Lofton, et al. v. McNeil Consumer & Specialty Pharmaceuticals, et al. Disappointing for North Carolina Drug Injury Sufferers

March 26, 2012, by

In a decision affecting anyone suffering from an Asheville drug injury, a federal appeals court in Texas upheld a lower court's ruling against a family who claimed that drug companies, as well as the U.S. Food and Drug Administration, had failed to warn of potentially deadly consequences of a certain over-the-counter medication.

The case, Lofton, et al. v. McNeil Consumer & Specialty Pharmaceuticals, et al., started in 2000 with the death of Christopher M. Lofton.


As our Asheville personal injury attorneys understand it, Lofton came down with a fever in May of that year. He took over-the-counter Motrin to help alleviate his symptoms. Two days later, his skin broke out in a rash, and he rushed to the hospital. He was released a short time later, though he continued taking Motrin for his pain. But the condition of his skin continued to deteriorate. He went to a dermatologist, who diagnosed him with Stevens-Johnson Syndrome, which is a skin disorder that is caused by an infection or allergic reaction. This is a less-advanced form of Toxic Epidermal Necrolysis (TEN), which is a rare but life-threatening skin disease that is typically caused by a reaction to a medication.

The next day, Lofton was rushed to the emergency room, but was soon transferred to the hospital's burn unit, where he began immediate treatment for TEN. He died several days later.

According to the lawsuit, the FDA is aware of a connection between ibuprofen, the active ingredient in Motrin, and these rare diseases. In 2005, the FDA began requiring drug makers to warn consumers that skin rash and blisters are signs of allergic reaction.

The family requested from the FDA that there be additional labeling requirements that specifically noted the connection to SJS and TEN, but the FDA declined that request, saying there is no definitive, causal link between the two.

Lofton's family then filed the suit claiming negligence and product liability.

The defendants in the case requested a judgment be handed down by a judge, rather than a jury, and countered that the claim that they had failed to warn consumers about the risks before 2005 fell on a requirement of proof known as "fraud-on-the-FDA." Essentially, this means that someone was injured by a product that was approved by the FDA based on false information.

Drug companies, in essence, have a responsibility to let the FDA know all the information they know about the drug they hope to sell. If they withhold any information or don't properly research the product, they can be held liable for fraud.

At the end of the day, the courts found that the family hadn't shown that the drug companies had intentionally withheld or misrepresented important information regarding the dangers of the drug.

Still, our Asheville drug injury attorneys believe that anytime you purchase a drug from off the shelf, particularly for a common ailment, you have the right to trust that it will be safe to consume. This court ruling shows just how complex such litigation can be and illustrates the need for an experienced law firm whenever a patient has been harmed by medical malpractice, a defective medical device or dangerous pharmaceuticals.

If you or someone you love has suffered an over-the-counter drug injury in North or South Carolina, it is critical for you to contact the injury attorneys at Grimes Teich Anderson LLP. Call 1.800.533.6845. No Attorney Fees Until You've Been Paid.

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