“Don’t major in minor things.” A wise professor once shared those words and they’ve always stuck. As a general approach to life, it makes a lot of sense. Learning to let go of the small stuff is easer said than done, but it is usually well worth the effort. But the same does not
Two Out of Three Ain’t Bad
Today we bring you another generally favorable Essure preemption decision. Plaintiff brought three causes of action against the manufacturer and the court dismissed two of them. So, in the immortal words of Jim Steinman as belted out by Marvin Lee Aday, we shouldn’t be sad because two out of three ain’t bad. And one of the two is actually quite good. So, we certainly aren’t crying icicles like Meat Loaf. More like when we went looking for a ruby in a mountain of rocks, we came up with a sapphire instead.
We’ve written about Essure cases over the years, like here and here. And in many ways Ortiz v. Bayer Corp., 2022 U.S. Dist. LEXIS 226472 (E.D.N.Y. Dec. 13, 2022), is not much different. Plaintiff alleged injuries from a permanent contraceptive device and brought claims for failure to train, manufacturing defect, and breach of express warranty. The types of claims that sometimes skirt around the twin guards of PMA preemption—Riegel express preemption and Buckman implied preemption. The court dismissed the training and warranty claims but ruled plaintiff did enough at the pleadings stage to keep her manufacturing defect claim.
The failure to train warning took a double hit as both expressly and impliedly preempted. First, to the extent plaintiff demanded training beyond what the FDA requires, they were asking the state to impose an obligation on defendants that was “different from or in addition to” federal requirements and therefore was expressly preempted. Id. at *10. That left plaintiff’s argument that they were pursuing a “parallel” claim that defendants breached a purported duty to train under New York law. But the court ruled that a general negligent undertaking claim under state law falls short of any “clearly articulated state law duty or cause of action to parallel the federal training requirements.” Id. at *11. That’s a useful aspect of the preemption argument that negligent undertaking claims are too broad to be genuinely equivalent to a specific FDA physician training obligation.
Eighth Circuit Upholds Jury Verdict for Plaintiff in Hip Implant Case
We think that a product can either be in a “defective condition unreasonably dangerous” or not in a “defective condition unreasonably dangerous.” But it can’t be both. Unfortunately, the Eighth Circuit did not see things our way in deciding defendant’s appeal in Bayes v. Biomet, Inc., — F4th –, 2022 WL 17661149 (8th Cir. Dec. 14, 2022). This metal-on-metal hip implant case went to trial in October 2020 and the jury awarded plaintiff $20 million on a split verdict. The jury found in favor of defendant on strict liability design defect but for plaintiff on negligent design defect. The problem is under Missouri law, both causes of action require a finding that the product was in a defective condition unreasonably dangerous. Despite that, the Eighth Circuit was unwilling to find the verdict inconsistent or excessive.
While both causes of action require a defective condition unreasonably dangerous – in fact the exact same language was used in both jury instructions — there are differences between the claims. Which is where the court focused. In strict liability the product must be unreasonably dangerous “when put to a reasonably anticipated use.” Id. at *2. Negligence does not carry the same use requirement but rather requires a finding that the manufacturer failed to use ordinary care to design a reasonably safe product. Id. The Eighth Circuit found it was possible for the jury to have concluded there was proof the product was not used in a reasonably anticipated manner and therefore find for defendant on strict liability and against defendant on negligence which does not require the same element. Id.
Defendant argued that whether the product was put to a “reasonably anticipated use” was undisputed and should have been considered functionally stipulated. Defendant did not challenge reasonable use in its closing argument, but that was not enough for the appellate court. “The absence of contrary argument by [defendant] did not create a constructive stipulation obviating the necessity of a jury finding on an element of [plaintiff’s] claim.” Id. at *3. The court was also disinclined to defendant’s argument because at trial defendant offered evidence that the device was implanted not in the “optimal position.” So, evidence of medical misuse of the device ironically came back to disadvantage the defendant. Having introduced the evidence, the defendant could not complain on appeal that the jury might have agreed.
