$7.3M Astellas Pharma Off-Label Marketing and FCA Settlement

Digital Journal 2014-04-16 The whistleblower attorney team of Sheller P.C. announced today that Astellas Pharma U.S., Inc. has agreed to pay $7.3 million to resolve allegations by the Sheller whistleblower client that Astellas violated the False Claims Act by submitting fraudulent claims to government healthcare programs while marketing off-label the antifungal drug Mycamine for use in children. Court […]

Sheller Spars With FDA

pharmalot,silverman,ed,risperdal,fda,petition

Lawyer Spars With FDA Over J&J Risperdal Court Documents by Ed Silverman, Pharmalot In an unusual tactic, an attorney is prodding the FDA to seek documents that purportedly detail side effects caused by the Risperdal antipsychotic, but cannot be released publicly due to a court order. The documents were sealed by a Philadelphia judge as […]

Sheller on Lawyer Spars With FDA Over J&J Risperdal Court Documents

Pharmalot.com, Pharmaceutical Industry News 2013-07-11 In an unusual tactic, an attorney is prodding the FDA to seek documents that purportedly detail side effects caused by the Risperdal antipsychotic, but cannot be released publicly due to a court order. The documents were sealed by a Philadelphia judge as part of ongoing litigation over claims the Johnson […]

Sheller in Philadelphia Inquirer “FDA Slow to Ask J&J for Drug Data”

The Philadelphia Inquirer & “Fierce Pharma” 2013-07-10 The U.S. Food and Drug Administration is dragging its feet in addressing concerns that Johnson & Johnson’s antipsychotic drugs Risperdal and Invega are dangerous, a Philadelphia lawyer says in letters to the federal agency, and the company should allow those alleging harm from the medicines to release information […]

Sheller on American Law Journal TV discussing FDA and Pharma Executives,

The American Law Journal 2013-06-16 Attorney Stephen Sheller sparred with pharmaceutical defense attorney Hope Freiwald of Dechert law firm on the television program The American Law Journal. The attorneys, joined by Pharmalot author Ed Silverman, Atlanta pharmaceutical product liability attorney Matthew Harman in a program moderated by attorney Christopher Naughton discussed the FDA and drug […]

Sheller in Philadelphia Inquirer “High Court Sides with Philadelphia Drug Firm”

2013-06-25 In a case involving a Philadelphia company, a divided U.S. Supreme Court ruled Monday that federal pharmaceutical laws preempt a person’s ability to sue in state court alleging that a generic drug is designed badly and therefore is dangerous. The court’s 5-4 decision in Mutual Pharmaceutical Co. v. Bartlett is a victory for the […]