The other day we learnedthat the U.S. Supreme Court will decide Vaccine Act preemption in Bruesewitz v. Wyeth. We’ll have plenty of time to obsess about the Bruesewitz case itself in the coming months, so today we’ll just use it as a convenientexcuse to get a couple of things out of the way.

Good-Bye Colacicco
Remember Colacicco v. Apotex? At one point it was all (more…)

As long-time readers know, this blog was founded by a couple of guys who first got to know each other defending co-defendant manufacturers in the Orthopedic Bone Screw Mass Tort. That fact significantly colors what you read here. A lot of the issues that we harp on– off-label use, medical device preemption, fraud on the FDA, cross-jurisdictional class action tolling, broken device cases, expert testimony on issues of (FDA) law (that’s (more…)

A recent case, Koger v. Synthes North America, Inc., 2009 WL 5110780 (D. Conn. 2009), underscores what should be a simple fact of life in product liability litigation involving orthopedic implants in particular, and implanted medical devices in general –plaintiffs shouldn’t expect to get anywhere with nothing more than a broken device.

That’s because the environment inside the human body is really hostile. (more…)

It’s that time of year. Yeah, we know, it’s neither new nor original to do top ten lists – but it’s still fun. Except when it isn’t.

How much fun can it be to review all those times in the past year when we’ve been kicked in the teeth? That’s right. Here are our top (or should we say bottom) ten worst prescription drug/medical device decisions of 2009.

True, there are still a (more…)

We love it when our readers share good ideas with us. For one thing, it saves us the trouble of having to think up ideas ourselves. Today we’re sharing a couple of those with you.

Ted Heise, who’s at Cook Medical, was reading our post on methods of proving up FDA-related evidence. He took the time to let us know that, if the fact of FDA pre-market approval is what’s at issue, there’s another avenue of judicial (more…)

We tried to think of a great issue to explore today – and struck out. So instead we’ll discuss this and that – various things that we’re aware of, but that we haven’t gotten around to mentioning.

Pigs Get Fat, Mississippi Got Slaughtered

The top of the agenda, of course, is a review of Judge Weinstein’s Zyprexa decision that we threw up a post about the other day (so we could (more…)

We’re not the first to mention this, but we want to make sure our readers know. The recently released House version of the administration’s healthcare reform package contains what is billed as pilot projects for “medical liability reform.” It’s a brief nod in the direction of the elephant in the room – limiting the incessant litigation that drives up the expense of every aspect of healthcare in this country, from the doctors, to the hospitals, to (more…)

We must be pretty poor bloggers. Our throwaway piece on there not being mousepads in hotel rooms drew (for us) a record 3500+ hits last Friday, courtesy of links from Above the Law and Instapundit. That’s second only to Wyeth v. Levine. And it generated over 1000 hits on Saturday and another 800+ on Sunday – both records for those days of the week.

Newsflash: more people care about mousepads than about drug and medical (more…)

We have rules at this blog: We don’t criticize drug and device companies, and we don’t criticize defense law firms.

But we’re making an exception here, and we bet you can understand why: Shook Hardy won an interesting case last week involving the sleeping pill Ambien. More than a dozen folks from Shook Hardy subscribe to this blog. Yet none of those subscribers told us about the firm’s victory! We learned about the Ambien decision (more…)

We’ve decided to get a couple of off-label use-related items off of our to-do-eventually list today. The first we’ve alluded to already. It’s the First Amendment litigation that Allergan recently commenced against the FDA involving the truthful “promotion” of off-label use (specifically use of Botox to treat muscle spasticity). The second is a new law review article on off-label use: R. Dresser & J. Frader, “Off-Label Prescribing: (more…)