In recent years, worry over the blood thinning drug Pradaxa in some cases has led to lawsuits against Boehringer Ingelheim. The plaintiffs argue that the company knowingly over-marketed the drug or sold it for an inappropriate dosage, causing many to suffer from serious medical complications. The plaintiff’s main argument against the pharmaceutical giant is that it didn’t warn consumers about Pradaxa’s potential side effects of severe blood clotting.
The FDA approved Pradaxa in 1997 as a blood thinner to be taken by people with a history of cardiovascular disease, but did not require that it be used only by these patients. The Food and Drug Administration did not require the manufacturer to conduct the necessary studies on Pradaxa before approving the drug and did not require that the study results be submitted to them in order to be approved. Because of this, Pradaxa was available without a prescription for all ages.
One of the most publicized lawsuits against Pradaxa concerns the case brought against the company by the family of a woman who suffered a massive heart attack after taking Pradaxa. The plaintiff in this case alleged that when she developed a clot in her leg, she sought medical care at the hospital only to be told that doctors could not find a clot. She was eventually diagnosed with end-stage renal failure and given a kidney transplant.
Other lawsuits against Pradaxa include one brought by the family of a man who died in a swimming pool while he was taking the drug. His family contends that while he was on Pradaxa, his heart stopped pumping blood and he collapsed and died almost immediately. They also claim that a co-worker, whom the plaintiff claims was aware of Pradaxa’s side effects, was not able to give him the dose that he needed on the day he died and that his condition deteriorated rapidly.
There have been several lawsuits brought against the company by children who say that they developed heart problems or strokes because of the use of Pradaxa. Some of these cases involve parents who were prescribed the medicine by their pediatrician to treat symptoms such as low blood pressure in the face of severe symptoms such as seizures. Some children are said to have had strokes as a result of taking the medicine.
No matter the case brought against Pradaxa, there are other lawsuits that may affect the company, but the most publicized include a case brought against a California physician by a woman whose husband died of heart disease, just weeks after he took Pradaxa. The plaintiff’s attorneys have argued that because the doctor did not tell her of its possible side effects, she should be liable for his death. There have been other cases in which the plaintiff’s attorneys claim that the doctor actually encouraged or caused the patient to take more than the recommended dose.
The question of who should sue? In most cases, a lawsuit would be brought against the physician who prescribes Pradaxa, but since the FDA does not regulate the drug industry, the FDA can not police this issue. Many physicians, both in the U.S. and Europe, work within the system set up by the European Medicines Agency (EMA) to settle claims involving drugs.
Because the EMA regulates the use of drugs in the U.S., the burden of proving a link between the dose prescribed and a side effect falls on the plaintiff. It must show that the doctor knew or should have known that the potential side effect would occur, and that he failed to warn the patient adequately.