For many years, people have turned to the medical profession in search of solutions to their health problems. Doctors have been hailed as heroes when medication and medical devices worked as intended. However, with the vast range of drugs available on the market today, some fallout and failure is to be expected, especially as drug and device manufacturers sometimes take shortcuts in order to maximize profits.
Some consumers have to consume a cocktail of medications to deal with the various symptoms they experience, and in a rushed world, medical practitioners don’t always have the time to adequately consider an individual patient’s medical history or medication blend to ensure that they do not suffer injury as a result of a design or manufacturing defect. One of the most common cases is Pradaxa, which we will discuss in this article.
Who Is to Blame When A Drug or Medical Device Is Defective?
Thousands of consumers are disheartened by the many instances of people who are suffering due to defective drugs and or medical devices. There are people who blame drug companies for being over-eager to rake in profits, to the extent that they don’t follow proper research procedures, and take shortcuts when it comes to manufacturing crucial drugs to keep people alive. No matter what the reason, it is a concern which should be addressed quickly in order to prevent unnecessary injuries, diseases, and even death in the future.
People trust their physicians, and see no need to avoid drugs that are touted in the media. They trust government agencies to oversee the manufacturers of medical devices and drugs to ensure that their products are safe and beneficial to patients. However, that is not always the case. Oftentimes, lobbyists make their case to the FDA, pushing for a drug to be approved despite incomplete or insufficient clinical trials. However, even more commonly, the testing phase does not always uncover all the dangers of a certain drug. It’s only when a consumer has taken a certain medication for an extended time that the dangers are exposed.
One example of this would be Pradaxa, a blood thinner with the active ingredient dabigatran which has been linked to thousands of side effects, and more than 1,000 deaths due to fatal bleeding events since the medication was approved by the Food and Drug Administration (FDA) in 2010. Within of the launch, three-hundred and seven reports to the ISMP were generated. The fact that the ISMP received more reports on Pradaxa than on 98.7% of the other drugs they regularly monitor clearly illustrates the fact that the drug’s safety was a serious concern.
In 2012, Boehringer Ingelheim, the manufacturer of Pradaxa, recalled a batch of the product, specifically the 75 mg capsules, and cited a potential packaging defect as the reason for temporarily taking the product off the market. The company warned that the damaged bottle could potentially let moisture in, thus harming the drug. An antidote to the bleeding was only fully approved by the F.D.A. in April 2018. In this article, we will discuss this drug in more detail, and explain what you could do if you or a loved one suffered ill effects from taking Pradaxa or any other bad drugs or medical devices.
Consumer Alert Now aims to inform you of the dangers of known dangerous drugs and your potential recourse, should you or a loved one suffer injury as a result of a defective device or dangerous drug. Therefore, it is important for patients to be aware of the facts before they allow robots to handle serious medical surgeries. The truth is that while machines are advanced and arguably have steady “hands”, they are no substitute for a human doctor’s well-trained critical thinking and practiced skills.
Pending Bad Drug & Medical Device Lawsuits
Every year, thousands of consumers are injured - some even die - due to the side effects of dangerous prescription medications or devices. At any point in time, many different investigations are underway, which often result in personal injury lawsuits.
Both prescription drugs and over-the-counter medication can have devastating side effects on a person’s health. Because deadly side effects are not always anticipated during clinical trials, the medication often makes it onto the market. When a drug is reported to have caused injury or death, or when the Food and Drug Administration (FDA) identifies it as dangerous that outweigh its benefits, it is known as a defective drug.
In most cases, pharmaceutical companies will recall the drug in order to prevent any further injuries. When a pharmaceutical company knowingly markets a dangerous drug, they may even be held liable for the injuries sustained by the consumer. When many consumers experience side effects, injuries or death because of the same drug, they often file class action suits.
