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We disagree with plenty of courts on plenty of things, but most of the time it’s at least arguably just a conflict with one of our pro-defense views.  But occasionally, very occasionally, we run into a decision that’s just plain wrong on some factual or legal aspect.  Blackburn v. Shire U.S., Inc., 2022 WL 16729466 (11th Cir. Nov. 7, 2022) (thankfully unpublished), is such a decision.

Continue Reading Blackburn – That’s Just Plain Wrong

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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

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Today’s guest post is by Jim Fraser of Greenberg Traurig.  Jim is a long-time product liability defense lawyer, but who also worked as a litigation attorney in FDA’s Office of the Chief Counsel (“OCC”).  Utilizing his FDA perspective, he offers some useful suggestions on the regulatory aspects of defending drug or medical device product liability cases.  As always, our guest-posters are 100% responsible for what they wrote, deserving all of the credit and (any) of the blame.

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Lawyers defending drug and medical device companies in product liability litigation routinely deal with FDA-related issues.  For example, they present expert witnesses to testify that their clients complied with the applicable regulatory requirements, they move to exclude purportedly “bad” FDA documents (e.g., FDA Form 483s and Warning Letters), and they file summary judgment motions arguing that the FDCA or FDA regulations preempt plaintiffs’ claims.

Continue Reading Guest Post – What a Product Liability Defense Lawyer Learned While Working for FDA.

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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

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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

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An interesting issue recently arose (but was not resolved) in In re: Proton-Pump Inhibitor Products Liability Litigation, 2022 WL 2188038 (D.N.J. June 17, 2022) (“PPI”).  The ability of an FDA expert witness to testify was challenged under 18 U.S.C. §207, a federal conflict of interest statute.  We have never seen that statute invoked in connection with an ex-FDA witness before, and apparently neither has anyone else, since the opinion observes that “the fact pattern presented here is something of an unprecedented issue.”  Id. at *4 (citation and quotation marks omitted).  So we thought we’d alert our readers.

Continue Reading Regulatory Witnesses – Something Else To Watch

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At the end of the term, the Supreme Court, in Ruan v. United States, 2022 WL 2295024,142 S. Ct. 2370 (2022), vacated the convictions of a couple of alleged “pill mill” doctors under the Controlled Substances Act upon finding that the government’s proof in their criminal trial did not meet the standard required