Texas preemption and fraud decision in medical device case

In a Texas federal district court, summary judgment has been granted to defendants in a Class III medical device case on preemption grounds.  The devices at issue were hip implant components and bone cement used in the procedure.  Scott v. Pfizer, Inc., Slip Copy, 2008 WL 508641 (E.D.Tex.). 

One defendant sought to dismiss malice/fraud and misrepresentation allegations on the ground that they were not specifically pleaded.  The court dismissed those allegations because they did not meet a "who, what, when and where" pleading specificity standard.  The manufacturer of the implant has also moved for summary judgment on the other claims of the plaintiff, but that motion has not yet been decided.

The other defendant who manufactured the bone cement moved for summary judgment on preemption grounds.  The bone cement was a device that was grandfathered in as a Class III device with the inception of the Medical Device Act in 1976.  There was a recent Louisiana case that granted preemption for a product in a similar posture that I discussed in a earlier post (read here).  The Texas court agreed that preemption should apply to this device.  This decision was made before the Supreme Court ruled in the Reigel case a couple of weeks ago.

Plaintiff also claimed that there was a violation in the manufacturing processes of the defendant and sought to raise a question of fact as to the claim of a manufacturing defect.  The defendant offered proof that the product was manufactured properly, and that it met the manufacturing specifications.  In the absence of contrary proof, the court held that summary judgment should be granted because plaintiff could not show that there was in fact a manufacturing defect.