Plaintiff paradise waits for Vioxx trial

Leonel Garza was 71 when he died of a heart attack, 23 years after being diagnosed with heart disease and decades after a heart attack and a quadruple bypass.
But his lawyers who are suing Merck & Co. say it was the Vioxx that he took for arm pain for 17 days that killed him. Jury selection is scheduled to begin Tuesday in Rio Grande City, a town of about 12,000 people less than five miles from the Texas-Mexico border.
Even though the New Jersey pharmaceutical giant is facing hundreds of lawsuits from people who took the once-popular painkiller before it was pulled from the market, Garza's case would have little hope of making it to trial anywhere but the Rio Grande Valley, some legal experts say.
"What you're seeing is a case that is strong in the merits for Merck but has got to be balanced on the challenges Merck will face in that jurisdiction," said Peter Bicks, a New York City lawyer who has successfully defended large companies in Texas and has been watching the Vioxx litigation. "This jurisdiction has been viewed as one of the toughest jurisdictions for corporate defendants in the country."
But Leila Watson, a Birmingham, Ala., plaintiff attorney with about 70 Vioxx cases, said Garza was "exactly the kind of patient there should have been a warning for."
"Nobody should have given this patient Vioxx, and I don't fault the doctors," she said.
The Valley is a known prize for "venue shopping" by trial lawyers looking for large verdicts from sympathetic jurors, said Bill Summers, president of the Rio Grande Valley Citizens Against Lawsuit Abuse.
"If the company they're suing has even a remote tie to the Valley they want to come here, because they think they can get a better deal," Summers said.
The Valley became the national poster child for the costs of lawsuit abuse in April 2002, when hundreds of doctors closed their offices to protest insurance premiums that had quadrupled in a few years because of the high number of medical malpractice lawsuits.
Doctors began to leave the region in such numbers that some specialties were unavailable to the more than 1 million people who live there.
"Many courts in other counties would toss this case because of the standard that no reasonable juror could find for the plaintiff in this situation," said Victor Schwartz, counsel to the American Tort Reform Association. "It's been our experience that many of the courts in the Rio Grande Valley are very, very friendly to plaintiffs' counsel and let cases go forward."
The ATRA named the overwhelmingly Mexican-American region at the bottom of Texas Rio Grande Valley the nation's top "judicial hellhole" for 2005, a distinction it gives to places where judges uphold "extraordinary" jury awards and seem to favor plaintiffs over defendants.
Bicks said Merck's biggest challenge likely would be with jury selection, when defense attorneys can ferret out jurors who may have a bias against big business.
He cautioned that Merck's argument that Garza didn't take the drug long enough to suffer any heart damage hasn't been the slam dunk Merck might have hoped for.
"From a tactical standpoint a plaintiff may have decided this case isn't worth a pursuing in another jurisdiction," he added. "But from a legal standpoint these cases so far have survived."
Merck & Co. withdrew Vioxx from the market in September 2004 when a study showed it could double risk of heart attack or stroke if taken for 18 months or longer. However, it says no such risk has been shown for shorter periods.
According to Garza's lawyers, Garza was given Vioxx on April 4, 2001, and suffered a fatal heart attack 17 days later. Merck said he was given a week's supply; the plaintiff's lawyer has said it was a month's worth of the drug.
"I'm not aware of any good scientific data, even if you accepted everything plaintiffs say, to show a risk in the time frame in this case," Merck lawyer Richard Josephson said.
The FDA decided in April 2005 that there doesn't appear to be an elevated risk of heart attacks from taking Vioxx for short periods.
Plaintiff attorney Joe Escobedo, who is seeking unspecified damages for Garza's family, did not return calls for comment on the case.
But in other media reports, he has criticized the defense team for a delay tactic that is not unusual in the Valley, in which local state representatives are hired on to the team so that the case cannot open until the close of the biennial legislative session in Austin.
Last January, state Sen. Juan "Chuy" Hinojosa, D-McAllen, joined the defense for one day. He withdrew from the case the next day, saying he didn't know Merck planned to file a continuance.
Hinojosa has gotten bad press before for joining defense teams in high-profile cases, including the first rollover case against Bridgestone/Firestone Inc. to go to trial, in McAllen, in 2001.
Merck quickly hired Rep. Rene Oliveira, D-Brownsville, and filed a second legislative continuance.
Josephson, heading the defense team, said Oliveira has been playing an active role in the case.

