Articles Posted in Defective Drugs

The blood thinner Xarelto was introduced in 2011 by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, and Bayer Health Care. The prescribed medication is used by millions of Americans nationwide as a way to reduce the risk of stroke. Xarelto may also be prescribed to reduce the risk of deep vein thrombosis, pulmonary embolism, and other blood clot related injuries. Xarelto was originally approved by the Food and Drug Administration (FDA) to be used for patients who have had hip or knee replacement surgery and were therefore at a higher risk of developing blood clots. The FDA later revised their approval to include the additional ailments previously listed.

Xarelto may also be prescribed to patients that are suffering from an irregular heartbeat, commonly referred to as atrial fibrillation. Patients with atrial fibrillation are already at an increased risk for blood clot formation—and if blood clots were to form in the heart and travel to the brain, risk of stroke is prevalent as well. Xarelto should, according to the label provided by its manufacturers, reduce the risk of blood clots. But many patients have found out the hard way that some of the side effects of taking Xarelto are much more dangerous than the conditions they faced that lead them to taking the drug in the first place.

Most anticoagulants that are competition for Xarelto are available with reversal agents that can be used if a patient taking one of these prescriptions begins to suffer from uncontrolled bleeding. Many blood thinners carry the risk of this happening, but Xarelto users suffer a higher number of incidents than patients that are taking other prescriptions for the same ailments. That means if someone who was on Xarelto suffered from a brain bleed, or any other form of uncontrolled bleeding, it would be extremely difficult for doctors to reverse the issue. If the bleeding were to persist despite medical efforts—Xarelto patients are at a higher risk of serious injury and even death. Continue reading

More women are continuing to come forward, accusing pharmaceutical company Pfizer of not giving them proper warning that taking cholesterol drug Lipitor might cause them to develop type 2 diabetes. In their Lipitor diabetes lawsuits, the plaintiffs claims that the drug manufacturer was aware of these side effects but did not act to make sure that the public knew about them, too

It wasn’t until 2012-six years after Lipitor entered the market-that the U.S. Food and Drug Administration demanded that manufacturers of drugs that lower cholesterol, also known as statins, modify their labeling to include some of the more dangerous risks involved, including memory loss and diabetes. Statins are prescription meds that are supposed to be used, along with diet and exercise, to lower bad cholesterol. Pfizer, however, denies that Lipitor was the cause of the women’s diabetes. Instead, the company has suggested that they developed the disease because of other risk factors, such as obesity or high blood pressure.

Still, as of August 2014, Reuters reports, nearly 1,000 women had filed drug injury lawsuits against Pfizer naming Lipitor as the cause of their diabetes. A federal judicial panel has consolidated all Lipitor Diabetes lawsuits in the US into one courtroom in South Carolina.

Plaintiffs recently filed at least 13 Zoloft injury lawsuits against Pfizer Inc. The women claim that their babies were born with birth defects caused from taking Zoloft. They say that doctors prescribed the antidepressant, which they took while they were pregnant.

The plaintiffs believe that the drug maker either knew that Zoloft cause the birth defects or if not then they should have been aware that it did. They contend that the drug maker should have notified them about the serious risks to their children.

The women are claiming that Zoloft is defective, dangerous, doesn’t come with the proper warnings, and should not be sold or marketed. They want compensatory and punitive damages for past, ongoing, and future pain and suffering, injuries sustained, and losses.

High cholesterol is one of the most common medical conditions for patients in the United States, and the market for medication to treat the condition is a multibillion dollar industry. Many doctors attribute at least part of the uptick in high cholesterol, or hypercholesterolemia, to poor diet and nutrition, alcohol consumption, and family genetics. The supersized diet popular in the United States has led to a marked increase in high cholesterol cases which, left untreated could result in cholesterol deposits in major arteries, ultimately leading to heart attack and stroke. The Center for Disease Control claims that one in every six Americans is diagnosed with hypercholesterolemia, making the quest to find a viable cure an urgent one at the very least.

There are a variety of treatments on the market for hypercholesterolemia, including statins like Lipitor and Crestor. Statins, according to the Mayo Clinic, block a substance in the body that is necessary to make cholesterol. In addition, the hospital notes that the medication may also help your body “reabsorb cholesterol that has built up in plaques on your artery walls, preventing further blockage in your blood vessels and heart attacks.” According to the latest study, the problems arise when niacin is added to a patient’s usual statin.
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It can ruin the most delicious of meals; put the most dedicated fan out of commission just in time for the big game. Millions of Americans deal with the incessant burning sensation centered in the chest after a meal, and many of them reach for heartburn medication such as Prilosec OTC and Prevacid. These medications are proven to work exceptionally well at reducing levels of stomach acid, sometimes to as low as 10% of their original levels. These drugs, especially proton pump inhibitors such as Nexium are now coming under increased scrutiny as researchers have begun to find a link between consuming high doses of the drug for a significant amount of time and broken bones.

The Food and Drug Administration is continuing to investigate the risk of developing brittle bones and an increased risk for fracture as a result of taking proton pump inhibitors, and will now require the drugs to be sold with a warning label. After seven tests done over the course of a decade, the FDA has acknowledged a significant percentage of patients who used the drug were more subject to broken bones, especially around the hips and wrists, than those who were not prescribed the medication. According to NPR, “six of the studies showed an increased risk of fractures, and some showed the risk was greater among people who used higher doses or took the drugs longer.” Research seems to suggest that the longer the drug is taken, the higher risk for fractures. This is substantiated by a Canadian study also referenced by NPR, in which participants who took PPIs for seven years or longer were five times more likely to sustain fractures than those who did not take the medication.
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German pharmaceutical company Boehringer Ingelheim has agreed to pay $650 million to settle thousands of consumer lawsuits involving its blood thinner medication Pradaxa.

