Wilson v. Amneal Pharm., L.L.C.

• Decision Date: 31 December 2013
• Docket Number: Case No. 1:13-cv-00333-CWD
• Parties: GEORGE PATRICK WILSON, Plaintiff, v. AMNEAL PHARMACEUTICALS, L.L.C., a New Jersey Corporation, and JOHN and JANE DOES I through X, whose true identities are presently unknown, Defendants.
• Court: U.S. District Court — District of Idaho

GEORGE PATRICK WILSON, Plaintiff, v. AMNEAL PHARMACEUTICALS, L.L.C., a New Jersey Corporation,and JOHN and JANE DOES I through X, whose true identities are presently unknown, Defendants.

Case No. 1:13-cv-00333-CWD

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF IDAHO

Dated: December 31, 2013

MEMORANDUM DECISION ANDORDER

INTRODUCTION

This matter is before the Court on Defendant Amneal Pharmaceuticals, L.L.C.'s Motion for Judgment on the Pleadings (Dkt. 11) and its Motion to Take Judicial Notice (Dkt. 18), as well as Plaintiff George Wilson's Motion to Conduct Discovery Pursuant to Fed. R. Civ. P. 56(d) (Dkt. 15).¹ The Court conducted a hearing on all pending motions on December 20, 2013. For the reasons that follow, the Court will grant Amneal's motion for judgment on the pleadings in part, and grant its motion for judicial notice. Wilson's motion to conduct discovery will be denied.

BACKGROUND

Wilson filed his complaint in the District Court of the Fourth Judicial District for the State of Idaho, in Ada County, on April 12, 2013. Amneal removed the action to this Court on July 30, 2013, based on diversity of citizenship. According to the pleadings, Wilson was seen by his physician and prescribed an antibiotic, Bactrim, which was filled with a generic product manufactured by Amneal. Wilson took the drug for over one week.² Wilson developed a reaction, and was treated for Stevens-Johnson syndrome, a condition that causes blisters and a rash. Stevens-Johnson syndrome can result in severe disfigurement and death. TABER'S CYCLOPEDIC MEDICAL DICTIONARY, 18th Ed. p. 1833 (1997).³

Wilson alleges seven causes of action under Idaho state law against Amneal. In his first cause of action for strict liability, Wilson alleges that Amneal manufactured Bactrim; Wilson expected the drug to reach him without substantial change from the condition in which it was sold; the drug did reach him without substantial change from the condition in which it was sold and had been manufactured; and that the drug was unsafe for its foreseeable use and was otherwise defective and unreasonably dangerous. Second, Wilson alleges defective design in that the drug Bactrim was unreasonably dangerous and in a defective condition when put to its reasonably anticipated use. He further contends Amneal failed to use ordinary care in the manufacture and testing of the drug Bactrim,thereby creating an unreasonable risk of foreseeable injury to Wilson. Third, Wilson alleges negligent manufacture, contending that the drug Bactrim was unreasonably dangerous and in a defective condition when put to its reasonably anticipated use, and that Amneal failed to use ordinary care in the manufacture of the drug Bactrim. Fourth, Wilson alleges failure to warn on the basis that Amneal failed to give proper notice and instructions as to the defects and dangers of the drug Bactrim. Fifth, Wilson alleges Amneal negligently failed to warn Wilson of the dangers associated with taking the drug Bactrim, which dangers included blisters in his mouth and a rash on his lower extremities, and onset of Stevens-Johnson syndrome. And finally, in Counts Six and Seven, Wilson alleges breach of express and implied warranty.

In its Answer, filed on August 6, 2013, Amneal admits that it manufactures and sells to pharmacies the generic form of Brand Name Bactrim, known as "Sulfamethoxazole and Trimethorprim" (Generic Bactrim), and that it has manufactured and sold Generic Bactrum since June 23, 2008. The antibiotic must be prescribed by a health care professional.

Amneal denies the allegations of liability in the complaint, and affirmatively asserts that Wilson's claims are barred, either by the statute of limitations; lack of privity; or preemption. Attached to Amneal's answer are three additional documents supporting Amneal's defenses. The first is an FDA approval letter dated January 27, 2005, approving Interpharm's Abbreviated New Drug Application (ANDA) for Generic Bactrim. (Ans. Ex. A, Dkt. 6.) Next, on January 22, 2010, the FDA issued a letter to Amneal acknowledging Interpharm, Inc.'s transfer of ownership of the ANDA for various drugsto Amneal, including rights to Generic Bactrim. (Ans. Ex. B, Dkt. 6.) Finally, Amneal attached its label (aka "Package Insert") for its Generic Bactrim, both the current version and two prior versions. (Ans. Ex. C, Dkt. 6.) In each of the versions, the label has identified Stevens-Johnson syndrome and other severe skin reactions as potentially life threatening side effect of Generic Bactrim.⁴

Amneal filed its motion seeking judgment on the pleadings on November 26, 2013. In support of its motion, Amneal asks the Court to take judicial notice of the three exhibits attached to its Answer, and also of three additional FDA documents. (Request for Judicial Notice, Dkt. 18.) These additional documents include an October 17, 2002 approval letter from the FDA to Mutual Pharmaceuticals, the brand name drug manufacturer of Bactrim, together with the approved label; a July 27, 2010 letter from the FDA to Mutual Pharmaceuticals together with the revised label for Brand Name Bactrim; and an August 29, 2012 letter from the FDA to Mutual Pharmaceuticals together with a revised label for Brand Name Bactrim.

