Vioxx Trial Update:Statement on Vioxx Product Liability Trial inNew JerseyWHITEHOUSE STATION, N.J., Jan. 16, 2007 – Merck & Co., Inc. plans to vigorously defend itself in a jury trial set for opening arguments on January 22 in the Superior Court of New Jersey in Atlantic County. The Company believes the evidence will show that VIOXX did not cause Frederick Humeston or Brian M. Hermans to have heart attacks as they claim, and that Merck provided appropriate information about VIOXX to the medical, scientific and regulatory communities.
“Both of these men unfortunately had the medical problems that cause people to have heart attacks or sudden cardiac death, regardless of whether they were taking VIOXX,” said Hope Freiwald of Dechert LLP in Princeton, N.J., outside counsel for Merck. “In addition to their individual risk factors for developing coronary disease, both men actually had significant coronary disease, which develops over decades and had nothing to do with their use of VIOXX.” Judge Carol Higbee of the Superior Court of New Jersey, Atlantic County, will preside over the trial.
In one case, Kathleen Hermans Messerschmidt alleges that her brother, Brian Hermans of Waupaca, Wisconsin, suffered a fatal heart attack at or around September 15, 2002 after allegedly taking VIOXX for approximately 19 months. An autopsy showed that Mr. Hermans, who was 44 years old at the time of his death, had an enlarged heart and multi-vessel coronary artery disease. The evidence also will show that Mr. Hermans had a strong family history of heart disease and early death. In addition, the evidence will show he had untreated high cholesterol and high blood pressure. Further, records show that Mr. Hermans died from an arrhythmia and had methadone and fluoxetine in his system at the time of death.
In the other case, Frederick Humeston of Boise, Idaho, alleges that he took 56 pills of VIOXX over a period of 141 days before he suffered a heart attack on September 18, 2001 at the age of 56. Testing showed that Mr. Humeston had coronary artery disease consistent with his risk factors, including elevated cholesterol, being overweight, and having elevated blood pressure. Mr. Humeston also was under severe job-related stress, as documented throughout his medical history. The Humeston case was previously tried in September 2005. A jury ruled in favor of Merck but Judge Higbee subsequently set aside the verdict.
“Plaintiffs will have a difficult time proving that it was VIOXX, and not each man’s longstanding medical problems, that caused these heart events,” added Ms. Freiwald.
The trial may be conducted in two phases. The first phase would address whether Merck properly informed the medical community, including the men’s individual doctors, about the risks and benefits of VIOXX. The second phase would address each plaintiff’s claim that the prescribing doctor would not have prescribed VIOXX had the doctor been warned differently and that VIOXX caused the particular heart attack at issue. Merck has objected to the structure of the trial because of the potential for jury confusion and because the jury may be asked to decide key issues before it hears all of the facts of the plaintiffs’ cases.
“This trial will combine two completely different cases. The plaintiffs are from different states, with different legal standards, alleging different injuries based on different durations of use over different periods of time. And both men had different pre-existing medical problems that explain their injuries,” added Ms. Freiwald.
The Company voluntarily withdrew VIOXX in September 2004, in response to a Mercksponsored study called APPROVe. In that study, there was a small increased relative risk of heart attack after 18 months of continuous use in the patients taking VIOXX compared to patients taking a sugar pill.
“Merck acted responsibly—from researching VIOXX prior to approval in clinical trials involving almost 10,000 patients – to monitoring the medicine while it was on the market – to voluntarily withdrawing the medicine when it did,” said Kenneth C. Frazier, executive vice president and general counsel of Merck.
Merck is represented by Diane Sullivan, of Dechert LLP in Princeton, N.J. and Paul Strain, of Venable LLP in Baltimore.
Status of Litigation As of September 30, 2006, the claims related to more than 3,000 alleged VIOXX users have been dismissed before being scheduled for trial. Of those, more than 1,100 were dismissed with prejudice either by plaintiffs themselves or by judges, meaning they cannot be filed again. Another 2,000 were dismissed without prejudice.
Of the 26 plaintiffs whose claims have been scheduled for trial, the claims of six were dismissed, the claims of seven were withdrawn from the trial calendar by plaintiffs, and juries have decided in Merck's favor nine times and in plaintiffs’ favor four times. A state judge set aside one of the nine Merck verdicts.
As for the four plaintiffs’ verdicts, Merck already has filed an appeal or sought judicial review in each of those cases, and in one of those four, a federal judge overturned the damage award shortly after trial.
About Merck Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit www.merck.com.
Forward-Looking Statement This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the cautionary statements in Item 1 of Merck's Form 10-K for the year ended Dec. 31, 2005, and in its periodic reports on Form 10-Q and Form 8-K, which the Company incorporates by reference.
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Media Contact: Casey Stavropoulos Investor Contact: Graeme Bell (202) 247-0705 (908) 423-5185
Posted: January 2007
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