United States: Guest Post: Christmas Came Early On December 8 – Favorable Developments In Fosamax & Accutane Litigation

Last Updated: December 14 2017
Article by James Beck

This guest post is by Kevin Hara, an associate at Reed Smith and relatively frequent contributor to the Blog. Here, he discusses two recent favorable procedural developments in further appeals from two really awful decisions by intermediate courts of appeals. As always, our guest posters are 100% responsible for what they write – due 100% of the credit, as well as any blame. Take it away Kevin.

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SCOTUS Calls For Solicitor General's Views In Third Circuit Fosamax Case

Friday December 8 was a day with two items that are particularly noteworthy because of their potentially momentous implications. Remember the Blog's previous lambasting of the Third Circuit's unprecedented Fosamax preemption decision and the haymaker that court unleashed on the drug and device industry, in In re Fosamax (Alendronate Sodium) Products Liability Litigation, 852 F.3d 268 (3d Cir. 2017)? Now, there is positive news to report. The Supreme Court has invited the Solicitor General "to file a brief in this case expressing the views of the United States." Merck, Sharp & Dohme Corp. v. Albrecht, et al., No. 14-1900 (Order, Dec. 8, 2017).

What is that? Here is SCOTUSBlog's description:

"CVSG" stands for "call for the views of the Solicitor General." In most cases in which someone is seeking review of the lower courts' decision, the Court will issue a straightforward grant or denial. But sometimes the Court will want the government's views on what it should do in a case in which the government isn't a party but may still have an interest — for example, because the interpretation of a federal statute is involved. So the Court will issue an order in which it "invites the Solicitor General to file a brief expressing the views of the United States." It isn't an "invitation" in the sense that the federal government gets to decide whether it wants to file a brief at all, because the Court expects the government to file. There is no deadline by which the government is required to file the brief, however. And the government's recommendation, although not dispositive, will carry significant weight with the Court.

In Fosamax, this development is important because it signals that the case stands out from the general certiorari pool, meaning that review is more likely to be granted. Statistics are surprisingly hard to come by, but a law review article, Thompson & Wachtell, "An Empirical Analysis of Supreme Court Certiorari Petition Procedures: The Call for Response and the Call for the Views of the Solicitor General," 16:2 G. Mason L.R. 237 (2009), analyzed ten years of Supreme Court cases (1994-2004) and concluded:

The overall grant rate increases from 0.9% to 34% following a CVSG from the Court; in other words, the Court is 37 times more likely to grant a petition following a CVSG. For petitions on the paid docket, the grant rate increases even more, to 42%; a paid petition is 47 times more likely to be granted following a CVSG.

Id. at 245 (emphasis added). If those somewhat dated statistics are even close to currently accurate, the Fosamax CVSG is a big deal.

Recall that the Third Circuit grossly misinterpreted the "clear evidence" preemption test from Wyeth v. Levine, which held that without clear evidence that the FDA would not have approved the label change, a court cannot rule a manufacturer's compliance with federal and state law is impossible, and thereby preempted, already an exacting defense. As the Blog explained in praising the petition for certiorari, the Third Circuit distorted Levine, applied an unprecedented standard, and ruled that a manufacturer could not invoke preemption without "clear and convincing" evidence that the FDA would have rejected a proposed warning. Thus, not only did the Third Circuit reverse summary judgment for the manufacturer in more than 1000 cases, it rendered impossibility preemption even more difficult than the anti-preemption justices in Levine intended. The Blog also discussed the Product Liability Advisory Council's amicus brief in support of the petition here, which explained that the Third Circuit's decision invites further lower court confusion, obliterates the district court's ruling that was supported by undisputed evidence, encourages pharmaceutical manufacturers to flood the FDA with proposed label changes, and threatens to stifle the innovation necessary to develop new, potentially life-saving drugs.

This latest development raises defense hopes that SCOTUS will grant the petition, and finally reverse one of the worst decisions of 2017, which would be a huge win for the manufacturer in particular, and of greater significance for the big picture for pharmaceutical companies and consumers in general. Stay tuned.

