Schedin v. Ortho–Mcneil–Janssen Pharms., Inc. (In re Levaquin Prods. Liab. Litig.)

• Decision Date: 23 January 2013
• Docket Number: No. 11–3117.,11–3117.
• Citation: 700 F.3d 1161
• Parties: In re LEVAQUIN PRODUCTS LIABILITY LITIGATION. John Schedin, Plaintiff–Appellee v. Ortho–McNeil–Janssen Pharmaceuticals, Inc., Defendant–Appellant.
• Court: U.S. Court of Appeals — Eighth Circuit

700 F.3d 1161

In re LEVAQUIN PRODUCTS LIABILITY LITIGATION.

John Schedin, Plaintiff–Appellee

v.Ortho–McNeil–Janssen Pharmaceuticals, Inc., Defendant–Appellant.

No. 11–3117.

United States Court of Appeals,

Eighth Circuit.

Submitted: May 17, 2012.

Decided: Nov. 30, 2012.

Rehearing and Rehearing En Banc Denied Jan. 23, 2013.^*

Charles Lifland, argued, Los Angeles, CA, Tracy Joan Van Steenburgh, Dana M. Lenahan, Minneapolis, MN, John Dames, Chicago, IL, Cynthia Ann Merrill, Los Angeles, CA, on the brief, for appellant.

Charles M. Wolfson, argued, New York, NY, Ronald S. Goldser, Minneapolis, MN, Lewis J. Saul, New York, NY, on the brief, for appellee.

Before RILEY, Chief Judge, BYE and MELLOY, Circuit Judges.

RILEY, Chief Judge.

In 2005, John Schedin suffered Achilles tendon ruptures while taking the drug Levaquin, which Ortho–McNeil–Janssen Pharmaceuticals, Inc. (OMJP) markets in the United States. Schedin sued OMJP and others for failing to warn adequately of the risk of tendon rupture in patients who, like Schedin, are elderly and taking concomitant corticosteroids. A jury found OMJP primarily liable, awarding Schedin compensatory and punitive damages. OMJP appeals the district court's denials of its motions for judgment as a matter of law (JMOL) and a new trial. We affirm in part and reverse in part.

I. BACKGROUNDA. Factual Background

Levofloxacin is a fluoroquinolone antibiotic OMJP marketed in the United States under the brand name Levaquin.¹ In February 2005, Dr. John Beecher prescribed both Levaquin and a corticosteroid to Schedin, who was then seventy-six years old. Schedin suffered a rupture of his left Achilles tendon and a partial tear of his right Achilles tendon after taking the drug combination.

At that time, Levaquin's package insert warned, in relevant part:

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

The warning had been largely in this form since 2001, when OMJP voluntarily added the second sentence. In 2004, the United States Food and Drug Administration (FDA) made this language mandatory for all fluoroquinolones. ²

The Levaquin package insert consisted of over fifteen pages of small print information about the drug, including its proper use and possible side effects. The tendon warning appears in the last of the ten paragraphs in the “Warnings” section. The package insert also contained sections titled “Contraindications,” “Precautions,” and “Adverse Reactions,” among others. The tendon warning from Levaquin's package insert also appeared in the Physicians' Desk Reference (PDR), a common medical publication that contains label information about numerous drugs.

The tendon warning remained largely unchanged between 2001 and 2008. In 2008, the FDA sent OMJP a letter directing OMJP to set off Levaquin's tendon warning in a black box because the 2001 warning was inadequate (2008 letter). In the 2008 letter, the FDA expressed concern about the large number of adverse event reports about tendon injuries it continued to receive, despite the tendon warnings required for fluoroquinolones as a class. The FDA concluded, based upon its new analysis of such reports, “the current Levaquin labeling does not adequately warn healthcare providers and patients.” OMJP had access to all adverse event reports relating to Levaquin.

In 2002, the United Kingdom Medicines Control Agency (MCA) issued a report linking Levaquin to a greater incidence of tendon injuries than other fluoroquinolones. The MCA recommended reviewing data from the United States to determine whether that data supported this conclusion. An OMJP affiliate sponsored a study (Ingenix study) in 2002 that concluded Levaquin did not materially increase the risk of tendon rupture more than other fluoroquinolones.

In addition to package inserts, drug companies communicate with physicians about their products using the PDR, in-person visits by sales representatives, “Dear Doctor” letters sent to individual physicians, and other methods. One article suggested properly worded and highly publicized “Dear Doctor” letters may contribute to reducing undesirable prescribing practices.

Dr. Beecher testified he learns about drug side effects from package inserts, a summary of the PDR, medical literature, sales representatives, and his colleagues. Dr. Beecher testified he prescribes 250 to 300 drugs in his practice and does not have enough time to check all package inserts for changes to the warnings. He reported relying on sales representatives “only minimally,” saying he “probably relie[s] on drug reps more than [he] think[s],” but tries “very hard to be objective.” Dr. Beecher noted he would have appreciated having more knowledge about the risk of prescribing Levaquin and a corticosteroid together.

