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Today's Stories September 20, 2006 Christopher
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September 20, 2006 A ScorecardThe Merck Vioxx LitigationBy EVELYN PRINGLE In the homestretch leading up to the latest trial in New Orleans, the score in the Vioxx litigation was 5 to 4 in favor of Merck. However, in mid-August, 2006, a New Jersey victory for Merck was thrown out reversing the score to 5 to 4 in favor of plaintiffs. But none of the winning plaintiffs should count their chickens before they are hatched because according to Merck's SEC filing on August 7, 2006, although the company has set aside $685 for attorney fees and legal defense costs:
And furthermore, Merck states in its SEC filing, "At this time, the Company believes that its insurance coverage with respect to the Vioxx Lawsuits will not be adequate to cover its defense costs and any losses." A New Orleans trial is now underway, and during his September 12, 2006, opening statement, the plaintiff's attorney, John Boundas, told the eight-member jury that Merck lost sight of the truth and patient safety, in the company's zeal to promote the blockbuster painkiller Vioxx Mr Boundas, along with co-counsel Steve Kherkher, is representing plaintiff, Robert Smith, in the third federal case to go to trial. US District Judge Eldon Fallon told the jury that he expects the trial to last 2 1/2 to three weeks, and will include half-days on Saturday. Under the company's first top executive hired from the business rather than the medical community, Merck marketed a "dangerous, defective drug that never ever should have been prescribed, and never ever warned about the dangers," Attorney Kherkher told the jury. According to Mr Kherkher, the doctor who prescribed Vioxx for Mr Smith, has said that about a half-dozen Merck sales representatives "would drum into him, 'Vioxx, Vioxx, Vioxx,'" Mr Smith was taking Vioxx for pain resulting from a knee injured in a softball game in 1998. All federal Vioxx product liability lawsuits have been consolidated and transferred to the US District Court for the Eastern District of Louisiana with Judge Fallon presiding. Judge Fallon has informed attorneys on both sides that he plans to try 5 cases in 2006, selected from four categories to include: (1) heart attack with long term use; (2) heart attack with short term use; (3) stroke; and (4) cardiovascular injury that occurred after the labeling changes were made on Vioxx in April 2002, describing the results of the VIGOR trial. After conducting the five trials, Judge Fallon has said he wants to work out a global settlement for the 5,700 federal Vioxx cases on his docket. After the first trial, Judge Fallon had attorneys from both sides choose two more cases for trial in his court. Mr Smith's trial is the first case chosen by Merck. His case is a category 4 because he started taking Vioxx six months after the heart attack warning was added to the label. As the trial was ready to begin, lawyers for the plaintiffs accused Merck of trying to sweeten the jury pool with an adverting campaign aimed at making people think better of the company. "Merck is going around the back door, hoping to get folks to forget about this killer drug and, instead, think a bunch of nice warm thoughts about the company that manufactures it," said Vioxx steering committee spokesman, Russ Herman, in a news release. The first Vioxx trial took place a little over a year ago, and on August 19, 2005, a Texas jury awarded $24 million in actual damages, plus $229 million in punitive damages, to the widow of Robert Ernst, a Vioxx user who died suddenly in May 2001 at age 59, after taking Vioxx for 8 months. Company documents and emails revealed at the trial showed that Merck was aware of the cardiovascular risks (CV) of Vioxx as early as 1997. Attorney, Mark Lanier, presented jurors with one 1997 email that read: "The possibility of increased C.V. events is of great concern," said Merck scientist, Dr Alise Reicin. "I just can't wait to be the one to present those results to senior management," she added. The jury also saw a "Dear Doctor" letter from 2001, in which Merck told physcians that in the largest trial ever of more than 4000 Vioxx patients, only 0.5% or 20 patients, suffered cardiovascular events, when in fact, the jury learned, 14.6% or 590 patients experienced cardiovascular problems. The jury also learned that in April 2001, Dr Brent Wallace, the