The plaintiffs in Acosta-Aguayo v. Walgreen Co., 2023 U.S. Dist. LEXIS 34836 (N.D. Ill. March 2, 2023), visited their friendly neighborhood drug store and bought a lawsuit. Well, first they bought pain relief patches. Those patches were over the counter (OTC) products. No prescriptions were required. Maybe those pain patches worked and maybe they
Fraud
Federal Court: No Evidence that Allergan’s Textured Breast Implants Had a Higher Incidence of Cancer Than Other Manufacturers’ Implants

This post is from the non-Reed Smith side of the blog.
We don’t usually report on securities-law cases, but today we do. That is because the well-reasoned decision in question, In re Allergan PLC Securities Litigation, 2022 WL 17584155 (S.D.N.Y. 2022), has major implications for the parallel Textured Breast Implant MDL now pending in…
Criticizing FDA Reporting Systems Should Not Be Enough To Plead A Warnings Claim

Two weeks ago, we decried the pattern that some courts follow in allowing shifting slates of boilerplate allegations to cases to discovery. The decision in Corrigan v. Covidien LP, No. 22-cv-10220, 2022 U.S. Dist. LEXIS 210296 (D. Mass. Nov. 21, 2022), reminded us of another of our post-TwIqbal pet peeves: when courts treat sweeping legal conclusions as if they were plausible factual assertions. The basic allegations in Corrigan were that the plaintiff’s surgeon used defendant’s surgical stapler to perform an anastomosis—reattachment of two parts of the digestive tract—in connection with removing part of his sigmoid colon (for unspecified reasons, but often diverticulitis or cancer) and the anastomosis later leaked, leading to further surgical intervention. As we said two weeks ago, medical device manufacturers are not insurers. That makes sense because surgery on humans, even done by the best surgeons, in the best hospitals, and with the best devices and equipment, has less than a 100% success rate. Anastomoses leak, infections develop, hernias recur, patients report post-operative pain, and all manner of complications and less than optimal outcomes occur. A common refrain when scientists are presented with a surgical study reporting no complications or failures is that the study was too small, too short, and/or insufficiently rigorous. Thus, a common procedure with a very high success rate will still generate large numbers of reported failures, like anastomoses that leak. This is part of why rates, and particularly comparative rates, provide more useful information about devices and surgeries than do gross numbers.
Even more authoritative sources than this Blog agree with us. FDA, for instance, makes clear that data from its Manufacturer and User Facility Device Experience (“MAUDE”) database “is not intended to be used either to evaluate rates of adverse events or to compare adverse event occurrence rates across devices.” The reasons for this are not a secret: “The incidence, prevalence, or cause of an event cannot be determined from this reporting system alone due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about frequency of device use.” Directly stated, “[t]he submission of an MDR itself is not evidence that the device caused or contributed to the adverse outcome or event.” FDA’s description of the MAUDE database also makes clear in a number of places that the data may be outdated or incomplete for various benign reasons.Continue Reading Criticizing FDA Reporting Systems Should Not Be Enough To Plead A Warnings Claim
N.D. Cal. Dismisses Baby Food Label Claims

Tonight, with great pleasure, we will hand out candy to tiny costumed neighbors – the three- and five-year-olds from across the street, who call us “Miss Rachel,” and the seven- and 10-year-olds from next door, who come over daily to play with the new puppy, among others. (Not too many others, we fear – we…
Proton Pump Plaintiffs Can’t Meet Burden on Michigan Immunity Exception

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…
D.N.H Dismisses ECT Fraud Claims; Fumbles Others

Few medical treatments suffer from an image problem as bad as electroconvulsive therapy (ECT). We remember when it was called electro shock therapy. We also remember its gruesome depiction in One Flew Over the Cuckoo’s Nest. But modern medicine has redeemed ECT. It can be a genuinely effective treatment for maladies such as depression…
NDNY Dismisses Energy Drink Fraud Case

Fraud via omission of facts is a popular plaintiff lawsuit theory, but many of those lawsuits themselves suffer from the omission of plausibility and specificity. In Womack v. Evol Nutrition Assocs., 2022 U.S. Dist. LEXIS 145754 (N.D.N.Y. Aug. 16, 2022), the plaintiff filed a purported class action alleging that a manufacturer of energy drinks failed…
Chocolate Ice Cream Fraud Plaintiff Gets Just Desserts
New Jersey Federal Court Applies North Carolina Law to Cut Back Pelvic Mesh Case

It is beach weather, but which beach? The Jersey shore is close, has fun boardwalks and rides, and offers the comfort of the familiar. Then again, you must pay to get on sand covered with New Yorkers. The Outer Banks are lovely, with dunes, wild horses along the surf, splendid lighthouses, and the spot where…
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…