Avandia Lawsuit Plaintiffs Ordered to Produce Basic Medical Records in MDL

A federal judge has ordered that all plaintiffs who have filed an Avandia lawsuit in federal court must produce basic medical records, including proof that they used the diabetes drug and documentation of the injury they claim to have suffered as a side effect of Avandia.

The order, issued on December 22 by U.S. District Judge Cynthia M. Rufe, warns plaintiffs that failure to produce basic medical records could result in the dismissal of their case. There are currently at least 549 lawsuits over Avandia that have been filed against GlaxoSmithKline PLC, the manufacturer, in federal court and consolidated as part of a multidistrict litigation (MDL) in the Eastern District of Pennsylvania.

All of the claims involve allegations that GlaxoSmithKline failed to adequately warn about the risk of serious injuries from Avandia side effects, including an increased risk of heart attacks, strokes, congestive heart failure, liver failure, bone fractures and vision loss.

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The order requires that all plaintiffs produce proof that they used Avandia, which can take the form of pharmacy records or prescriber’s medical records. Failing those, the plaintiff can file an affidavit explaining their Avandia use and detailing what efforts they made to attain those records and why the records are no longer available.

Plaintiffs must also produce medical records of the prescribing doctor from the present back to one year before the date of their Avandia problems. They must also provide medical records that establish and describe the alleged Avandia injury.

Those who fail to produce the required records, or fail to show good cause as to why those records are not available, will be considered to have a “Threshold Deficiniency” and could have their lawsuit dismissed, the court order states.

Avandia (rosiglitazone) is a type 2 diabetes drug approved by the FDA in 1999. It is a thiazolidinedione agent, which acts by increasing the body’s sensitivity to insulin and aiding in the management of blood sugar in diabetics.

Several studies, including some by Avandia’s manufacturer, GlaxoSmithKline PLC, have indicated that users of Avandia face an increased risk of heart attacks, congestive heart failure, liver failure, bone fractures, macular edema and death. In November 2007, the FDA required that Avandia carry a “black box” warning highlighting the increased risk of heart attacks.

In 2008, Public Citizen filed a petition with the FDA calling on the agency to issue recall of Avandia, indicating that the number of serious and potentially life-threatening side effects outweigh any potential benefits provided by the diabetes drug. The FDA has not yet taken any action on the petition. The American Diabetes Association (ADA) also recommended against the use of Avandia in the same year.

The Avandia lawsuits in federal court are consolidated and centralized before Judge Rufe for pretrial litigation. The first Avandia trials in the MDL are expected to begin this summer if settlements or other resolutions are not reached before then.


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