Schedin v. Ortho–mcneil–janssen Pharmaceuticals Inc.

• Decision Date: 04 March 2011
• Docket Number: Civil No. 08–5743 (JRT).
• Citation: 776 F.Supp.2d 907
• Parties: John SCHEDIN, Plaintiff,v.ORTHO–McNEIL–JANSSEN PHARMACEUTICALS, INC., Defendant.
• Court: U.S. District Court — District of Minnesota

776 F.Supp.2d 907

John SCHEDIN, Plaintiff,

v.ORTHO–McNEIL–JANSSEN PHARMACEUTICALS, INC., Defendant.

Civil No. 08–5743 (JRT).

United States District Court, D. Minnesota.

March 4, 2011.

Mikal C. Watts, Watts Law Firm, LLP, Corpus Christi, TX; Ronald S. Goldser, Zimmerman Reed, PLLP, Minneapolis, MN; and Lewis J. Saul, Lewis Saul & Associates, Portland, ME, for plaintiff Schedin.John Dames and William V. Essig, Drinker Biddle & Reath LLP, Chicago, IL; William H. Robinson, Jr., LeClair Ryan, Washington, DC; and Tracy J. Van Steenburgh, Nilan Johnson Lewis, PA, Minneapolis, MN, for defendant.

MEMORANDUM OPINION AND ORDER DENYING DEFENDANT'S MOTION FOR JUDGMENT AS A MATTER OF LAW

JOHN R. TUNHEIM, District Judge.

Plaintiff John Schedin brought claims against defendant Ortho–McNeil–Janssen Pharmaceuticals, Inc. (“Ortho–McNeil”) for failure to warn about certain risks he was taking in using its drug, Levaquin, namely tendon rupture. His case was the first case tried in a larger multi-district litigation involving numerous plaintiffs. The jury found for Schedin, and defendant has moved for judgment as a matter of law. Ortho–McNeil argues that Schedin's failure to warn claims required the jury to return a verdict that is inconsistent with, and thus preempted by, federal law, specifically Food and Drug Administration (“FDA”) regulations made pursuant to the Food, Drug, and Cosmetic Act (“FDCA”). See, e.g., 21 C.F.R. § 201.57 (requirements on the format and labeling for prescription drugs). Ortho–McNeil contends that the Levaquin label was approved by the FDA and was subject to strict guidelines related to changes of labeling that left it unable to alter the warnings on the drug's label. Further, Ortho–McNeil argues that Schedin's state punitive damages claim is based on “fraud on the FDA” and is therefore similarly pre-empted. Because the Court finds that Schedin's state law failure to warn claims are not preempted by the FDCA, Ortho–McNeil had many options at its disposal to effectuate an adequate warning, and Schedin's case does not hinge on a defrauding of the FDA, the Court denies the motion.

BACKGROUND

Schedin was prescribed Levaquin for an upper respiratory infection in February 2008 and, after eight days of consuming the drug, suffered bilateral Achilles tendon ruptures. (Compl. ¶ 108, Docket No. 1.) At the time Schedin was prescribed Levaquin, the drug contained a warning regarding tendon rupture stating:

Tendon effects: Ruptures of the shoulder, hand, Achilles tendon, or other tendons that required surgical repair or resulted in prolonged disability have been reported in patients receiving quinolones, including levofloxacin. Post-marketing surveillance reports indicate that this risk may be increased in patients receiving concomitant corticosteroids, especially in the elderly.

(Def. Ex. 12.) Schedin claims this label alone was inadequate to warn him of the risk he was taking in using Levaquin, in part because of the way the warning was worded, where it was located in the label insert and not easily noticed, and because it did not warn that Levaquin had higher tendon toxicity than other fluoroquinolones.

At the time Schedin was prescribed Levaquin, it was already subject to class labeling as a fluoroquinolone, a class of broad-spectrum antibiotics, and the FDA had not yet mandated a black box warning for the specific injury Schedin suffered.¹ OrthoMcNeil asserts that it could not have instituted a black box warning independently without an FDA mandate. See 21 C.F.R. § 201.80(e) (“If a boxed warning is required, its location will be specified by the [FDA].”). Schedin concedes that Ortho–McNeil probably could not have unilaterally instituted a black box warning. However, he contends that Ortho–McNeil knew of the risk posed by Levaquin and could have taken numerous other steps to warn consumers about those risks, such as sending out “Dear Doctor” letters, having sales representatives meet and confer with doctors, hosting training seminars, and other such measures to draw attention to the risks. As a result, Schedin argues his state law claims are not pre-empted by the FDCA.

ANALYSIS

I. STANDARD OF REVIEW

Under Rule 50 of the Federal Rules of Civil Procedure, judgment as a matter of law is appropriate if no reasonable juror could return a verdict for the nonmoving party. Weber v. Strippit, Inc., 186 F.3d 907, 912 (8th Cir.1999). In analyzing a Rule 50 motion, the Court must consider the evidence in the light most favorable to the nonmovant, resolve all factual conflicts in the nonmovant's favor, and give the nonmovant the benefit of all reasonable inferences. Ogden v. Wax Works, Inc., 214 F.3d 999, 1002 (8th Cir.2000). “[J]udgment as a matter of law is proper when the record contains no proof beyond speculation to support the verdict.” Heating & Air Specialists, Inc. v. Jones, 180 F.3d 923, 932–33 (8th Cir.1999) (internal quotation marks omitted).

