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This one's a real head-scratcher...



MetroTimes, the Detroit "alternative" newspaper, has a very one-sided article concerning a defamation suit launched by Morton Grove Pharmaceuticals, Inc. against the Ecology Center of Ann Arbor. The Center has been blasting Morton Grove for its legal sale of Lindane for head lice.

Lindane has been banned for agricultural use by the EPA, and is also banned in many other countries for this use. But for the treatment of persistent lice it remains authorized by the FDA. The latter, in a public health advisory, has emphasized that "Lindane is approved as a second-line treatment for topical treatment of pediculosis and scabies in patients "who have either failed to respond to adequate doses, or are intolerant of, other approved therapies." Second-line therapy is defined as:

1) The patient cannot tolerate the first-line drug of choice or;
2) The patient has used the first-line drug of choice as instructed and the treatment has failed.

For second line treatment Lindane has proven safe and effective. The majority of adverse events occurred in patients with contraindications to the use of Lindane, in patients who used the medication in excessive amounts, or in those who misused the Lindane product. Of the adverse event cases in the FDA database with a serious outcome (hospitalization, disability or death), only a small used Lindane according to the directions in the label. Other patients did not use Lindane according to directions in the label. Most commonly, patients often reapplied Lindane because of continued itching after the treatment, either on their own volition or at their doctor´┐Żs negligent recommendation, contrary to the explicit instructions on the package.

Three deaths due to Lindane use have been confirmed by the FDA, although many more deaths have been reported by those who attack Morton Grove. The three confirmed deaths all included use of Lindane not in accordance with the label, including multiple topical applications or oral ingestion. Lindane toxicity was confirmed by autopsy in a child, and was diagnosed before death in one adult. The third death occurred in an adult who ingested Lindane for suicide purposes.

Morton Grove produces a legal product that is the last resort for thousands of people (mostly school-children) suffering from head lice. In 12 years, Morton Grove reports just 22 complaints of adverse reactions and just one lawsuit.

This has not stopped the likes of the Ecology Center screaming that "After more than a half century of use and thousands of reports of illness and deaths blamed on the pesticide, the federal government has banned all uses of lindane -- except by those who rub it on their scalps and bodies to kill lice and mites."

This will be an interesting torts suit to follow.

 

 


Rafael Mangual
Project Manager,
Legal Policy
rmangual@manhattan-institute.org

Katherine Lazarski
Manhattan Institute
klazarski@manhattan-institute.org

 

Published by the Manhattan Institute

The Manhattan Insitute's Center for Legal Policy.