Recovering from a bad case of PR

Everyone agrees that Celebrex and Vioxx were great brands. They told a compelling story of how astute science brought relief to millions of patients. The competition between these two cox-2 brands simply added a bit of extra tension to the tale.
"From a pharmaceutical marketing perspective it was beautiful," admits Mike Rea, managing director of IdeaPharma, a pharmaceutical marketing firm. "This was a market waiting for a brand. The audience was sold something they didn't need but definitely really wanted. It was more than a side effect that all but killed the drugs."As far as branding is concerned, Vioxx and Celebrex both did a great job," Rea continues. "They both talked up the selectivity and how they avoided the side effects of other NSAIDS. The world believed that cox-2s were safer. And while they were talking about the GI [gastrointestinal] safety, they were not talking about the cardiovascular safety profile."According to Rea, the side effects profiles of the cox-2s were more or less the same as for older non-steroidal anti-inflammatory drugs (NSAIDS) -- only the incidence of severe side effects was lower. Furthermore, much cardiovascular safety data was also in the public domain. "But these were brands, not products," he says. "I reckon physicians would probably have still prescribed these products. I'm not sure the world was looking with open eyes."Merck and Pfizer's actions are something for the courts to decide. However, concerns about the cardiovascular safety of the cox-2s were being raised in medical publications as early as 2001. Rumors grew, concerns were voiced. Then on 30 September 2004, Merck announced that, following the analysis of three-year's worth of data in a post-marketing study, Vioxx would be voluntarily withdrawn worldwide.All hell broke out. Merck shares immediately plunged 30 percent. Other cox-2s fell under the spotlight. In December 2004 a clinical trial showed an increased risk in cardiovascular events for patients taking Pfizer's Celebrex, and the fear of a class effect from cox-2 products spread. The panic even reached non-cox-2 anti-inflammatory painkillers; trials were stopped because of a perceived increase in risk."This is one of the problems with branding," admits Jon Parton, global director of branding at pharmaceutical company AstraZeneca. "The pessimist says you shouldn't do global branding, because if it goes wrong it goes down big-style everywhere. But my belief is that you plan for success. If you have a problem you own up to it."This is a good lesson to learn, but a hard one to implement when it comes to the crunch. David Wood, chairman of Interbrand Wood Healthcare, a healthcare consultancy, says that the companies were understandably cautious in their reaction to the safety concerns. "They were slow at first. They seemed a bit more defensive, with companies assuring that their products didn't have the safety issues that were claimed. Then there appeared to be attempts to justify along the lines of 'We are doing all we can to ensure the safety of patients.' Announcements of withdrawals followed (Vioxx and then Bextra). It almost seemed as if companies were waiting to see what the competition was doing first before taking steps to withdraw."Of course, the decision to withdraw a product with annual sales of over $2 billion and a flagship brand is not made lightly or quickly. "These were enormously important, and profitable, products for each of these companies, each of which had been approved by the regulatory authorities, so quite understandably they were not going to be withdrawn easily nor without adequate evidence," says Wood."There is probably no ideal way to pull a product for safety reasons," Wood continues. "The product brand is probably scarred forever, and the corporate brand is obviously severely impacted as well. Clearly in this case Merck is continuing to suffer far more than Pfizer, since Bextra was only available through hospitals, and consequently was little known by the public at large, while Vioxx was a very high-visibility, 'public' brand."IdeaPharma's Rea believes that the situation could have been handled much better, however, and some of the corporate damage could have been avoided. "Merck acted more like Perrier did when traces of benzene were found in its water," he says. "First it denied everything, then had to keep backtracking. Sure, Merck was unlucky to have the more 'dangerous' drug, but it always seemed to be forced into communication. And the actual withdrawal was particularly badly handled?it was almost an admission of guilt in the first