doctor who prescribed the Vioxx to Mr Ernst, had received the "Dear Doctor" letter with the grossly understated statistics. Mr Lanier also presented documents to the jury to show that Merck sales reps had at one time earned a $2,000 bonus if one of their doctor-clients prescribed Vioxx to their patients more than 55% of the time, and also earned another $2,000 if the rate went higher than 61% Members of the jury were shown a training document that instructed sales reps to play "Dodgeball," to avoid answering questions if doctors tried to discuss the cardiovascular risks. In a training video played at trial, Merck told sales reps that Vioxx did not increase the risk of heart attacks. To demonstrate how Merck used intimidation tactics to silence medical researchers who spoke out about the risks associated with Vioxx, Mr Lanier presented the jury with a copy of a January 2001, letter from Stanford Medical School professor, Dr James Fries, written to then Merck CEO, Ray Gilmartin, that described how Merck researcher, Dr Louis Sherwood, called Dr Fries to try and get him to make another Stanford professor stop making negative comments about Vioxx during college lectures. According to Dr Fries in the letter, Dr Sherwood warned that if the professor did not stop, he would "flame out" and "there would be consequences for myself and Stanford." After listening to all the evidence, the panel of five women and seven men ruled that Merck failed to warn doctors of the dangers of Vioxx, that the drug was improperly designed, and that Merck's negligence caused Mr Ernst's death. Upon learning of the verdict, Texas Attorney General, Greg Abbott, who has sued Merck on behalf of the state's Medicaid program, told reporters that the verdict "validates why my office brought suit against this company in the first place." "The jury concluded," Mr Abbott, stated, "that the untimely death of Mr. Robert Ernst was the direct result of his taking Vioxx." "The verdict also shows why Texas deserves to get its money back from Merck; the company purposely peddled a drug on the open market that it knew could harm people," he said. "Merck compounded this problem by giving false information to the state's Medicaid program about the drug's safety," Mr Abbott in Consumer Affairs.com, August 19, 2005. The jurors told the Wall Street Journal at the time, that it took them less than one hour to dismiss the claim that Vioxx was not responsible for Mr Ernst's death and that they were outraged by what they saw as Merck's cover-up of the risks associated with Vioxx. A factor that largely swayed the jury was Merck's failure to add a warning for patients on the Vioxx label, even after the company began warning doctors that the drug could be linked to CVs. Juror, David Webb said during an interview on Good Morning America on August 20, 2005, "$229 million was the amount of money that Merck would gain if they put off changing the label." On the August 19, 2005, edition of CNN's Newsnight, juror Rhonda Wade echoed Mr Webb. "Our award," she said, "was based on the fact that once they figured out they had no choice but to make the label change, they chose to stall it in order to make as much as $229 million." "Looking through their evidence," she stated, "time after time, you could see where they knew about the CV events and how important it was and they didn't do anything about it." "That's what made up my mind," Ms Wade told CNN. Under Texas law, the punitive damage award in the Ernst case will be cut substantially and Merck has announced its intention to appeal the verdict. In the next trial, on November 3, 2005, Merck won a favorable verdict when a New Jersey jury found the company was not liable for the non-fatal heart attack in 2001,of Federick Humeston, a Boise, Idaho postal carrier who had taken Vioxx for about two months. Mr Humeston alleged that his use of Vioxx caused a blood clot to form in his leg, which in turn caused his heart attack. The New Jersey jury disagreed. However, in August 2006, New Jersey Judge, Carol Higbee, threw out the verdict that favored Merck and ordered a new trial based on new evidence involving allegations made in the December 2005, New England Journal of Medicine, that said Merck had deleted data about 3 heart attacks among patients who had participated in the Vioxx VIGOR trial. The original and incorrectly stated results of the VIGOR trial were published in the same medical journal in 2000. On August 17, 