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Merck's Mess

Oct 13, 2004 | Forbes It yanked Vioxx three years after the first studies raised safety alarms. That delay could hurt patients and shareholders alike.

On Sept 3. Newton Acker, 71, died of a stroke while on a bicycling vacation with his wife in southern France. His three grown children were stunned. Apart from his arthritis, Acker was exceptionally healthy.He had low cholesterol and low blood pressure and bicycled 5,000 miles a year. His parents had lived to age 90.

Four weeks later Merck &Co. pulled Vioxx from the market after a study showed it doubled the risk of heart attacks and stroke. "That's the answer,"Acker's son, Kenneth, an F-16 training pilot in Arizona, immediately thought. His dad had been taking Vioxx for 14 months before his death. Kenneth blames Merck for failing to act sooner and plans to sue. "We don't need the money. We just want my father back," he says.

Prominent doctors are calling for congressional investigations, and European regulators are scrutinizing the safety of similar drugs such as Pfizer's Bextra and Celebrex. Merck will be lucky to survive a legal onslaught that easily could rival the $13.3 billion in damages paid out so far by Wyeth in a far smaller drug recall, the fen-phen fiasco. "This may be the biggest drug safety catastrophe in U.S. history," says Vanderbilt epidemiologist Wayne Ray, who published a study linking high doses of Vioxx to heart attacks in 2002. Until this month "there was a solid wall of denial" from Merck, he says. "We need to investigate why the [safety] signals were ignored."

Wyeth's diet pills, Redux (dexfenfluramine) and Pondimin (fenfluramine), were taken by 6 million Americans before getting yanked off the market in 1997 because of a link to heart-valve defects. Vioxx was swallowed by 20 million patients in the U.S. in five years on the market and by some estimates caused 30,000 heart attacks. Cleveland Clinic cardiologist Eric Topol says the number of injured parties could go as high as 160,000. Merck says such extrapolations are unreliable. "The potential liability is mind-boggling," says drug industry analyst Hemant Shah. "Every person who took Vioxx and had a heart attack is a potential litigant."

Merck Chief Executive Raymond Gilmartin says that none of Merck's earlier Vioxx studies had found excess risk; as soon as that changed, the company quickly pulled the drug even though some of its own consultants advised against it. "This kind of behavior, considering only the interests of patients, should reconfirm people's confidence in the drug industry," he says.

But even before the recall more than 400 lawsuits had been filed on behalf of Vioxx patients, according to LexisNexis' "Mealey's Reports." New York law firm Parker & Waichman was flooded with 3,000 calls and e-mails in the week following the Vioxx recall. Partner Jerrold Parker says at least 20% of the calls involve very serious injury or death. Christopher Seeger, a plaintiff's lawyer in 75 Vioxx injury cases, says: "I've never had the phones ringing off the hook like this."

From the moment it hit the market in 1999, Vioxx had one vital claim: It was a safer painkiller that didn't cause ulcers as often as older drugs do. But just two years later cardiologists warned of a potential problem: Merck's own 8,000-person study, the same one that showed Vioxx reduced ulcer complications, also found that patients on the drug had more than double the risk of heart problems of those on another painkiller, naproxen (the ingredient in over-the-counter Aleve). Merck dismissed the result, insisting that the discrepancy was due to an extra heart benefit from naproxen. (Merck still contends this is the case.)

Merck touted this theory for three years--even as three epidemiological studies found evidence that Vioxx increased heart attack risk; it said the studies were unreliable and contradicted by several other studies showing no risk. Merck finally yanked Vioxx when it saw the results of its own 2,600-patient trial, aimed at showing that Vioxx had the extra benefit of preventing polyps from forming in the colon. Instead, the trial found that patients on Vioxx longer than 18 months had twice the risk of getting a heart attack or stroke of those on a placebo.

Merck's defense of the tort suits will hinge on the difficulty of proving that Vioxx was the culprit in any one heart attack, instead of smoking, cholesterol or other causes. In cases filed so far, "other risk factors were sufficient to cause the event" regardless of what medications the patients might have been taking, says a Merck lawyer.

But the uncertainty cuts both ways. What's to stop juries from blaming Vioxx for strokes and heart attacks that would have occurred anyway? And what if smoking-gun e-mails turn up that show Merck knew the risks and refused to act? asks lawyer Jay Mayesh of firm Kaye Scholer.

This case is sure to cost Merck and its insurers billions in damages and may spread a pall of legal liability over other drugmakers. For patients and Big Pharma alike, the prescription pill business is going to get ugly.

The Lawyers' Next Targets

Viotxt's withdrawal has set off a feeding frenzy among trial lawyers. These drugs could be vulnerable to lawsuits, too.

Drug Maker Global Sales 
 
Zyprexa  Eli Lilly $4.3 billion 
 
A group convened by the American Diabetes Association says the schizophrenia drug raised diabetes risk more than rival pills did. Lilly disputes this but confirms that 75 lawsuits have been filed.
Paxil  GlaxoSmithkline  $3.1 billion
 
Warnings that this antidepressant and others may be linked to suicidal thoughts in children could lead to a flurry of lawsuits alleging GSK failed to disclose the risks, which it denies.
Neurontin  Pfizer $2.7 billion 
 
In May a Pfizer subsidiary pleaded guilty and paid the feds $430 million for promoting the epilepsy drug for unapproved uses. Now injury lawyers are piling on; one potential class action has been filed. 
Prempro  Wyeth $1.3 billion
 
Almost 2,000 suits involving 3,136 women who took estrogen-replacement drugs Premarin or Prempro have been filed since big medical trials showed both raise the risk of heart attack and that Prempro raises breast cancer risk. Wyeth says Prempro's possible breast cancer risk was disclosed.
Bextra  Pfizer $990 million
 
Lawyers are scrutinizing Bextra because it is in the same class as Viotxt2. Two short-term studies in heart surgery patients hint it may raise heart risk, but Pfizer says postsurgery use was never approved. 
Accutane Roche $410 million
 
A handful of suits have been filed related to this acne drug's potential to cause birth defects and its alleged link to suicides. Roche says birth-defect links have been prominently disclosed.
Crestor AstraZeneca $130 million 
 
One case is pending in Mississippi, but the constant drumbeat about possible liver and muscle side effects from Public Citizen, an advocacy group, could lead to more. AstraZeneca insists Crestor, a cholesterol-lowering drug, is safe. Allison Fass and M.H.

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