Alaska Injury Law Blog

The FDA has recalled 14 Hydroxycut weight loss supplements after receiving reports of severe liver damage that led to the death of a 19-year-old man, and a liver transplant in another supplement user, as well as reports of jaundice and liver enzyme elevation. Symptoms of liver injury include jaundice (yellowing of the skin or whites of the eyes) and brown urine. Other symptoms include nausea, vomiting, light-colored stools, excessive fatigue, weakness, stomach or abdominal pain, itching, and loss of appetite. Other adverse events include seizures, cardiovascular disorders, and rhabdomyolysis, a serious type of muscle damage. The supplement manufacturers, Iovate Health Sciences USA of Blasdell, N.Y., and Iovate Health Sciences of Oakville, Ontario, in Canada, have agreed to voluntarily cooperate with the FDA.

The death occurred in 2007, but the FDA did not learn of it until March, 2009, a delay that is not unusual given that supplement manufacturers are subject only to voluntary, not mandatory, reporting of adverse events. And, unlike drug manufacturers who must follow strict disclosure regulations regarding active ingredients, supplement manufacturers are not required to disclose precise ingredients to the FDA, but can hide behind the “proprietary blend” rubric. This makes it especially difficult for the agency to identify the toxic substances causing the adverse events. The FDA was unable to identify the precise substance believed to be at work here, but the pattern of injury suggests that adverse events may occur regardless of dosage or the length of use of the product.

The surprise here is not that untested diet supplements can cause hepatotoxicity, even at recommended doses, or that there is no free lunch in the world of weight loss supplements. The surprise is that Hydroxycut is still in business. Remember its tattered history of using ephedra in its products, using deceptive before and after photographs, and falsely claiming that it had scientific data of its product’s effectiveness (when, in fact, study participants were dropping out due to adverse events and the company replaced them with new study participants). The surprise is that our current regulatory scheme has allowed the company to remain in business at all.

The FDA has again issued a nationwide alert to consumers about weight loss products that have been “spiked” with undeclared drugs. The FDA identified Herbal Zenicol, Slimbionic, and Xsvelten, bringing its list of adulterated weight loss products to a total of 72 products. The products were spiked with fenproporex (a controlled substance not approved for marketing in the United States), fluoxetine (an antidepressant available by prescription only), furosemide (a potent diuretic available by prescription only), and cetilistat (an experimental obesity drug not approved for marketing in the United States). In the supplements the FDA previously found to be spiked, the supplements contained sibutramine (a controlled substance), rimonabant (a drug not approved for marketing in the United States), phenytoin (an anti-seizure medication), and phenolphthalein (a solution used in chemical experiments and a suspected cancer causing agent).

The FDA has warned that some of the supplements contained drugs far in excess of the maximum recommended dosage of the drug. The risks posed by these products include high blood pressure, seizures, tachycardia, palpitations, heart attack, or stroke.

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The Bush Administration’s attempt to provide complete immunity to the drug industry ended today with a 6-3 vote of the United States Supreme Court. (We previously explored the Bush Administration’s attempt to use the preemption doctrine improperly here and here.) The Court has now issued its decision in Wyeth v. Levine, ruling that patients injured by a drug can sue the drug’s manufacturer for damages, even if the FDA had approved the drug to be marketed. The decision upholds a $6.7m verdict in favor of a Vermont musician who had her arm amputated when Wyeth’s Phenergan, an anti-nausea drug, entered an artery and caused gangrene. The manufacturer claimed that it was entitled to complete immunity from suit based on the FDA’s approval, and that any state claims should be preempted.

This opinion completes a trio of Court decisions on the preemption doctrine. The first, Riegel v. Medtronic, Inc. v. Good, established that state products liability suits were preempted by federal medical device regulations unless there were other FDA violations. The second, Altria Group, Inc. v. Good, established that state claims based on unfair trade practices could be asserted against cigarette manufacturers even though cigarette labeling is regulated by the FTC.

Today’s decision in Wyeth v. Levine is an essential one because the FDA is not able to ascertain before marketing all the risks of a drug or errors in labeling. When there is negligence by the manufacturers, the safeguard of the courts is needed to protect consumers fully. If the FDA were the only safeguard in the system, and there were no checks-and-balances provided by the courts, consumers would unquestionably be at greater risk. There is no doubt that the Court’s decision today was the correct one.

The GAO released a 77-page audit report today critical of the FDA’s efforts to protect consumers from dangerous diet supplements. Since manufacturers became required to report adverse events, well-known to be underreported even in the best of circumstances, the FDA has seen a three-fold increase in the number of adverse events reported. Over 948 adverse event reports were received, and 596 of them were mandatory reports submitted by industry. Those included 9 deaths, 64 life-threatening illnesses, and 234 hospitalizations. Once underreporting is accounted for, the FDA estimates that the true number of adverse events exceeds 50,000 adverse events. The audit was conducted at the request of Congressman Henry Waxman, and several other members of Congress.

The GAO ticked off the items we know already: that the FDA should request more power from Congress to regulate the diet supplement industry, that the FDA can’t require that a company remove tainted supplements from the marketplace, that the public does not know there has been no testing of the products for safety and efficacy, and that manufacturers should register with the FDA and disclose the specific supplements and ingredients to the agency. We certainly know that “consumers remain vulnerable to risks posed by potentially unsafe products.”

Key Events in the Regulation of Dietary Supplements

The Texas Attorney General’s office has announced that its litigation against Mannatech has been concluded with a settlement agreement. The agreement mandates that Mannatech return $4m to customers and its founder, Sam Caster, must pay $1m in fines. Caster is also barred from serving as a director, officer, or employee of the company for 5 years, and cannot participate in any multilevel marketing program for 5 years. Caster had been sued twice before by the Texas AG’s office for deceptive marketing of another company he ran, Eagle Shield.

The litigation was filed in 2007, and accused Mannatech of using an illegal marketing scheme to defraud consumers Mannatech markets supplements called “glyconutrients” that supposedly provide the body with “essential sugars” that promote “better communication” between cells and support the immune system. Leading scientists are critical of the company’s theory of “glycobiology,” and one was prompted to characterize the product as literally, a sugar pill (well known in science as a placebo with no active ingredients).

Still pending is the litigation against three other defendants named in the litigation, H. Reginald McDaniel, a Mansfield physician who has been long associated with the company, and two charitable organizations tied to the company, MannaRelief Ministries and Fisher Institute for Medical Research. The litigation accused them of violating the Texas Deceptive Trade Practices Act and the Texas Food, Drug and Cosmetic Act.