Blood clots can be deadly and blood thinners are important medications in battling them, but they are also risky. For a long time, blood thinners like warfarin were most commonly used, but required careful monitoring of patients by their doctors. More recently several drug companies have developed newer blood thinners, supposedly safer and more convenient that the older drugs. One of these is Pradaxa, made by Boehringer Ingelheim.
Although drugs like these are supposed to be less risky than warfarin, a number of Pradaxa lawsuits have been filed over the dangers this particular blood thinner poses to patients. Excessive bleeding has cost some patients their lives and Boehringer Ingelheim is now paying the price for these deaths. Plaintiffs in cases claim that the company never warned them adequately of the risks and that they promoted a drug as safer than it actually is.
What is Pradaxa?
Made by Boehringer Ingelheim and approved for use by the U.S. Food and Drug Administration (FDA) in 2010, Pradaxa is just one of several newer blood thinners designed to prevent or treat the formation of life-threatening blood clots. Some patients are prone to blood clots because of genetics, but most often people need blood thinners after surgery, a crucial time during which clots can form and cause blockages in the lungs, heart, or brain.
Pradaxa is a brand name for a generic substance developed by the German pharmaceutical company. The drug is called dabigatran and it belongs to the class of drugs called thrombin inhibitors. These medications interfere with a protein called thrombin, which is a crucial part of the clotting process of blood. Pradaxa and other thrombin inhibitors have a different mechanism of action from warfarin, which according to the drug companies makes them more effective and safer.
The Risk of Excessive Bleeding
All blood thinners, both old and new, come with the risk of excessive bleeding. They inhibit the clotting process, so there is always the possibility that a cut or accident could cause dangerous and uncontrollable bleeding. Although warfarin has a lot of downsides, it does have an antidote to reverse its action and stop excessive bleeding. Not all of the newer blood thinners do.
Pradaxa did not originally come with an antidote, which meant that many patients were at serious risk of bleeding to death if something went wrong. Boehringer Ingelheim did eventually create an antidote, but it was not approved and released for use until 2015, five years after the blood thinner had been placed on the market.
The Risk of Heart Attack
Pradaxa has also been found to increase the risk of a patient having a heart attack. A study published in 2012 showed that that risk was higher than in other blood thinners, including warfarin and other newer medications. The results were significant enough that the study authors recommended that doctors take serious caution before prescribing patients Pradaxa.
Negligent Misrepresentation
It is general knowledge that blood thinners may cause excessive bleeding. However, patients who took Pradaxa and then experienced dangerous bleeding are filing lawsuits because they believe that Boehringer Ingelheim misrepresented Pradaxa as safe and effective, more so than its competitors like warfarin and other older products.
Boehringer Ingelheim is being accused of falsely marketing and selling Pradaxa as a safer alternative to warfarin. One of the main selling points Boehringer Ingelheim used is the fact that patients do not have to be as closely monitored on Pradaxa as they would on warfarin. A study reported in 2014 that this statement is not necessarily true. The study showed that patients on Pradaxa were actually more likely to experience dangerous intestinal bleeding than those on warfarin. The lack of monitoring may be the reason that the risk is higher with Pradaxa.
The risk of bleeding excessively on Pradaxa were especially high before Boehringer Ingelheim developed its antidote. In the five years in between the company continued to promote a drug that could cause irreversible bleeding. Many patients are suing because they believe that this was negligent behavior, unethical marketing, and fraudulent.
Reasons to File a Pradaxa Lawsuit
Thousands of people have already filed lawsuits against Boehringer Ingelheim because of the harm caused by Pradaxa. Some of the many reasons plaintiffs believe the company owes them compensation include mispresenting the drug as safer and effective than others, falsely claiming that the drug did not require patient monitoring, falsely claiming that all patients could safely take the same dose, failing to develop a procedure for saving people with uncontrolled bleeding, and intentionally hiding facts about Pradaxa’s dangers and risks.
Current Lawsuits
Some of the lawsuits that Boehringer Ingelheim is facing over Pradaxa are from people who suffered, but survived taking the medication. Unfortunately more of these cases are being brought by people who lost a loved one to excessive bleeding while on Pradaxa. Individual cases include a man who suffered from intestinal bleeding after just a few weeks on the medication, a man whose wife died after taking Pradaxa, and a man who experienced a brain hemorrhage after switching from warfarin to Pradaxa.
These are just a few of the examples of the many cases coming up against or being settled by Boehringer Ingelheim. Thousands of the cases were consolidated in Illinois in a multidistrict litigation. Before the case could go to trial and be heard before a judge, Boehringer Ingelheim decided to settle and ended up paying $650 million. Many of the plaintiffs and their lawyers were pleased with the settlement and felt that the company had received justice in a clear case of negligence, in spite of the fact that Boehringer Ingelheim never admitted to any wrongdoing.
If you suffered excessive bleeding while taking Pradaxa, or lost a loved one to this drug, you may be able to make your case and seek compensation from Boehringer Ingelheim. A lawyer can tell you if you have a case, and if you do, what steps you need to take to bring it to court to seek justice and the money you deserve for your suffering.
Sources
- http://www.bmj.com/content/349/bmj.g4670
- http://www.fda.gov/Drugs/DrugSafety/ucm396470.htm
- https://www.boehringer-ingelheim.com/news/news_releases/press_releases/2015/19_october_2015_dabigatranetexilate.html
- http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm282820.htm
- http://www.forbes.com/sites/larryhusten/2014/05/28/boehringer-ingelheim-settles-us-pradaxa-litigation-for-650-million/ - 79174ac5268a
- http://www.reuters.com/article/us-heartattack-pradaxa-idUSTRE8082CX20120109