We recently read the pain pump decision, Creech v. Stryker Corp., 2012 WL 33360, at *5 n.6 (D. Utah Jan. 6, 2011). Most of the opinion addresses pretty much mundane disputes on heavily fact-bound questions: (1) whether the risk was scientifically knowable as of the date of this plaintiff’s injury, and (2) whether the
By now Restatement (Second) of Torts §402A (1965) is so old as to be thought of as somewhat antediluvian. The American Law Institute’s unfortunate adoption of “strict liability” (sufficiently unfortunate, the ALI has done away with it except for manufacturing defect) missed a lot of product liability issues – the learned intermediary rule for one – that have become extremely widespread and important in product liability over the last 45 years. To rectify this situation, and deal with all the issues unanticipated in 1965, the ALI in 1997 adopted what amounts to a book in and of itself: the Restatement (Third) of Torts, Products Liability.
One place where the ALI was prescient in 1965 was in recognizing that some products had inherent risks that, no matter what, could not be designed away. Such products, the ALI recognized, were “especially common” in the context of prescription drugs:
There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs. . . . Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous. The same is true of many other drugs, vaccines, and the like, many of which for this very reason cannot legally be sold except to physicians, or under the prescription of a physician. . . . The seller of such products, again with the qualification that they are properly prepared and marketed, and proper warning is given, where the situation calls for it, is not to be held to strict liability for unfortunate consequences attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable product, attended with a known but apparently reasonable risk.
Restatement (Second) of Torts §402A, comment k (1965) (emphasis added).
Comment k thus says a lot of things. Prescription medical products – those “which for this very reason [that is, because they are “quite incapable of being made safe”] cannot legally be sold except . . . under the prescription of a physician” – aren’t “defective” unless there’s something wrong with their “preparation” or “warnings.” Thus, the unavoidably unsafe concept is inherently incompatible with the concept of design defect because no matter what their design they are “incapable of being made safe.”Continue Reading Comment K, Some of the Way
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
A few weeks ago, a judge for the Southern District of Ohio, applying Ohio law, granted in part the defendants’ summary judgment motion in a fentanyl patch case. Importantly, the court killed the plaintiff’s core failure to warn claim, as well as smacking down a “fraud on the FDA” claim in cursory fashion. Miller v.
OK, not really. But we have had a chance to review yesterday afternoon’s oral argument transcript in Bruesewitz v. Wyeth, and here’s what went down (for a lot of Bruesewitz backstory, click here for our prior posts).
David Frederick argued on behalf of the petitioners. Adhering to the rule of three, Frederick said the Third Circuit was wrong for three reasons when it ruled that the Vaccine Act expressly preempts state-law design defect claims. First, argued Frederick, the language of the Act itself does not explicitly preempt design defect claims. Second, the question of whether or not an injury was “unavoidable” should be determined on a case-by-case basis, rather than triggering a broad express preemption of all design defect claims (Section 22(b)(1) of the Vaccine Act, which lies at the heart of this dispute, states that manufacturers are not liable if the side effects were “unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.”). Finally, Frederick advanced the “think about the children” policy argument – i.e., preemption of design defect claims exposes kids to unnecessary safety risks. He also suggested that it will be very rare to see a design defect case get out of vaccine court and go to a state court jury, because proving causation and the availability of an alternative design is not easy. In other words, don’t worry about disincentivizing manufacturers with the specter of massive liability, because it is unlikely to happen.
Kathleen Sullivan argued on behalf of Wyeth. Although she was immediately beset by questions, primarily from Justice Sotomayor and Justice Ginsburg, Sullivan was able to argue (persuasively, in our opinion) that the petitioners’ reading of the statute ignores its plain language and meaning. In essence, there are three types of products claims one could bring against a manufacturer: manufacturing defect, design defect, and warning defect. Section 22(b)(1), read as a whole, makes clear that only manufacturing and warning defect claims survive; manufacturers are not liable for unavoidable risks where the vaccine was “properly prepared” and accompanied by proper…warnings.” In other words, if the vaccine wasn’t made right, you lose the protection of 22(b)(1). If you didn’t slap an appropriate warning on the vaccine, you lose the protection of 22(b)(1). Otherwise, you’re protected, since the statute did not include any clauses recognizing design defect claims. Sullivan also hit hard on the policy arguments supporting preemption of design defect claims, highlighting that the legislative history shows Congress was concerned about a vaccine “crisis,” where “manufacturers were being driven out of the vaccine business, imperiling the nation’s…vaccine supply by design defect claims that did survive summary judgment.”
