Pharmaceuticals failed to warn African Americans of drug's dangers

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.

Christopher Cueto of the Law Office of Christopher Cueto in Belleville will be representing them.

As of May 11, the case has not yet been assigned to a judge.

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.

When drug companies first attempted to introduce Tegretol to the market, the FDA refused to approve the medication, saying it "would appear to be an agent that possesses significant toxicity," the suit states. On April 10, 1967, after a drug manufacturer's further attempts to introduce the drug to the U.S. market, the FDA found that Tegretol had little to no margin of safety based on animal studies performed, the complaint says.

"There is an overall attempt by the sponsor to reduce the significance of the findings of toxicity in the experimental animals and we [the FDA] feel that a clear statement of this agent's toxicity is called for," the FDA wrote according to the complaint.

Finally, on March 11, 1968, after Novartis submitted repeated applications for Tegretol, the FDA approved the drug but only for the treatment of pain associated with trigeminal neuralgia, the plaintiffs claim.

In 1973, Novartis, formerly CIBA Pharmaceuticals, began pushing the FDA to approve Tegretol as a treatment for epilepsy. Novartis hailed the drug's safety and its non-carcinogenic nature, according to the complaint.

The FDA, unswayed by Novartis's alleged one-year rat study that Novartis used to prove the drug to be non-carcinogenic, approved Tegretol's use only on epileptic patients who did not respond to treatment with other drugs, the suit states.

However, Novartis took the FDA's approval and used it to aggressively market Tegretol for use as a first-line treatment of epilepsy, plus for a broader use as an anticonvulsant drug and as a mood stabilizer, the complaint says. While marketing the drug's efficacy, Norvatis failed to inform the public of its associated dangers, such as Stevens Johnson Syndrome and Toxic Epidermal Necrolysis Syndrome, both of which cause severe skin reactions, the suit claims.

"Defendants knew or should have known a significant portion of deaths and severe side effects, described herein, resulted from carbmazepine products have included African American persons and children who were found to have increased risks of carbmazepine SJS and TEN in the medical literature," the suit states.

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.

"Plaintiffs' serious and permanent injuries, came about as a foreseeable and proximate result of the Defendants' dissemination of inaccurate, misleading, materially incomplete, false and otherwise inadequate information concerning the effects of exposure and ingestion of the drug to the medical community, physicians, Plaintiffs' physicians, Plaintiffs and other foreseeable users of the drug," the complaint says.

Because of their ingestion of the drug, the plaintiffs claim they or their deceased relatives suffered severe and permanent injuries, physical impairment, disfigurement, physical pain and loss of enjoyment of life and incurred medical costs.

Plaintiffs include Jesse Blount; Kevin Bucktooth; Gloria Burrup; Keya Gill through her mother, Nicole Henry; Renee Richardson on behalf of the deceased Augustine Hackman; Dustin Hoskins through his mother, Tammy Hoskins; Michelle Mays; Lynda McCann; Heather McConkey through her mother, Shirley Miller; Annette Mendoza; Latoya Monroe; Ricardo Padilla through his mother, Estela Padilla; Edward Patino; Ronnie Rhodes; James Roberts; Allison Sargent; Tammy Smith; Crystal Vance-Heckerthorn; and Robert Paul Volz.

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.

St. Clair County Circuit Court case number: 10-L-203.