Sometimes we read an opinion and think to ourselves, we couldn’t have said it better ourselves. That is true of the analysis of failure to report claims in McGee v. Johnson & Johnson, 2023 WL 4765454 (W.D. Pa. Jul. 26, 2023). We’ve been railing against Stengel v. Medtronic, Inc., 704 F.3d 1224 (9th
Failure to Report
Mixed Bag of Holdings from EDNY in Class II Non-invasive Facelift Device Case

He didn’t win, but he sure looked beautiful. Luca, that is. Faithful readers know that our beautiful standard poodle puppy made his show debut last weekend in Massachusetts. He is learning the ropes and settling down – winning will come in time. We can’t express how thrilled we were to be ringside for these first…
Fallacious FDA Reporting Claim Finally Falls

Product liability litigation over Class III medical devices is an interesting creature. Absent something unusual, cases and litigations should not get past motions to dismiss. That is pretty clearly what Congress intended when an express preemption provision was added to the Medical Device Amendments of 1976. We understand that each plaintiff may think her case is exceptional in that it should meet the exception to the rule of preemption. (We do not really think the plaintiff lawyers think that, although they sure argue it enough.) But the usual is more common than the unusual by definition. When you hear hoof beats, you should look for a horse not a zebra, unless you happen to be in a part of the world where zebras are endemic or end up in a zebra enclosure in a zoo. When you hear Class III medical device product liability case, you should look for all claims to be dismissed unless there is something as unusual as a basis to claiming the plaintiff’s particular device deviated from its FDA-approved specifications.
In 2001, the Supreme Court made getting past motions to dismiss harder when it held in Buckman that plaintiffs could not recover claims predicated on violations of FDA regulations. An unfortunate fiction developed post-Buckman—particularly after Riegel v. Medtronic, Inc. 552 U.S. 312 (2008)—that plaintiffs could assert “parallel claims” that were neither expressly preempted by the provisions of the MDA nor impliedly preempted under Buckman. We, and others, have described the purported path of a parallel claim as being like navigating between Scylla and Charybdis, a monster and whirlpool on opposite sides of a narrow strait per ancient Greek mythology. Without claiming that mythology is the same as fiction—we are not touching that with a twenty foot sarissa—we can say that a true parallel claim is as rare as a striped unicorn or perhaps a flying horse. The unfortunate fiction of which we spoke above has taken shape with particularly egregious appellate decisions like Bausch such that some trial courts are advised, when they hear the hoof beat of a Class III medical device product liability case, to expect Pegasus or his stripy, horned pal to gallop around the corner.
Viewed over the course of more than five years and many decisions, three of which have featured in prior posts (here, here, and here, which drew honorable mention honors in 2018), we think Bausch delayed the inevitable in Gravitt v. Mentor Worldwide, LLC, __ F.Supp.3d __, 2022 WL 17668486 (N.D. Ill. Dec. 14, 2022), by insisting that parallel claims for failure to report adverse events to FDA exist. After an unnecessary odyssey, the manufacturer of a Class III breast implant won summary judgment on the last of plaintiffs’ claims, alleged failure to report adverse events to FDA. (We say “plaintiffs,” but the decision referred to the plaintiff with the implant—who we will call the “plaintiff”—by her first name and the consortium plaintiff by his first name. In terms of whether the last claim was supported, the court referred the female plaintiff only and somehow omitted any reference to “burden.” These are usually signs that at least one claim will survive summary judgment.) A shout out to Dustin Rawlin and his colleagues for sticking it out on this case and sending us this decision.…
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Adverse Event Reports Not Newly Acquired Information for CBE Label Change

Today’s case is a favorable prescription drug preemption decision making a key holding on newly acquired information and adverse event reporting. It is a one-off case involving the prescription drug Korlym which is used to treat Cushing’s Disease. Pietrantoni v. Corcept Therapeutics Inc., 2022 WL 16857262 (D. Mass. Nov. 10, 2022). Plaintiff’s claims break down into three categories—design defect, failure to warn, and failure to monitor. Plaintiff dismissed her design defect claims and the failure to monitor claims are based on fairly unique facts. So, the case boils down to failure to warn which itself had two sub-categories—failure to warn based on product labeling and failure to warn based on failure to report adverse events. One is dismissed and the other is delayed.
Korlym was approved by the FDA in 2012. During the approval process, the FDA conducted a Medical Review of the drug which included information about endometrial thickening and the related complications experienced by users. Id. at *6. Therefore, the warnings that were approved to accompany the drug included the risks of vaginal bleeding and endometrial changes. Id. (full warnings set out in opinion at *7). The label was revised in 2016, but there was no change to these warnings. Plaintiff was prescribed the drug in 2018 and used it for approximately 10 months. She experienced complications that led to an emergency surgical procedure and further complications to future fertility. Id. at *8.
The opinion contains a nice recitation of the history of prescription drug preemption – Wyeth v. Levine, PLIVA, Inc. v. Mensing, Mutual Pharmaceutical Company v. Bartlett, and Merck Sharp & Dohme Corp. v. Albrecht. These four cases makeup the “analytical framework” for prescription drug preemption. Wyeth and Mensing establish that preemption hinges on the availability of the Changes Being Effected (“CBE”) procedure. If a manufacturer can unilaterally change the label without prior FDA approval via the CBE procedure, a warning deficiency claim is not preempted. Albrecht clarified, however, that even where the CBE procedure is available, if the manufacturer can demonstrate by clear evidence that the FDA would not have approved the change, the claim is preempted. …
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PMA Preemption Holds Up Against California Law in California State Court

California state court is not the place most products liability defendants want to end up. Unfortunately, today’s case had to stay in state court because plaintiff sued the defendant’s device representatives who had direct contact with the plaintiff. The reps, like plaintiff, were California residents and destroyed diversity jurisdiction. The decision, however, in James v.
Third Circuit Upholds Dismissal of Generic Drug Claims

There’s more than one way to cook an egg. And, there’s more than one way to dismiss a case. In Bennett v. Teva, the district court decision was based on preemption. The Third Circuit took a different route basing their dismissal on TwIqbal. While we would have preferred an appellate win on preemption…
Connecticut Recognizes a Failure-to-Report Claim

Today’s case is Glover v. Bausch & Lomb, Inc., — A.3d –, 2022 WL 2035805 (Ct. S. Ct. Jun. 7, 2022). And all we can say is Boo! Not a Halloween, Casper-type Boo! But a real Queen of Putrescence-type Boo! Because unfortunately, the Connecticut Supreme Court, responding to a certified question from the…
Lack Of Proximate Cause Evidence Dooms Misrepresentation And Warnings Claims

Under Fed. R. Evid. 9(b), “[i]n alleging fraud or mistake, a party must state with particularity the circumstances constituting fraud or mistake.” In our sphere, federal courts are quite variable in how they apply this standard when deciding 12(b)(6) motions. In particular, MDLs seem to have an unfortunate habit of allowing general allegations to support…
Mostly Good Preemption Decision Out of the District of Columbia

We write on a gorgeous spring day in suburban Philadelphia, with Passover imminent for us and Easter for many we love. Today’s decision contains more than enough “good” to sustain the positive vibe. Ward v. Zoll Lifevest Holdings LLC, 2021 WL 7907066 (D.D.C. Sept. 20, 2021) is a D.C. District case from last September…
Tipping the Scales on Failure to Report in Missouri

In our 50-state survey on failure to report claims, we described Missouri as an “up in the air” state, with courts on both sides of the issue failing to cite or consider prior significant precedent. Now the Eastern District of Missouri has weighed in bringing the issue a little closer to the ground.
In Schnulle…