Second Phase Of N.J. VIOXX® Product Liability Trial Begins
WHITEHOUSE STATION, N.J. - Following the first phase of a two-plaintiff, two-phased trial that the Court itself described as “something new,” a state court jury in Atlantic City, N.J., today found that Merck & Co., Inc. did not fail to provide an adequate warning to prescribing physicians about an increased risk of heart attacks from VIOXX prior to September 2002, but did fail to do so prior to September 2001. At the same time, the jury found that the Company violated a state consumer statute, but has not yet assessed damages.
As a result of the Merck verdict, one of the two plaintiffs, Kathleen Hermans Messerschmidt, who filed suit on behalf of her brother, Brian M. Hermans, will not be able to seek compensatory or punitive damages in the second phase of the trial.
The time periods involved in the jury’s verdict reflect the dates of the heart events allegedly suffered by the two VIOXX users who were the focus of the trial. Frederick Humeston suffered a heart attack on Sept. 18, 2001. Meanwhile, Ms. Messerschmidt alleged her brother suffered a fatal heart attack on Sept. 15, 2002, five months after the FDA-approved label change.
The trial now continues into the second phase, which will address the claim that Mr. Humeston’s prescribing doctor would not have prescribed VIOXX had his doctor been warned differently. It also will address whether VIOXX was a substantial contributing factor in his heart attack.
Finally, as a result of the finding regarding the state consumer statute claim, the jury in the second phase also will address what amount, if any, should be paid as reimbursement for the out-of-pocket costs associated with Mr. Hermans’ and Mr. Humeston’s purchase of the medicine.
Merck has objected to the structure of the trial because of the potential for jury confusion and bias and because the jury was asked to decide issues before it heard the facts of the plaintiffs’ cases. Merck noted that the primary question addressed by the jury – whether Merck generally failed to warn “prescribing physicians” – is not an element of any claim brought by these two plaintiffs and cannot be answered in a factual vacuum.
As Merck has argued repeatedly to the Court, the phased approach to this trial enabled plaintiffs to present evidence that had nothing to do with the information the prescribing physicians actually considered in deciding to prescribe the medicine. At the same time, Merck was prohibited from showing the jury the information that entered into those decisions.
Numerous juries considering all of the facts of individual cases in more typical, single-phase trials have already held that Merck acted appropriately with regard to the warnings given to doctors around the country.
In the second phase of this trial, the Company will present evidence to show that Mr. Humeston’s heart attack was related to his longstanding medical problems, not VIOXX.
“Mr. Humeston unfortunately had the kind of medical issues that cause people to have heart attacks every day, regardless of whether they were taking VIOXX,” said Hope Freiwald of Dechert LLP in Princeton, N.J., outside counsel for Merck. “In addition to his individual risk factors for developing coronary disease, the evidence will show that Mr. Humeston actually did have coronary disease. This takes decades to develop and had nothing to do with his use of VIOXX.”
Judge Carol Higbee of the Superior Court of New Jersey, Atlantic County, is presiding over the trial.
Merck is represented by Diane Sullivan, of Dechert LLP in Princeton, N.J., and Paul Strain, of Venable LLP in Baltimore, Md.
Status of Litigation
As of Dec. 31, 2006, the claims related to more than 4,025 alleged VIOXX users have been dismissed before being scheduled for trial. Of those, more than 1,225 were dismissed with prejudice either by plaintiffs themselves or by judges, meaning they cannot be filed again. More than 2,800 plaintiffs have had their claims dismissed without prejudice.
Excluding these first-phase results, juries have found in favor of Merck nine times and in favor of plaintiffs four times. Three mistrials have been declared as a result of hung juries after plaintiffs failed to prove their claims. One of the mistrials was retried resulting in one of the nine Merck victories. Last August, a state court judge set aside one of Merck’s nine victories, involving the case of Frederick Humeston, whose case was retried as part of this trial. In addition to the cases that went to trial, another 14 cases scheduled for trial were either dismissed or withdrawn from the trial calendar by plaintiffs before a jury was even selected.
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.
For information regarding additional cases scheduled for trial in 2007 visit www.merck.com/newsroom/VIOXX/.
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.
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, 2006, and in its periodic reports on Form 10-Q and Form 8-K, which the Company incorporates by reference.
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