Pradaxa Patients Can't Stop the Bleeding, Houston pradaxa helpline concerned about our Houston seniors on pradaxa. Houston pradaxa lawyers Filing lawsuits
Less than 24 hours after Loraine Franklin fell on the kitchen floor of her Georgetown home, she was dead.
It was December 29, 2011, and Franklin's daughters say today that, had Franklin, 80, not been prescribed a blood thinner called Pradaxa, she'd have lived to see the new year and subsequently celebrate her 60th wedding anniversary.
Instead, they say, the fall caused a blow to her head, which caused an intracranial hemorrhage, which doctors at the hospital could not stop. All the doctors could do, the daughters say, is make Franklin as comfortable as possible as her speech became slurred and the blood pooled in her skull.
Like hundreds of thousands of others with a heart condition called atrial fibrillation, which raises the risk of stroke, Franklin had been told of the benefits of the recently FDA-approved Pradaxa over its comparatively ancient counterpart, Coumadin. What she hadn't been told about, according to her daughters, was Pradaxa's most significant drawback: There is no effective reversal agent for a traumatic bleeding event.
Had Franklin been taking Coumadin — as she had years before — she would have left the hospital with a headache and a slight concussion, her daughters say. With Coumadin, doctors have a variety of ways to keep a patient from bleeding to death. Instead, according to Franklin's daughters, Pradaxa turned a simple fall into a death sentence.
Which is why Franklin's daughters are suing Pradaxa's German manufacturer, Boehringer Ingelheim, in federal court. They say the company did not adequately warn doctors and patients of the lack of an antidote. They're just two of dozens of clients represented by the Texas law firm Watts Guerra Craft, whose mass-tort team opened the floodgates by filing the first Pradaxa-related cases in November 2011.
The timing coincided with Boehringer's announcement that it had recorded 260 Pradaxa-related fatal bleeding events worldwide between March 2009 and October 2011. The FDA followed suit by announcing a post-market safety review. Regulators in Japan had already asked Boehringer to issue "Dear Doctor" letters to health-care professionals warning of the bleeding risk, and Australian regulators issued a safety advisory as well.
However, the FDA, per its announcement, "continues to believe that Pradaxa provides an important health benefit when used as directed," and Boehringer representatives told the Houston Press that 260 recorded deaths are not outside the parameters of a major clinical trial that the FDA and its global counterparts relied on in approving the drug in the first place. Company representatives also say the risks were not hidden or minimized.
Pradaxa has been a boon to Boehringer's bottom line. But if Loraine Franklin's daughters get their way, the drug will be off the market — just not soon enough for their mother.
If ever there was a drug that could use a makeover, it's warfarin.
Warfarin (brand name Coumadin) was introduced to the marketplace in 1948 not as a medicine but as a rat poison. Six years later, probably to the surprise of rats as much as anyone else, the FDA approved warfarin as an anticoagulant, and it remained the choice of treatment for patients with a type of irregular heartbeat — atrial fibrillation — for more than 50 years.
The most common type of arrhythmia, atrial fibrillation occurs when one or both of the heart's upper chambers do not beat in sync with the lower chambers. With blood flow disrupted, clots can form, which can lead to heart attack and stroke. The U.S. Centers for Disease Control and Prevention estimates that about 2.6 million Americans currently suffer from atrial fibrillation; the CDC predicts the number will grow to 12 million by 2050. (The median age is 66.8 years for men and 74.6 years for women.)
Medically speaking, warfarin is what some physicians refer to as "a pain in the ass." It interacts negatively with a legion of other drugs, and because it works in part by interfering with vitamin K, patients have to avoid any foods high in that vitamin like leafy greens, liver, green tea and cauliflower. Patients' blood must also be regularly monitored — once every three or four days at first, then once or twice a month; the test, known as the International Normalized Ratio, measures how "thick" or "thin" a patient's blood is. Too thick, and the patient is at an elevated risk of clotting; too thin, and the higher the risk of bleeding.
Even the nonprofit watchdog group the Institute for Safe Medication Practices — which never has a shortage of what it considers frightening new Pradaxa statistics — is blunt when describing warfarin's risks.
According to the institute's April 2012 report, "Inhibiting the blood clotting process in elderly patients ranked as one of the highest risk outpatient drug treatments in all of medicine, with the leading agent, warfarin, accounting for 33 percent of all emergency hospitalizations for drug adverse effects in the elderly patient population."
Yet because of its low cost and respectable success rate (given the complications), this highly annoying, inconvenient treatment has been the standard-bearer for the treatment of atrial fibrillation. In the mid-2000s, however, no fewer than eight pharmaceutical companies took a fresh look at this market, estimated to be worth $10 billion-$20 billion.
In 2010, Boehringer, a 120-year-old family-owned company, beat everyone to the U.S. market with Pradaxa. According to the FDA, approximately 1.1 million prescriptions were dispensed between October 2010 and August 2011; an estimated 371,000 patients filled their prescriptions from outpatient retail pharmacies during that period.