This Just In . . . Three New Jersey Accutane Plaintiff Verdicts Overturned

            In 2008, three Florida resident plaintiffs, in a joint trial, won jury verdicts in New Jersey state court on claims that Hoffman-La Roche had not adequately warned about the alleged link between ingesting Accutane and developing inflammatory bowel disease.  Two days ago, the New Jersey Superior Court Appellate Division reversed.  Sager v. Hoffman-La Roche, Inc., Docket No. A-3427-09T4 (N.J. Sup. Ct. App. Div. Aug. 7, 2012) (link here).   

            The court’s analysis is pretty straightforward – First, what law applies?  Answer:  The parties agreed to apply the substantive law of Florida.  Slip op. at 38.  Second, what is Florida law on a failure to warn claim?  Answer:  “the plaintiff must prove that the warning to the physician was inadequate, that the inadequacy of the warning proximately caused his or her injury, and that he or she suffered an injury from using the drug.”  Slip op. at 40.  Third, did plaintiff fail to prove any of these elements?  Answer:  Yes, no proximate cause.  Slip op. at 49.

            The deciding factor for the New Jersey Appellate Court was the controlling published decision by Florida’s intermediate appellate court in an Accutane case – Hoffman-La Roche, Inc. v. Mason, 27 So. 3d 75 (Fla. Dist. Ct. App. 2009), review denied, 37 So. 3d 848 (Fla. 2010).  The trial court had distinguished that case as a short, per curiam “outlier.”  But the appellate court ruled:  “It is not our place . . . to second guess the appellate courts of Florida and the wisdom of their decisions.  The published opinion in Mason, short and unsigned as it may be, is binding Florida precedent.”  Slip op. at 44-45.

On facts “markedly similar” to the New Jersey cases, the Mason court held that a critical consideration on proximate cause is “whether the doctors would have still prescribed the drug to plaintiffs, even if the manufacturer had supplied a more pointed warning.”  Slip op. at 42 (citing Mason).  In  Mason, the prescribing physician testified that he  “would still be willing to prescribe Accutane to his patients [today] even if there was evidence showing that it could cause IBD in rare cases.” Mason, 27 So. 3d at 77.  And “even if the warning label contained all of the information suggested by [plaintiff’s] expert, he would still have prescribed the medication for [plaintiff].” Id. 

Virtually identical testimony was given by the three prescribers in the New Jersey cases.  Slip op. at 46-49.  Therefore, because Mason is “the controlling Florida precedent, which must be applied here on the proximate cause issue,” slip op. at 44, the court held

This crucial testimony by each of the prescribing dermatologists clearly establishes that all three plaintiffs cannot surmount Mason’s binding legal test for proximate cause in a Florida learned intermediary situation.  . . . [T]he inescapable conclusion is that the trial proofs failed in this case to establish proximate causation under controlling Florida precedent.

Slip op. at 49. 

            Jury verdicts reversed – final judgments in favor of defendants in all three cases. 

Accutane Warnings Adequate as a Matter of Law

This just in.  A federal MDL court in Florida has granted summary judgment in an Accutane case, holding that the drug's warnings with respect to inflammatory bowel disease ("IBD" - the same claims that have produced significant jury awards in certain other venues that shall remain nameless) are adequate as a matter of New York law.  The main holding:

Here, Defendants argue that [defendant's] extensive IBD warnings in place during the time Plaintiff used Accutane (in 2004) were adequate as a matter of law. The Court agrees. The Physician Package Insert plainly and prominently identified inflammatory bowel disease by name as a possible consequence of taking Accutane. This risk information appeared in the “WARNINGS” and “ADVERSE REACTIONS” sections of the insert. It also identified the common symptoms of IBD and instructed what should be done if those symptoms appeared. . . . Both independently and taken together, these formulations communicated the same essential message to prescribing physicians: IBD is a potential risk of Accutane.

In re Accutane Products Liability Litigation, MDL 1626, slip op. at 10 (M.D. Fla. July 24, 2012).  Once an adequate warning is given, the defendant's duty is complete.  "[Defendant] had no duty to warn Plaintiff directly or otherwise ensure that her prescribing physician conveyed appropriate warnings to her."  Id. at 11.

Moreover, under New York's "across the board" application of comment k, the adequate warning precludes design-related claims:

[U]nder New York law, an adequate warning bars design defect liability against the manufacturer. . . .  Although a prescription drug is by its nature an inherently unsafe product and would in the usual case impute strict liability to its manufacturer, a defense is provided against such liability when the drug is properly prepared, and accompanied by proper directions and warning.  Therefore, even though its side effects may cause injury, a prescribed drug, accompanied by adequate warnings, is not defective, nor is it unreasonably dangerous.

Slip op. at 11-12 (emphasis added) (quoting in part NY Court of Appeals decision).

This is why on this Blog we push removal before service and other means of obtaining federal subject matter jurisdiction.  There has yet to be a judicial hellhole in federal court.

Thanks to Mike Imbroscio at Covington for passing this gem along.

Update: New Jersey Supreme Court Accepts Certification In Kendall

We previously wrote in less than glowing terms about the New Jersey Superior Court, Appellate Division’s decision in Kendall v. Hoffman-La Roche, Inc., slip op. (N.J. Super. A.D. August 5, 2010). We explained that “the court essentially ruled that, due to the defendant's adequate and extensive warnings about other risks (birth defects and suicide), the plaintiff could evoke the discovery rule by saying she was distracted by those warnings from another warning about a less well-established risk (inflammatory bowel disease) that she suffered.” We called that decision “wrongheaded,” and that was when we were being polite.

Rightheadedness may be on the way. On February 3, 2011, the New Jersey Supreme Court granted defendants’ petition and accepted certification of the appeal. According to the court’s website, the court has framed the issue as follows: “Is plaintiff’s claim involving the medication Accutane® time-barred pursuant to the presumption of the Product Liability Act, N.J.S.A. 2A:58C-4, that FDA-approved warnings provide adequate notice of the risks?” No briefing schedule has been set.

Congrats to Michael X. Imbroscio and Paul W. Schmidt of Covington & Burling, who filed the petition for certification. We’ll let you know how it turns out.