COLUMBIA, S.C. (AP) -- It's now up to a Spartanburg County judge to decide how much a Johnson & Johnson subsidiary should pay South Carolina for deceptive marketing of an antipsychotic drug. If the judge agrees with attorneys for the state, that number could be in the billions of dollars.
Last month, a jury ruled that Janssen Pharmaceutica, Inc. -- a subsidiary of the New Brunswick, N.J.-based drug manufacturer -- had violated the South Carolina Unfair Trade Practices Act by sending misleading letters to about 7,200 doctors in South Carolina downplaying the links between diabetes and its schizophrenia drug Risperdal.
The blockbuster antipsychotic lost patent protection in 2008. Johnson & Johnson said last month that Risperdal Consta, the long-acting version of the drug, generated $1.5 billion in sales last year.
The company also made tens of thousands of drug marketing-related phone calls that minimized Risperdal's link to diabetes, improperly claimed the drug was safer than other competing medications, and enclosed misleading information inside drug packages, the jury found.
In the Nov. 10, 2003, letter, a Janssen official said research showed Risperdal was not associated with an increased risk of diabetes when compared to other drugs or patients receiving no treatment at all.
"Evidence also suggests that RISPERDAL is associated with a lower risk of diabetes than some other studied atypical antipsychotics," Janssen vice president Ramy Mahmoud wrote.
The company also argues that, if South Carolina had truly feared for patients' safety, the state would have requested an injunction stopping any prescriptions from being filled, noting that an expert for the state testified that there were no facts to support any risk of death in the elderly as a result of taking the drug.
"There is no evidence in the record that Risperdal has actually caused any South Carolina patients to experience adverse effects related to the alleged risks," Janssen attorneys wrote in a brief filed April 15. "This case is novel: there was no precedent -- not a single authority -- that so much as suggested that an FDA-approved package insert could be the subject of a state law deceptive trade practices claim."
Saying that the drug manufacturer acted in good faith, attorneys for Johnson & Johnson also argue that it sent the "Dear Doctor" letter without being asked to do so by the U.S. Food and Drug Administration and that drug regulators never expressed any concern over the package insert.
But the FDA did voice worries about the 2003 communications, issuing a warning letter in 2004 in which it called the company's argument "false or misleading" because of its claims that Risperdal is safer than other drugs and failed to include information about minimizing diabetes-related ailments.
Violations of this South Carolina law carry potential penalties of up to $5,000 apiece. In a court exhibit, attorneys for the state argued that they see the number of violations as potentially including every single prescription, sample box or "Dear Doctor" letter written since the mid-1990s -- numbers that reach into the millions when totaled up.
Considering the 620,000 Risperdal prescriptions written for people on Medicaid and the state health plan alone, that could mean more than $3.1 billion -- without even taking into account any of the sample boxes or "Dear Doctor" letters the state also argued were in violation of the law.
Janssen spokesman Greg Panico said the company was disappointed in the South Carolina jury's verdict but did not know if it would appeal, the action Janssen has taken against a Louisiana verdict ordering the company to pay nearly $258 million for misrepresenting Risperdal's links to diabetes.
South Carolina's case over Risperdal is the fourth to go to court. A Pennsylvania case was dismissed in June, and a case in West Virginia was dropped in December.
Attorneys for both sides have until next week to file final briefs to Judge Roger Couch, who has said he will rule later on the damages amount. Drug company lawyers say no one in South Carolina was harmed by its Risperdal marketing and that fines shouldn't be severe.
Last month, a jury ruled that Janssen Pharmaceutica, Inc. -- a subsidiary of the New Brunswick, N.J.-based drug manufacturer -- had violated the South Carolina Unfair Trade Practices Act by sending misleading letters to about 7,200 doctors in South Carolina downplaying the links between diabetes and its schizophrenia drug Risperdal.
The blockbuster antipsychotic lost patent protection in 2008. Johnson & Johnson said last month that Risperdal Consta, the long-acting version of the drug, generated $1.5 billion in sales last year.
The company also made tens of thousands of drug marketing-related phone calls that minimized Risperdal's link to diabetes, improperly claimed the drug was safer than other competing medications, and enclosed misleading information inside drug packages, the jury found.
In the Nov. 10, 2003, letter, a Janssen official said research showed Risperdal was not associated with an increased risk of diabetes when compared to other drugs or patients receiving no treatment at all.
"Evidence also suggests that RISPERDAL is associated with a lower risk of diabetes than some other studied atypical antipsychotics," Janssen vice president Ramy Mahmoud wrote.
The company also argues that, if South Carolina had truly feared for patients' safety, the state would have requested an injunction stopping any prescriptions from being filled, noting that an expert for the state testified that there were no facts to support any risk of death in the elderly as a result of taking the drug.
"There is no evidence in the record that Risperdal has actually caused any South Carolina patients to experience adverse effects related to the alleged risks," Janssen attorneys wrote in a brief filed April 15. "This case is novel: there was no precedent -- not a single authority -- that so much as suggested that an FDA-approved package insert could be the subject of a state law deceptive trade practices claim."
Saying that the drug manufacturer acted in good faith, attorneys for Johnson & Johnson also argue that it sent the "Dear Doctor" letter without being asked to do so by the U.S. Food and Drug Administration and that drug regulators never expressed any concern over the package insert.
But the FDA did voice worries about the 2003 communications, issuing a warning letter in 2004 in which it called the company's argument "false or misleading" because of its claims that Risperdal is safer than other drugs and failed to include information about minimizing diabetes-related ailments.
Violations of this South Carolina law carry potential penalties of up to $5,000 apiece. In a court exhibit, attorneys for the state argued that they see the number of violations as potentially including every single prescription, sample box or "Dear Doctor" letter written since the mid-1990s -- numbers that reach into the millions when totaled up.
Considering the 620,000 Risperdal prescriptions written for people on Medicaid and the state health plan alone, that could mean more than $3.1 billion -- without even taking into account any of the sample boxes or "Dear Doctor" letters the state also argued were in violation of the law.
Janssen spokesman Greg Panico said the company was disappointed in the South Carolina jury's verdict but did not know if it would appeal, the action Janssen has taken against a Louisiana verdict ordering the company to pay nearly $258 million for misrepresenting Risperdal's links to diabetes.
South Carolina's case over Risperdal is the fourth to go to court. A Pennsylvania case was dismissed in June, and a case in West Virginia was dropped in December.
Attorneys for both sides have until next week to file final briefs to Judge Roger Couch, who has said he will rule later on the damages amount. Drug company lawyers say no one in South Carolina was harmed by its Risperdal marketing and that fines shouldn't be severe.