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Drug Maker Hid Internal Bleeding Dangers

Another anticoagulant is in the news for flawed clinical trials and for failing to warn consumers as well as medical professionals of the internal bleeding risks associated with a product that has no antidote. Eliquis as opposed to older anticoagulants, is a one dose oral medication that helps reduce the risk of blood clots and stroke without requiring patient-specific dosages or patient monitoring. As such, Bristol-Myers Squibb and Pfizer developed the drug and marketed it as a safer alternative to former blood thinners.

Like other new anticoagulants Xarelto (rivaroxaban), and Pradaxa (dabigatran etexilate), Eliquis works by interrupting the blood-clotting (coagulation) process. Both Eliquis and Xarelto block an enzyme called Factor Xa during the blood clotting process, preventing a protein called thrombin from forming.  Pradaxa directly blocks the formation of thrombin. While there has been an antidote found for Pradaxa, Xarelto and now Eliquis are under attack for their lack of antidote that the marketers rush over for patients and doctors to accept this efficient drug as is, as opposed to the older ones, on grounds of false claims of safety.

Companies developed these anticoagulants for patients looking for an alternative to warfarin (Coumadin, Jantoven), which requires doctors to monitor patients closely. Warfarin works by blocking clotting factors that rely on Vitamin K. This then allows doctors to use Vitamin K as an antidote if someone suffers uncontrollable bleeding while on the mediation. Due to its usage, Warfarin is much cheaper and less-profitable than the patent-protected new anticoagulants. The companies formulated an easier drug that can sell [1].

Eliquis Side Effects and Legal Battles

The side effects associated with Eliquis are similar to all anticoagulants. Some of these side effects are deadly as blood thinners increase the risk of uncontrollable bleeding. The risk is increased when taken at the same time as popular drugs like Aspirin and nonsteroidal anti-inflammatory drugs (NSAIDs). The next question that some may ask is, “Why not stop the medication?”. People who stop taking Eliquis face an increased risk of blood clotting and other thrombotic events if it is not replaced with an alternative anticoagulant. To make matters worse, there are other lawsuits involving Eliquis that mention other side effects including, bruising easily, developing skin rash, internal bleeding and brain hemorrhaging.

As such, lawsuits have started to come forth in an effort to hold the drug manufacturers accountable. In July 2015, the first of two Eliquis lawsuits was filed by the widow of a man who died from uncontrollable bleeding after taking the blood thinner [2].

  • The widow, Deborah J. Herschell, filed the lawsuit against Bristol-Myers Squibb, alleging the drug maker misrepresented Eliquis as having been proven in tests to be safe and effective. Other allegations included in the lawsuit are claims that Bristol-Myers Squibb cut costs and hired incompetent agents to conduct the main study (ARISTOLE study) on which the approval of Eliquis was reportedly chiefly made. As reported on Lawyersand Settlements.com, among the issues that allegedly came from the study were unreported death, the loss of subjects for follow-up, dispensing errors and “changing and falsifying records, including records disappearing just before the FDA made a site visit, reportedly on the order of an employee of Bristol-Myers Squibb (BMS).” The lawsuit also claims that the manufacturers promoted Eliquis as superior to warfarin in direct-to-consumer advertisements and promotional items to the Herchell’s doctor but failed to inform them of the lack of an antidote. She is suing for compensation for pain and suffering, emotional distress, loss of enjoyment of life, medical expenses, lost wages, and punitive damages.
  • Plaintiff Lester L. Baldwin Jr alleges that the drug manufacturer committed fraud in their conduct of the ARISTOTLE study aforementioned as the central study in which the drug was approved on. The suit claims that BMS concealed the side effect which occurred in the test users of Eliquis including, “a death which went unreported (whereas one purpose of the study was to study the rate of death in Eliquis users compared to others in Coumadin); loss of subjects to follow up; major dispensing errors including indication that certain subject were getting Eliquis when they were not…” and much of what constitutes as poor quality control. Due to the marketing and convincing of BMS and Pfizer, Lester was admitted to the hospital with numbness and loss of feeling in his right hand, which doctors attributed to a severe intracranial hemorrhage. Lester had been taking Eliquis for only a few days but what it lead to was life threatening. Because there was no way for doctors to stop the bleeding, his condition worsened for several days even after he discontinued use of Eliquis. He has brought claims for compensatory and punitive damages, equitable relief, and such other relief deemed necessary [3].

While the need for effective anticoagulant drugs is certainly strong, with an estimated 5.8 million Americans and 6 million Europeans suffering from non-valvular atrial fibrillation as well as the lifetime risk of developing the condition is at an estimated 25 percent for people who are 40 and older, this does not give drug manufacturers the privileged to disparage facts and side effects that are more harmful than beneficial just to push a drug [4]. If anything, this risk of developing this condition and its deadly consequences should encourage drug makers to promote a drug that is effective and safe and to put people before profits.

Dolman Law Group

At the Dolman Law Group in Clearwater, Florida, our experienced bad drug attorneys know hwo to take on large pharmaceutical companies and how to stand up for the rights of innocent consumers. These cases can be complex and can take some time, but we will not stop working for your best interests and to get you the compensation you deserve for a wrongful death lawsuit or any other claim that is in accordance with taking the blood thinner Eliquis. Call our office today for a free consultation at (727) 451-6900.

Dolman Law Group
800 North Belcher Road
Clearwater, FL 33765
(727) 451-6900

https://www.dolmanlaw.com/legal-services/defective-medication-attorneys/

References:

[1] https://www.drugwatch.com/eliquis/lawsuits/
[2] http://topclassactions.com/lawsuit-settlements/lawsuit-news/330616-eliquis-lawsuits-allege-drug-maker-hid-internal-bleeding-dangers/
[3] http://www.aboutlawsuits.com/wp-content/uploads/2015-06-15-Herschell-Complaint.pdf
[4] https://www.lawyersandsettlements.com/articles/eliquis/eliquis-lawsuit-side-effects-blood-20751.html
[5] http://www.aboutlawsuits.com/wp-content/uploads/2015-07-28-Baldwin-Complaint.pdf
[6] https://www.drugwatch.com/2013/01/09/fda-approves-eliquis/