MARTINSBURG - A man is suing Janssen Research & Development for allegedly wrongfully representing one of its drugs.
Janssen Research & Development LLC; Janssen Ortho LLC; Janssen Pharmaceuticals Inc.; Bayer Healthcare Pharmaceuticals Inc.; Bayer Pharma AG; Bayer Corporation; Bayer Healthcare LLC; Bayer Healthcare AG; and Bayer AG were all named as defendants in the suit.
Jermaine Tavon McMillan was prescribed Xarelto, according to a complaint filed Feb. 20 in the U.S. District Court for the Northern District of West Virginia.
McMillan claims when warning of safety risks of Xarelto, the defendants negligently or wantonly and/or fraudulently represented to the medical and healthcare community, the Food and Drug Administration, to him and the public in general, that Xarelto had been tested and was found to be safe and/or effective for its indicated use.
The defendants concealed their knowledge of Xarelto's defects from McMillan, the FDA, the public in general and/or effective for its indicated use, according to the suit.
McMillan claims the defendants negligently or wantonly and improperly failed to perform sufficient tests, if any, on humans using Xarelto during clinical trials, forcing McMillan and his physicians, hospitals and/or the FDA to rely on safety information that applies to other non-valvular atrial fibrillation treatment and DVT/PE treatment and prophylaxis.
As a result of the defendants' acts and omissions, the plaintiff was caused to suffer serious and dangerous side effects including life-threatening bleeding, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and emotional and mental anguish, diminished enjoyment of life, shortened life expectancy, medical expenses, loss of earnings or earning capacity and other economic and non-economic damages, according to the suit.
McMillan claims the defendants concealed their knowledge of the defects in their products from him, his physicians, hospitals, pharmacists, the FDA and the public in general.
William Foster, spokesperson for Janssen Pharmaceuticals said Xarelto is an important anticoagulant used to treat and reduce the risk of life-threatening blood clots.
"After more than three years on the U.S. market, and more than 2 million patients prescribed in the U.S. to date, the benefit-risk profile of Xarelto remains favorable and consistent with its clinical trials," Foster said. "All anticoagulants, or blood thinners, carry the risk of bleeding, and the prescribing information for Xarelto has always warned of these risks."
Foster said blood thinners are important and potentially life-saving medicines that should be taken by patients as prescribed by a doctor and should not be discontinued without a discussion with a doctor.
"We will continue to defend against the claims raised in this litigation," Foster said.
McMillan is seeking compensatory and punitive damages with pre- and post-judgment interest. He is being represented by J. Farrest Taylor of the Cochran Firm.
The case is assigned to District Judge Gina M. Groh.
U.S. District Court for the Northern District of West Virginia case number: 3:15-cv-00019