No Plaintiff has done so. Therefore, Plaintiffs' argument that they have not had an opportunity to seek specific causation expert testimony is meritless.
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The Court provided that opportunity in CMO 65, not a single Plaintiff came forward, and by not coming forward in response to CMO 65, Plaintiffs have waived that argument. The Court went on to provide Plaintiffs with a fourth and final opportunity to come forward with non-expert evidence:. With regard to non-expert evidence, in an abundance of caution, the Court will provide Plaintiffs with a fourth and final opportunity to come forward. Plaintiffs have argued that 15 days is not sufficient time to marshal their evidence.
Thus, the Court will afford them an additional 60 days. The Court notes that the only facts that Plaintiffs have stated they may need to discover other than expert testimony to defend against summary judgment is information from their own treating physicians and their own patient records.
They have not requested any discovery from Defendants or other third-parties. Given the nature of the evidence that Plaintiffs claim they need time to marshal, specifically their request to marshal their own medical records and information from their own treating physicians, the Court finds 60 days sufficient. The Court also noted that Plaintiffs had not "stated how long they need to marshal this evidence or suggested any proposed timeline for obtaining it.
Thus, the additional 60 days did prove sufficient.
In addition to the omnibus responses to summary judgment filed by the Plaintiffs' Steering Committee, Dkt. They contend that 1 they were not diabetic before taking Lipitor, 2 they were diagnosed with diabetes after taking Lipitor, and 3 they did not have certain risk factors for diabetes, even though they had others. See Dkt. At oral argument counsel stated this was "the best thing I could come up with with nonexpert evidence," that "[t]hey are not diabetic before taking the medication, they took Lipitor and then they became diabetic. The Court entered a text order stating that these Plaintiffs must submit to the Court any evidence that they wished to the Court to consider.
In response, Plaintiffs literally dumped boxes upon boxes of documents on the Court, with no discernment or suggestion as to which documents they claimed precluded summary judgment. Nevertheless, the Court reviewed these documents as well, almost all of which were completely irrelevant. For example, the documents include pictures from colonoscopies, EKGs, and pap smear results.
The Court held oral argument on the omnibus motion on November 1, , and the matter is now before the Court for a decision. On September 24—25, , the Court heard extended oral argument on Defendant's motions to exclude common expert witnesses, including Plaintiffs' general causation experts. One of the primary issues raised both in briefing and at oral argument was the importance of dosage. Lipitor is prescribed in four different doses: 10 mg, 20 mg, 40 mg, and 80 mg.
Plaintiffs' general causation experts initially "opine[d] that Lipitor can cause diabetes, without specifying the precise dose at which this effect begins. If a study suggested an increased risk of diabetes, the experts "ascribe[d] the risk to all doses.
However, Pfizer argued that "[d]ose is critical to proving general causation," and that Plaintiffs lacked reliable evidence that Lipitor causes diabetes at doses less than 80 mg. After reviewing the studies relied on by the experts and their opinions, the Court was concerned about whether Plaintiffs' experts had sufficient facts and data to support their causation opinions at all doses of Lipitor, and even whether the experts would be willing to offer an opinion at low doses, given the available data. See In re Seroquel Products Liab.
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June 18, Expert offering a causation opinion "declined to even speculate" about doses of The Plaintiffs' experts agreed, and some even emphatically argued, that there was a dose-response relationship, meaning that any risk of diabetes is higher at higher doses of Lipitor, and the data with regard to 80 mg of Lipitor was starkly different from the data with regard to 10 mg of Lipitor.
Thus, the Court ordered supplemental briefing on this issue. See CMO 68, Dkt. After a thorough review of relevant caselaw and the expert opinions at issue, the Court issued an order on October 22, , holding that "at least where the experts agree that there is a dose-response relationship and where there is evidence that an association no longer holds at low doses, dose certainly matters, and Plaintiffs must have expert testimony that Lipitor causes, or is capable of causing, diabetes at particular dosages.
