Florida Appellate Court Authorizes the Use of the Risk-Utility Test in Complex Medical Device Cases

On October 7, 2020, Florida’s Fourth District Court of Appeal affirmed a defense verdict in favor of a medical device manufacturer and in doing so approved of the trial court’s use of the risk-utility test and not the consumer expectations test in the jury instructions. Cavanaugh v. Stryker Corp., — So. 2d —, 2020 WL 5937405 (Fla. 4th DCA Oct. 7, 2020). The wrongful death lawsuit was filed against multiple defendants, including the manufacturer of a medical device used to remove blood and clear the surgical field, following the death of a patient during lung removal surgery. The claims against the medical device manufacturer included strict liability design defect, strict liability failure to warn, and negligence.

The plaintiff settled with several health care professionals and only the claims against the manufacturer proceeded to trial. At trial, the plaintiff proposed a jury instruction where the jury could find that the product was unreasonably dangerous if the plaintiff established either the consumer expectations test (which determines liability based on whether the product fails to perform as safely as an ordinary consumer would expect when used as intended or when used in a manner reasonably foreseeable by the manufacturer) or the risk-utility test (which determines liability based on whether the risk of danger in the design outweighs the benefit). The defendant manufacturer, however, proposed that the jury instruction include only the risk-utility test (a product is unreasonably dangerous if the risk of danger in the design outweighs the benefit). The trial court rejected the plaintiff’s proposed instruction and adopted the defendant’s risk-utility instruction.

Continue reading

The Ship Has Sailed on Plaintiffs’ Efforts to Recover for Mere Fear of Contracting COVID-19

On February 21, 2020, the cruise ship Grand Princess embarked from San Francisco, headed to Hawaii.  Among the ship’s 3,533 passengers and crew were 62 people who had been exposed to COVID-19 on the ship’s immediate prior trip to Mexico.  The Hawaii voyage was curtailed and the ship docked off the cost of California for two weeks, during which passengers were confined to their rooms and two dozen people tested positive.  A number of personal injury lawsuits followed, the majority of which have been coordinated before Hon. R. Gary Klausner in the U.S. District Court for the Central District of California.

Continue reading

Circuit Does Not Quite Clarify the Supreme Court’s Not-Quite-Clarification of “Clear Evidence” in Albrecht

The U.S. Supreme Court’s 2019 decision in Merck Sharp & Dohme, Inc. v. Albrecht, 139 S.Ct. 1668 (2019), discussed here and here addressed impossibility preemption in label change lawsuits. In Albrecht, the Supreme Court purported to clarify the standard arising from Wyeth v. Levine, 555 US 555 (2009) that a labeling claim against a manufacturer is preempted for “impossibility” if there is “clear evidence” that the FDA would have rejected a manufacturer’s proposed label change. Albrecht explained that impossibility preemption requires the “manufacturer to show that it fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve changing the drug’s label to include that warning.” But Albrecht left unclear what the “clear evidence” showing entails and left open several important questions about how it is to be applied.

Continue reading

Hierarchy of Scientific Evidence Reigns Supreme: NJ Appellate Division Affirms Exclusion of Experts in Accutane Litigation

In In re: Accutane Litigation (A-4952-16T1) — an appeal decided just 10 days after oral argument — the New Jersey Appellate Division applied the New Jersey Supreme Court’s landmark decision In re Accutane Litigation, 234 N.J. 340 (2018) (Accutane 2018), arising from the same multicounty litigation, to affirm exclusion of two of plaintiffs’ experts and dismissal of more than 3,000 cases.

The Accutane multicounty litigation involves thousands of cases in which plaintiffs claim the prescription acne medication caused inflammatory bowel disease (IBD). The litigation has been divided into two parts, based on the sub-type of IBD injury alleged: cases in which plaintiffs claim Accutane caused Crohn’s disease (CD) and cases in which plaintiffs claim it caused ulcerative colitis (UC).

Recap: The NJ Supreme Court’s Decision in Accutane (2018)

On the CD side of the litigation, in 2015 the trial court granted a motion to exclude two plaintiffs’ experts, a gastroenterologist and a statistician, from testifying that Accutane caused CD. The Appellate Division reversed.

In 2018, the New Jersey Supreme Court reversed the Appellate Division and affirmed the trial court’s exclusion of the experts. In its landmark decision, the Supreme Court reconciled New Jersey’s framework for analyzing the reliability of expert testimony set forth in N.J.R.E. 702 and 703 with the federal standard set forth in Daubert v. Merrell Dow Pharm., Inc. In particular, the Court incorporated Daubert’s factors “for use by our courts” in assessing expert testimony reliability, but stopped short of declaring New Jersey a “Daubert jurisdiction.” The Court incorporated these factors because they “dovetail with the overall goals of” New Jersey’s “evidential standard and would provide a helpful — but not necessary or definitive — guide for our courts to consider when performing their gatekeeper role concerning the admission of expert testimony.”

