A product is not defective simply because someone was harmed by it. That seems a simple enough point. Courts often acknowledge it, though sometimes in a perfunctory, mumbling fashion. What gives teeth to the mumbling is when state law requires the plaintiff to show a safer alternative product. If really pressed, many plaintiffs cannot articulate

A (relatively) long time ago in a state not so far away, the Michigan Legislature enacted the Michigan Product Liability Act.  It contained a provision providing the manufacturers of FDA-approved drugs with immunity from product liability absent the application of two narrow exceptions.  A challenge to the constitutionality of the provision soon followed and the

We remember how, shortly after the atrocious decision in Johnson & Johnson v. Karl, 647 S.E.2d 899 (W. Va. 2007), rejecting altogether the learned intermediary rule, litigation tourists visiting West Virginia argued that Karl represented that state’s “public policy” and therefore the learned intermediary rule could not apply even to their out-of-state cases under

What follows is a post authored by Jaclyn Setili, a Reed Smith associate.  She is discussing what we believe is the first extension of Mensing/Bartlett preemption to claims involving pharmacies – something we’ve previously proposed as theoretically possible, but had yet to see.  As always, our guest posters are entitled to 100% of the credit (and any blame) for their blogposts.

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As a Mitten native (that’s Michigan for the uninitiated), this guest blogger is regularly on the lookout for good news connected with her home state.  Typically this involves events of the sporting championship variety, but cause for celebration has been scarce of late on that front (see, e.g., Michigan football, an impressive early season dominance culminating in two close late season losses and a devastating defeat in the Orange Bowl; the Red Wings, currently sitting in last place in their division and slipping progressively further away from a Stanley Cup title since their last championship win in 2008; and the Lions, every year, forever). Even reports of Detroit’s flourishing restaurant scene and a slot in the New York Times’ 52 Places to Go in 2017 fail to inspire much collective awe from this guest blogger’s big-coastal-city friends and colleagues.

As it turns out, however, we need only look a few months back to the In re Lipitor MDL (which we have blogged about before, most recently here, and in which all but one of the cases have now been dismissed) for such news.  In In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices and Products Liability Litigation, 2016 WL 7368203 (D.S.C. Nov. 1, 2016), the district court ultimately granted plaintiffs’ motions to remand, but in the process became the first court ever (as far as we know) to apply impossibility preemption to bar warning claims against a pharmacist selling a branded drug.

The details: The two actions at issue were originally filed in Michigan state court; each plaintiff alleged that Lipitor caused her to develop Type II diabetes, and that the manufacturer failed to properly disclose the risks associated with the drug.  That defendant removed both cases to the Eastern District of Michigan based on diversity jurisdiction; from there the cases were transferred to the MDL court.  Plaintiffs named a local pharmacy in order to destroy diversity.  While the parties agreed that the pharmacy and at least one named plaintiff in each case were residents of Michigan, defendants claimed that the pharmacy was fraudulently joined and that the non-Michigan plaintiffs were fraudulently misjoined.  Plaintiffs moved to remand.

As we and the MDL court know all too well, to establish that a nondiverse defendant has been fraudulently joined, a removing party in the Fourth Circuit must show either:  (1) “outright fraud” in plaintiff’s pleading of jurisdictional facts, or (2) that there is no possibility that plaintiff would be able to establish a cause of action against the in-state defendant in state court.  2016 WL 7368203, at *1 (emphasis added).  That is always an uphill battle.  Here, defendants argued that there was no possibility that plaintiffs could state a claim against the pharmacy where plaintiffs allegedly purchased the drug under Michigan law for four reasons:  (a) their claims were preempted by federal law, (b) Michigan’s seller immunity statute bars pharmacy claims, (c) the pharmacy had no duty to warn plaintiffs, and (d) the learned intermediary theory further barred plaintiffs’ claims.

Of primary importance for our purposes is the court’s analysis of the first ground, preemption.  The court first noted plaintiffs’ admission that they “may not have a claim regarding labeling with respect to . . . a pharmacy.”  Id. at *2.  The court swiftly concluded that even if it were possible to state such a claim, it would be preempted by federal law because, under the Federal Drug and Cosmetic Act, “a pharmacy has no authority to unilaterally change a drug’s label.”  Id.  Thus, any claims based on labeling were preempted under PLIVA, Inc. v. Mensing, 131 S. Ct. 2567, 2571 (2011).  In other words, the court concluded that there was no possibility that plaintiffs could establish a cause of action against a pharmacist based on labeling.  That result is a first, and could be a big deal.


