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New Stuff FIled Under "A" (Accutane and Acetabular Hip)

By James M. Beck and Mark Herrmann

A couple of brief notes on new decisions:

(1) In Accutane litigation, plaintiff's expert Ronald Fogel is now 0-2 under Daubert. The latest opinion excluding his testimony does so because his opinions overreached the medical literature on which they were based. The holding:

Both [the articles], in their review of the existing literature, case reports and scientific data, only formed hypotheses, not opinions of causation. Without some scientific data to close the gap between hypothesis and opinion, Dr. Fogel cannot do more.

Slip op. at 4. Tip of the cyberhat to Michael Imbroscio at Covington.

In the acetabular hip litigation, Covert v. Stryker Corp., 2009 WL 2424559 (M.D.N.C. Aug. 5, 2009), granted a PMA preemption motion to dismiss. The court rejected the following plaintiff's arguments against preemption: (1) Riegel essentially invalidated 21 C.F.R. §808.1(d)(1), to the extent that it would limit preemption of state tort claims (such as implied warranty that "incidentally" regulate medical devices. There is considerable criticism of Hofts v. Howmedica Osteonics Corp., 597 F. Supp.2d 830 (S.D. Ind. 2009). 2009 WL 2424559, at *4-7. (2) Preemption motions to dismiss may be brought against parallel violation allegations. There's no obligation to wait for summary judgment, especially after Twombly/Iqbal. 2009 WL 2424559, at *8-10. (3) Far from undercutting the preemption defense, allegations of fraud on the FDA are themselves preempted. 2009 WL 2424559, at *11. (4) To escape preemption, parallel violation claims must be "genuinely parallel." Thus FDA warning letters issued after plaintiff's surgery are insufficient unless some allegation ties them to the device implanted in the plaintiff. 2009 WL 2424559, at *12-16. There's a pithy summation of what Twombly/Iqbal require to plead an adequate parallel violation claim:

In order to ?survive? MDA pre-emption under Twombly, a plaintiff must point to a specific federal requirement, show how it was violated, and in this case, show how said violation resulted in the injury complained of.

2009 WL 2424559, at *16 n.10. (5) a plaintiff has to plead specific statements and causation to allege an express warranty or consumer fraud claim that might escape preemption. 2009 WL 2424559, at *16.

Keep those wins coming.

Full post as published by Drug and Device Law on August 12, 2009 (boomark / email).