Vioxx Legal Issues

The November 1, 2004 issue of Forbes describes the death of a 71-year-old athlete who was on a bicycling vacation with his wife in southern France when he died of a stroke. Mr. Newton Acker had low cholesterol and low blood pressure and bicycled 5,000 miles each year. His parents had lived to age 90. Mr. Acker’s son, Kenneth, believes the Vioxx that his father took for arthritis for 14 months before his death explains the mystery. Kenneth plans to sue.

The November 14, 2004 New York Times details the plight of a 32-year-old father of three boys in Katy, Texas. The construction worker had just reported for work at Houston’s Hobby Airport last May when he collapsed from a heart attack. Although he survived, he remains in a nursing home in Luftin, Texas, suffering from brain damage sustained from oxygen deprivation to his brain during the attack.

The Wall Street Journal reports of a lawsuit against Merck filed by relatives of a 37-year-old man who took Vioxx for a month and died from a heart attack at a car wash. The trial is scheduled for May 2005.

These Vioxx users are among the 160,000 injured parties estimated by Cleveland cardiologist Eric Topol.

What is the status of Vioxx litigation?

More than 400 lawsuits have already been filed in state and federal courts in California, Texas, Florida, New Jersey, Alabama, Mississippi, and Arkansas against Merck over Vioxx. Two are seeking class-action status. The first lawsuit was filed in 2001 and one is scheduled for trial in December. Estimates put the litigation costs to the company up to $12 billion. Merck disclosed it has product liability insurance for Vioxx claims up to $630 million. New-York based Hughes Hubbard & Reed LLP has represented Merck & Co. for over 25 years. American Lawyer magazine ranks Hughes Hubbard among the top 20 US law firms.

In a Tampa Vioxx lawsuit, Merck cited 30 affirmative defenses to a heart attack victim’s allegations of strict liability, negligence, negligent misrepresentation and fraud.

What is Merck’s liability for Vioxx injuries?

Plaintiff attorneys will be certain to highlight Merck’s knowledge of Vioxx’s dangers at an early stage. On November 1, 2004, The Wall Street Journal reported that Merck e-mails and marketing materials and interviews with outside scientists showed the company aggressively fought for years to keep safety concerns from destroying Vioxx’s commercial prospects.

The Journal reported that a March 9, 2000 e-mail from Merck research director Edward Scolnick to associates acknowledged an elevated risk of heart attack and stroke was “clearly there” and called it a “shame.” But the company’s statements continued to deny the increased risk of cardiovascular injury.

Further, a company training document designed to help Merck representatives deal with physicians’ questions about Vioxx’s cardiovascular safety. Each of the first 12 pages is dedicated to a single “obstacle” which represents sample physician statements, such as “I am concerned about the cardiovascular effects of Vioxx.” Each of the final four pages contains a single word in capital letters: “DODGE!”

In the November 5, 2004 editorial of The Lancet, Richard Horton states: “Today we publish results from a cumulative meta-analysis which show that the unacceptable cardiovascular risks of Vioxx (rofecoxib) were evident as early as 2000 – A full 4 years before the drug was finally withdrawn from the market by its manufacturer, Merck.”

How has Merck treated physician experts?

Merck unsuccessfully sued Joan-Ramon Laporte of the Catalan Institute of Pharmacology in Barcelona, Spain. In an institute publication, Dr. Laporte repeated criticisms of Merck’s handling of Vioxx previously published in the British journal, The Lancet.

Merck officials sent him a “correction” to publish, but Dr. Laporte responded that there would be no correction. Merck officials approached him two more times before filing suit in a Spanish court against Dr. Laporte, demanding a public correction of inaccurate information. In January 2004 a judge ruled that Dr. Laporte’s publication accurately reflected the medical debate about the cardiovascular safety of Vioxx and ordered Merck to pay court costs.

Merck withdrew its financing of about $140,000 of an annual pharmaceutical meeting of Spanish family physicians it had supported for the previous eight years after the organizer refused to remove Dr. Laporte from the program.

Merck warned Dr. Gurkirpal Singh, a Stanford University researcher and prominent COX-2 expert, that he would “flame out” unless he stopped giving “anti-Merck” lectures. Merck canceled Dr. Singh’s presentations it had been scheduled to sponsor. Dr. Singh had repeatedly requested Merck for more cardiovascular safety data.

When Merck refused, Dr. Singh added a slide to his presentations that showed a man hiding under a blanket, representing the missing data. In October 2000, Louis Sherwood, a Merck official, called James Fries, a Stanford University Medical School professor, and complained that Dr. Singh’s lectures were “irresponsibly anti-Merck and specifically anti-Vioxx.”

Mr. Sherwood suggested that if this continued, Dr. Singh would “flame out” and there would be consequences for Dr. Fries and for Stanford. Dr. Fries complained to Merck CEO Gilmartin about “a consistent pattern of intimidation of investigators by Merck” on Vioxx.

What will the US government do?

Physicians are demanding an investigation into FDA’s failure for to take appropriate action and failure to safeguarding public health. As part of a federal health care investigation under criminal statutes, the Justice Department has subpoenaed Merck for information related to the company’s Vioxx research, marketing, and selling activities. The Securities and Exchange Commission has begun an informal inquiry, possibly about misleading shareholders about the safety profile of Vioxx.

Senator Charles E. Grassley, an Iowa Republican and chairman of the Senate Finance Committee, called for a Congressional hearing to address Vioxx’s safety problems. Raymond V. Gilmartin, Merck’s CEO, and Lester M. Crawford, Jr., FDA’s acting commission, have been requested to provide testimony at the hearing scheduled to begin November 18, 2004.
How will Merck’s behavior affect product liability tort reform?

Merck encouraged 20 million Americans to use Vioxx with full knowledge that it could increase their risk of heart attack and stroke – a situation which the St. Petersburg Times describes as “a textbook case of corporate negligence and deception.”

The Times continues: “With $2.5-billion in Vioxx sales last year [2004], Merck could emerge as Exhibit A for those who argue sizable damage awards are needed to curb gigantic corporations seeking profit while concealing risks to customers … a vivid example of the risks of putting profit ahead of consumer safety.”

How should a Vioxx victim proceed?

Proving causation is one of the most important elements in just about any product liability lawsuit, yet it is generally the least understood by the general public.

Patients who are prescribed medications with significant side effects are usually suffering from serious medical conditions. Proving that the drug was a significant contributor to the injury in the presence of other pre-existing health conditions is very difficult. Merck will rely on the causation defense and assert that the victim’s injury is unrelated. Proving that the drug’s defects and dangers adds complexity and uncertainty to these lawsuits.

Vioxx victims should choose a law firm with extensive experience and success in pharmaceutical litigation. Our law firm has a proven track record. We represent individuals in a number of different states in Vioxx lawsuits.

We are accepting new cases and we handle all of our cases on a contingent attorney fee and cost basis with a fee percentage starting at one-third of the total recovery. We advance all of the costs of investigation and litigation and the client is only responsible to pay us back if we obtain a money recovery from which those costs can be paid.

Please feel free to contact us through our contact page, email, or by calling us at 1-800-748-7115, if you have any questions or if you would like us to evaluate your case or represent you.