Pharmaceuticals Failed to Warn African Americans of Drug’s Dangers

Kelly Holleran, Madison/St. Clair Record (Edwardsville, Illinois), May 12, 2010

The makers of a popular drug used to treat epilepsy and bipolar disorder find themselves named as defendants in a lawsuit in which consumers claim the drug causes life-threatening skin problems, including a syndrome that causes the top layer of a person’s skin to shed and die.

Nineteen plaintiffs from across the country filed a lawsuit April 27 in St. Clair County Circuit Court against the makers of drug products that contain carbamazepine. Defendants include Novartis Pharmaceuticals Corp., CIBA Pharmaceuticals and Sandoz Pharmaceuticals Corp.

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The plaintiffs claim doctors prescribed either them or their deceased relatives carbamazepine drug products, which caused them to develop a skin rash, itching, skin discoloration, skin exfoliation, shedding of the hair, shedding of the nails, loss of skin pigmentation, hives, burns, scarring, damaged eyesight, permanent damage to their internal organs, hypersensitivity, Stevens Johnson Syndrome or Toxic Epidermal Necrolysis Syndrome or a combination of all of the above.

Carbamazepine–a mood-stabilizing and anticonvulsant drug usually used to treat epilepsy and bipolar disorder–has been sold under the brand name Tegretol, the drug the plaintiffs ingested to treat their conditions, according to the complaint. Tegretol, a drug that has existed since 1966, has a storied history.

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Different races, such as African Americans, Hispanics, native Indians, Asians and Caucasians, face an increased risk of developing SJS and TEN because of their genetics. African Americans and Asians remain especially prone to developing the life-threatening skin conditions because of a gene they have a tendency to carry, the complaint says.

Despite the connection to race and the dangers of the drug, Novartis did nothing for years to warn physicians or consumers of the possible health concerns, the plaintiffs claim. In December 2007, after the FDA forced the Tetragel manufacturer to place a warning label on the drug, it provided a warning to Asians and recommended they be tested for the gene before ingesting the medication, according to the complaint. Still, the warning failed to caution African Americans to do the same, the suit states.

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In their 20-count complaint, the plaintiffs allege strict products liability, breach of express warranty, negligence, misrepresentation by omission, negligence per se, negligent misrepresentation, fraud and misrepresentation, fraud by concealment, violation of consumer protection laws, breach of implied warranties, constructive fraud, intentional infliction of emotional distress, negligent infliction of emotional distress and wrongful death.

They seek compensatory damages, statutory remedies, a disgorgement of profits, pre-judgment interest, costs, punitive damages and other relief the court deems just. They also want Novartis to pay for testing and medical monitoring costs, which they say may save their lives.

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