In re Baycol Products Litigation

• Citation: 596 F.3d 884
• Decision Date: 03 March 2010
• Docket Number: No. 08-3524.,08-3524.
• Parties: In re BAYCOL PRODUCTS LITIGATION. David Flesner, Appellant, v. Bayer AG; Bayer Corporation, a wholly owned subsidiary of Bayer AG; SmithKline Beecham Corporation, doing business as GlaxoSmithKline PLC, doing business as GlaxoSmithKline, Appellees.
• Court: U.S. Court of Appeals — Eighth Circuit

596 F.3d 884 In re BAYCOL PRODUCTS LITIGATION.
David Flesner, Appellant,
v.
Bayer AG; Bayer Corporation, a wholly owned subsidiary of Bayer AG; SmithKline Beecham Corporation, doing business as GlaxoSmithKline PLC, doing business as GlaxoSmithKline, Appellees. No. 08-3524. United States Court of Appeals, Eighth Circuit. Submitted: October 22, 2009. Filed: March 3, 2010.

[596 F.3d 886]

Wendy R. Fleishman, argued, Annika K. Martin, New York, NY, Heather A. Foster, Elizabeth J. Cabraser, San Francisco, CA, on the brief, for appellant.

Philip S. Beck, argued, Adam Hoeflich, Susan A. Weber, Catherine Valerio Barrad, Chicago, IL, Peter W. Sipkins, Minneapolis, MN, Fred T. Magaziner, Michael Thomas Manuel, Philadelphia, PA, on the brief, for appellees.

Before LOKEN, Chief Judge, HANSEN and MELLOY, Circuit Judges.

MELLOY, Circuit Judge.

This is a failure-to-warn case involving the prescription drug Baycol, a cholesterol-reducing medication. The case comes to us after the district court¹ granted Bayer's motion for summary judgment on Flesner's claims for strict liability, negligence, express and implied warranty, and unjust enrichment. On appeal, our decision focuses on whether the district court abused its discretion in finding that Flesner failed to present competent expert testimony on medical causation, requiring entry of summary judgment. We also address whether the district court abused its discretion in striking, as untimely, Flesner's supplemental expert report. For the following reasons, we affirm the judgment of the district court on both issues.

I.

Cerivastatin, marketed under the brand name Baycol, is a prescription cholesterol-reducing medication manufactured by Appellees Bayer AG and its subsidiary Bayer Corporation and marketed by Appellees Bayer and GlaxoSmithKline. Baycol is a member of a class of drugs called statins. Doctors routinely prescribe statins to lower the lipid levels of patients diagnosed with high cholesterol, with the goal of decreasing the risk of heart disease and stroke. In August 2001, Bayer withdrew Baycol from the market after a number of deaths were linked to Baycol use and reports suggested a link between Baycol and myopathy.²

After Bayer withdrew Baycol from the market, plaintiffs throughout the country commenced lawsuits asserting various claims, including strict liability, negligence, breach of express and implied warranty, medical monitoring, and unjust enrichment. Due to the number of lawsuits initiated, the Judicial Panel on Multidistrict

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Litigation consolidated plaintiffs' cases in the District of Minnesota under 28 U.S.C. § 1407. See In re Baycol Prods. Liab. Litig., 180 F.Supp.2d 1378, 1380 (J.P.M.L. 2001). Among those plaintiffs is Appellant, David Flesner.

Flesner, a sixty-seven-year-old California resident, has been treated by his primary-care physician, Dr. Milan Brandon, since 1969. Flesner first sought treatment for back and neck pain when Dr. Brandon treated him for an on-the-job injury in 1988. Dr. Brandon prescribed a variety of medications to treat this pain. Flesner also received chiropractic treatment from Dr. Robert McPherson, beginning in August 2000, when Flesner suffered an injury from being hit by a tree branch and began to suffer neck and back pain. Dr. Gary Miller later took over chiropractic treatment for Flesner's back and neck pain.

Flesner's experience with statins began in November 1999 when Dr. Brandon prescribed Zocor, and later Provachol, after diagnosing Flesner with high cholesterol. In February 2001, after weighing the risks and benefits associated with the medication, Dr. Brandon prescribed Baycol to Flesner. On March 15, 2001, Flesner complained to Dr. Miller about "general body fatigue and pain, with specific complaints of severe pain in his lower back, hips, and legs." During the same month, Flesner requested that Dr. Brandon renew his Baycol prescription. Dr. Brandon complied.

Flesner continued to express concern about muscle pain to Dr. Miller though May 2001. In late May 2001, Flesner complained in a note to Dr. Brandon about pain in his lower back and groin and dark red blood in his urine. Dr. Brandon informed Flesner that a kidney stone was the likely cause of these symptoms. Flesner continued to complain to his doctors about this pain through June and July 2001.

