State Vioxx Trial Is Set as Drug Suits Boom

By Lisa Girion

June 27, 2006 12 AM PT

Times Staff Writer

Stewart Grossberg soldiers into a Los Angeles courthouse this week as the latest combatant in a drug litigation war that’s made the pharmaceutical industry the nation’s No. 1 target of product liability lawsuits.

Grossberg, a retired Northridge construction manager, blames Merck & Co.’s pain reliever Vioxx for a heart attack he suffered in 2001. He is the first California plaintiff among more than 23,500 nationwide to have his suit against Merck go to trial. Opening arguments are set for today.

The Vioxx suits are part of an explosion in litigation as consumers seek damages for alleged harmful side effects from an array of drugs that critics say were aggressively sold without sufficient testing or warning.

More than 71,000 drug lawsuits have been filed in federal courts since 2001 and untold others in state courts. Such suits now account for more than a third of all product liability filings in federal courts, outnumbering asbestos, tobacco and auto safety claims by a widening margin since 2002, according to a new analysis conducted by legal research firm Thomson West for the Los Angeles Times.

The suits, which expose drug firms to billions of dollars in potential damages, could change how drugs are made and marketed. The litigation boom also is prompting calls for more tort reform and major regulatory changes aimed at improving patient safety.

Drug companies and business advocates contend that the industry is being unfairly targeted. Lay jurors, ill-equipped to parse good science from bad, cannot properly decide highly technical cases, they say. And, they argue, many of the suits are baseless anyway, drummed up by trial lawyers trying to cash in on drug companies’ deep pockets.

“It’s like a moth to the flame with trial lawyers,” said Lisa Rickard, president of the U.S. Chamber Institute for Legal Reform, a pro-business group critical of much of the litigation. “Once one gets success in one area, then they flock to it.”

The suits, however, appear to have encouraged many consumers to make more informed decisions. Traffic on clinical trial websites is picking up, and doctors report patients are coming in armed with data and sophisticated questions.

“They are thinking for themselves, and they are not accepting their physicians’ recommendations lock, stock and barrel,” said David Webster, a health industry consultant.

Juries in Vioxx trials that began last year have awarded four plaintiffs nearly $300 million, although various state damage caps are expected to reduce that total to less than $50 million.

The largest of the Vioxx jury awards so far -- $253 million -- was for Carol Ernst, a Texas widow who blamed the pain reliever for her husband’s death from heart problems.

“It’s nice to have been able to send a message to not only Merck, but the other pharmaceutical companies,” Ernst said. “But it doesn’t bring Bob back.”

The storm of litigation stems in part from fundamental changes in the pharmaceutical industry’s business practices intended to boost sales and profits, experts say. Drug makers once focused largely on potentially lifesaving medications for dreaded diseases such as cancer. Sales for such drugs are limited, but patients are more willing to accept greater risks of side effects.

But many drug makers have turned much of their attention to treatments with ready-made mass markets: people with common and chronic problems such as depression, high cholesterol, sexual dysfunction and joint pain. Since the late 1990s, drug makers also have pumped up demand by augmenting traditional sales efforts aimed at physicians with television commercials and other consumer advertising.

This business model begot the era of blockbuster drugs -- those with annual sales of $1 billion or more. They now account for more than a third of the market, drive big profits and help millions of people lead more active lives.

But by scaling up the market, they have also expanded the scope of possible harm from any one drug that gets to patients before serious side effects are understood or well known. That creates the potential for blockbuster liability, especially when the side effect is more serious than the condition that prompted the drug’s use in the first place, as is alleged in Vioxx cases.

At the same time, experts said, drugs can now get to consumers more quickly because manufacturers and advocates for patients with serious diseases persuaded regulators to allow expedited safety and efficacy reviews. Vioxx was used by 20 million people before Merck pulled it off the market in September 2004, concluding it doubled the risk of heart attacks and strokes.

