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On July 13, 2018, the Food and Drug Administration (FDA) recalled Valsartan because they contain the contaminant N-Nitrosodimethylamine (NDMA). The FDA noted that valsartan products pose an unnecessary risk to patients. There are seven things you should know about this recent recall.

  1. What is NDMA?

NDMA is a contaminant. According to the EPA, it is a semivolatile organic chemical. It can be either naturally occurring or synthetically made. It is not currently produced in the United States. NDMA can be unintentionally produced through chemical reactions, especially those that involve alkylamines. It is also an intended by-product of chlorination of wastewater through use of chloramines. These chloramines are used to disinfect the water. There is a risk that NDMA is a possible drinking contaminant.

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Researchers from Louisiana State University’s Health Science Center and Seattle Children’s Hospital were given a five-year federal grant by the National Institutes of Health (NIH) to study whether or not muscle power training exercises can improve the walking abilities of children with cerebral palsy (CP).

Is this exciting? It really is.  Anything that can advance the ball for people with cerebral palsy is wildly exciting.

How will this study be conducted?

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As of September 2018, there are over 1,500 Bair Hugger warming blanket lawsuits pending in the MDL in Minnesota.

In one typical case, a New York couple claims that a surgical warming blanket used after the husband’s hip replacement operation caused severe infections, resulting in four additional surgeries. A man and his wife filed a lawsuit in New York on Nov. 25, 2015, against 3M, the manufacturer of the Bair Hugger forced-air warming system. Medical facilities commonly use this blanket during knee and hip replacement operations. In addition to 3M, the lawsuit lists the Arizant Healthcare, Inc. and its subsidiaries as Defendants.

The value of surgical blanket lawsuits is still being determined

The value of surgical blanket lawsuits is still being determined, but many of these infection cases involve serious injury and death.

During the surgery on Oct. 24, 2012, medical personnel used a Bair Hugger on the man’s left hip, supposedly to help regulate body temperature. However, the warming blanket might have introduced bacteria into the surgical site, resulting in infection. The Plaintiff received five surgeries within 16 months, including the original surgery, and he now struggles with mobility and needs crutches to walk.

Per the lawsuit: “Due to the infection, Plaintiff needed four additional surgical procedures to remove the implant and clean the infected area within sixteen months from the original implant surgery, and he continues to suffer limited mobility, requiring crutches to ambulate.”

According to diverse news reports, this Plaintiff is far from alone; many consumers across the nation have taken legal action after illnesses they’ve acquired after using the Bair Hugger, following hip and knee surgeries.

The Plaintiffs noted that 3M sent a letter to the FDA way back in June 1997, that warned of possible contamination issues with this product.

 

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Sprue-like enteropathy is an intestinal condition involving chronic diarrhea, nausea, stomach severe stomach discomfort and rapid weight loss.  Sprue-like enteropathy is very similar to celiac disease, which causes adverse reactions to the consumption of gluten.  Much like celiac disease, sprue-like enteropathy can damage and erode the intestinal villi (tiny finger-like fibers on the inside of the intestines that help absorbs nutrients from food).  This type of damage or erosion of the intestinal villi is referred to as villous atrophy.  When villous atrophy is caused by adverse reaction to gluten the condition is classified as a celiac disease. Sprue-like enteropathy is used to categorize villous atrophy resulting from other causes such as drug reactions (see below). If left untreated, sprue-like enteropathy and villous atrophy can permanently damage the body’s ability to process and absorb nutrients in food resulting in chronic malnutrition.  The condition is very serious and can easily become life-threatening.

Sprue-Like Enteropathy Caused by Blood Pressure Medications

shutterstock_151822316-200x300Sprue-like enteropathy can be caused by use of olmesartan – a popular high blood pressure medication sold under the brand name Benicar.  It is also sold under the names Benicar HCT, Tribenzor, and Azor.  Benicar works to treat blood pressure problems by causing blood vessels to relax and expand making blood flow easier and lowering overall blood pressure.  Benicar is manufactured by the Japanese pharmaceutical company Daiichi Sankyo, Inc.  After first being released in 2002, Benicar has rapidly gained popularity and has been prescribed to over 12 million patients in the U.S.  In 2012 a study by the Mayo Clinic first established a link between prolonged use of Benicar and sprue-like enteropathy.  This prompted the FDA to conduct its own review and in 2013 the FDA released a public safety announcement warning that Benicar can cause sprue-like enteropathy.  After the FDA announced the warning label for Benicar was amended to include this safety risk.

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Donald Trump’s hair reportedly turned orange by a Just for Men hair product.  This is probably a serious thing to Trump but less so to the rest of us.  But there a real concern about these Just for Men products.  An increasing number of men are reporting severe allergic reactions to “Just For Men” hair and beard products. The reactions include burning, difficulty breathing, dizziness, faintness, hives, rash, redness, scarring, and swelling. The reactions are being reported not just by new users, but also by long-time users who had previously never experienced any problems. The reactions are so severe that some users had to go to the emergency room, or even be hospitalized. Many users needed antibiotics and steroids to treat the reactions.

