11, 2001, at A1 (reporting FDA officials prevented agency scientist from discussing the scientific information relevant to the risk that the diabetes drug Rezulin
caused liver damage).
followed by Rezulin
(troglitazone) in 2000, and Vioxx (rofecoxib) in
2014) (addressing plaintiffs' "comparable tort claim under the Alabama Extended Manufacturer's Liability Doctrine"); In re Rezulin
Graham had previously been successful in removing the unsafe drugs Omniflox, an antibiotic, Rezulin
, a diabetes treatment, Fen-Phen and Redux, weight-loss drugs, and phenylpropanolamine, an over-the-counter decongestant, from the U.S.
The FDA's approval and subsequent withdrawal of Rezulin
was one of the first major public relations crises for the agency.
She has been lead trial counsel for cases involving Prempro, Rezulin
, Fen/Phen and other prescription medications.
Examples are hypoglycemia and weight gain from insulin and sulfonylureas, as well as other less common but important side effects such as liver failure from troglitazone (Rezulin
, withdrawn from the market in 2000), coronary artery disease from rosiglitazone, bladder cancer from pioglitazone, pancreatitis from incretin mimetics or DPP-4 inhibitors, and lactic acidosis from metformin.
Arikawa and colleagues demonstrated the effectiveness of [RT.sup.2] Profiler PCR Arrays in distinguishing between a diabetes drug that was discontinued due to high liver toxicity, troglitazone (Tro), previously sold as Rezulin
, and two other drugs still on the market, rosiglitazone (Rosi, sold as Avandia[R] and pioglitazone (Pio, sold as ACTOS[R]).
Fifty percent of Americans take a least one pharmaceutical medicine; 20% are taking 3 or more prescriptions daily with over 100,000 deaths per year from taking drugs as prescribed.8 Recent danger issues have caused many drugs to be removed from the market, such as Vioxx, M.I., GI bleeding; Baycol, rhabdomyolysis; Rezulin
, liver failure; Avandia, M.I., stroke (still on the market despite FDA panel recommending recall!).
9-10), Johnston notes that more than half the investigators involved in the Rezulin
studies for type II diabetes received some form of remuneration from the sponsor.
Plaintiffs' lawyers did not discover its dangers; the drug had already left the market before a jury verdict came in against it; increases in talk about improving drug safety policy also had predated liability for this drug; and personal-injury litigation did not generate information to benefit the consuming public."); Epstein, supra note 145, at 60-61 ("The drugs that usually generate the most litigation- such as Rezulin
and Vioxx- usually are withdrawn before litigation commences.
One study, the TRIPOD (Troglitazone in Prevention of Diabetes) study, treated patients with gestational diabetes, a precursor of insulin resistance and diabetes, with troglitazone (Rezulin
), however, because of severe toxic liver effects; troglitazone has been taken off the market and is no longer available.