Patients with a serious medical condition known as atrial fibrillation, also known as “Afib,” a type of irregular heartbeat, are generally required to take a prescription blood thinner or oral anticoagulant medication. Blood thinners have been on the market for decades, and the most popular one is Warfarin, invented in late 1940s and approved for use in the U.S. in 1954. Pradaxa is a newer type of oral anticoagulant that can lead to serious and irreversible damage, and the company failed to warn of these dangers.
Warfarin was originally sold under the brand name Coumadin but has been a relatively lost cost generic for many years. While it is generally safe and effective, it can lead to internal bleeding if the dosage is not correct. These risks can be curtailed by having routine blood work to determine how the drug is working and avoiding certain foods. If there is an adverse event, doctors are able to quickly reverse the side effects with the use of an antidote.
As our Boston Pradaxa injury attorneys can explain, several major drug makers wanted to knock Warfarin generics out of their place atop the market by developing something they claimed was newer, safer, more convenient, and all around better. These new oral anticoagulant meds include Pradaxa, as well as Xarelto and Eliquis. The problem is the only thing that was true, in large part, about these marketing claims for the new blood thinners was that they were new. As it turned out, they were very dangerous, often given at the wrong dose under directions from the drug company, and led to serious internal bleeding events. Unlike Warfarin, there was no reversal agent for these drugs approved by the U.S. Food and Drug Administration (FDA), so many people died from taking them.
While several studies have shown that there are real risks associated with all of these drugs, including Pradaxa, the manufacturers keep trying to argue their drugs are perfectly safe and do not pose unreasonable risks. According to a recent news article in MedPage Today, researchers conducting “real-world studies” are establishing a strong link between taking dabigatran, which is the off-brand name for Pradaxa, and brain bleeding risks. However, study authors have found this risk to be somewhat lower than when taking Warfarin. The study also found the risk of stroke and hemorrhaging to be commensurate with Warfarin.
The drug company will likely want to use this study to show that their drug is as safe, if not safer than Warfarin. This may not be of much help when dealing with a products liability lawsuit after taking Pradaxa and suffering a brain bleed, because the issue is not only whether the drug can cause intracranial bleeding.
Many products liability lawsuits, such as the ones filed against the makers of Pradaxa and makers other dangerous drugs, deal with manufacturing a dangerous medication. There is no question that if a drug company that makes a drug that was defective and harms people, it can be the basis for liability. This is however, not the only claim that is typically brought.
Informed Consent to Take a Medication Issues
Many drugs can work exactly as intended and still result in side effects ranging from a minor irritation to death. This is nothing new, and we have all heard a drug commercial where the warnings are explained. When a patient is suffering from a medical condition, manufacturers are instructed to speak with their doctor about the possible treatment options and what risks and benefits are posed by each respective option. Only after hearing all known risks and weighing them against the potential benefit can a patient take an informed decision.
In some cases, the odds of a serious adverse event occurring are relatively low. Sometimes the issue only occurred in less than 1 percent of patients during clinical trials. In other cases, the doctor may say the chance of a dangerous side effect occurring or other complication is very high. The benefit however may outweigh those risks, and the option of not taking the medication may be even more dangerous. A patient may decide to take the risk of a dangerous or experimental drug. If that decision is made after adequate warning and receipt of all necessary facts, they are within their rights to take that chance.
The problem occurs when the drug manufacturer does not reveal known risks to the physicians. The doctor, in turn, cannot obtain proper informed consent from a patient if critical, relevant information isn’t available – information about which the company knew or should have known. Actual knowledge of certain dangers can be difficult to prove, absent some written internal memo or other communication or research establishing this fact. However, one can argue the company should have known about a dangerous condition if adequate safety testing was not conducted. If the company in turn fails to warn doctors and the U.S. Food & Drug Administration, this failure to warn is commonly used to establish these product liability lawsuits.
Post Market Surveillance Studies Involving Pradaxa
Moreover, the study discussed in this article was a post-market surveillance study. This is, by its very nature, not a pre-market clinical trial. In a clinical trial, the company doing the testing. It’s usually a physician or other qualified researcher who has entered into a contract to work on studies. Qualified patients are selected to participate, and must endure a detailed informed consent protocol. They understand the risks of the study and understand what the drug is supposed to do. They are also possibly paid for their participation in the study, depending on the type of study.
With a surveillance study, they are just looking at case files of people who had brain bleeding after taking Pradaxa. These people did not agree to participate in any type of study, but more importantly, they were not explained the risks when taking the drug, because the company marketed it as a safe and convenient alternative to Warfarin.
The FDA does have a drug review process, which is supposed to many years and require rigorous testing. However, companies have found a number of shortcuts, such as the Fast Track program, Breakthrough Therapy, Accelerated Approval, Priority Review and, of course, the 510(k) premarket approval, which allows approval of drugs “substantially similar” to previously-approved medications. A study published in the Journal of the American Medical Association revealed one-third of all FDA approved drugs between 2001 and 2010 were involved in some type of adverse safety event.
If you are the victim of Massachusetts product liability, call the Law Offices of Jeffrey S. Glassman for a free and confidential appointment — 1-888-367-2900.
Real-World Study Confirms Lower Brain Bleed Risk with Dabigatran, November 13, 2017, By Salynn Boyles, MedPage Today
More Blog Entries:
New Options to Prolong Knee Replacement Surgery, Aug. 12, 2017, Boston Defective Knee Replacement Lawyer Blog