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Lone Pine Stands Tall in Zostavax MDL — Part 2
Earlier this year we blogged about the Lone Pine order entered in the Zostavax MDL that required those plaintiffs alleging that the anti-shingles vaccine caused them to get shingles (1,189 of them) to produce evidence of specific causation by means of a PCR test. The goal of the Lone Pine order was to winnow out non-meritorious claims. That was Part 1. Defendant’s motion to dismiss all 1,189 plaintiffs because not a single one produced the required test result or even asked for an extension – that was Part 2. Without evidence of specific causation, the court dismissed about half the cases in the MDL.
Shingles are caused by the same virus that also causes chicken pox, although the adult disease shingles is much more dangerous. The virus remains in the body for life and can either lie dormant or reactivate and cause shingles. Almost everyone over the age of 30 in the United States has had chicken pox and therefore carries the “wild-type virus” in their systems. In re Zostavax Products Liability Litigation, 2022 WL 17477553, *2 (E.D. Pa. Dec. 6, 2022). The vaccine consists of the Oka strain of the virus, a live-attenuated virus that is a weakened form of the wild-type. Defendant presented “uncontradicted medical authority” that the only way to know whether a person’s shingles was caused by the wild-type virus or the Oka strain is through a PCR test. In fact, plaintiffs’ own expert testified that specific causation could only be determined with a PCR test. Id. That is the same expert who failed to perform a differential diagnosis ruling out the wild-type virus in 5 bellwether cases that were therefore dismissed on summary judgment. That is what led to the entry of the Lone Pine order. If none of the bellwether plaintiffs had sufficient causation evidence, the court wanted to know which plaintiffs did.
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How Many Judges Does it Take to Toss Out a Tootsie Roll Case?
The world may never know how many licks it takes to get to the center of a Tootsie Roll Pop, but we do know it only took three judges on the California Court of Appeals to affirm a demurrer in Tootsie Roll’s favor.
Did you know Tootsie Rolls first came on the market in 1896 and were originally delivered by horse and buggy? Or that they were said to be Frank Sinatra’s favorite candy? And long before the wise old owl bit into the Tootsie Roll pop, the candy was advertising on television dating back to the 1950s. Tootsie Roll has had its home base in New York, New Jersey, and Chicago – where they are still manufacturing 64 million rolls every day. So, what could possibly be wrong with a Tootsie Roll? According to the FDA, nothing, and that’s why the court dismissed the putative class action in Beasley v. Tootsie Roll Indus., 2022 Cal. App. LEXIS 982 (Cal. Ct. App. Nov. 30, 2022).
Plaintiff alleged that she consumed Tootsie Rolls from 2010 to 2016 apparently without knowing that they contained artificial trans fats in the form of partially hydrogenated oils (PHOs). Note: PHOs were on the label. Having consumed the Tootsie Rolls, Plaintiff alleged she was at an increased risk for conditions like cardiovascular disease and type 2 diabetes. PHOs aside, Tootsie Rolls are essentially chocolate flavored sugar. So, sure they play their role in all those nasty obesity-related health conditions. But that cannot serve as the basis for an Unfair Competition Law (“UCL”) claim or an implied warranty claim. As it turns out, thanks to very specific language from both the FDA and Congress, neither could the presence of PHOs before 2018.
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Sales Representative’s Presence in Operating Room Not Enough to Beat Fraudulent Joinder
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. Where the line is drawn between presence and participation, and possibility liability or not, is extremely fact sensitive. And as the court in Owens v. Boston SCI Corp. concluded, in the absence of facts, conclusory allegations of participation are not enough. 2022 U.S. DIST. Lexis 212427, *7 (E.D. Mo. Nov. 23, 2022).
Plaintiff underwent surgery involving implantation of a pelvic mesh medical device. Plaintiff alleged complications following surgery and filed a lawsuit against the manufacturer alleging design defects and against one of the manufacturer’s sales representatives for failure to warn both plaintiff’s surgeon and plaintiff. The manufacturer removed the case to federal court alleging the sales representative, who was not diverse to plaintiff, was fraudulently joined. Plaintiff moved to remand.
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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Southern District of New York Puts Non-Drowsy Labeling Claims To Bed
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.
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Two Strikes Against Plaintiff’s Experts in Texas Pelvic Mesh Case
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.
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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.