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Articles Posted in Pharmaceuticals

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CHICAGO, April 18, 2016: A Chicago law firm stated today that it is investigating the filing of lawsuits nationwide against AstraZeneca, the makers of Prilosec and Nexium. Moll Law Group has been contacted and is currently investigating claims of chronic kidney disease, acute kidney injury, acute interstitial nephritis, renal failure, kidney failure, and heart attack. Nexium and Prilosec are Proton Pump Inhibitors (PPIs) that are used to decrease the amount of acid produced in the stomach.

Proton Pump Inhibitors are commonly used to treat gastroesophageal reflux disease (GERD) and peptic ulcer disease (PUD). Prilosec, originally approved as Losec in 1988, was the first member of the Proton Pump Inhibitor class of medications. Nexium is a second generation Proton Pump Inhibitor said to be an improvement on Prilosec. Both are manufactured by AstraZeneca.

A February, 2016 issue of the Journal of the American Medical Association (JAMA), published the results of a new study which showed a higher risk of chronic kidney disease in patients using Proton Pump Inhibitors like Nexium (esomeprazole), Prilosec (omeprazole), and similar prescription and over-the-counter medications. The results showed the risk of chronic kidney disease was higher with prolonged use. Continue reading →

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Cancer is one of the worst medical conditions that a person can suffer. No matter what kind of cancer you have or the stage at which you are diagnosed, the treatment can be painful, lengthy, and difficult for the patient and his or her family. Modern medicine has developed a considerable number of drugs, therapies, and treatments designed to combat cancer and to help soften the blow of symptoms associated with intensive therapies like chemotherapy.

Recently, a well-known cancer drug called Taxotere, primarily used to treat breast cancer, has been linked to permanent hair loss in patients who take the drug as a cancer treatment. A number of lawsuits have already been filed against the drug’s manufacturer, Sanofi-Aventis, alleging that the company failed to provide an adequate warning about the potential for suffering permanent hair loss as a result of taking Taxotere.

When it was first released into the market, Taxotere’s label stated that patients’ “hair generally grows back” following completion of the treatment cycle. According to the manufacturer’s own studies, however, roughly three percent of all patients reported experiencing recurring or permanent hair loss. Since it was first approved, the drug has been approved for use in other types of cancer treatment, including gastric cancer, head and neck cancer, non-small cell lung cancer, and prostate cancer.

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The U.S. Food and Drug Administration (FDA) has launched an investigation into whether the agency was correct in approving the prescription blood thinner Xarelto. Since hitting the market in 2011, Xarelto has been prescribed to millions of patients. Major household product and drug manufacturer Johnson & Johnson created Xarelto and submitted the product for clinical testing prior to seeking approval from the FDA.

The drug was developed as a replacement for warfarin, an older prescription intended to prevent strokes from occurring in patients that suffer from atrial fibrillations, which is a heart-rhythm disorder. Administering warfarin requires close supervision to prevent complications from arising. Too little warfarin can lead to strokes, while too much can lead to other dangerous complications.

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The West Virginia legislature has passed a bill that adopts the learned intermediary rule for the state. This doctrine has major implications for liability in cases involving dangerous prescription drugs and defective medical devices. According to the learned intermediary doctrine, when a drug or device manufacturer provides a warning to the physician about the product, its intended uses, and its potential complications, and the doctor then interacts with the patient in regard to the drug or the device, the manufacturer cannot be held liable for damages arising from the consumer’s use of the drug or device.

Since its inception in 1995, the learned intermediary doctrine has been controversial. Opponents of the doctrine argue that it prevents consumers who have suffered severe harm due to a defective device or drug from recovering compensation from the manufacturer or distributor.

Proponents of the doctrine state that a physician who interacts with the patient after receiving instructions from the manufacturer or distributor is in the best position to inform the consumer. They also argue that manufacturers typically do not have direct routes to marketing their devices and pharmaceuticals to patients and consumers directly and that imposing a duty on the manufacturer would put an undue burden on the physician-patient relationship.

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It seems like there is a never-ending stream of dietary health supplements hitting the market each day. While many of these supplements are considered hot trends or major miracle breakthroughs that can remedy a variety of ailments, they can also pose serious health risks to consumers. There have also been too many major news events involving dietary supplements that were so dangerous they had to be removed from the market entirely.

Recently, the U.S. Food and Drug Administration (FDA) issued eight separate warning letters to companies that manufacture products containing cannabidiol (CBD) that are intended for use as dietary supplements. According to these warning letters, the companies’ claims that the CBD-containing products can help treat certain conditions like cancer, lupus, post-traumatic stress disorder, and other ailments were not appropriately verified by the FDA.

CBD products are non-narcotics containing ingredients derived from cannabis sativa, a plant that is also used to make the narcotic drug marijuana. Although some states have decriminalized and even legalized marijuana consumption, it remains illegal on the federal level.

