Philadelphia, PA (PRWEB) November 04, 2013
Healthcare giant Johnson & Johnson and its subsidiary, Janssen Pharmaceuticals (J&J), will pay the federal government more than $2 billion in civil settlement and criminal fines to settle charges that Janssen Pharmaceuticals illegally marketed the blockbuster antipsychotic drug Risperdal®.(1)
“This is the largest civil criminal settlement in the history of the qui tam False Claims Act for a single drug,” says Stephen A. Sheller, founding partner of Sheller, P.C. in an interview with The American Law Journal. According to Pro Publica, the whistleblower settlement is among the top five civil and criminal pharmaceutical company settlements in U.S. history and is the largest for a single drug. The settlement also includes the drug Invega®, which is a byproduct of Risperdal.
Sheller, P.C.,a mass torts and whistleblower/qui tam law firm, filed the first complaint in the matter in 2004(1) on behalf of a whistleblower, a former J&J pharmaceutical sales representative.
The claim involves whether J&J and Janssen illegally promoted Risperdal for unapproved uses in children and adolescents, including conduct disorders and attention deficit hyperactivity disorders, as well as for behavioral disturbances in elderly dementia patients. The United States government also contends in the court documents(1) that J&J made false and misleading statements about the safety of Risperdal, and that J&J paid “kickbacks” to physicians in order to induce the doctors to prescribe Risperdal.
“The way J&J marketed these drugs to nursing homes and nursing home physicians was as a ‘chemical restraint,’” says the whistleblower’s attorney, Sheller, P.C. partner Brian J. McCormick, Jr., citing court documents(1) during the American Law Journal interview. "They actually used to use the term ‘caregiver relief,’ because if the patient was on the drug they really didn’t have to take care of them because they were in a stupor.”
According to the drug company prescribing literature, Risperdal was originally approved by the Food and Drug Administration (FDA) only for schizophrenia and then specific types of bipolar mania. U.S. law prohibits drug companies from marketing drugs to health care professionals for unapproved conditions and populations.
Risperdal was once J&J’s best-selling “franchise” drug, with sales in the U.S. and internationally of $24.2 billion from 2003 to 2010, with $4.5 billion in 2007 alone according to reports by Bloomberg.(2) The drug went generic in 2008.
“Everybody knows J&J for Band Aids, baby shampoo and Q-Tips,” continues McCormick in The American Law Journal interview. “This case is important nationally because it shows that no pharmaceutical or health care company is above the law... I think what got to (the whistleblower) was what the company was doing to the elderly, how they were promoting this drug to that niche market of people that couldn’t do anything in response, who really didn’t have anyone looking out for them. I think that was the final straw.”
“J&J, the parent company of Janssen, is having product problems,” says Sheller, citing a Newark Star-Ledger report(3) “the DePuy hip implants that are failing, manufacturing plant contaminations and recently J&J came under fire for knowing about an alarming rate of failure for its vaginal mesh yet continued to sell for female organ prolapse.”
Sheller and McCormick have now been counsel for whistleblowers in off-label marketing and failure-to-warn cases that have brought more than $6 billion in recoveries for the United States government in just four years. In addition to J&J, Sheller’s record settlements include Eli Lilly (Zyprexa, $1.4 billion, 2009)(4), Pfizer (Zyvox/Geodon, $2.3 billion, 2009)(5) and AstraZeneca (Seroquel, $520 million, 2010)(6).
Sheller is also known for pursuing Phillip Morris for consumer fraud in the $10.1 billion “light” tobacco verdict.(7)
The Sheller firm also represents individuals who allege to have been injured by Risperdal.(8,9) “I personally believe Risperdal is the worst of all the antipsychotics,” Sheller tells The American Law Journal. “In my opinion, it has one of the worst adverse event profiles by far.”
Sheller’s clients in multiple Risperdal injury lawsuits (8,9) allege they have developed gynecomastia, a serious condition where young boys and men have developed large or female-shaped breasts after taking Risperdal. According to court documents, some of the boys have been forced to have mastectomies to correct the condition. While a number of cases have already settled(10), Sheller, P.C. still represents hundreds of these young men and boys.
Sheller and McCormick laud the team in the Philadelphia U.S. Attorney’s Office for their investigation, including Assistant U.S. Attorneys Margaret Hutchinson, Louis Lappen and Charlene Fullmer.
“Once again, the U.S. Attorney’s office in Philadelphia has supported whistleblower efforts and successfully prosecuted a significant case, recouping hundreds of millions for the government and its citizen taxpayers,” concludes Sheller in the American Law Journal interview.
Joining Sheller as co-counsel in the matter is the Philadelphia law firm Duane Morris LLP and Florida attorney Gary Farmer.
Other cases against J&J for illegally marketing Risperdal that have recently settled or reached a verdict include the states of Arkansas for $1.1 billion(11), Louisiana for $258 million(12), South Carolina for $327 million(13) and Texas for $158 million(14).
The case is: U.S. ex rel. Victoria Starr v. Janssen Pharmaceutica Prods., L.P., No. 04-1529
(1) United States ex. rel. Victoria Starr, et al. v. Janssen Pharmaceutica Prods., L.P., No. 04-1529
(2) "J&J Said to Agree to Pay $1 Billion in Risperdal Marketing Probe" Bloomberg News, January 6, 2012
(3) "Johnson & Johnson discloses government probe of hip implants, surgical mesh" Newark Star-Ledger, February 22, 2013
(4) United States ex. rel. Robert Rudolph, et al. v. Eli Lilly and Company, No. 03-943
(5) United States ex. rel. Ronald Rainero, et al. v. Pfizer, Inc., No. 07-11728
(6) United States ex. rel. James Wetta, et al. v. AstraZeneca Corp., No. 04-0379
(7) Price v. Philip Morris USA, 848 N.E.2d 1 (Ill. 2005)
(8) In re Risperdal Litigation, March Term 2010, No. 296 (Philadelphia County Court of Common Pleas)
(9) In re Risperdal/Seroquel/Zyprexa Litigation, Case No. 274 (Superior Court, Middlesex County, N.J.)
(10) "Johnson & Johnson Agrees to Settle Risperdal Suits" Bloomberg News, October 4, 2012
(11) State of Arkansas v. Ortho-McNeil-Janssen Pharmaceuticals Inc., CV07-15345,
Pulaski County Circuit Court (Little Rock) Arkansas
(12) Caldwell ex rel. State of Louisiana v. Janssen Pharmaceutical, 04-C-3967,
27th Judicial Court, St. Landry Parish, Louisiana (Opelousas)
(13) State of South Carolina v. Janssen Pharmaceuticals, 2007-CP-4201438,
Circuit Court for Spartanburg County, South Carolina (Spartanburg)
(14) Texas v. Janssen LP, D-1GV-04-001288, District Court, Travis County, Texas (Austin)
About Sheller, P.C.
The Philadelphia-based attorneys of Sheller, P.C. represents plaintiffs nationwide injured by consumer products including drugs and medical devices as well as whistleblowers reporting corporate and government wrongdoing.
In practice since 1977, Stephen A. Sheller and Sheller, P.C. have challenged some of the largest corporations in the country including tobacco, auto, and drug and medical device manufacturers. The firm has been counsel in more than $6 billion in whistleblower recoveries for the U.S. government, some of the largest in U.S. history.(1,4,5,6)