Brief Fact Summary. Mr. Garza complained of numbness and left arm pain to his doctor who prescribed him Vioxx. After allegedly taking Vioxx for approximately three weeks, two blood clots formed and he died. His wife and children sued Merck for defective design and marketing of the drug. Plaintiffs lost their design defect claim on appeal.
Synopsis of Rule of Law. Under product defect strict liability claims, plaintiffs are required to prove both general and specific causation on the defendant’s part. General causation asks whether a substance is capable of causing a particular injury in the general population. Specific causation asks whether that substance caused a particular individual’s injury.
Issue. Whether Plaintiffs presented legally sufficient evidence of a causal link between Garza’s use of Vioxx and his fatal heart attack.
Held. No. Under both marketing and design defect claims, plaintiff are required to prove both general and specific causation on Merck’s part. To establish general causation, plaintiffs were required to show that Vioxx is a substance capable of causing death in the general population. The court held that the clinical trials that plaintiffs relied upon established general causation. To establish specific causation, plaintiffs were required to show that Vioxx actually caused Garza’s death. Merck agued that plaintiffs’ trial evidence on specific causation was insufficient because plaintiffs’ expert Dr. Simonini did not rule out with reasonable certainty that the cause of Garza’s death was the progression of his pre-existing cardiovascular disease. Plaintiffs countered that they did rule that cause by showing that both his March 27 and April 4 physical examinations showed him to have “stable cardiac status” before he took the Vioxx; his death was caused by two fresh blood clots that occurred after taking Vioxx, and that the simultaneous formation of two clots is very rare without the introduction of a causative agent like Vioxx; and that the formation of clots is the type of problem caused by Vioxx. The court agreed with Merck, however, finding that plaintiffs did not meet their burden because they did not offer evidence excluding other causes of Garza’s death to a reasonable certainty.
Discussion. A plaintiff in a products liability suit must prove actual cause. To prove actual cause, a plaintiff may have to produce expert testimony on both general and specific causation.