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.

Shady Grove Gets Better

Sometimes things turn out better than they first seemed.  Myriad examples come to mind:  The wild card in baseball.  Most anything that William Shatner does.  Madonna at the Super Bowl.  Ace Ventura, Pet Detective.  Wrapping figs in bacon (alright, that might’ve sounded good from the start).  You may not agree, but you get the idea. 

These examples popped into our heads (they really did) after we read Leonard v. Abbott Labs., No. 10-CV-4676 (ADS)(WDW), 2012 U.S. Dist. LEXIS 30608 (E.D.N.Y. Mar. 5, 2012), an opinion that addresses, among other things, a state-law restriction on class actions and whether that restriction or FRCP 23 applies in a federal diversity action.

Why does this make us think of things turning out better than they first seemed?  Because the Leonard decision applies the Supreme Court’s reasoning in Shady Grove Orthopedic Assoc. v. Allstate Ins., 130 S. Ct. 1431 (U.S. 2010).   And that decision didn’t seem very good (for us) when it first came out.  It raised the concern that plaintiffs, armed with this decision, would circumvent state limitations on class actions by filing a diversity action in federal court and arguing that the class action criteria of FRCP 23 apply, not the state-law limitation.   

To give you the background, Shady Grove involved a New York law that prohibited certain class actions “to recover a penalty.”  N.Y. Civ. Prac. Law Ann. §901(b).  The Shady Grove plaintiff sought to avoid this prohibition by filing his class action claims to recover certain penalty amounts in federal court instead of New York state court.  Ultimately, the Supreme Court decided whether this maneuver would work.  And it did.

The Supreme Court’s decision was as complicated as these procedural/substantive questions generally get, but it was made even more so by the fact that the Court’s decision was formed via plurality and partially concurring opinions.  For the plurality, Justice Scalia considered (1) whether FRCP 23 and the New York law actually conflicted, and (2) if so, then FRCP 23, not the New York law, must be applied, unless FRCP 23 is ultra vires (here, meaning non-procedural) of the Rules Enabling Act.  Shady Grove, 130 S. Ct. at 1437 (plurality opinion).  Justice Scalia found a conflict and determined that FRCP 23 was not ultra vires of the Rules Enabling Statute – that is, it was procedural.  Id. at 1437-44.  So FRCP 23 should be applied.  Id.

Justice Kennedy’s partially concurring opinion had a slightly different approach and is the key to the Leonard decision.  Justice Kennedy agreed with the two-step inquiry cited by Justice Scalia.  Id. at 1450-51 (concurring opinion).  But he believed that the second-step must address more than whether the federal rule was procedural.  The Rules Enabling Act also requires that federal rules “not abridge, enlarge or modify any substantive right.”  Id. at 1451.  So the Court must also consider whether applying the federal rule would alter state rights or remedies, even if the state law appears at first look to be only procedural: 

A federal rule, therefore, cannot govern a particular case in which the rule would displace a state law that is procedural in the ordinary use of the terra but is so intertwined with a state right or remedy that it functions to define the scope of the state-created right.

Id. at 1452 (concurring opinion). 

If so, the state law will apply.  Now, despite this additional inquiry, Justice Kennedy still sided with the plurality because he determined that the New York law was in fact procedural, not substantive.  In other words, Justice Kennedy’s and Justice Scalia’s opinions ultimately got to the same conclusion and formed a majority holding that the class action criteria of FRCP 23 should apply, not the limitations of the New York law. 

This brings us back to Leonard.  That decision involves many plaintiffs and claims, but we’re interested in the part of the decision that addresses one plaintiff’s claim under the Ohio Consumer Sales Practices Act (OCSPA).  Like the New York law, the OCSPA had a provision prohibiting certain class actions.  Leonard, 2012 U.S. Dist. LEXIS 30608, at *27.  But it was quite different.  It wasn’t a broad prohibition against any class action seeking to enforce a particular remedy like penalties.  Rather, it prohibited only class actions that were brought under the OCSPA and based on acts or conduct that had not yet been declared deceptive or unconscionable by an Ohio administrative rule or court decision.  Id.

Now, the plaintiff in Leonard conceded that no Ohio administrative rule or court decision had declared the conduct about which he was complaining to be deceptive or unconscionable.  Id. *27-28.  So the defendant moved to dismiss.  The plaintiff, however, invoked Shady Grove, arguing that the OCSPA’s class action prohibition was abrogated by FRCP 23, which governed what claims can be maintained as class actions in federal court.  Id. at *28.

Here’s where Shady Grove gets better than it first seemed.  The Leonard court did not accept plaintiff’s rote application of the plurality reasoning in Shady Grove – that FRCP 23 abrogates all state-law limitations on class actions.  The Leonard court looked closely at the reasoning of both the plurality and concurring opinions in Shady Grove.  It determined, as other courts have, that the proper way to read Shady Grove is to apply the key portions of Justice Kennedy’s reasoning, which enunciates the “position taken by those [Justices] who concurred in the judgment on the narrowest grounds.”  Id. at *32. 

