If a loved one died while taking Pradaxa, attorney Chris Mellino welcomes you to contact our Cleveland office today for a free consultation. You may also be able to file a personal injury lawsuit if you suffered a serious adverse side effect, such as a heart attack, while taking the medication.
When Did the FDA Approve Pradaxa?
The FDA approved Pradaxa on October 19, 2010. As German manufacturer Boehringer Ingelheim stated in its press release, the 150 mg pill was approved to reduce the risk of stroke in patients with atrial fibrillation, or Afib, after an 18,000-participant trial showed the drug had benefits over the anticoagulant warfarin, or Coumadin.
“[Warfarin] has the potential for interactions with many commonly used medications, as well as certain foods,” the release stated. “As a result, patients taking warfarin must maintain a consistent diet and have their INR monitored and managed through regular blood tests and dose adjustments.” Pradaxa, on the other hand, “does not require blood monitoring or related dose adjustments and has no recommended dietary restrictions.”
Pradaxa: Statistics and Risks
Unfortunately, “Pradaxa’s benefit of cutting the rate of fatal or debilitating strokes comes at the risk of internal bleeding, which can also cost lives,” Reuters reported November 12, 2011. “Boehringer Ingelheim said that 260 cases of fatal bleeding have been linked to its new stroke prevention pill Pradaxa so far.”
Two months later, CBS News reported that Afib patients who took Pradaxa had a 33 percent higher chance of suffering a heart attack than those who took warfarin.
“The finding, from Cleveland Clinic researchers Ken Uchino, MD, and Adrian V. Hernandez, MD, PhD, is based on data from seven clinical trials that enrolled 30,514 patients,” CBS stated. Still, the researchers said Pradaxa’s benefits outweighed its potential to cause harm.
June 14, 2012, Huffington Post reported that the FDA had been alerted to 542 Pradaxa-related deaths in 2011, according to the Institute for Safe Medication Practices. This number allegedly surpassed every FDA-approved drug on the market, including warfarin.
That same day, Reuters alerted readers that some of the best heart doctors in the country were wary of prescribing the blood thinner.
“The good news is you now have an alternative to warfarin,” Dr. Alan Jacobson told writer Ransdell Pierson. “The bad news is you can kill a patient as easily with the new drug as you could with the old drug [since the] average patient doesn’t understand anything about the new drug, or what the risks are, or what other medicines he can or can’t take.”
Still, the FDA stood its ground, stating, “FDA has not changed its recommendations,” on November 2, 2012. “Pradaxa provides an important health benefit when used as directed.” By February 7, 2014, more than 1,000 people had died, per nytimes.com.
One week after that article, the Journal of the American College of Cardiology (JACC) published a Pradaxa study in which 112 of 9,183 participants suffered a stroke, and 323 suffered hemorrhaging. Researchers concluded that some people taking the drug could benefit from having their blood monitored.
Pradaxa Manufacturer’s Response to Deaths and Lawsuits
As of June 2012, Boehringer Ingelheim declined to comment on the number of people who’d died while taking Pradaxa or the near-two dozen federal lawsuits that families had filed against the company for failing to warn about the drug’s potential risks, per Reuters.
Employees did, however, express concern about the above-mentioned JACC study, according to internal emails and memos that Chief Judge David R. Herndon released to the public in January 2014.
“This publication will more harm than be useful for us,” one email stated, per nytimes.com. “Can’t this be avoided?”
Why Should I Trust Chris Mellino to Handle My Pradaxa Lawsuit?
First, Mellino Law Firm does not advertise. Attorneys and satisfied clients send us the majority of our cases. Others find us online.
Second, Chris Mellino is respected throughout northeast Ohio for his ability to dig below the surface and make sure no fact is overlooked. In fact, Chris has been involved in several landmark cases, including Moskovitz v. Mt. Sinai Medical Center (1994) and Watkins_v._Cleveland_Clinic_Foundation (1998). In the latter, he and his previous partner were awarded the largest verdict in the state that year.
Third, personal injury claims are time consuming and labor intensive, so we’re selective about the cases we accept. Some firms take every case that walks in the door, settle those cases for the first amount the defendant offers in order to fund their next commercial, and leave clients in the hands of “case managers.” We only pursue compensation for patients who’ve suffered a severe injury or disability. By limiting the number of claims we accept, we’re able to give each one the attention it deserves.
Last but not least, since 2010, Mellino Law Firm is the only personal injury law firm in Cleveland to be accepted into Primerus, which screens potential members by speaking to judges, other lawyers, bar associations, clients, and insurance carriers about a firm’s integrity, work product, fee structure, education, civility, and community service.
If you have questions about an injury you suffered while taking Pradaxa, attorney Chris Mellino invites you to contact our office for a free consultation.