PHILADELPHIA (CN) - Janssen Pharmaceuticals and Bayer "fervently marketed" an anticoagulant drug, Xarelto, "with no regard to the accuracy and misrepresentations of their misleading advertising," and without regard for reports of 356 serious, disabling or fatal injuries in a single quarter for which it was the primary suspect, the heir of a woman who allegedly died from the drug claims in court.
Della Wise sued Janssen Research & Development and affiliates and Bayer Corp., in the Court of Common Pleas, for the death of her aunt, Mattie Edgin.
"As a result of Defendants' intense marketing, '[a]bout 130,000 U.S. prescriptions were written for Xarelto in the first three months of 2012,' resulting in large profits, as Xarelto costs approximately $3,000 a year versus $200 for generic warfarin," a drug prescribed for the same reasons, the complaint states, citing the June 2012 article, "Pradaxa and Xarelto: Top Heart Doctors Concerned Over New Blood Thinners," from Huffpost Healthy Living.
Wise claims the defendants pushed Xarelto with false claims that patients who took it did not need regular monitoring for bleeding or blood clots (emboli). But the drug caused 72 deaths in the first three months of 2013 in Germany alone, according to the complaint.
It states: "Due to the defective nature of Xarelto, persons who were prescribed and ingested Xarelto, for even a brief period of time, including the Ingesting Decedent herein, were at increased risk for developing life-threatening bleeds. Due to the flawed formulation of Xarelto, which according to defendants does not require regular blood monitoring or frequent doctor follow-up, raises concerns about the risk of stroke, bleeding, and blood clots if not taken properly or absorbed properly, particularly in patients with poor renal function. In addition, '[p]rominent
U.S. [cardiologists and health care professionals] stress that neither new drug [Xarelto] has a known antidote for a bleeding emergency, as warfarin does." (Citation to same article.)
"Even more significantly, in the first quarter of 2012, The Institute for Safe Medication Practices 'identified 356 reports of serious, disabling, or fatal injury in which rivaroxaban was the primary suspect drug. The report more than doubled from the previous quarter total of 128 cases,'" the complaint states.
"However, when the findings were discussed with defendants, 'the company told us that it had reviewed the same data and saw no signal of a safety issue that needed to be addressed.'" (Citation to The Institute for Safe Medication Practices omitted.) "Defendants placed more value into ensuring that their profits would continue instead of working on minimizing the serious, disabling, or fatal injuries that were occurring due to the drug they were marketing and promoting."
Wise seeks punitive damages for fraud, wrongful death, consumer law violations, negligence, failure to warn, product liability, unreasonable marketing of a dangerous drug, and breach of warranty.
She is represented by W. Steven Berman with Napoli, Bern, Ripka & Shkolnik, of Marlton, N.J.