In re Meridia Products Liability Litigation

Citation328 F.Supp.2d 791
Decision Date07 July 2004
Docket NumberNo. 5:02-CV-8000.,5:02-CV-8000.
CourtUnited States District Courts. 6th Circuit. United States District Court of Northern District of Ohio
328 F.Supp.2d 791
No. 5:02-CV-8000.
United States District Court, N.D. Ohio.
July 7, 2004.

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Caroline Catchings Donlon, Law Offices of Daniel E. Becnel, Jr., Reserve, LA, Christina M. Janice, John R. Climaco, Scott D. Simpkins, Climaco Lefkowitz Peca Wilcox & Garofoli, Cleveland, OH, Daniel E. Becnel, Jr., Reserve, LA, Donald F. Hildre, Thomas D. Haklar, Dougherty, Hildre, Dudek & Haklar, San Diego, CA, Jane H. Walker, Jean M. Geoppinger, Louise M. Roselle, Stanley M. Chesley, Waite, Schneider, Bayless & Chesley, Cincinnati, OH, Dianne M. Nast, Roda & Nast, Lancaster, PA, for Plaintiff.

Anne M. Kordas, Tucker Ellis & West, Cleveland, OH, for Defendant.

Leon B. Taranto, Schmeltzer, Aptaker & Shepard PC, Washington, DC, for Movant.

MEMORANDUM AND OPINION, [Resolving Doc. No. 232, 240, 266, 299, 302]

GWIN, District Judge.

On December 5, 2003, Abbott Laboratories, Abbott Laboratories International Co., Abbott Laboratories Inc., and Knoll Pharmaceutical Co. (collectively "Pharmaceutical Defendants" or "Defendants") moved the Court for summary judgment in the present matter. [Doc. 232] On January 12, 2004, Plaintiffs responded, opposing the motion. [Doc. 264] Defendants replied on January 26, 2004. [Doc. 270]

In a related matter, Defendants move the Court for an order striking the affidavit of Keith Altman [Docs. 266, 269, 280, 299, 302] and for an order excluding Plaintiffs' expert witnesses. [Docs. 240, 261, 271]

For the reasons described below, the Court GRANTS, in part, Defendants' motion to exclude the expert testimony of Arnold Schwartz, Ph.D. and DENIES as moot Defendants' motion to strike the affidavit of Keith Altman. Ultimately, the Court GRANTS Defendants' motion for summary judgment as to all of Plaintiffs' claims against the Pharmaceutical Defendants.


This action, consolidated for pretrial proceedings by the Judicial Panel on Multidistrict Litigation, involves the diet drug Meridia (a.k.a., Sibutramine Hydrochloride Monohydrate). With their actions, Meridia Plaintiffs allege that their use of Meridia caused cardiovascular and cerebrovascular injuries. The claimed injuries include heart attack, stroke, tachycardia,1 heart palpitations, chest pain, high blood pressure, hypertension, and death. While Plaintiffs do not describe their injuries in detail, some Plaintiffs allege that their injuries are "serious and permanent." See e.g., Outlaw v. Abbott Labs., Inc., 5:04-cv-8001, compl. at ¶ 29. Other Meridia Plaintiffs allege that the drug was ineffective for weight loss or that they are at increased risk for developing future injury as a result of their ingestion of Meridia.

Abbott Laboratories manufactures, markets, and distributes Meridia within the United States. Before being absorbed by

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Abbott, Defendant Knoll Pharmaceuticals Co. did the same. In this action, the Meridia Plaintiffs sued Knoll Pharmaceutical Co. ("Knoll"), Abbott Laboratories ("Abbott"), BASF Aktiengesellschaft ("BASF AG"), BASF Corp., and SmithKline Beecham Corp., doing business as GlaxoSmithKline.2 With their amended complaint, the Meridia Plaintiffs state claims for strict product liability, negligence, negligence per se, violation of state consumer protection statutes, breach of express and implied warranties, and medical monitoring. The Meridia Plaintiffs seek to recover damages for deaths and personal injury, refunds, restitution, and equitable relief.

Meridia acts as an anti-obesity medication by slowing the body's dissipation of serotonin, a brain chemical associated with satiety, and norepiniphrine. Around 1980, Boots Pharmaceuticals developed Meridia as an anti-depressant, but never applied for FDA approval as an obesity medication. Boots Pharmaceuticals sold the drug formulation to Knoll. In 1990, Knoll began specifically testing Meridia as a diet drug. On November 22, 1997, the FDA approved the marketing of Meridia in the United States as a diet drug, at dosages of 5, 10, and 15 milligrams. Knoll began marketing Meridia through pharmacies in February 1998. On March 2, 2001, Abbott Laboratories acquired Knoll Pharmaceuticals.

