Bristol-Myers Squibb ($BMY) and Sanofi ($SNY) scored a victory in a False Claims Act marketing case over their blood-thinner, Plavix, as a federal judge in New Jersey tossed out some allegations from a former Sanofi sales rep that the company made misleading statements about the med to gain more Medicare and Medicaid coverage.
U.S. District Judge Freda Wolfson partially dismissed claims from Elisa Dickson, a former Sanofi-Aventis sales rep, who alleged that the company told her to falsely promote Plavix to docs. Dickson said she was instructed to promote the drug as better than aspirin for stroke patients, for example, even though trial data showed the drug was not effective for that population. And Sanofi allegedly told Dickson to focus her Plavix sales calls on docs whose patients were mainly covered by Medicare or Medicaid, The New Jersey Law Journal reports.
But Wolfson disagreed with most of Dickson’s claims. Dickson did not prove that Plavix was prescribed for anything other than its on-label use, Wolfson noted in her ruling. Thirty-three states only reimburse a drug if it’s medically necessary, she added, and Dickson did not explain in her argument why Plavix doesn’t fit the bill.
Wolfson also rejected Dickson’s claims that Plavix was only put on lists of approved drugs for each state’s Medicaid program based on misleading information. There were “simply no allegations how any of defendants’ allegedly false promotional statements were material to, or had any bearing on, the decisions” made by formulary committees, Wolfson said. Plus, Dickson’s complaint doesn’t mention specific docs who received false marketing and then prescribed Plavix to Medicare and Medicaid beneficiaries.
Bristol-Myers Squibb is not commenting on the case, a company spokesman told FiercePharma in an email. And Sanofi does “not comment on pending litigation,” the company told FiercePharma in a separate note.
The positive ruling deals a shot of good news to the companies, which have encountered other pushback over Plavix marketing. In 2013, the Department of Justice (DoJ) said it would probe disclosures to the FDA about the med’s effectiveness in certain patients. And two U.S. state attorneys general have alleged in other suits that Bristol-Myers and Sanofi knew–or should have known–since 2003 that some patients don’t get Plavix’s full benefits.
By Emily Wasserman
Source: Fierce Pharma
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