Misleading Risperdal, Duragesic Patch Claims Prompt Fines in West Virginia LawsuitMar 4, 2009 | Parker Waichman LLP
Risperdal maker Johnson & Johnson has been ordered by a West Virginia judge to pay a hefty fine over a 2003 letter to doctors that obfuscated the antipsychotic drug's diabetes risk. According to Bloomberg News, the same judge also assessed a smaller fine after finding that doctors were misled about the risks and benefits of the company's Duragesic pain patch.
Risperdal is one of class of drugs called atypical antipsychotics. Other atypical antipsychotics include Eli Lilly's Zyprexa, and AstraZeneca's Seroquel. These drugs have long been linked to an increased risk of weight gain and diabetes. According to Bloomberg News, in 2003, the Food & Drug Administration (FDA) required the makers of antipsychotics to warn about this risk.
The State of West Virginia had brought suit against Johnson & Johnson and its Janssen unit over claims made in the 2003 letter to doctors, Bloomberg News said. The FDA had already cited the same letter for being misleading. West Virginia Circuit Court Judge Martin Gaughan agreed, writing that the letter was "deliberately constructed to circumvent the FDA's mandated warning for an increased risk of diabetes, and deliberately constructed to mislead health-care professionals."
According to Bloomberg News, the judge fined Johnson & Johnson $1.95 million for the letter and an additional $2 million for Risperdal sales calls made in West Virginia from November 2003 to July 2004.
The makers of antipsychotics have faced increasing scrutiny over the way these drugs are marketed. Hundreds of lawsuits have been filed by individuals who claim the drug's diabetes risks were hidden. Meanwhile, federal and state authorities have, like West Virginia, filed lawsuits over the drugs' illegal promotion.
Earlier this year, Eli Lilly agreed to pay $1.4 billion in fines to settle federal charges over its promotion of Zyprexa. Documents unsealed in Seroquel litigation indicate that, among other things, AstraZeneca directed sales reps to downplay the drug's diabetes risks.
In West Virginia, Judge Gaughan also assessed Johnson & Johnson and Janssen a $525,000 fine for distributing a brochure that contained misleading information about the Duragesic patch. According to a report on WOWKTV.com, the FDA had also warned the companies that the brochure was misleading.
In his order, Judge Gaughan wrote that "The defendants were twice put on notice by previous [FDA] warning letters that its promotional materials for Duragesic contained false or misleading statements; however . . . the defendants then willfully sent the false or misleading Duragesic [brochure] to West Virginia health care providers to make its medication Duragesic more appealing for sale.”
Fentanyl patches, like the Duragesic Patch, have long been linked to accidental overdoses. In December 2007, FDA issued an alert, warning patients and doctors that there was a high danger of accidental overdose associated with the use of fentanyl patches, including the Duragesic Pain Patch. At the time, the FDA attributed the overdoses to patch “misuse” and ordered all fentanyl patch makers to create special “medication guides” for patients that spell out the dangers of overdoses and improper use in easy-to-understand language.