From that point, the decision to apply the OCSPA’s limitation on class actions became easy.  Justice Kennedy’s concurrence requires a review of whether the state law, even if seemingly procedural, so involves state-created rights that it defines their scope.  Well, the OCSPA limitation does just that.  It completely eliminates a plaintiff’s right to bring an OPSCA action based on conduct that has not been addressed by an administrative rule or court decision.   In other words, it is very much “intertwined with a right or remedy” so “that it functions to define the scope of the state-created right.”  Shady Grove, 130 S. Ct. at 1452 (concurring opinion).  This is much different from the New York law, which by its terms could apply to causes of action from jurisdictions other than New York.  As the Leonard court put it, the OCSPA limitation, unlike the New York law limitation:                      

is not a pan-substantive rule that applies to federal claims or to claims based on other state’s laws.  Rather it applies only to a violation of [the OCSPA] – indicating its substantive nature.

Leonard, 2012 U.S. Dist. LEXIS 30608, at *35.

So, in practice, Shady Grove might not be so bad, at least when it comes to state-law limitations on class actions.  In fact, depending on the language of the state-law limitation, it could be another tool to prevent plaintiffs from forum shopping a class action that they otherwise might not have. 

OTC Drug Plaintiff Fit To Be Fryed In New York

Just when we’re disgruntledly packing away our “Fry Mumia” buttons for the last time (guilty as sin, that one was), we get word from New York that the plaintiff in one of Dechert’s Tylenol cases lost a Frye-based appeal.  Unfortunately, because Ratner v. McNeil-PPC, Inc., ___ N.Y.S.2d ___, 2011 WL 5865657 (N.Y.A.D. Nov. 22, 2011), is one of our cases, we can’t supersize this post.  But we can give you an outline of what happened.


First, Ratner is an example of the philosophy behind this blog – that a defense win anywhere helps defendants everywhere.  A few years ago we (well, Bexis) participated in an amicus brief filed by the Product Liability Advisory Council, Inc. (“PLAC”) in a case called Parker v. Mobil Oil.  That appeal turned out well, producing an excellent Frye-based expert opinion – Parker v Mobil Oil Corp., 857 N.E.2d 1114 (N.Y. 2006).  Parker, in turn became the foundation for the recent win in Ratner.

So what happened?

Ratner involved a drug containing acetaminophen.  Massive overdoses of this drug can cause liver failure, which is not disputed.  Ratner, however, did not involve any sort of overdose – plaintiff claimed only routine, therapeutic doses of the drug, significantly expanding the scope of liability, if allowed .  Fortunately, the trial court found no valid scientific basis for the claim and granted summary judgment.  In Ratner, the Appellate Division affirmed, holding that none of the plaintiffs’ four experts had scientifically valid causation opinions.

The key issue in Ratner was not any particular test or technique used by the plaintiffs’ experts, but rather whether those tests could even be applied, given a fundamental lack of underlying scientific evidence.  The court recognized this hurdle as a “separate inquiry” not tied to novelty:

[W]here there is no novel or innovative science involved, or where the tendered scientific deduction has been deemed generally accepted as reliable, there remains a separate inquiry applied to all evidence. This inquiry is “whether there is a proper foundation – to determine whether the accepted methods were appropriately employed in a particular case.”

Ratner, 2011 WL 5865657, at *7 (quoting Parker).  The plaintiff’s “novel theory of cauastion” – “that therapeutic acetaminophen use caused the plaintiff's liver cirrhosis” – not any particular methodology, was at issue.  Id. at *8

The plaintiff’s experts claimed to be relying on “extrapolation” from the known hepatic risks of the drug in overdose situations.  Id.  The court held that there was nothing from which to extrapolate.  Absent adequate underlying data, the claimed “extrapolation” was simply an expert’s “ipse dixit.”  Ratner, 2011 WL 5865657, at *9.  All the plaintiff really offered was a pair of widely separated case reports of people who, after taking the drug in therapeutic quantities, later suffered liver trouble.  That was not enough:

[O]bservational studies or case reports are not generally accepted in the scientific community on questions of causation. . . . [T]he two aforementioned case studies relied upon by the plaintiff constitute merely observational data which are of a lesser caliber than controlled clinical studies from which results can be reviewed and verified.

Id. at *10.

Not only were case studies inherently insufficient, but these (even for case studies) were pretty weak.  For one thing, their authors did not reach causation conclusions.  “The two studies merely hypothesized that the liver injuries sustained by the patients therein were related to ingestion of therapeutic doses of acetaminophen and that further study was warranted.”  Id.  Or, as another author:

state[d] that the clinical importance . . . was unclear, and the authors of the study did not interpret the finding . . . to be indicative of serious liver injury.

Id. at *10.  Thus, the plaintiff’s experts were attempting to draw conclusions from purported bases of their opinions that went well beyond what those initial authors felt was justified.

And more.  Because acetaminophen had been around for a long time, there were plenty of (and much better) contrary data – “thousands of journal articles” – that “acetaminophen is safe in therapeutic doses, even for individuals suffering from liver disease."  Ratner, 2011 WL 5865657, at *10.

Since the plaintiffs’ experts’ opinions were:  (1) based upon minimal and comparatively weak data, (2) that was contradicted by large amounts of more powerful data, and (3) went beyond the conclusions that even the reporters of that weak data felt was justified, those opinions were “fundamentally speculative.”  Id. at *11.  Thus, the trial court had properly excluded those opinions and entered summary judgment:

[W]hen an expert seeks to introduce a novel theory of medical causation without relying on a novel test or technique, the proper inquiry begins with whether the opinion is properly founded on generally accepted methodology, rather than whether the causal theory is generally accepted in the relevant scientific community. Here, the plaintiff failed to meet that burden.

Id.