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Marvin v. Zydus Pharmaceuticals USA Inc.

United States District Court, W.D. Wisconsin

April 28, 2016



BARBARA B. CRABB District Judge

Plaintiffs in this civil action are suing defendants Zydus Pharmaceuticals (USA) Inc. and Wyeth Pharmaceuticals, Inc. for the wrongful death of Shirley Johns, who died allegedly from injuries incurred when she took a drug commonly known as Amiodarone. Before the court is defendant Zydus Pharmaceuticals (USA) Inc.’s motion to dismiss the complaint against it on the following grounds: (1) plaintiffs’ claims are barred by Wisconsin’s three-year statute of limitations, Wis.Stat. § 893.54; and (2) plaintiffs do not have a private right of action with respect to their negligence per se claim that defendant Zydus failed to provide a medication guide for the Amiodrone sold to Johns because the Food, Drug and Cosmetic Act, 21 U.S.C. § 337, limits enforcement of its provisions to actions brought by the United States. Dkt. #22.

I am denying defendant Zyfus’s motion to dismiss with respect to timeliness because it is not clear from the complaint that plaintiffs’ claims are barred by the statute of limitations. I am reserving ruling on its motion with respect to plaintiffs’ negligence per se claim because further briefing from the parties is needed to determine whether such a claim is preempted by § 337 of the Food, Drug and Cosmetic Act.


In resolving a motion to dismiss pursuant to Fed.R.Civ.P. 12(b)(6), the court must accept as true all well-pleaded factual allegations in the complaint, Adams v. City of Indianapolis, 742 F.3d 720, 728 (7th Cir. 2014), and view them in the light most favorable to the non-movant, Santiago v. Walls, 599 F.3d 749, 756 (7th Cir. 2010) (quoting Zimmerman v. Tribble, 226 F.3d 568, 571 (7th Cir. 2000)). “Threadbare recitals of the elements of a cause of action, supported by mere conclusory statements, do not suffice.” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (citing Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 555 (2007)). For purposes of the present motion, I will accept as true the following allegations of fact from plaintiffs’ first amended complaint. Dkt. #16.

Shirley Johns was a 77-year-old resident of Crandon, Wisconsin who had a diagnosis of atrial fibrillation. She died on November 19, 2012, allegedly from Amiodarone-induced lung disease. (Amiodarone has many side effects, the most serious being pulmonary toxicity-lung disease.) Plaintiffs Judy Marvin, Beverly Schultz, Patricia Collins, Robert Elick and Sandra Conley are the children of Shirley Johns; all of them reside in Crandon, Wisconsin. Plaintiff Conley is the next friend of the estate of Shirley Johns.

Defendants Wyeth Pharmaceuticals, Inc. and Zydus Pharmaceuticals (USA) Inc. are New Jersey corporations involved in the distribution, marketing, promotion, sale, labeling and design of amiodarone hydrochloride (or Amiodarone). Wyeth was the initial manufacturer and distributor of Amiodarone in the United States. In 1985, it received approval from the Food and Drug Administration to market and sell Cordarone (its named brand of Amiodarone) as a drug of last resort for patients suffering from recurrent life-threatening ventricular fibrillation and ventricular tachycardia when those conditions would not respond to other available anti-arrhythmic drugs and therapies. On September 16, 2008, Zydus received approval from the Food and Drug Administration to manufacture, market, sell and distribute a generic formulation of Amiodarone. As it does with all generic drug approvals, the Food and Drug Administration required Zydus to provide patients prescribed the drug with approved labels, warnings and medication guides containing the exact same information required of Wyeth as the brand formulation manufacturer.

A medication guide is a “plain English” description of the dangers of a drug. The Food and Drug Administration requires drug manufacturers to issue medication guides with certain prescribed drugs and biological products when the agency determines the information is necessary to prevent serious adverse effects. In that case, patients are to be informed about a known serious side effect or patient adherence to directions for the use of a product are essential to its effectiveness. The agency requires manufacturers of Amiodarone to provide medication guides in lieu of “package inserts” or any other means by which the manufacturers may attempt to warn consumers of the effects of Amiodarone. Regulations promulgated by the Food and Drug Administration require each manufacturer who ships a container of Amiodarone to provide a sufficient number of medication guides to authorized distributors, packers and dispensers so that every consumer receives a guide with each Amiodarone prescription. 21 C.F.R. § 208.24(b).

After receiving approval from the Food and Drug Administration, Wyeth, Zydus and other companies sought to increase sales of Amiodarone for the “off-label” use as a “first-line anti-arrhythmic medication, ” or a drug of first choice in treating non-life threatening heart ailments. (“Off label” uses are those not yet approved by the Food and Drug Administration.) Although pharmaceutical companies may disseminate certain information about off-label uses, they must adhere to strict requirements. For instance, a manufacturer must submit an application to the Food and Drug Administration seeking approval of the drug for off-label use, provide its marketing materials to the Food and Drug Administration prior to dissemination, distribute the materials in unabridged form and include disclosures that the materials pertain to an unapproved use of the drug and, if the Food and Drug Administration deems it appropriate, provide “additional objective and scientifically sound information . . . necessary to provide objectivity and balance.” 21 U.S.C. § 360aaa. A drug manufacturer’s dissemination of information in violation of any of these provisions qualifies as a violation of the Federal Food, Drug and Cosmetic Act and regulations promulgated under it. Zydus did not adhere to these requirements.

Dr. Richard A. Reinhart prescribed Shirley Johns a 90-day course of 200mg Amiodarone tablets for treatment of atrial fibrillation, an off-label use of the drug. Shirley Johns filled the prescription at a pharmacy and ingested the Amiodarone according to instructions. In the spring of 2012, Johns began to experience shortness of breath, wheezing, trouble breathing, coughing, tiredness, weakness, nervousness, irritability, restlessness, decreased concentration, depression, impaired vision and stomach, leg and chest pain. Johns asked Dr. Reinhart about the effects of Amiodarone and underwent tests for pulmonary toxicity, but Dr. Reinhart told her that her lungs looked perfect. Later it was determined that a mistake had been made in reading those tests. Johns died on November 19, 2012.

The bottles of Amiodarone that Shirley Johns received were each marked with “MANUFACTURER ZYDUS PHARM, ” identifying the bottles as manufactured, marketed and distributed by defendant Zydus. Defendant failed to provide up-to-date warning labels or the medication guides required by the Food and Drug Administration to any of the pharmacies from which Johns obtained Amiodarone.

Plaintiffs filed their complaint in this action on November 20, 2015.


A. Statute of ...

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