Holding that pre-existing heart problems can’t be ruled out as a cause of death, San Antonio’s 4th Court of Appeals reversed a $7.75 million judgment in a case in which the plaintiffs alleged that taking the pain medication Vioxx caused a 71-year-old man’s death in 2001.

The May 14 decision in Merck & Co. Inc. v. Garza, et al. is the first reversal at the appellate level of a judgment favoring a plaintiff in a Vioxx case. According to a Merck news release, the judgment in Garza was one of five that favored plaintiffs since the company pulled Vioxx off the market in September 2004. Merck removed Vioxx from shelves after a study found that the drug doubled the risk of heart attacks and strokes among patients who took it 18 months or more.

In April 2006, a 229th District Court jury in Rio Grande City awarded Leonel Garza’s family $7 million in actual damages and $25 million in punitive damages after finding that marketing and design defects in Vioxx caused his death. The trial court reduced the punitive damages to the $750,000 limit set by Texas Civil Practice & Remedies Code §41.008(b)(1)(A). Merck appealed the judgment.

Among other things, Merck argued in its brief to the 4th Court that the plaintiffs’ general causation and specific causation evidence was legally and factually insufficient to support the judgment. General causation addresses whether a substance is capable of causing a particular injury or condition in the general population, and specific causation deals with whether a substance caused a particular individual’s injury.

In its brief, Merck argued that the Texas Supreme Court ruling in 1997′s Merrell Dow Pharmaceuticals Inc. v. Havner required plaintiffs to present at least two statistically significant studies showing that Vioxx at the same dose and duration as taken by Garza more than doubled the risk of heart of attack. None of the studies the plaintiffs presented met Havner’s requirement, Merck alleged. According to Merck’s brief, Garza took Vioxx between seven and 25 days before he died.

Merck further alleged in the brief that at the time of his death, Garza had received treatment for cardiovascular disease for more than 20 years. Opinion testimony by the plaintiffs’ expert witness did not rule out the progression of Garza’s severe cardiovascular disease as a plausible cause of his death, Merck contended.

The Garza family argued in its brief to the 4th Court that Garza’s condition was stable when he began taking Vioxx. “Mr. Garza’s cardiac work-up at the time he began taking Vioxx revealed a person described by his cardiologist as having “stable cardiac status,’ ” according to the family’s brief.

The 4th Court decided Garza based on Merck’s specific-causation argument. “Even viewing all the evidence in the light most favorable to plaintiffs, we conclude the evidence is legally insufficient to support a finding that plaintiffs negated, with reasonable certainty, Mr. Garza’s preexisting heart condition as a plausible cause of his death,” Justice Sandee Bryan Marion wrote in the opinion joined by Justices Catherine Stone and Phylis Speedlin. [ See the court's opinion.]

David Hockema, lead attorney for Garza’s widow, says the 4th Court seems to be saying a plaintiff has to show that a defective product was the sole cause of a death. “The jury was told there can be more than one cause,” says Hockema, a partner in McAllen’s Hockema &Longoria.

“I guess the court of appeals is saying that it’s open season on elderly people who have health problems,” Hockema says.

Stephen G. Tipps, a partner in Houston’s Baker Botts and Merck’s lead appellate counsel in Garza, says the 4th Court’s ruling reaffirms Havner’s rule that plaintiffs in a pharmaceutical case must exclude other plausible causes of a death.

But Tipps says the Garza decision would have had “more far-reaching consequences” for Vioxx cases involving short-term usage of the drug if the 4th Court’s ruling had been based on general causation.

“Garza will not affect our cases Merck is appealing,” says W. Mark Lanier, founder of the Lanier Law Firm in Houston.

Lanier, who is not involved in Garza, won verdicts in three Vioxx suits — including the $253 million that an Angleton jury awarded in 2005′s Ernest v. Merck & Co., Inc., a verdict the trial court reduced to $26 million.

“In each of our cases, our experts proffered strong testimony that excluded other causes for the victims’ heart attacks,” Lanier says. “While we do not agree with the San Antonio court that the plaintiff bears the burden of disproving the defendant’s theories, we went that extra mile.”

As a result of the 4th Court’s decision, the Garza family will receive nothing.

In November 2007, Merck agreed to pay $4.85 billion to settle Vioxx claims. “This case was excluded from the settlement,” Tipps says.