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We have had occasion over the years to opine on cases involving allegations against sales representatives who are present in the operating room—a not uncommon practice when medical devices are being used.  While the practice is not uncommon, what is rare are instances where a sales representative participates in the surgery.  Rare, but not non-existent.  

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. 

Continue Reading Adverse Event Reports Not Newly Acquired Information for CBE Label Change

It’s the start of cold and flu season, so why not talk about cough syrup.  Most cough medicines come in two versions – daytime and nighttime.  The nighttime version typically contains an antihistamine which are known to cause drowsiness.  Daytime versions often contain an expectorant (to thin and loosen mucus) and a cough suppressant.  A common cough suppressant is dextromethorphan hydrobromide (DXM).  That is the ingredient at issue in Goldstein v. Walmart, Inc., 2022 U.S. Dist LEXIS 196743 (S.D.N.Y. Oct. 28, 2022). 

Walmart sells its own brand of OTC cough medicine containing DXM and the label says “Non-Drowsy.”  Plaintiff alleges she relied on that statement in selecting the medicine and she became unexpectedly drowsy after taking it.  She filed a putative class action alleging breach of express warranty, breach of the Magnuson-Moss Warranty Act, and violations of various state consumer protection laws.  Defendants moved to dismiss all claims as preempted.

The federal regulations governing OTC medicines are found in monographs which are promulgated by the FDA and set the approved active ingredients for a class of drugs as well as any conditions under which they are considered safe and effective.  Id. at *7-8.  There is a monograph for Cold, Cough, Allergy, Bronchodilator and Antiasthmatic drugs.  It requires certain products in this class to carry a warning that the drug may cause drowsiness.  DXM is not one of them.  Id. at *8. 

The FDCA has an express preemption clause for OTC drugs – requirements that are “different from or in addition to” or “not otherwise identical with” the FDCA are preempted.  Product liability claims have an exception, but this is not a products case.  The opinion does a thorough walk through of the relevant case law.  Id. at *21-31.  Plaintiff tried to squeeze her claims through a small gap in the preemption window: “preemption does not preclude a state-law claim if the state requirement is outside the scope of the relevant federal requirements.”  Id. at *23.  Courts within the Southern District of New York have approached the scope question and reached slightly different conclusions. 

Continue Reading Southern District of New York Puts Non-Drowsy Labeling Claims To Bed

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

Defendants in Pizzitola v. Ethicon, Inc., filed motions to exclude two of plaintiff’s experts and both decisions (two orders issued) heavily favored the defense, rejecting recurrent design defect arguments by plaintiffs.

The product at issue is synthetic pelvic mesh.  Plaintiff’s first challenged expert was a gynecologic surgeon.  While is area of practice may overlap with issues in the case, his report went well beyond both relevant issues and his area of expertise.  Namely, plaintiff’s expert wanted to opine that lots of things were alternative designs that in fact were not.  Starting with a different medical procedure altogether.  “It is not an alternative design of any product.  In fact, it is not a product at all.”  Pizzitola I, 2022 U.S. Dist. LEXIS 184352, *6 (S.D. Tex. Oct. 7, 2022).  Plaintiff argued the testimony was relevant to a risk/utility analysis but showing that a different medical procedure may be safer, “does not affect whether a product has utility and/or risks.”  Id. at *7.  The decision to perform a different medical procedure lies within the medical judgment of the treating surgeon and has no bearing on the design of the device at issue.  Id. 

Continue Reading Two Strikes Against Plaintiff’s Experts in Texas Pelvic Mesh Case

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.

Today’s decision comes from In re: Proton Pump Inhibitor Products Liability Litigation—an MDL pending in New Jersey.  But the decision is all about the 197 Michigan plaintiffs in the MDL.  The plaintiffs who either live in Michigan, got their prescription in Michigan, were diagnosed with their injury in Michigan, and/or received treatment for their

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

We could have titled today’s post something like Back to Basics or Legal Writing 101 because that is how the opinion in McGuire v. Abbott Laboratories, Inc., 2022 WL 4295402 (E.D. Tex. Sep. 15, 2022) reads.  In other words, it provides a lot

It has been just about two years since the Central District of California dismissed the claims in Nexus Pharmaceuticals, Inc. v. Central Admixture Pharmacy Services, Inc. as impermissible attempts to privately enforce the FDCA and therefore impliedly preempted.  We blogged about that decision back then.  At that time, we noted that while the case arose