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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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In the past two years, the Food and Drug Administration (FDA) and Pfizer have made several announcements on the drug Xeljanz. None of them have been good.

The FDA has reported on Xeljanz’s association with pulmonary embolisms, severe heart issues, cancer, and death. This comes nine years after the FDA approved it to treat psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis. Former Xeljanz patients have begun to file lawsuits against Pfizer. These Xelijanz lawsuits allege that the drug caused them to suffer severe side effects.

Xeljanz

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In recent years, studies have found an association between paraquat, an herbicide, with several adverse health effects.  Most notably, the concern is Parkinson’s disease.  An Illinois man filed a new suit in state court alleging that his decades of paraquat exposure caused him to develop Parkinson’s.  There are many more Paraquet lawsuits expected in 2021.  Let’s unpack what these cases are about.

Paraquat is toxic

Paraquat is an extremely toxic herbicide.  Nobody is really arguing this point. The herbicide is primarily used for controlling weeds and grasses. It is manufactured by agribusiness giant Syngenta.

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Within the past year, many lawsuits have been filed against Teva Pharmaceuticals. These suits allege that Teva’s Paragard IUD fractures upon removal, resulting in fragments being left in the uterus. The plaintiffs claimed this caused them to undergo additional removal procedures, which would have been unnecessary had this defect not occurred.  The purpose of this page is to provide a status update on the current state of the Paragard lawsuits as of late January 2021.  Other Paragard law firms and websites are providing updates on this litigation, and I would encourage you to follow them here, here, and here.

Certainly, the biggest news in the short history of this litigation was last month when these lawsuits were centralized into an MDL in Georgia federal court.  This means there will be a class action in which all federal court cases will be consolidated in Georgia under one judge.  So if you have a federal case in California, Texas, Florida, or anywhere, it will end up.

Let’s start out by talking about some of the science behind these cases.  Usually, what fuels litigation is that studies come out and lawyers jump on these studies to bring lawsuits.  In this litigation, it might be a little bit backward.  It took a while for plaintiffs’ lawyers to pick up on the problems with Paragard.  Now a new study this year further supports the contention Paragard lawyers are making.

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A federal class-action lawsuit on Elmiron was filed in October 2020. Its plaintiffs allege that it causes pigmentary maculopathy. This comes after recent studies have reported on Elmiron’s association with retinal damage.

These Elmiron eye damage lawsuits are expected to explode as people are learning that their eye injuries may be associated with Elmiron.  This could be an extremely large mass tort and it has earned the interest of drug injury lawyers everywhere.

Elmiron

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Beovu was supposed to be the big new revenue-making drug for pharmaceutical giant Novartis last year. Beovu was designed for the treatment of wet age-related macular degeneration (wet AMD), a common eye condition that can cause blindness if not treated. Novartis invested heavily in the development of Beovu and was counting on the drug’s dosing advantages to help it tap into the massive market share currently held by the leading AMD drug – Eylea. But an onslaught of major safety concerns and anticipated Beovu lawsuits quickly crushed the money-making potential of Beovu. Rather than abandon its investment, Novartis is now trying to repurpose Beovu to treat other eye conditions.

Development of Beovu

The treatment of certain common eye conditions, particularly age-related macular degeneration, is big business in the pharmaceutical world. Really big. Age-related macular degeneration (AMD) comes in 2 forms (wet and dry) and it is the leading cause of blindness in the world today. An estimated 11 million people in the U.S. suffer from AMD. If not properly managed and treated, AMD can result in serious vision impairment or blindness.

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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 micro-textured 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 because of taking proton pump inhibitors (PPIs) Prilosec, Nexium, and the variations of both drugs. PPIs are used to treat many 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 stomach ulcers. Also, they can 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, Protonix, Dexilant, or Zegerid.

What are PPI side effects?

Commonly found side effects may include a headache, diarrhea, constipation, nausea, and itching. Serious long-term side effects may include infections and bone fractures. PPIs can also be very bad for your kidneys as well. According to an April 2016 study published in the Journal of the American Society of Nephrology, PPIs are linked to serious kidney complications. It showed that patients who took PPIs were about 96% more likely to get kidney failure than those who did not. PPIs users were also 28% more likely to develop chronic kidney disease after five years of taking PPIs. According to a 2017 study published in Gut, there may be a link between PPIs and gastric cancer. This study was documented by Hong Kong-based researchers. They looked at 63,000 adults in Hong Kong over a nine-year span that ranged from 2003 to 2012. They discovered that those who took PPIs such as Nexium and Prilosec doubled their risk of gastric cancer. This contrasts with other heartburn drugs, which did not increase any risk. The study is very relevant to the current lawsuit involving Nexium and Prilosec that is being filed in the New Jersey court.

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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 the 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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