Staying Ahead in Life Sciences: 2023 in Review and 2024 Trends – Part 2

As part of the life science community, Berkley Life Sciences (BLS) stays current on litigation trends and regulatory developments that affect the industry. BLS presents these updates in an annual webinar with Kim Schmid, Executive Managing Partner at Bowman & Brooke.

BLS is offering a series of three articles highlighting information from the webinar, such as a review of pertinent litigation and mass tort trends, new case law developments, regulatory updates, and what to watch for in 2024.

Part Two of this series will focus on defense decisions and key case law developments.

Defense Decisions

Several defense verdicts concerning life science products were reached in 2023. Two decisions of particular interest are discussed below.

Bosely Sr. v DePuy Synthes Sales Inc., et al. (W.D. Washington)

Plaintiff Bosely underwent knee surgery in 2014. His surgeon used the DePuy Synthes Attune implant. Bosely claimed the device failed, and he had to undergo a second surgery. DePuy Synthes denied liability and disputed causation. DePuy Synthes further argued that Bosely’s surgeon was fully informed of the potential for component loosening based on the “Instructions For Use” accompanying the device. In an unusual twist, Bosely’s treating surgeon testified on behalf of DePuy Synthes and attributed the failure of the implant to loosening. Based on this testimony, a defense verdict was reached.

Benestad v Johnson & Johnson and Ethicon, Inc. (S.D. Florida)

Benestad filed a short-form complaint in a West Virginia district court as part of an MDL involving alleged defects in pelvic repair system products. The complaint was transferred to the Southern District of Florida. The plaintiff alleged that the surgical mesh product used in the surgery was negligently and defectively designed, permanently disabling her. The defense questioned the plaintiff’s credibility, claiming that she had made false statements under oath in a separate workers compensation case, blaming a work injury, and not the surgical mesh, for her disability. As further evidence, the defense showed the jury surveillance video and recent photographs of the plaintiff engaging in activities at her own gym, at a hotel gym, and on vacation, all of which contradicted the plaintiff’s disability claim. The plaintiff’s counsel tried to explain, insisting to the jury that the plaintiff was injured by the mesh, but did not tell the jury about the workers compensation case because she was embarrassed. In less than 3 hours, the jury returned with a defense verdict.

Other Significant Legal Developments

New Federal Rule of Evidence 702: Testimony by Expert Witnesses

On December 1, 2023, Rule 702 came into force to help clarify the standard for expert testimony in civil cases. Notably, the new language added to this rule of evidence focuses on the “reliable application” of scientific or technical methodology to the facts of the case. There are some early signs that this new language will keep alleged experts promoting unreliable liability theories out of the courtroom.

It is also worth noting that the judge, not the jury, has the task of deciding if the proffered testimony meets the criteria of Rule 702. This should help ensure an objective determination of the admissibility of the evidence. Furthermore, gatekeeping responsibility does not end once admissibility is determined; it is an ongoing judicial duty.

In December 2023, the first big test of the new rule was before the Federal Court of the Southern District of New York in In re Acetaminophen (S.D.N.Y. 2023), an MDL assessing plaintiffs’ claim that Tylenol taken by pregnant women could cause autism in children. Applying Rule 702, the Honorable Denise Cote granted the defendant’s Daubert motion to exclude the testimony of plaintiffs’ general causation experts.

This was a critical ruling by Judge Cote in this litigation: since the evidentiary testimony was not admissible, the MDL could not move forward. At the time of the Daubert hearing on plaintiffs’ liability experts, more than 440 cases were pending in the MDL.

In granting the defendant’s motion, Judge Cote found there was insufficient scientific evidence to link Tylenol or acetaminophen use during pregnancy to autism or other neurological conditions in the child, such as ADHD. Based on this Daubert ruling, the Tylenol autism MDL was dismissed in late December 2023. While plaintiffs’ counsel initially stated that plaintiffs intended to appeal, plaintiffs now seem to be abandoning the federal venue and instead are filing cases in various state courts nationwide in the hope of receiving a more favorable evidentiary ruling.

Repeat of Drug Manufacturer Immunity (Michigan)

Since 1996, Michigan law has immunized drug manufacturers from product liability claims if the FDA approves both the drug at issue and the label. Michigan was the last state in the nation to repeal this protection for drug companies. Specifically, on December 7, 2023, Governor Gretchen Whitmer signed into law bipartisan legislation repealing the Michigan immunity law. Although some question whether the change in the law will be applied retroactively, most legal experts agree that the new law does not apply to cases already filed or injuries that occurred prior to February 13, 2024.

“Failure to Innovate” Litigation

In Gilead Sciences, Inc. v. Superior Court, 2024 WL 94462 (Cal. Ct. App.), the court accepted the novel legal theory of “failure to innovate.” This decision is under appeal. By way of background, Gilead developed and sold one of the first medications to treat HIV/AIDS: tenofovir disoproxil fumarate (TDF). TDF effectively suppressed the effects of HIV, but it also carried a risk of skeletal and kidney damage. It was approved by the FDA in 2001, saving countless lives. While developing TDF, Gilead discovered a similar drug: tenofovir alafenamide fumarate (TAF). Plaintiffs alleged that Gilead knew that TAF could be as effective as TDF while carrying a lower risk of adverse effects and that Gilead deferred the development of TAF out of concern that immediately developing TAF would reduce the financial return on TDF. Plaintiffs argued that, while TDF is not defective, Gilead was still negligent and breached a duty of reasonable care by deferring the development of TAF to maximize profits, essentially putting profits over safety. There are over 25,000 plaintiffs in the California consolidated action alleging kidney injury and bone loss due to taking TDF.