Though Dr. Beecher knew of the risk of tendon rupture associated with Levaquin, he did not read and was not aware of the 2001 warning, regarding elderly patients taking corticosteroids, when he prescribed Levaquin to Schedin. OMJP did not send a “Dear Doctor” letter about the 2001 warning, and there is no evidence OMJP's sales representatives attempted to communicate that warning personally to Dr. Beecher. Monica Sadar, an OMJP sales representative who visited Dr. Beecher several times per year, testified (1) her practice was “to discuss package insert changes with all practitioners,” but she did not specifically remember discussing the 2001 warning with Dr. Beecher; (2) her notes from meetings with Dr. Beecher do not indicate such a discussion; and (3) the Levaquin sales aids she used did not mention the risk of tendon rupture.

Dr. Beecher testified he would not have prescribed Levaquin to Schedin if he had known about the 2001 warning or what he knows now. Dr. Beecher also stated he no longer prescribes Levaquin unless a patient specifically requests it.

B. Procedural History

Schedin sued OMJP in federal district court, properly invoking the court's diversity jurisdiction. See28 U.S.C. § 1332. Schedin alleged he was injured by OMJP's failure to warn Schedin and Dr. Beecher sufficiently about the risk of tendon rupture in elderly patients taking Levaquin and concomitant corticosteroids.³ Schedin claimed OMJP negligently failed to (1) take adequate steps to alert doctors to the information in the 2001 warning, and (2) warn of Levaquin's tendon toxicity relative to other fluoroquinolones.

After a jury found OMJP primarily liable, awarding Schedin compensatory damages of $630,000 (after reducing the overall assessment of damages by 15% due to Dr. Beecher's contributing fault) and punitive damages of $1,115,000, OMJP moved for JMOL and a new trial. OMJP appeals from the district court's denial of OMJP's motions. We have jurisdiction under 28 U.S.C. § 1291.

II. DISCUSSIONA. Applicable Law and Standard of Review

We apply Minnesota law to Schedin's failure-to-warn claim. ⁴See Winthrop Res. Corp. v. Stanley Works, 259 F.3d 901, 904 (8th Cir.2001) (“As a federal court sitting in diversity jurisdiction, we apply the law that the forum state would apply.”). In addition, “[w]hen federal jurisdiction is premised on diversity of citizenship, a federal district court applies the sufficiency standards of the state in which it sits,” in this case Minnesota. Carpenter v. Auto. Club Interinsurance Exch., 58 F.3d 1296, 1301 (8th Cir.1995).

A district court must grant JMOL if “there is no legally sufficient evidentiary basis for a reasonable jury to find for [the non-moving] party.” Minn. R. Civ. P. 50.01(a); seeMinn. R. Civ. P. 50.02 (concerning renewed motions for judgment as a matter of law). We review de novo the district court's denial of JMOL. See Weber v. Strippit, Inc., 186 F.3d 907, 912 (8th Cir.1999).

The standard for granting a new trial is “less rigorous than the standard for granting” JMOL. Clifford v. Geritom Med, Inc., 681 N.W.2d 680, 687 (Minn.2004). A new trial is merited when “the verdict is so contrary to the preponderance of the evidence as to imply that the jury failed to consider all the evidence, or acted under some mistake.” Id. (quoting LaValle v. Aqualand Pool Co., 257 N.W.2d 324, 328 (Minn.1977)) (internal marks omitted); see also Minn. R. Civ. P. 59.01(g). We review the district court's denial of “a new trial for a clear abuse of discretion.” Harrison v. Purdy Bros. Trucking Co., 312 F.3d 346, 351 (8th Cir.2002) (quoting Duty v. Norton–Alcoa Proppants, 293 F.3d 481, 495 (8th Cir.2002)) (internal quotation marks omitted).

B. Failure to Warn

Schedin presents two theories of failure-to-warn liability, alleging OMJP negligently failed to (1) use adequate means to inform Dr. Beecher of the 2001 warning against use of Levaquin with elderly patients on corticosteroids, and (2) include comparative tendon toxicity information in the package insert. Because OMJP was not entitled to JMOL or a new trial in light of Schedin's first theory, we need not address whether the district court erred in denying OMJP's motions based upon Schedin's comparative toxicity theory because any such error was harmless—Schedin was entitled to compensatory damages based on the first theory, even if the district court erred as to the comparative toxicity theory. Cf. Thomlison v. City of Omaha, 63 F.3d 786, 791 (8th Cir.1995) (determining any error in granting JMOL on certain claims was harmless where the “the district court's judgment [on plaintiff-appellant's other claim] preserved her full monetary and other relief”).

A plaintiff asserting a negligent failure-to-warn claim under Minnesota law “must show: (1) the defendant[ ] had reason to know of the dangers of using the product; (2) ‘the warnings fell short of those reasonably required,’ breaching the duty of care; and (3) the...