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In re Norplant Contraceptive Products Liab. Lit.
Christopher Matthew Parks, Parker & Parks, Port Arthur, TX, for Plaintiffs.
F. Lane Heard III, Williams & Connolly, Washington, DC, for Defendants.
Pending before the court is "Wyeth's Motion For Partial Summary Judgment Re The Learned Intermediary Doctrine/Causation," filed by Defendants American Home Products Corporation, Wyeth-Ayerst Laboratories, Inc., and Wyeth Laboratories, Inc. (collectively "Defendants"), on May 25, 1999 (Dkt.# 712, 713).1 A response was filed on behalf of Plaintiffs represented by the law firms of Provost ★ Umphrey and Ness, Motley, Loadholt, Richardson & Poole on May 12, 2000 (Dkt.# 747). Additionally, a number of Plaintiffs filed individual responses,2 while some Plaintiffs individually filed joinders to the response filed by Provost ★ Umphrey, and Ness, Motley, Loadholt, Richardson & Poole, adopting at least some of the arguments made therein.3 Defendants filed a reply in support of their motion on June 16, 2000 (Dkt.# 758) and a supplemental reply on August 10, 2000 (Dkt.# 762). Defendants contend that they are entitled to partial summary judgment because the learned intermediary doctrine shields them from liability for most of Plaintiffs' claims.
Also pending is "Wyeth's Motion For Partial Summary Judgment Re Conditions For Which There Is No Evidence Of Causation" (Dkt.# 716, 717), filed on May 25, 1999.4 Once again, Plaintiffs represented by Provost ★ Umphrey and Ness, Motley, Loadholt, Richardson & Poole filed a joint response (Dkt.# 752), and several Plaintiffs' responded individually. On June 16, 2000, Defendants replied to the responses (Dkt.# 760). Upon careful consideration of the parties' submissions in light of the applicable law, the court finds that Defendants' motion for partial summary judgment regarding the learned intermediary doctrine should be GRANTED in part and DENIED in part. Defendants' motion for partial summary judgment regarding conditions for which there is no evidence of causation should be GRANTED.5
This is a multidistrict products liability action involving the Norplant prescription contraceptive device manufactured by Defendants. In 1991, Defendants introduced Norplant to the market after more than two decades of research and development. Norplant is a long term, reversible birth control device that consists of six plastic capsules. See Fact Sheet: Norplant and You (Planned Parenthood Federation of America, Inc., New York, N.Y.), Jan. 1997, at 1, available at, http://www.plannedparenthood.org/birth-control/norplant.htm.
Each of these capsules contains the synthetic hormone levonorgestrel. Id. The capsules are implanted below the skin of a woman's upper arm and, while implanted, constantly release a small dose of levonorgestrel into the blood stream. Id. Levonorgestrel prevents pregnancy by keeping the ovaries from releasing eggs, thickening the cervical mucus, and deterring sperm from joining with an egg. Id. Statistics show Norplant to be a highly effective method of birth control: fewer than four out of 100 women who use Norplant for five years will become pregnant. Id. at 2.6
Central to all claims of each Plaintiff in this litigation is the assertion that Defendants failed to adequately warn consumers and their prescribing physicians or healthcare providers about the dangerous side effects associated with Norplant. In their motion for partial summary judgment regarding the learned intermediary doctrine, Defendants seek summary judgment against all Plaintiffs claiming to have suffered any of the 26 primary side effects listed in the "Adverse Reactions" section of Norplant's physician labeling.7 Defendants contend that, even if their labeling is shown to be inadequate, the learned intermediary doctrine requires Plaintiffs to put on evidence showing that the inadequate warnings proximately caused their alleged injuries, and they have failed to do so.
Defendants also move for partial summary judgment against all Plaintiffs who have allegedly suffered any side effect other than the 26 listed as "Adverse Reactions" in Norplant's labeling. Plaintiffs collectively allege more than 950 other side effects (hereinafter "exotic conditions").8 In short, Defendants argue that summary judgment as to the exotic side effects is proper because Plaintiffs, who have the burden to prove causation, have not come forward with any scientifically reliable evidence on general causation.
While the extensive facts of this case are well documented in other orders and opinions and need not be fully recounted here, a brief overview of the procedural history is in order. Beginning in 1994, thousands of lawsuits were filed against Defendants in state and federal courts throughout the nation. Pursuant to 28 U.S.C. § 1407, the Judicial Panel on Multidistrict Litigation transferred all federal Norplant cases to this court for consolidated pretrial handling on December 6, 1994. 28 U.S.C. § 1407(a) (). Once transferred to this court, Plaintiffs sought certification of a nationwide class of all persons who have suffered or may suffer injury as a result of using Norplant. The court denied that motion as premature on August 5, 1996, finding that bellwether trials were needed to assess the propriety of certifying such a class under Rule 23(b)(3) of the Federal Rules of Civil Procedure.
After several Plaintiffs were selected for the first of three bellwether trials and the parties had completed discovery, Defendants moved for summary judgment on the basis of the learned intermediary doctrine. Similar to the instant motion concerning the learned intermediary doctrine, Defendants argued that the doctrine required them to warn only Plaintiffs' prescribing physicians about the dangerous propensities of Norplant, not each individual patient, and that there was no evidence that Defendants had failed to adequately do so or that their allegedly inadequate physician warnings were the producing cause of Plaintiffs' injuries. In re Norplant Contraceptive Prod. Liab. Litig., 955 F.Supp. 700, 702-03 (E.D.Tex.1997), aff'd, 165 F.3d 374 (5th Cir.1999). The court found that the learned intermediary doctrine did indeed apply to the bellwether Plaintiffs' claims whether asserted under a theory of strict products liability, negligence, breach of implied warranty of merchantability, misrepresentation, or consumer fraud under the Texas Deceptive Trade Practices Act ("DTPA")...
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