Heather Isringhausen Gvillo May 28, 2015, 12:48pm


A Madison County lawsuit against the makers of Xarelto alleging the medicine designed to prevent strokes instead created an inability for her blood to congeal properly has been removed to the MDL court, joining roughly 250 other similar actions.

The defendants in this suit, originating in Madison County, claim this case is just one of the many product liability lawsuits filed across the country concerning Xarelto, “a pharmaceutical product used to prevent blood clots, treat deep vein thrombosis and pulmonary embolism, and in patients recovering from knee or hip replacement surgery.”

The Judicial Panel on Multidistrict Litigation established an MDL proceeding on Dec. 12 in the Eastern District of Louisiana for Xarelto complaints, which is assigned to federal judge Eldon E. Fallon.  This case was removed to the MDL court on March 5. It was transferred with four others from various jurisdictions.

The defendants originally filed a notice of removal to the U.S. District Court for the Southern District of Illinois on Feb. 20, with the intention to eventually remove the case to the MDL.

The defendants argued removal was appropriate because the amount in controversy exceeds $75,000 and diversity of citizenship exists.

Plaintiff Sonja Lemoins filed a 90-count complaint on Jan. 22 against Janseen Research and Development, formerly known as Johnson and Johnson Pharmaceutical Research and Development LLC, Janseen Ortho LLC, Janseen Pharmaceuticals Inc., formerly known as Janseen Pharmaceutica Inc., formerly known as Ortho-McNeil-Janseen Pharmaceuticals Inc., Bayer Healthcare Pharmaceuticals Inc., Bayer Pharma AG, Bayer Corporation, Bayer Healthcare LLC, Bayer Healthcare AG and Bayer AG.

In her complaint, Lemoins alleges the defendants manufactured a drug called Xarelto, allegedly marketing it as a safe and effective treatment reducing 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, the suit states. During the trial, however, Lemoins claims the defendants learned that bleeding from certain sites within the body increased in people taking the medication.

“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 allegedly spent at least $11 million promoting the drug and garnered about $582 million in sales in 2011, the suit states. The defendants are accused of overstating the drug’s effectiveness and failing to disclose its anti-coagulation effects.

In turn, the plaintiff claims there were 2,081 serious adverse events associated with the drug filed in 2012, and 151 resulted in death. Specifically, Lemoins allegedly 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 states.

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.”

Lemoins blames the defendants for contributing to the injuries, 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, Lemoins 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.

Lemoins seeks a judgment of more than $4.35 million, plus costs, attorney fees and other relief the court deems just.

She is represented by attorneys John J. Driscoll and Christopher J. Quinn of The Driscoll Firm in St. Louis.

The defendants are represented by Terry Lueckenhoff and John E. Galvin of Fox Galvin in St. Louis.

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