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.
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.
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.
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.”
Courts have struggled for decades to define the constitutional limitations on personal jurisdiction over major product manufacturers who sell their products nationwide. The central tension has been determining the validity and potential scope of the “stream of commerce” theory in a world of advancing technology and associated evolution of business operations and practices. That tension is increasing as state courts decide what kind of nexus is required, between a defendant’s “forum-directed” commercial activities and the plaintiff’s claim, to justify the exercise of specific jurisdiction. Specifically, how purposefully forum-directed and how closely tied to the specific claim must the activities be?
Stream of commerce theory posits that a defendant that has placed a product into the nationwide channels of commerce should anticipate that its products will thereby be “swept” into any state and if it causes injury there, it will be subject to suit. In its purest form, the theory collides to some degree with the fundamental limiting requirement that a defendant may be haled into a forum to litigate only where it has “purposely availed” itself of the privilege of doing business by, for example, directing its products into the forum.
A California federal judge tossed a proposed class action against allegedly “worthless” biotin dietary supplements on preemption grounds earlier this week, citing the Ninth Circuit’s recent decision in Dachauer v. NBTY, Inc., 913 F.2d 844 (9th Cir. 2019).
In Greenberg v. Target Corp., et al., the plaintiff filed a putative class action alleging that labeling for Target’s Up & Up brand of biotin dietary supplements was misleading under California’s Unfair Competition Law (UCL) and Consumer Legal Remedies Act (CLRA).