Friday, June 29, 2007

Lilly May Face More Zyprexa Lawsuits After FDA Letter

Bloomberg News
Lilly May Face More Zyprexa Lawsuits After FDA Letter
By Rob Waters and Margaret Cronin Fisk
June 29, 2007

June 29 (Bloomberg) -- Eli Lilly & Co. may attract more lawsuits alleging it failed to warn users that a psychiatric drug was linked to diabetes after the pharmaceutical company received a letter from U.S. regulators.

The U.S. Food and Drug Administration told Lilly in March it would delay the approval of Symbyax for depression because the agency wanted more information about the risk of diabetes in the medicine's prescribing label. Symbyax combines Lilly's antipsychotic pill Zyprexa and the antidepressant Prozac.

The FDA's request, in a letter to Lilly obtained by Bloomberg, may bolster plaintiffs' suits against the Indianapolis company over side effects tied to Zyprexa, lawyers said. Lilly has paid more than $1.2 billion to settle 29,000 claims that patients weren't adequately warned that Zyprexa can cause diabetes, weight gain and pancreas infections.

``When the FDA says something damning about the warnings of a drug, it's admissible as evidence on the reasonableness of the manufacturer's decisions,'' said David Logan, dean of the Roger Williams University School of Law in Bristol, Rhode Island, in an interview. ``It would likely carry some weight with juries.''

Logan isn't involved in Zyprexa litigation and hasn't been an expert witness in product-defect lawsuits.

In addition to the individual claims, at least eight states have sued the company on behalf of their Medicaid health programs for the indigent, alleging Lilly concealed risks and marketed the drug for unapproved uses.

Studies have shown that Zyprexa and other, similar medications known as atypical antipsychotics are associated with weight gain and an increased risk of diabetes. These studies prompted the FDA to require Lilly and other drugmakers to warn doctors of the risks in September 2003 and again in March 2004.  

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