Vioxx Litigation

Plenty Of Massachusetts Claimants – But Are The Cases Worthwhile For Lawyers?

Published: 1:00 am Mon, December 6, 2004

By admin Massachusetts Lawyers Weekly

The buzz among plaintiffs’ lawyers starts with a “V” and ends with an “X.” Whether it ends with successful lawsuits remains to be seen.Litigation over recalled painkiller Vioxx promises to be the largest products liability mass tort since asbestos and tobacco.

But local lawyers say the claims are not without their challenges and predict that the number of plaintiffs who will ultimately recover damages will be small.

Merck & Co.’s decision to take its popular anti-inflammatory medication off the market was the largest voluntary drug recall in history. Although attorneys in Massachusetts had already begun preparing products liability claims against the pharmaceutical giant prior to its Sept. 30 announcement, they report that the litigation has since picked up pace and volume.

“Before [the recall] we had some inquiries from people who had taken Vioxx and had had adverse side effects,” says Brian R. Cunha, a Fall River lawyer. “Once the product was pulled and the information with regards to Merck’s prior knowledge of the adverse effects was known, our phones have been ringing off the hook.

”Plaintiffs’ attorneys anticipate that the drug’s withdrawal will enhance their odds of convincing jurors that Vioxx caused their clients’ health problems. (See “Personal Injury Lawyers Look To Vioxx Recall To Boost Plaintiffs’ Cases” in the Oct. 25 edition of Lawyers Weekly USA.)

And a recent analysis by Merrill Lynch concluded that Merck’s liability could be as high as $17.6 billion over the next decade — based on the possibility of nearly 51,000 successful lawsuits with jury awards or settlements ranging between $100,000 and $300,000, plus another $2 billion for nuisance suits.However, lawyers caution that medical causation in such claims remains difficult to prove and that the range of plaintiffs who will ultimately recover will be narrow, because the risks associated with the drug — heart attacks and strokes — are among the most prevalent diseases in the country. As a consequence, they say time and effort need to be devoted to the screening of potential plaintiffs.

Also of critical importance is the ability to leverage working relationships with attorneys in other states. Although it remains likely that Vioxx lawsuits will be consolidated into multidistrict litigation in federal court because of their volume, attorneys anticipate bringing their claims in individual cases in state forums across the country, where they retain greater control over the litigation and where the climate is perceived as being friendlier to the plaintiffs’ bar.

“We’re proceeding cautiously with these cases,” says Medford attorney Robert J. Bonsignore. “It’s challenging, but it’s risky and it’s very expensive.”

Causation Pros And ConsThe recall of Merck’s second best-selling drug has helped plaintiffs overcome an initial hurdle with respect to general causation, lawyers agree.

“We were investigating some cases before the recall,” reports Boston lawyer David C. Strouss, who with Marilyn T. McGoldrick has filed one of the first Vioxx suits in Massachusetts. “If there were any doubts, they dissipated with the recall.”

Of even greater significance was Merck’s disclosure of documentation indicating that the company knew of the health risks associated with its product as far back as four years ago, remarks Bonsignore.

“The question is what did Merck know and when did they know it — that’s what all these pharmaceutical liability cases boil down to,” concurs Cunha, adding that the evidence so far against Merck has been “fairly damning.”

Not only is the evidence strong that the drug maker knew of the risks and chose to keep its product on the market, but epidemiology literature is also conclusive in establishing Vioxx as a substantial contributing cause of heart attacks and strokes among individuals prescribed the medication, adds Strouss.

“There is a story that makes sense about how this drug works in the body,” he says. “We’re not just taking it from the population study outcomes — it’s also in conjunction with toxicology and pharmacology studies.”

But the recall and the disclosure of internal documents do not necessarily lead to an automatic recovery, warns Bonsignore.

“In this particular case you need to prove fraud and you have to show that Merck knew of the increased risks and did not disclose them to the government or to users in a way that was reasonable at the time,” he explains, pointing out that the drug maker had maintained a level of compliance with Food and Drug Administration regulations. “So you have to show there was some wrongdoing and that the wrongdoing kept the FDA from acting appropriately.”

Bonsignore also points to the need to retain experts to examine and counter the voluminous amounts of medical data and studies put forward by Merck.

“There’s going to be a big fight among experts,” predicts Strouss. “Not only in epidemiology, but also in pharmacology and toxicology.”

Most notably, the principal challenge faced by plaintiffs’ attorneys is establishing medical causation — determining which victims suffered heart attacks and strokes specifically as a result of taking Vioxx, as opposed to other contributing factors.

“Because of the prevalence of these kinds of illnesses, there’s frequently some medical history — of high cholesterol, hypertension — that can be a cause of heart attack or stroke,” observes Strouss. “So the major issue in these cases will be the defense that something else caused that health outcome.”

Unlike suits over the diet combination fen-phen, in which the majority of claimants obtained some sort of recovery, notes Boston attorney Douglas K. Sheff, the injuries caused by Vioxx are graver, but are not so easily attributable to the drug. As a result, lawyers need to be more selective about which claims to take on, he says.

