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Articles Posted in Pharmaceuticals

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Pharmaceutical companies have made some incredible breakthroughs when it comes to developing drugs that can help people cope with a variety of conditions. In some cases, these drugs can provide a life-changing solution for people who suffer from painful and debilitating conditions. For all their benefits, however, pharmaceuticals can pose serious and life-threatening dangers to patients. Two of the most recent drugs to come under scrutiny for posing an unreasonable risk to patients are Prilosec and Nexium. Both drugs are manufactured by AstraZeneca and fall within the pharmaceutical category of proton pump inhibitors. This type of medication is commonly prescribed to treat gastroesophageal reflux disease (GERD) and peptic ulcer disease (PUD). First approved in 1988 under the brand name Losec, Prilosec is a first-generation proton pump inhibitor. Nexium is a second-generation version of the drug that was marketed as an improved version of Prilosec.

According to a recent study in the Journal of the American Medical Association (JAMA), proton pump inhibitors are associated with an increased risk of chronic kidney disease. The risk of developing this condition increases when the patient takes the drug over a prolonged period of time. Cases involving kidney-related conditions have already surfaced in patients who have taken Nexium and Prilosec. A man in Tennessee, for example, has been diagnosed as having interstitial nephritis, renal failure, and a heart attack after taking Prilosec and Nexium pursuant to a physician’s prescription.

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Moll Law Group and Bayer have entered into a settlement agreement under which Moll Law Group agreed to dismiss with prejudice the pending litigation on behalf of its client in The United States District Court of and for the Southern District of Illinois. Pursuant to the terms of the settlement, Bayer agrees to pay the Plaintiff $1.5M and holds no admission of liability or wrongdoing of any position whatsoever in connection with any matters relating to Plaintiff’s alleged use of Ocella or otherwise.

The case involves a young woman who consumed the birth control pill, Ocella, manufactured by Bayer. In 2011, the young woman was 23-years and was a first time birth control user. Within weeks of her Ocella use, Plaintiff began experiencing problems that led to surgeries and partial loss of vision. The complaint, filed in 2013, states that the Plaintiff was prescribed Ocella and suffered injury including, but not limited to, loss of vision, blood clotting and various brain traumas that required continuous surgery.

Ocella is an oral birth control medication with a combination of 2 hormones: an estrogen (ethinyl estradiol) and a progestin (drospirenone). The complaint cites studies that suggest drospirenone is a diuretic that can cause an increase in potassium levels in the blood. This can lead to a condition known as hyperkalemia (elevated blood potassium levels). Hyperkalemia can cause heart rhythm disturbances, such as extra systolies, pauses or bradycardia. If left untreated, hyperkalemia can be fatal. If hyperkalemia disrupts the normal heart rhythms, the flow of blood through the heart can be slowed to the point that it permits blood clots to form. Blood clots in the heart can lead to heart attacks, or the clots can break off and travel to the lungs where they can cause pulmonary embolism, or can travel to the legs where it can cause deep vein thrombosis, or it can travel to the brain causing a stroke.

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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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