place." Companies should look like they are always in control. "The people who should know most about a drug is the manufacturer," Rea says. "[B]eing forced into the open by statements and data from others looks bad. Instead you need to be in front of the curve of knowledge. Pfizer seemed to be better at stating publicly the facts of research and being on the front foot by offering analyses. Pfizer seemed to know what was going on."AstraZeneca's Parton says that honesty and openness are the only options for long-term success. "If Pfizer or Merck are shown to have misled deliberately then no one will trust the company anymore, and that would affect all other brands. It is good business to be ethical. It is not in our interests to by sly and crooked. Otherwise you end up like Enron. We are not whiter than white, but being honest is best for business."Wood agrees and suggests that product brands should have a strategy for handling such events -- including their own withdrawal. His advice is to "be ready, have a plan, be open and honest, and reinforce the parent brand by being smart and responsible. Step one is to recognize that there is always the potential for issues because we work in a very difficult industry. And the fact is that no amount of clinical trial testing can truly and adequately simulate actual years in the marketplace. Also learn that safety is the number one issue for society and that is what corporate brands need to stand for. Safety and responsibility."This is the kind of situation in which whatever you've been saying about yourself, and having your corporate brand stand for, must be mirrored in your actions," Wood continues. "Merck has long held a reputation of strong ethical responsibility with its consumers and customers, represented by their 'people before profits' mantra.? However, their lack of fast action, and demonstrated commitment to doing the right thing, were doubtless seen to run counter to the kinds of statements they had been making about themselves."Rea also notes that Merck tended to respond to developments as Merck, whereas Celebrex often came out with Celebrex press statements. "By responding badly you affect how you go forward as a company. It is not just Vioxx but Merck that is damaged now. On the other hand Pfizer has lost Bextra and may lose Celebrex, but we probably won't lose Pfizer."Wood, in contrast, suggests that such major issues should be given adequate attention from top management. "The companies could probably have used their corporate brand and top management to much better effect. The standard in handling this kind of event was set by J&J and McNeil years ago during the Tylenol poisoning, when the chairman took personal responsibility, acted fast, and communicated openly and fully with all relevant constituencies. Unfortunately top management of both companies was largely silent on this occasion," he continues, referring to Merck and Pfizer.The advice all sounds obvious, really: good behavior gets results. But does it really make much difference? Rea admits that, as with a lot of branding, it is difficult to measure, but he does think that the contrasting situations of Pfizer and Merck today may stem from their handling of the cox-2 catastrophe. Appropriate and "on brand" behavior, even in a crisis, may be enough to make the difference between failure or survival. In this case, it may have influenced the FDA's decisions when it reviewed all the cox-2 data in February 2005. "The panel was very split. It is difficult to say that the final decision was due to a difference in the molecules or marketing, but it could be a bit of both," says Rea. "Not everyone agreed that the risk profile of Celebrex was okay to leave it on the market. But maybe Pfizer just looked a bit more credible and a few votes were swayed in its favor."Nevertheless, whether Merck or Pfizer comes out of this affair intact, it has had a devastating effect on the credibility of the pharmaceutical industry as a whole. No matter how well a pharma company manages its brand, chances are its reputation will still rank lower than most tobacco companies. "It's not just the responsibility of individual companies -- the industry as a whole must make a more concerted effort to not simply counter negative publicity, but to tell its story to a public that frankly knows very little about the realities of the [...] industry," states Wood. "We need to be careful about demonizing an industry, which, ultimately, is about improving and saving human lives. But the industry must start helping itself, and these recent events have served only to set it back."

