Trends to Watch: 2023 Pharmaceutical, Medical Device & Health Care Litigation

Fewer - But Larger - Products Liability MDLs 

The Judicial Panel on Multidistrict Litigation (JPML) received fewer requests to create new MDLs over the past year (granting only a handful), yet the few that were created are likely to be significantly larger than average MDLs of years past. The push for multi-defendant MDLs, and a focus on products sold and broadly used for decades, such as over-the-counter drugs or retail products, are changing the size and scope of potential MDLs. The In re Acetaminophen - ASD/ADHD Prods. Liab. Litig., MDL No. 3043, may grow to include hundreds of thousands of plaintiffs, according to the plaintiffs' bar—especially given its focus on store brand acetaminophen widely used during pregnancy. Similarly, the pending motion to transfer in the In re Hair Relaxer Marketing, Sales Practices, and Prods. Liab. Litig., MDL No. 3060, may also grow to hundreds of thousands of plaintiffs, as the motion to transfer alleges injuries from use of hair relaxer products sold by dozens of companies over the course of several decades. The In re 3M Combat Arms Earplug Prods. Liab. Litig., MDL No. 2885, currently has over 260,000 claimants, while In re Zantac (Ranitidine) Prods. Liab. Litig., MDL No. 2924, topped 160,000 claimants. And most MDLs now also include consumer class action claims as well, further expanding their scope. It is therefore likely we will see more, not less, of these "mega" MDLs.

"Independent Laboratories" Fueling MDLs

Purportedly "independent" labs such as Valisure, which claimed to have allegedly found cancer-causing substance in the blood pressure drug valsartan and Emery Pharma, which claimed to have detected a carcinogen in the heartburn drug ranitidine (Zantac), are playing an increasingly important role in prompting the start of both media and regulatory activity that fuel the rise of mass tort litigation and MDL requests. In the last two years, these laboratories have been responsible for significant litigation over dry shampoo, deodorant, and sunscreen allegedly containing benzene and other chemicals. And the Valisure and Emery Pharma citizens petitions launched MDLs involving Valsartan and Zantac that are ongoing. In the Zantac MDL, in particular, plaintiffs used Emery Pharma test results and scientists to argue that amounts of NDMA to which users of Zantac were exposed were significantly higher than the levels found by FDA and industry in the products. On December 6, 2022, MDL Judge Robin Rosenberg excluded plaintiffs' general causation experts under FRE 702 and granted summary judgment to the defendants, finding the methodology used by Emery Pharma and other experts was flawed and unreliable. But this result came only after three years and millions of dollars in litigation cost to the defendants. Plaintiffs intend to appeal the ruling, but we expect this playbook to create and use junk science funded by the plaintiffs' bar will continue and expand to other types of products.

Shift of Mass Tort Focus from Prescription Drugs to Over-the-Counter Drugmakers and Retailers

With the Acetaminophen MDL and Zantac MDL as prominent examples, plaintiffs have recently shifted their focus away from prescription drugs, where proof of use may be harder to show, to over-the-counter drugmakers, retailers, and distributors as targets of mass tort litigation. In the Acetaminophen MDL, for example, plaintiffs named retailers and pharmacies, such as Wal-Mart, Costco, CVS, Walgreens, and Target as defendants selling the over-the-counter drug acetaminophen (also sold under the brand name Tylenol), but did not also name the manufacturers or holders of federal regulatory approval to manufacture, market, and label such products. Unlike prescription drugs where product identification and proof of use may be fully dispositive issues, and where the learned intermediary doctrine and testimony from prescribers may present summary judgment grounds, over-the-counter drugs have fewer factual and legal obstacles. And while federal preemption may present strong defenses for the manufacturers of such drugs, plaintiffs may not encounter as many legal obstacles when they focus on the marketing activity or dispensing of retail pharmacies. We expect this shift in focus and attempt to evade the industry's strongest legal defenses to continue well into 2023 and beyond.

Federal Rules Committee Changes and the Long-Awaited Restoration of the Court as the Gatekeeper

The Federal Rules Committee continues to explore rule changes to help better manage mass torts, such as proof of injury and proof of use requirements, as well as other novel tools in an MDL court's arsenal to avoid the dumping of dubious claims into large MDLs for years without scrutiny from the court. To that end, the Committee on Rules of Practice and Procedure's MDL Subcommittee is considering a new Rule 16.1 to address the court's role in managing MDLs. While additional work is needed to complete this process, and relief may be more than a year away, the proposals appear headed in a positive direction for litigants.

Long-awaited changes to Federal Rule of Evidence 702 may finally restore federal courts to their proper "gatekeeping function." The Advisory Committee on the Federal Rules of Evidence unanimously approved a proposal to amend FRE 702 and the comment period has since closed, paving the way for a new and approved rule to go into effect as soon as December 2023. The two proposed changes are to (1) expressly add a "more likely than not" standard to the admissibility requirements of the rule, and that (2) the expert's opinion is a reliable application of the principles and methods to the fact. The first proposed change will codify that the proponent of the expert testimony must first show the court that "more likely than not," it has satisfied the reliability requirements of the rule. The second change requires the court to then also determine whether the opinion is a reliable application of methods and principles, thus requiring the court to look at the conclusions of the opinion itself. Taken together, the court will no longer be able to kick expert challenges to the jury on the grounds it goes to weight and not admissibility. And the comments confirm that prior courts deferring challenges to expert testimony as those of weight, and not admissibility, were incorrect under Rules 702 and 104. The amended rule ensures the trial judge first evaluates whether the expert opinion is reliable and therefore admissible, leaving it for the jury to then decide weight and credibility.