Current Lawsuits

Serostim

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Serostim
Serostim is a recombinant human growth hormone marketed and sold by Serono.  Serostim is used to treat AIDS wasting, a condition involving profound involuntary weight loss in AIDS patients.

Background 
In August 1996, the FDA approved Serostim to treat AIDS wasting, At the time, AIDS wasting was a defining condition of AIDS and the leading cause of death among AIDS patients.   Shortly after Serostim was approved, however, a new class of drugs -- protease inhibitors -- came on the market.  These drugs, when used in various combinations commonly known as "AIDS cocktails,” dramatically improved the treatment of HIV/AIDS.  As a result, AIDS wasting became much less common. Since AIDS wasting was less common, Serostim became much less crucial for AIDS patients..  The lawsuit alleges that Serono, faced with a slowing demand for the drug, embarked on a campaign to get doctors to prescribe Serostim even when it was not medically necessary.  It allegedly used a variety of schemes including: 

(1)    Fraudulently promoting the use of an unapproved medical device that incorrectly diagnosed people as having AIDS wasting, and thus in need of Serostim;

(2)    Paying doctors and sending them on lavish trips to encourage them to prescribe Serostim; and

(3)    Marketing Serostim to doctors for uses that were  not approved by the FDA.

In October 2005, Serono agreed to settle a criminal case brought by the federal government over the illegal promotion of Serostim. Serono pled guilty and agreed to pay $704 million to state and federal governments. In announcing the criminal plea and civil settlement, the U.S. Attorney in charge of the case stated that “nearly 85% of prescriptions written for Serostim were not medically necessary.”

PAL Member Litigation
In February 2006, PAL members joined a lawsuit alleging Serono's illegal promotion of Serostim caused consumers and third-party payors to pay for Serostim treatments that were not necessary.  The case is pending in the U.S. District Court for the District of Massachusetts.

Update: EMD Serono, Inc. and Merck Serono International, S.A., the defedants, recently agreed to settle the case for $24 Million.  The Court granted preliminary approval to the settlement on February 14, 2007. Notice of the settlement was published and distributed to class members. The Court issued a Final Approval of the Settlement on December 12, 2007, and settlement funds were distributed in early 2008 to consumers and third party payors who had submitted valid claims. 

View the press release announcing the settlement.

Full information about the settlement, including how to submit a claim for reimbursement, a FAQ, and copies of claim forms, is available at www.serostimsettlement.com

Serostim Plaintiff Class
Members of the class for the Serostim lawsuit included individuals and third-party payors who paid for any portion of the cost of Serostim from January 1, 1996 to the present.

Serostim case documents:

• Final Order Approving Settlement (December 12, 2007)
• Press release, February 20, 2007
• Court Order, granting preliminary approval to the settlement, filed February 14, 2007
  
• Settlement and Release, filed February 1, 2007
  
• Third Amended Complaint, filed October 16, 2006

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