In early 2017, a federal judge in South Carolina dismissed more than 2,000 cases filed against Pfizer over allegations that the pharmaceutical company’s top-selling cholesterol-lowering drug, Lipitor, causes type 2 diabetes. The cases are now on appeal before the U.S. Court of Appeals for the Fourth Circuit.
It was not long after the U.S. Food and Drug Administration (FDA) warned in 2012 that Lipitor had been linked to an increased risk of diabetes that pharmaceutical giant Pfizer was hit with a wave of lawsuits by women who allege that the company knew about possible serious side effects of Lipitor but failed to properly warn the public.
The FDA approved Lipitor in 1996 as a way to prevent cardiovascular disease by lowering cholesterol. Pfizer first communicated the drug’s link to high blood sugar and increased risk for diabetes in February 2012 — only after the FDA’s Division of Metabolism and Endocrinology Products requested Pfizer update the drug’s labeling to indicate these risks.
The lawsuits claim the drugmaker knew about or should have known about the diabetes risks of Lipitor before marketing it as a safe and effective treatment. They accuse the drugmaker of neglecting to adequately warn patients and doctors of the full range of Lipitor’s health risks.
These lawsuits were eventually consolidated into a multidistrict litigation (MDL) and centralized in a single court in the District of South Carolina. They were joined by hundreds more lawsuits, bringing the total actions against Pfizer to more than 2,000. The federal judge overseeing the proceedings ultimately dismissed most of the cases before they could go to trial. He excluded almost all of the plaintiffs’ expert testimony and ruled that the plaintiffs could not cite evidence in the record that would allow a jury to infer that Lipitor caused them to develop diabetes. Those lawsuits are now on appeal before the U.S. Court of Appeals for the Fourth Circuit.
People who filed lawsuits against Pfizer over allegations that Lipitor caused their diabetes are generally women who had a body mass index within the healthy range, kept a healthy diet, took Lipitor to decrease their risk for heart disease and were subsequently diagnosed with type 2 diabetes.
Smalls, Colbert and Hines are just three of the many women who filed Lipitor diabetes lawsuits against Pfizer between February 2012 and April 2013. Attorneys for a group of plaintiffs filing Lipitor diabetes lawsuits twice tried to get the U.S. Judicial Panel on Multidistrict Litigation to transfer all pending and future diabetes claims to a single court for consolidated pretrial proceedings. Both times Pfizer opposed the motions to consolidate the cases, claiming it would bring about lawsuits that would otherwise not be filed.
The first motion to centralize the claims came in April 2013. At that time, there were considerably fewer claims, and the panel said it was “disinclined to take into account the mere possibility of future filings” in its decision. Moreover, the claims that had been filed involved common plaintiffs’ counsel and many were already being coordinated before one judge. In fact, half of the then-pending actions were pending in just one district. For those reasons, the panel denied the motion for centralization at its July 2013 hearing session.
By 2014, however, the number of involved plaintiffs’ firms, actions, districts and judges had “grown considerably,” according to the panel. Plaintiffs’ attorneys filed a second motion for centralization that encompassed 56 actions, and the panel was aware of more than 170 additional related federal actions pending in more than 40 districts and before more than 100 different judges. Lipitor diabetes lawsuits were also pending in at least three state courts.
On February 18, 2014, the panel ordered all pending and future Lipitor diabetes claims be transferred to the U.S. District Court for the District of South Carolina under the name In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices and Products Liability Litigation (No. II) MDL-2502. The panel assigned the MDL to the Hon. Richard M. Gergel, who at the time was presiding over 14 of the 56 constituent actions — all pending in South Carolina.
“In our judgment, the increased presence of apparently unique counsel, coupled with the increased number of involved actions, districts, and judges, makes it highly difficult, if not impossible, to coordinate this litigation effectively on an informal basis,” the panel said in its transfer order. “Creation of an MDL likely will make it easier to coordinate, as needed, pretrial proceedings in both the state and federal cases, because there will now be just one judge handling the latter.”
In doing so, the panel rejected Pfizer’s argument that “an MDL will prompt an avalanche of filings of ‘non-viable’ Lipitor cases in an effort to coerce a settlement.” Instead the panel found “centralization will eliminate duplicative discovery, prevent inconsistent pretrial rulings and conserve the resources of the parties, their counsel and the judiciary.”
Part of the reason the panel decided to consolidate the personal injury actions under an MDL was because the complaints are highly similar. Plaintiffs allege that they have developed type 2 diabetes as a result of taking Lipitor.
They contend that Pfizer failed to adequately warn physicians and consumers of the risk of developing type 2 diabetes from taking Lipitor and that the company knew or should have known that the risks of Lipitor included developing diabetes.
According to the lawsuits, Pfizer failed in its duty to monitor Lipitor’s safety and is liable for “negligent and wrongful conduct in connection with the design, development, manufacture, testing, packaging, promoting, marketing, distribution, labeling, and/or sale of Lipitor.” Plaintiffs accuse Pfizer of negligently, recklessly, and/or carelessly marketing Lipitor without adequate instructions or warnings.
Once the MDL was established, the court selected two cases to serve as bellwether cases, or test cases, for the MDL. The cases, Daniels v. Pfizer and Hempstead v. Pfizer, were meant to be the first to go to trial beginning in November 2015. The start of the trial was delayed due to the court’s criminal caseload.
Leading up to the first trial, the court considered plaintiff’s testimony from medical experts. On March 20, 2016, the court issued a forty-page order excluding plaintiff’s expert opinions, except for the opinion of epidemiologist Dr. Singh that Lipitor 80 mg causes diabetes.
Plaintiffs in the MDL all took dosages of Lipitor less than 80 mg. None of the plaintiff’s experts could provide a method to determine whether a patient developed diabetes from Lipitor or from other risk factors. They testified that they themselves could not determine whether Lipitor caused a particular patient’s diabetes.
“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,” court documents state.
Among the opinions excluded was that of endocrinologist Dr. Quon. According to court documents, the court concluded Quon reached his conclusion via a literature review but “admittedly cherry-picked studies to support his conclusion rather than considering the totality of the literature.”
In 2016, the court remanded certain cases in the MDL to certain state courts and remanded 70 lawsuits to federal courts in California. On February 27, 2017, the Lipitor diabetes MDL was officially closed after the court dismissed all remaining pending claims under the MDL and the Judicial Panel on Multidistrict Litigation ceased to transfer and consolidate new cases to the MDL.
The court said it dismissed the cases because the plaintiffs could not provide evidence that they developed diabetes from taking Lipitor or that would allow a jury to infer that Lipitor is capable of causing diabetes at dosages of less than 80 mg. Plaintiffs have appealed the court’s decision to the U.S. Court of Appeals for the Fourth Circuit.
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