FDA Colludes With Merck To Avoid Vioxx Liability - Part I

Washington, DCThe FDA is still helping Merck escape liability for the Vioxx disaster. Texas Judge Randy Wilson, who is overseeing the Texas state court proceedings, recently granted Merck's motion to dismiss possibly thousands of lawsuits, essentially because the FDA refuses to acknowledge that Merck concealed information about the safety risks of Vioxx.

Merck says that all failure-to-warn claims are preempted because, in order to maintain a lawsuit, the plaintiffs must prove that Merck misrepresented or withheld information about the safety risks of Vioxx from the FDA.

A Texas statute enacted in 2003, cited as support for the motion, says that, if the warnings accompanying a "pharmaceutical product" are approved by the FDA, then "there is a rebuttable presumption that the" drug manufacturer is "not liable with respect to the allegations involving failure to provide adequate warnings."

The only way a plaintiff can rebut the presumption is "by establishing that" the drug maker "withheld from or misrepresented to the United States Food and Drug Administration required information that was material and relevant to the performance of the product and was causally related" to the plaintiff's injury.

This is an impossible feat for Vioxx victims because, as Judge Wilson specifically pointed out in ruling on the motion, "There is no question but that the FDA has not made a determination that material and relevant information was either withheld or misrepresented concerning Vioxx."

"In Texas, more than 1,300 cases were filed after the 2003 Texas law was enacted," according to Merck's legal team in an April 20, 2007, press release.

"In addition," it states, "there are approximately 2,000 cases pending in other jurisdictions that may be subject to this Texas law. The failure-to-warn claim has been the primary theory asserted by plaintiffs' attorneys in the VIOXX trials to date."

"Given the extent of federal regulation, and the extent to which the FDA is empowered to investigate and regulate drug manufacturers who fail to provide required information, permitting a Texas jury or judge to make the same inquiry would impinge on a uniquely federal issue," Judge Wilson said, in his ruling in the case titled Ledbetter v Merck, No 2005-59499, slip op at 9 (Harris County, Tex Apr 20, 2007).

According to Merck attorney Ted Mayer in the press release, "The Texas Legislature enacted its law to ensure that jurors are not asked to second-guess the doctors and scientists at the FDA who conduct an extensive review."

These statements makes a mockery of the under-oath testimony by FDA scientists and experts who have served on FDA advisory panels who specifically stated that Merck did conceal information from the FDA and that by doing so, killed tens of thousands of Americans, in a November 18, 2004, hearing before the Senate Finance Committee to evaluate whether the FDA had done enough to protect the public against Vioxx.

In his opening statement, then Committee Chairman Senator Charles Grassley (R-Iowa) set the tone for the hearing on what he referred to as the biggest drug disaster in US history. "Merck acknowledged that Vioxx carried with it serious cardiovascular risk, when it withdrew the drug from the market," he said.

However, during today's hearing, he added, "we will hear about the red flags that were raised about those risks in the years before and the years after Vioxx was approved by the Food & Drug Administration."

A 20-year career scientist at the FDA, Dr David Graham testified and described how the FDA and Merck went to great lengths to try to suppress his findings from a 3-year Vioxx study because it showed that, by allowing Merck to make billions of dollars from the continued sale of Vioxx, the FDA was in large part responsible for the deaths of tens of thousands of Americans.

Dr Graham told the Committee, "Vioxx is a terrible tragedy and a profound regulatory failure."

He said he became worried about the potential public health risk after the Gastrointestinal Outcomes Research study (VIGOR) indicated that the heart attack risk was increased 5-fold because (1) Vioxx would be used by millions of patients; (2) heart attack is a fairly common event; and (3) even a small increase in risk could mean tens of thousands of patients might be seriously harmed or killed.

"If these three factors were present," Dr Graham said, "I knew that we would have all the ingredients necessary to guarantee a national disaster."

He then worked with Kaiser Permanente in California on the study that took nearly 3 years to complete and concluded that high-dose Vioxx significantly increased the risk of heart attacks and sudden death and should not be prescribed.

"This conclusion," Dr Graham told the panel, "triggered an explosive response from the Office of New Drugs, which approved Vioxx in the first place and was responsible for regulating it postmarketing."

The response from senior management was equally stressful, he testified. "I was pressured to change my conclusions and recommendations and basically threatened that if I did not change them, I would not be permitted to present the paper at the conference," he said.

