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In re Lipitor Atorvastatin Calcium Mktg., Sales Practices, & Prods. Liab. Litig.

United States District Court for the District of South Carolina, Charleston Division

May 6, 2016, Decided; May 6, 2016, Filed

MDL No. 2:14-mn-02502-RMG

Opinion

 [*765]  CASE MANAGEMENT ORDER NO. 72

This Order relates to all cases.

This matter is before the [**3]  Court on Pfizer's Motion to Exclude Expert Testimony and Claims that Lipitor is Not Effective for and Should Not Be Approved for Primary Prevention in Women, (Dkt. No. 970). For the reasons stated below, the motion is GRANTED IN PART AND DENIED IN PART.

I. Background

All Plaintiffs in this MDL are women who used Lipitor "to lower the LDL cholesterol and triglycerides in the blood and/or as a primary prevention measure to decrease the risk of developing CVD [cardio vascular disease]." (Dkt. No. 160 at ¶ 17). Plaintiffs generally allege that Lipitor caused their Type 2 diabetes and that Defendant failed to adequately warn them about the diabetes risk associated with  [*766]  Lipitor.1 (See generally Dkt. No. 160). Plaintiffs also allege that Lipitor was negligently designed because, among other things, it "was not effective for women as a measure of primary prevention of CVD." (Id. at ¶ 80). Additionally, Plaintiffs allege claims based on the combination of alleged ineffectiveness and alleged dangerousness. (See id. at ¶ 67 (alleging that Defendant was negligent "[i]n its promotion of Lipitor (atorvastatin calcium) in an overly aggressive, deceitful and fraudulent manner despite the lack of evidence [**4]  demonstrating its effectiveness in women and despite the evidence as to the product's defective and dangerous characteristics due to its propensity to cause Type 2 Diabetes."); id. at ¶ 80 (alleging the drug was negligently designed because "it contained insufficient, incorrect, and defective warnings," which failed to alert health care professionals and users "of the risks of adverse effects and the lack of benefit for women.")).

At issue in the instant motion are opinions by Plaintiffs' experts that (1) Lipitor is not effective for primary prevention in women, (2) that there is no evidence that Lipitor is effective for primary prevention in women, and/or (3) that Lipitor should not have been approved for primary prevention in women.2 As an initial matter, Plaintiffs state in briefing that they "do not assert, and their experts do not opine that Lipitor is not effective for primary prevention in women. Rather, these experts opine that there is [**5]  insufficient evidence to show that Lipitor is effective for primary prevention in women." (Dkt. No. 1046 at 6 (emphasis in original)). However, Plaintiffs do specifically allege in their Master Complaint that Lipitor is "not effective for women as a measure of primary prevention of CVD," (Dkt. No. 160 at ¶ 80 (emphasis added)), and at least some of Plaintiffs' experts state this opinion. (See Dkt. No. 970-12 at 155-56 ("Q. Is it your opinion that women with diabetes receive no benefit from [] taking Lipitor? A. Correct.")). Therefore, where applicable, the Court will consider and address both opinions.

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185 F. Supp. 3d 761 *; 2016 U.S. Dist. LEXIS 68829 **

IN RE: LIPITOR (ATORVASTATIN CALCIUM) MARKETING, SALES PRACTICES AND PRODUCTS LIABILITY LITIGATION

Prior History: In re Lipitor (Atorvastatin Calcium) Mktg., Sales Practices & Prods. Liab. Litig., 2015 U.S. Dist. LEXIS 92124 (D.S.C., Feb. 2, 2015)

CORE TERMS

prevention, label, statins, efficacy, studies, authors, effective, statistically significant, preempted, CARDS, advertising, reduction, heterogeneity, diabetes, confidence, regulation, interval, opines, tests, state law, cardiovascular, misleading, ratio, federal law, statistical, scientific, preemption, secondary, hazards, acquired information