Medical Malpractice Case of the Month
December 1999

Dozens of lawsuits have been filed since the Mayo Clinic first reported in its July 8, 1997, emergency report that the use of the diet-drug combination of anorectic drugs Fenfluramine ("Fen") and Phentermine ("Phen") is linked to serious heart problems. As a result of that study and others, the Food and Drug Administration ("FDA") issued an emergency announcement on September 15, 1997, for a voluntary recall of the drugs, as well as Dexflenfluramine, a purified form of Fen. On November 6, 1997, the FDA again warned consumers that some products being sold as substitutes for these banned drugs may be dangerous. The FDA has also threatened legal action against the manufacturer of "Herbal Phen-Fen" (the most popular alternative to the banned Fen-Phen drugs) for misleading consumers.

To assess the extent of the potential health risks, The Wall Street Journal recently report that the off-label combination of Fen-Phen was prescribed to approximately 18 million people each month in 1996. While Fen and Phen were individually approved for use by the FDA years ago, their combined or off-label use has never been explicitly approved by the FDA. The definition of an "off-label" drug is when it is prescribed for a purpose differing from that specifically approved by the FDA. For example, a medicine might be prescribed in combination with other drugs, for a different condition, or at a different dose, than the label specifies as the FDA approved use. An off-label use is not illegal. However, there may be risks associated with the use of off-label drugs, and many plaintiff's lawyers will no doubt allege that physicians have not fully informed patients of the potential risks. Moreover, these drugs were approved by the FDA on the condition that they be prescribed only for obesity and in conjunction with a medically-supervised regimen for weight loss.

The four most serious side effects of Fen-Phen are primary pulmonary hypertension, heart valve deterioration, abnormal EKG rhythms and brain damage. In July, 1997, the Mayo Clinic reported a Fen-Phen study of 24 women; all were diagnosed to have a fibrous thickening of their cardiac valves leading to pulmonary hypertension. The mechanism by which these drugs cause pulmonary hypertension is not yet fully known, and, since the Mayo Clinic study was based on a small observational group, it does not definitely establish an increased risk of valvular heart disease with all Fen-Phen use. Because of the seriousness of the heart problems and their rarity in otherwise healthy (albeit, obese) women, the FDA issued the emergency announcement for a voluntary recall. While some experts argue that the extent of any health problems are based on more media speculation than on studies from the scientific community, providers who prescribed these drugs must be aware of the potential liability inherent in their actions.

Since the FDA is precluded from regulating the diet supplement industry, it cannot take Herbal Phen-Fen off the market. However, the FDA can take legal action to force the manufacturer to change its product's name if the company, by mimicking the prescription drug names, is making claims that the Herbal Phen-Fen causes weight loss and can treat obesity.

Given the large number of suits already filed, the American Trial Lawyers Association ("ATLA") has formed the "Fen-Phen/Redux Litigation Group." The formation of this group is a clear sign that more suits are expected. The number of Fen-Phen and Redux lawsuits could potentially reach the volume of the DES, Dalkon Shield, asbestos or breast implants tort claims. The Fen-Phen cases, however, may be easier to prove because, in some patients, the damage can be caused within a few months. Patients who develop symptoms while using the drugs, and who have medical records from both before and after such use which demonstrate that the symptoms developed subsequently to, or concurrently with, the drugs usage, may have legitimate claims. Even in light of the fact that future medical studies, or experts at trial, must still establish a link between the drugs and heart problems to brain damage.

Regardless of the unsettled causation issues, the lawsuits have named physicians, manufacturers, and weight loss clinics. The causes of actions alleged in the various complaints are strict liability, fraudulent and negligent misrepresentation and concealment, conspiracy, unjust enrichment, breaches of express warranty and warranty of merchantability, negligent and intentional infliction of emotional distress, false advertising, willful and wanton misconduct, loss of consortium, corporate responsibility and equitable relief.

In fact, the first Fen-Phen/Redux class action complaint was filed on July 9, 1997, the day after the FDA published its advisory regarding the drugs. The plaintiffs in this suit are seeking to have a nationwide class certified on behalf of everyone who has been or may be injured by the drugs. The causes of action alleged in this complaint include strict liability, negligence, breaches of express and implied warranty, and equitable relief seeking updated product warnings and medical monitoring for those who have used the drugs in the past. Since then, plaintiffs have filed at least seven separate federal class actions seeking nationwide or statewide medical monitoring, and millions in compensatory and punitive damages. The plaintiffs are now asking the Judicial Panel of Multidistrict Litigation ("MDL") to consolidate all of the suits. While expansion to a national class action is unlikely given previous Supreme Courts rulings, as well as federal circuit court opinions limiting mass tort class actions, it is conceivable that an MDL could be set up. The plaintiff's argue that consolidation of the cases with the MDL will eliminate overlapping or inconsistent class determinations.

Malpractice claims against physicians prescribing Fen-Phen are attractive because, in many cases, the drugs were prescribed to people who were not grossly over-weight, but, rather, seeking cosmetic weight loss. Further, plaintiffs could allege that the drug manufacturers became aware in the early 1990s that Fen-Phen was being prescribed in combination by weight loss centers and physicians and that the manufacturers knew, or should have known, that the combination was not sale. This may open the door to allegations that, despite having knowledge of the dangers involved, there was a concerted effort by the manufacturer and providers to endorse the off-label use of the purpose of cosmetic weight loss rather than to solely treat obesity. Even the FDA, itself, has been accused of concealing reports that Fen-Phen was a suspect in at least 70 deaths since 1974. The explosion of Fen-Phen related lawsuits has just begun. The scientific community will, of course, continue its research into the full effects of the drugs. Meanwhile, potential defendants are carefully watching current legal developments as trickle-down liability (seen in the DES and breast implant cases) may affect many health care providers.

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