Merck and vioxx
Dec. 12, 2005 Hung Jury in First Federal VIOXX® Product Liability Trial
WHITEHOUSE STATION, N.J., Dec. 12, 2005 – Merck & Co., Inc. is disappointed a federal court jury in Houston, Texas could not return a verdict in Plunkett v. Merck and is prepared for a retrial, if that becomes necessary.
“We presented evidence that there is no medical or scientific evidence showing short-term use of VIOXX increases the risk of heart attack and no evidence that it contributed in any way to the unfortunate death of Richard Irvin,” said Philip Beck, of the law firm of Bartlit Beck, Merck’s lead trial lawyer in the case. “Mr. Irvin only took VIOXX for less than a month. He suffered multiple long-standing risk factors for a heart attack including partially clogged arteries. We believe that Mr. Irvin would have suffered a heart attack when he did, whether he was taking VIOXX or not.”
“If a retrial is scheduled we will be right back with the same facts,” said Kenneth C. Frazier, senior vice president and general counsel of Merck. “The VIOXX litigation will go on for years. We have the resources and the resolve to address these cases, one by one, in a reasonable and responsible manner.”
The lawsuit was originally filed in Palm Beach County, Florida in May 2003 by Mr. Irvin's surviving spouse, Evelyn Irvin Plunkett. The case was re-filed in the federal Multidistrict Litigation (MDL) as case number 05-4046 in 2005.
The MDL is based in federal court in New Orleans; the Plunkett case was tried in Houston because of the effects of Hurricane Katrina. The Judge presiding over the MDL has said he plans to schedule three additional trials on a monthly basis, starting in February 2006. Merck is represented in the Plunkett case by Philip Beck and Tarek Ismail of Bartlit Beck of Chicago.
Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck discovers, develops, manufactures and markets vaccines and medicines in more than 20 therapeutic categories. 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
This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements 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, 2004, and in its periodic reports on Form 10-Q and Form 8-K, which the company incorporates by reference.
May 6, 2005
Congress Probes Merck's Vioxx Sales Tactics
A Congressional committee dug into Merck & Co.'s marketing practices yesterday, trying to determine whether the company's sales representatives misled doctors about the health risks of Vioxx, the pain killer withdrawn from the market last September.
While the House Government Reform Committee was grilling Merck executives, the company's CEO, Raymond Gilmartin, was being shown the door. And in Chicago, a law firm said it will file "the first class action lawsuit on behalf of all Italian citizens who allegedly died or were seriously injured" by Vioxx.
The Senate has held numerous hearings on the Vioxx matter but yesterday's House session produced a mound of internal Merck documents not previously seen. Among them were written guidelines for "detailers," the sales representatives who visit doctors to promote drug company's products.
Merck's detailers were instructed to make eye contact with doctors while firmly shaking their hand. More significantly, when doctors asked about Vioxx' increasing the risk of heart attack and stroke, the detailers were instructed to give them a pamphlet written by Merck's marketing department.
The pamphlet claimed that Vioxx was eight times safer for heart patients than similar painkillers. It omitted Merck's only findings that Vioxx produced a fivefold increase in heart attack and stroke risk compared with naproxen, another popular pain killer.
On the other hand, Rep. Tom Davis (R-Va.), who chairs the panel, said that a "wide-awake" physician would have known of the increased risks, which had been disclosed in a Merck press release and published in the New England Journal of Medicine
A New Direction?
Merck's new chief executive, insider Richard T. Clark, said he wants Merck to become a "growth company" once again. Pfizer, GlaxoSmithKline and Novartis all grew larger than Merck during Gilmartin's tenure.
Among the headaches Clark has inherited are the thousands of personal injury and wrongful death suits filed against Merck by Vioxx users and the loss of $2.5 billion in annual Vioxx sales.
Arriving late at the Vioxx class action ball, a Chicago law firm says it will file a class action lawsuit on behalf of all Italians who died or were injured by Vioxx.
"Vioxx should never have been marketed in the first place, in light of the known risks of Cox-2 inhibitors," said attorney Kenneth B. Moll. The representation of Italian consumers was undertaken in cooperation with CODACONS, the non-profit organization established by Italian law with a mandate to safeguard consumers.
The lawsuit seeks the establishment of a medical monitoring fund to pay for the testing of Italian consumers for dangerous side effects of Vioxx.
MERCK CO INC
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Statement by Kenneth C. Frazier, Senior Vice President and General Counsel Of Merck and Co., Inc. WHITEHOUSE STATION, N.J., Aug. 22, 2005 - Friday's verdict in Texas was a disappointment to all of us at Merck because we know we acted responsibly. WHITEHOUSE STATION, N.J., Sept. 30, 2004—Merck & Co., Inc. today announced a voluntary worldwide withdrawal of VIOXX® (rofecoxib), its arthritis and acute pain medication.
