Merck v. Garza (Tex. App. - San Antonio 2008)
Merck & Co. Inc. v. Garza (Tex.App.- San Antonio [4th Dist.] May 14, 2008) (Marion)
(Vioxx jury award reversed, causation, preexisting condition as cause not ruled out)
REVERSED AND RENDERED: Opinion by Justice Marion
Before Justices Stone, Marion and Speedlin
04-07-00234-CV Merck & Co., Inc., (APPELLANTS/CROSS-APPELLEES) v. Felicia Garza, et al.,
(APPELLEES/CROSS-APPELLANTS)--Appeal from 229th District Court of Starr County
Related case : Merck & Co, Inc. v. Ernst (Tex.App.- Houston [14th Dist.] May 29, 2008)
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Merck v. Garza (Tex. App.- San Antonio, May 14, 2008)
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Opinion by: Sandee Bryan Marion, Justice
Sitting: Catherine Stone, Justice
Sandee Bryan Marion, Justice
Phylis J. Speedlin, Justice
Delivered and Filed: May 14, 2008
REVERSED AND RENDERED
At the time of his death on April 21, 2001, Leonel Garza was seventy-one years old and had a
history of heart problems. On March 27, 2001, Mr. Garza visited his cardiologist, Dr. Michael Evans,
because he had been experiencing "[i]ntermittent numbness, left arm pain and weakness that had
started the day before and was occurring on and off over a 24-hour period." During this visit, Dr.
Evans gave Mr. Garza a one-week sample supply of Vioxx to ease the pain in his arm. This was the
first time Mr. Garza had taken Vioxx. Following his appointment with Dr. Evans, Mr. Garza
underwent several tests, including an ultrasound of his neck to check blood circulation in the brain
and a cardiolite stress test to check blood flow in the heart. On April 4, 2001, Mr. Garza returned to
the doctor for the test results, this time seeing Dr. Evans' partner, Dr. Juan Posada. Because Mr.
Garza's stress test showed a "mild abnormality," Dr. Posada recommended a cardiac catheterization,
which Mr. Garza declined pending his next appointment with Dr. Evans. Although Dr. Posada does
not recall giving Mr. Garza more Vioxx, Mr. Garza's wife testified that he did. On April 21, 2001, Mr.
Garza died of a heart attack. Mrs. Garza and the Garzas' children (collectively, "the plaintiffs") sued
Merck & Co., Inc. on design defect and marketing defect strict liability claims based upon allegations
that Merck's prescription drug Vioxx caused Mr. Garza's death. This is an appeal from a jury verdict
in favor of the plaintiffs.
CAUSATION
Under both their design defect and marketing defect claims, plaintiffs were required to prove both
general and specific causation. See Merrell Dow Pharmaceuticals, Inc. v. Havner, 953 S.W.2d 706,
714 (Tex. 1997). 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. Id. To establish specific causation, plaintiffs may rely on studies showing an
increased risk of their particular injury resulting from exposure to the substance at issue to raise a
fact question on causation. Id. at 714-15. However, "if there are other plausible causes of the injury
or condition that could be negated, the plaintiff must offer evidence excluding those causes with
reasonable certainty." Id. (citation omitted).
Merck argues plaintiffs' evidence on specific causation is insufficient because plaintiffs did not rule
out, with reasonable certainty, the most plausible cause of Mr. Garza's heart attack, which was the
progression of his preexisting cardiovascular disease. At trial, plaintiffs' expert, Dr. Simonini,
conceded Mr. Garza had cardiac problems and was a "high-risk patient." Mr. Garza was seventy-one
years old and overweight; he had already suffered one heart attack; he had had quadruple bypass
surgery sixteen years before his death; he had high blood pressure and high cholesterol; and he
had some diseased arteries. He had been smoking for almost thirty years and continued to smoke
until his death. Dr. Simonini admitted that continuing to smoke puts one at risk, even someone like
Mr. Garza who was taking blood pressure and cholesterol medication, and smoking may reduce the
benefits of any such medication. Dr. Simonini also conceded that the type of heart disease Mr.
