Johnson & Johnson Ordered to Pay $4,475,000
West Virginia Circuit Judge Martin Gaughan has ordered Johnson & Johnson and its Janssen Pharmaceutica subsidiary to pay civil penalties totaling $4,475,000.00 for making false or misleading statements to West Virginia physicians about two of its products - Risperdal, an antipsychotic
The State of West Virginia was represented by three private attorneys, including Clark Perdue partner, Andrew List, with Barry Hill of Anapol, Schwartz, Weiss, Cohan, Feldman & Smalley in Wheeling WV, and Robert Goldberg of Charleston WV. The case, filed in 2004, was tried to the Court last fall. Judge Gaughan entered a 77 page order on February 25, 2009. Prior to trial, the judge found that the defendants had made false or misleading statements, as a matter of law. At trial, the issues were how many violations occurred and the amount of the penalty to assess for each violation. The parties stipulated to the number or instances that could qualify as violations.
The court assessed $5,000 per violation for each message delivered personally to a West Virginia doctor by a company sales representative and $500 for each statement conveyed by letter or sales brochure, for a total award of $4.475 million.
Drug Alert: RAPTIVA
- Drug: Raptiva
- FDA approval: in 2003 to treat psoriasis.
- Means of administration: by injection once a week.
- Adverse events:
- Suppression of immune system creating risk of serious, life-threatening infections, such as bacterial sepsis, viral meningitis, invasive fungal disease and other opportunistic infections.
- Rare and usually fatal condition called progressive multifocal leukoencephalopathy (PML). PML is an extremely serious neurologic disease caused by a virus which affects the central nervous system. When PML occurs, it is usually in people with weakened immune systems resulting in irreversible neurologic function and death. Symptoms of PML may include weakness on one side of the body, blurred or loss of vision, fatigue, memory loss, disorientation or a loss of balance. Reported PML cases to date involve use of Raptiva for over three years.
- FDA actions: October 16, 2008 black box and February 19, 2009 FDA Public Health Advisory warning of the adverse events listed in paragraph 4, above.
- Health Canada action: Raptiva removed from the Canadian market.
- European Medicines Agency action: Recommends Raptiva be removed from the European market.
Clark, Perdue & List is investigating Raptiva cases where there has been a serious infection or development of PML after use of Raptiva. A blank intake questionnaire for your use may be downloaded here.
Please e-mail or call with any questions.