In the Pharmaceutical Industry the Pain Drug Market is Expected to Be Worth $25 Billion over the Next Few Years.

Research and Markets (http://www.researchandmarkets.com/reports/c31301) has announced the addition of Pain Drugs: Problems and Opportunities to their offering.
Pain is one of the largest pharmaceutical markets, forecast to reach $25 billion in the next few years, but it has also been plagued by problems including the failure of Vioxx and Celebrex. This report examines the nature of pain, what went wrong with the COX-2 inhibitors, and the alternative approaches and drugs that may fill the resulting void.
Pain comes in many forms and treatments range from non-drug therapies like psychological, surgical and neurostimulus, to analgesics, opiods and even cannabinoids. This report explores these various methods and identifies drugs currently on the market or under development that may replace the COX-2 inhibitors.
Reasons to Purchase
-- Understand the nature of pain and why it is a therapeutic challenge
-- Identify the companies and the drugs and treatment protocols that are poised to replace the void left by the failure of COX-2 inhibitors
-- Analyze the competitive landscape of the $25 billion pain market
Target Audience
-- Business development execs/managers seeking partnership opportunities
-- Marketing and senior execs/managers wishing to understand the competitive landscape
-- Research and development execs/managers wanting to know the current state-of-the-art
-- Venture capitalists and fund managers seeking investments
-- Analysts and journalists researching the market for treating pain
-- Others seeking to understand the driving factors and market dynamics
Drugs Mentioned
-- Carbex
-- Celebrex
-- Codeine
-- Imitrex
-- Luvox
-- Marplan
-- Nardil
-- Neurontin
-- OxyContin
-- Parnate
-- Paxil
-- Prozac
-- Topamax
-- Tylenol/Acetaminophen
-- Vicodin
-- Vioxx
-- - Xyrem
-- Zarontin
-- Zoloft
-- Zomig
Topics Covered
Introduction
The Nature of Pain
Pain's Many Forms
-- Acute Pain
-- Internal Organs
-- Migraine Headache
-- Cluster Headache
-- Chronic Pain
-- Neuropathic Pain and Cancer Pain
-- Phantom Limb Pain and Other Manifestations
Treatment - Non-drug
-- Psychological
-- Local and Regional Methods
-- Surgery
-- Sympathetic Blockade
-- Neurostimulatory Methods
-- Anesthesia Pumps
Treatment - Drugs
-- Non-opioid (non-narcotic) Analgesics
-- Opioids (narcotics)
-- Tranquilizers
Non-painkiller Drugs
-- Anti-epileptics
-- Antidepressants
-- Cannabinoids
Companies Mentioned
Abbott
Pfizer
Purdue
Merck
Medtronic
Janssen-Cilag
Johnson & Johnson
Takeda
For more information visit http://www.researchandmarkets.com/reports/c31301

Vioxx: Showdown in Rio Grande

NEW YORK (CNNMoney.com) - The Garza family faces off against Merck this week in a Texas border town, in the fourth lawsuit to blame Vioxx, the market-pulled painkiller, for causing heart attacks.
The family of Leonel Garza, 71, sued Merck and blames Vioxx for Garza's fatal heart attack in 2001. Jury selection begins on Tuesday, at a state court in Rio Grande City, a town of 12,000 in Starr County near the border with Mexico. Judge Alex Galbert will preside over the case, held in 229th judicial district court.
Nearly 10,000 lawsuits have been filed against Merck, following the withdrawal of Vioxx from the market on Sept. 30, 2004. Merck (down $0.19 to $33.06, Research), based in Whitehouse Station, N.J., pulled Vioxx, an arthritis painkiller, off the market after a study showed an increased risk of heart attacks and strokes in patients using the drug for at least 18 months.
Garza was given a one-week supply of Vioxx 25 mg samples for pain in his arm about one month before his death on April 21, 2001, according to Merck. Merck also said that Garza had a 23-year history of heart disease and had survived one heart attack prior to taking Vioxx.
Ted Mayer of Hughes, Hubbard & Reed, outside counsel for Merck, said in a recent press release that "there is no reliable scientific evidence that Vioxx caused Mr. Garza's heart attack. At the time of Mr. Garza's heart attack, he exhibited numerous major risk factors for coronary artery disease."
Repeated calls for comment by CNNMoney were not returned by Hockema, Tippit & Escobedo, the Texas firm representing the Garza family.
This will be the third trial to be held in Texas, and its outcome could be seen as a tie-breaker in the ongoing series of suits against Merck.
The most recent trial, the Plunkett v. Merck wrongful death case, ended in a hung jury on Dec. 13, 2005 in a federal court in Houston under U.S. District Court Judge Eldon Fallon, has been scheduled for retrial on Feb. 6. The retrial is scheduled to begin on Feb. 6 in New Orleans, the original seat of Fallon's court before it was displaced by the destruction of Hurricane Katrina.
Evelyn Irvin Plunkett of St. Augustine, Fla., sued Merck for the 2001 death of her husband Richard Irvin, who took the drug for one month before his fatal heart attack. The jury was unable to reach a verdict. Right after the non-sequestered jury began deliberations, the New England Journal of Medicine published an editorial reporting that Merck had deleted information regarding Vioxx-related deaths from a study it provided to the journal in 2000. Merck denied the claim, but plaintiff lawyer Jere Beasley said it undermines the credibility of Merck's key witness Alise Reicin, the company's vice president of clinical research.
Merck lost its first Vioxx case in Texas state court, but won the second case in its home state of New Jersey.

