Judge Freda Wolfson of the U.S. District of New Jersey has granted some relief for drugmakers Bristol-Myers Squibb and Sanofi-Aventis in a complicated multidistrict whistleblower lawsuit against the two companies over marketing claims involving the blood-thinning medication Plavix. Wolfson granted motions to dismiss several claims made by former Sanofi sales representative Elisa Dickson, alleging that the company instructed her to lie to doctors about aspects of the drug’s effectiveness. Among the allegations, Dickson says that she was instructed to tell doctors that Plavix was more effective than aspirin for stroke patients, even though there is no clinical evidence to back up that claim. Dickson also claims that she was instructed to focus sales calls on doctors who treated a high percentage of patients covered by Medicare and Medicaid. Bristol-Myers and Sanofi marketed Plavix jointly, according to court documents.
Wolfson dismissed a majority of Dickson’s claims, including 33 False Claims Act (FCA) claims regarding Medicare, specifically Part D coverage, and 43 state-level Medicaid claims. The judge did however; fail to dismiss 17 federal-level and seven state-level claims made under the FCA. Wolfson ruled that because the relator (Dickson) did not claim that Plavix was excluded under Medicare Part D, as well as not say the drug was recommended for anything other than its on-label use, that she failed to prove a proper FCA claim. Wolfson said that the relator did not properly define the term “medical necessity,” which is a requirement for Part D reimbursement in the 33 states in which the judge dismissed the claims. Wolfson did not see why under this criteria, Plavix would not be considered a viable choice since it is FDA approved. Similarly Wolfson also dismissed claims that most states placed Plavix on their Medicaid-approved list based on false information, failing to find a convincing argument made by the relator. Wolfson did however, refuse to dismiss claims regarding 17 states’ Part D coverage and seven states’ Medicaid claims due to “cost effective” provisions written in the states’ laws. Wolfson called those claims “plausible,” as Plavix is roughly as effective as aspirin for stroke patients, although being much more expensive.
The lawsuit against Bristol-Myers and Sanofi began in March 2011 in the Southern District of Illinois, with the Judicial Panel for Multidistrict Litigation transferring the case to New Jersey in February 2013. Neither Bristol-Myers or Sanofi, nor Chris Cueto, the relator’s attorney would comment on the ruling, with a Sanofi representative stating that the company does “not comment on pending litigation.” Along with several other MDL cases, the Justice Department investigated the drug in 2013, along with two states’ attorneys claiming in lawsuits that not all patients are genetically disposed to receive the Plavix’s full benefits. This comes after the Food and Drug Administration (FDA) added a “black box” warning on the drug’s labeling in 2010, stating that patients with a certain genetic makeup cannot metabolize the drug, putting them at risk for heart attack and stroke. Despite the dismissals, Wolfson’s docket still contains 250 Plavix-related cases, although that number is down from a previous high of 311.
Fierce Pharma – Emily Wasserman
The Legal Examiner – Shezad Malik MD, JD
New Jersey Law Journal – Charles Toutant