VIOXX(R) Trial Update: Statement on VIOXX(R) Product Liability Trial Scheduled in Starr County, Texas
Merck & Co., Inc. will conduct a vigorous defense in theproduct liability lawsuit, Garza v. Heart Clinic, Evans, Posada andMerck & Co., Inc., which is scheduled to go to trial before a jury onJan. 24, 2006, in the 229th Judicial District Court of Starr County,Texas. The company believes the evidence in this case will show thatVIOXX did not cause the unfortunate heart attack of Leonel Garza, Sr.
Mr. Garza, 71, died of a heart attack on April 21, 2001, following23 years of cardiovascular disease and a prior heart attack.Approximately one month before his death, Mr. Garza was given aone-week supply of VIOXX 25 mg samples for arm pain.
"There is no reliable scientific evidence that VIOXX caused Mr.Garza's heart attack," said Ted Mayer of Hughes Hubbard & Reed,outside counsel for Merck. "At the time of Mr. Garza's heart attack,he exhibited numerous major risk factors for coronary artery disease.His autopsy report lists acute myocardial infarction as the cause ofhis death and notes evidence of severe atherosclerotic disease in allof Mr. Garza's coronary arteries. We are confident that any fair jurywill find that VIOXX had nothing to do with the unfortunate passing ofMr. Garza since there is no reliable scientific evidence thatshort-term use of VIOXX increases cardiovascular risk."
Texas State District Court Judge Alex W. Gabert will preside overthe case.
A separate VIOXX product liability case, Plunkett v. Merck, isscheduled to be retried before a jury in New Orleans before FederalDistrict Court Judge Eldon Fallon on Feb. 6, 2006. Jurors in theoriginal trial, held in Houston in December, were unable to reach averdict, resulting in a mistrial.
"We intend to defend these cases individually over many years,"said Kenneth C. Frazier, senior vice president and general counsel ofMerck. "Merck acted responsibly - from researching VIOXX prior toapproval in clinical trials involving almost 10,000 patients - tomonitoring the medicine while it was on the market - to voluntarilywithdrawing the medicine when it did."
The company voluntarily withdrew VIOXX in September 2004 inresponse to a Merck-sponsored study, called APPROVe. In that study,there was an increased relative risk of thrombotic events in patientstaking VIOXX continuously for 18 months compared to patients taking asugar pill. That increased relative risk did not appear to bestatistically significant until 30 months or more of continuous use,and there was no detectable difference in risk for patients takingVIOXX for a short duration.
About Merck
Merck & Co., Inc. is a global research-driven pharmaceuticalcompany dedicated to putting patients first. Established in 1891,Merck currently discovers, develops, manufactures and markets vaccinesand medicines to address unmet medical needs. The Company devotesextensive efforts to increase access to medicines through far-reachingprograms that not only donate Merck medicines but help deliver them tothe people who need them. Merck also publishes unbiased healthinformation as a not-for-profit service. For more information, visitwww.merck.com.
Forward-Looking Statement
This press release contains "forward-looking statements" as thatterm is defined in the Private Securities Litigation Reform Act of1995. These statements are based on management's current expectationsand involve risks and uncertainties, which may cause results to differmaterially from those set forth in the statements. The forward-lookingstatements may include statements regarding product development,product potential or financial performance. No forward-lookingstatement can be guaranteed, and actual results may differ materiallyfrom those projected. Merck undertakes no obligation to publiclyupdate any forward-looking statement, whether as a result of newinformation, future events, or otherwise. Forward-looking statementsin this press release should be evaluated together with the manyuncertainties that affect Merck's business, particularly thosementioned in the cautionary statements in Item 1 of Merck's Form 10-Kfor the year ended Dec. 31, 2004, and in its periodic reports on Form10-Q and Form 8-K, which the Company incorporates by reference.
Mr. Garza, 71, died of a heart attack on April 21, 2001, following23 years of cardiovascular disease and a prior heart attack.Approximately one month before his death, Mr. Garza was given aone-week supply of VIOXX 25 mg samples for arm pain.
"There is no reliable scientific evidence that VIOXX caused Mr.Garza's heart attack," said Ted Mayer of Hughes Hubbard & Reed,outside counsel for Merck. "At the time of Mr. Garza's heart attack,he exhibited numerous major risk factors for coronary artery disease.His autopsy report lists acute myocardial infarction as the cause ofhis death and notes evidence of severe atherosclerotic disease in allof Mr. Garza's coronary arteries. We are confident that any fair jurywill find that VIOXX had nothing to do with the unfortunate passing ofMr. Garza since there is no reliable scientific evidence thatshort-term use of VIOXX increases cardiovascular risk."
Texas State District Court Judge Alex W. Gabert will preside overthe case.
A separate VIOXX product liability case, Plunkett v. Merck, isscheduled to be retried before a jury in New Orleans before FederalDistrict Court Judge Eldon Fallon on Feb. 6, 2006. Jurors in theoriginal trial, held in Houston in December, were unable to reach averdict, resulting in a mistrial.
"We intend to defend these cases individually over many years,"said Kenneth C. Frazier, senior vice president and general counsel ofMerck. "Merck acted responsibly - from researching VIOXX prior toapproval in clinical trials involving almost 10,000 patients - tomonitoring the medicine while it was on the market - to voluntarilywithdrawing the medicine when it did."
The company voluntarily withdrew VIOXX in September 2004 inresponse to a Merck-sponsored study, called APPROVe. In that study,there was an increased relative risk of thrombotic events in patientstaking VIOXX continuously for 18 months compared to patients taking asugar pill. That increased relative risk did not appear to bestatistically significant until 30 months or more of continuous use,and there was no detectable difference in risk for patients takingVIOXX for a short duration.
About Merck
Merck & Co., Inc. is a global research-driven pharmaceuticalcompany dedicated to putting patients first. Established in 1891,Merck currently discovers, develops, manufactures and markets vaccinesand medicines to address unmet medical needs. The Company devotesextensive efforts to increase access to medicines through far-reachingprograms that not only donate Merck medicines but help deliver them tothe people who need them. Merck also publishes unbiased healthinformation as a not-for-profit service. For more information, visitwww.merck.com.
Forward-Looking Statement
This press release contains "forward-looking statements" as thatterm is defined in the Private Securities Litigation Reform Act of1995. These statements are based on management's current expectationsand involve risks and uncertainties, which may cause results to differmaterially from those set forth in the statements. The forward-lookingstatements may include statements regarding product development,product potential or financial performance. No forward-lookingstatement can be guaranteed, and actual results may differ materiallyfrom those projected. Merck undertakes no obligation to publiclyupdate any forward-looking statement, whether as a result of newinformation, future events, or otherwise. Forward-looking statementsin this press release should be evaluated together with the manyuncertainties that affect Merck's business, particularly thosementioned in the cautionary statements in Item 1 of Merck's Form 10-Kfor the year ended Dec. 31, 2004, and in its periodic reports on Form10-Q and Form 8-K, which the Company incorporates by reference.
posted by Chris Placitella at 9:24 AM
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