New Jersey Supreme Court Grants Review of Accutane Cases

Also on December 8, the New Jersey Supreme Court granted the appeals in all of the Accutane cases that the appellate court revived back in July. The Blog has monitored the Accutane litigation through many of the twists and turns of its tortuous existence for more than a decade, first with the Accutane MDL, and then with the New Jersey cases. As a resident of the San Francisco Bay Area, when I think of the Accutane litigation, I automatically picture Lombard Street, often touted "The Crookedest Street In The World," with its eight hairpin turns and switchbacks that span the 600 feet of the street's natural 27° grade. In fact, Lombard Street is not even the most crooked street in San Francisco, because Vermont Street, has a greater sinuosity at 1.56 versus 1.2 for Lombard, though Vermont at seven turns, has one fewer than its more famous cousin. Lombard Street and its adornment of brick red and beautiful flowers attracts thousands of tourists per year. This meandering avenue is difficult to traverse, requires careful navigation, has been around a long time, and produced extreme frustration for those who occupy it: if it sounds familiar, bear in mind that the Accutane litigation likewise has a lengthy history, ongoing since 2003, has zigged and zagged, and neither side is particularly thrilled with the results. The Blog has discussed many of the good aspects here, (vacating plaintiff verdicts) here, (dismissals based on learned intermediary doctrine) here, (MSJ granted) and here (warnings adequate as a matter of law), as well as the very bad Appellate Division decisions earlier this summer, when the court reinstated more than 2000 causation based dismissals.

With that in mind, here is a very brief summary of the mind-bending history of the Accutane saga and the battle over the proper expert testimony that has hopefully neared its dénouement. As already discussed at length, the Appellate Division reversed the trial court's decision that excluded plaintiffs' expert causation testimony, reviving more than 2000 lawsuits. Not surprisingly, the manufacturer appealed, supported by amicus briefs from 21 of New Jersey's largest employers, including many Roche competitors, the HealthCare Institute of New Jersey, the New Jersey Chamber of Commerce, the American Medical Association, and eight scholars and professors of law. When it comes to expert testimony, New Jersey unfortunately travels The Road Not Taken, applying a "relaxed" standard of expert testimony in toxic tort cases, as set forth in Rubanick v. Witco Chemical Corp., 125 N.J. 421 (1991), rather than the more rigorous federal Daubert standard. Under Rubanick, expert testimony may be admitted "even though it is controversial and its acceptance is not widespread," only if "it is based on a sound methodology that draws on scientific studies reasonably relied on in the scientific community and has actually been used and applied by responsible experts or practitioners in the particular field." Id. at 447. In Kemp v. State, 174 N.J. 412, 425-426 (2002), the court ruled that the inquiry was not based on reasonableness, but instead examines "whether comparable experts in the field [would] actually rely on that information. Kemp, 174 N.J. at 426 (citations and quotations omitted). Since Rubanick and Kemp, New Jersey courts have continued the state's unique application of scientific expert testimony with an approach distinct from the more exacting federal standard, resulting in inconsistency, confusion, and the morass of the Accutane litigation.

As the Blog discussed, and the amici explained, the Accutane trial judge applied a standard similar to Daubert, but the Appellate Division reversed the decision based on Rubanick. In so doing, the appellate court essentially ignored the gold standard of scientific evidence, epidemiological studies all but one which failed to "demonstrate[] a statistically significant increased risk of developing Crohn's disease." In re Accutane Litigation, 451 N.J. Super. 153, 168 (App. Div. July 28, 2017). Nonetheless, the Appellate Division allowed the plaintiffs' experts to rely on evidence that should have been excluded as unreliable, such as animal studies, anecdotal case reports, and analogous medicines – in other words, scientifically unsound data. Id. at 165-166. Similarly to the Fosamax decision, this represents not only bad law and bad precedent, but also has far-reaching implications. Pharmaceutical manufacturers and health professionals resoundingly decried the Accutane decision as one that will stifle research and development, and the practice of medicine out of the uncertainty of scientific evidence, and fear of legal reprisals. The amici implored the New Jersey Supreme Court to adopt Daubert's methodology to reaffirm the trial court's role as a gatekeeper to ensure that only reliable scientific evidence informs the jury's decision. Again, the industry can take heart in the court's order granting review of the Appellate Division's abysmal decision, and hope that the New Jersey Supreme Court will allow modern scientific principles, rather than the unreliable and questionable methods, to govern expert testimony. If that occurs, no doubt will the New Jersey high court reinstate the trial court's ruling, and order dismissal of the more than 2000 cases for lack of causation evidence.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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