737 F.3d 378 (6th Cir. 2013), 12-6195, Strayhorn v. Wyeth Pharmaceuticals, Inc.
|Docket Nº:||12-6195, 12-6198, 12-6200, 12-6203, 12-6208, 12-6209, 12-6210.|
|Citation:||737 F.3d 378|
|Opinion Judge:||RONALD LEE GILMAN, Circuit Judge.|
|Party Name:||Gloria STRAYHORN, et al., Plaintiffs-Appellants, v. WYETH PHARMACEUTICALS, INC., et al., Defendants-Appellees.|
|Attorney:||Collyn A. Peddie, Law Offices of Collyn Peddie, Houston, Texas, for Appellants. Henninger S. Bullock, Mayer Brown LLP, New York, New York, for Appellees Schwarz and Alaven. Jeffrey F. Peck, Ulmer & Berne LLP, Cincinnati, Ohio, for Appellees Watson, Duramed, Pliva, and Barr. Richard A. Oetheimer, ...|
|Judge Panel:||Before: GILMAN, GRIFFIN, and STRANCH, Circuit Judges. GILMAN, J., delivered the opinion of the court, in which GRIFFIN, J., joined and STRANCH, J., joined in part. STRANCH, J. (pp. 40-55), delivered a separate opinion concurring in part and dissenting in part. JANE B. STRANCH, Circuit Judge, conc...|
|Case Date:||December 02, 2013|
|Court:||United States Courts of Appeals, Court of Appeals for the Sixth Circuit|
Argued: July 31, 2013.
Rehearing and Rehearing En Banc Denied Jan. 23, 2014.[*]
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Collyn A. Peddie, Law Offices of Collyn Peddie, Houston, Texas, for Appellants.
Henninger S. Bullock, Mayer Brown LLP, New York, New York, for Appellees Schwarz and Alaven.
Jeffrey F. Peck, Ulmer & Berne LLP, Cincinnati, Ohio, for Appellees Watson, Duramed, Pliva, and Barr.
Richard A. Oetheimer, Goodwin Procter LLP, Boston, Massachusetts, for Appellee Teva.
These seven consolidated cases are among the many that have been filed nationwide against the manufacturers of both the prescription drug Reglan and its generic equivalent, metoclopramide. The plaintiffs allege that they ingested generic metoclopramide and, as a result, developed a serious neurological disorder known as tardive dyskinesia. They filed suit against both the generic and brand-name manufacturers, alleging a wide variety of product-liability claims.
The makers of the generic metoclopramide moved to dismiss the claims against them, arguing that all of the plaintiffs' claims are preempted by the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. §§ 301-399f, under the Supreme Court decision in PLIVA, Inc. v. Mensing, __ U.S. __, 131 S.Ct. 2567, 180 L.Ed.2d 580 (2011). And the brand-name manufacturers moved for summary judgment, contending that they are not liable to the plaintiffs because none of the plaintiffs ingested Reglan.
The district court granted both motions. For the reasons set forth below, we AFFIRM the judgment of the district court and DENY the plaintiffs' pending motion to certify a proposed question to the Tennessee Supreme Court.
A. Factual background
The basic facts are undisputed, and the lawsuits filed in the district court for each of the consolidated cases are identical to one another. We will therefore refer to the seven consolidated cases as " the present case."
The manufacturers of Reglan are Alaven Pharmaceuticals LLC; Pfizer, Inc.; Schwarz Pharma, Inc.; Wyeth Pharmaceuticals, Inc.; Wyeth LLC; and Wyeth, Inc. We will refer to these defendants collectively as the Brand-Name Manufacturers. The makers of generic metoclopramide are
Actavis Elizabeth LLC; Barr Pharmaceuticals, Inc.; Duramed Pharmaceuticals, Inc.; Generics Bidco I LLC; McKesson Corporation; Mutual Pharmaceutical Co.; Northstar RX, LLC; PLIVA, Inc.; Ranbaxy Pharmaceuticals, Inc.; TEVA Pharmaceuticals USA, Inc.; The Harvard Drug Group; United Research Laboratories, Inc.; and Watson Laboratories, Inc. We will refer to these defendants collectively as the Generic Manufacturers.
