Woman Sues Generic Drug Company, Recieves $21 Million

March 12, 2013

991548_prescription_bottle_-_blank_label.jpgDangerous drug lawyers at Pintas & Mullins highlight the troubling story of a woman who was prescribed a generic pain reliever, sulindac, and suffered from a severe side effect that burned the majority of her skin off and rendered her permanently blind. In a lawsuit against the manufacturer, she was awarded $21 million.

Karen Bartlett of Plaistow, New Hampshire was prescribed the mild pain pill after experiencing shoulder pain in 2004. Within a few weeks after taking the drug, Bartlett's skin started degrading, falling off her body in chunks, until almost two-thirds of it was completely gone. She was placed in a medically-induced for several months, until she was able to be admitted to a burn unit, where she stayed for two more months. She suffered permanent lung and esophagus damage and is now legally blind. Her burn surgeon described her pain as hell on earth, and testified for her in court.

Bartlett filed a lawsuit against sulindac's manufacturer, Mutual Pharmaceutical Company, arguing that the design of the drug was dangerous and defective. She received $21 million by a jury trial, a verdict that an appeals court later upheld. Bartlett doesn't want anyone else to go through what she did, and believes sulindac should be taken off the market completely.

Her reaction is characterized as a severe form of Steven John's Syndrome (SJS), which is fatal in about 15% of cases. SJS is a rare skin disease, which forms lesions and blisters on the skin, usually around the mouth, throat, eyes, genital tract, and intestines. When it progresses, SJS causes skin to deteriorate and detach completely, such as in a third-degree burn, but the disease is far more serious than a burn.

SJS is a known and labeled potential side effect of pain medications, even of over-the counter medications like Motrin. Nearly a decade ago, a seven-year-old girl took Children's Motrin and subsequently developed SJS, causing her to lose 90% of her skin and her eyesight. She will only have 20% capacity of her lungs for the rest of her life.

The little girl's family filed a lawsuit against Motrin, alleging the company did not provide enough warnings about the life-threatening side effects. The jury placed 100% liability on Motrin, and awarded the family $63 million.

Dilantin, a popular anti-seizure medication, is also linked to SJS, and has been subject of much litigation over the past few years. Dilantin is currently one of the most widely-prescribed anti- seizure medications in the United States, and Stanford estimates that one in 10,000 Dilantin patients suffer serious SJS reactions. The drug is manufactured by Pfizer, and in 2011, the family of a child who took Dilantin received nearly $4 million in a settlement after their child died. Eight other companies make generics of Dilantin, including Mylan and Baxter.

Because the drug that Bartlett took was the generic for Clinoril, leaders in the industry closely watched her trial to see how the judge and jury would rule. Two years ago, in Pliva v. Mensing, the Supreme Court made a decision that significantly limited the ability of consumers to sue generic drug companies, because they do not have control over the drug's labeling or design. The Supreme Court ruled that generic drug manufacturers could not be held liable for failing to warn patients of the risks of taking their drugs.

However, Bartlett claimed in her lawsuit that the drug itself was defective, not the warning label, which enabled her case to make it to trial. Mutual still disagrees with this argument, claiming that the company was not responsible for the drug's design. By law, generic manufacturers must adhere to the same ingredients and designs as the brand-name version of the drug.

Today, Bartlett has undergone 13 eye operations but is still legally blind. She can no longer drive or work. Her lungs and esophagus are extremely damaged, and she has much trouble eating and drinking. To her, whether the drug that changed her life was a generic or brand name does not matter. She believes both drug companies be held accountable for selling dangerous drug to unknowing consumers.

Prescription drug lawyers at Pintas & Mullins highlight this story to bring the possibility of generic drug company litigation to public attention. All drug manufacturers should be held responsible for injuring and killing patients with their defective products. If you or someone you love was seriously injured by prescription or over-the-counter drug side effects, you may be entitled to compensation for medical bills, lost wages, and pain and suffering.