I do think that settlement had something to do with the fact that a former chief of the FDA was able to reveal what Johnson and Johnson didn’t want the public to see
Philadelphia, PA (PRWEB) October 10, 2012
For the second time in two weeks, Johnson and Johnson (J&J) came to the bargaining table with motivation to settle national bellwether lawsuits (1,2) over injuries to boys and young men allegedly caused by its once blockbuster drug Risperdal. (3)
The six confidential settlements may have been prompted by subpoenas requiring J&J’s CEO Alex Gorsky to testify in the first three cases (4) and plans to call former FDA Commissioner David Kessler, M.D., to testify in several of the other cases by plaintiff’s lawyers at Sheller, P.C. (5)
"I do think that settlement had something to do with the fact that a former chief of the FDA who served under both Republican and Democratic presidents was able to reveal some of what Johnson & Johnson didn’t want the public to see," said Sheller, P.C. trial attorney Brian J. McCormick. Jr. (6) McCormick and Sheller attorney Claudine Homolash were preparing to select a jury on Thursday morning in the third trial case when the settlement was finalized.
Risperdal is an atypical antipsychotic drug originally approved by the FDA for psychotic disorders such as schizophrenia and bipolar mania, but not, at that time, for children. Boys prescribed the drug claimed in the lawsuits they developed breasts that, in a number of cases, required mastectomies or other reconstructive surgery. (3, 4)
Risperdal was approved for children in late 2006. Sheller attorneys are now petitioning the FDA to revoke that approval. (7) The FDA is accepting public comments. (8)
According to Law 360 LexisNexis, attorney Stephen Sheller said he thought J&J made a smart business move by deciding to settle the cases rather than risk what he described as “an atom bomb” in the form of a jury's potential damage award. (6)
Dr. Kessler, chief of the FDA for seven years, and also a pediatrician, wrote in his expert report "The promotion of non-approved uses by a manufacturer, because it undercuts the system and safeguards of drug regulation, is concerning. The promotion of non-approved uses in the most vulnerable children of powerful drugs is most concerning. Janssen's promotion of Risperdal, a powerful drug, for non-approved uses in the most vulnerable children is deeply troubling." (9)
Risperdal had been a profit center for the drug company with global sales peaking at $4.5 billion as its top seller in 2007, according to Bloomberg reports. (10)
In the past several years, J&J has faced a number of legal challenges involving Risperdal. The New York Times reported last month that J&J agreed to pay $181 million to resolve claims by 36 states and the District of Columbia for promoting the drug and the similar formulation Invega for unapproved uses. (11) Previously, juries in Arkansas ($1.1 billion), Louisiana ($258 million) and South Carolina ($327 million) have decided that J&J illegally marketed the drug. (12,13,14)
A statement from J&J subsidiary Janssen said “Since the early 1990s, Risperdal has improved the lives of countless people throughout the world who suffer from the devastating effects of serious mental illness.” (3)
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About Sheller, P.C.
Sheller, P.C. represents plaintiffs injured by drugs and whistleblowers reporting pharmaceutical industry wrongdoing. The firm's defective drug and medical device attorneys are currently litigating cases involving J&J’s DePuy metal on metal hip implant injuries, (15) and J&J’s antibiotic Levaquin and ruptured tendons. Other matters under investigation by Sheller attorneys include dialysis using the FDA recalled (17) GranuFlo and NaturaLyte compounds at Fresenius and other dialysis centers as reported by the New York Times (18,19) and Allergan Lap-Band systems (20,21). Details can be found on Sheller.com.
In practice since 1977, Sheller, P.C. has challenged some of the largest corporations in the country including tobacco, auto, and drug and medical device manufacturers. As counsel in three of the largest whistleblower settlements in U.S. history totaling over $4.2 billion (22,23,24), the Sheller whistleblower leadership team continues to represent whistleblowers in other cases across the country.
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(1) Aron Banks v. Ortho-McNeil-Janssen Pharmaceuticals Inc. et al., case 100100618, Philadelphia Court of Common Pleas
(2) SB v. Ortho-McNeil-Janssen Pharmaceuticals Inc., case number 100503629; Kreves v. Ortho-McNeil Janssen Pharmaceuticals Inc., case number 100103671; JK v. Ortho-McNeil-Janssen Pharmaceuticals Inc., case number 100100652; and CC v. Ortho-McNeil-Janssen Pharmaceuticals Inc., case number 100503672 in the Philadelphia Court of Common Pleas.