Over Defendant's strenuous objections, the Court re-opened expert discovery and allowed additional time for Plaintiffs to serve supplemental reports offering opinions as to whether Lipitor causes diabetes at dosages of 10 mg, 20 mg, 40 mg, and 80 mg. The parties served supplemental expert reports on general causation in December of and January of , and then filed supplemental briefs on Pfizer's motion to exclude Plaintiffs' general causation expert testimony in February of See CMO 50, Dkt.
The Court heard additional oral argument on March 18, In a forty-page order issued on March 30, , the Court ultimately excluded Plaintiffs' expert opinions on general causation, except for the opinion of Plaintiffs' epidemiologist, Dr. Singh, that Lipitor 80 mg causes diabetes. CMO 68, Dkt. The Court found Dr. Singh's 10 mg opinion was not based on sufficient facts and data and that Dr.
Plaintiffs conceded that Dr. Singh could not offer an opinion at Lipitor 20 mg or Lipitor 40 mg if the Court excluded his opinion regarding Lipitor 10 mg. The Court also excluded the opinions of Dr.
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Quon, an endocrinologist who ostensibly reached his conclusion via a literature review but who admittedly cherry-picked studies to support his conclusion rather than considering the totality of the literature, id. Roberts, a cardiologist, who claimed in her report to use the Bradford Hill method used by epidemiologists but who seemed to misunderstand the methodology's basic premise in deposition, who cherry-picked studies for consideration and failed to consider contrary evidence, and who failed to provide any analysis of particular dosages as required by CMO 49, id.
Gale, who failed to provide any analysis of particular dosages as required by CMO 49 and who ascribed the risk observed at Lipitor 80 mg to all dosages of Lipitor. Thus, the only admissible opinion on general causation is Dr. Singh's opinion regarding Lipitor 80 mg. Diabetes is a complicated and progressive disease, and a number of factors, including genetics, diet, exercise, age, and weight play a significant role in the development of new onset diabetes.
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This makes teasing out the role of Lipitor, if there is one, in the development of a particular patient's diabetes difficult. Interestingly, none of Plaintiffs' general causation experts could think of a method to determine whether a particular patient's diabetes was caused by Lipitor or caused by other risk factors and testified that they themselves could not determine whether a particular patient's diabetes was caused by Lipitor. Plaintiffs' specific causation experts have never diagnosed a patient with Lipitor-induced or statin-induced diabetes outside of this litigation, and they could not identify anyone else who applied their methodologies to do so outside of this litigation.
Plaintiffs in this MDL are not the first to grapple with the problems of proving causation where the alleged injury is a complicated, progressive, multi-factor disease like diabetes. In Guinn v. AstraZeneca Pharm. LP , F. The expert first testified that "she knew of no methodology for ruling out alternative causes [of diabetes ]" and then later testified that other potential causes were "not solely responsible" because plaintiff developed diabetes after taking Seroquel and other risk factors remained constant.
The Eleventh Circuit held that this reliance on temporal proximity did not "satisfy the requirement that a differential diagnosis consider possible alternative causes. The Eleventh Circuit also rejected the expert's second explanation that all risk factors work together to cause diabetes, holding that "[a]n expert Similarly, in Haller v. LP, F. Again, plaintiff's expert could not rule out other possible causes of diabetes or the possibility that these other risk factors were solely to blame.
The court held that temporal connection is legally insufficient and the last additive factor argument was "largely temporal proximity in disguise. These same issues surfaced with Plaintiffs' specific causation experts in this MDL. The first bellwether Plaintiff, Plaintiff Daniels, proffered the testimony of Dr. David Handshoe on the issue of specific causation. The second bellwether Plaintiff, Plaintiff Hempstead proffered the testimony of both Dr.
Handshoe and Dr.
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Murphy on the issue of specific causation. Pfizer moved to exclude the testimony of both experts, Dkt.
Murphy determined that the most reliable data suggested a relative risk ratio of developing diabetes while taking Lipitor to be around 1. Thus, the Court turned to Dr. For purposes of the motion to exclude Dr. Murphy's testimony, the Court assumed that general causation could be established.