In the first such case to make it to trial, Metabolife International of San Diego was ordered yesterday to pay $4.1 million to four people who had strokes or heart attacks after taking the company’s ephedra diet pills.
A federal jury in Birmingham, Ala., found the company’s flagship product, Metabolife 356, was “unreasonably dangerous” under the state’s manufacturer liability laws.
The decision was reached after reviewing testimony by expert witnesses and thousands of consumer complaints that Metabolife recently turned over to federal regulators.
Metabolife’s ephedra products, used in weight loss and to improve athletic performance, contain combinations of caffeine and ephedra, a herbal stimulant.
The ephedra products raise blood pressure and increase the heart rate and have been linked by scientific studies and medical experts to various health problems.
Metabolife, the largest manufacturer of ephedra diet products, insists that the supplements are safe when used as directed.
The company’s lawyer, Lanny Davis, said yesterday’s jury decision was “shocking.” Metabolife will appeal, he said.
“The undisputed evidence presented to the jury showed that every single plaintiff conceded that they did not read, much less follow, instructions and warnings on the Metabolife label, including the need to consult a health care practitioner,” Davis said.
“For over 10 years, every human clinical study conducted by respected scientists has shown that these products are safe and effective when taken as directed on the Metabolife label.”
David Fawal, an attorney for the four plaintiffs who sued Metabolife, said the company’s response was “disingenuous.”
Two of the four plaintiffs relied heavily on at least one label marking that was prominently displayed on the front of each Metabolife bottle: “Independently Laboratory Tested for Safety.”
That marking was removed from Metabolife’s product in 2000, after the health problems that involved Fawal’s clients occurred.
During the trial, jurors learned that the so-called safety test listed on Metabolife’s bottle was performed on rats and dogs and involved a Metabolife forerunner product, not Metabolife 356, Fawal said.
The two-week trial was notable for one bizarre twist: Metabolife’s founder and co-owner, Michael Ellis, refused to have his deposition taken or to answer questions posed by the plaintiffs’ attorneys, asserting his Fifth Amendment right.
The judge allowed the plaintiffs’ attorneys to question an empty chair.
The attorneys asked question after often-damaging question, to which the judge replied on Ellis’ behalf that Ellis was asserting his Fifth Amendment right not to incriminate himself, Fawal said.
“It made a damning impression,” Fawal said. “The guy didn’t even have the gumption to defend his product, and he took the Fifth on the safety of the product.”
The jury award in Alabama does not bode well for the company, which faces more than 100 personal injury cases in state and federal court. The company or its insurers already have paid about $5 million to settle 29 cases. An additional nine cases were dismissed, and one was granted a summary judgment.
The company is also the subject of criminal investigations by the Justice Department and the Internal Revenue Service.
Investigators for the Justice Department are looking at whether Ellis lied to the Food and Drug Administration about the existence of consumer complaints that allege serious side effects were caused by the diet pills.
In 1998, in letters to the FDA, Ellis said the company had not received any consumer complaints of serious side effects.
But in August, on the same day the Justice Department investigation became public, Metabolife turned over 14,700 reports by people who said they experienced health problems after taking the pills, including strokes, heart attacks and seizures.
The FDA had sought to get the reports through intervening in court cases like the one that went against Metabolife yesterday, but were unsuccessful.
Yesterday, Metabolife announced that it was turning over to the FDA an additional 1,480 customer complaints that had been missed earlier because of what Davis called a “computer glitch.”
Metabolife said the records mention three deaths, 20 heart attacks and 24 strokes.
As with the earlier consumer reports, Davis said they were anecdotal and did not provide evidence that the company’s products caused the problems. As a result, the company did not lie when it denied having reports of serious side effects, he said.
The investigations and the pending lawsuits against Metabolife come at a time when the federal government is deciding whether to impose tougher restrictions on ephedra products or even ban them outright.