While we are often critical of federal courts that reach out to make new state law, today we commend a far-away judge for bringing California’s learned intermediary doctrine law back to its basics. The case is Sanchez v. Boston Scientific Corp., No. 2:12-cv-05762, 2014 U.S. Dist. LEXIS 114122 (S.D. W. Va. Aug. 18, 2014),
Our first reaction to Zeman v. Williams, 2014 U.S. Dist. LEXIS 91501 (D. Mass. July 7, 2014), wasn’t related to the fact that it involved a federal court recognizing a cause of action previously unrecognized by Massachusetts state courts. Our first reaction was that the case shouldn’t be complicated. The plaintiff participated in a clinical trial involving a bilateral gene transfer, which is a new procedure intended to treat Young-Onset Parkinson’s Disease. Id. at *3. As the “bilateral” in its name implies, a bilateral gene transfer consists of two injections of genes into the brain, one into the right side and one into the left. Id. at *3-4. But (plaintiff alleged) the surgeon gave both injections to the left side. Id. at *4.
It seems fairly easy to identify the problem here. If an engineer designs a twin-engine plane, and the mechanics put both engines on the left side, you’ve got a good idea who made the mistake. If the Doublemint gum company told its casting director to hire blond twins for its commercial, and the casting director hired some guy named Roy, you can be pretty sure who made that mistake too. So whom did the Zeman plaintiffs sue over the improper procedure? The manufacturer and the Institutional Review Board (“IRB”), of course.Continue Reading Federal Court Finds a Duty With Regard to Consent Forms in Clinical Trials That the State Court Had Not Previously Recognized
We used to spend a lot of time defending against medical monitoring claims – cases where the plaintiff has not suffered any actual injury, but claims he or she is at risk of a future injury and demands that the defendant pay for future medical surveillance. We do not, however, see these kinds of cases so much anymore. The plaintiffs’ bar seems to have figured out that there is little money in medical monitoring in the drug and medical device context because the claimed future monitoring – say an annual blood test – often costs only a few hundred dollars. Medical monitoring cases therefore pencil out for the plaintiffs’ attorneys only when brought as class actions.
But medical monitoring class actions don’t work either. Every plaintiff treated with a drug or medical device has a medical condition, usually requiring follow-up medical care. The trick then is determining which follow-up (if any) is attributable to a drug or device risk and which is attributable to the plaintiff’s existing medical condition. You also have to look at the adequacy of the warnings, and at their impact, and at what monitoring the patient might actually need, and at whether the claimed monitoring actually promises medical benefit, etcetera, etcetera. Because these will be different inquiries for every patient, individual issues are the undoing of medical monitoring class actions, which is why they don’t get filed anymore.
We provide this preface because of the latest rejection of medical monitoring, this time in the First Circuit. The plaintiffs in Genereux v. Raytheon Co., No. 13-1921, 2014 WL 2579908 (1st Cir. June 10, 2014), claimed workplace exposure to beryllium. (Yes, we know it’s not a drug or medical device, but it’s a really interesting opinion with crossover appeal, so bear with us.) Beryllium is a useful substance with known hazards: Exposure can cause Chronic Beryllium Disease, which damages the lungs and can impair organ function. Id. at *2. The precursor to Chronic Beryllium Disease is something called “beryllium sensitization,” which is regarded as a testable, abnormal medical finding. People with multiple positive tests for beryllium sensitization are at a higher risk of Chronic Beryllium Disease. Id.
The critical part of Genereux is that the plaintiffs claimed neither beryllium sensitization nor Chronic Beryllium Disease. No injury at all. Nothing. Nada. Zilch. How do we know that? Because the plaintiffs’ expert said so – he could not confirm that any plaintiff or any class member had developed even the precursor condition. Id. at *3.Continue Reading Money for Nothing? Not Here
One of us was recently on a conference call discussing possible federal rules amendments (no, not e-discovery), and concern was raised about federal judges making up new grounds for liability in cases based on state law, a problem that several speakers complained was particularly widespread in class actions.
We’ve seen that in drug/device cases as well, particularly but hardly exclusively in cases involving preemption, where judges run roughshod over state law in support of novel theories of liability. Most of the posts under our Erie Doctrine topic header concern this problem.
