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COVID-19: Maryland Laws, Policies and Legal Resources from Miller & Zois. Includes information and updates on Maryland and Federal laws and regulations impacting Maryland residents and businesses.

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According to the findings of a recent study, taking benzodiazepines such as Xanax or Valium during pregnancy could significantly raise a woman’s risk of having an ectopic pregnancy. In this study, published by Stanford University in the journal Human Reproduction, scholars found that pregnant women taking these drugs to reduce anxiety or induce sleep have a 50% increased chance of developing life-threatening complications.

Normal Pregnancies vs. Ectopic Pregnancies

In a normal pregnancy, a fertilized egg will attach itself to the lining of the uterus in order to begin the growing process. However, an ectopic pregnancy will occur if the fertilized egg implants and grows outside of the main cavity of the uterus.

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Breast augmentation is the most prevalent cosmetic procedure in the United States, with estimates ranging that 1 to 3 million women have some type of breast implant. For years, there has been developing research about the possibility of implants increase the risk of certain cancers, but the evidence was considered too slim to create any action towards addressing the problem.

breast implant cancerNow, the FDA has finally issued a safety warning about the risks of using breast implants manufactured by the company Allergan. The warning requested Allergan to recall all of their microtextured implants in the United States, citing new sufficient evidence showing a link between their products and breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). This recall will most likely cause a significant increase in breast implant cancer lawsuits, including class action lawsuits for medical monitoring.

The warning is not without precedent, as there have been similar recalls for Allergan breast implants in Canada, Australia, and France within the past year. However, the FDA was hesitant to issue on their own recall due to “insufficient evidence” that indicated a connection between textured implants and the rare lymphoma cancer. Despite this, hundreds of women around the country have been taking Allergan to court based on claims that their breast implants were the cause of their illness.

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A November 2018 article in the BMJ reported a study concluding what many lawyers have known for a long time: patients who use sodium-glucose cotransporter 2 (SGLT2) inhibitors are twice at risk of having lower limb amputations than other diabetes medications. The scientists also reported that SGLT2 inhibitors are also linked to diabetic ketoacidosis.

What Are SGLT2 Inhibitors?

Sodium-glucose cotransporter 2 (SGLT2) inhibitors are medications that lower blood sugar in adults who have type 2 diabetes. They are used to complement diet and exercise. SGLT2 inhibitors may be available as a single-ingredient product or combined with other diabetic medications including metformin. They reduce the amount of glucose being absorbed by the body through the kidneys. This helps to reduce blood sugar by removing excess glucose through urine.

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A lawsuit recently filed in the U.S. District Court District of New Jersey alleges that someone received stomach cancer as a result of taking proton pump inhibitors (PPIs) Prilosec, Nexium, and the variations of both drugs. PPIs are used to treat many different stomach conditions, but can create even worse problems in the stomach as well. Before informing yourself on this lawsuit, you must first inform yourself on PPIs, specifically Nexium and Prilosec. You must also inform yourself about their potential side effects.

What are Proton pump inhibitors?

Proton pump inhibitors (PPIs) are medications that reduce the amount of stomach accident found in the stomach lining. They help relieve symptoms of acid reflux, a condition in which food or liquid goes back up to the esophagus. PPIs can also help treat a stomach ulcer. In addition, they can also treat lower esophagus damage resulting from acid reflux. PPIs can be used to treat heartburn as well. They come in various brand names such as Prilosec, Nexium, Prevacid, AcipHex, Portonix, Dexilant, or Zerid.

PPI side effects

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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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