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One key point where implied preemption differs from express preemption is that express preemption is inherently limited by the language of the particular statute that contains the pertinent preemption clause, whereas general principles of implied preemption have broad application to all similar cases.  Since the preemption of agency fraud claims recognized in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), was based entirely on implied preemption, Bexis has kept track of non-FDCA applications of Buckman implied preemption in his book.  See § 5.02[4][c] n.294.  Non-FDA-related findings that federal agency fraud claims are preempted include:

Farina v. Nokia, Inc., 625 F.3d 97, 104 (3d Cir. 2010) (FCC); Transmission Agency of Northern California v. Sierra Pacific Power Co., 295 F.3d 918, 932 n.10 (9th Cir. 2002) (FERC); Nathan Kimmel, Inc. v. DowElanco, 275 F.3d 1199, 1204-06 (9th Cir. 2002) (EPA); Murray v. Motorola, Inc., 982 A.2d 764, 770 n.6 (D.C. 2009) (FCC); McCall v. Pacificare, Inc., 21 P.3d 1189, 1199 n.9 (Cal. 2001) (Health Care Financing Administration); Timaero Ireland Ltd. v. Boeing Co., 2021 WL 963815 at *6-7 (N.D. Ill. March 15, 2021) (FAA); LCS Group v. Shire LLC, 2019 WL 1234848 at *6 (S.D.N.Y. March 8, 2019) (patent office); In re Volkswagen “Clean Diesel” Marketing, Sales Practices, & Products Liability Litigation, 264 F. Supp.3d 1040, 1054-55 (N.D. Cal. 2017) (EPA); Syngenta Crop Protectin v. Willowood, 2016 WL 6783628 at *1 (M.D.N.C. Aug. 12, 2016) (EPA); Giglio v. Monsanto Co., 2016 WL 1722859 at *3 (S.D. Cal. April 29, 2016) (EPA); Offshore Service Vessels, LLC v. Surf Subsea, Inc., 2012 WL 5183557 at *11-12 (E.D. La. Oct. 17, 2012) (Coast Guard); Ramirez v. E.I. Dupont De Nemours & Co., 2010 WL 3529509 at *2 (M.D. Fla. Sept. 3, 2010) (EPA); Lockwood v. Sheppard, Mullin, Richter & Hampton, LLP, 2009 WL 9419499 at *7 (C.D. Cal. Nov. 24, 2009) (patent office); Beck v. Koppers, Inc., 2006 WL 2228910 at *1 (N.D. Miss. April 7, 2006) (EPA); Hill v. Brush Engineered Materials, Inc., 383 F. Supp.2d 814, 822 (D. Md. 2005) (EPA, OSHA); Williams v. Dow Chemical Co., 255 F. Supp.2d 219, 232 (S.D.N.Y. 2003) (EPA); Morgan v. Brush Wellman, Inc., 165 F. Supp.2d 704, 722 (E.D. Tenn. 2001) (Dept. of Energy); Zwiercan v. General Motors Corp., 2002 WL 31053838, 58 Pa. D. & C.4th 251, 266 (Pa. Com. Pl. 2002) (NHTSA); Redelmann v. Alexander Chemical Corp., 2002 WL 34423377 (Ill. Cir. July 26, 2002) (EPA).

Now Buckman preemption is the centerpiece of In re Ford Motor Co. F-150 & Ranger Truck Fuel Economy Marketing & Sales Practices Litigation, ___ F.4th ___, 2023 WL 3029837 (6th Cir. April 21, 2023).  Indeed, at least one aspect of Ford F-150 is favorable to Buckman preemption in a way that should be useful in the drug/device field.…

Continue Reading Automotive Preemption Case Has Buckman Front and Center

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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…

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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…

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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 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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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…

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Bexis’ Book

FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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