The opinion, Schrecengost v. Coloplast Corp., 2019 WL 6465398 (W.D. Pa. Dec. 2, 2019), recently “predicted” that Pennsylvania would allow strict liability design and warning defect claims in cases involving prescription medical products. Id. at *11-13. In so doing Schrecengost was not only wrong, but loud wrong. First, without even a serious discussion, Schrecengost
We had been waiting for the Utah Supreme Court’s decision in Burningham v. Wright Medical for some time. As we pointed out in a blogpost when Burningham was first certified by the district court (Utah is one of the few courts allowing district court certification), over a year ago, “[p]ractically no court has . .
First, we’ve endured MDL courts messing around with Utah law and ignoring the usual congruence in the treatment of prescription drugs and prescription medical devices under Restatement (Second) of Torts §402A, comment k (1965). We covered that kerfuffle here, here, here, and here. More recently, the Fifth Circuit in In re
Strict liability is not the same as absolute liability. We learned that truth in law school, but too many plaintiff lawyers and judges seem to have unlearned it along the way. The key separator between strict liability and absolute liability is comment k to section 402A of the Restatement (Second) of Torts (1965), which observes
We have a guest post today, from Luther Munford of Butler Snow. He’s been doing some thinking about how something analogous to the “two schools of thought” medical malpractice doctrine should apply to medical product liability cases. As always with out guest posts, our posters deserve 100% of the credit, and any blame, for
When it comes to design defect claims and FDA pre-market approved (“PMA”) medical devices, “preemption” is our reflexive reaction. That’s entirely reasonable, given the many decisions that preempt state-law design-related claims since Riegel v. Medtronic, Inc., 552 U.S. 312 (2008). We collect then all here.
Nevertheless, there are some judges, particularly (but not
About two years ago, in our post “How Does a Bad Idea Get Implanted,” we discussed what at the time seemed a California peculiar argument that the “unavoidably unsafe” product doctrine epitomized by Restatement (Second) of Torts §402A, comment k (1965) was somehow limited to implantable – as opposed to non-implantable – medical
A funny thing happened on the way to a defense verdict last year—after the jury decided that the defendant’s product was not defective, the MDL judge told the jurors that perhaps they did not “fully understand” and instructed them to try again. So the jury went back into the jury room, and having been duly
Bexis, who took some lumps in probably the worst Wisconsin product liability decision ever (he filed PLAC’s amicus brief in Thomas v. Mallett, 701 N.W.2d 523 (Wis. 2005)), just read what we believe is the best Wisconsin law decision ever – at least in the drug/medical device sandbox that we inhabit. The decision is In re Zimmer Nexgen Knee Implant Products Liability Litigation, 2016 WL 6135685 (N.D. Ill. Oct. 21, 2016) (since the caption is a mouthful, we’ll call it “ZNKI“).
Here’s why ZNKI is favorable on Wisconsin legal issues.
First, as our longstanding 50-state survey on the learned intermediary rule points out, Wisconsin is one of nine states in which only federal courts predicting state law have had occasion to adopt the learned intermediary rule. Looking more closely at these nine, Wisconsin is one of only two states (South Dakota being the other) where only federal district courts have reached this holding. What isn’t there, but is discussed in ZNKI, is that some courts have (without much reasoning) refused to predict Wisconsin’s adherence to the rule. Refusing to dodge the issue, ZNKI forthrightly examines both Wisconsin precedent and the general state of the law and concludes that Wisconsin would join the nationwide learned intermediary consensus:
[F]ederal courts applying Wisconsin law have reached different conclusions about the doctrine’s applicability. The vast majority of states, however, do employ some version of the doctrine. In addition, this court’s research suggests that those courts that have declined to apply the doctrine under Wisconsin law have done so in cases involving prescription drugs, not medical devices, and those courts offer no reason to believe that the Wisconsin Supreme Court would not adopt this majority rule if presented with the issue.
In the context of . . . surgery, a patient must rely on the experience and judgment of his or her surgeon, who selects the appropriate implant and educates the patient about the particular risks − based on the patient’s particular circumstances and physiology. . . . Given that context, and given the widespread acceptance of the doctrine throughout the country, the court believes it is likely that the Wisconsin Supreme Court would apply the learned intermediary doctrine in this case.
ZNKI, 2016 WL 6135685, at *19-20 (numerous citations omitted). As we’ve pointed out recently, the learned intermediary rule is, if anything, enjoying a renaissance, with thirteen straight state high court adoptions since the infamous Karl case (since overruled by statute) was the only supreme court to go the other way.
This post is from the non-Reed Smith side of the blog.
We found it strange that last month’s decision in Jenkins v. Boston Scientific Corp., 2016 WL 1448867 (S.D.W. Va. April 12, 2016), held – almost as a throw-away point – that Texas law wouldn’t apply Restatement (Second) of Torts §402A, comment k (1965) to medical devices as it does to prescription drugs. That’s a notable, indeed almost unprecedented, result.
Jenkins did recognize that Texas law has, for a long time, applied comment k across-the-board to bar design defect claims against all prescription drugs. Id. at *5, citing Carter v. Tap Pharmaceuticals, Inc., 2004 WL 2550593, at *5 (W.D. Tex. Nov. 2, 2004) (“Under Texas law, all FDA-approved prescription drugs are unavoidably unsafe as a matter of law.”). Carter is hardly the only Texas case for applying comment k generally to bar design defect claims. We collected that law in our 2011 Comment K,Some of the Way post: Centocor, Inc. v. Hamilton, 310 S.W.3d 476, 516 (Tex. App. 2010) (comment k “provide[s] a defense to a design defect claim”), rev’d on other grounds, 372 S.W.3d 140 (Tex. 2012); Schwarz v. Block Drug Co., 1999 WL 274409, at *1 (5th Cir. 1999) (“Under comment K of the Restatement of Torts (Second) § 402A, a drug manufacturer is responsible in damages only if it failed to warn of a defect of which it knew or should have known.”) (unpublished, in table at 180 F.3d 261); Reyes v. Wyeth Laboratories, 498 F.2d 1264, 1273-74 (5th Cir. 1974) (applying unavoidably unsafe standard without individualized assessment); Holland v. Hoffman-La Roche, Inc., 2007 WL 4042757, at *3 (N.D. Tex. Nov. 15, 2007) (“[p]rescription drugs are not susceptible to a design defect claim where, as here, the drug is “accompanied by proper directions and warning”); Hackett v. G.D. Searle & Co., 246 F. Supp.2d 591, 595 (W.D. Tex. 2002) (“[t]he Court thus holds that under Texas law and comment k of the Restatement, Defendants can only be held strictly liable if the drug was not properly prepared or marketed or accompanied by proper warnings”).
However, after recognizing Texas law with respect to comment k and prescription drugs, Jenkins declined to apply comment k in the same fashion to medical devices:
I reject [defendant’s] contention that Texas’s absolute bar for FDA-approved prescription drugs, applies here, given that the products are neither FDA-approved nor prescription drugs. See Lofton v. McNeil Consumer & Specialty Pharm., 682 F. Supp.2d 662, 679 (N.D. Tex. 2010) (refusing to “take a leap not taken by Texas courts” in applying comment k categorically outside the prescription drug context).
2016 WL 1448867, at *5 (citation omitted).
That’s it. The entire extent of the discussion of Texas law on this point is one sentence and one citation. Absent is any discussion of why the policy reasons that have led Texas courts to apply comment k in every prescription medical product case over the last forty years don’t apply to prescription medical devices.
But what about Lofton?