Recently, in the context of an IVC filter case, the Third Circuit Court of Appeals certified two questions to the Pennsylvania Supreme Court:

1. Under Pennsylvania law, must a plaintiff bringing a negligent design claim against a prescription medical device manufacturer prove that the device was too harmful to be used by anyone, or may

Plaintiffs love to tell juries how horrible the defendant’s product is.  They’ll tell them how the product kills people – even though the plaintiff in the case didn’t die.  They’ll try to bring up purported cancer risks although the plaintiff doesn’t have cancer.  They’ll argue that, if the defendant’s device were to fail, they’d face

The same Missouri Supreme Court that couldn’t be bothered to review a 22-plaintiff consolidation that resulted in a ten-figure verdict in a talc case saw fit to review a defense verdict in a pelvic mesh case.  One wonders where justice stands among that court’s priorities.  At least the verdict was affirmed – if only barely,

We’ve blogged numerous times about the tentative, non-final, and informal status of FDA warning letters (and untitled letters and similar enforcement precursors like Form 483s).  We’ve cited precedent, FDA internal manuals, FDA’s own position taken in formal briefing, and learned treatises on FDA law.  That an FDA warning letter has no binding legal effect (indeed,