On January 9, 2024, the California Court of Appeals issued a ruling that reverberated throughout the state of California and in all other corners of the country. The appellate court concluded that a manufacturer's duty to exercise reasonable care could extend beyond the duty not to make a defective product in some circumstances. The court, cognizant of the import of its decision and potential ramifications, was careful to state it was not imposing a duty on the manufacturer to innovate or to make products safer, but if the company already knows of a safer product design, then it needs to reasonably act and make that safer product available.

In its unanimous decision, California’s First District Court of Appeal relied heavily on the company’s internal documents to find that “everyone has a duty to act reasonably not to cause foreseeable harm to others,” which applies to pharmaceutical manufacturers when they decide to commercialize alternative drugs.

Preemption Ruling

In 2015, various plaintiffs filed separate suits in federal court alleging that the off-label use of Zofran during pregnancy to treat morning sickness caused birth defects. In re Zofran (Ondansetron) Products Liability Litigation, 57 F.4th 327 (1st Cir. 2023). These suits were based in part on the theory that Glaxo Smith Kline engaged in an intentionally misleading plan to market Zofran for pregnancy in violation of state law by failing to warn that animal studies showed the drug's potential to harm pregnant women and fetuses when ingested during pregnancy. The JPML created a multidistrict litigation proceeding for the individual suits, assigning the case to the District of Massachusetts.

In rejecting the plaintiffs’ claims, the court concluded that (1) The studies cited by the plaintiffs were old news: the FDA had already reviewed the information available five times in the past, and each time, it found no scientific support for a warning about birth defects; and (2) Plaintiffs’ arguments were based on scientific standards “not utilized by the FDA,” and thus, they were preempted. According to the court, "plaintiffs were improperly seeking to have courts second-guess the FDA’s methods and conclusions." (“The BFDs - The Ten Best Prescription Drug/Medical Device Decisions of ...”) In ruling for the defense, the appellate court focused on the FDA’s extensive regulation of drug labeling and its clear desire and intent to prevent “over-warning.” It also recognized that the FDA imposes tight restrictions on what a drug manufacturer can say regarding off-label uses.

This preemption decision in January 2023 affirmed the dismissal of all claims in the Federal Zofran MDL, dismissing all 425 Zofran lawsuits pending against GSK.

Learned Intermediary and Warnings Ruling

Cates v. Zeltiq Aesthetics, Inc. centered around the “CoolScultping System,” a Class II medical device for cosmetic surgery. The plaintiff sued after developing a condition known as “Paradoxical Adipose Hyperplasia.” In lay terms, instead of a reduction of fatty tissue in the treatment area, the opposite occurs — the fat cells swell and expand. The Eleventh Circuit affirmed summary judgment on both the failure to warn and design defect claims.

In granting summary judgment on the failure to warn claim, the court noted that the adverse reaction alleged had been included in label warnings: the device carried a specific warning about the risk of Paradoxical Adipose Hyperplasia as an identified potential risk. The court then applied the learned intermediary doctrine. Under this doctrine, a device manufacturer’s duty is to warn the physician who prescribes the device. The Eleventh Circuit also noted that the Florida Supreme Court previously had held that the adequacy of a warning “can be resolved as a question of law where the warning is accurate, clear, and unambiguous.” Here, based on the label, it was undisputed that the potential for an adverse reaction of the type alleged was known to healthcare providers and was adequate as a matter of law.

While not necessary for the decision, the court also noted that, in this case, the plaintiff signed a consent form that included a waiver. The court concluded that a confirmed warning given to the patient was useful to have but not legally necessary. The learned intermediary doctrine means a device manufacturer’s duty is to warn the physician who prescribes the device. Here, that warning was given.

The court also rejected the design defect claim. In doing so, the court first considered whether Florida’s test for design defect is measured by consumer expectations or the risk-utility test. Ultimately, the court concluded that it need not decide which test applied because the plaintiff’s claim failed under either standard: (1) A known potential side effect is not a design flaw, and (2) the plaintiff failed to identify a suitable, safer alternative design. Moreover, the court noted that the plaintiff’s own expert acknowledged that the device was safe and effective.

PFAS Decision

In In re E.I. du Pont de Nemours & Co. (personal injury litigation – 6th Cir. 2023), a class action lawsuit, the plaintiff sued ten manufacturers of per- and polyfluoroalkyl chemicals, commonly known as PFAS. The district court certified the class and defined the class membership as every person “subject to the laws of Ohio” who has measurable PFAS in their blood serum. On appeal, the Sixth Circuit stated that the parties agreed that trace amounts are present in the blood of every person residing in the U.S. Ultimately, the Sixth Circuit concluded that the plaintiff lacked standing for failure to show that they had suffered an injury that was traceable to any named defendant and that such injuries could be redressed by the court.

The plaintiffs had failed to connect the PFAS to any named defendant and had no facts supported by inference that any of the defendants caused PFAS to end up in the plaintiff's blood. Notably, in deciding this case, the court stated: "Seldom is so ambitious a case filed on so slight a basis.”

Be on the lookout for Part 3 of this series, focusing on recalls, regulatory updates, and what to watch for in 2024. Click here for the webinar, “Stay Ahead in Life Sciences: 2023 in Review and 2024 Trends.

Authored by Cindy Khin, Berkley Life Sciences, Life Sciences Casualty Resolution Director