In fact, he told the panel, one manager recommended that he should be barred from presenting his findings and that Merck should be told about the study results.

Dr Graham testified that the study estimated that, in the US, nearly 28,000 excess cases of heart attack or sudden cardiac death were caused by Vioxx.

He also explained that, if the risk level seen in the 2 Merck sponsored trials, VIGOR and APPROVE, was applied, the likely number of excess cases of heart attack or sudden cardiac death in the US "ranges from 88,000 to 139,000 Americans," and of these, "30-40% probably died," he said.

Dr Graham explained that he and his team of researchers wrote a manuscript for publication in a peer-reviewed medical journal, but senior managers at the FDA would not grant clearance for its publication, even though it was accepted by a prestigious journal after rigorous peer review.

"Until it is cleared," he told the panel, "our data and conclusions will not see the light of day in the scientific forum they deserve and have earned, and serious students of drug safety and drug regulation will be denied the opportunity to consider and openly debate the issues we raise in that paper."

The FDA also teamed up with Merck in legal filings in failed attempts to prevent Dr Graham from being subpoenaed by Vioxx victims to testify about his finding in depositions for lawsuits filed against Merck.

On April 6, 2006, Andrews Publications reported that a federal judge has ordered Dr Graham to testify in the Vioxx multidistrict litigation proceeding. "US District Judge Eldon Fallon of the Eastern District of Louisiana cleared the way for Graham to be deposed by denying the FDA's motion to quash a plaintiffs' steering committee subpoena compelling the scientist's appearance."

The FDA fought the subpoena, claiming that Dr Graham's deposition would divert the agency's time and resources, cripple its ability to fulfill its statutory mandate and that there was no need for the deposition, given the statements he has already made publicly.

Judge Fallon denied the motion, saying, "This court does not see how the deposition of one employee during non-working hours would cripple the FDA's ability to function."

Noting that discovery motions are based on individual facts and decided on a case-by-case basis, Judge Fallon said, "much as this court will not write litigants a blank check, it will not deal the FDA a trump card," according to Andrews.

By now, it's no secret that medical professionals who stand up to drug makers and the FDA often end up with the short end of the stick. Vioxx was taken off the market on September 30, 2004. In October 2004, prominent cardiologist and researcher Dr Eric Topol of the Cleveland Clinic, posted a column on The New England Journal of Medicine's Web site, and called for a congressional review of the Vioxx "catastrophe."

"The senior executives at Merck and the leadership at the FDA," he wrote, "share responsibility for not having taken appropriate action and not recognizing that they are accountable for the public health."

In a subsequent Vioxx lawsuit, Dr Topol gave a taped deposition and described how Merck retaliated against him and tried to destroy his career. According to a November 30, 2005, article in the Wall Street Journal, by Heather Won Tesoriero:

"During his deposition testimony, Dr Topol said that a colleague at the Cleveland Clinic, Richard Rudick, the director of clinical research, told him that Raymond Gilmartin, the former chief executive and chairman of Merck, called a Cleveland Clinic board of trustee member to complain about Dr Topol. The call came in mid-October 2004, two weeks after Merck withdrew Vioxx from the market and after Dr Topol published harsh criticisms of Merck over Vioxx in the New York Times and the New England Journal of Medicine."

"Dr Topol said that, according to Dr Rudick, Mr Gilmartin called Malachi Mixon, chairman of the board of trustees at the Cleveland Clinic, and 'said to Mr Mixon, what has Merck ever done to the Cleveland Clinic to warrant this?'"

Dr Topol testified that Gilmartin's approach "appalled" him. Less than a week after his taped deposition testimony was played in a Houston courtroom, Dr Topol lost his title as chief academic officer of the Cleveland Clinic's medical college.

Merck's mass-marketing of Vioxx has resulted in a financial liability for all Americans. During the November 18, 2004, hearing, the ranking Democrat on the committee at the time, Senator Max Baucus, noted the tax dollars wasted on Vioxx: "In the 5 years that Vioxx was on the market, Medicaid spent more than $1 billion on the drug," he said.

In addition, he pointed out, government programs are paying the medical bills for patients injured by Vioxx. "Medicaid bears the cost of any additional medical care necessary when drugs cause injury," Senator Baucus said.

Also see Part II: FDA Colludes With Merck To Avoid Vioxx Liability - Part II