An Urine Allergy Labeling Violation Leads to a Class-Action Lawsuit
Recently, a lab in the United States has launched a legal suit against GlaxoSmithKline, one of the leading makers of an array of allergy medicines and conventional medications used to cure allergies and asthma. The allergy labs have alleged that GlaxoSmithKline is responsible for causing increased cases of asthma and eczema, due to the fact that they did not conduct enough allergy tests on their clients.
They also claimed that the company failed to warn them that their drugs could cause side effects. A lawyer from the allergy labs has even gone as far as to threaten to sue GlaxoSmithKline in Federal Court.
United Allergy Labs Lawsuit
The legal suit was filed by the National Institute of Health, an agency of the United States government. According to the institute, the company did not provide the required safety data sheets until after the products had already been released into the US market. This, they claim, was inadequate since the drugs should have been evaluated based on clinical trials that involved large groups of people.
Furthermore, it was not enough that the drugs were supposed to be tried in a small number of patients with relatively weak immune systems, before determining whether they would work. Allergy testing should also be done before drugs are released into the public, according to the institute.
According to the complaint, GlaxoSmithKline did not test its drugs on any part of the population under its purview.
Neither were they able to determine whether any patients who took the drugs developed any allergic reactions. Even if they did conduct a small-scale allergy trial for a few years ago, the results of which were never released, the legal group maintained that there was no sufficient evidence that the drug’s ingredients have any effect on allergic reactions. In addition, the company did not provide proof that its drugs are safe when taken by pregnant women, and it also did not respond to calls for transparency.
The case was turned over to a law firm in Philadelphia, Pennsylvania, after it was discovered that the U.S. attorney general’s office had failed to turn over documents in the case.
It is not clear what those records contained, but the legal group is requesting the documents from the General Services Administration, or GSA, the agency in charge of federal agencies concerning worker compensation, including the Food Drug and Administration. The FDA was not involved in the case, nor was it made aware of it until after the legal group began looking for the documents. The court does not yet have a date set for the trial.
There is also the possibility that the legal group may win its lawsuit.
If the FDA or other regulating agencies are found to have conducted improper research on the drugs, they may be liable for monetary damages. In the past, such cases have been won by the plaintiffs themselves, but the United States government has since appealed the ruling in a bid to protect its commercial interests. A victory may also dampen pharmaceutical mergers and acquisitions, since mergers and acquisitions are often seen as a way to bolster the company’s finances.
Attorneys who represent the United allergy labs lawsuit claim that the testing was done in response to a risk of an adverse reaction to the widely used steroid corticosteroids hydrocortisone.
The FDA stated that it cannot recall or regulate products containing hydrocortisone. Hydrocortisone is widely used as a medication to treat allergies and can cause temporary blemishes in those who are sensitive to it. The legal group is asking the court to force the FDA and other regulating agencies to take action and has filed a lawsuit against GlaxoSmithKline, one of the largest pharmaceutical companies in the world. They are seeking class-action status for their suit, which could make the FDA take action against other firms if the suits are successful.