Fraud On The FDA

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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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Product liability litigation over Class III medical devices is an interesting creature.  Absent something unusual, cases and litigations should not get past motions to dismiss.  That is pretty clearly what Congress intended when an express preemption provision was added to the Medical Device Amendments of 1976.  We understand that each plaintiff may think her case is exceptional in that it should meet the exception to the rule of preemption.  (We do not really think the plaintiff lawyers think that, although they sure argue it enough.)  But the usual is more common than the unusual by definition.  When you hear hoof beats, you should look for a horse not a zebra, unless you happen to be in a part of the world where zebras are endemic or end up in a zebra enclosure in a zoo.  When you hear Class III medical device product liability case, you should look for all claims to be dismissed unless there is something as unusual as a basis to claiming the plaintiff’s particular device deviated from its FDA-approved specifications.

In 2001, the Supreme Court made getting past motions to dismiss harder when it held in Buckman that plaintiffs could not recover claims predicated on violations of FDA regulations.  An unfortunate fiction developed post-Buckman—particularly after Riegel v. Medtronic, Inc. 552 U.S. 312 (2008)—that plaintiffs could assert “parallel claims” that were neither expressly preempted by the provisions of the MDA nor impliedly preempted under Buckman.  We, and others, have described the purported path of a parallel claim as being like navigating between Scylla and Charybdis, a monster and whirlpool on opposite sides of a narrow strait per ancient Greek mythology.  Without claiming that mythology is the same as fiction—we are not touching that with a twenty foot sarissa—we can say that a true parallel claim is as rare as a striped unicorn or perhaps a flying horse.  The unfortunate fiction of which we spoke above has taken shape with particularly egregious appellate decisions like Bausch such that some trial courts are advised, when they hear the hoof beat of a Class III medical device product liability case, to expect Pegasus or his stripy, horned pal to gallop around the corner.

Viewed over the course of more than five years and many decisions, three of which have featured in prior posts (here, here, and here, which drew honorable mention honors in 2018), we think Bausch delayed the inevitable in Gravitt v. Mentor Worldwide, LLC, __ F.Supp.3d __, 2022 WL 17668486 (N.D. Ill. Dec. 14, 2022), by insisting that parallel claims for failure to report adverse events to FDA exist.  After an unnecessary odyssey, the manufacturer of a Class III breast implant won summary judgment on the last of plaintiffs’ claims, alleged failure to report adverse events to FDA.  (We say “plaintiffs,” but the decision referred to the plaintiff with the implant—who we will call the “plaintiff”—by her first name and the consortium plaintiff by his first name.  In terms of whether the last claim was supported, the court referred the female plaintiff only and somehow omitted any reference to “burden.”  These are usually signs that at least one claim will survive summary judgment.)  A shout out to Dustin Rawlin and his colleagues for sticking it out on this case and sending us this decision.…

Continue Reading Fallacious FDA Reporting Claim Finally Falls

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We’ve seen many plaintiffs allege that drug and/or medical device manufacturers committed “fraud on the FDA” and bemoan that Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), prevents them from recovering based on such allegations.  Buckman still doesn’t prevent them from trying every form of evasive legal chicanery known to man to…

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The recent appellate False Claims Act (“FCA”) decision in Dan Abrams Co. LLC v. Medtronic Inc., ___ F. Appx. ___, 2021 WL 1235845 (9th Cir. April 2, 2021), has us scratching our heads.  It’s like riding a legal roller coaster.  Some parts are really high, and others are really low.

Bexis first ran across…

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Truly unique cases are, well, unique. Most cases involve variations or combinations of cases we have seen before. Sometimes you get different results between two decisions on basically the same case with a single fact different. In February, we posted on an Eastern District of Pennsylvania decision on a motion to dismiss in a case…

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Private plaintiffs love to scream “fraud on the FDA”!  Agency fraud is their magic potion for dissolving any FDA action that they don’t like.  Just assert that the FDA was bamboozled and invite some jury somewhere to ignore what the FDA actually did.  Unfortunately for the other side, Buckman Co. v. Plaintiffs Legal Committee,…

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Today’s post is an update to our post from just a few weeks ago regarding McWilliams v. Novartis AG, No. 2:17-CV-14302 (S.D. Fla.). At that time, the court denied summary judgment on plaintiff’s failure to warn claims, but applying New Jersey law dismissed plaintiff’s claim for punitive damages. Since the case involves an FDA-approved…

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With Bexis having originally conceived the preemption argument that became Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), we are always on the lookout for ways in which plaintiffs attempt to circumvent Buckman’s result and thus  to pursue private litigation over fraud on the FDA.

