It’s cold here in Philadelphia and in much of the country. Really cold, your-car-makes-weird-noises-you-start-it cold. When it’s this cold up here, people start fantasizing about moving to Florida and leaving their snow shovels, rock salt, hats, coats, gloves, and all that behind.
Is there a point to this about drug and device law, you may
Will The Supreme Court Tackle a Plaintiff End-Run Around No Private Right of Action?
Okay, that’s a klutzy title. The football obsession doesn’t leave us until the morning after the Super Bowl. But the Iggles have been ignominiously bounced from the NFL playoffs, so the Supreme Court oral arguments have been our favorite spectator sport over the last week. One involved the continuing saga of the Anna Nicole Smith
Prempro Short Term Use Rule 702 Decision – Favorable
Here’s an important decision that we can’t say much about because we’re involved up to our eyeballs in this litigation. The MDL magistrate judge in the HT litigation has granted a Daubert motion excluding plaintiffs’ expert testimony that short term use (less than three years) causes ductal breast cancer. This will affect a lot of
Caronia Update: What Went Down At The Oral Argument
We’ve blogged about United States v. Caronia before. In fact, some might say we’re a bit obsessed by it, and with good reason; the First Amendment’s a big deal to us, and Caronia represents an opportunity for a Court of Appeals to pass on the constitutionality of FDA’s draconian and convoluted off-label promotion rules.
On The Preemption Radar Screen
It’s not exactly drugs/devices, but it’s food (which is close), and it’s preemption, and it’s the Supreme Court, so we thought we’d let you know. There’s a pending cert. petition called National Meat Ass’n v. Brown, No. 10-224. One of the questions presented, which attracts our attention, is:
Did the Ninth Circuit err
Already DTC (Done Through Causation) – More Thoughts About A DTC Exception
We blogged about the highly suspect decision in Centocor, Inc. v. Hamilton, 310 S.W.3d 476 (Tex. App. 2010), and last month awarded it the dubious honor of our #4 worst drug/device decision of all 2010.
Well, that isn’t all we’ve done. We (well, Bexis) submitted an amicus brief in Hamilton in the Texas Supreme Court earlier this week. Doing that required us to sit down and think about the supposed (except in New Jersey) “DTC (direct to consumer) exception” to the learned intermediary rule – more than we had before (which was relatively little). And it just so happened, that when we exercised our brains, we came up with more thoughts.
As we mentioned in the earlier post, the first problem with Hamilton was that it wasn’t even a DTC advertising case. Instead, it was a situation where the defendant provided patient-friendly material (a videotape) to the doctors and those doctors had the final say in whether the plaintiff ever saw the material.
Our gut reaction then was that this sort of professionally-mediated information wasn’t what anybody really considered DTC advertising. Now, having looked at that question further, we know we’re right. Why? Well, for one thing the FDA says so. The Agency itself doesn’t consider a videotape (or anything else) provided to a physician for the physician use with patients (or otherwise) to be DTC advertising – or “advertising” at all.
Nope.Continue Reading Already DTC (Done Through Causation) – More Thoughts About A DTC Exception
Bad Facts Make Bad Law
We just saw LeFaivre v. KV Pharmaceutical Co., No. 10-1326, slip op. (8th Cir. Jan. 19, 2011), and all we can say is bad facts make bad law – sort of, anyway. The bad facts are these:
KV stipulated as part of the Consent Decree that it had sold drugs that were “adulterated” as
Preclusive Effects of Class Action Certification Denials
Just a quickie post about today’s Supreme Court oral argument in Smith v. Bayer, a copy of the transcript here. This is the case where the, once the Baycol MDL had denied class certification, the plaintiffs tried for certification of an identical class in West Virginia state court.
In the interim, as we
Helpful Pain Pump Case on Comment K and Warning Causation
We wish everyone a nice Martin Luther King Day. Today not only honors a great American, it has also evolved into a day of service. That says something profound and wonderful about the honoree. We’ll do our best to observe the spirit of the day. There are all sorts of service. A friend in SoCal is helping to paint a lifeguard station. That makes us wildly jealous, given that we are staring outside at sheets of ice and awaiting the next visit of “Wintery Mix.”
Frankly, we were a little worried about whether this blog could render any real service today. There’s been a Monday curse of late, as we’ve opened the last couple of weeks with kvetch-fests on truly dreadful opinions (Bausch, Stevens, and Bartlett). But recently the Middle District of Tennessee rode to the rescue and delivered a useful opinion in a pain pump case, Rodriguez v. Stryker Corp., 2011 U.S. Dist. LEXIS 1252 (Jan. 5, 2011). It grants summary judgment to the defendants and supports its ruling with common sense and clear thinking.
The plaintiff in Rodriguez underwent shoulder surgery in 2004, including installation of a pain pump. A follow-up procedure in 2008 showed that the cartilage in the plaintiff’s shoulder had been destroyed. The plaintiff filed a lawsuit claiming that the pain pump had caused chondrolysis (a condition marked by destruction of the articular cartilage). The plaintiff alleged causes of action for strict liability, negligence, and breach of implied warranty.
The court applied Comment K to the strict liability claim, concluding that with “unavoidably unsafe products” such as a prescription medical device, the only issue was whether the manufacturer had failed to supply appropriate warnings. Rodriguez, 2011 U.S. Dist. LEXIS 1252, * 19. See how straightforward that was? Unlike the Bartlett case, the court didn’t conflate design defect and failure-to-warn theories.Continue Reading Helpful Pain Pump Case on Comment K and Warning Causation
Why Bother?
The other day the Pennsylvania Superior Court (an intermediate appellate court), sitting en banc no less, decided to weigh in on Vaccine Act preemption. See Wright v. Aventis Pasteur, Inc., 2011 Pa. Super 9, slip op. (Pa. Super Jan. 11, 2011). Briefly, the court did the same thing as the intermediate Georgia court did