Were Janssen and Bayer Corrupt or Lazy?
In November of 2011 the FDA approved the use of a new anti-coagulation medication used in patient’s suffering from atrial fibrillation (AF). Atrial fibrillation is a condition that causes palpitations and an irregular heartbeat. There is an increased risk in heart disease as well as strokes in patients suffering from AF. In January of 2012, William Packard, a patient suffering from (AF), made an appointment with his physician regarding the use of the latest medication.
Mr. Packard’s physician believed the new medication would be more successful than the old treatment because it did not require the patient to go through the extensive monitoring he had previously endured. Within six months of taking the medication, William Packard began suffering from headaches and various episodes of confusion. He was promptly admitted to a hospital where he was diagnosed with subdural hemorrhaging, which is where bleeding occurs outside of the brain. Although emergency surgical attempts were made to inhibit the bleeding, William Packard was pronounced dead only five days after being admitted.
Later that year in mid July of 2012, Thomas Dunkley’s physician prescribed the same new anti-coagulant medication to treat his AF. On July 26th, Dunkley began to experience severe head pains. He suffered through the agonizing pain for five more days until he was pronounced dead on August 1st. Dunkley died within two weeks from when he started taking the medication.
The new anti-coagulant medication that was prescribed was Xarelto (rivaroxaban).
Xarelto a new form of anti-coagulants that has been linked to fatal bleeding with no reversal agent. Reversal agents are crucial in emergency situations. Unlike rival medications such as Pradaxa, emergency dialysis is not able to safely remove the drug from the patient’s system leading to death. Bayer knew about the serious health risks with Xarelto and failed to indicate them in any warnings. Why would such a well known company fail to mention something so important? Despite the apparent danger of the medication, Bayer and its partner, Johnson & Johnson, continued to engage in a major marketing campaign. The marketing of Xarelto was so successful that sales totaled approximately $1 billion in the last year.
However, Bayer now faces an unusually high amount of injury and wrongful death lawsuits. Bayer’s major defense is based on only two studies, one of which was paid for by Bayer and the other paid for by Janssen, a subsidiary of Johnson & Johnson. The first study was published in the New England Journal of Medicine on September 8th 2011 titled “Rocket AF”. The study compared Xarelto with Warfarin in the prevention of stroke and the treatment of AF. It was determined that there were “no significant differences in rates of major and clinically relevant non-major bleeding” among patients being treated with Xarelto or Warfarin.
The second study, titled “Einstein PE” was also published in the New England Journal of Medicine on April 5th 2012. The study focused on the comparison of Xarelto, a direct factor Xa inhibitor, and a completely different type of anti-coagulant, Enoxaparin Sodium, a low molecular weight heparin. The study determined Xarelto to have “superiority for major bleeding” when compared with Enoxaparin.
Both studies failed to mention the lack of a reversal agent, which is a critical factor when producing this type of drug. The idea that the manufacturer was ignorant to the potential dangers of their product is preposterous and alarming. Bayer and Janssen continue to praise and recommend their product, regardless of the fact that Xarelto has been linked to more than 2,000 adverse cases throughout 2013.
Ned McWilliams, an attorney with the Levin Papantonio law firm, is currently investigating the rising number of Xarelto lawsuits. “Jansen and Bayer’s refusal to supply doctors and patients the information necessary for the safest and most effective use of their drug is wholly unacceptable,” states McWilliams. Over 150 patients have died from complications brought on by Xarelto.
The families of the deceased claim that the dangers of the medication were not only known by the companies, but that the information was intentionally withheld. Bayer, a company with a history of covering up deadly complications, has made an immense effort to hide any prior knowledge of Xarelto to avoid profit loss.