In a recent Stevens Johnson Syndrome lawsuit, the U.S. Food and Drug Administration (FDA) acknowledged that change is needed for how the medical community and pharmaceutical companies regard this condition. This Stevens Johnson Syndrome lawsuit incited the FDA to propose that generic drug companies are treated the same as brand-name companies, in terms of product liability.

According to the Stevens Johnson Syndrome lawsuit, a New Hampshire woman named Karen Bartlett had been given a prescription pain medication to treat the aches in her shoulder. Ingesting the medication caused the severe allergic reaction of Stevens Johnson Syndrome, which left her disfigured and nearly blinded. Like most Stevens Johnson Syndrome victims, she was treated in a burn unit, with skin detaching from her body.

While Bartlett survived her ordeal, she sued the manufacturer of the painkiller, alleging product liability and negligence. She had initially won the case with a $21 million verdict, but the verdict had been vacated in February 2014 on an appeal made by the company. The appeal was based on the fact that the medication Bartlett had been prescribed had been a generic version of the drug, and had not been brand-name Clinoril.

Under current product liability rules for pharmaceutical companies, patients are able to sue the manufacturers of the actual brand-name drugs for serious injuries, but are barred from any lawsuits against generic drug makers. While many would argue that the drug is the same regardless if its brand-name or generic, as it carries the same risks, the prescribing labels apparent in the brand-name drugs do not apply to generic drugs under current rules.

However, this Stevens Johnson Syndrome lawsuit initiated the call for current rules to be updated. In November 2013, the FDA announced a proposal to allow generic drug manufacturers to change and update their product labels, as brand-name drug manufacturers currently do. If this proposal passes, generic drug manufacturers could no longer hide behind the word ‘generic,’ and would be susceptible to product liability lawsuits just like brand-name drug makers.

Most generic drug companies oppose this idea heavily, with some arguing that this rule may drive up the cost of generic drugs due to the litigation costs. Other critics of the proposal pointed out that this policy shield allowed generic drug companies to have lowered health care costs by about $1.2 trillion over the last 10 years, because they are not as expensive as brand-name prescriptions.

Even some generic drug manufacturing representatives agree with the proposal, state that patients should have the same ability to seek compensation for an injury suffered, whether or not the drug is generic or brand-name. Other supporters of the proposal state that this change is necessary because of the compared availability of generic drugs and brand-name drugs — with generic drugs being so easy to obtain, it is only right that the consumers’ rights are protected.

Overview of Stevens Johnson Syndrome Complications

Stevens Johnson Syndrome is an extreme, allergic skin reaction, which typically affects the surface area of the skin, and mucus membranes of the body. This is an exceedingly rare condition, with only 300 cases diagnosed per year in the United States. This condition typically occurs in adults rather than children. If a patient were to get Stevens Johnson Syndrome, it would typically be within the first two weeks of starting the medication, and would begin with flu-like symptoms.

However, after the initial week, red or purplish blisters appear on the patient. Typically, the blisters cover 10 percent to 30 percent of the body, and cause permanent scarring and disfigurement of the skin surface area, could cause potential organ damage, and blindness. If the side effects are severe enough, the patient could possibly die from the condition, making timely diagnosis vital.