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.

SOURCES:

FDA: News Release--5/1/09

Missouri AG: News Release--3/27/03; News Release--5/4/04

Medical Literature: Hydroxycut hepatotoxicity: A case series and review of liver toxicity from herbal weight loss supplements, World J Gastroenterol 2008 December 7; 14(45): 6999-7004; Hepatotoxicity associated with weight loss supplements: A case for better post-marketing surveillance; World J Gastroenterol 2009 April 14; 15(14): 1786-1787.

New York Times: Studies of Dietary Supplements Come Under Growing Scrutiny, 6/23/03

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

We often look to the FDA to regulate this industry, and forget the excellent work done by state agencies. Remember, it was the Texas FDA that began the work against the dangerous marketing of ephedra, which the FDA later took over. In the past, state agencies in California, New York and Florida have also taken strong positions against dangerous or deceptively marketed supplements. The fundamental problem, however, is that we cannot rely on state-by-state regulation; the problem requires a federal solution. Only a few states are large enough to fund their state FDA adequately or support litigation efforts like those of the Texas AG. (And then there is Utah, where the diet supplement industry is treated like a state-sponsored drug cartel.) While we must encourage the efforts of states like Texas, the states should not be left to clean up the industry themselves. The fact that Texas had to bring the litigation at all speaks volumes about the larceny DSHEA permits and the harm that has come from the FDA's inaction. The FDA should be handling these problems with a consistent and unrelenting regulatory effort, and Congress should amend DSHEA to permit the FDA to do its job.

Sources:

Star-Telegram, Feb. 27, 2009

Texas AG's Complaint

Final Judgment against Caster

Final Judgment against Mannatech

Neil O'Donnell has been selected for inclusion in the 2009 Edition of The Best Lawyers in America. The publication states that selection to Best Lawyers is based on an exhaustive and rigorous peer-review survey by the top attorneys in the country and is considered a singular honor.

Recent congressional testimony by the Legislative Director of the Consumer Federation of America (CFA) catalogued several major trends in the insurance industry over the past two decades. Most of these trends are extremely adverse to consumers including small businesses. The first trend is the "hollowing out" of the benefits provided in many insurance policies through more restrictive coverage provisions and expanding exclusions that are poorly understood by the insureds who purchase these legally complex documents. The second trend is that many major insurance companies have turned their "claims operations into 'profit centers' by using computer programs and other techniques designed to routinely underpay policy holder claims." As a result, the percentage of each premium dollar that goes to pay claims has fallen dramatically over the past 20 years, producing "unprecedented profits" for insurance company shareholders and insurance company executives at the expense of the insureds. The full report can be found at:
Testimony of Travis V. Plunkett, Legislative Director, Consumer Federation of America, 7/29/08.

Best Lawyers in America has now released its law firm rankings for 2009, and has ranked Atkinson, Conway & Gagnon #1 in the Products Liability category in both the Alaska and Anchorage surveys. The Alaska Personal Injury Law Group is the practice group within the firm of Atkinson, Conway & Gagnon handling claims in the specialty areas of law such as products liability, negligence, wrongful death, catastrophic injury, and insurance bad faith claims.

Benchmark: Litigation has released its 2009 rankings, as well. Reprising its 2008 listing by the organization, Atkinson, Conway & Gagnon was again listed as one of five law firms in Alaska selected for its premier "highly recommended" listing.

Both organizations utilize peer review surveys of practicing lawyers as an independent and objective means of determining which law firms are regarded by their peers as performing exceptional legal work.

Richard E. Vollertsen, one of the Alaska Personal Injury Law Group's attorneys, has just been selected as "Lawyer Of The Year" by Best Lawyers In America. Mr. Vollertsen is one of three lawyers to be recognized from Alaska, and the only lawyer recognized in the specialty practice of Personal Injury Litigation. Another lawyer from his firm, Bruce E. Gagnon, was also selected by Best Lawyers as "Lawyer of the Year" in the specialty practice of Corporate Law.

Best Lawyers in America is one of the oldest publications rating lawyers in the United States, and is the gold standard for accuracy and integrity. Best Lawyers in American compiles its lists of outstanding attorneys by conducting exhaustive peer-review surveys in which thousands of leading lawyers confidentially evaluate their professional peers. The lawyers being honored as “Lawyers of the Year” received particularly high ratings in their surveys by earning a high level of respect among their peers for their abilities, professionalism, and integrity. Steven Naifeh, Managing Editor of Best Lawyers, says, “We continue to believe – as we have believed for more than 25 years – that recognition by one’s peers is the most meaningful form of praise in the legal profession. We would like to congratulate Richard E. Vollertsen on being selected as the ‘Alaska Best Lawyers Personal Injury Litigator of the Year’ for 2009.”

The bright spot in today's news is that the FDA has announced its initiative against "contaminated weight loss products." One has to applaud the agency's efforts because diet supplements, in general, and weight loss products, in particular, have been "spiked" with pharmaceutical drugs for some time. The reason diet supplement marketers do this is because: 1.) drugs work, whereas diet supplements rarely do; and 2.) they can get away with it. The agency has been manacled in its enforcement efforts by the restrictions imposed by DSHEA, but it has also been substantially impaired in its efforts because of a lack of political will to regulate this wayward industry where it can. Thus, these kinds of initiatives are a breath of fresh air.

