Stevens Johnson Syndrome Attorney Reviewing "Failure to Warn" and Generic Drug SJS Cases

June 16, 2011, 6:00PM. By Jane Mundy

Wilmington, NCAttorney Greg Jones (Greg Jones & Associates PA) is currently reviewing and working on Stevens Johnson Syndrome (SJS) cases for "failure to warn." "For instance, we allege that Dilantin fails to warn," says Jones, "and many other drugs linked to SJS—including generic drugs—have inadequate warning."

Any product can be defective if adequate warnings are not provided to the consumer about its use. Lots of drugs, however, do provide adequate warning, including black-box warnings. "In these cases there is little we can do against the manufacturer, so we will see if there is a medical malpractice component to these cases," says Jones.

Typically, Jones is seeing claimants who have taken sulfa-based drugs such as Bactrim and Non-Steroidal Inflammatory Drugs (NSAIDs), both prescription and over-the-counter (e.g., Ibuprofen) medications. As well, SJS has been linked to a host of other drugs, from Children's Motrin to Levaquin. Taken over the course of several weeks, any of these drugs can lead to SJS. "Most issues like SJS that are caused by pharmaceuticals are greatly underreported to the FDA," says Jones. "It's like a California forest fire."

SJS victims usually develop a severe rash, which is an allergic reaction to a drug, and some sufferers have problems with their eyes and mucous membranes. "If these symptoms aren't treated, you could wind up in a burn unit with significant organ damage, including your skin," says Jones.

Tragically, some doctors, especially in rural hospitals, don't recognize SJS symptoms because it is a rare allergic reaction—and left untreated, the victim could develop Toxic epidermal necrolysis, known as TEN. (SJS is considered a milder form of TEN, which is life-threatening.)

"Some doctors may never have seen SJS except one instance at medical school," says Jones. "A lot of my clients have told me that their doctors call in other doctors to look at their symptoms. I like it when doctors bring a photographer in (as long as my client agrees) because it is extremely useful evidence. So whenever possible, get these pictures, even if your doctor disagrees. Sometimes photographs go to the drug company and you might never see them again…"

And to make matters worse, some doctors will even delay diagnosis and treatment and that could mitigate the patient's circumstances. "For instance, I see Bactrim cases where the doctor keeps them on it and in that case, it can turn into a medical malpractice case," says Jones. "When you present with these conditions it can lead to worsening and irreversible injuries so there could be a medical malpractice claim against the doctor and a product liability claim against the manufacturer."

How can you go after the manufacturer with a generic drug case? Jones says that a lot of generic drug cases are currently before the Supreme Court and a decision will likely come down this summer. "The question is whether or not you can maintain a lawsuit against a generic drug such as Reglan," Jones explains. If generic drug companies have their way, anyone who has been injured from taking a generic drug would have no legal recourse. "Obviously I oppose that view and I continue to review and accept generic cases pending the court's decision."

In 2009, the Supreme Court ruled in Wyeth v Levine that makers of brand-name drugs may be sued under state law for failing to warn consumers about the risks. The decision came about mainly because drug companies can sometimes change the labels on their products without permission from the FDA. According to The New York Times (March 30, 2011), justices heard arguments regarding the giant generic drug manufacturer Actavis. The main question raised is whether makers of generic drugs—whose products must use the same warning labels as the corresponding brand-name drugs and who cannot alter those labels—can be held liable for "Failure to Warn" consumers of any potential risks and side effects from their products.

In January 2010, a federal appeals court said that patients could sue generic drug manufacturers under state law for "failing to warn," which extends the 2009 Supreme Court ruling (above).

In March 2011, appeals courts ruled against the generic Reglan makers in three consolidated cases brought by women who suffered severe stomach problems and a neurological disorder from the drug. According to the NYT, "the federal regulatory regime did not block claims under state law."

Meanwhile, lawsuits are underway against Johnson & Johnson, the manufacturer of Children's Motrin, for failure to warn of the risk of Stevens Johnson Syndrome. Sadly, many children have suffered, yet this drug, and many others linked to SJS, is still on the market.