“We’ve had an increase in the use of relatively untested drugs to the tune of millions and millions of people,” said Benjamin Zipursky, a Fordham University law professor. “Everybody who watched years’ worth of old guys with sore shoulders being able to play tennis again because they were taking Vioxx got up and went to their doctors and said, ‘How about I try this?’ ”

The federal docket is a barometer of litigation activity, but not a complete picture of its scope. Although more Merck plaintiffs have taken their claims to federal courts, suits against other companies, including tobacco and automakers, more often play out in state courts.

The analysis of federal dockets shows that drug suits peaked in 2004 with 22,372 filings -- more than 10 times the number four years earlier. That surge was driven largely by the partial unraveling of a settlement of litigation over the diet drug combination known as fen-phen. That legal quagmire began nearly a decade ago and has cost Wyeth, which made one of the two drugs in the fen-phen cocktail, more than $21 billion.

Since then, the biggest single target of suits has been Merck’s Vioxx. The New Jersey-based company has vowed to take every suit to trial. But analysts expect the company to eventually settle and spend as much as $50 billion in all.

Grossberg is one of 2,500 Californians whose Vioxx claims have been consolidated under Superior Court Judge Victoria Chaney in Central Civil West, a Los Angeles courthouse so renowned for jackpot jury awards that lawyers on both sides of the bar call it “the bank.”

A widowed grandfather who likes to go to car shows, Grossberg says he asked his doctor about Vioxx for his arthritis pain after seeing advertisements touting its benefits. He says he had been taking Vioxx for two years and was otherwise healthy when, at 66, he suffered a heart attack.

Grossberg alleges that even though Merck had many red flags that the drug could cause serious cardiovascular harm, it sought fast-track approval from the government to sell Vioxx and designed a study to deceive the medical community about its safety. He contends that internal Merck documents show that even after its own study confirmed Vioxx raised users’ risk for cardiovascular problems, the company failed to warn patients and physicians of the true risk and mounted an aggressive marketing campaign aimed at heading off any concern.

Merck sold more than $9 billion worth of Vioxx, Grossberg’s lawyers note, before taking the drug off the market. In November 2004, Grossberg suffered an episode of angina.

“I was short on breath,” he recalled later. “And there again something’s wrong.”

Doctors discovered plaque buildup in blood vessels that had been normal in 2001 and inserted a stent. Grossberg said he tired easily now.

Merck says it promptly and candidly shared what it knew about the risks associated with Vioxx with the Food and Drug Administration, the medical community and the public.

The company also contends that Vioxx had nothing to do with Grossberg’s heart problems because he used the drug intermittently. What’s more, Merck says, his cholesterol level and his father’s fatal heart attack at 52 made him a prime candidate for cardiovascular problems.

“Mr. Grossberg would have had his heart attack whether or not he ever took Vioxx,” Merck lawyer Thomas Yoo said.

The litigation boom is prompting calls for reforms -- including curbs on consumers’ ability to sue drug makers, enhanced patient protections and a sweeping overhaul of drug regulations.

One wild card in the litigation is an extraordinary effort by the Bush administration to scuttle much of it. The FDA issued a legal opinion in January asserting that FDA-approved labels should give pharmaceutical firms broad legal immunity.

Policymakers are caught between two types of consumers. One type is those taking so-called lifestyle drugs who are relatively healthy and who have a low tolerance for side effects. The other is those patients with cancer, Alzheimer’s and other life-threatening diseases.

The litigation will probably not cause pharmaceutical firms to back off their pursuit of blockbuster drugs. For every one like Vioxx that ends up a liability, there are many others that drive big profits.

“The pharmaceutical industry is constantly looking for its new money drug,” L.A. consumer lawyer Brian Katabek said.

“There’s a rush to get them on the shelves.”

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Legal troubles

The pharmaceutical industry was the top target of product liability lawsuits last year.

Cases litigated by the pharmaceutical industry in federal courts

(In thousands)

‘01: 2.7

‘02: 9.5

‘03: 13.3

‘04: 22.4

‘05: 17.0