“My sense is that some of the older folk who have taken Vioxx and have other complicating problems will have a more difficult time relating the Vioxx to their heart attack or stroke, whereas a younger person without any prior medical history will have a much simpler job,” estimates Cunha.

Careful Selection Required

By Merck’s accounts, approximately 20 million patients in the U.S. have taken Vioxx since its introduction in 1999. While such a number indicates the potential magnitude of the mass tort, it also underscores the importance of screening through potential plaintiffs.

“There are going to be so many people who took Vioxx who are not going to be entitled to anything, that separating the wheat from the chaff is going to be quite a chore,” comments Sheff.

“We’ve taken to screening extremely hard,” echoes Bonsignore, who reports that out of the 20 claims he is currently handling, five “look good.”Attorneys report they perform careful reviews of medical records to assess the viability of an individual’s claim. Sheff also turns to a nurse on staff at his office to conduct a second review of the records, as well as doctors to conduct higher-level evaluations.

“We’ve already rejected dozens, if not hundreds of cases,” he remarks. “But when the cases are accepted, they can be significant, because they’re death cases, they’re stroke cases.”

Because very few claims present a potentially viable case, Sheff notes, attorneys need a large pool from which to draw. To this end, he has compiled a “kit” of prepared letters and forms that he offers to referring attorneys, who can in turn mail it to their clients.

“If they have 3,000 clients, they might have 100 people send the forms back,” he estimates. “They send me those and they’re done — in return for which they get a healthy referral fee upon completion of these cases.”

Recruiting clients through advertising is not viable, according to Bonsignore, who appraises the cost of a successful ad campaign between $100,000 and $150,000.

“You would need to get a set number of returns on that,” he comments. “But there’s not going to be more than a handful of potential cases, and there’s competition out there.”

However, Strouss and McGoldrick, who have obtained most of their cases through referrals from other firms, report a surprisingly high percentage of qualifying claims. They speculate that the referring attorneys, familiar with the requisite criteria, have already screened out the weaker claims.

Formats And Forums

Although it is estimated that Merck will have to contend with hundreds of lawsuits over Vioxx’s side effects, attorneys did not anticipate the suits would be consolidated as class actions.

“Not because there’s not enough in terms of numbers,” explains Cunha. “The problem is the so-called typicality requirement which requires that all of the injuries be generally typical. I’m not sure that they are.”

Rather, he expects Vioxx claims to proceed as a mass tort with many individual cases, similar to the fen-phen claims, where more than 200 individual actions were filed.

“You consolidate as much as you can for as long as possible, but in the end each of these cases will be an individual case,” agrees Bonsignore, who notes that the asbestos model of litigation — in which multiple cases were tried at once — no longer applies. “That’s just not happening any more in bad drug litigation.”Strouss and McGoldrick, who filed suit in Superior Court on behalf of an individual 69-year-old woman who had suffered a heart attack while taking Vioxx, also states they would be pursuing claims on a case-by-case basis. Although they concede such an approach can be expensive, their experience has been that it results in better outcomes for their clients.

“The key in these cases oftentimes is to try to keep them in state court,” notes Sheff, expressing an opinion shared by many plaintiffs’ attorneys.Bonsignore, who recalls the “devastating” effect of a couple of “bad” rulings in federal court in the litigation over the diabetes drug Rezulin, declares the federal courts in many jurisdictions to be very “unfriendly.” Once in the federal system, cases can automatically become part of multidistrict litigation, where attorneys are subject to MDL rules and lose control over discovery, observes Strouss.

“There can even be dispositive rulings that you would have had very little input into,” he warns of the group litigation process.

To ensure that their clients’ claims remain in state court, Bonsignore suggests that many suits would be brought “to the defendant’s doorstep” in New Jersey, where Merck’s headquarters are located. He also anticipates bringing the claims of Massachusetts clients to other receptive states where he has already established relationships with local counsel.

“You have to be adept at working with the various different places where these cases can be filed, and you have to have relationships with attorneys all over the country,” acknowledges Sheff, who has established connections with a consortium of lawyers around the nation, some of whom he has known for 20 years.

“We build alliances and that gives us a lot more clout when we go to negotiate and maximize a decent value for our clients,” he remarks.

“The defendant must know that you’re willing to try the case,” comments Bonsignore. “That’s the importance of having a team in place, because [Merck] knows that I’m going to try the case and that, similarly, the local lawyer I have is also ready to go to trial.”

Most of the Massachusetts plaintiffs’ lawyers say they would follow early Vioxx trials around the country as an indicator of what defenses Merck might raise and what awards might be issued.

“The first handful of cases are going to tell everything,” states Cunha.

“If the first cases that go to trial are strong medical causation cases, they could set the tone for this litigation and future claims,” agrees Strouss.

“But it all depends on what kind of cases go forward,” he adds, pointing to the mixed results obtained in the fen-phen heart valve damage cases that opted out of the settlement with American Home Products.

Attorneys are keeping an eye out not only for the outcome of cases in other states, but also for interim decisions, which could be of potential significance to the claims of Massachusetts plaintiffs, Strouss says.