Schedin v. Ortho-Mcneil-Janssen Pharms., Inc., Civil No. 08–5743 (JRT).

• Decision Date: 26 August 2011
• Docket Number: Civil No. 08–5743 (JRT).
• Parties: John SCHEDIN, Plaintiff, v. ORTHO–McNEIL–JANSSEN PHARMACEUTICALS, INC., Defendant.
• Court: U.S. District Court — District of Minnesota

808 F.Supp.2d 1125

John SCHEDIN, Plaintiff,

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

Civil No. 08–5743 (JRT).

United States District Court, D. Minnesota.

Aug. 26, 2011.

Mikal C. Watts, Watts Law Firm, LLP, Corpus Christi, TX, Ronald S. Goldser, Zimmerman Reed, PLLP, Minneapolis, MN, 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, Tracy J. Van Steenburgh, Nilan Johnson Lewis, PA, Minneapolis, MN, for Defendant.

MEMORANDUM OPINION AND ORDER

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, specifically the risk of tendon rupture. Schedin's action was the first case tried from many plaintiffs whose claims have been consolidated for coordinated pretrial proceedings in multi-district litigation. The jury found for Schedin and awarded compensatory and punitive damages. Ortho–McNeil now moves for a new trial claiming the verdicts are against the clear weight of the evidence and that the defendant was denied a fair trial by erroneous evidentiary rulings and improper closing arguments by Schedin. Ortho–McNeil also moves for judgment as a matter of law (“JMOL”) on substantially the same issues as those raised in the motion for a new trial.¹ Ortho–McNeil argues the recent Supreme Court decision in PLIVA, Inc. v. Mensing, ––– U.S. ––––, 131 S.Ct. 2567, 180 L.Ed.2d 580 (2011), should control the Court's analysis on these motions. Because the Court finds that Mensing is inapplicable to a brand-name manufacturer such as Ortho–McNeil, that the verdicts were not against the clear weight of the evidence, and that Ortho–McNeil was not denied a fair trial, the Court denies the motion for a new trial. Further, because the standard of review for JMOL is more stringent than that for a new trial, the Court denies the motion in so far as it rests on the same arguments as the motion for a new trial. As far as the JMOL rests on pre-emption arguments, the Court finds no pre-emption and denies the motion.

BACKGROUND

Plaintiff John Schedin was prescribed Levaquin for an upper respiratory infection in February of 2008 and, after eight days of consuming the drug, he 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 that stated:

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. Trial Ex. 12.) Schedin brought claims against Ortho–McNeil, arguing the label was inadequate to warn his physician of the risks of Levaquin related to tendon injuries. Schedin sought both compensatory and punitive damages. He also alleged violations of Minnesota's Consumer Fraud Act. See Minn.Stat. § 325F.69. On December 8, 2010, a jury found for Schedin on his failure to warn claim—awarding him compensatory damages of $700,000 and punitive damages of $1,115,000. (Docket Nos. 183, 184.) The jury found for Ortho–McNeil on the consumer fraud claim.

ANALYSIS

I. DUTY TO WARN AFTER MENSING

As an initial matter, Ortho–McNeil submitted a letter to the Court arguing that the Supreme Court decision in Mensing, issued after briefing on the instant motions, should dictate the outcome of these motions. (Docket No. 257.) Mensing discussed pre-emption in the context of prescription drugs. Pre-emption is the application of the Supremacy Clause of the U.S. Constitution,² 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 Prods. Liab. Litig., No. 01–MDL–1396, 2004 WL 45503, at *5 (D.Minn. Jan. 05, 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)). Express pre-emption is not at issue in this case.

However, where Congress has not expressly pre-empted state law, a court will infer implied pre-emption “where it is impossible for a private party to comply with both state and federal law, and where under the circumstances of a particular case, the challenged state law stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.” Crosby v. Nat. Foreign Trade Council, 530 U.S. 363, 372–73, 120 S.Ct. 2288, 147 L.Ed.2d 352 (2000) (alterations, citations, and internal quotation marks omitted). Therefore, “a conflict arises when compliance with both federal and state regulations is a physical impossibility....” Automated Med. Labs., Inc., 471 U.S. at 713, 105 S.Ct. 2371 (internal quotations omitted). “Impossibility pre-emption is a demanding defense.” Wyeth v. Levine, 555 U.S. 555, 129 S.Ct. 1187, 1199 (2009).

