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

Court of Appeals of Texas·Decided December 10, 2008·No. 04-07-00234-CV·Published

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

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,

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

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.

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 studies indicated a more than two-fold risk of serious cardiovascular “adverse experiences” suffered by the people who participated in the studies. He said these adverse effects had been replicated in four other randomized clinical trials. In each trial, the cardiac adverse effect manifested itself within twelve weeks or less of taking Vioxx. Dr. Topol summed up his concerns about Vioxx as follows: “But given all these things - - that is, statistical power, lack of cardiovascular patients, and four randomized trials . . . there’s a pretty strong case that the risk of Vioxx for heart attacks can occur at any time after the initiation of the medicine.” In 2004, Merck decided to withdraw Vioxx from the market based on the results of another clinical study that showed “an increase in cardiovascular events that was statistically significant [within 36 months].”

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

Merck & Co., Inc., (APPELLANTS/CROSS-APPELLEES) v. Felicia Garza, (APPELLEES/CROSS-APPELLANTS) (Merck & Co., Inc., (APPELLANTS/CROSS-APPELLEES) v. Felicia Garza, (APPELLEES/CROSS-APPELLANTS)) — published by Counsel Stack Legal Research, free access to 12M+ legal documents.

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