Pradaxa is one such drug, which has caused serious bleeding emergencies (haemorrhages), formation of blood clots inside blood vessels (thromboembolic events) and even death. The blood thinner (dabigatran etexilate) is facing thousands of lawsuits due to the fact that the company did not provide an antidote for its bleeding risks.
About the Pradaxa Class Action Lawsuit
Pradaxa, a prescription blood thinner product of Boehringer Ingelheim, was approved in October 2010, to help prevent atrial fibrillation (afib or irregular heartbeat) which is not caused by heart valve problems and strokes in patients. This is achieved by reducing the risk of blood clots forming in the heart and traveling to the brain. It was also approved for treating pulmonary embolisms and deep vein thrombosis (DVT) in individuals who have received intravenous blood thinners for up to ten days.
Deep vein thrombosis is a serious medical condition which occurs when a patient develops a blood clot which lodges inside a blood vessel of the lung. As a thrombin inhibitor, Pradaxa blocks the central clotting agent in the blood, known as thrombin. Pradaxa is supposed to reduce the risk of formation of blood clots.
Personal injury and wrongful death lawsuits against Boehringer Ingelheim started streaming in from 2010. In 2011, Pradaxa was blamed for 3,781 adverse medical events, and 542 deaths. According to the Institute for Safe Medication Practices, there have been more injuries and deaths reported to be linked to Pradaxa than any of the other eight hundred drugs the organization monitors.
Prior to this, the market was cornered by warfarin for sixty years. However, warfarin required rigid monitoring of the blood, which was not needed by Pradaxa patients. As a result, 725,000 opted for Pradaxa by 2012. Common side-effects of Pradaxa include mainly gastrointestinal symptoms, such as stomach pain or upset, burning and indigestion. Patients who have mechanical prosthetic heart valves are warned not to take the medication.
Unfortunately, the drug caused severe bleeding, for which there was no antidote until 2015. Bleeding events caused by warfarin could be managed by using vitamin K, but there was no way to stop Pradaxa-related bleeding events. As a result, thousands of patients experienced the results of uncontrollable bleeding, including death. The nature of the drug - which is a blood thinner - makes it prone to causing excessive bleeding. As such, many patients who suffered from uncontrollable gastrointestinal, rectal and brain bleeding.
By early 2014, Pradaxa had been linked to over 1,000 fatalities. The British Medical Journal (BMJ) published a report in July that year, alleging that the manufacturer purposely withheld critical data which showed how monitoring the plasma levels of Pradaxa patients could have improved the safety of the drug.
The lawsuit is based on the fact that Boehringer Ingelheim, manufacturers of Pradaxa (dabigatran), a blood thinner (anticoagulant), failed to provide an antidote for the bleeding it caused until 2015. This oversight led to hundreds of casualties as well as thousands of lawsuits.
A multidistrict litigation, started in 2012, consolidated approximately 4,000 claims against the drug manufacturer.
The lawsuit concluded in May 2014, when Boehringer Ingelheim agreed on a settlement of $650 million for approximately four thousand lawsuits. This followed their payment of $95 million to the U.S. government in October 2012 in settlement of a whistleblower case relating to the company’s off-label marketing of several drugs. Since then, the company has not disclosed any additional settlements. However, many patients did not recover damages in the initial claim.
In October 2015, the Food and Drug Administration approved a Pradaxa antibody, Praxbind (idarucizumab) to rapidly reverse the former drug’s anticoagulation effects. Praxbind has shown promise in terms of potentially saving the lives of patients during major bleeding events. Additionally, the FDA also approved Pradaxa for the prevention of venous thromboembolism (VTE) specifically for patients who have just undergone hip or knee replacement surgery.
However, during the period spanning October 2012 to May 2014, Pradaxa users recovered no damages, despite the fact that they had no antidote to the haemorrhages caused by Pradaxa. Between the time of those settlements and the release of the antidote in 2015, patients still faced the risk of bleeding episodes. In fact, people are still at risk of bleeding.
