Hundreds of Women Sue Pfizer; Failure to Warn of Diabetes Risk Alleged

Class Action Litigation Report

May 15, 2014

Pharmaceuticals

Hundreds of Women Sue Pfizer; Failure to Warn of Diabetes Risk Alleged

By Julie A. Steinberg

May 12 - Hundreds of suits have been filed over the last few months in federal multidistrict litigation by women alleging the popular cholesterol-lowering drug Lipitor caused them to develop type 2 diabetes, and plaintiffs' attorneys say that's just the tip of the iceberg (In re Lipitor (Atorvastatin Calcium) Mktg., Sales Practices and Prod. Liab. Litig., J.M.P.L., No.2502, transfer order 2/8/14).

More than 450 suits are now pending in MDL No. 2502, according to an April 15 statistics report.  Plaintiffs say thousands more suits are expected, but manufacturer Pfizer Inc. says it's premature to estimate.

Regardless of the final tally, both sides are now gearing up for fiercely contentious litigation over how safe the commonly prescribed cholesterol-reducing drug is, and whether general and specific causation can be established in these cases, attorneys interviewed by Bloomberg BNA say.

"I think the biggest challenge is overcoming the public perception that Lipitor is a drug with minimal risks for women," Christopher Coffin, a member of the Plaintiffs' Steering Committee and whose firm submitted the motion to centralize the suits, said in an April 29 e-mail.

"We have the evidence to show otherwise, and we'll continue to develop that evidence, but Pfizer's marketing of Lipitor has been masterful in creating a perception that the drug only presents minor risks," Coffin said.

The Consolidation

The U.S. Judicial Panel on Multidistrict Litigation consolidated in February the then-pending 56 suits and transferred them to Judge Richard M. Gergel of the U.S. District Court for the District of South Carolina .

The February consolidation came after the JPML panel, in August 2013, initially declined to assign all the cases to one judge.

More than 29 million people in the U.S. have been prescribed Lipitor (also known as atorvastatin calcium) since its approval in 1996, Pfizer said.

Women Face Higher Risk

Plaintiffs allege women face a higher risk than men for developing type 2 diabetes. The warning on Lipitor, which belongs to the class of drugs known as statins, doesn't adequately caution against this risk, they say.

Women, who make up all the current plaintiffs, have a 7-fold higher risk than men, because women metabolize statins differently than men, H. Blair Hahn, plaintiffs' lead counsel in the MDL, told Bloomberg BNA in a May 12 interview and related e-mails.

"There is an increased risk of diabetes in men as well. However, we have chosen to pursue female cases only at this time because the increased risk is greater in women than men," Hahn said.

Pfizer knew of the diabetes risk as early as 1996, Hahn said, but a combination of factors may account for the emergence of the litigation now. With physicians seeing more patients on statins who are developing diabetes, and more medical research, "it's coming to the forefront of public knowledge," he said.

Long-range studies over the past few years show an increasing risk of diabetes, Hahn said. Studies in Europe and Japan also pointed to this problem.

The heightened risk to women is an even newer finding, according to an earlier filing before the MDL panel by a group of plaintiffs who supported centralization.

"[I]t is only recently that the scientific community has discovered what Pfizer knew or should have known since 1996, that the use of Lipitor increases the risk of diabetes in both men and women," according to the Nov. 1, 2013, brief filed by Hahn.

"And it is even more recently that researchers outside Pfizer have discovered that women using statins have a higher risk of contracting diabetes than men. That is why there were so few cases on file in July 2013 and why the cases filed to date are only the tip of the iceberg," the brief said.

Pfizer Says Drug is Safe

But Pfizer said Lipitor has been extensively studied and is safe and effective.

"There is an overwhelming consensus in the medical community regarding the benefits of Lipitor and statin therapy in men and women. The safety and efficacy of Lipitor is supported by nearly two decades of research and more than 400 ongoing or completed clinical trials involving over 80,000 patients," the company said in a May 9 statement e-mailed to Bloomberg BNA.

Hahn said he expects the suit count eventually to reach 10,000.

In addition to the federal proceedings, Lipitor litigation is ongoing in several state courts, with 50 cases in West Virginia, 200 in Illinois, and 3,000 in California, Hahn said.

But Pfizer says it's skeptical about that figure.

"Claims and speculation about the volume of cases that might be filed at some future point are inherently unreliable and typically greatly overstate the actual size of the docket," the company said in the e-mail.

And earlier, in a Nov. 1, 2013, brief opposing centralization, Pfizer said the mere existence of an MDL can encourage excess filings.

Warning History

According to the plaintiffs, Lipitor's label before February 2012 didn't warn patients or physicians about any potential relationship changes in blood sugar levels and use of the drug.

