Plaintiffs’ attorneys are predicting that Merck & Co.’s recall of its popular arthritis medication Vioxx will significantly enhance their odds of convincing jurors that the popular arthritis medication caused their clients’ heart attacks and strokes.
The pharmaceutical giant’s Sept. 30 announcement that it’s taking Vioxx off the market has opened the floodgates to thousands of lawsuits throughout the nation.
“I think the litigation will certainly increase,” said Andy Birchfield, a Montgomery, Ala. plaintiffs’ attorney who has filed 58 Vioxx suits in Alabama, Florida, Georgia, Mississippi, New Jersey and Virginia.
While the number of Vioxx suits may not reach the magnitude of such mass torts as the claims over the diet drug combination fen-phen, the damages awarded to individual Vioxx plaintiffs may be more significant because of the severity of injuries caused by the arthritis drug, according to several plaintiffs’ lawyers.
“You’re talking about heart attacks and strokes,” Birchfield said.
In contrast, many fen-phen claims resulted in minor damages of $6,000 or less.
Merck had already been hit with hundreds of lawsuits prior to the recall, including 150 suits filed in New Jersey, where its headquarters is located.
Houston personal injury attorney Mark Lanier predicted that if early trials produce favorable plaintiffs’ verdicts, the amount of litigation will dramatically increase.
“At the first positive verdict, expect many more to be filed,” he said.
Lanier said that it’s hard to put personal injury cases into a class because of the unique damages of each plaintiff. But Carlene Lewis, a Houston attorney whose firm has filed 300 cases in Texas, said that because of the volume of litigation, it’s likely that Vioxx lawsuits will be consolidated at some point into a multi-district litigation.
Merck’s decision to pull Vioxx off the shelf followed the release of a new clinical trial that found patients taking a low dose of Vioxx for 18 months were twice as likely to have a heart attack or stroke as patients taking a placebo.
The company estimates that about 20 million U.S. patients have taken Vioxx since its introduction in 1999.
Vioxx is among a class of drugs called COX-2 inhibitors that are among the newest non-steroid anti-inflammatory drugs. Lanier said that other COX-2 inhibitors, such as Celebrex, have so far not been shown to have the same negative cardiovascular effects as Vioxx.
Eliminating A Hurdle
The recall “will certainly help from the plaintiffs’ perspective,” said Birchfield. “More people have heard Vioxx has been pulled off the market, and that there were safety concerns. If it had not been pulled off the market, that’s a big hurdle for plaintiffs to overcome.”
Birchfield is representing a plaintiff in the first Vioxx case headed for trial. Scheduled to be heard in December in U.S. District Court in Alabama, the suit was filed by William Cook, a 50-year-old retired miner who suffered from joint problems. Cook began taking Vioxx in 1999, and suffered a heart attack a year later.
Birchfield said his client did not have a history of heart problems.
“Vioxx is a dangerous drug. The risk outweighed the benefits. Merck knew this and kept it on the market,” he alleged. “Sales took precedence.”
Lewis said the recall “will help all of our cases with regard to general causation. It confirms the position we’ve taken all along – that Vioxx causes myocardial infarctions.”
According to Richard Gabriel, president of Decision Analysis, a Los Angeles trial-consulting firm, Merck’s recall “will have a significant effect in jury selection.”
“Jurors look for concessions that are made about liability. They could very easily see this as a type of concession of [Merck's] liability,” he said.
The lawsuits accuse Merck of knowingly marketing a defective product, and of failing to properly warn the public about its risks.
“Vioxx has bad cardio effects on people,” Lanier said. “It increases the risks of heart attacks, raises blood pressure and increases stroke risks. Merck knew this [and] hid this.”
Until the latest study was released, Merck had consistently denied a link between Vioxx and an increased risk of heart attack and stroke.
Early Verdicts Significant
Several plaintiffs’ attorneys said they will closely follow early Vioxx trials to see what defense Merck mounts, and how generous jurors are in awarding damages.
“If past history in this sort of litigation is true, the first cases are significant,” Lewis said.
In a case headed for trial in early spring in U.S. District Court in Texas, Lewis and Lanier are representing Keith Stubblefield, a 37-year-old man who died of a heart attack after taking Vioxx for about a month for back pain.
Gabriel agreed that plaintiffs’ attorneys would be scrutinizing early verdicts as an indicator of the size of settlements in later cases. If those first juries return either defense verdicts or award only minor damages, this won’t bode well for future claims.
Gabriel noted that in a similar scenario, Bayer voluntarily removed Baycol – an anti-cholesterol drug – from the market in 2001. The first verdict was in favor of the defense, and as a result, “a lot of the settlements in the Baycol case were a lot lower” than plaintiffs had hoped for, he said.
Merck has refused to discuss its defense strategy. But company spokesman Tony Plohoros said that the company “continues to believe that it has strong and meritorious defenses to lawsuits brought against it.”
Drug product liability cases pose unique challenges for both defendants and plaintiffs, according to experts.
For example, Gabriel said, many people are biased against pharmaceutical companies even without knowing the particulars of a case. Jurors may believe that drug companies are so profit-obsessed they are likely to ignore or slant research showing that one of their products may be dangerous, he explained.
“It brings up the ghosts of tobacco and other products that have had significant problems,” Gabriel said. “There are a number of these attitudes that go into the mix when you’re trying to select a jury.”
But plaintiffs also have to be careful in juror selection, he said.
”In a lot of cases involving products that are consumed, jurors have . hindsight biases, and say to a plaintiff, ‘You need to show me that this particular product was the one that caused the problem,’” Gabriel said. “Once they start isolating different lifestyle factors and other health factors, sometimes you can’t pin it down.”
He said that jury selection will be interesting, because “the drug manufacturers are looking to probe people’s biases because they have these broad biases against drug manufacturers, while the plaintiffs are looking to probe jurors who have significant biases against individuals and the way they live their lives.”
Because of the role lifestyle factors can play in these kinds of cases, plaintiffs’ lawyers will need to seriously consider this issue in deciding which claims to pursue.
For example, Birchfield said that his firm screened out some potential claimants because they could not find a strong connection between Vioxx and the patients’ heart attacks.
Further, the more promising cases will involve plaintiffs with serious damages. Birchfield said that each of the 58 suits he has filed against Merck involves either a stroke or heart attack as a result of taking Vioxx.
Compounding Merck’s defense challenge is a 2001 letter from the FDA rebuking the company for a promo
tional campaign that minimized potentially serious cardiovascular problems caused by Vioxx.
As reported in The Wall Street Journal, the letter described a news release titled “Merck Confirms Favorable Cardiovascular Safety Profile of Vioxx” as “simply incomprehensible.”
This could create a problem for Merck, said Gabriel.
“If plaintiffs can say, ‘You started doing promotional literature which touted the opposite of what some of the clinical trials are showing,’ that starts to show a level of intent to the jurors, and that conscious disregard really can have a significant impact,” he said.
Merck’s response will be to “educate jurors” about how extensively it researches new drug products and how difficult it is to predict with certainty a medication’s potential side effects, he predicted.