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Attorney General Lockyer Announces $41.8 Million Settlement of Multi-State Consumer Protection Case Over Marketing of Synthetic Thyroid Hormone

Thursday, July 29, 1999
Contact: (415) 703-5837

(LOS ANGELES) - Attorney General Bill Lockyer today announced that California and 36 other states have reached a $41.8 million settlement with Knoll Pharmaceutical Company and BASF Corporation over the alleged fraudulent and misleading marketing of the synthetic thyroid drug Synthroid.

"This is a case of false, deceptive and misleading marketing practices involving a legitimate product," Lockyer said. "We found the company trying to keep consumers in the dark about the availability of other equivalent, but less expensive products. This is unacceptable. With the settlement, the company has agreed to halt its deceptive and misleading sales practices."

Lockyer said California's share of the payment will be around $3.1 million. The case was brought by the Attorney General's Consumer Law Section.

The multi-state consumer fraud case involves the marketing of Synthroid, Knoll's brand of a synthetic thyroid hormone used to treat hypothyroidism, a condition in which a person's thyroid gland fails to produce sufficient thyroid hormone. A common treatment is the use of a synthetic thyroid hormone replacement drug known as levothyroxine sodium. Over eight million patients in the United States take levothyroxine sodium daily. Manufactured and sold by Knoll, Synthroid is the dominant and most expensive brand of levothyroxine sodium product on the market.

In announcing the settlement with Knoll, the attorneys general noted that the safety or efficacy of Synthroid or any other synthetic thyroid hormone replacement product was never an issue and that individuals who are currently taking the product should not stop taking it because of today's announcement. They further cautioned that individuals who use the product should continue their current medically recommended regimen and discuss treatment questions with their physician.

Among other things, the consumer complaint alleged that Knoll deceptively: (a) attempted to prevent the publication of a study which claimed to show that Synthroid and some generic levothyroxine sodium products were bioequivalent; (b) claimed that Synthroid was a reference product or the standard for levothyroxine sodium products, and was unique or superior to competing brands of levothyroxine sodium products; and (c) claimed that no other competing brand of levothyroxine sodium product was equivalent to or useful in place of Synthroid.

In entering the settlement, Knoll admitted no wrongdoing or any of the facts alleged by the Attorneys General. The settlement agreement requires that in the future Knoll not make any false, misleading or deceptive claim regarding Synthroid or any other levothyroxine sodium product in advertising, promotion or labeling, regarding:

1. superiority or other characteristics of the product;

2. bioequivalence of the product to any other drug or new drug, or lack thereof;

3. the status of the product as a reference, standard;

4. the cost of switching the product;

5. any other manufacturer's product;

6. any medical rationale for specifying the use or continued use of one product over another;

7. the scope, findings or existence of any scientific study, whether published or not, concerning the product.

Joining California Attorney General Lockyer in the settlement were the attorneys general in the states of Arkansas, Arizona, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Maryland, Massachusetts, Michigan, Missouri, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Rhode Island, South Carolina, Tennessee, Texas, Vermont, Virginia, Washington, West Virginia and Wisconsin.

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