The company issued a statement Wednesday to publicize its agreement, which will most likely settle the majority of the 4,000 cases brought against the company by patients who’d used the drug and their families. The victims have alleged that Boehringer Ingelheim failed to adequately warn them that using the drug, which is prescribed to prevent blood clots, could cause serious and sometimes fatal bleeding that is not easily reversible. Additionally, many patients’ attorneys are claiming that the company misled patients and their doctors about Pradaxa’s risks and about its advantages over warfarin, an older treatment for blood clots. According to the New York Times, the first case is set to go to trial this coming September.

In a company statement, Boehringer stated that is stood behind Pradaxa and the drug’s effectiveness, saying that it “continued to believe that the lawsuits lacked merit.” The company agreed to the settlement so that it could move on from the incident.

“Time and again, the benefits and safety of Pradaxa have been confirmed,” said Desiree Ralls-Morrison, senior vice president and general counsel of Boehringer Ingelheim USA.

Pradaxa was approved in 2010 and was one of the first drugs in a new group of blood thinners intended to replace the warfarin treatment, which had required patients to submit to frequent blood tests and maintain a strict diet. One of Pradaxa’s main selling points, according to the NY Times, was its convenience because it did not require any tests or dietary restrictions. So far the drug has been prescribed to about 850,000 patients across the United States, and has been linked to more than 1,000 deaths, according to the Institute for Safe Medication Practices and the NY Times. Despite the risks, the company as well as the FDA agree that the benefits of the medication outweigh the potential adverse side effects.

Problems arose soon after Pradaxa arrived on the drug market however, and emergency department doctors and trauma surgeons started becoming alarmed because of an influx of patients using drug were arriving with life-threatening bleeding that did not always respond to standard treatments. Currently there is no antidote to stop bleeding of Pradaxa patients, although Boehringer is still in the midst of developing one.
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Boehringer Ingelheim says that it will pay $650 million to resolve more than 4,000 drug defect cases involving Pradaxa, its anticoagulant. Despite settling, the drug manufacturer is denying any wrongdoing.

Pradaxa has been named in numerous incidents involving excessive bleeding complications. The U.S. Food and Drug Administration has received notice of 12,494 injuries and 1,158 deaths involving Pradaxa users just in the last four years.

The blood-thinning drug was approved in 2010 to prevent strokes in patients suffering from atrial fibrillation. It is supposed to stop the formation of clots. The FDA has also approved Pradaxa to treat pulmonary embolisms and deep vein thrombosis, and the drug is used for off-label purposes that are not FDA-approved.

Many plaintiffs are claiming that Pradaxa was improperly presented as an improvement to Warfarin, another blood thinner. The drug injury lawsuits contend that the manufacturer did not warn users that unlike Warfarin, there is no antidote available to reverse the internal bleeding that can happen from taking Pradaxa. (Warfarin’s antidote is vitamin K.) Plaintiffs believe that Boehringer Ingelheim willfully used deceptive marketing practices that endangered the public, did not reveal the risks involved, and failed to develop proper treatment methods for patients who would experience severe bleeding reactions.

Other claims made against Pradaxa:

• It was presented as a safer drug than Warfarin, even though the risks associated with Pradaxa are the same or greater.
• The manufacturer didn’t warn that the bleeding could prove deadly.

Elderly people seem especially prone to the Pradaxa-related bleeding problems. Pradaxa was touted as the first drug of its type to not require dietary restrictions or regular testing.

A lot of the dangerous drug lawsuits name uncontrollable internal bleeding as a serious side effect of Pradaxa. Other serious side effects linked to Pradaxa include kidney bleeding, internal bleeding, heart attack, brain hemorrhage, gastrointestinal bleeding, and death.

Critics have questioned the clinical trials that were involved in getting FDA approval for Pradaxa. The drug was approved because of the results from RE-Ly, a clinical study that compared the drug to Warfarin. Some experts are saying that the study was flawed.

In Massachusetts, please contact our Boston Pradaxa injury lawyers if you believe that use of this anticoagulant caused injury to you or a loved one. You may have reason to pursue your products liability case against Boehringer Ingelheim and others. For example, depending on the specifics of your case, you also may have grounds to file a Massachusetts medical malpractice case against your prescribing doctor, as well as injury cases against other responsible parties.

Boehringer Ingelheim Settles US Pradaxa Litigation For $650 Million, Forbes, May 28, 2014
FDA approves Pradaxa to prevent stroke in people with atrial fibrillation, FDA, October 19, 2010
Warfarin, MedlinePlus

More Blog Posts:
Pradaxa’s Deadly Side Effects, Drug Injury Lawyers Blog, November 13, 2013
Pradaxa Lawsuit Claims Drug’s Side Effects Caused Woman to Bleed to Death, Boston Injury Lawyers Blog, April 30, 2012

FDA Cuts Sleep Aid Dosage in Half among Side Effect Concerns, Drug Injury Lawyers Blog, May 27, 2014 Continue reading