the cellular level. Paraquat kills weeds by causing a chain reaction of oxidative stress within plant cells, and it turns out that the neurons in the part of the brain associated with Parkinson’s disease are particularly prone to oxidative stress. Paraquat enters the blood stream through the skin or mucous membranes, and when it reaches the neurons in the brain, causes a chain reaction of oxidative stress that ultimately kills them.
Paraquat litigation has been quietly been going on for almost ten years, but it was not until late 2020 that the broader litigation began to pick up steam. A motion to create the federal multidistrict litigation was filed in April 2021 (your author filed the motion), which led to the federal cases being transferred to Nancy Rosenstengel in the Southern District of Illinois. As of June 15, 2022, there were 1,292 active cases in the federal paraquat MDL, with other cases pending in the consolidated state proceedings in California.
By the time the federal MDL was formed, state-court litigation in Illinois had been ongoing for years, and in fact, those cases settled just before the first trial was set to begin, meaning extensive discovery had been completed by the time the federal litigation began. As a result, much of the discovery work that often bogs down litigation could be borrowed from the state litigation, and Judge Rosenstengel set an aggressive schedule for resolving the litigation.