Regulation

Lawsuit drives home real damage tainted weight loss products can cause

10-Jan-2014 - By Hank Schultz
A- A+

Cases of sibutramine tainting in weight loss products are nothing new.  But a recently-filed lawsuit drives home the real harm such products can cause, and the insidious way in which they have penetrated the marketplace.

In a case filed in New York on Jan. 6,  Army reservist Sainah Theodore alleged she bought some diet pills in Natural Food Health Center, a  health food store in Brooklyn.  The pills were called Natural Lipo X, and were part of a bait-and-switch scheme.  Although not listed on the label, testing has shown the product contains caffeine, sibutramine,  an active pharmaceutical, and phenolphthalein, a laxative.

Product hyped as natural

“When a consumer asks for a stimulant free, natural weight-loss supplement product Defendant, Natural, sells them Natural Lipo X,” the complaint says.

“She had actually taken a similar product a year earlier,” said Marc Ullman, a Garden City, NY-based attorney who is co-counsel on the case. “She said, ‘I need some more of what you gave me last year’ and this is what they sold her.”

After several days of use, Theodore started suffering insomnia, and started displaying increasingly severe psychotic symptoms, including aggressive behavior in public, stopping her car in the middle of an intersection, and attacking a pillow with a knife.

Although Theodore’s psychological symptoms have subsided, her real damage persists, Ullman said. As a result of the symptoms brought on by use of the product, Theodore was forced to decline being deployed overseas with her Army reserve unit, thereby significantly damaging her Army career, he said.

Pharmaceutical pulled from market

Sibutramine was most recently manufacturered by Abbott Laboratories and marketed as a weight-loss pharmaceutical  under the brand name Meridia. It was pulled from the market by FDA in 2010 over concerns of greater risk of strokes and heart attacks among patients with underlying heart disease. Tests by Flora Research Laboratories in Grants Pass, OR on the leftover product in Theodore’s possession showed Natural Lipo X contained sibutramine.  The tests showed the presence, but the limited amount of product precluded tests on the concentration of the drug, Ullman said, so the dosage Theodore received can’t be correlated to what used to be recommended for Meridia.  But judging by the severity of her symptoms (at one point Theodore had been unable to sleep for several days, the complaint says), one can infer that the levels of the drug in the pills were significant. And it’s also easy to infer that little quality control was exercised in the manufacture of the pills.

As to who manufactured the pills, that remains unknown, Ullman said.  Also unclear at this point is whether Natural is a private label distributor.  The product label contains no lot numbers and is “totally defective,” Ullman said. But the provenance of the product is something he and co-counsel Brian Pascale intend to find out during the discovery process. It's especially troubling in that Theodore was doing what industry advocates suggest consumers do to avoid tainted products, namely eschew the Internet and buy from a trusted brick-and-mortar retailer.

Ullman said he is usually quite skeptical of lawsuits in which plantiffs allege that they’ve been harmed by a manufacturer’s product.  But when he got a look at Theodore’s case, he was eager to participate, he said.

“Phenolphthaline and sibutramine are common adulterants in these products. Sadly, what we see in these products is a cocktail of stimulants and laxatives,” Ullman said. “The bottom line is the person who made this product is a criminal. I want people like this out of our industry.”

Related topics: GMPs, QA & QC, Product claims, Regulation, Slimming ingredients gain weight and momentum , Weight management