The Judge in the ObTape device litigation has allowed another manufacturing defect claim to go to trial with no direct evidence that the device implanted in the plaintiff had a manufacturing defect.  See In re Mentor Corp. ObTape Transobturator Sling Prods. Liability Litig., 2015 U.S. Dist. LEXIS 140263 (M.D. Ga. Oct. 15, 2015).  In denying the manufacturer’s motion for summary judgment, the court relied solely on a review conducted by plaintiff’s experts of sample ObTape devices—that is, devices other than the one implanted in the plaintiff.  The experts found that the pore sizes of those other samples were at times outside of the alleged manufacturing requirement of 40 to 100 microns.  Relying solely on this, the court rejected the manufacturer’s argument that plaintiff had not shown a manufacturing defect in the device implanted in her.  The court explained its reasoning, which from our point of view is less than convincing:

One way to prove a manufacturing defect is to test the specific subject product against manufacturing standards.  For example, in BIC Pen Corp., the parties tested the cigarette lighter that caused the plaintiff’s injuries.  346 S.W.3d at 540-41.  But Mentor [the manufacturer of ObTape] did not point the Court to any authority that such testing is the only way to establish a manufacturing defect under Texas law.  Here, Mrs. Sanborn relies on the same evidence as the Phase I Georgia Plaintiffs, whose specific ObTape was not tested, either.  Rather, their experts tested a number of ObTape samples and concluded that a substantial portion of each ObTape tested had pores smaller than 40 microns.  In re Mentor, 711 F. Supp. at 1376.  At this time, the Court remains satisfied that this evidence is sufficient to create a genuine fact dispute on Mrs. Sanborn’s manufacturing defect claim.  Mentor’s summary judgment motion on the manufacturing defect claim is thus denied.  The Court may reconsider this issue when ruling on any motion for judgment as a matter of law that may be presented at trial.

Id. at *8-9.


Continue Reading MDL Judge Allows Manufacturing Defect Claim to Go to Trial with No Direct Evidence of a Defect in the Device Actually Implanted in Plaintiff

It wasn’t a complete win, but the summary judgment outcome in Rheinfrank v. Abbott Laboratories, Inc., ___ F. Supp.3d ___, 2015 WL 4743056 (S.D. Ohio Aug. 10, 2015), has to put a spring in the step of the defendants as they approach trial.  What’s left doesn’t strike us as a very good warnings case.  Rheinfrank involved claims that the antiepileptic drug Depakote caused the minor plaintiff’s birth defects.  Make no mistake about it, Depakote has a known association with such injuries.  First approved in 1983, it’s been a Pregnancy Category D drug since 1988, meaning, according to FDA regulations, that:

there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but the potential benefits from the use of the drug in pregnant women may be acceptable despite its potential risks.

21 C.F.R. §201.57(c)(9)(i)(A)(4).  Not only that, since 2003, this drug has carried a black box “teratogenicity” warning, as well as other quite explicit, and all-caps, language to the same effect.  For details, see 2015 WL 4743056, at *2-3.

Plaintiff-mother had used Depakote for years, through four previous uneventful pregnancies.  Id. at *1.  On her fifth pregnancy, even though Depakote came with all these warnings, she continued to take it.  Id.  Her allegations did try to change the subject, however.  In addition to claiming that the black box warning (more about that later) and all the other teratogenicity language were inadequate, she asserted that the defendants failed to warn altogether about “developmental delay.”  Id. at *5.


Continue Reading Preemption (and Other Things) Defanging Depakote Claims

This post is from the non-Reed Smith side of the blog.

In the latest decision from the Pelvic Mesh MDL, the court ordered a consolidated trial of no fewer than thirty-seven plaintiffs with nothing in common save claiming injury from the same product.  See Mullins v. Ethicon, Inc., C.A. No. 2:12-cv-02952, slip op.  (S.D.W. Va. Aug. 4, 2015).  The consolidation is an attempt at a Rule 23(c)(4) single-issue class certification without the class action – since class actions are never certified anymore in personal injury prescription medical product litigation (as demonstrated here).  To reach the same procedural result, Mullins limits consolidation to defect/breach of duty and “general causation”:

[T]he consolidated trial will only involve . . . issues concerning the design of the [defendant’s mesh]  and whether that design was reasonably safe.  Determining reasonable safeness necessarily involves consideration of the [product’s] capability to cause injury.  As a result, causation will be relevant to the consolidated trial but only in the general sense. In other words, the pertinent issue will be whether the [product] can cause injury (general causation), not whether it did in fact cause injury to a particular plaintiff (specific causation).

Mullins, slip op. at 5 (citation omitted).


Continue Reading Further Deconstruction of the Law in Pelvic Mesh

Yes, we’re well aware of the latest development in the Pelvic Mesh MDL.  See Mullins v. Ethicon, Inc., C.A. No. 2:12-cv-02952, slip op. (S.D.W. Va. Aug. 4, 2015).  However, due to Reed Smith’s Pelvic Mesh representations, we’re constrained in what we can say.  We’ll just have to let prior, non-Mesh posts speak for us

Since the inception of the blog we’ve taken interest in “flip side” lawsuits in which a plaintiff sues one of our manufacturer clients making allegations diametrically opposed to what we  usually see in product liability litigation – that, far from being injurious or “defective” − our client’s product is so valuable that the plaintiff can’t do without it, and is suing because of some threat to his/her supply of that product.

The first time we commented on such suits, the plaintiffs were suing the government, claiming a constitutional right to try investigational drugs.  We opposed that, knowing that, were such a right recognized, our clients would be the next targets of such constitutionally empowered plaintiffs, because our clients, not  the government, had the drugs in question.  The courts ultimately said “no,” see Abigail Alliance v. von Eschenbach, 495 F.3d 695 (D.C. Cir. 2007), but the lawsuits followed anyway.  Most of these cases involved desperately ill people grasping at investigational straws because there was no cure (or even reliable treatment) for their conditions (muscular dystrophy, multiple sclerosis, and similarly devastating and fatal conditions).  We summed this kind of litigation up recently in reviewing the first comprehensive law review article on the subject.


Continue Reading Still No Duty To Supply Drugs – In 22 States

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

Today the World Cup takes another day off before it starts its semifinals to determine who will play for the Trophy on Sunday.  I know this only because other people have told me.  Left to my own predilections, I’d know none of it.  But other people’s interest and intense enthusiasm for these games has swept

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