(3) Bloomberg “Johnson and Johnson agrees to settle five Risperdal suits” businessweek.com/news/2012-10-04/johnson-and-johnson-agrees-to-settle-five-rispersal-suits
(4) The Legal Intelligencer, 10/5/12 “First Risperdal trial ends with settlement” law.com/jsp/pa/PubArticlePA.jsp?id=1202573753392&First_Risperdal_Trial_Ends_With_Settlement
(5) The Philadelphia Inquirer “Philly Pharma” blog "Former FDA chief David Kessler says J&J broke the law in promoting Risperdal" philly.com/philly/blogs/phillypharma/Ex-FDA-chief-David-Kessler-says-JJ-broke-the-law-in-promoting-Risperdal.html
(6) LexisNexis/Law 360, 10/4/12 “J&J resolves 5 Risperdal off-label marketing cases” law360.com/productliability/articles/384301/j-j-resolves-5-risperdal-off-label-marketing-cases)
(7) The Philadelphia Inquirer, 10/5/12 “Johnson and Johnson settles five Risperdal suits” philly.com/philly/business/20121005_Johnson___Johnson_settles_five_Risperdal_suits.html
(8) Regulations.Gov regulations.gov/#!searchResults;rpp=25;po=0;s=FDA-2012-P-0857
(9) The Philadelphia Inquirer “Philly Pharma” blog “Ex-FDA chief David Kessler says J&J broke the law in promoting Risperdal” philly.com/philly/blogs/phillypharma/Ex-FDA-chief-David-Kessler-says-JJ-broke-the-law-in-promoting-Risperdal.html
(10) Bloomberg “J&J Settles Risperdal Lawsuit on Opening Day of Trial”, September 10, 2012 bloomberg.com/news/2012-09-10/j-j-settles-risperdal-lawsuit-on-opening-day-of-trial.html
(11) New York Times “Johnson and Johnson Unit Settles State Cases Over Risperdal” nytimes.com/2012/08/31/business/johnson-johnson-unit-settles-state-cases-over-risperdal.html?_r=1
(12) State of Arkansas v. Ortho-McNeil-Janssen Pharmaceuticals Inc., CV07-15345, Pulaski County Circuit Court (Little Rock) Arkansas
(13) Caldwell ex rel. State of Louisiana v. Janssen Pharmaceutical, 04-C-3967, 27th Judicial Court, St. Landry Parish, Louisiana (Opelousas)
(14) State of South Carolina v. Janssen Pharmaceuticals, 2007-CP-4201438, Circuit Court for Spartanburg County, South Carolina (Spartanburg)
(15) Fay Dorney-Madigtz and plaintiffs v. DePuy Orthopaedics, Inc., Depuy, Inc., Johnson & Johnson Services, Inc., and Johnson and Johnson, Inc., U.S. District Court for the Eastern District of Pennsylvania, 5:11-cv-00124-RBS
(17) FDA: Fresenius Medical Care North America, NaturaLyte and GranuFlo Acid Concentrate fda.gov/MedicalDevices/Safety/ListofRecalls/ucm309990.htm
(18) Dialysis treatments using GranuFlo and NaturaLyte at Fresenius and other dialysis centers sheller.com/practice-areas/practice-areas.php?title=dialysis-treatments-using-granuflo-and-naturalyte-at-fresenius-and-other-dialysis-centers
(19) The New York Times “Dialysis Company’s Failure to Warn of Product Risk Draws Inquiry” nytimes.com/2012/06/15/health/fda-investigates-fresenius-for-failure-to-warn-of-risk.html
(20) Allergan Lap-Band AP System sheller.com/practice-areas/practice-areas.php?title=allergan-lap-band-ap-system
(21) Bloomberg News “Allergan Pulled Teen Lap-Band Plan as Criticism Mounted” bloomberg.com/news/2012-10-03/allergan-pulls-teen-lap-band-plans-as-criticism-mounts.html
(22) United States, ex. rel. James Wetta, et al. v. AstraZeneca Corp., No. 04-0379 (E.D. Pa.)
(23) United States, ex. rel. Ronald Rainero, et al. v. Pfizer, Inc., No. 07-11728 (D. Mass.)
(24) United States, ex. rel. Robert Rudolph, et al. v. Eli Lilly and Company, No. 03-943 (E.D. Pa.)