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Warning Not Enough to Avoid Liability?

Pharmaceutical companies have frequently been harangued in the past for their “failure to warn” about the risks involved in using their products even if they knew or should have known that the risk was there. The Food and Drug Administration (FDA) have required these companies to modify their warning labels to reflect these risks, which have provided a “cut off” for patients who may have suffered personal injury for using the product. After all, they’ve been warned.

That may no longer be enough for these drug companies to avoid liability.

A recent ruling by the Pennsylvania Supreme Court for dangerous drug products effectively elevated the liability threshold for drug companies regarding products that carry too high a risk of harm to be ever marketed in the first place. In other words, if a drug is deemed too dangerous, the drug company is liable for any harm that happens to its users even if the company clearly warned patients and doctors about the associated risks.

A Xarelto lawsuit is often associated with serious and uncontrollable bleeding that poses a risk to the health and life of the patient. Xarelto (rivaroxaban) is an anticoagulant of the class direct factor Xa (10-a) inhibitors or xabans, and like all blood thinners pose a risk of bleeding for its users. However, because Xarelto has no known reversal agent, its introduction into the market despite this lack may be interpreted by the courts as negligence based on the recent Pennsylvania ruling.

That is probably what Kentucky resident Virginia Stuntebeck was counting on when she filed a Xarelto lawsuit in Pennsylvania state court, naming Xarelto US distributor Janssen Ortho LLC and manufacturer Bayer Corp among others as defendants. Janssen had been served first, and the company succeeded in petitioning for a transfer of the case to federal court. However, the federal court promptly returned the case to Pennsylvania state court because Bayer is based in that state.

When and if the case finally makes it to trial, it is probable that there will be many more that had been filed in the meantime, which may mean that Janssen and Bayer may be in the bag for their dangerous drug. The payouts and settlements will probably be for hefty sums, but considering that Janssen has posted more than $800 million in sales in the US alone for 2013, they can probably afford it.