Shockingly, despite more than a thousand deaths caused by Pradaxa, the drug is still on the market. The FDA did not take it off the market, and neither did the manufacturer. Instead, the U.S. Food and Drug Administration only warned that missing doses or suddenly stopping the medication may increase the user’s risk of a stroke or blood clots. These conditions may lead to permanent disability or even death.
When taken in conjunction with other medications, Pradaxa may result in potentially dangerous drug interactions. Some of the substances with which Pradaxa may have negative interactions include, antacids, St. John’s wort, aspirin, non-steroidal anti-inflammatory drugs, dronedarone, ketoconazole, cyclosporine, rifampin, mifepristone.
Despite a federal court judge’s recommendation that any remaining federal lawsuits against the Boehringer Ingelheim be shut down in 2017, there has been no final action. As such, state and local courts are still hearing Pradaxa lawsuits.
Pradaxa Lawsuit: The Specifics
In an ongoing dispute, the manufacturers of Pradaxa, Boehringer Ingelheim is accused of endangering the public by misleading the doctors and their patients about the benefits and more importantly, the risks of the drug. Additionally, some of the evidence presented suggests that the manufacturer marketed Pradaxa as a safer, more effective alternative to warfarin. Although warfarin has been in use for decades, patients find it hard to manage, as it potentially interacts with certain vegetables.
The makers of Pradaxa misrepresented it as a one-size-fits-all treatment, which meant that there was no need for dosage adjustments, check-ups and laboratory blood testing.
Many plaintiffs claim that the manufacturer was negligent in failing to establish treatment protocols for potential bleeding episodes, and that led to devastating injuries and death. Furthermore, Boehringer recommended removing the drug from patients’ bloodstreams using dialysis. Yet, most medical professionals strongly disagree with this recommendation, as patients who are suffering from severe bleeding episodes may find it hard to tolerate dialysis. It is simply an unavailable and unrealistic treatment.
In failing to adequately warn doctors and patients of the risks of the drugs, Boehringer Ingelheim should be held accountable for willful endangerment of the public. Some plaintiffs feel that the drug was released into the market prematurely without an antidote. Initially, Boehringer claimed that the drug would not need an antidote, as serious events would only occur in rare cases. They further claimed that the fatal bleeding risk of warfarin was more than 40% higher than that of Pradaxa, according to the RE-LY study which secured the drug’s approval.
Plaintiffs claim that the drug was not adequately labelled and that the company’s deceptive marketing practices placed people at risk. Some complaints include the fact that the company made significant profits while thousands of patients sustained serious injuries and hundreds died.
The manufacturer surpassed $1 billion in Pradaxa sales for the 2011 fiscal year.
Meanwhile, the company remains resolutely behind Pradaxa, despite the numerous claims filed in federal court. Although four trials were planned to be conducted between August 2015 and February the following year, Boehringer Ingelheim settled the cases, closing the MDL case in December 2017.
On November 12, 2018, Boehringer Ingelheim told Reuters that two-hundred and sixty instances of fatal bleeding have been linked to Pradaxa. They claimed that the death risk was still below the rate which emerged during the clinical trial which led to the approval of the drug. The company further stated that fifty reported cases of death were considered a “reasonable order of magnitude”. Later, the drug manufacturer confirmed the new global number, which was in excess of five times the number previously reported.
European regulators recommended that patients have their kidneys checked prior to starting Pradaxa treatment. Japanese regulators informed Boehringer that they should issue a strong warning to doctors about the risk of potentially fatal bleeding in patients using Pradaxa.
Do Not Crush List: Pradaxa
Pradaxa is on the Institute for Safe Medication Practices (ISMP)’s Do Not Crush List.