The “Just For Men” website tells users to always first do a patch test before using the product: “Always do a simple skin allergy (alert) test 48 hours before you use your Just For Men product. Do the patch test on the inside bend of your elbow each and every time.” The products include a similar warning.

The culprit appears to be p-Phenylenediamine (PPD), a dye derived from coal tar that helps color hair. The Centers for Disease Control and Prevention (CDC) lists PPD as a contact allergen. It was voted “Allergen of the Year” by the American Contact Dermatitis Society in 2006, a finding that was published in the journal Dermatitis. Its allergic nature was subsequently confirmed by a 10-year review of the allergen in 2011 that was also published in Dermatitis. A Consumer’s Dictionary of Cosmetic Ingredients says that PPD can cause “intense skin irritation and blisters.”

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Xarelto is a new-generation blood thinner that was initially approved by the U.S. Food & Drug Administration in October 2011.  Xarelto is intended to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, to treat deep vein thrombosis (DVT) and pulmonary embolism (PE). The drug is also to reduce the risk of recurrence of DVT or PE, and for prophylaxis of DVT for patients undergoing hip and knee replacement surgery.

This drug has made Bayer and Johnson & Johnson a fortune.  It has also left them as the defendants in 21,400 Xarelto bleeding lawsuits from patients or surviving families allege they have suffered gastrointestinal and cerebral hemorrhages, hemorrhagic strokes and other types of bleeding issues that have caused injury or death.   Xarelto carries a significant risk of severe, and sometimes even fatal, internal bleeding – and there is no reversal agent available if serious bleeding occurs with Xarelto use.

Xarelto Lawsuit Allegations

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womanNexium, or esomeprazole, is a drug that is used to treat heartburn and excessive amounts of acid in the stomach. Specifically, it is used to treat duodenal and gastric ulcers, esophagitis, gastroesophageal reflux disease (GERD), and Zollinger-Ellison syndrome. Nexium is a proton pump inhibitor (PPI) that decreases the amount of acid produced in the stomach. Other drugs that are in the same class as Nexium include Prevacid and Prilosec. Approximately 15 million Americans use PPIs that are sold both as prescription and over-the-counter.  Nexium sales exceed $3 billion a year.

Nexium is a controversial drug.  At one point, bone fracture lawsuits were all the rage because there was data suggesting Nexium, particularly the long-term use of Nexium, would cause bone fractures and breaks.  We believed many of these cases were meritorious.  But the litigation did not get very far.

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The FDA has recently expressed concern about a certain group of medications called SGLT2 Inhibitors. This category of drugs includes popular prescription medications such as Invokana and Farxiga. Although these drugs have been, by all accounts, fairly successful when treating Type 2 diabetes. But,  they have produced their fair share of side-effects. Specifically, users of drugs such as Invokana are now reporting high levels of blood acid, the effects of which have landed some users in the ER.  While no deaths have been reported, there is no question that if these reports are accurate, these levels of blood acid could cause serious injury and death.  Accordingly, plaintiffs’ lawyers are investigating whether there is a connection between these drugs and these high acid levels and, if so, whether these drug makers knew about these risks and simply failed to inform patients and doctors.   If these dots are connected – and there is reason to think they might be – there are likely to be both serious injuries and lawsuits seeking compensation for those injuries.

The preceding paragraph was written some time ago.  In May 2017, there are 230 lawsuits pending in a federal MDL in New Jersey.

SGLT2 Inhibitors

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pills2New data suggests an association between melanoma skin cancer and Viagra. This has led many patients suffering from erectile dysfunction to question whether the benefits of this drug justify the risk of death that many accompany it.

If you or someone you love has developed melanoma while taking Viagra, you may have an injury or wrongful death lawsuit against Pfizer who has never adequately warned patients and their doctors of this risk. If you believe you have a claim, call our lawyers for free at 800-553-8082 or get a free Internet consultation. We can discuss your options with you.

The Association Between Viagra and Melanoma

The understanding of the potential risks of melanoma with Viagra took flight in 2014 for the general public when Harvard Medical School released a new study indicating that Viagra users were 84% more likely to develop melanoma skin cancer.

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testosterone2
Testosterone supplements have found themselves in the news quite a bit lately.  Unfortunately, for manufacturers, this is not good news. Because these lawsuit are on the fast track to being a very big deal.

There is a lot of research coming out with sudden fury that suggests that testosterone treatments for men can cause an increased risk of heart attacks and strokes that can lead to serious injury and death.  A study published this week in the medical journal Plos One, indicated that researchers found a two-fold increase in the risk of heart attack in the three months after an initial prescription among men aged 65 years and older, and a two to three-fold increase among younger men with a history of heart disease.  This is huge, especially considering millions of men are taking these hormonal treatments, and many are learning for the first time of the extent of the risk.

Products in this category are:

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