Product News and Recalls

J&J wants to expand marketing for drug

According to a story in the Washington Post, Johnson & Johnson has applied to the U.S. Food and Drug Administration to get approval of another use for its anti-clotting drug Xarelto.

Johnson & Johnson currently markets Xarelto for reducing the risk of blood clots in patients after knee or hip replacement surgery, and reducing the risk of stroke and other blood clots in people with a type of irregular heartbeat. The company has applied to the FDA for permission to market the drug for lowering the risk of clots forming around stents propping open arteries in the heart.

The report says selling the same product for multiple conditions and patient groups is a common and lucrative practice for Johnson & Johnson.

But the company has also been penalized for illegally marketing products for unapproved uses.

A federal court in Arkansas recently fined Johnson & Johnson $1.2 billion – among the biggest awards on record for a state-related fraud case involving a pharmaceutical company – over allegations that the company promoted the drug for unapproved uses or downplayed risks.

Thousands of lawsuits over two Johnson & Johnson medical devices accuse the company of similar deceptive tactics.

Transvaginal mesh implants, used to treat urinary incontinence and pelvic organ prolapse, have generated widespread complaints about health problems including organ perforation and debilitating pain.

And metal-on-metal hip implants manufactured by Johnson & Johnson subsidiary DePuy Orthopaedics were recalled in 2010 following thousands of reports of premature failure and toxic metal debris breaking off and getting in patients’ bodies.

Plaintiffs claim the company actively marketed both devices despite being aware of those problems.

You should consult with a doctor if you have any ongoing symptoms or health concerns. If you have significant injuries, you should also consult with a lawyer familiar with the DePuy hip implant or transvaginal mesh case to discuss your legal rights.

See the story here: http://www.washingtonpost.com/business/industries/johnson-and-johnson-seeks-fda-ok-for-fifth-use-of-anticlotting-drug-xarelto-for-stent-patients/2012/05/09/gIQAVt7SDU_story.html