The consensus on the call was that, while a serious problem, judicial expansion of state tort law in diversity jurisdiction cases is a substantive issue ill-suited to solving by a federal rules change. But it occurs to us that it could be addressed by a federal statute, since Congress may legislate concerning the powers of the federal judiciary, to the extent that those powers are not set by the Constitution. The venerable Anti-Injunction Act, 28 U.S.C. §2283, is one example of such legislation that springs readily to mind.Continue Reading There Ought To Be A Law
As large swaths of the country continue to get pounded by a variety of winter precipitation, we know that there are many over-the-counter cold and flu preparations being consumed by our readers. We assume many of our readers have minor children who are taking the pediatric versions of these preparations after suitable review of the
This post is not from the Dechert side of the blog, since they are involved in Reglan litigation.
Last evening, just before quitting time on the East Coast, we found the Sixth Circuit’s affirmance of the Rule 12 dismissal (that means no expensive discovery necessary) of seven Reglan cases under Tennessee Law. See Strayhorn v. Wyeth Pharmaceuticals, Nos. 12-6195, et al., slip op. (6th Cir. Dec. 2, 2013). The court also affirmed summary judgment against another set of defendants – affiliated with the original innovator manufacturer.
Because of that, we call this type of result a “one–two punch” case. That means that the plaintiffs – who took the generic version of the drug only – are: (1) knocked out of the box against the generic manufacturer by preemption under PLIVA v. Mensing, 131 S. Ct. 2567 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013); and (2) barred from suing the original innovator manufacturer of the drug by the very simple and basic fact that the plaintiff never used that defendant’s product.
First, the generic side:
Plaintiffs had filed the usual kitchen-sink type complaint alleging everything from design defect to consumer fraud. Plaintiffs abandoned consumer and unjust enrichment claims, but appealed dismissal of everything else. Strayhorn, slip op. at 7.
Back in September we gave you the end of the year holiday season countdown. With Halloween behind us, we are down to Hanukkah (15 days away (Mensch on a Bench is already sold out for 2013)), Thanksgiving (16 days away) and Christmas (42 days to go). If someone would make a scarecrow holding a
There’s been a lot of movement amongst the bloggers on this site over the last two years. And now there’s more. Sullivan – that’s me – has moved to Cozen O’Connor. I’ll miss my old firm, Dechert. But I’m excited about my move to Cozen, and I look forward to continuing to give you my thoughts on drug and device law, and sometimes pop culture, from within Cozen’s walls. And, for me, those walls will be in two Cozen offices, one in downtown Manhattan (where I practiced for years when I started my career) and the other in Cherry Hill, New Jersey. Now, Cherry Hill is a great town. I was in that office Friday when I began drafting this post. But today I’m in Manhattan. That’s different. If for no other reason than the views. It’s hard to beat the Freedom Tower as it’s being completed or ships sailing their way down the Hudson River into New York Harbor.
Frankly, if you’re in an office in just about any town other than New York City, “you lose that battle, you lose that battle nine times out of ten.” But that’s not the real advantage of spending much of my time in Cozen’s New York office. The most important benefit is that I now have the ultimate “bona fides” to counter what has been a distinctly Philadelphia voice on this blog. The New York-Philadelphia rivalry has now hit the legal blogosphere. If all else fails, I can just say, “fuhgeddaboudit.”Anyway, here’s my first Cozen post.
So where were we? Oh yes, the learned intermediary doctrine. On Friday, we reported on Calisi v. Abbott Labs., 2013 U.S. Dis. LEXIS 139257 (D. Mass. Sept. 27, 2013), a decision in which the court excluded plaintiff’s warnings expert thereby ending plaintiff’s failure to warn claim. Underlying that decision was the court’s refusal to adopt plaintiff’s argument that Abbott had “assumed a duty” to warn the plaintiff directly rather than warn her doctor because Abbott had earlier communicated directly with plaintiff via a patient video and direct-to-consumer (DTC) advertising.Continue Reading Moving on to a New Law Firm; Still Discussing the Learned Intermediary Doctrine