We posted earlier this month about Joseph v. Baxter, in which Judge James Carr (of the Northern District of Ohio) severed and remanded claims against the non-diverse health care providers to create diversity as to the drug company defendant.

We raised a few questions at the end of that post, asking, among other things, whether the holding was limited to situations where (1) the drug company removed before it was aware that health care providers (more…)

Bloomberg News reported this moments ago:

“Roche Holding AG, the world’s biggest maker of cancer drugs, is pulling its Accutane acne medicine from the U.S. market after juries awarded at least $33 million in damages to users who blamed the drug for bowel disease.”

Here’s our take: The cause of inflammatory bowel disease is unknown. There’s essentially no scientific evidence linking Accutane to that condition. (Here’s a (more…)

Judge Weinstein granted three more summary judgment motions yesterday in the Zyprexa mass tort. The reasoning is essentially the same for two of them – the statute of limitations ran, and there was no warning causation under the learned intermediary rule. The third case had no statute of limitations issue, and was solely a causation decision. Briefly:

In Morrison v. Eli Lilly, the drug helped the plaintiff with fewer adverse (more…)

This post is largely about drug and medical device litigation “inside baseball.” Some of it’s going to be really technical. So if you’re looking for philosophical musings, or just a chuckle or two over the latest bizarre goings on in our neck of the woods, come back later.

But if you’ve ever had to worry about pleading and proving FDA actions without formal discovery – especially doing it on Rule 12 (more…)

It only took five years and two reversals on appeal, seeIn re St. Jude Medical, Inc., 425 F.3d 1116, 1119-21 (8th Cir. 2005); In re St. Jude Medical, Inc., 522 F.3d 836 (8th Cir. 2008), but the class action allegations in the St. Jude/Silzone litigation are finally history. The trial court reluctantly (”on a blank slate” the court would have certified the class, yet again) struck those allegations the other day. (more…)

Vitek manufactured and distributed Proplast dental implants, used to treat degeneration of the temporal mandibular joint in the jaw. The FDA recalled those implants in 1991. The whole world sued.

Vitek declared bankruptcy.

Dr. Charles Homsy was an officer, director, and shareholder of Vitek.

Homsy skipped the country.

DuPont manufactured a raw ingredient that Vitek used to manufacture the implants.
(more…)

A couple of issues in Svindland v. The Nemours Hospital, 2009 U.S. Dist. LEXIS 43315, No. 05-417 & 05-441 (E.D. Pa. May 19, 2009), caught our eye — namely: (1) whether to exclude comparative risk evidence and (2) whether to allow plaintiffs to discover the raw clinical data that formed the basis of published medical articles.

Svindland involved two medical malpractice cases brought by the parents of infants who died after heart surgery (more…)

We have been frequent critics of the FDA’s efforts to prohibit truthful promotion of off-label uses. We’ve arguedthat these restrictions contrary to the public health because they limit the ability of the most knowledgeable party (the drug manufacturer) to communicate with the medical community about the risks and benefits of cutting edge medical therapy. Actually, even the FDA (sometimes) admits this:

FDA does recognize, however, (more…)

Last Friday, the Pennsylvania Superior Court (an intermediate appellate court in Pennsylvania) issued a long awaited (some three years long) decision in the Baycol case, Pauley v. Bayer. We’ve been interested in Pauley because the trial court opinion being appealed was probably the best Pennsylvania/state court generally authority on inadmissibility of anecdotal adverse event reports. SeePauley v. Bayer Corp. (more…)

Does “situational ethics” mean that your ethics change to fit the situation?

Because “practical lawyering” sure seems to mean that your legal status should change to fit the situation.

We couldn’t help but laugh when we read Hadley v. Wyeth Laboratories, Inc., No. 14-07-01055-CV, slip op (Tex. App. [14th Dist.] May 28, 2009) (link here).

There’s nothing funny about the opinion on its face. Dr. Hadley and Wyeth had (more…)