Pharmaceutical Products Cause Sudden Death

If you have read our article, “Plaintiffs v. Merck,” in the past you are probably familiar with lawsuits against Merck and its drugs Viagra, Cialis, and Levitra. The lawsuits were filed by plaintiffs who claimed that the drug caused them to suffer from erectile dysfunction, including impotency, and they sought damages for their pain and suffering. The district court in Chicago ruled in favor of Merck, and the plaintiff’s attorney was instructed to pursue a class action suit. The plaintiffs, however, appealed the decision, arguing that the courts had no authority to award damages based on the results of medical research. A three-judge panel of the U.S. Circuit Court of Appeals for the Seventh Circuit refused to enjoin Merck from selling Viagra, and in June of 2021 the Supreme Court declined to hear the appeal.

Although there was no actual evidence at the time of filing the lawsuits, Merck apparently provided false information to the FDA about the severity of the adverse events it reported to the Food and Drug Administration (FDA).

According to the FDA, Merck incorrectly reported to the FDA about the results of clinical trials in six countries, all of which had substantial positive results. Merck further misrepresented the quantity and frequency of reports to the FDA. According to the FDA, Merck did not provide any explanation as to why the company overstated the adverse events it reported to the FDA, and therefore, remained silent during the whole investigation.

Plaintiffs also claimed that Merck was guilty of negligence because they provided a medication to HIV/AIDS patients in violation of the AIDS Act.

Merck did not provide an approved treatment for HIV/AIDS because it did not believe that there was a need for a treatment for HIV/AIDS. According to the plaintiffs, the FDA did not make this obvious to Merck, and as a result, the company was guilty of negligence in failing to warn patients about the potential side effects of Viagra. The FDA further claims that this negligence was the reason for patients suffering from injuries and illnesses caused by Merck’s defective drugs. Specifically, the FDA claims that Merck’s Y fluconazole (antifungal agents) contained ingredients that can cause serious liver damage and, in some cases, even liver failure. As a result of these and other related injuries and illnesses, thousands of HIV-infected individuals have lost their lives.

The FDA claims that this is the reason that it is required that pharmaceutical companies warn patients and others about the serious side effects that can result from taking certain shingles vaccines, and that Merck was aware of these risks prior to prescribing shingles vaccines to patients.

While the FDA is not accusing Merck of deliberate misconduct – i.e., the intent to purposefully mislead the public – it does claim that the company failed to give reasonable warning to patients about the possible side effects of their shingles vaccines. For instance, Merck did not advise its patients that taking these shingles vaccines could result in serious health problems.

Another major point of the lawsuit focuses on how Merck withheld important data from the FDA concerning the dangerous side effects that its shingles vaccine was known to cause.

Specifically, the FDA did not learn that Merck had signed a consent form requiring that it disclose all relevant data concerning the adverse events that its vaccine could cause. As a result of this, the FDA never received information which could have been useful in determining whether Merck’s vaccine was safe or not. In addition to withholding this information, the FDA did not find out that Merck employees were instructed to deceive the FDA by keeping this information from them. As a result of these and other facts, the FDA decided that Merck’s drug Mercury was unsafe for use and was recalled in 2021.

There are many lawsuits like the one filed against Merck, and there are likely more to come.

According to Dr. Edward Kloce, editor-in-chief of the “The New England Journal of Medicine,” the recalls and lawsuits are an indication, “A new era of lawsuits is under way against pharmaceuticals.” This is especially true with drugs for diabetes. Since diabetes is one of the most common conditions that require multiple medications, having it cause harm to the employee’s own body makes the lawsuits against pharmaceuticals all the more reason to be cautious. For these reasons and many others, it is essential to be diligent in protecting ourselves and our loved ones from the dangers of pharmaceutical products.