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

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.


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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.
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A couple of weeks ago, we talked about Westminster Kennel Club Dog Show.  We were eagerly anticipating the Best in Show competition, which was slated to feature a Standard Poodle – the breed of our heart – along with a Portuguese Water Dog whose record of wins was unprecedented in dog show history.  Based on this past record, the “PWD” was heavily favored to “take the Garden.” The Best in Show judge (few assignments in dogdom carry more prestige) built the tension in the sold-out stadium to a fever pitch.  The dogs submitted to painstaking “hands on” examinations, they “free-stacked,” they gaited.   And they gaited again.  Finally, the judge, flanked by AKC officials, strode purposefully to the table to “sign the book,” then returned to the center of the ring, microphone turned on, purple and gold rosette and trophy in hand.   He made a moving speech about the history of the event, and he praised the lineup of seven gorgeous group winners.   Pausing one more time for effect, he announced, “Best in Show at the 139th Westminster Kennel Club Dog Show is . . .  the Beagle!”  The Beagle? Make no mistake – “Miss P” is a spectacular show dog, with many Best in Show wins to her credit.  She is a striking example of her breed.  And she is very, very cute.   But it just wasn’t what we expected.

We also thought we knew what to expect when we began reading the recent decision of the Superior Court of New Jersey – Atlantic County — in the Accutane Multicounty Litigation. This litigation, in which plaintiffs allege that Isotretinoin (Accutane’s chemical name) causes Inflammatory Bowel Disease (“IBD”) and Crohn’s Disease (“CD”), has been pending since 2003, and we have been troubled, at times, about an apparent plaintiff bias. Appellate courts have agreed with us, overturning a number of plaintiffs’ verdicts. (See here and here, for example.)  But we were most pleasantly surprised this time.

In In re Accutane Litigation, 2015 WL 753674 (N. J. Super. Law. Feb. 20, 2015), the Court considered defendant’s motion to exclude plaintiffs’ general causation and biostatistics experts.  The Court explained that New Jersey applies a standard less stringent than Frye’s “general acceptance” standard, in determining whether expert testimony is admissible.  Under the guiding Rubanick decision of the New Jersey Supreme Court (125 N.J. 421 (1991)), “if the methodology by which the expert reached a conclusion is sound, the conclusion may be introduced into evidence.”  Accutane, 2015 WL 753674 at *4 (citation to Rubanick omitted).  Later, in Kemp v. The State of New Jersey,  174 N.J. 412 (2002), the Supreme Court held that the trial court was obligated to conduct an evidentiary hearing “any time an expert’s theory has not attained ‘general acceptance,’” and that the failure to do so is “plain error.” Accutane, 2015 WL 753674 at *6 (citations to Kemp omitted).  Hence the moniker “Kemp hearing” to describe hearings such as the one that was the subject of the Court’s decision.


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This post is from Bexis:

In a decision reflective of how attorney solicitation dredges up bad cases that should never have been filed, a New Jersey appellate court has handed the defense three wins in its Accutane litigation involving inflammatory bowel disease (“IBD”).  Gaghan v. Hoffman-La Roche, Inc.,Nos. A-2717-11T2, et al., slip op. (New Jersey Super. A.D. Aug. 4, 2014)Gaghan involved three appeals, two from defense verdicts and one from a plaintiff’s verdict, affirming the defense wins and reversing the one adverse verdict.  The trial had been something of a circus – three unrelated Accutane plaintiffs’ cases tried together.  All three plaintiffs were litigation tourists from California, so that state’s law applied, which is probably why the decision is unpublished.  It certainly is detailed enough to be published, had it not been one state’s courts opining on the law of another state.


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Several years ago we vacationed in Toronto. Back then, the Drug and Device Law Son split his time between hockey and videogames. He was a goalie, so, like his dad, he was always on defense. We visited the Hockey Hall of Fame, tap-danced on the glass floor in the CN Tower, had dinner at Wayne Gretzky’s restaurant, took in a Maple Leafs game, and wandered around the huge underground mall. With the sort of weather that reigns in the True North, an underground mall (really an entire underground city) makes a lot of sense. We noticed that many of the stores had a slogan on the walls: “The World Needs More Canada.” It’s hard to argue with that. Canada has pretty much everything we like (a nice standard of living, cultural offerings, and poutine), and not so much of those things we don’t like (crime, arrogance, and crocodiles).   How can you not admire a country that has given us Joni Mitchell, Bobby Orr, and Pamela Anderson, as well as the inventors of the zipper, basketball, and Trivial Pursuit?  And we look back with fondness at a college road trip adventure, when we drifted across the border to empty the town of Magog of Molson Brador.  (Bexis points out that Canada is also responsible for the rock groups Rush and BTO.  Hmmmm.  That fact might prompt us to reconsider the whole premise of this paragraph.)

Every once in a while we have the opportunity to blog about drug and device developments north of the border, involving matters also being litigated in the USA. As we said above, there’s a lot to like about Canada.  But its class action law is usually something we don’t like so much.  Canada’s application of class action certification rules is considerably more liberal than the corresponding rules here — excepting, perhaps, certain rogue counties in Southern Illinois.  Nevertheless, we are pleased to relay some good news from the Canadian courts.  Our friends at Covington, specifically Michael Imbroscio, sent us a decision by the Quebec Superior Court rejecting certification (what they call “authorization” in Quebec) of a proposed class action alleging that Accutane (isotretinoin) caused inflammatory bowel disease (IBD), in Lebrasseur v. Hoffman – La Roche Limitee, (Quebec Superior Court file no. 500-06-000512-109). The decision is in French, which we cannot read (though the Drug and Device Law Son says he can, and even has the grades to prove it), so we are trusting Covington’s summary.  But for those of you who claim the ability to read Proust and Moliere in the original, here is a copy of the Quebec court’s opinion.


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