Merck & Co., Inc., (APPELLANTS/CROSS-APPELLEES) v. Felicia Garza, (APPELLEES/CROSS-APPELLANTS)

CourtCourt of Appeals of Texas
DecidedDecember 10, 2008
Docket04-07-00234-CV
StatusPublished

This text of Merck & Co., Inc., (APPELLANTS/CROSS-APPELLEES) v. Felicia Garza, (APPELLEES/CROSS-APPELLANTS) (Merck & Co., Inc., (APPELLANTS/CROSS-APPELLEES) v. Felicia Garza, (APPELLEES/CROSS-APPELLANTS)) is published on Counsel Stack Legal Research, covering Court of Appeals of Texas primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

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Merck & Co., Inc., (APPELLANTS/CROSS-APPELLEES) v. Felicia Garza, (APPELLEES/CROSS-APPELLANTS), (Tex. Ct. App. 2008).

Opinion

i i i i i i

OPINION

No. 04-07-00234-CV

MERCK & CO., INC., Appellant

v.

Felicia GARZA, Individually and on Behalf of The Estate of Leonel Garza, Sr., Leonel Garza, Jr., Luis Jamie Garza, and Lauro Guadalupe Garza, as Heirs to The Estate of Leonel Garza, Sr., Appellees

From the 229th Judicial District Court, Starr County, Texas Trial Court No. DC-03-84 Honorable Alex Gabert, Judge Presiding

Opinion by: Sandee Bryan Marion, Justice

Sitting: Catherine Stone, Justice Sandee Bryan Marion, Justice Phylis J. Speedlin, Justice

Delivered and Filed: December 10, 2008

REVERSED AND RENDERED IN PART, REVERSED AND REMANDED IN PART

In an opinion and judgment dated May 14, 2008, we reversed the trial court’s judgment and

rendered a take-nothing judgment in favor of appellant. Appellees, who were the plaintiffs below,

filed a motion for rehearing. We vacate our earlier judgment, withdraw our earlier opinion, and issue

this opinion and judgment in their place. Although we grant appellees’ motion for rehearing, we

reverse the judgment in their favor on their design defect claim and render a take-nothing judgment 04-07-00234-CV

on that claim. Because of juror misconduct, we reverse the trial court’s judgment in all other

respects and remand for further proceedings.

BACKGROUND

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.

On appeal, Merck raises a number of complaints, including challenges to the sufficiency of

the evidence on causation, whether the plaintiffs’ state law tort claims are preempted by federal law,

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and whether jury misconduct occurred. We conclude the trial court’s judgment must be reversed

because we believe jury misconduct occurred, thus warranting a remand of this cause. Because we

remand for further proceedings we do not address Merck’s challenges to the factual sufficiency of

the evidence in support of the jury’s verdict. However, because we are required to address all issues

that may require us to render in favor of either party, we will address Merck’s challenges to the legal

sufficiency of the evidence supporting the verdict on the plaintiffs’ marketing defect and design

defect claims, as well as Merck’s preemption argument.

CAUSATION

In its first issue, Merck asserts the plaintiffs did not present legally sufficient evidence of a

causal link between Mr. Garza’s use of Vioxx and his fatal heart attack. Under both their marketing

defect and design defect claims, plaintiffs were required to prove both general and specific causation.

See Merrell Dow Pharm., Inc. v. Havner, 953 S.W.2d 706, 714-15 (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.

A. General Causation

On appeal, Merck insists the evidence is legally insufficient because the plaintiffs did not

introduce into evidence at least two statistically significant scientific studies showing Vioxx at the

same dose and duration as taken by Mr. Garza more than doubled the risk of heart attack. According

to Merck, Havner requires experts to base their causation opinions on reliable epidemiological or

other scientific evidence when, as here, there is no direct experimental evidence of causation. Merck

views Havner as requiring that epidemiological studies show more than a doubling of the risk and

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that any study relied upon by a causation expert be statistically significant; i.e., the study must have

a confidence level of ninety-five percent that does not include a value of 1.0 or below. We do not

construe Havner as narrowly as Merck, nor do we believe Havner established such a bright-line test

for causation. Instead, the Havner Court “emphasize[d] that courts must make a determination of

reliability from all the evidence.” Id. at 720. The Court “[drew] no conclusions . . . other than to

point out that there are a number of reasons why reliance on a relative risk of 2.0 as a bright-line

boundary would not be in accordance with sound scientific methodology in some cases. Careful

exploration and explication of what is reliable scientific methodology in a given context is

necessary.” Id. at 719. “Courts should allow a party, plaintiff or defendant, to present the best

available evidence, assuming it passes muster under Robinson, and only then should a court

determine from a totality of the evidence, considering all factors affecting the reliability of particular

studies, whether there is legally sufficient evidence to support a judgment.” Id. at 720. In this case,

plaintiffs relied on clinical trials to establish causation. We therefore follow Havner’s mandate to

determine from a totality of the evidence whether there is legally sufficient evidence to support the

jury’s implied finding on general causation.

On appeal, Merck concedes clinical trials “are considered the best type of epidemiological

evidence for determining the relationship between an agent and a disease or health outcome.” At

trial, the head of Merck’s Department of Epidemiology, whom the plaintiffs called as an adverse

witness, characterized clinical trials as “much more powerful that an epidemiology study.” As to

the clinical trials conducted with Vioxx, plaintiffs offered the deposition testimony of Dr. Eric

Topol, who was subpoenaed for the deposition and did not serve as an expert for either party. Dr.

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Topol explained that Merck conducted several clinical trials for the purpose of extending Vioxx into

new areas, such as prevention of colon polyps and prostate cancer, and to identify stomach problems.

Although these studies excluded patients with cardiac conditions, Dr. Topol said the results of the

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Merck & Co., Inc., (APPELLANTS/CROSS-APPELLEES) v. Felicia Garza, (APPELLEES/CROSS-APPELLANTS), Counsel Stack Legal Research, https://law.counselstack.com/opinion/merck-co-inc-appellantscross-appellees-v-felicia-g-texapp-2008.