$21 Million Stevens Johnson Syndrome Award Upheld

Concord, NHFor patients who wish to use Advil or any other drugs linked to a risk of Stevens Johnson syndrome, the risks of the drug may outweigh any benefits. That was the claim made in a Stevens Johnson syndrome lawsuit recently considered by the courts. For patients who want to use drugs like Advil, ibuprofen or a variety of painkillers and anti-inflammatory drugs, the pain of Stevens Johnson syndrome is probably far worse than the condition the drug is treating.

The lawsuit, filed against Mutual Pharmaceutical Co, alleged the company's drug, sulindac (which, it should be noted, is not Advil or an ibuprofen), resulted in a woman developing Stevens Johnson syndrome (SJS) and then Toxic Epidermal Necrolysis. (TENS, the more severe form of Stevens Johnson syndrome.) According to News & Insight (9/28/10), the plaintiff, Karen Bartlett, filed a strict liability lawsuit against Mutual Pharmaceutical, alleging the company failed to include warnings about the risk of TENS associated with the medication.

Bartlett was given sulindac (the generic version of Clinoril) in 2005 for bursitis. She took the medication for two weeks, but the consequences of taking the non-steroidal anti-inflammatory medication will affect her for life. On February 1, 2005, Bartlett was admitted to the hospital with blisters and eye irritation. A week later, she was transferred to a burn unit, where doctors found that up to 65 percent of her skin had sloughed off. She spent 70 days in the hospital, had 11 eye surgeries (which included five corneal transplants) and is still legally blind. At one point, her eyelids fused to her eyeballs. Bartlett spent at least a month in a medically induced coma and was tube-fed for a year following her ordeal. She also suffered two major episodes of septic shock, according to court documents.

In addition to permanent eye injuries, Bartlett suffered damage to her esophagus, preventing her from eating normally, damage to her vagina, preventing her from having sexual relations, and permanent scarring and disfigurement to her face and body.

Although Bartlett's lawsuit made a variety of claims against Mutual, all of the claims except the design defect claim were dismissed or voluntarily withdrawn. Ultimately, Bartlett claimed that the risks of sulindac outweighed the benefits, making the drug unreasonably dangerous.

In 2010, the jury awarded Bartlett $16.5 million for pain, suffering and loss of the enjoyment of life, $2.4 million for future medical expenses, $1.25 million for past medical expenses, and additional fees and damages. In all, the jury awarded Bartlett around $21 million. Mutual appealed the award.

In May 2012, the court affirmed the jury's decision, finding that sulindac is a recognized cause of SJS/TENs and that the jury's award was not so disproportionate that it should be set aside.