Amneal argues that Wilson's first five causes of action asserting product liability claims against it are preempted by federal law, because Amneal, a generic drug manufacturer, has a mandatory federal duty of "sameness." In other words, Amneal is required by federal law to manufacture and sell Generic Bactrim with the same chemicalequivalency and bioequivalency as Brand Name Bactrim, and to use the exact same label approved by the FDA for Brand Name Bactrim. Thus, Amneal is prohibited by federal law from altering the design, composition, or label of Generic Bactrim unless Brand Name Bactrim's design, composition, or label has been changed first. Central to Amneal's argument are two recent decisions of the United States Supreme Court, both of which held that state law is preempted by federal law when it is impossible for a private party to comply simultaneously with state and federal requirements. See Mut. Pharm. Co., Inc. v. Bartlett, 133 S. Ct. 2466 (2013), affirming its earlier decision in Pliva, Inc. v. Mensing, 131 S. Ct. 2567 (2011).

In response, Wilson filed a motion requesting permission to conduct discovery under Fed. R. Civ. P. 56(d), and contending that the Court is required to convert Amneal's motion for judgment on the pleadings into a motion for summary judgment because Amneal attached to its Answer FDA-approved documents, as well as Amneal's Generic Bactrim labels. If the Court considers the motion under Rule 56, Wilson contends he is entitled to conduct discovery to oppose Amneal's motion. Alternatively, Wilson argues that the federal preemption analysis under Bartlett and Pliva does not apply to his product liability claims (counts one through five), and that Count Four, for failure to warn, should be interpreted as a failure to update package inserts and warnings, which claim does survive preemption.

Amneal argues also that Wilson's sixth and seventh causes of action for breach of express and implied warranty are subject to dismissal because Idaho does not recognize the causes of action absent privity of contract. Wilson concedes his seventh claim, forbreach of implied warranty, may be dismissed based upon lack of privity, but argues that privity of contract is not required to support a claim for breach of express warranty.

Lastly, Wilson opposes Amneal's request for judicial notice on the grounds that, while notice may be taken of the existence of the FDA documents, the Court may not consider the accuracy of their contents. Amneal, on the other hand, urges the Court to consider the documents. Amneal argues the warning label (Exhibit C to Amneal's Answer) is referred to and therefore incorporated by reference into Wilson's Complaint, and the remaining documents are publically accessible on the internet and published by a federal agency as matters of public record.

DISCUSSION

1. Standard of Review

According to Federal Rule of Civil Procedure 12(c), a judgment on the pleadings is properly granted when, "taking all allegations in the pleading as true, the moving party is entitled to judgment as a matter of law." McGann v. Ernst & Young, 102 F.3d 390, 392 (9th Cir. 1996). In determining whether a complaint states a cognizable claim under Rule 12(c), courts apply the same legal standards applicable to motions brought under Rule 12(b)(6). Cafasso, U.S. ex rel. v. General Dynamics C4 Systems, Inc., 637 F.3d 1047, 1054, n. 4 (9th Cir. 2011) ("we have said that Rule 12(c) is functionally identical to Rule 12(b)(6) and that the same standard of review applies to motions brought under either rule.").

A Rule 12(b)(6) motion to dismiss tests the sufficiency of a plaintiff's claim for relief. The relevant inquiry is whether the plaintiff's allegations are sufficient underFederal Rule of Civil Procedure 8(a), which sets forth the minimum pleading requirement, i.e., that the plaintiff provide a "short and plain statement of the claim showing that the pleader is entitled to relief," and "give the defendant fair notice of what the ... claim is and the grounds upon which it rests." Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 555 (2007).

When reviewing a motion to dismiss, the court must accept as true all nonconclusory, factual (not legal) allegations made in the complaint, Ashcroft v. Iqbal, 556 U.S. 662, 679 (2009); Erickson v. Pardus, 551 U.S. 89 (2007), and draw all reasonable inferences in favor of the plaintiff, Mohamed v. Jeppesen Dataplan, Inc., 579 F.3d 943, 949 (9th Cir. 2009). "While a complaint attacked by a Rule 12(b)(6) motion to dismiss does not need detailed factual allegations, a plaintiff's obligation to provide the grounds of his entitlement to relief requires more than labels and conclusions, and a formulaic recitation of the elements of a...