From Merck Press Release
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WHITEHOUSE STATION, N.J., Oct. 21, 2004 - Merck & Co., Inc. today announced that earnings per share (EPS) for the third quarter of 2004 were $0.60, including a $0.25 unfavorable effect associated with the company’s voluntary worldwide withdrawal of VIOXX. The unfavorable impact includes estimated customer returns of product previously sold, write-offs of inventory held by Merck and costs to undertake the withdrawal of the product. Net income was $1,325.6 million, including a $552.6 million unfavorable effect related to the withdrawal of VIOXX. Worldwide sales were $5.5 billion for the quarter, including a $491.6 million unfavorable effect related to the withdrawal of VIOXX.
As previously disclosed, federal and state personal injury lawsuits involving individual claims, as
well as several putative class actions have been filed against the company with respect to
VIOXX. As of Oct. 15, the company has been served or is aware that it has been named as a
defendant in approximately 300 lawsuits, which include approximately 900 plaintiff groups
alleging personal injuries resulting from the use of VIOXX. Certain of these lawsuits include
allegations regarding gastrointestinal bleeding, cardiovascular events and kidney damage. The
company has also been named as a defendant in several putative class actions seeking medical
monitoring as a result of the putative class members’ use of VIOXX. In addition, certain state
court actions seek various remedies under state consumer fraud and fair business practice
statutes, including recovering the cost of VIOXX purchased by individuals and third-party
payors such as union health plans (all of the actions discussed in this paragraph are collectively
referred to as the “VIOXX Personal Injury Lawsuits”).
As previously disclosed, in addition to the VIOXX Personal Injury Lawsuits, a number of purported class action lawsuits also were filed in the third quarter of 2003 and the first quarter of 2004 by several individual shareholders in the United States District Court for the Eastern District of Louisiana naming as defendants the company and several current or former officers of the company, and alleging that the defendants made false and misleading statements regarding VIOXX in violation of the federal securities laws (the “VIOXX Securities Lawsuits”). The plaintiffs request certification of a class of purchasers of the company’s common stock between May 22, 1999 and Oct. 22, 2003, and seek unspecified compensatory damages and the costs of suit, including attorney fees. After the announcement of the withdrawal of VIOXX, the company was named as a defendant in three additional purported securities class action lawsuits filed in federal courts in New Jersey and Pennsylvania. These later-filed actions request certification of a class of purchasers of company stock during various periods between Sept. 23, 2003 and Sept. 30, 2004. The allegations in the later-filed actions are similar to those in the earlier-filed actions, except that the later-filed actions also contain allegations relating to the withdrawal of VIOXX from the market. The company has been advised by the attorneys for the plaintiffs that the complaint on the earlier-filed consolidated actions will be amended to include allegations regarding the withdrawal of VIOXX and to extend the purported class period until Sept. 30, 2004.
As previously disclosed, in March 2004, two shareholder derivative actions (the “VIOXX Derivative Lawsuits”) were filed in the United States District Court for the Eastern District of Louisiana naming the company and certain members of the Board (past and present), together with certain executive officers, as defendants.
In addition to these shareholder actions, since the announcement of the withdrawal of VIOXX, four putative class actions have been filed against the company, two in the United States District Court for the Eastern District of Louisiana and two in the United States District Court for the District of New Jersey (the “VIOXX ERISA Lawsuits” and, together with the VIOXX Securities Lawsuits and the VIOXX Derivative Lawsuits, the “VIOXX Shareholder Lawsuits”) on behalf of certain of the company’s current and former employees who are participants in certain of the company’s retirement plans asserting claims under the Employee Retirement Income Security Act (“ERISA”). The lawsuits make similar allegations to the allegations contained in the shareholder lawsuits described above.
The company has product liability insurance for claims brought in the VIOXX Personal Injury Lawsuits of up to approximately $630 million after deductibles and co-insurance. This insurance provides coverage for legal defense costs and potential damage amounts that have been or will be incurred in connection with the VIOXX Personal Injury Lawsuits. The company believes that this insurance coverage extends to additional VIOXX Personal Injury Lawsuits that may be filed in the future. Certain of the company’s insurers have reserved their rights to take a contrary position with respect to certain coverage and there could be disputes with insurers about coverage matters. The company also has additional insurance with respect to the VIOXX Shareholder Lawsuits which it believes will apply to cover defense costs and losses, if any.
The company is unable at this time to determine whether the company’s insurance coverage with respect to the VIOXX Personal Injury Lawsuits and the VIOXX Shareholder Lawsuits (collectively, the “VIOXX Lawsuits”) will be adequate to cover its defense costs and losses, if any.
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