Learned Intermediary

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Anybody interested in generic drug preemption undoubtedly remembers Bartlett v. Mutual Pharmaceutical Co., 659 F. Supp. 2d 279 (D.N.H. 2009), as one of the earliest detailed examinations of such arguments post-Levine.  Whether one agrees with the conclusions of that decision or not (we mostly don’t), it certainly demonstrated that Judge Laplante was almost as thorough and conscientious an opinion writer as the late Ed Becker of the Third Circuit.  We do not make that comparison lightly.
Well, there’s now a second Bartlett opinion – Bartlett v. Mutual Pharmaceutical Company, Inc., 2010 U.S. Dist. Lexis 69825 (D.N.H. July 12, 2010), and not only is it just as detailed – but the defendant does considerably better (although not entirely so).  There are a lot of issues, so we’ll just highlight them here:
Adequacy of warning – The court refuses to hold as a matter of law that the warning was adequate – that “hypersensitivity” and “severe skin reactions” were the legal equivalent of a specific warning about Stevens-Johnson syndrome, which is frequently fatal.
Warning causation – Summary judgment is granted on warning claims based upon the prescriber’s admitted failure to read the defendant’s warnings.  There is a lengthy discussion of this recurring issue.Continue Reading A Second Significant Decision in Bartlett v. Mutual Pharmaceutical

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Philadelphia has seen more than its share of perplexing decisions. This is where the Founders gave Delaware the same number of Senators as New York. The great painter Thomas Eakins scandalized his high-strung, high society patrons by permitting female students to paint male nude models. Bad career move. Fregosi let Mitch Williams pitch to Joe Carter. Another bad career move. Somebody here thought of pouring cheez-wiz over low-grade, high-grease meat. Oddly, a good career move. And as for John Oates’s porn stache — well, the less said the better. And, yes, there have been some judicial decisions that made us scratch our cyber noggins.
But sometimes courts here get it right. That happened a couple of weeks ago in the Commonwealth’s case against Janssen over Risperdal. The court issued a nonsuit that was a model of clear thinking. The written opinion came out on Friday, and it was well worth the wait. Commonwealth v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., No. 2181 (Phila. Ct. Comm. Pleas June 25, 2010).
Speaking of perplexing decisions, let’s depress ourselves for a moment by remembering how the Commonwealth decided to bring cases against manufacturers of atypical antipsychotics. (We’ve blogged about that case a number of times, including here.) A Texas plaintiff firm shopped the representation to the Pennsylvania Attorney General, who politely declined. (Chalk that up to prescience). Then the Governor’s office, in an unusual move, took over the case and hired the Texas firm. It was a no-bid, contingent contract. Did we mention that the Texas firm had made significant campaign contributions to the Governor? The propriety of this smelly deal is in front of the Pennsylvania Supreme Court, and we’re keeping our fingers crossed that the Justices will put an end to these shenanigans, which reek of conflicts of interest and pay-to-play politics. (Disclosure: Bexis wrote much of the WLF amicus brief on this issue, so it’s not as if we’re disinterested.)Continue Reading A Typically Splendid Philadelphia Decision

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SCOTUS short-lists are sort of like Golden Globe ceremonies or TMZ episodes for law nerds like us. We get giddy when the Sunday talking heads gush about the likely candidates, or warn about who’s out of the mainstream and might provoke a filibuster. One of the short-listers is Diane Wood, a judge on the Seventh…

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We just love to see our victories put to good use by other lawyers in later cases.

So we got a big kick out of Pustejovsky v. Wyeth, No. 4:07-CV-103-Y, 2009 U.S. Dist. LEXIS 101513 (N.D. Tex. Sept. 4, 2009).

We didn’t get a big kick out of the facts, since we had nothing to…

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We have rules at this blog: We don’t criticize drug and device companies, and we don’t criticize defense law firms.

But we’re making an exception here, and we bet you can understand why: Shook Hardy won an interesting case last week involving the sleeping pill Ambien. More than a dozen folks from Shook Hardy subscribe…

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This just in:

Adam W. Mason had won a $7 million jury verdict in Florida state court on a claim that Hoffman-La Roche had not adequately warned about the alleged link between ingesting Accutane and developing inflammatory bowel disease.

This morning, in a per curiam decision, the Florida First District Court of Appeal reversed. Hoffman-La…

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A federal trial court has held that West Virginia public policy forbids applying the learned intermediary doctrine even to patients treated outside of West Virginia.
Thus: An Alabama physician prescribes a drug to an Alabama resident. The resident uses the drug in Alabama and is allegedly injured by the drug there. Alabama law recognizes the…

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Bexis’ Book

FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
Learn more about this book