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Synthroid Manufacturer Settles with 37 States

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Updated December 13, 2003

July 29, 1999 -- BASF subsidiary Knoll Pharmaceuticals, the company that manufactures the popular thyroid drug Synthroid, will pay 37 states a total of $41.8 million in a settlement with the states' Attorneys General. In order to avoid litigation, the company agreed to the terms of the multi-state settlement. According to Knoll spokeswoman Linda Mayer, "the payment will be made within 30 business days." Funds will be used at the state level for consumer education, litigation, public protection or local consumer aid, as well as attorney's fees and investigative costs.

The Attorneys General from the 37 states -- which included New York, Texas, and Maryland -- had alleged that Knoll was legally violating consumer protection statutes when it made claims that the Synthroid brand of thyroid hormone replacement was better than competing brands. The Attorneys General were also basing their case on allegations that Knoll tried to interfere with the publication of a study -- commissioned by the company itself -- showing that Synthroid was not more effective than its competitors.

There are no allegations that the Synthroid product is itself a problem. Rather, the concerns have focused on marketing approaches that suggested that the Synthroid brand was better - - claims disproven by the company's own research. Knoll is not admitting to any wrongdoing or having broken any laws in its marketing, but it has agreed to stop making any false, misleading or deceptive claims about Synthroid in future marketing efforts.

The states included in today's Attorney's General's settlement include the following: Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, 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.

Despite these findings, and despite the fact that company is facing a major consumer class action lawsuit over the allegations that the company suppressed this research, [link url=http://thyroid.about.com/library/weekly/aa071299.htm]Synthroid still costs as much as two to three times the price of its competitors.

This development is the latest in a series of setbacks that have plagued the thyroid drug manufacturer. See my February 1999 two part series, Synthroid Under Siege, Part I / Part II which looks at the status of the Synthroid lawsuit, government concerns over Knoll's overpricing, and other issues.

While today's agreement does not benefit Synthroid users individually, it also does not interfere with the separate class action settlement process. Many Synthroid user have filed to be certified as part of the class for the suit against Knoll. According to an interview I conducted with Knoll spokesperson Veronica Apostolico, this agreement with the Attorneys General does not stop, affect or otherwise have an impact on that class action lawsuit, which is still in progress as a separate case. [For the history of the lawsuit, see my January 1998 two-part expose', [link url=http://thyroid.about.com/library/weekly/aa012798.htm]The Synthroid Settlement: Fair Payoff or Patient Ripoff? Part 1 / Part 2.]

Synthroid is Knoll's brand name for levothyroxine sodium, the synthetic T4 thyroid hormone replacement drug -- used to treat hypothyroidism. Synthroid is the top selling brand of thyroid hormone, and the third most prescribed drug in the U.S., used by an estimated 8 million people in the United States alone. Recent research reported on in the New England Journal of Medicine has indicated that a majority of thyroid patients actually feel better on a combination of two drugs, rather than on Synthroid or other levothyroxine drugs alone.

Synthroid, along with other brands of levothyroxine, are currently going through the new drug application process, due to government findings of [link url=http://thyroid.about.com/library/weekly/aa090197.htm]levothyroxine's significant stability and potency problems. These drugs are STILL not fully regulated in 1999, and action won't be taken until late in 2000.

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