Alaska Injury Law Blog

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.

Sources:

FDA Press Release, March 20, 2009

FDA Press Release, December 22, 2009

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.

Sources:

Wyeth v. Levine

Reigel v. Medtronic, Inc.

Altria Group, Inc. v. Good

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

1990
The Nutrition Labeling and Education Act of 1990 amended the Federal Food, Drug, and Cosmetic Act to require most foods, including dietary supplements, to bear nutrition labeling.

1994
DSHEA amended the Federal Food, Drug, and Cosmetic Act to create a new regulatory category, safety standard, labeling requirements, and other rules for dietary supplements. Under DSHEA, dietary supplements are generally presumed to be safe.

2002
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 amended the Federal Food, Drug, and Cosmetic Act to require all food companies, including dietary supplement companies, to register with FDA no later than December 12, 2003, to provide information on the name and address of the facility and, to some extent, the types of products they manufacture or sell.

2004
FDA was successful in banning ephedra after thousands of adverse events, including a number of deaths, and a lengthy legal process.

2006
The Dietary Supplement and Nonprescription Drug Consumer Protection Act amended the Federal Food, Drug, and Cosmetic Act to require dietary supplement companies that receive a serious adverse event report to submit information about the event to FDA.

2007
FDA finalized its Current Good Manufacturing Practice regulations to establish quality control standards for dietary supplements. The final rule became effective on August 24, 2007, but companies have 10, 22, or 34 months from the effective date of the rule to comply, depending on company size.

2007
Serious adverse event reporting requirements for dietary supplement companies became effective on December 22.

Sources:

GAO Report