The US District Court in South Carolina has issued four case management orders in the Lipitor (Atorvastatin Calcium) Products Liability Litigation, MDL No. 2:14-mn-02502-RMG. Plaintiffs allege that Lipitor caused their Type 2 diabetes, that Pfizer failed to adequately warn about the alleged risk of developing Type 2 diabetes while taking Lipitor, and that it misrepresented Lipitor’s effectiveness for primary prevention in women.
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.”
- Pfizer was negligent”[i]n its promotion of Lipitor in an overly aggressive, deceitful and fraudulent manner despite the lack of evidence 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.”
Plaintiffs have primarily focused on their failure to warn claim. However, the master complaint alleges 12 causes of action including negligence, negligent misrepresentation, negligent design, and fraud and misrepresentation —
Four Case Management Orders
Judge Richard Mark Gergel issued four case management orders on May 6:
- No. 75, where the court excluded the expert testimony of Dr. Murphy, that Lipitor caused Ms. Hempstead’s Type 2 diabetes. The court found that while Dr. Murphy purported to use a five-part test, her opinion was only based on “(1) the fact that Lipitor increases the risk of diabetes and (2) that Ms. Hempstead developed diabetes after taking Lipitor.” The Court explained that neither Dr. Murphy nor counsel could point to evidence, specific to Ms. Hempstead, that supported Dr. Murphy’s opinion other than a temporal relationship. The Court held that while there are circumstances where temporal proximity is particularly compelling, such circumstances are not present here. The Court also noted that while Dr. Murphy discussed other risk factors, she never provided any explanation as to why these other risk factors, alone or in combination, were not sufficient to cause diabetes independent of Lipitor exposure.
- No. 74, which grants in part and denies in part Pfizer’s Motion to Exclude the Testimony of Plaintiffs’ Regulatory Expert G. Alexander Fleming.
- No. 73, which grants in part and denies in part Pfizer’s Motion to Exclude the Testimony of Dr. John Abramson. He may opine on whether particular marketing materials are misleading and may opine as to whether physicians would want to know certain information in making prescribing decisions. He may not, however, opine that Defendant has a “duty” or “obligation” to take specific action.
- No. 72, a 37-page opinion, grants in part and denies in part 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. Defendant’s motion to exclude Dr. Wells’ re-analysis of the ASCOT data under rule 702 is denied.
Lipitor has been implicated in a national epidemic of type 2 diabetes in women taking the drug. In August 2011, the FDA requested that Pfizer make labeling changes for Lipitor based upon the FDA’ s comprehensive review, including clinical trial data. The label change required Pfizer to warn of the changes in blood sugar levels when taking Lipitor.
Defective design, inadequate warnings, and inadequate instructions led to serious patient complications, including type 2 diabetes, among many women. Even though Pfizer knew of the risks for several years, medical providers were unaware that the use of Lipitor caused type 2 diabetes in female patients.