Garza had put him at risk for having another heart attack. Mr. Garza's autopsy revealed the "aorta
shows stress of severe atherosclerotic disease," "extensive scarring and old fibrosis along the
posterior lateral and anterior lateral segments of the heart and also along the ventricular septum,"
"severe atherosclerotic diseases of all coronaries," and "the bypass graft shows severe disease."
Despite Mr. Garza's history of heart problems, plaintiffs contend they excluded, with reasonable
certainty, the possibility that his fatal heart attack was caused by his preexisting heart condition by
establishing the following: Mr. Garza's two physical examinations, between March 27 and April 4 of
2001, showed him to have "stable cardiac status" before he began taking Vioxx; his death was
caused by the two fresh occlusions (or clots) that occurred after he began taking Vioxx; Dr.
Simonini's testimony that the simultaneous formation of two clots is very rare without the
introduction of a causative agent like Vioxx; and the formation of clots is the type of problem
caused by Vioxx.
As support for their contention that Mr. Garza's heart condition was stable, plaintiffs point to Dr.
Posada's notes following his April 4, 2001 examination of Mr. Garza in which he stated "stable
cardiac status . . . ." The result of Mr. Garza's stress test revealed the tip of Mr. Garza's heart did
not get enough blood flow. In Dr. Evans' opinion this result indicated an artery supplying blood to
that area of the heart was blocked. However, Dr. Simonini noted this was "a very small area of the
heart, and it was stable from [a previous test]." Dr. Simonini explained that the stress test revealed
Mr. Garza's heart had only a "mild abnormality." Dr. Simonini said that sixty percent of Mr. Garza's
heart emptied every time the heart squeezed and this fraction was within normal range and was a
"good predictor of staying alive longer."
Plaintiffs also relied on Mr. Garza's autopsy, which revealed that Mr. Garza's heart attack was caused
by the simultaneous formation of two clots in two of Mr. Garza's vein graphs from his bypass
surgery. Plaintiffs contrast the autopsy results with the results of the stress test that showed blood
flow to these same areas was good and there was no evidence of blockage. According to Dr.
Simonini, the simultaneous formation of the two clots in two different arteries was a "rare"
occurrence, and it would be difficult to explain why Mr. Garza suffered a heart attack within a few
weeks of his stress test absent the Vioxx. However, if his taking Vioxx was added to the scenario,
Dr. Simonini opined "then you have a causative effect" because "[y]ou have something that has
been shown to cause clots, and now you could explain this - this simultaneous event of two vessels
being blocked . . . at the same time." Dr. Simonini concluded Vioxx caused Mr. Garza's heart attack.
Although plaintiffs were not required to establish specific causation in terms of medical certainty, nor
to conclusively exclude every other reasonable hypothesis, because Mr. Garza's preexisting
cardiovascular disease was another plausible cause of his death, the plaintiffs were required to offer
evidence excluding that cause with reasonable certainty. See Merrell Dow, 953 S.W.2d at 720. We
do not believe plaintiffs met their burden. Dr. Simonini's causation opinion is based on the premise
that, despite a recent scan that was only mildly abnormal, two clots formed simultaneously in two
different arteries sometime after Mr. Garza began taking the Vioxx and such an occurrence was
"rare." However, no scientific evidence was offered to support Dr. Simonini's opinion that the two
clots were "rare" for someone with Mr. Garza's risk factors. Also, Dr. Simonini provided no scientific
connection between exposure to Vioxx for less than twenty-five days and the simultaneous
formation of two clots. 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.
Therefore, the judgment should be reversed and a take-nothing judgment rendered in favor of
Merck. (1)
Sandee Bryan Marion, Justice
1. Because this issue is dispositive, we need not address Merck's remaining issues on appeal or the
issues raised in plaintiffs' cross-appeal. See Tex. R. App. P. 47.1.