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
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
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
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
We put up an initial post about Bausch v. Stryker Corp., ___ F.3d ___, 2010 WL 5186062 (7th Cir. Dec. 23, 2010), back in December, only four days (including Christmas) after it was decided. But Bausch is so spectacularly bad – on more than one issue – that it deserves a more thorough bashing. We’ve called some opinions we’ve seen “spherical error,” but with Bausch things get so bad that we’d have to add a couple of more dimensions to the sphere to have an apt comparison.
Anyway, Bausch went south on not just one, but two, major issues: pre-market approved (“PMA”) medical device preemption and Twombly/Iqbal pleading. With respect to preemption, Bausch created a circuit split – explicitly backing the partial dissent in Bryant v. Medtronic, Inc., 623 F.3d 1200 (8th Cir. 2010) (we previously discussed Bryant here). Bausch, 2010 WL 5186062, at *6. That has the advantage of creating a direct circuit split over the extent of PMA preemption, and direct circuit splits are one thing upon which successful United States Supreme Court appeals are based.
But on TwIqbal, what Bausch is conceptually worse than just disagreeing with a decision we like. Rather, the court essentially rebelled against the spirit and letter of Twombly and Iqbal – two controlling decisions of the Supreme Court that it was bound by the fundamental workings of our court system to follow. Bausch’s rationale, as we will see, retreats to the “let discovery solve everything” mindset that TwIqbal overturned. In a sense, that’s not terribly surprising, since Judge David Hamilton had previously taken the same track (if less explicitly) in his previous opinion while still on a district court judge in Hofts v. Howmedica Osteonics Corp., 597 F. Supp. 2d 830 (S.D. Ind. 2009). As we’ve previously pointed out, Hofts had been widely rejected as contrary to TwIqbal. If you keycite Hofts on Westlaw, you’ll see that the decision has accumulated an impressive 10 adverse citations (only two of which are mere “distinguisheds”) in less than two years. But to become the first post-TwIqbal appellate court to raise the red flag of outright rebellion, Judge Hamilton seems to have acquired some new, and somewhat disturbing, allies.
Preemption first. In one sense Bausch is fairly narrow. It affirmed, or else plaintiffs didn’t appeal, the dismissal of everything in a product liability suite involving a PMA device other than so-called “parallel” violation claims. So even with Bausch there’s not a whole lot left to the suit. Real violation claims aren’t particularly easy to plead, but they’re even harder to prove, so this is just the beginning. The easy stuff to take to a jury – warning related claims, particularly – are out of the case.
But in another sense Bausch is shockingly broad. The opinion doesn’t exhibit any inclination at all to police what plaintiffs claim as purported violations. To explain properly what’s going on, we first ought to briefly (for us, anyway) recapitulate how this concept of “parallel” violation claims came to be.Continue Reading Bashing Bausch
Last Friday, FDA finally released its long-awaited Transparency Initiative (now called the Phase III Transparency Report), and luckily, the troubling proposals we previously blogged about didn’t make it into the final version. In fact, our first-blush reaction to the Initiative is that this is a “baby steps” document. FDA is beefing up its website with
We defense lawyers enjoy reading lengthy opinions that analyze key defense issues and rule in our favor. But it can be more satisfying to read a short opinion in favor of the defense on an issue we care about. Short opinions usually show that the law on a particular point is settled. Rounds v. Genzyme
The Monday curse continues! Another bad case that makes us feel so disappointed, so cheated, so sad, so … Monday.
We have blogged on the Bartlett case before. We did it here. And here. And here. And here. And that’s not all. It’s been the gift that keeps on giving. Though, as was the case over the holidays, some of those gifts were items we’d just as soon return. Make no mistake about it, Judge LaPlante works hard and writes lengthy, scholarly opinions. He seems thoughtful and diligent. Some of what he wrote we liked a lot. Some — not so much. Being thoughtful and diligent doesn’t always make you right. (And sometimes one can be thoughtless and lazy and still be utterly right. Every day we bank on that possibility.)
In the Bartlett case the plaintiff suffered truly horrific injuries, claiming they were the result of a generic anti-inflammatory drug called Sulindac. The details are in our earlier posts, so let’s get right to the bottom line: the jury returned a verdict of $21 million. The defendant filed a motion for judgment as a matter of law and, in the alternative for a new trial. Last week, Judge LaPlante denied those motions. Bartlett v. Mutual Pharmaceutical Co., 2010 WL 5494053 (D. N.H. Jan. 5, 2010).
The coverage we’ve seen so far of this decision emphasizes the defendant’s claims that the trial was unfair because the plaintiff lawyer inserted all sorts of prejudicial stuff (including putting up on the screen a precluded question about the company’s net sales — supposedly an accident due to a computer “glitch”) as well as the defendant’s claim that the judge seemed biased because he said a few things that defendant construed as rooting for the plaintiff, and also appeared to get teary-eyed during emotional testimony (the Judge told the jury the next day that it was only an allergy).Continue Reading The Bartlett Saga Continues: Reversal Bait
As we predicted it might, two months ago when we discussed IMS Health, Inc. v. Sorrell, the Supreme Court today granted certiorari in this very interesting First Amendment case. We will soon (in the legal biz that means a year) get a ruling on the degree of First Amendment protection to which truthful speech
Ever since the JPMDL (that,s “Judicial Panel on Multi-District Litigation” for you non-lawyers), refused to create an MDL – twice – for pain pump litigation, there’s been guerilla warfare all over the country in cases involving these devices (and also for the unfortunate manufacturers of the anesthetic drug used in them). A lot of recent pain pump decisions have involved lousy pleading, but not all of them. A few of the more advanced pain pump cases have reached the summary judgment stage. We’ve already written a post on one of the first, Meharg v. I-Flow Corp., 2010 WL 711317 (S.D. Ind. March 1, 2010), that granted summary judgment.
Well, now, thanks to Kim Schmid and her team at Bowman & Brooke, we’re quite pleased to report on another – this time from Ohio. Krumpelbeck v. Breg, Inc., ___ F. Supp.2d ___, 2010 WL 5475616 (S.D. Ohio Dec. 27, 2010). Like Meharg, plaintiff Krumpelbeck came from a state, Ohio, that’s on our master list as recognizing the state of the art defense. Thus, a critical issue was what was known about any link between pain pumps and the plaintiff’s injury (chondrolysis) at the time of the plaintiff’s surgery on March 3, 2005.
Turns out – not much. Even the turncoat prescriber (we hate it when that happens) had to admit that, at the time he didn’t know anything about it until two years later, and that the pump seemed to help his patients. 2010 WL 5475616, at *1-2 ¶¶4, 16. It seems that the first public disclosure of this risk occurred on March 23, 2006. Id. at *2 ¶12. Nobody could find any medical literature from the 2005 era linking chondrolysis and pain pumps. Id. at *2-3 ¶¶19-21.
Summary judgment!
Ohio, like most states doesn’t impose any duty to warn of scientifically unknown information:
There is no duty to warn of unknown and unknowable hazards. The test focuses on the state of knowledge at the time the product left the manufacturer’s hands and at the time the product was used.
2010 WL 5475616, at *5 (citation omitted); accord id. at *6 (“Ohio law restricts the duty to warn to known or knowable risks”).Continue Reading In An Ohio State Of (The Art) Mind