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Fresenius Medical Care, a German medical company, has entered into a settlement agreement to resolve a landslide of cases brought against it involving its GranuFlo and NaturaLyte products used in dialysis treatments. Both of these products are dialysates and were used in thousands of dialysis clinics across the United States to treat patients experiencing kidney disease and kidney failures. Roughly one in every 500 Americans suffers from some illness that affects the kidneys and must undergo dialysis on a regular basis. Dialysis is a process that cleanses blood and eliminates toxins and wastes before returning it into the patient’s blood.

GranuFlo is a powder concentrate, and NaturaLyte is a liquid version of the same substance. The chemicals are used in dialysis machines to help neutralize the increased production of acid that can occur during the dialysis process.

In 2012, the U.S. Food and Drug Administration issued a Class I recall of both products after determining that the products posed severe threats to patients. Class I recalls are the most serious level of recall that the FDA can initiate and are appropriate when the product in question poses a substantial risk to patients, including the possibility of death.

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For many of us, pharmaceuticals can offer a life-saving alternative to suffering from terrible conditions and injuries. In some unfortunate situations, however, certain pharmaceutical companies fail to appropriately design, manufacture, and market their drug products. One such example is Xarelto, a drug that is designed as a blood thinner. Now, thousands of lawsuits alleging health problems associated with taking Xarelto are pending in a multi-district litigation proceeding in the Eastern District of Louisiana.

The U.S. Food and Drug Administration (“FDA”) approved the drug for administration to patients who underwent knee or hip replacements to help reduce blood clots and associated risks. In the fall of 2011, the FDA broadened the approval of Xarelto to help treat patients who experience an irregular heartbeat, also known as atrial fibrillation. It is currently believed that millions of individuals have been prescribed Xarelto since it first hit the market.

Some patients taking Xarelto have reported suffering severe health consequences associated with the drug. Blood thinners can cause unwanted gastrointestinal bleeding and other conditions of a hemorrhaging nature. In response to these issues, the FDA issued two black box warnings. This is the strictest warning that the FDA can impose on a pharmaceutical product. To assign a black box warning, the FDA must find reasonable evidence that the drug is associated with a serious hazard.

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This month, a panel of federal appellate judges upheld the dismissal of a plaintiff’s action against the manufacturer of the generic drug allopurinol, based on preemption. In Houston v. United States, the plaintiff alleged that in 2011 he was diagnosed with gout, which is a type of arthritis, and prescribed allopurinol. This drug is a generic version of the brand name drug Zyloprim. Roughly 30 days later, the plaintiff indicated that he developed a rash on his face and pain in his eye. He was eventually diagnosed with Stevens-Johnson syndrome (SJS), a life-threatening skin condition, which his treating physicians attributed to a reaction to the allopurinol.

The plaintiff initiated an action in 2014 against the drug maker, Qualitest, the medical facility, and his health care provider, alleging that the drug maker failed to provide an adequate warning about the risk of developing SJS after taking the drug. The plaintiff also alleged a design defect claim. The health care facility and physicians were funded by the federal government, so the United States removed the action to federal court. All three defendants then filed a motion to dismiss, which the district court granted.

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Xarelto, a drug commonly used to treat strokes and to prevent blood clots, has come under fire for the severe risks it poses to patients. Although there has not been a recall of the drug, a number of plaintiffs have filed lawsuits alleging that they experienced severe complications as a result of taking Xarelto.

According to the plaintiffs’ complaints, Xarelto caused uncontrollable bleeding to occur. The medication is designed to disrupt blood clotting patterns to prevent strokes from occurring, but it lacks an antidote to prevent any incidences of bleeding from becoming life-threatening. The plaintiffs alleged that the manufacturer did not properly warn against the dangerous risk of bleeding episodes and the inability to stop them once they start.

Instead, the manufacturer advertised Xarelto as being safe and providing a more convenient solution than wafarin, another drug prescribed to combat blood clots and strokes. Unlike Xarelto, however, wafarin has a known antidote that doctors can use to stop bleeding episodes. In reality, Xarelto has been associated with a number of devastating and life-threatening conditions, including gastrointestinal bleeding, brain hemorrhages, strokes, and death.

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According to nationwide reports, families are bringing countless lawsuits against the makers of the drug Zofran and related substances, alleging that the use of the anti-nausea drug resulted in children being born with severe birth defects. As a result of the high number of Zofran and related drug lawsuits being brought, they have been consolidated in a multidistrict litigation, or MDL, in the District Court of Massachusetts in Boston. The United States Judicial Panel on Multidistrict Litigation has named the action MDL No. 2657, or In Re: Zofran (Ondansetron) Products Liability Litigation.

The prescription drugs Zofran, also known as ondansetron, and Zuplenz have been associated with severe and debilitating pregnancy complications and birth defects. Doctors initially prescribed the drugs to pregnant women to help curb the high levels of vomiting and nausea that pregnant women often experience. Studies have linked the drugs to birth defects, causing families who have suffered grave consequences as a result to bring lawsuits against the maker of the drug, GlaxoSmithKline, claiming that the company marketed the drug to the public without first obtaining appropriate U.S. Food and Drug Administration (“FDA”) approvals.

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