The NJ Appellate Division’s Application of Accutane (2018)

In 2017, while the appeal from the trial court’s order excluding the CD causation testimony was pending, the trial court conducted a 10-day Kemp hearing concerning the UC side of the litigation and granted a motion to bar two more of plaintiffs’ experts, a gastroenterologist (the “UC-gastroenterologist”) and an epidemiologist (the “UC-epidemiologist”), from testifying that Accutane caused UC. The trial court held the experts’ methodologies were unsound, in part because they “disregarded the fundamentals of the scientific method, particularly the medical-evidence hierarchy” by, for example, “[deviating] from the accepted scientific methodology in elevating case reports and animal studies above epidemiological studies.” This decision resulted in dismissal of 3,231 claims.

Initially, the UC-plaintiffs’ appeal was stayed pending the NJ Supreme Court’s decision on the CD side of the litigation. Thereafter, the Appellate Division requested supplemental briefing as to whether the newly incorporated Daubert factors applied, and whether remand was required. All parties agreed the Daubert factors applied, even though Accutane (2018) was decided after the trial judge’s decision here.

Applying Accutane (2018), the Appellate Division affirmed, finding that the trial judge did not abuse his discretion in excluding the testimony of the plaintiffs’ UC experts. The court held that although these UC experts appeared qualified, their opinions incorporated the “same methodological defects identified by the Court” in Accutane 2018, “including the disregarding of eight of the nine epidemiological studies in favor of animal studies and case reports.”

Relying on Accutane (2018) and the “Reference Manual on Scientific Evidence,” the Appellate Division underscored the accepted hierarchy of scientific evidence, with meta-analyses “at the top, followed by single randomized trials, systematic reviews of observation studies, single observational studies, physiological studies, and unsystematic clinical observations” at the bottom. The court noted that plaintiffs’ UC experts relied exclusively on lower forms of evidence, such as animal studies and individual case reports, in reaching their causation opinions, and disregarded an almost uniform body of epidemiological evidence that found no association between Accutane and UC. The UC experts also dismissed published studies that examined thousands of subjects as “underpowered,” yet relied on single case reports and small animal studies. The Appellate Division held this amounted to a failure “to apply the methodology followed by other experts in the field.”

Although epidemiological studies were “slightly more supportive of an association between Accutane” and UC than they had been of an association between Accutane and CD, the Appellate Division held there was not enough scientific evidence “of a difference between these subtypes of” IBD “to warrant excluding the causation experts’ testimony on CD while allowing similar expert causation testimony as to” UC. The court held that “the trial judge did not abuse his discretion in barring the expert testimony in question. Instead, he engaged in the very same type of gatekeeping which the Supreme Court approved in its prior decision.”

While this Appellate Division decision is unpublished, it should bring an end to the Accutane IBD litigation after more than a decade. This well-reasoned opinion, which focuses on the reliability of expert methodology, can serve as persuasive support for parties seeking to exclude unsubstantiated scientific expert testimony.

Third Circuit Clarifies Next Steps in Fosamax Decision

On remand from the U.S. Supreme Court, the U.S. Court of Appeals for the Third Circuit has in turn remanded the case to the district court to determine whether state law claims are preempted by federal law in the 500+ lawsuits pending regarding the medication Fosamax in Merck Sharpe & Dohme v. Albrecht. As previously discussed on this blog in May 2019, the United States Supreme Court held that the issue of federal preemption is one to be decided by the court and not a jury, while somewhat clarifying the “clear evidence” standard governing the analysis.

Continue reading

Massachusetts Court Upholds Temporary Ban on the Sale of All Vaping Products

While various states and municipalities grapple with how to address the proliferation of e-cigarette or vaping product use associated lung injury (EVALI) and the related uptick in e-cigarette use among young people, Massachusetts has taken a drastic measure to protect its residents. On September 24, 2019, Massachusetts became the first state to ban the sale of all vaping products after Governor Charlie Barker issued an emergency order that took effect immediately and would remain in effect for four months. The Order states:

“The sale or display of all vaping products to consumers in retail establishments, online and through any other means, including all non-flavored and flavored vaping products, including mint and menthol, including tetrahydrocannabinol (THC) and any other cannabinoid, is prohibited in the Commonwealth.”

Continue reading