It should also be noted that the bioavailability of oral dabigatran etexilate (Pradaxa) increases by as much as 75% when consumed without the shell, and opening, breaking, or otherwise administering the pill without its capsule shell significantly increases the risk of severe bleeding. It is not recommended that people who have difficulty swallowing capsule chew or break Pradaxa. Instead, a doctor should be consulted to provide alternative options. This recently occurred when nurses at a care facility opened Pradaxa capsules and sprinkled the pellets over patient’s food. Parties want a statement included to warn users against chewing, opening or breaking the tablets.
However, malpractice and personal injury attorneys continue to file lawsuits on behalf of individuals. It is possible that a judicial panel may end up grouping the cases if other people claim that they were also injured by Pradaxa.
Are You Eligible for a Pradaxa Lawsuit & Compensation?
Patients who were not a part of the 2014 settlement, but who took Pradaxa before Praxbind was introduced, might be entitled to compensation. That means, if you have suffered severe haemorrhaging or another Pradaxa-related injury in the period spanning May 2014 to October 2015, you may have a valid case.
Some of the monetary awards may cover:
- Medical bills
- Pain and suffering
- Lost wages
- Other financial losses
- Funeral expenses (if a loved one died)
If you have been injured by Pradaxa or another dangerous drug or medical device, you have a right to legal representation, whether it is as part of a class action suit, or an individual lawsuit. Common types of prescription medication lawsuits include:
Improper instructions / failure to warn - This is when the product labelling fails to provide proper usage instructions or fails to warn patients of potential risks or drug interactions. This also applies to “off-label” marketing for drugs.
Drug design defects - When a medication that was properly manufactured, but the side effects far outweigh the potential benefits and cause the user harm, this could be grounds for a lawsuit. Some of the side effects might include nausea, vomiting, dizziness and vertigo.
Drug manufacturing defect - When a batch of drugs was diluted or if something tainted it during the manufacturing process, and this causes harm to the end user, that would be grounds for a lawsuit.
Strict liability claims apply specifically to product liability cases, but the above examples are typically considered negligence. Product liability cases are when defendants put a medication on the shelf. They are then responsible for any outcomes.
Finding Help for a Pradaxa Lawsuit Near Me
If you or a loved one experienced injury or death as a result of using Pradaxa or another drug, call Consumer Alert Now at (800) 511-0747. This also applies if you have received a letter from your pharmacist or doctor alerting you to issues with your medication.
We follow the latest updates on recalled drugs and related class action suits and we are committed to helping you get justice and compensation. Do not let a loss of income and medical costs add insult to your injury. It will be up to the legal team to proof that the dangerous drug or medical device caused the injury or death.
Having proof that you have taken the drug in question is important. Your doctor or pharmacists should have the necessary proof. The defendant’s legal team will try to dispute that their drug caused your illness, but you can rely on us to prove the connection between your health condition and the drug in question.
In most cases, the drug manufacturer will be the responsible party in a drug-related case, as they have an obligation to provide safe and effective medication, and to test and research their products properly before making it available to the public.
If you wish to join a class action suit that is being held out of state, it is still beneficial to hire an attorney who has no borders to represent you. Class action suits involve large teams of plaintiffs, attorneys and pharmaceutical company representatives. Instead of being just one person with a claim, hiring a national firm means that you will have someone in your corner, and you will have a contact who can represent you properly.
Consumer Alert Now work closely with the lawyers who are working on the case, thus ensuring that your voice is heard and your interests protected. You can rely on us, because our affiliate attorneys have won millions of dollars in lawsuits similar to your own. They have the experience and dedicated to the pursuit of justice. They have the resolve to guide you past the insurance companies towards justice.
Do not allow medical costs to add further pressure to an already negative situation. Medication should make you better, not worse, and drug manufacturers should take responsibility for their negligence.
If you need help with joining a Pradaxa class action suit, or if you have been injured by a dangerous drug or medical device and want to learn more about other class actions that you could join, please call Consumer Alert Now at (800) 511-0747, no matter where in the U.S. you are. We operate on a national level and we are ready to help you obtain justice.