The Mensing Court held that a generic drug manufacturer meets the burden of impossibility pre-emption for state failure to warn claims by showing that it could not “independently satisfy those state duties” due to its position in the Food and Drug Administration's (“FDA”) regulatory scheme. Mensing, 131 S.Ct. at 2581. Under Mensing, Ortho–McNeil argues Schedin's claims against it are pre-empted since they required “independent action” by the FDA. This “independent action” standard of Mensing, however, is not controlling for several reasons.

First, the Supreme Court noted that its finding of impossibility pre-emption of state law failure to warn claims for generic manufacturers did not apply to brand-name manufacturers. Rather, the Mensing Court explicitly affirmed its previous ruling in Wyeth that failure to warn claims against brand-name manufacturers are not pre-empted.³ Mensing, 131 S.Ct. at 2581 (“We recognize that from the perspective of [plaintiffs], finding pre-emption here but not in Wyeth makes little sense. Had [plaintiffs] taken ... the brand-name drug prescribed by their doctors, Wyeth would control and their lawsuits would not be pre-empted.”) (emphasis added). Since Levaquin is a brand-name drug, the pre-emption analysis of Wyeth, not Mensing, controls.

Secondly, the manner in which the Mensing Court defined the duty of generic manufacturers—to maintain exactly the same label as the brand-name product—implies a heightened duty for brand-name manufacturers since the brand-name manufacturers are the only entities that ever would be able to initiate a label change during the relevant time periods. In both Wyeth and Mensing, as in the instant case, the FDA regulations at the time of the contested prescription did not empower the FDA to require label changes of manufacturers. See Mensing, 131 S.Ct. at 2588 n. 9 (Sotomayor, J., dissenting). In 2007, the FDA was given that authority. Pub. L. 110–85, § 901, 121 Stat. 924–26. However, under the pre–2007 statutory framework applicable to Wyeth, Mensing, and this case, a brand-name manufacturer was the only entity in the trifecta of actors (the FDA, the brand-name manufacturer, and the generic) that could strengthen an inadequate label. ⁴

Congress and the FDA have always been clear, however, that they want warnings strengthened when necessary. The FDA requires that warnings “shall describe adverse reactions and potential safety hazards [and] limitations in use imposed by them....” 21 C.F.R. § 201.57(e) (2001). Manufacturers are required to develop post-market risk identification and analysis systems. 21 U.S.C. § 355(k). Furthermore, since risks associated with a drug may accumulate over time, manufacturers

must keep records of clinical experiences ... [,] record and report certain adverse events to FDA, and must also annually report a “summary of significant new information from the previous year that might affect the safety, effectiveness, or labeling of the drug product” and a “description of actions the applicant has taken or intends to take as a result of this new information.”

Brief for the Unites States as Amicus Curiae Supporting Respondents at *5–6, Mensing, 131 S.Ct. 2567 (Nos. 09–993, 09–1039, 09–1501), 2011 WL 741927 (2011)[hereinafter “U.S. Amicus Brief”] (citing various applicable FDA regulations).

Unlike these clear mandates applicable primarily to brand-name manufacturers, the Mensing Court found the FDA regulations only empowered a generic manufacturer to ask the FDA to ask the brand-name manufacturer to change the label. Since “requesting FDA assistance would have satisfied the [generic m]anufacturers' federal duty [to advise the FDA of adverse events, but] would not have satisfied their state tort-law duty to provide adequate labeling [,]” claims premised on the manufacturers' failure to make such a request were pre-empted. Mensing, 131 S.Ct. at 2578. Brand-name manufacturers under the FDA's pre–2007 regime, however, did not face the same constraints since they could strengthen a label without prior FDA approval. “It is beyond dispute that the federal statutes and regulations that apply to brand-name drug manufacturers are meaningfully different...