Plaintiffs love to claim fraud on…

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Ever since Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), held that state-law claims alleging fraud on the FDA are preempted, plaintiffs have been attempting to find some other way of bringing claims that attribute FDA actions to a defendant’s false pretenses.  Since preemption is based on the Supremacy Clause, and the constitutional relationship between the federal and state legal systems, the doctrine doesn’t apply where recovery is sought under a federal statute.  Since the False Claims Act (“FCA”) is a federal statute, sporadic attempts have been made to bring private fraud-on-the FDA-claims under that statute.  Bexis, who invented what became the Buckman fraud-on-the-FDA/implied-preemption defense in the Bone Screw litigation, even worked on an amicus brief in one such case, United States ex rel. Gilligan v. Medtronic, Inc., 403 F.3d 386 (6th Cir. 2005), that was ultimately decided (favorably to the defense) on other grounds.

A little less than a year ago we reported on an excellent FCA result in United States ex rel. D’Agostino v. EV3, Inc., 153 F. Supp.3d 519 (D. Mass. 2015).  Ever since we’ve been holding our breath, because the First Circuit has been known for pro-plaintiff rulings in cases against our drug and medical device clients.  Indeed, the First Circuit once led our list the worst drug/medical device cases of the year for two years running – in 2012 and 2013.  Whether something’s changed since then in the First Circuit, we can’t say.  But we can report that the district court’s dismissal of fraud-on-the-FDA-based FCA claims in D’Agostino has just been affirmed with an excellently reasoned decision.  See D’Agostino v. EV3, Inc., ___ F.3d ___, 2016 WL 7422943 (1st Cir. Dec. 23, 2016).

The facts in D’Agostino were thoroughly explained in our prior post.  Briefly, the relator (a fired sales rep) alleged that the defendants pulled fast ones on the FDA with respect to the approvals/supplemental approvals of two medical devices, one called “Onyx” and the other “Axium” (these defendants evidently like “x” as much as did the former Standard Oil of New Jersey).  The relator-plaintiff claimed that the defendants:  (1) sought approval of Onyx for a narrow indication, but intended to promote it more broadly off-label (exactly the claim in Buckman); (2) failed to live up to promises made to the FDA concerning extensive surgeon training in using Onyx (also a form of fraud on the FDA); (3) concealed the failure of Onyx’s active ingredient in a different device (ditto); and (4) failed to recall earlier versions of Axium after obtaining FDA approval (not fraud on the FDA, but a theory that could dangerously penalize innovation).  See D’Agostino, 2016 WL 7422943, at ??? (for some reason WL has omitted star paging, so we’ll also cite to the slip opinion), slip op. at 4-8.  Critically, although the FDA was informed of all of these claims, the Agency never instituted any enforcement action, nor did the government elect to join the D’Agostino FCA action.  Id. at 9, 15.  As discussed in the prior post, the district court dismissed all of these claims with prejudice as futile.…

Continue Reading Fraud on the FDA Doesn’t Fly Under the FCA Either

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It wasn’t a complete win, but the summary judgment outcome in Rheinfrank v. Abbott Laboratories, Inc., ___ F. Supp.3d ___, 2015 WL 4743056 (S.D. Ohio Aug. 10, 2015), has to put a spring in the step of the defendants as they approach trial.  What’s left doesn’t strike us as a very good warnings case.  Rheinfrank involved claims that the antiepileptic drug Depakote caused the minor plaintiff’s birth defects.  Make no mistake about it, Depakote has a known association with such injuries.  First approved in 1983, it’s been a Pregnancy Category D drug since 1988, meaning, according to FDA regulations, that:

there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but the potential benefits from the use of the drug in pregnant women may be acceptable despite its potential risks.

21 C.F.R. §201.57(c)(9)(i)(A)(4).  Not only that, since 2003, this drug has carried a black box “teratogenicity” warning, as well as other quite explicit, and all-caps, language to the same effect.  For details, see 2015 WL 4743056, at *2-3.

Plaintiff-mother had used Depakote for years, through four previous uneventful pregnancies.  Id. at *1.  On her fifth pregnancy, even though Depakote came with all these warnings, she continued to take it.  Id.  Her allegations did try to change the subject, however.  In addition to claiming that the black box warning (more about that later) and all the other teratogenicity language were inadequate, she asserted that the defendants failed to warn altogether about “developmental delay.”  Id. at *5.…

Continue Reading Preemption (and Other Things) Defanging Depakote Claims

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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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