2006, the Seeger Weiss LLP law firm announced in a press release that the verdict in favor of Merck had been vacated after oral argument in the New Jersey Superior Court. "The Honorable Carol E. Higbee ruled that the November 2005 trial verdict should be vacated on various grounds," Seeger Wiess said in the press release, "including findings by the New England Journal of Medicine that Merck had failed to report material cardiovascular safety data in connection with the publication of its landmark Vioxx clinical study know as Vigor." "The judge's ruling," Seeger Weiss said, "nullifies the verdict for all purposes, and will allow plaintiff, Frederick "Mike" Humeston, a new day in court." Seeger Weiss partners Christopher Seeger and David Buchanan argued the vacatur motion at the hearing. In response to the decision, Mr Seeger stated: "It was difficult for our trial team to hear Merck's witnesses repeatedly distort the truth about the Vigor study results." "The judge's ruling today," he said, "corrects just the latest injustice committed on the entire Humeston family by Merck and ratifies the proper functioning of the judicial process." This is not good news for Merck's legal defense team because since the conclusion of the first trial, even more studies have surfaced that show the risks associated with Vioxx can occur almost as soon as a person starts taking the drug. According to a study by Canadian researchers, Vioxx can raise the risk of heart attacks in less than two weeks. The researchers found that over 25% of 239 elderly patients who had heart attacks while using Vioxx, did so within six to 13 days, according to the study published online on May 2, 2006, by the Canadian Medical Association Journal And there is more bad news for the Merck team from researchers at the University of Newcastle in Australia in a study released this month, which determined that the heart attack risks are most pronounced in the first month after patients begin taking Vioxx. A second study that was also released this month by researchers at Harvard School of Public Health, Brigham and Women's Hospital and Harvard Medical School, based on 114 trials involving more than 116,000 patients, found a 2.9-fold increased risk for arrhythmia with Vioxx users, a 43% increased risk of peripheral edema (swelling of the arms and legs), a 55% increased risk of hypertension, and a 2.3-fold increased risk of adverse kidney events in Vioxx users. The latter two studies will be published in the October 4, 2006 print edition of the Journal of the American Medical Association, but were released online a month ahead of publication. The research also confirms that low doses of Vioxx increases the risk of heart attack and in some cases, within 30 days of starting the pills. Merck's main argument from day one has been that the heart risk does not occur until people are on Vioxx for 18 months. "It is clear that Vioxx increases the risk of heart attack. And that increase in risk begins with the first tablet a patient takes," said Dr David Graham, associate director for science in the Office of Drug Safety at the FDA, in an editorial accompanying the online JAMA studies. "For tens of thousands of patients who experienced MI (myocardial infarction) while taking (Vioxx)," he said, "the drug may have been the decisive risk factor, over and above any other risk factors, that contributed to the occurrence of this life changing and potentially fatal event." In the editorial, Dr Graham also points the finger of blame for the Vioxx disaster at the FDA. "In this case," he wrote, "they knew before the drug came on the market that Vioxx increased the risk of heart attack." This past spring, much to the dismay of Merck's legal team, Vioxx plaintiffs subpoenaed Dr Graham's testimony as an expert witness, and his deposition testimony is expected to used in several Vioxx lawsuits. A mistrial was declared in the first federal Vioxx trial to go to a jury, on December 12, 2005, when the panel was unable to reach a verdict after three days of deliberations. The lawsuit was filed on behalf of the widow of Richard Irvin, a Florida man who died of a heart attack in 2001, after using Vioxx for about one month. According to a court decision filed in the case on February 2, 2006, Mr Irvin was a 53-year-old man with severe lower back and hip pain, weighed approximately 230 lbs, and was 6' tall. On April 9, 2001, he asked his son-in-law, an emergency room physician, to give him