According to allegations raised in a recent product liability case against Boehringer Ingelheim, the plaintiff suffered a massive embolic stroke as a direct result of taking the defendant’s anticoagulant medication, known as Pradaxa.
The Pradaxa lawsuit was brought by two residents of Sonoma County, California, who are demanding compensatory damages for permanent impairment and injuries allegedly incurred from the defendant’s product. The claimants Jefferson Finney and Jonathan Staub filed their case in California Superior Court (Santa Clara County), but it was removed for conditional transfer to coordinated litigation pending in Illinois district court under the guidance of Judge David R. Herndon. Besides manufacturer Boehringer Ingelheim, Walgreens Pharmacy and CVS Pharmacy, are also named as defendants.
Summary of Pradaxa lawsuit allegations
As detailed in the plaintiffs’ personal injury/product liability complaint, Jonathan Staub was prescribed Pradaxa in 2012 to treat his atrial fibrillation (AF). The goal was to stop blood clots from forming inside the patient’s heart. However, it was later found that Staub had developed a large thrombosis (blood clot) in his left atrial chamber, which brings into question Pradaxa’s clot-preventing abilities.
On June 30, the blood clot in Staub’s heart migrated up to his brain causing him to suffer a “mid-cerebral artery distribution embolic stroke.”
It is further argued that because of Pradaxa’s bleeding risks, Staub’s doctors were unable to give him clot-busting medications to treat the effects of his stroke, causing him to suffer further injury and permanent impairment. As a consequence, Staub has since been diagnosed with left shoulder subluxation, neurological injuries and left-sided hemiparesis – characterized by the inability to move one side of the body.
The suit contends that due to the defendant’s negligence, Staub is now permanently impaired, and if Boehringer had only recommended monitoring of blood clot formation in patients through routine tests, the claimant may have not suffered a stroke.
Due to Pradaxa’s varying impacts on different patients who suffer from AF, argue the plaintiffs, the defendant manufacturer should have advised patients and their doctors to monitor the drug’s anticoagulant effects, as some who are overmedicated may show excessive bleeding or hemorrhaging while, on the other extreme, another patient may suffer adverse effects of clotting.
Unlike its precursor Coumadin (Warfarin), Pradaxa does not have a sure-fire antidote to stop its anticoagulant action, and as such, patients who suffer a stroke while on Pradaxa, cannot be given normal clot-busting drugs that would normally help warfarin patients.
Pradaxa labeled as unavoidably unsafe for AF patients
Staub and his legal spouse Finney claim that Pradaxa is unsafe for its intended use in patients with atrial fibrillation, and that unlike Warfarin, the medication does not allow testing for efficacy of anticoagulation through routine blood draws. Dangers of Pradaxa exposure, according to the suit, are increased risk of blood clots, strokes, neurological impairment, paralysis and/or death.
Damages sought in the case include those for all related medical bills, hospital expenses and ongoing treatment for Staub, plus lost income and future reduced earnings. Jonathan Finney is also suing for loss of consortium on the basis that owing to his partner’s permanent injuries, he will be deprived the support and consortium of his spouse.
Five causes of action are leveled in the suit, including: strict product liability – failure to warn or instruct; strict product liability – manufacturing defect; product liability negligence; product liability negligence -failure to warn or instruct, and loss of consortium. The claimants are demanding a trial by jury.
- National Stroke Association, Hemiparesis http://www.stroke.org/site/PageServer?pagename=hemiparesis
- Food and Drug Administration (FDA), (December 19, 2012), FDA Drug Safety Communication: Pradaxa, http://www.fda.gov/Drugs/DrugSafety/ucm332912.htm