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IN RE REZULIN PRODUCTS LIABILITY LITIGATION

August 13, 2004.

In re: REZULIN PRODUCTS LIABILITY LITIGATION (MDL No. 1348). This Document Relates to: 01 Civ. 3458, 01 Civ. 3459, 01 Civ. 3460, 02 Civ. 1721, 02 Civ. 1723, 02 Civ. 8395.


The opinion of the court was delivered by: LEWIS KAPLAN, District Judge

MEMORANDUM OPINION

Plaintiffs in these actions seek damages for personal injuries allegedly sustained as a result of their use of the prescription diabetes medication Rezulin. Although the complaints assert numerous claims, the defendants contend that all properly are construed as seeking recovery for failure to warn of Rezulin's side effects.*fn1 Plaintiffs do not contest this characterization.*fn2 Defendants Warner-Lambert Co. and Pfizer, Inc., move for summary judgment dismissing the complaints on the grounds that there are no genuine issues of material fact with respect to the adequacy of the Rezulin warnings as to the specific injuries alleged by these plaintiffs. In addition, they seek judgment as a matter of law as to certain claims on the additional basis that there is no issue of fact as to general causation.

  All six cases originally were brought in state courts — three in Mississippi*fn3 and three others in Texas*fn4 — and then, following removal, were transferred here by the Judicial Panel on Multidistrict Litigation. The Texas plaintiffs have submitted a joint opposition to the motion, while the Mississippi plaintiffs have defaulted.

  I. Adequacy of Warnings

  A. Facts

  Insofar as is relevant here, plaintiffs claim that they were injured by ingestion of Rezulin and that the manufacturer defendants failed adequately to warn them of the drug's alleged adverse effects. Defendants rejoin that the injuries claimed by these plaintiffs are among the possible side effects of the drug concerning which their warnings were entirely adequate. It is appropriate therefore to begin by identifying the nature of the claimed injuries.

  As explained in greater detail in a recent opinion, familiarity with which is assumed, each of plaintiffs was required to complete a Fact Sheet under oath, detailing among other things the nature of the plaintiff's alleged injuries. The responses are treated as interrogatory answers.*fn5 The injuries claimed in their Fact Sheet responses by the plaintiffs to whom this motion is directed are "severe headaches" and "dizziness,"*fn6 "headaches" and "dizziness,"*fn7 "dizziness," "headaches," "diarrhea,"*fn8 "nausea,"*fn9 "swelling in the feet" (i.e., edema) and "pain in the body,"*fn10 and "pain in the right side near the ribs."*fn11 Defendants' Rule 56.1 Statement asserted, on the basis of these responses, that these were the claimed injuries. Plaintiffs submitted no adequate response to that statement.*fn12 The factual assertions set forth in Defendants' Rule 56.1 Statement therefore are deemed true for purposes of the motion, thus establishing that the only injuries complained of are those set forth in the Fact Sheet responses.

  It is further uncontroverted that each of the injuries claimed by these six plaintiffs was identified as a potential side effect of Rezulin in a table in the Physicians' Desk Reference under the heading ADVERSE REACTIONS, which summarized side effects observed in patients who participated in Rezulin clinical trials.*fn13 For each side effect, including the six here alleged, the table reported the rate of occurrence observed, respectively, in the placebo and Rezulin patient trial groups:
Adverse Effect Placebo (n=492) Rezulin (n=1450)
Nausea 4 6
Dizziness 5 6
Headache 11 11
Peripheral Edema 5 5
Pain 14 10
Diarrhea 6 5
  Accordingly, physicians were warned of these potential side effects of Rezulin. The only issue is whether the warnings were adequate.

  B. Discussion

  1. The Learned Intermediary Doctrine

  These are diversity actions in which the substantive issues are governed by state law. The parties agree that Mississippi law applies to the claims in Sanders, Maxwell and Grayer and that Texas law governs the claims in Barnes, Adams and Allen.

  The pertinent standards are substantially similar. Both states recognize the learned intermediary doctrine in pharmaceutical products liability cases. A manufacturer's duty to warn of possible side effects runs to the prescribing physician, not to the patient.*fn14 A plaintiff in a prescription drug failure to warn case therefore has the burden of proving that (1) the warning to the physician was defective, and (2) the inadequate warning proximately caused the plaintiff's injury, i.e., that adequate warnings would have persuaded the physician not to prescribe the drug in question.*fn15

  2. The Texas Claims

  Under Texas law, the adequacy of a warning usually is a question of fact for a jury.*fn16 In appropriate cases, however, a warning may be held adequate as a matter of law and the issue resolved on summary judgment.*fn17 In Rolen, for example, the Texas Court of Appeals held that "if a warning specifically mentions ...


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