The medical device manufacturer, Boston Scientific, has created a device which will allow patients suffering from atrial fibrillation to wean themselves off of blood thinners.
The device, known as The Watchman, is a device which is implanted into the Left Atrial Appendage (LAA) resulting in a permanent plug. The procedure to insert the device is minimally invasive and involves the use of a catheter.
The news that the U.S. Food and Drug Administration had approved the device was treated with cautious optimism by those who suffer from atrial fibrillation. Atrial fibrillation is a condition that affects nearly 6 million Americans and is thought to be the most common type of irregular heartbeat. The condition can be quite dangerous due to the fact that in patients who suffer from AF, blood pumped into the LAA often pools. If blood pools and remains stagnant, it has the potential to form clots. These clots can then travel to other parts of the body, although most often they make their way to the brain, resulting in an ischemic stroke.
Prior to the invention of this device, doctors typically treated AF patients with blood thinners, although these products come with their own set of issues.
Xarelto And AF Patients
Xarelto, which was approved as a blood thinner by the FDA in 2011, has been used as a treatment for AF since that time. Initially, doctors were thrilled with the drug because it allowed them to monitor their patients on a less frequent basis. The manufacturers of Xarelto, Bayer AG and Johnson & Johnson, advertised the drug as a “one size fits all” type of drug, indicating that the dose would be the same for the patient it is prescribed to.
Older blood thinners, like Warfarin, require patients to return to their physicians for frequent checkups to make sure that factors like exercise, diet, and other medications haven’t impacted the dosage needed. These rechecks can be as often as once a week and are very disruptive to the everyday life of patients.
What the manufacturers didn’t tell the medical community or the public, was that the drug comes with some very dangerous side effects of its own, which many believe outweigh the benefits.
The Side Effects
Perhaps the most dangerous issue with Xarelto is the fact that there is currently no antidote for the drug. This means that if a patient begins to bleed uncontrollably, their body will not begin to clot the blood. Doctors are unable to reverse the effects of the drug and are typically forced to perform blood transfusions. This differs from blood thinners like Warfarin, where physicians are able to administer Vitamin K and encourage clotting naturally.
Patients have also reported that they suffered from side effects like gastrointestinal bleeds, spinal hematomas, brain hemorrhages, rectal bleeding, and liver dysfunction after beginning Xarelto.
Patients Pursuing Legal Action
In more than 5,000 cases, patients or their loved ones have chosen to file a Xarelto lawsuit, alleging that the drug caused them serious harm. They are seeking financial compensation for their medical expenses, lost earnings, and pain and suffering.
Nearly 500 of these lawsuits are wrongful death claims filed by the family of someone who passed away while taking Xarelto. They believe that the drug caused their loved one’s untimely death and that, as a result, they should be compensated for the services and support the deceased offered them, medical expenses, funeral and burial expenses, and more.
In December of 2014, the Judicial Panel on Multidistrict Litigation consolidated federally-filed Xarelto lawsuits into MDL 2592. The panel felt this consolidation was appropriate considering each lawsuit contains similar questions of fact. Additionally, the MDL will help to prevent duplicate discovery and help all parties involved save time and money.