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In re Accutane Prods. Liab.

United States District Court for the Middle District of Florida, Tampa Division

June 15, 2007, Decided ; June 15, 2007, Filed

Case No. 8:04-md-2523-T-30TBM, MDL: 1626


 [*1289]  ORDER

THIS CAUSE comes before the Court upon Defendants' Motion to Exclude General Causation and Labeling Testimony of Dr. Ronald Fogel (Dkt. # 411) and Plaintiffs' Response thereto (Dkt. # 444). Upon review of the pleadings, memoranda, and attachments, the Court concludes that the Motion should be granted.

Plaintiffs contend that Accutane (an acne medication) causes inflammatory bowel disease (IBD) and psychiatric problems. Their complaints have been divided into separate groups or tracks according to the type of injury alleged. This Order deals only with the general causation issue of the IBD track cases.

"General causation is concerned with whether an agent increases the incidence of disease in a group and not whether the [**14]  agent caused any given individual's disease." Michael D. Green, et al., Reference Guide on Epidemiology, in Reference Manual on Scientific Evidence 333, 392 (Federal Judicial Center, 2d. ed. 2000). Dr. Fogel opines that Accutane is a cause of IBD. The issue before this Court is whether the methodology Dr. Fogel employed in reaching this opinion meets the legal standard of reliability set forth in Daubert v. Merrill Dow Pharmaceuticals, 509 U.S. 579, 113 S. Ct. 2786, 125 L. Ed. 2d 469 (1993).

IBD, as used by Dr. Fogel, refers to two diseases characterized by inflammation of the gastrointestinal tract: ulcerative colitis and Crohn's disease. Both are chronic conditions with periods of remission and exacerbation that generally occur and reoccur over a patient's lifetime. "Crohn's disease and ulcerative colitis are most commonly diagnosed in late adolescence and early adulthood, but the diagnosis may occur at all ages." Edward V. Loftus, Jr. 1,  [*1290]  Clinical Epidemiology of Inflammatory Bowel Disease: Incidence, Prevalence, and Environmental Influences, 126 Gastroenterology 1504, 1507 (2004). The number of new cases, across all age groups, is 16 - 20 per 100,000 people. Dr. Fogel acknowledges that [**15]  this number would be somewhat higher for a group in their late teens and early adulthood, the group that would most likely use Accutane to treat acne. (Fogel depo., Exhibit E to Defendant's Motion to Exclude at 179-180).

The exact cause or causes of IBD is unknown, but the scientific community has identified certain risk factors. According to Dr. Loftus:

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511 F. Supp. 2d 1288 *; 2007 U.S. Dist. LEXIS 43690 **


Subsequent History: Summary judgment granted by Stupak v. Hoffmann-La Roche, Inc., 2007 U.S. Dist. LEXIS 60498 (M.D. Fla., Aug. 17, 2007)

Prior History: In re Accutane Prods. Liab., 2007 U.S. Dist. LEXIS 32236 (M.D. Fla., May 2, 2007)


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