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Plaintiffs continue to come forward, accusing Fresenius Medical Care of failing to inform patients about the risks involved with GranuFlo. This medical powder used in kidney dialysis treatment to help clean the blood of patients. Now, there are around 5,500 GranuFlo injury cases, many of which were filed in U.S. District Court in Boston and Middlesex Superior Court in Massachusetts. Fresenius is based in Waltham, MA.

GranuFlo has been linked to a greater risk of heart attack and metabolic alkalosis, which involves the body fluids having too much bicarbonate in the blood. Metabolic alkalosis can lead to more serious health issues, including hypoxemia, hypokalemia, high blood pressure, and cardiac arrhythmia.

Many of the Massachusetts defective medical device plaintiffs have noted that when Fresenius eventually told dialysis clinicians about the risks, it initially chose to only notify its own clinics. Their claims point to a company memo that Fresenius sent to its clinicians warning that the powder may cause cardiac event-related risks. Product labeling, which can lead to dosing errors, appears to be the main cause of this problem.

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In previous blog posts, our drug injury law firm has written about the risks associated with taking Yasmin and Yaz birth control pills. Now, we want to make sure you are aware that Beyaz, another birth control pill made by Bayer, also carries an increased risk of blood clots, heart attack, and stroke.

Beyaz was introduced into the market in 2010. The U.S. Food and Drug Administration approved the drug because it is similar to the Yaz birth control pill. They are both contraceptive pills that are estrogen/progesterone-based. The difference is that Beyaz has folic acid, which can lower the risks of a neural tube defect should the birth control fail.

Since then, the FDA has told Bayer to modify its warnings on the Yaz label to more clearly disclose the blood clot-related risks. The agency put out a warning in 2011 notifying the public that birth control with drospirenone, a synthetic hormone, has been linked to a greater risk of blood clot. According to the preliminary results of one FDA-funded study, drospirenone in a contraceptive ups the risk of blood clots by about 1.5 times compared to in women who use hormonal birth control.

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Now that 95% of eligible plaintiffs have opted in, the $100 million defective medical device settlement between NuvaRing manufacturer Merck & Co. and 3,800 claimants will stand.

A district court judge had approved the birth control injury settlement earlier this year. Merck, however, could have backed out of the agreement if not enough plaintiffs agreed to join.

The company maintains that “substantial” evidence proves that the contraceptive device is safe. It is settling the NuvaRing lawsuits without denying or agreeing to the claims.

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Attention Deficit Disorder, or ADD (ADHD in some children includes hyperactivity) generally becomes evident when children and young adults are in school and start to experience difficulties in class or concentrating on homework. Diagnosis and treatment of this complex disorder is extremely difficult, and there has been heated debate on the medications used to treat ADD and ADHD for as long as these drugs have been on the market. The strong steroid medications often produce a lengthy list of side effects that can significantly alter a child’s quality of life. Doctors must weigh the positive effects of the treatment with negative side effects before making the decision to prescribe the medication to children.

Children suffering from the symptoms of ADD/ADHD may:
• Be easily distracted, miss details, forget things, and frequently switch from one activity to another • Have difficulty focusing on one thing • Have trouble completing or turning in homework assignments, often losing things (e.g., pencils, toys, assignments) needed to complete tasks or activities • Have difficulty processing information as quickly and accurately as others • Talk nonstop • Have trouble sitting still during dinner, school, and story time • Blurt out inappropriate comments, show their emotions without restraint, and act without regard for consequences • Have difficulty waiting for things they want or waiting their turns in games (Source: National Institute of Mental Health)
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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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In an unexpected ruling, the Seventh Circuit Court of Appeals has denied GlaxoSmithKline PLC’s motion to dismiss a drug defect lawsuit blaming the pharmaceutical company for a man’s suicide. The wrongful death case, filed by the widow of Stewart Dolin, contends that it was the six paroxetine tablets, which he took as prescribed, that prompted him to kill himself in 2010. Paroxetine is a generic version of Paxil.

Dolin’s widow, Wendy Dolin, claims that the warning on the generic Paxil’s bottle was inadequate because it failed to caution that there was an increased suicide risk for adults. She believes that her husband experienced the serious side effect called Akathisia, which has been linked to certain Selective Serotonin Reuptake Inhibitors that are prescribed for anxiety and depression. The resulting inner agitation and restlessness can be so intense that some experts have said that a person might wish to end his/her life.

Under the law, generic drug makers are not allowed to change the labeling designated by the makers of brand name drugs. They must use the same exact wording on their products’ labels. This can make it tough for a consumer to file a drug injury case against the manufacturer.

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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

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In an attempt to combat next-morning impairment caused by several brands of sleep aids, the Food and Drug Administration has slashed the recommended dosage of Lunesta in half to one milligram. This is just the latest in a move to combat numerous dangerous side effects caused by the potent medications including Lunesta and its competitor Ambien. The FDA lowered the dose further from its original recommendation of two milligrams and advised its manufacturer, Sunovion Pharmaceuticals to reflect this change on the label.

The smaller dose reduces the amount of the powerful drug left in the patients’ bloodstream in the morning. The FDA aims to eliminate the dangerous side effects that may impair a patient’s ability to drive or operate machinery while taking a prescription sleep aid. The New York Times as well as several other news outlets alleges the change came in part from the result of a British study on 91 subjects in 2012. The study concluded that patients who consumed three milligrams of Lunesta experienced “severe impairment of memory and motor skills the morning after taking the drug, compared with a placebo.” The study also found the earlier prescribed dose of two milligrams, which was thought to be safe, can still “hamper driving, memory and coordination for up to 11 hours after the drug was taken.” Researchers found that most of the patients did not know or realize that they were actually impaired, potentially creating an extremely dangerous situation.
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A New Jersey jury recently awarded a substantial $1.59 million verdict to a victim who was prescribed the acne drug Accutane and developed Ulcerative Colitis. The jury found that Hoffman-LaRoche and Roche Laboratories, which manufactures Accutane “failed to provide Kamie Kendall Ries…with adequate warning of the health risks.” Ries’ winning verdict is a good sign for the thousands of victims who developed Colitis after taking the drug.

According to the American Osteopathic College of Dermatology, Accutane (generic name: Isotretinoin) is a powerful drug prescribed for severe acne. The potent medication is a natural derivative of Vitamin A and is only used in extreme cases where acne does not respond to any other treatment including creams and antibiotics. Over two million patients have consumed the drug since it first came on the market in the mid-1980s. Notably absent from the lengthy list of side effects is the risk for Colitis, which thousands of patients claim they developed after taking the drug.
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