In February 2012, the FDA required a warning change for all statin drugs, noting the possibility of increased blood sugar levels and other side effects .

In a Feb. 28, 2012, public communication announcing the label change, the agency said, "FDA continues to believe that the cardiovascular benefits of statins outweigh these small increased risks."

Responding to the FDA, plaintiffs said, Pfizer added language to the Warnings and Precautions section of the Lipitor label that

said: "Increases in HbA1c and fasting serum glucose levels have been reported with HMG-CoA reductase inhibitors, including Lipitor."

But even this warning, that use of statins can cause an increase in blood glucose levels, is insufficient, according to plaintiffs.

Pfizer attempted to "ride the fence," and "say as little as possible," Hahn said. In addition to being inadequate, the warning is "nonsensical," he said.

"By way of comparison, in August 2013 the manufacturer of Crestor, another statin, added a warning to its labeling that increases in blood glucose with that drug -- may exceed the threshold for the diagnosis of diabetes mellitus,-" the plaintiffs' Nov. 1, 2013, brief said in a footnote. Crestor is marketed by AstraZeneca.

Pfizer maintains that its warnings are adequate.

"The Company has at all times provided physicians with accurate information regarding the benefits and potential risks of Lipitor in the medicine's FDA-approved label," Pfizer told Bloomberg BNA.

In its brief opposing centralization, Pfizer quoted from the FDA's statement that Lipitor has a favorable risk-benefit profile.

-The Food and Drug Administration (FDA) has expressly observed that the "benefit [of statins] is indisputable," and that "the cardiovascular benefits of statins outweigh [the] small increased risk[]- of elevated blood sugar levels, on which plaintiffs base their claims," Pfizer said in the filing.

Issues in Litigation-

As in other pharmaceutical litigation, both sides predict causation will be a major issue.

Hahn said specific causation will be a hurdle for plaintiffs. "Pfizer has no real defense on general causation," he said May 1.  "But on the question of whether Lipitor caused a specific individual's DM (diabetes mellitus), Pfizer will challenge on 1) the client would have developed DM anyway and 2) they will claim Lipitor saved the individual's life and DM is a small price to pay."

In its e-mailed statement, the company said patients using the medication are already at high risk for diabetes.

"Pfizer denies the plaintiffs' claims that Lipitor caused their new onset diabetes, a medical condition that is highly prevalent in the patient population prescribed statins, and we intend to vigorously defend against the allegations," Pfizer said.

Fast Track

Hahn and Coffin said they expect the Lipitor litigation to proceed on a fast track.

"The Judge has indicated that he intends to set the first trial in July of 2015, so we anticipate an aggressive schedule for discovery and motions practice," Coffin said.

Plaintiffs have begun engaging in some discovery, he said, and "the discovery process will accelerate rapidly in the coming months."

Hahn is with Richardson, Patrick, Westbrook & Brickman LLC in Mt. Pleasant, S.C.

Coffin is with Pendley, Baudin & Coffin, LLP in New Orleans.

Plaintiff's Liaison Counsel is Marc C. Tanenbaum in Charleston, S.C.

Defendants' Lead Counsel is Mark S. Cheffo of Quinn Emanuel Urquhart & Sullivan LLP in New York.

Defendants' Liason Counsel is Michael T. Cole of Nelson Mullins Riley & Scarborough LLP in Charleston.

To contact the reporter on this story: Julie A. Steinberg in Washington at jsteinberg@bna.com

To contact the editor responsible for this story: Steven Patrick at spatrick@bna.com

For More Information

The Lipitor motion to transfer is at http://www.bloomberglaw.com/public/document/IN_RE_Lipitor_Atorvastatin_Calcium_Marketing_Sales_Practices_and_/2

Hundreds of Women Sue Pfizer; Failure to Warn of Diabetes Risk Alleged, Class Action Litigation Report (BNA)

© 2014 The Bureau of National Affairs, Inc. All Rights Reserved. Terms of Service

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The Lipitor plaintiffs' response in support is at http://www.bloomberglaw.com/public/document/IN_RE_Lipitor_Atorvastatin_Calcium_Marketing_Sales_Practices_and_/3.

Pfizer's opposition to transfer is at http://www.bloomberglaw.com/public/document/IN_RE_Lipitor_Atorvastatin_Calcium_Marketing_Sales_Practices_and_/4.

Hundreds of Women Sue Pfizer; Failure to Warn of Diabetes Risk Alleged, Class Action Litigation Report (BNA)

© 2014 The Bureau of National Affairs, Inc. All Rights Reserved. Terms of Service

http://www.bloomberglaw.com/ms/document/XTIDUIS000000 // PAGE 4