Vioxx suit contends death a 'reaction'

RIO GRANDE CITY - Attorneys for the family of 71-year-old man argued Wednesday that his fatal 2001 heart attack was a sudden reaction to Merck & Co.'s painkiller Vioxx and not the result of 23 years of heart disease.
Joe Escobedo, the Leonel Garza family attorney, said in his opening statement that Garza was told after a stress test shortly before he died that he had a less than 2 percent chance of dying of a heart attack within a year.
"Vioxx caused Mr. Garza's death," Escobedo said. "Mr. Garza did have [cardiovascular] risk factors, but they were under control."
The suit was filed against the drug's maker by relatives of Garza, of Rio Grande City. He suffered a fatal heart attack in 2001, and the jury may ultimately decide if that was the result of 23 years of heart disease or the Vioxx he took for arm pain the 17 days before he died.
Garza's attorneys are seeking $1 billion in punitive damages from Merck.

Federal court releases medical journal e-mails over Vioxx study

NEW ORLEANS -- In the world of scientific research, the language was strong stuff. "Your explanation lacked scientific objectivity," an editor for the New England Journal of Medicine wrote to a researcher whose study, published in 2000, has become a major focus of federal and state lawsuits involving the painkiller Vioxx.

"That's pretty serious. That's pretty serious," Dr. Mark Frankel, director of the Scientific Freedom, Responsibility and Law program at the American Association for the Advancement of Science, said Wednesday. Researchers are expected to be utterly impartial. "This is serious criticism. Obviously, this case has implications far beyond the journal," Frankel said. He said he is looking forward to reading the researchers' response. Dr. Claire Bombardier, the lead researcher from the University of Toronto, has sent a response to the journal, and the university will comment once it is published, university spokesman Steven de Sousa said Wednesday. A brief statement from the journal said communications with authors are confidential. "Once our concerns have been fully pursued and answered, we will publish the results," it said. The e-mail from its executive editor, Dr. Gregory D. Curfman, was released Tuesday by U.S. District Judge Eldon Fallon, who is in charge of pretrial matters for all 4,050 federal lawsuits against manufacturer Merck & Co. Another 5,150 cases have been filed in state courts, many of them in New Jersey. So far, the jury message has been mixed. A Texas state court awarded $253 million in damages, though state law will cut that to at most $26.1 million. A New Jersey state court absolved Merck. The first federal trial ended with a jury hung 8-1 in Merck's favor, and will be retried starting Feb. 6 in New Orleans. In all three trials, each side has cited Bombardier's study, called VIGOR, as proving its point about whether Merck promptly disclosed the drug's cardiac risks. But while the federal jury was deliberating whether Merck was responsible for Richard Irvin's death in Florida, the New England Journal of Medicine published an editorial criticizing researchers for leaving out critical data from the VIGOR report. Lawyers for Irvin's widow have said the editorial bolsters their claims that Merck hid the drug's dangers. The company pulled the drug in 2004, after another study found that taking it for at least 18 months doubles the risk of heart attacks. Kent Jarrell, a spokesman for Merck's attorneys, repeated earlier statements: nothing was hidden; the heart attacks occurred after a study cut-off date; and the Food and Drug Administration had all of the data before the study was published. Attorneys for the company questioned Curfman on Tuesday. "We are prepared when that issue comes up in any trial to explain what happened and how we believe that everything was done properly by Merck," Jarrell said Wednesday. In his e-mail to the VIGOR study's lead author, Curfman listed five points which the journal expects the authors to make in a correction. One was omission of three heart attacks from the data; another that including them "would have invalidated your claim" that only people already at risk of a heart attack were at a greater risk from Vioxx. The article doesn't mention a cut-off date for reporting heart attacks, Curfman wrote, and even if it had, NEJM and other journals expect updates. "This is especially important for a potentially serious drug adverse effect" such as a heart attack, he wrote. Curfman's comment about lack of objectivity came in a written discussion of the study's statement that people taking naproxen had one-quarter as many heart attacks as those on Vioxx because naproxen protects the heart. It should have noted the flip side _ the possibility that Vioxx might be harmful, Curfman wrote. "The relative risks were presented so as to favor naproxen and discount the possibility that rofecoxib might be harmful."