II. FAILURE TO WARN CLAIMSA. Pre-emption Principles

Whether Schedin's state law failure to warn claims are pre-empted by conflict preemption with federal law is the central question posed by Ortho–McNeil's motion for judgment as a matter of law. The Supremacy Clause of the United States Constitution provides that the “Laws of the United States ... shall be the supreme Law of the Land.” U.S. Const. art. VI, cl. 2. The principle of pre-emption is the application of this clause, resulting in the rule that any “state law that conflicts with federal law is without effect.” Cipollone v. Liggett Grp., Inc., 505 U.S. 504, 516, 112 S.Ct. 2608, 120 L.Ed.2d 407 (1992) (internal quotation marks omitted). “Preemption is disfavored in areas of historic importance to the states' police powers—areas such as public health and safety.” In re St. Jude Med. Inc. Silzone Heart Valves Prod. Liab. Litig., No. 01–MDL–1396, 2004 WL 45503, at *5 (D.Minn. Jan. 5, 2004) (citing Kemp v. Medtronic, Inc., 231 F.3d 216, 222 (6th Cir.2000)).

Pre-emption can be either express or implied. Express pre-emption is found when Congress “pre-empt[s] state law by so stating in express terms.” Hillsborough Cnty., Fla. v. Automated Med. Labs., Inc., 471 U.S. 707, 712–13, 105 S.Ct. 2371, 85 L.Ed.2d 714 (1985) (citing Jones v. Rath Packing Co., 430 U.S. 519, 525, 97 S.Ct. 1305, 51 L.Ed.2d 604 (1977)). In addition to express pre-emption, “a court may find that Congress impliedly preempted such claims by ‘conflict’ if 1) compliance with both federal and state law is impossible, or 2) the claims would stand as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.” Mensing v. Wyeth, Inc., 588 F.3d 603, 608 (8th Cir.2009) (alteration and quotation marks omitted) (citing Crosby v. Nat'l Foreign Trade Council, 530 U.S. 363, 372–73, 120 S.Ct. 2288, 147 L.Ed.2d 352 (2000)), cert. granted, ––– U.S. ––––, 131 S.Ct. 817, 178 L.Ed.2d 550 (2010) (No. 09–993). Therefore, “a conflict arises when compliance with both federal and state regulations is a physical impossibility....” Automated Med. Labs., Inc., 471 U.S. at 712–13, 105 S.Ct. 2371. (emphasis added) (internal quotations omitted); see also, Mensing, 588 F.3d at 608 (finding no conflict preemption for manufacturers of generic drugs in a state failure to warn action). “Impossibility pre-emption is a demanding defense.” Wyeth v. Levine, 555 U.S. 555, 129 S.Ct. 1187, 1199, 173 L.Ed.2d 51 (2009). The Supreme Court recently evaluated the FDCA and pre-emption and described the process by which such determination should be made:

Our answer to [the] question [of pre-emption] must be guided by two cornerstones of our pre-emption jurisprudence. First, the purpose of Congress is the ultimate touchstone in every pre-emption case. Second, in all pre-emption cases, and particularly in those in which Congress has legislated in a field which the States have traditionally occupied, we start with the assumption that the historic police powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress.

Wyeth, 129 S.Ct. at 1194–95 (internal citations, alternations, and quotation marks omitted).

Articulating Congress' purpose in the enactment of and amendments to the FDCA, the Wyeth Court noted:

[When Congress] enlarged the FDA's powers to protect the public health and assure the safety, effectiveness, and reliability of drugs, [it] took care to preserve state law.... In 2007, ... Congress ... granted the FDA statutory authority to require a manufacturer to change its drug label based on safety information that becomes available after a drug's initial approval. In doing so, however, Congress did not enact a provision in the Senate bill that would have required the FDA to preapprove all changes to drug labels.... [T]hrough many amendments to the FDCA and to FDA regulations, it has remained a central premise of federal drug regulation that the manufacturer bears responsibility for the content of its label at all times.

Id. at 1196–98 (emphasis added) (internal citations, quotation marks, and alterations omitted).

With the Wyeth Court's interpretation of Congress' intent in mind, the remaining question is whether, in the instant case, compliance with both state and federal law regarding adequate warnings presented Ortho–McNeil a “physical impossibility” such that state law must yield to the federal law. Automated Med. Labs., Inc., 471 U.S. at 713, 105 S.Ct. 2371. “The question before this court is whether [Ortho–McNeil] can both fulfill a state law duty to warn and comply with the FDCA. Does federal law forbid [Ortho–McNeil] from taking steps to warn [its] customers?” Mensing, 588 F.3d at 610–11. B. Defendant's Obligation to Maintain Adequate Warnings

Ortho–McNeil argues that since Levaquin was already subject to an FDA approved label, FDA regulations would not have permitted Ortho–McNeil to alter the label to provide stronger warnings. Even if Ortho–McNeil is correct about an...