We posted earlier about the Appellate Division’s 113-page whopper reversing a plaintiff’s Accutane verdict in McCarrell v. Hoffman-La Roche, Inc., 2009 WL 614484 (N.J. Super. A.D. March 12, 2009). Well, more than a year later, a second Accutane verdict meets the same fate. Here’s a copy of the opinion, Kendall v. Hoffman-La Roche,
A sharp-eyed reader (who wishes to remain nameless) yesterday put together our Bruesewitz user’s guide with our post last Tuesday about the Superior Court affirming (and confirming) in the Lance case that strict liability design defect claims don’t don’t lie against the manufacturers of prescription medical products in Pennsylvania.
The reader’s comment was: “Do you
When the Levine, Riegel, and Kent cases were briefed in the United States Supreme Court, we provided our readers with “users’ guides”/”guided tours” that summarized the defense side arguments and pointed out whatever we thought was interesting.
Today we’re continuing that tradition with the Bruesewitz (sooner or later we’ll memorize how to spell that) v. Wyeth case on Vaccine Act preemption, which the Court will decide this coming term. Being defense lawyers, we only review our own side’s arguments (in public, at least), but all the Brusewitz briefs are available on a this nifty website provided by the ABA.
We remember those days well, as we (well, Bexis) defended DTP manufacturers against the same sort of bizarre design defect claims at issue in Bruesewitz – that an alternative “safer” design can render a vaccine categorically defective, even though that design was not FDA approved. See White v. Wyeth Laboratories, Inc., 533 N.E.2d 748 (Ohio 1988) (the Ohio Supreme Court rejecting the theory). See also Wyeth br. at 19-21 (detailing regulatory history of supposed “alternative” designs of DTP). Basically no alternative “acellular” DTP vaccine received FDA approval for use in the relevant age group until 1996 – 4 years after the injury claimed in Bruesewitz.Continue Reading Users’ Guide to Defense Briefs in Bruesewitz v. Wyeth
We know that some followers of this blog are law professors and law students. Conversely anybody who follows the blog knows that we like – really like – the more sensible approach that the Supreme Court took towards pleading in Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007), and Ashcroft v. Iqbal,
Last week we reported on two recent decisions by the Pennsylvania Superior Court (an intermediate appellate court) in fen-phen litigation. Well, there was a third shoe out there, and yesterday it dropped. In Lance v. Wyeth, No. 2905 EDA 2008, slip op. (Pa. Super Aug. 2, 2010), affirmed – for the first time in a reported appellate decision in Pennsylvania – that the restrictions on strict liability recognized by the Pennsylvania Supreme Court in Hahn v. Richter, 673 A.2d 888 (Pa. 1996), precluded any claim for strict liability design defect in product liability litigation involving prescription drugs (and, we presume, medical devices as well.
Although Appellant labels her claim as “negligent and unreasonable marketing,” her proposed cause of action duplicates a design defect claim, seeking to impose strict liability on [defendant] because [its drug] was unreasonably dangerous. With our Supreme Court’s adoption of comment k, a design defect claim for strict liability is not cognizable under Pennsylvania law when it is asserted against a manufacturer of prescription drugs. For purposes of strict liability and §402A, a drug cannot be deemed unreasonably dangerous, even if it is defectively designed, so long as the drug is manufactured properly and contains adequate warnings.
Slip op. at 7-8 ¶15. We’ve made the argument, of course, that Hahn precluded strict liability of any sort (other that manufacturing defects, which are pretty rare), but now we’ve got an appellate court for the proposition.
But then the court goes and recognizes a negligent design claim for a prescription drug. That’s better than strict liability, given Pennsylvania’s weird evidentiary restrictions, but not by all that much. The court bases it on two things: (1) that Restatement of Torts §395 “contains no exemption or special protection for prescription drugs” and (2) the statement in Restatement of Torts §402A that strict liability “is not exclusive, and does not preclude liability based upon the alternative ground of negligence.” Slip op. at 10-11 ¶¶18-19.Continue Reading Pennsylvania Fen-Phen Appeals – The Third Shoe Drops
The folks over at 360 have a story this morning about the decision, Judy v. Pfizer, Inc., No. 042-1946-02, slip op. (Mo. Cir. St. Louis Co. July 27, 2010), in which the court denied a consumer fraud claim loosely predicated on off-label use/off-label promotion of Neurontin. We’re, of course, pleased to see that, but
A new book, Being Wrong, tries to describe the process of how people get things wrong, how it feels, and what it means. Wrongness can include all sorts of errors, including optical illusions, memory failures, neurological deficits, flights of imagination, or irrational beliefs. A worthy addition to this catalogue of wrongology can be found in a recent learned intermediary case, In re Levaquin Prods. Liab. Litig., 2010 U.S. Dist. LEXIS 75054 (D. Minn. July 26, 2010).
We just returned from a deposition of a prescriber, so this issue is near and dear to our hearts right now. Let’s put aside the issue of whether the plaintiff ever specifies what the warning should have been. (Usually they don’t. It descends into a game of whack-a-mole.) In most pharmaceutical failure-to-warn cases, it turns out that even if the requisite warning had been supplied to the prescriber — indeed, if it had been writ large in neon and hung a few inches from the doctor’s nose — it wouldn’t have made any difference; the same medicine would have been prescribed in the same way at the same time in the same dose. Because it’s called the learned intermediary defense, some might rashly conclude that the burden of proof would be on the defendant to prove that the warning would have made no difference. But what the learned intermediary defense means is that the issue is whether the learned intermediary – usually the doctor — was warned, not the ultimate consumer. And then it becomes an issue of causation: did the lack of a warning make any difference? That burden, friends, is on the plaintiff. (That’s our position, anyway. We’re not saying all jurisdictions agree; only the smart ones.)
The Levaquin opinion seems perfectly muddle-headed as to burden of proof. At one point it says, “If a defendant properly establishes the facts necessary to support the learned intermediary defense, a patient will be unable to show that the defendant’s failure to warn the prescribing physician is a proximate cause of the patient’s injury.” Levaquin, 2010 U.S. Dist LEXIS 75054, *5. That is not clear and definitely not helpful. Later, the court discusses an earlier case that held that “a plaintiff must identify some omitted information that would have convinced the prescribing physician to alter the recommended course of treatment in order to establish causation for failure to warn under Minnesota’s learned intermediary doctrine.” Id. at * 23 (citing Bruzer v. Danek Medical, Inc., 1999 U.S. Dist. LEXIS 4483 (D. Minn. 1999)). That sounds more like putting the burden of proof on the plaintiff, where it should be. But when we look at how the Levaquin court treated the facts in the case, it’s hard to believe that it didn’t get burden of proof wrong, as well as just about everything else.Continue Reading Wrong on Learned Intermediary