The district court took the following facts from the plaintiffs' amended complaint as true for the purpose of ruling on the Generic Manufacturers' Motion to Dismiss:
Reglan is a prescription drug, and metoclopramide is its generic bioequivalent. (Am.Compl.¶ 6.) Reglan and metoclopramide's product labeling recommends them for use as short-term therapies for symptomatic gastroesophageal reflux— heartburn— and acute and recurrent diabetic gastric stasis— bloating. ( Id. ¶ 13.) The labels recommend therapy for up to twelve weeks in adults for heartburn, but they did not contain a durational limit for bloating. ( Id. ¶ 14.) At no time have Reglan or metoclopramide been shown to be either efficacious or safe when used for long-term treatment. ( Id. ¶ 15.)
Reglan and metoclopramide affect the brain's movement center, typically causing involuntary, repetitive movements. ( Id. ¶ 7.) Overuse of Reglan and metoclopramide can result in extra-pyramidal symptoms including, but not limited to, tardive dyskinesia, dystonia, and akathisia, Parkinsonism, and Reglan-induced tremors. ( Id. ¶ 8.) Reglan and metoclopramide have also been associated with central nervous system disorders, depression with suicidal ideation, visual disturbances, and memory loss. ( Id. ) Tardive dyskinesia, dystonia, and akathisia are serious neurological movement disorders resulting in involuntary and uncontrollable movements of the head, neck, face, arms, or truck [sic], as well as involuntary facial grimacing and tongue movements, including tongue thrusting, tongue chewing, extreme anxiety, and restlessness or other involuntary movements. ( Id. ¶ 9.) These disorders have no known cure. ( Id. ¶ 10.)
Patients using Reglan or metoclopramide for longer periods of time are at an " unreasonably dangerous increased risk of developing one or more severe and permanent neurological movement disorders, significantly and substantially greater than disclosed or suggested in the product labeling for the drug or in any other materials disseminated by the defendants to either the medical community or the public." ( Id. ¶ 16.) Ordinary consumers would not appreciate the risk of developing one or more incurable severe neurological movement disorders when taking Reglan or metoclopramide as discussed above. ( Id. ¶ 17.) Similarly, a prudent manufacturer would not market Reglan or metoclopramide due to the risk of severe and permanent neurological movement disorders and the availability of less dangerous alternative treatments. ( Id. ¶ 18.)
Reglan is the reference listed drug (" RLD" ) in abbreviated new drug applications (" ANDAs" ) for generic versions of metoclopramide. ( Id. ¶ 25.) ANDAs for new drugs must disclose to the Food and Drug Administration (" FDA" ) the drug's chemistry, pharmacology, and other matters, including its proposed labeling. ( Id. ¶ 26.) For the FDA to approve a drug's ANDA, its ANDA must include proposed labeling which discusses data and information about the risks and side effects of the drug, the drug's test results, results of animal studies, results of clinical studies, and
the drug's bioavailability, all of which enable physicians or other foreseeable prescribers to use the drug safely. ( Id. ) Federal law requires the owner of an FDA-approved ANDA to ensure that the drug's labeling remains accurate and adequate, to conduct safety surveillance for adverse drug effects, and to periodically report to the FDA data related to the safety of the drug or the accuracy of its label. ( Id. ¶ 27.) The FDA has not approved Reglan and metoclopramide for long-term or pediatric use. ( Id. ¶ 28.)
The Amended Complaint contains three categories of claims: those against the Brand Name Defendants, the Generic Defendants, and all Defendants.... Plaintiffs allege that all Defendants knew or should have known that most physicians did not know or fully appreciate the seriousness of the risks associated with Reglan or metoclopramide. ( Id. ¶ 31.) Moreover, all Defendants knew that physicians commonly prescribed the drug for inappropriate long term and pediatric use, as well as short term use for certain adults. ( Id. ) Thus, all Defendants " should have known that the Physician's Desk reference monograph for Reglan and the package inserts for Reglan and metoclopramide were deficient, inaccurate, [or] false and misleading in communicating [information] to the medical community in general, to physicians, or to the public." ( Id. ) Plaintiffs allege that all Defendants " failed to adequately inform physicians and misled [them] about the risks associated with their metoclopramide drug products." ( Id. ¶ 33.)
Plaintiffs aver that all Defendants " knew or ... should have known that the labeling for Reglan and generic metoclopramide substantially understated the frequency of acute and long term side effects of the drug." ( Id. ¶ 35.) Thus, all Defendants " failed to use reasonable care to ascertain or communicate to physicians or to the public information that would constitute adequate and effective warnings." ( Id. ) Additionally, all Defendants knew through their own studies or " publicly available published literature" that doctors...
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