PENNSYLVANIA RECORD

A Kentucky woman is suing the makers of the anti-coagulant drug Xarelto

in Philadelphia’s Court of Common Pleas over allegations that she experienced severe internal and gastrointestinal bleeding two years ago after being prescribed the drug for atrial fibrillation.

Attorney W. Steven Berman, of the Marlton, N.J. firm Napoli Bern Ripka Shkolnik & Associates, filed suit earlier this month on behalf of Virginia G. Stuntebeck, who said she was admitted to the hospital in mid-February of last year, a year-and-a-half after she was prescribed the drug by her physician.

According to the mass tort claim, Xarelto, an anti-coagulant primarily used to reduce the risk of, and/or treat, stroke and systemic embolism in patients with non-valvular atrial fibrillation, was routinely marketed as a “one size fits all drug.”

The makers of the drug misinformed patients and their healthcare providers as to the necessity of routinely monitoring those requiring a blood-thinning agent.

The lawsuit says that the defendants created a new pharmaceutical that is not, from a safety perspective, any better than another drug called warafin, even though Xarelto may be slightly easier to use and administer.

“The idea of this apparently easier-to-use anticoagulant evidently appealed to physicians, who were subject to extreme marketing and promotion by the Defendants, but ignores patient safety,” the complaint reads.

The marketing materials for Xarelto suggest that the drug represents a therapeutic simplification and therapeutic progress because it didn’t require patients to undergo periodic monitoring with blood tests and because there were no dietary restrictions, the suit states.

The drug companies, however, failed to address in their warning for the product the increased risk of serious and fatal bleeding, despite the fact that the information on their website originating from a clinical trial says patients taking Xarelto, compared to those taking warafin, have more gastrointestinal bleeding incidences and require more blood transfusions.

In spite of this reference, the plaintiff’s complaint states, the information is still “wholly inadequate,” because it is not conveyed in the boxed warning on the Xarelto label.

The drug was first approved by the U.S. Food and Drug Administration in July 2011.

The lawsuit also says that the drug companies “fervently marketed Xarelto using print advertisements, online marketing on their website, and video advertisements with no regard to the accuracy and repercussions of their misleading advertising in favor of increasing sales.”

As a result of the defendants’ “intense marketing,” about 130,000 prescriptions were written for Xarelto in the U.S. during the first three months of 2012, resulting in large profits for the drugmakers, the lawsuit states.

Due to the nature of the drug, however, those prescribed Xarelto, even for a brief period of time, were at an increased risk of developing life-threatening bleeds, the suit claims.

The suit says that people taking Xarelto were told they do not require blood monitoring or frequent doctor follow-ups, even though there are concerns about the risk of stroke and blood clots while taking the pharmaceutical.

There were a reported 968 suspected “undesirable side effects” reported in Germany, including 72 deaths, in just the first eight months of 2013, according to the complaint.

“Defendants concealed their knowledge that Xarelto can cause life threatening, irreversible bleeds from the Ingesting Plaintiff, other consumers, the general public, and the medical community,” the lawsuit states.

The lawsuit contains counts of products liability, negligence, unreasonable marketing of a dangerous drug and unreasonable failure to remove the drug from the market, breach of implied and express warranties, fraud, and violation of consumer protection laws.

The plaintiff seeks unspecified compensatory and punitive damages, along with litigation costs and attorneys’ fees.

The defendants named in the complaint include Janssen Pharmaceuticals, Bayer Corp., and Johnson & Johnson Research and Development LLC.

On Monday, attorneys representing the defendants, Michael McTigue Jr. and Susan M. Sharko, of Drinker Biddle & Reath, filed a removal petition in federal court in Philadelphia seeking to have the litigation transferred to that venue on the basis of diversity of citizenship, since the plaintiff, a resident of Kentucky, and the defendants are citizens of different states.

The defense attorneys also say the amount-in-controversy requirement is satisfied since the damages are likely to exceed $75,000.

The state case ID number is 140201754 and the federal case number is 2:14-cv-01097-JHS.