In August 2001, after taking Baycol for nearly five months, Flesner discontinued his use of Baycol after reading in a newspaper article that Bayer had withdrawn Baycol from the market. Continuing to experience muscle pain and fatigue, Flesner sent a letter to Dr. Brandon in which he hypothesized that Baycol was causing his symptoms. On August 13, 2001, Dr. Brandon performed a blood test, which indicated that Flesner's creatine kinase ("CK")³ levels were slightly above normal—Flesner's CK level was 234; up to 200 is considered normal. Dr. Brandon informed Flesner that his elevated CK level was consistent with Flesner's suspicion that Baycol was the cause of his symptoms, but that "[a]ny pains related to Baycol should have long passed." Since discontinuing Baycol treatment, Flesner has had four CK tests, three of which have been outside of the normal range.

In July 2002, Flesner filed suit in the Southern District of California, alleging that, due to inadequate warnings, Baycol caused the various symptoms he suffered and continues to suffer. He asserted five claims under California law: (1) strict liability; (2) negligence; (3) breach of express warranty; (4) breach of implied warranty; and (5) unjust enrichment.

As a part of the consolidated Baycol litigation, Flesner's case was transferred from the Southern District of California to the District of Minnesota. Bayer subsequently brought a number of Daubert⁴ motions to exclude expert testimony. See generally, In re Baycol Prods. Litig., 532

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F.Supp.2d 1029 (D.Minn.2007). As it pertains to Flesner, the district court barred plaintiffs' experts Dr. Samuel Mayer and Dr. Stephen Raskin from testifying that Baycol was more toxic than other statins. Id. at 1047, 1068. In addition, the district court barred Dr. Mayer from testifying as to Baycol's long-term effects. Id. at 1048-51. Finally, the court barred Dr. Raskin from testifying as to the sufficiency of the Baycol warning label. Id. at 1068-69.

Three weeks after the district court's Daubert opinion, seven months after Dr. Mayer's deposition, and nearly a year after the court-imposed deadline for submission of case-specific discovery, Flesner submitted a supplemental expert report from Dr. Mayer. Bayer filed a motion to strike Dr. Mayer's supplemental report as untimely. The district court granted the motion to strike, finding that Flesner could not show good cause for the late submission and that Bayer would be prejudiced by the admission of Dr. Mayer's supplemental report. In the same opinion, the district court granted Bayer's motion for summary judgment on each of Flesner's claims. Flesner appeals both of these rulings. We affirm.

II.

District courts have broad discretion in establishing and enforcing deadlines and in maintaining compliance with discovery and pretrial orders. See Marmo v. Tyson Fresh Meats, Inc., 457 F.3d 748, 758-59 (8th Cir.2006). We review a district court's ruling only for "clear and prejudicial abuse of discretion." Wegener v. Johnson, 527 F.3d 687, 690 (8th Cir.2008). In this case, there is no question that Dr. Mayer's supplemental report was late— Flesner submitted the report nearly a year after the court-imposed deadline. The question is whether he was justified in doing so.

Flesner's only proffered reason for the delay was that Dr. Mayer "reviewed the records of Mr. Flesner in greater detail." This explanation is insufficient, as there is nothing in the record to indicate that Dr. Mayer could not have reviewed Flesner's records in detail at the time of his initial report. See id. at 693 ("[Plaintiff's] failure to exercise due diligence with respect to her expert's review of relevant medical records ... does not substantially justify her untimely disclosure."). In addition, it is not unreasonable to conclude that Bayer would be prejudiced by Flesner's late submission, given that Bayer had already deposed Dr. Mayer and moved for summary judgment based on his initial report and deposition. See Marmo, 457 F.3d at 760; accord Trost v. Trek Bicycle Corp., 162 F.3d 1004, 1008-09 (8th Cir. 1998) (stating that because defendant had prepared its summary judgment motion, in part, on initial disclosure of expert-witness testimony, the district court did not abuse its discretion in excluding plaintiff's untimely disclosed expert). For these reasons, the district court did not abuse its discretion.

III.

"We review the district court's grant of summary judgment de novo and may affirm on any basis supported by the record." Tenge v. Phillips Modern Ag. Co., 446 F.3d 903, 906 (8th Cir.2006). Summary judgment is appropriate when the evidence, viewed in the light most favorable to the nonmoving party, demonstrates "that there is no genuine issue as to any material fact and that the movant is entitled to judgment as a matter of law." Fed.R.Civ.P. 56(c); Henerey v. City of St. Charles, Sch. Dist., 200 F.3d 1128, 1131 (8th Cir.1999). "[T]he plain language of Rule 56(c) mandates the entry of summary judgment, after adequate time for discovery and upon motion, against a party who fails to make a showing sufficient to establish

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the existence of an element essential to that party's case, and on which that party will bear the burden of proof at trial." Celotex Corp. v. Catrett, 477 U.S. 317, 322, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986). We review for abuse of discretion the district court's decision to exclude expert testimony for purposes of determining whether there exists an issue of material fact. Gen. Elec. Co. v. Joiner, ...