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Delve into the crime stories of Elmore Leonard, whether in the form of the books, movies, or television shows, and you are likely to spend considerable time in Michigan and Florida.  True, Justified was set in Kentucky.  But Marshall Givens was forced to leave the Sunshine State after shooting a suspect (“Let’s just keep it simple: he pulled first,  I shot him”), and the big criminal organization he often contended with hailed from Detroit.  Leonard, also known as the Dickens of Detroit, was a native of Michigan and later spent much time in Florida.  Those two locations furnish a nice contrast between city and swamp, both settings being utterly sweaty and corrupt.

There is nothing especially sweaty about what we do, and we’d like to think that corruption is far, far away, but if you delve into our litigation docket, you are likely to encounter a tug of war between Michigan and Pennsylvania.  We live in Pennsylvania.  Our courts and laws seem inordinately fond of drug and device law plaintiffs.  By contrast, Michigan has just about the best, most pro-defense laws on the books, and, consequently, Michigan plaintiffs look to hightail it out of there and file their cases in a more hospitable jurisdiction – like, say, ours.

Recently in the Philly mass tort Risperdal litigation, a local judge did the right thing and told Michigan plaintiffs that they were stuck with Michigan law.  In Re Risperdal Litigation, 2015 Phila. Ct. Com. Pl. LEXIS 254 (Phila. CCP October 1, 2015).  The 13 plaintiffs were Michigan residents who claimed that they developed gynecomastia after taking Risperdal during adolescence.  The defendants filed summary judgment motions arguing that Michigan’s Products Liability Act applies and affords the defendants immunity on the plaintiffs’ claim for 1) negligence, 2) negligent design defect, 3) fraud, 4) strict liability – failure to warn, 5) strict liability – design defect, 6) breach of express warranty, 7) breach of implied warranty, 8) conspiracy, and 9) medical expense incurred by parents.  The plaintiffs disagreed.  They needed Pennsylvania law to apply, otherwise they would lose.

They lost.


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The short answer is “no.”  We are just borrowing a line from one of the original gangster movies, “Little Caesar,” which readers other than McConnell would most likely know from references in “The Sopranos,” if they know it at all.  (Or from here.)  The titular character in that flick was known as “Rico.”  RICO (Racketeer Influenced and Corrupt Organizations Act), on the other hand, was an anti-gangster law, enacted in 1970 as part of the Organized Crime Control Act.  In a number of posts (like here), we have decried the gangster tactics used by plaintiffs—particularly quasi-public plaintiffs—to use the threat of RICO’s treble damages and cost-shifting provisions to extort settlements from drug and device manufacturers.  Particularly for prescription medical products, RICO seems like an inappropriate vehicle for addressing alleged harms allegedly caused by such standard product liability allegations as inadequate disclosure of risks or off-label promotion.  A small blow to curtail the expansion of RICO was struck in Short v. Janssen Pharms., Inc., No. 1:14-CV-1025, 2015 U.S. Dist. LEXIS 61123 (W.D. Mich. May 11, 2015).

Short is yet another case stemming from pediatric use of Risperdal.  We have posted many times on various Risperdal cases with various theories of recovery, usually tied to the idea that the drug was improperly promoted for off-label use without disclosing the true risk of gynecomastia and other prolactin disorders, like hereherehere and here.  In Short, the plaintiff allegedly took Risperdal as a minor, developed gynecomastia, and sued in his own behalf under RICO and state consumer protection and product liability acts.  His problems were that he never paid a cent for the drug and that he was from Michigan.  We suspect the latter may be why RICO was at issue at all.


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We’ve seen an increase in allegations of “unjust enrichment,” particularly in strike suits seeking recovery of purely economic loss. A number of states don’t even recognize this theory as a separate cause of action (according to Bexis’ book, these include California, New Jersey, Pennsylvania, and Tennessee), and others preclude it when there is an “adequate