Imagine for a moment that it has been discovered that Pfizer had "spiked" its new blockbuster drug with a different, undisclosed drug, (or for that matter a diet supplement!). The FDA and the industry would be embroiled in immediate inquiries, and heads would roll. On the other hand, the FDA has known for decades about the illegal "spiking" of diet supplements with pharmaceuticals and has simply let the matter fester.

Be that as it may, the FDA has now released warnings as to a number of supplements, and has indicated that it will be seeking recalls of some of them. The supplements were found to contain sibutramine (a controlled substance), rimonabant (a drug not approved for marketing in the United States), phenytoin (an anti-seizure medication), phenolphthalein (a solution used in chemical experiments and a suspected cancer causing agent) or bumetanide (a diuretic). These substances all have pharmaceutical properties that include the laundry list of adverse effects one would expect. We have previously written about the deadly consequences of this type of adulteration here, and here, and we commend the agency for its efforts. Regardless whether the FDA is getting it or just getting around to it, this heightened scrutiny is long overdue.

Sources:

FDA News, January 8, 2009

FDA News, January 27, 2009

New York Times, February 9, 2009

Minnesota Star Tribune, February 9, 2009

International Herald Tribune, February 10, 2009

Judge Jack T. Camp, of the U.S. District Court, has sentenced the CEO of Hi-Tech Phamaceuticals, Jared Wheat, to 50 months in prison for illegally selling knock-off prescription drugs over the internet. He was also fined $50,000, and was required, along with the company and other defendants, to forfeit $3 million in proceeds received in the scheme. In the proceeding, the defendants admitted to operating a facility in Belize that manufactured generic versions of pharmaceutical drugs, such as Xanax, Valium, Ambien, Vioxx, Ambien, Zoloft, Viagra and Cialis, and selling the drugs over the internet without requiring a prescription.

A co-defendant, Sergio Oliveira, a sales associate, was sentenced to 20 months in prison and fined $20,000. The judge had previously sentenced two other Hi-Tech officials, Stephen D. Smith and Tomasz Holda, to 27 months and 16 1/2 months respectively.

Hi-Tech’s supplements include Stamina-Rx, which it claims to be a "maximum sexual stimulant," Lipodrene, supposedly capable of "advanced appetite control and metabolic stimulation," and Metanabol, marketed as a "revolutionary catalyst for increasing lean mass and strength."

Sources:

MSNBC, 2/3/09

The diet supplement industry has used innumerable methods of staying ahead of the posse (the FDA, the FTC, State AGs, and the courts). They have simply outrun regulation, and outfoxed the regulators. The industry has outlobbied the regulators, as well. Despite decades of scientific data and media disclosures, the industry is virtually unregulated, and the consumer still cannot trust that a diet supplement purchased on the open market is safe, effective, or unadulterated. "Caveat emptor, baby, caveat emptor" was also the chant of the Bush Administration in its approach to these issues.

A new report by the FDA asks the simple question whether the FDA is up to the challenge of regulating engineered nanoparticles in diet supplements. Without reading the report, we know the answer to be "no." The FDA is not set up to litigate, it has not been given a true mandate to regulate this industry, it is underfunded, and its scientists are squelched. But let's see what they say. "It is not clear that the supplement industry is conducting the rigorous testing needed either to understand the effects of nanoscale ingredients in its products or to back up product claims." We had to pay for a study to get to this conclusion? The industry doesn't do "rigorous testing". It doesn't on anything it sells, because it isn't legally required to do so. Instead, the industry does "rigorous marketing".

As for whether the agency is "up to the challenge," the report concludes: "The short answer is no." Three reasons are given: 1.) the agency doesn't have the capacity to identify nano-based supplements; 2.) the agency has little regulatory authority over such supplements; and 3.) the agency lacks the scientific expertise and resources to effectively regulate these supplements. The report recommends what has been obvious for decades now--increase the agency's regulatory authority, and increase its resources.

The report provides a summary of the regulatory history that brings us to the current DMZ of DSHEA, and it even tackles summarizing the regulatory efforts aimed at corralling ephedra. It provides a disturbing summary of the increased budget and mandate of the agency in inverse proportions to the number of agency employees expected to accomplish the agency's goals.
Ultimately, the report recommends that rational steps be taken, such as product registration, safety standards, market review, pre-market testing, adverse events reporting, and increased resources.

The report's appendix contains a list of over 40 supplements using nanoparticles, but it does not articulate the safety risks the consumer faces. These risks include not only the direct risk to consumers, but also to those manufacturing the products, and the risk to the water supply, the environment, and animals.

One has to appreciate the efforts of the agency to articulate this nano-concern, but the report merely states the obvious as to the flagrant regulatory gaps that have been with us for decades now. The agency has to step up to the plate, as does Congress. The Obama administration's stated goals suggest a new direction for the agency, and a return to science and consumer-based regulatory purposes. This will require that America step back from the gluttony of unbridled capitalism and the ritualistic zeal of woo. Perhaps we can, but I wouldn't bet on it.

Sources:

FDA: A Hard Pill To Swallow

IOM: Risk Assessment of Nanoparticles

Scientific American: Risk of Nanoparticles in Food