Caronia Decided — First Amendment Protects Off-Label Speech!
It finally happened. After two long years (plus one day) since oral argument, the U.S. Court of Appeals for the Second Circuit in a 2-1 split vote decided U.S. v. Caronia, tossing Alfred Caronia’s...
View ArticleA First Amendment Safe Harbor for Off-Label Promotion — The Right Course for...
It has been a busy month for legal commentators digesting the Second Circuit’s “landmark” decision in U.S. v. Caronia and its ramifications for the pharmaceutical industry. By ruling 2-1 that...
View ArticleGovernment Takes A “Pass” on the First Amendment
Last week it was reported across the internet that the FDA would not seek to appeal the Second Circuit’s majority decision in U.S. v. Caronia to the Supreme Court. Admitedly, in the wake of Caronia,...
View ArticleNavigating FDA Guidance on Facebook and Social Media
The FDA recently warned AMARC Enterprises, Inc., a California-based dietary supplement company, that its Facebook page (https://www.facebook.com/poly.mva) was not in compliance with FDA guidelines....
View ArticlePfizer $149 Million Rapamune Settlement Is More Proof That It’s Business As...
Two False Claims Act whistleblower lawsuits are being resolved as part of a $491 million settlement between Wyeth Pharmaceuticals, now a division of Pfizer, Inc., and the U.S. DOJ. This time around,...
View ArticlePlaintiff’s Lawyers File RICO Class Action Suit Against Abbott Over Depakote...
A well-known plaintiff’s law firm with a stable of union pension fund clients has used the Racketeering Influenced and Corrupt Organizations Act (“RICO”), which was originally enacted in 1970 to combat...
View ArticleMedtronic InFUSE Cases Signal That Off-Label Promotion Probably Not Illegal
A majority of plaintiffs seeking damages based on off-label promotion of Medtronic’s InFUSE Bone Graft system have been stopped in their tracks following several recent federal court decisions holding...
View ArticleJ&J to Pay $2.2 Billion To End Long-Standing Investigations By Feds
Charges of off-label marketing and kickback payments to physicians and long-term care pharmacy provider Omnicare are behind a $2.2 billion settlement agreement between Johnson & Johnson (“J&J”)...
View ArticleAegerion CEO’s Remarks On Television Highlight Off-Label Free Speech Issue...
According to the FDA’s Office of Prescription Drug Promotion (“OPDP”), Marc Beer, the CEO of biopharmaceutical firm Aegerion Pharmaceuticals, overstepped his bounds when he allegedly made misleading...
View ArticleFDA’s Social Media Guidance and the First Amendment – the Next Frontier
Now that Pharmarisc is back up and running, what better topic to discuss than the one that started this blog in the first place back in December, 2012 – the FDA’s incursion into manufacturers’ free...
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