Medical malpractice is another common source of litigation. Given the recent news that has come to light over the side effects of Xarelto (rivaroxaban) and the inaccurate dosing information that has led to injury and death, some victims wonder if they have grounds for a medical malpractice suit against their physician and health care provider.
The simple answer in most cases is no. Either by design or careless oversight, Bayer and Janssen provided the same misinformation to the medical profession as they did to health care consumers. The health care provider can only operate on the information they have. As long as the physician makes his or her decisions based on what s/he reasonably knows (or should have known) to be accurate, there are no grounds for malpractice.
It is true that prescribing physicians were aware of the possibility of serious bleeding with the new Factor Xa anticoagulants. This information came our earlier during litigation over a similar medication, Pradaxa (drug maker Boehringer-Ingelheim settled its cases in May 2014 for $650 million). The main issue over Xarelto is the dosage guidelines provided by Janssen.
For over six decades, physicians used warfarin, a form of rat poison, for the treatment of patients at risk for stroke due to blood clotting. A vitamin K antagonist, warfarin is inexpensive and the effects can be reversed if necessary. There are disadvantages, however. Because there are so many potential interactions, warfarin patients must be monitored closely. These patients must also have their blood tested for the amount of clotting factor present – and the dosage of warfarin must be adjusted accordingly.
In its advertising and promotional materials, Bayer and Janssen claimed that two standard doses (100 mg and 300 mg) were suitable for all patients. All a physician needed to do was determine which dosage to prescribe. This is the cause of action for today's Xarelto lawsuits. While it is true that the effects of Xarelto cannot be reversed and patients have bled to death because of it, recent research has shown that the severity of the bleeding is directly tied to the amount of the drug in the system. Had patients been monitored for clotting agent levels in their bloodstreams, some who have died might be alive today.
What has yet to be determined is whether the manufacturers of Xarelto were aware of this and deliberately withheld the knowledge, or failed to detect the dangers when they should have. This liability lies with the manufacturer, not the physician who prescribed the medication in good faith.
For more information on the Xarelto Litigation, visit Levin Papantonio’s Xarelto Lawsuit page.