something for pain. He gave Mr Irvin a prescription for Vicoprofen and Methocarbrnol, which he was unable to tolerate because it produced severe nausea and vomiting and provided no significant pain relief. Subsequently, Mr Irvin received some samples of Vioxx from a friend and it reduced his pain. On April 15, 2001, he contacted his son-in-law and requested a prescription for Vioxx and the prescription for 30 tablets was filled on April 22, 2001. Less than a month later, on May 15, 2001, Mr Irvin suffered a heart attack at work. Extensive resuscitative efforts were carried out but were unsuccessful, and according to court documents, Mr Irvin was pronounced dead at 9:02 am on May 15, 2001. Mr Irvin's wife, Evelyn, brought the lawsuit against on behalf of herself and Mr Irvin's two minor children, alleging that Vioxx was a defective product, that Merck knew Vioxx was defective, and failed to adequately warn Mr Irvin. Merck argued that none of the tests specifically showed that Vioxx ingested for less than a month can increase the risk of adverse cardiovascular events. The jury could not agree on a verdict and a mistrial was declared. On February 17, 2006, after sitting through a retrial, a New Orleans jury ruled in favor of Merck The next trial was held in New Jersey. On April 5, 2006, the jury held Merck liable for the heart attack of 77-year-old John McDarby, and awarded Mr McDarby $4.5 million in compensatory damages based on Merck's failure to properly warn of Vioxx safety risks. After a hearing on April 11, 2006, the jury also awarded Mr McDarby an additional $9 million in punitive damages. The same jury found Merck not liable for the heart attack of 60-year-old Thomas Cona, a second plaintiff in the trial. Mr McDarby had suffered a heart attack on April 15, 2004, and subsequently broke his hip when he collapsed. He sought compensatory damages for both the heart attack and hip fracture. While Merck attorneys tried to argue that Mr McDarby was an ex-smoker and had pre-existing conditions such as diabetes, his attorney countered by arguing that Merck was negligent in not telling physicians not to prescribe Vioxx to patients with Mr McDarby's risk factors. During the trial, the plaintiffs' attorneys, Robert Gordon and Mark Lanier, argued that Vioxx was put on the market without adequate testing and that Merck ignored warning signs about the drug's safety. They told the jury that Merck failed to inform federal regulators of the dangers of Vioxx, and spent hundreds of millions of dollars marketing a drug that the company knew was unsafe. While the jury found that Vioxx did not play a role in Mr Cona's heart attack, it did find that Merck was guilty of violating New Jersey's consumer fraud statute, and awarded $3,969 to Mr McDarby and $45 to Mr Cona on that claim. The jury said Merck deceived doctors about Vioxx's cardiovascular risks, and deliberately concealed information about those risks from physicians. Because the jury found consumer fraud in both cases, under New Jersey law, the plaintiffs were entitled to reasonable attorneys' fees, and the attorneys for the two plaintiffs have requested combined fees and costs of more than $5 million related to the prosecution of the fraud claim. At the next trial in Texas, on April 21, 2006, by a vote of 10 to 2, after deliberating for about 8 hours over 2 days, a state court jury found Merck liable for the fatal heart attack of a 71 year-old retiree, Leonel Garza, who had used Vioxx for less than one month prior to his death. Merck attorney, Richard Josephson, told reporters that the judge should have dismissed the case before it reached a jury because Mr Garza had many preexisting risk factors and the plaintiff's attorney had provided no scientific evidence to prove that Vioxx had caused Mr Garza's heart attack. The family's attorney, Joe Escobedo, said Vioxx was especially dangerous to Mr Garza because of his other risk factors. "Mr. Garza was the last person in the world that should have been taking Vioxx," he said. Mr Escobedo told the jury that Merck had known since 2000 that the drug posed heart risks but continued to sell it for four more years. The jury awarded Mr Garza's family $7 million in compensatory damages and another $25 million in punitive damages. Under Texas law, the punitive damage award will be reduced to $750,000. "We're really pleased," Mr Escobedo told reporters. "We thought that Mr. Garza's case was a very, very strong case." Since |