According to Plaintiffs, between November 22, 1997 and September 30, 2000, the FDA received 397 complaint reports from people using Meridia. Those complaints included reports of 152 hospitalized patients and 29 deaths, with 19 of those deaths from cardiovascular causes. On March 19, 2002, the consumer watchdog group Public Citizen petitioned the FDA to remove Meridia from the market.

Litigation followed in both state and federal courts. Responding to the state court actions, Abbott removed a large number of actions to federal court, principally based upon diversity jurisdiction. On August 15, 2002, the Judicial Panel on Multidistrict Litigation ("the MDL Panel") transferred the pending federal cases to this Court for consolidated pretrial proceedings. Subsequently, additional tag-along cases have followed. As the transferee court, this Court now determines if Plaintiffs' claims survive summary judgment.


Summary judgment is appropriate when the evidence submitted shows "that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law." Fed.R.Civ.P. 56(c). In seeking summary judgment, the moving party bears the initial burden of showing an absence of a genuine issue of material fact as to an essential element of the nonmoving party's case. Waters v. City of Morristown, 242 F.3d 353, 358 (6th Cir.2001). A fact is material if its resolution will affect the outcome of the lawsuit. Daughenbaugh v. City of Tiffin, 150 F.3d 594, 597 (6th Cir.1998) (citing Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986)). In deciding whether the moving party has met this burden, a court must view the facts and all inferences drawn from them in the light most favorable to the nonmoving party. Adickes v. S.H. Kress & Co., 398 U.S. 144, 158-59, 90 S.Ct. 1598, 26 L.Ed.2d 142 (1970). However, "a complete failure of proof concerning an

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essential element of the nonmoving party's case necessarily renders all other facts immaterial." Celotex Corp. v. Catrett, 477 U.S. 317, 323, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986).

Once the moving party satisfies this burden, the burden shifts to the nonmoving party to set forth specific facts showing a triable issue. Matsushita Elec. Indus. v. Zenith Radio Corp., 475 U.S. 574, 586, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986). It is not sufficient for the nonmoving party merely to show that there is some existence of doubt as to the material facts. See id.

A factual dispute stops summary judgment only if it is material, that is, if it relates to a matter essential to adjudication. The dispute must concern facts that, under the substantive law governing the issue, might affect the outcome of the suit. Anderson v. Liberty Lobby, 477 U.S. at 248, 106 S.Ct. 2505. The factual dispute also must be genuine. The facts must be such that if proven at trial a reasonable jury could return a verdict for the nonmoving party. Id. at 248, 106 S.Ct. 2505. "The disputed issue does not have to be resolved conclusively in favor of the nonmoving party, but that party is required to present significant probative evidence that makes it necessary to resolve the parties' differing versions of the dispute at trial." 60 Ivy Street Corp. v. Alexander, 822 F.2d 1432, 1435 (6th Cir.1987) (citing First Nat'l Bank of Arizona v. Cities Serv. Co., 391 U.S. 253, 288-89, 88 S.Ct. 1575, 20 L.Ed.2d 569 (1968)); see also Celotex, 477 U.S. at 322, 106 S.Ct. 2548.


With their motion for summary judgment, the Defendants claim that Plaintiffs do not create a material dispute of fact as to matters essential to Plaintiffs' claims. First, Defendants assert that Plaintiffs fail to offer sufficient evidence to create a material dispute of fact that Meridia causes harm in patients. Second, Defendants argue that their warnings to physicians were sufficient. Third, Defendants claim that Plaintiffs' design defect claim fails because (i) the Plaintiffs do not show material evidence that the risks of Meridia outweigh its benefits, (ii) there was no alternative design, and (iii) one cannot bring a design defect claim against "unavoidably unsafe" products. Fourth, Defendants argue that Plaintiffs have not offered evidence tending to establish a manufacturing defect. Fifth, Defendants state that there is no evidence of negligence per se. Sixth, Defendants assert that there is no material dispute of fact with regard to Plaintiffs' breach of warranty claims. Seventh, Defendants assert that Plaintiffs are unable to create a material dispute of fact with regard to a negligent or fraudulent misrepresentation, either under common law or statutory law. Finally, Defendants argue that Plaintiffs have not offered sufficient evidence to support their medical monitoring claim. If all of Defendants' assertions are true, none of Plaintiffs' claims against the Pharmaceutical Defendants survive summary judgment. The Court will analyze, in turn, the merits of Defendants' assertions.

I. Causation

In support of their motion for summary judgment, Defendants primarily argue that the Plaintiffs have failed to come forth with any evidence that Meridia causes compensable injury. If Defendants are correct, then Plaintiffs' claims for strict liability (all theories thereof), negligence, and negligence per se must fail. After all, causation of an alleged injury is an element of each of these claims. See In re Norplant Contraceptive Products Liability Litig., 215 F.Supp.2d 795, 830 (E.D.Tex.2002).

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Toxic tort cases present a unique challenge to the classical conception of causation. Other tort cases, such as slip-and-fall or car accident...

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