1. A 4-4 split by the Supreme Court is of no precedential value. It doesn’t bind any lower court to any position. Here, this means that the circuit split between the Second Circuit and Sixth Circuits remains. That means that immunity statutes are not subject to fraud-on-the-FDA exceptions in Ohio, Michigan, Tennessee, and Kentucky (the
Fraud On The FDA
Guided Tour Of Defense Briefs In Warner-Lambert v. Kent
The first wave of defense briefing is now complete in Warner-Lambert v. Kent. Like we did with the Riegel briefs, we thought our readers would like a guided tour. Now, the preemption issues in Kent are a little (OK, a lot) different than in Riegel – implied versus express; drug versus medical device…
Latest FDA/Solicitor General Preemption Amicus Filing – Kent
The Solicitor General, on behalf of the FDA, has recently filed amicus briefs in both the Riegel v. Medtronic and Warner-Lambert v. Kent (formerly Desiano) Supreme Court preemption cases. We’re doing a separate post on Riegel, but we did this one first because it’s more in the nature of “breaking news” – it…
Probing Statprobe
Judge Pratter’s recent decision in Wawrzynek v. Statprobe, Inc., No. 05-1342, 2007 WL 3146792 (E.D. Pa. Oct. 25, 2007), recently caught our eye. The decision raises a host of interesting questions.
First, how the heck do you pronounce that plaintiff’s name?
But wait, there’s more!
In a nutshell, Statprobe is a contract research organization that…
Warner Lambert v. Kent – What’s At Stake
Ever since the Supreme Court granted certiorari in Warner Lambert v. Kent the other day, we’ve been thinking about what’s at stake. We’ve seen the case described by Bloomberg as a “chance to extend a victory [defendants] won in 2001, when the Supreme Court said patients can’t sue companies for defrauding the U.S. Food and…
Warner-Lambert v. Kent: Broader Implications
The first question we’ll be asked, of course, is whether a decision in Warner-Lambert v. Kent, which involves a Michigan state law, will have broad national implications.
In a word, yes.
The Michigan law involved in Kent essentially bars product liability claims against manufacturers of prescription drugs — unless a manufacturer defrauded the FDA.…
Rule 702 Decision in Baycol Raises Interesting Legal Points
We’re so used to adverse decisions out of the District of Minnesota – what with the defibrillator MDLs “distinguishing” Buckman into near oblivion, and the heart valve MDL persisting in certifying classes despite being told not to by the Eighth Circuit – that good news from that district is like a breath of fresh air.…
Why The Texas Vioxx Decision Matters
Last weekend, we did a post on why preemption matters. The story has now evolved.
Judge Randy Wilson, in Harris County, Texas, is overseeing the Texas statewide coordinated Vioxx proceedings. Judge Wilson announced late last week (April 12, more or less) that he would be entering an order ruling in favor of Merck on…
Buckman Scorned (Implantable Defibrillators)
We just read one of the more remarkable decisions we’ve ever seen, insofar as it disregards controlling precedent. That opinion is In re Medtronic, Inc., Implantable Defibrillators Litigation, 2006 WL 3420285 (D. Minn. Nov. 28, 2006). To understand how this decision puts the preemption rabbit in the hat and then makes it disappear first…