Remember that weird case where the plaintiff was suing because the defendant removed a drug he liked from the market? Well, it was affirmed the other day, by the Eleventh Circuit. See Lacognata v. Hospira, Inc., No. 12-14078, slip op. (11th Cir. June 7, 2013) (unpublished). The affirmance isn’t much – all of one
2013
Guest Post – Something for Everyone: Mensing and Design Defect Preemption
Here’s a guest post prepared by Dick Dean and Corena Larimer, both of Tucker Ellis, on something we’ve been interested in as well – the transubstantivity of the implied preemption “impossibility” analysis of the Supreme Court’s Mensing opinion, with particular emphasis on generic drugs. They give a new twist to the argument, tying…
Battery Included
Certain carbon products are supposed to last forever. Houses should last more than 14 years, but they will need significant upkeep along the way. Well maintained cars can last more than 14 years, but we think most do not. We have a hard time thinking of many electrical products that last more than 14 years…
Breaking News – GSK Wins Citizenship Battle; Delaware It Is
TPPs Not Allowed To Throw Own Insureds Under The Bus
Third party payer plaintiffs (mostly insurance companies and union welfare funds in unholy alliance with plaintiff lawyers), have not been doing very well with their economic loss claims against (mostly) pharmaceutical companies – at least outside the rogue First Circuit − as anyone following our TPP topic posts can attest. So they’ve tried something new,…
We Greet a New Aredia-Zometa Dismissal with Abated Breath
You have almost certainly heard the phrase, “Waiting with bated breath.” As in: we awaited the Red Wedding scene in Game of Thrones with bated breath. Or: we greeted the Drug and Device Law Son’s diploma ceremony with bated breath. (The former was impressive and awful. As one friend wrote on his Facebook wall, if you had a favorite character in GoT, maybe now you don’t. The latter was the occasion for unalloyed joy, and we expect to be levitating for a while – at least until the first college tuition payment comes due.) Maybe you thought it was “baited breath,” as if referring to some sort of seafood-borne halitosis. But, no, it’s “bated,” meaning restrained, lessened, diminished, or stopped. The word and the phrase in which it typically resides have been around since at least Shakespeare. This is from The Merchant of Venice, Act I, scene iii: “With bated breath, and whispering humbleness.”
“Bated” is a variant of “abate,” a word that almost any lawyer has bumped up against more than a few times. Different jurisdictions can have slightly different meanings for the concept of abatement, but it usually refers to some external reason for putting off or dismissing a case. Like jurisdiction or, say, preemption, it offers a way of kicking a case on grounds pretty well divorced from the underlying merits. For that reason lawyers find it enthralling and non-lawyers find it maddening. In our days working on diet drug cases, it was amazing how many of the plaintiffs had filed for bankruptcy yet had not listed their tort claims as an asset of the estate. That omission, whether intentional or not, could lead to abatement of the tort action until things were set right in bankruptcy court, perhaps even reopening the bankruptcy proceedings. Or maybe the failure to list the claim could form the basis of an estoppel with respect to the tort claim. You denied having any such claim, so now you cannot pursue it. We have posted before on bankrupt plaintiffs.
Here in our charming little commonwealth of Pennsylvania, one common species of abatement arises when the plaintiff dies and the substitution of the estate is not accomplished properly. That abatement recently resulted in out-and-out dismissal of one of the cases in the Aredia-Zometa MDL — In re Aredia and Zometa Products Liability Litigation, 2013 WL 2317743 (M.D. Tenn. May 28, 2013). The Aredia-Zometa MDL is based in M.D. Tenn., but the particular case at issue was governed by Pennsylvania law. The facts are as convoluted as these things usually are, and the court seems to have been displeased with the way things were handled by the plaintiff’s side. It was actually the Magistrate Judge who seemed especially displeased and who initially recommended dismissal of the case. The plaintiff did not file timely objections, and the district court did not appear to wait with bated breath in adopting the recommendations.Continue Reading We Greet a New Aredia-Zometa Dismissal with Abated Breath
More Leveling of the Playing Field
Due to Reed Smith’s involvement in the pelvic mesh litigation, this post is from the Dechert side of the blog only.
Ex parte interviews of treating physicians – a subject near and dear to our hearts. Specifically, we rail against those jurisdictions that deny defense counsel the ability to investigate their cases through informal contacts…
Internet and Social Media Guidance: Still Wondering Whether the FDA Will Meet Its Deadline
In April, we updated (here) you on the long march to FDA guidance on the promotion of medical products over the Internet and social media. The FDA’s Director of the Office of Prescription Drug Promotion, Thomas W. Abrams, had just given an interview to Pharmalot and said that the FDA had made it…
Res Ipsa Loquitur, or Maybe Not
We haven’t written much about res ipsa loquitur on the blog, and today’s case doesn’t really qualify as a drug or device case per se, but it’s an interesting opinion and we thought it was worth sharing. The case is Hubbard v. Mellion, No. 108461, 2013 Kan. App. LEXIS 45 (May 17, 2013), and it’s an appellate decision reversing summary judgment in favor of a physician in a medical negligence case, on the basis of the appellate court’s finding that the lower court should have applied the doctrine of res ipsa loquitur. The case arose when plaintiff Hubbard underwent spinal surgery (involving various –otomies and –ectomies) to repair a herniated lumbar disc. During the procedure, the surgeon used a device known as a pituitary rongeur, which is a forceps-type instrument that’s used to remove part of the disc. Unfortunately, during Ms. Hubbard’s surgery, the tip broke off of one arm of the rongeur, and became lodged in her disc space. Hubbard, 2013 Kan. App. LEXIS at * 6. The surgeon tried to retrieve the tip but was unable to. Id. Ms. Hubbard claimed that she experienced continual pain as a result of having the fragment in her spine, and eventually underwent another surgery to remove it. Id. She later filed a negligence action in which she named the surgeon and the hospital, as well as the manufacturer of the rongeur, alleging that the latter was negligent for supplying a device that was in a dangerous and defective condition. However, as we’ve seen plaintiffs do in other medical device cases, plaintiff later decided to pursue the surgeon alone, and backed away from her defect theory. Really far away. Did a 180, in fact. Not only did plaintiff dismiss the manufacturer, her expert metallurgist authored a report in which he “ruled out the possibility that the rongeur failed due to a manufacturer’s defect, ruled out the possibility that the rongeur failed because it had been improperly maintained, and ruled out the possibility that the rongeur had failed due to normal wear and tear.” Id. at *11. The plaintiff’s expert’s sole causation opinion was that the rongeur tip had broken off due to user error – specifically, because the surgeon had applied too much force when using the instrument. Id. at *12.
The surgeon moved for summary judgment on the basis that plaintiff’s experts – a metallurgist, a neurosurgeon, and a quality management team leader from the rongeur manufacturer (id. at *11-12) – were not qualified to opine on the standard of care for a surgeon performing this type of procedure. Id. at * 14-15. The trial court agreed, and held that although these experts established that operator error had caused the rongeur to break, plaintiff had not shown that this error was outside the established standard of care. Id. at *15. On appeal, plaintiff argued that she was not required to present expert testimony on the standard of care because there were two exceptions to the requirement that applied in this case: the “common knowledge” exception and/or the doctrine of res ipsa loquitur. Id. at *20.Continue Reading Res Ipsa Loquitur, or Maybe Not
Duty To Train As Educational Malpractice
We’ve posted about the purported “duty to train” before. It’s another of those supposed torts (like duty to test) that’s really little more than duty to warn dressed up in different garb. Fortunately, as we pointed out in our prior post, the notion of an independent “duty to train” prescribers hasn’t really caught…