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Last year we posted about two major decisions by the New Jersey Supreme Court finally chopping the Accutane inflammatory bowel disease (“IBD”) litigation down to size.  Our post here contains links to all of our posts over the years on the Accutane litigation.  The point of note is that to get to those two decisions…

It’s been a long road.  Well after product liability litigation over Accutane and inflammatory bowel disease (“IBD”) had been thoroughly debunked everywhere else in the nation, such litigation lived on in New Jersey – for year after interminable year.  First, a number of trials occurred, but literally every verdict for the plaintiffs was reversed on…

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…

This guest post is by Reed Smith‘s Devin Griffin.  It deals with an important pending appeal in New Jersey’s version of Jarndyce v. Jarndyce – Accutane litigation.  As always with our guest posts, the author is 100% responsible for what follows, deserving of all the credit, and any blame.  Take it away Devin.

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No one can be all that happy with how the Accutane mass tort proceeding has played out in New Jersey. We have no involvement in that proceeding, but we have monitored it from afar, and it has been extraordinarily contentious.  The rub is that the parties have very little to show for the effort.  The…

If you read the decision in Rossitto v. Hoffmann-LaRoche Inc., 2016 N.J. Super. Unpub. LEXIS 1714 (N.J. App. Div. Jul 22, 2016), we think you’ll agree with our calling it “strong” criticism of two trial rulings that the appellate court firmly believed led to undue prejudice of the defendant.  The $18 million verdict awarded to two of four plaintiffs in a joint trial was vacated and the case is being remanded for a new trial.  This is not the first Accutane plaintiff’s verdict to be vacated by New Jersey’s appellate division, but rather another notch in the demise of this litigation which has seen a turn in favor of defendant since coming under new management.  Indeed, a quick search of the DDL blog for Accutane will show how the tide has turned.

The Accutane litigation is primarily comprised of claims alleging that the manufacturer failed to adequately warn about the risk of inflammatory bowel disease (“IBD”).  Therefore, the drug’s label takes center stage.  Here, the plaintiffs both used the drug with its 1984 label that included a warning that “Accutane has been temporally associated with IBD.”  Id. at *8.  In May 2000, after plaintiffs had stopped using Accutane, the label was revised to remove the word “temporally” and to add information about persistent IBD symptoms.  Id. at *18.

Although only one of the plaintiffs was a New Jersey resident, the parties agreed that New Jersey law would apply to both.  Id. at *34.  So, New Jersey’s “super-presumption” applies – that is if the warning given has been approved by the FDA, there is a rebuttable presumption of adequacy.  Id. at *37.  Called a “super-presumption” because it is “virtually dispositive” on failure to warn, it can be overcome with evidence of intentional concealment of a known risk or “substantial evidence of economically-driven manipulation of the post-market regulatory process.”  Id. at *37-38.  Plaintiffs got to trial in these cases because the New Jersey courts have found that as to the 1984 label plaintiffs have put forth enough evidence from which a reasonable jury could conclude they had rebutted the presumption.  Id.  at *55-56 (citing prior Accutane decisions addressing this issue).   But it’s a strong presumption so we decided to take the time to remind you about it.Continue Reading New Jersey Accutane Plaintiff Verdict Vacated – Appellate Division Strongly Criticizes Evidentiary Rulings

The demise of the New Jersey Accutane litigation under the new mass tort judge continues apace.  Today 31 more Accutane cases were dismissed for failure to establish warning causation under the learned intermediary rule.  The order is here, but the actual opinion is about halfway through the PDF, so keep looking, you’ll find it.…

Without pulling back the curtain all the way on how we find out about new decisions worth a pithy post, we occasionally re-learn about decisions when they are published or added to an electronic reporting service a few months later. When there is a slow week, this dynamic may prompt us to talk about an older decision, even if has already been the subject of a breaking news post. The summary judgment decision in In re Accutane Litigation, No. 271 (MCL), 2015 N.J. Super. Unpub. LEXIS 1216 (N.J. Super. Law Div. Apr. 2, 2015) was the subject of a breaking news post two months ago, but deserves another look, more for the story it tells about drug litigation than for its direct precedential value.

We have posted through the years about the tortured course of Accutane litigation over the risk of inflammatory bowel disease (“IBD”). (There have also been cases about birth defect and suicidality, but we are not focusing on those here.) In general, the news out of the MDL proceeding has been good for years, both on expert issues and the substance of plaintiffs’ claims.   For years, the news from the coordinated proceeding in New Jersey has been very bad, including a few large plaintiff verdicts. Issues with the judge who had overseen the New Jersey proceedings were highly publicized (but not by us), and it is easy to say that her assignment to a new post explained the sea change.

We can guess that the new judge’s look at old issues has been more balanced (from our view), as has the Appellate Division’s review of old decisions. There has also, though, been development in the case law on the New Jersey Product Liability Act (NJPLA) that undercut the legal basis for old (bad) decisions. The persistence of the defendant and willingness of the new judge to consider broad issues late in the life of the litigation bring us to the decision finding the IBD warnings since April 2002 to be adequate as a matter of law under the NJPLA, which sets up a potential adoption for cases where other state law may control.

The history of Accutane’s IBD warnings from the approval of the drug in 1984 through the discontinuation of its sale in 2009 is so extensive that we wonder how warnings claims—the only claims we think should be typically available for a prescription drug—ever could have had legs. As discussed below, we also wonder about other reasons why warnings claims should not have been viable. The court provides detailed findings of fact about the warnings for IBD, which included mechanisms for providing warnings not seen with most prescription drugs. Id. at **15-26. We assume the extra measures were driven by concerns about suicidality in teenage patients and birth defects in their offspring, but IBD was also described in the warnings accompanying blister packs (the only means of distribution since 1990), a guide that physicians had to acknowledge receiving in order to prescribe the drug, a guide that pharmacists had to provide to patients while filling their prescriptions, and brochure that physicians were encouraged to give to patients. Combined with a paragraph in the Warnings section of the package insert, the information provided to physicians warned them up, down, and side to side about the risk of IBD. That sounds a lot like an adequate IBD warning as a matter of law under any state’s law on prescription drug warnings.
Continue Reading Deeper Dive on New Jersey Accutane Summary Judgment Decision

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