So how did the Justices react to these core arguments? Of course, we have to offer the caveat that it is often a Talmudic exercise to guess at the meaning behind a particular Justice’s question, but the following patterns seem to have emerged:
Statutory Construction:
Chief Justice Roberts, Justice Alito, and Justice Scalia appeared to be most concerned about the plain language of the statute, and the extent to which the Court may go beyond that language to infer (or not infer) that Section 22(b)(1) has preemptive effect. For example:
Chief Justice Roberts asked whether the compensation scheme set up in the Vaccine Act evidenced a Congressional intent to preclude state law claims. Justice Sotomayor, on the other hand, asked Sullivan why Congress did not simply make vaccine court the exclusive forum for recovery, thereby foreclosing state lawsuits.Continue Reading Bruesewitz Blow By Blow
Last week we reported on two recent decisions by the Pennsylvania Superior Court (an intermediate appellate court) in fen-phen litigation. Well, there was a third shoe out there, and yesterday it dropped. In Lance v. Wyeth, No. 2905 EDA 2008, slip op. (Pa. Super Aug. 2, 2010), affirmed – for the first time in a reported appellate decision in Pennsylvania – that the restrictions on strict liability recognized by the Pennsylvania Supreme Court in Hahn v. Richter, 673 A.2d 888 (Pa. 1996), precluded any claim for strict liability design defect in product liability litigation involving prescription drugs (and, we presume, medical devices as well.
Although Appellant labels her claim as “negligent and unreasonable marketing,” her proposed cause of action duplicates a design defect claim, seeking to impose strict liability on [defendant] because [its drug] was unreasonably dangerous. With our Supreme Court’s adoption of comment k, a design defect claim for strict liability is not cognizable under Pennsylvania law when it is asserted against a manufacturer of prescription drugs. For purposes of strict liability and §402A, a drug cannot be deemed unreasonably dangerous, even if it is defectively designed, so long as the drug is manufactured properly and contains adequate warnings.
Slip op. at 7-8 ¶15. We’ve made the argument, of course, that Hahn precluded strict liability of any sort (other that manufacturing defects, which are pretty rare), but now we’ve got an appellate court for the proposition.
But then the court goes and recognizes a negligent design claim for a prescription drug. That’s better than strict liability, given Pennsylvania’s weird evidentiary restrictions, but not by all that much. The court bases it on two things: (1) that Restatement of Torts §395 “contains no exemption or special protection for prescription drugs” and (2) the statement in Restatement of Torts §402A that strict liability “is not exclusive, and does not preclude liability based upon the alternative ground of negligence.” Slip op. at 10-11 ¶¶18-19.Continue Reading Pennsylvania Fen-Phen Appeals – The Third Shoe Drops
We keep score here.
We keep the Drug/Vaccine Preemption Scorecard, collecting cases addressing preemption in the context of prescription drugs.
We keep the Device Preemption Scorecard, tracking device preemption cases since Riegel.
We keep the Cross-Jurisdictional Class Action Tolling Scorecard, tracking . . . well, if you understand what those words mean,
This, that, and the other thing.
Potpourri.
Odds and sods.
Whatever. This post is about stuff that we learned about recently that relate to our prior posts. Other than that, they have nothing in common with each other.
Together, they add up to enough material for a decent post.
On Monday, it’s the aura and majesty of the Supreme Court of the United States, descanting grandiloquently about issues of national importance.
On Tuesday, it’s the Appellate Court of Connecticut droning on about comment (k) to the Restatement.
On this blog, you never know what you’ll get.
Bad news: It’s Tuesday.
In Breen v.
This post is the work of Bexis alone; Herrmann had to stay on the sidelines today:
“We grow too soon old and too late schmart.”
That’s what the Pennsylvania Dutch say, and now that seems to be the story of the fen-phen litigation. After a fifteen-year run that produced billions of dollars in settlements, a