Articles Posted in Pharmaceuticals

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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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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In Saavedra v. Eli Lilly & Co., the plaintiffs brought suit against the manufacturer of the anti-depressant drug Cymbalta, alleging not that they overpaid for the product but that they were harmed because they received a product that had less value than what they expected to receive. The plaintiffs sought to certify four classes under consumer fraud protection statutes in four jurisdictions:  California, Massachusetts, New York, and Missouri. Initially, the trial court rejected these classes, stating that the plaintiffs had asserted an “unusual” theory of recovery. More specifically, the plaintiffs omitted any allegations indicating how they suffered or experienced the withdrawal symptoms.

Instead, the plaintiffs contended that they received a product that had less utility, which they defined as the benefit they believed they would receive from using the product. The trial court rejected this theory, noting that it focused only on the refund associated with users’ out-of-pocket costs. In reality, the prescription drug market’s price and value relationship is severed due to the nature of how prescription drugs are marketed and sold.

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