Xarelto makers sued over drug's alleged inability to congeal blood in timely manner

A woman alleges she and multiple people have suffered an inability for their blood to congeal in a timely manner after ingesting a medication designed to prevent strokes.

Bernadette Fuller filed a lawsuit Nov. 21 in St. Clair County Circuit Court against Janssen Research and Development and Bayer Healthcare Pharmaceuticals.

In her complaint, Fuller alleges the defendants manufactured a drug called Xarelto, marketing it as a safe and effective treatment that reduces the risk of stroke and systemic embolism.

The defendants began selling the drug in the United States in 2011 after conducting a series of clinical trials, according to the complaint. During the trial, however, the defendants learned that bleeding from certain sites within the body increased in people taking the medication, the suit states.

"Defendants use the results of the Rocket AF study, the Record studies, and the Einstein studies to promote Xarelto in their promotional materials, including the Xarelto website, which tout the positive results of those studies," the complaint says. "However, defendants' promotional materials fail to similarly highlight the increased risk of gastrointestinal bleeding and bleeding that required transfusion among other serious bleeding concerns."

The defendants spent at least $11 million promoting the drug and garnered about $582 million in sales in 2011, Fuller alleges. However, while promoting the drug, the defendants overstated its effectiveness and failed to disclose its anti-coagulation effects, according to the complaint.

In turn, there were 2,081 serious adverse events associated with the drug filed in 2012, and 151 resulted in death, the suit states. Fuller, in particular, suffered severe and personal injuries, including physical pain and mental anguish, experienced a diminished enjoyment of life, incurred medical costs and lost earnings, the complaint says.

In response to the lawsuit, Janssen issued this statement:

"Xarelto is an important anticoagulant used to treat and reduce the risk of life-threatening blood clots," the statement reads.

"After more than three years on the U.S. market, to date, the benefit-risk profile of  Xarelto remains favorable and consistent with the clinical trials. All anticoagulants, or blood thinners, carry the risk of bleeding, and the prescribing information for Xarelto has always warned of these risks. 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."

Fuller blames the defendants for contributing to the injuries and deaths, saying they negligently failed to investigate and fully define the safety profile or Xarelto and failed to provide adequate warnings about the drug, among other negligent acts.

In her complaint, Fuller alleges strict product liability, intentional infliction of emotional distress, negligent infliction of emotional distress, common law fraud, negligence, negligent misrepresentation, fraudulent misrepresentation and strict products liability.

Fuller seeks a judgment of more than $4.35 million, plus costs, attorney fees and other relief the court deems just. Attorneys John J. Driscoll and Christopher J. Quinn, of The Driscoll Firm in St. Louis, will represent her.

St. Clair County Circuit Court case number: 14-L-764.