Small Firms Can Successfully Try
Pharmaceutical Mass Torts
By Christa Zevitas
At least seven FDA-approved drugs have been withdrawn from the market since 1993, spurring a wave of litigation in the wake of deaths and severe side effects.
One of these drugs, fen-phen, has already produced multi-million dollar verdicts and settlements, while plaintiffs' attorneys believe that six others - Rezulin, Propulsid, PPA, Raxar, Posicor and Lotronex - are poised to yield equally impressive awards.
As these pharmaceutical mass torts gain momentum, more and more small-firm attorneys will have an opportunity to grab a piece of the action.
While most of the new ground will continue to be carved out by larger or more specialized firms, there are several ways for enterprising generalists to enter the fray, says Ramon Lopez, the California attorney who coordinated a stunning $4.83 billion global settlement with the makers of the diet drug fen-phen.
According to Lopez, smaller firms can handle these cases as long as they employ a few basic case management strategies. The key to success lies in learning both how to identify winning suits and locate other lawyers involved in the litigation with whom you can team up to bolster your case, Lopez says.
"The bottom line is, you have to make yourself bigger than them," says Lopez, partner in a 21-lawyer firm in Newport Beach, Calif.
He stresses that plaintiffs' attorneys dedicated to particular pharmaceutical torts are more than willing to team up with others or give them advice on successful strategies.
"A lot of small firms that haven't made the commitment to [pharmaceutical] cases use us as co-counsel because we bring all our experts and the work product we've developed," he says. "Plus, we have the ability to have a large trial team there for them if they need it."
Philadelphia solo Phil Rush took a different approach, teaming up with two other small firms to share discovery, depositions and demonstrative evidence. The result was an $8 million fen-phen verdict in February 2000.
Rush had known one of the solos for years and found the other at a meeting of Philadelphia fen-phen attorneys. Six months before trial, Rush asked those two lawyers to team up with him.
"I realized that having three lawyers who were all intimately involved in similar cases would ensure that everyone's work product was more thorough and fool proof. After all, three sets of eyes are better than one," he says. "It also saved everyone a good deal of time because we divided up work that was applicable to all three cases.
"One lawyer, for example, had a particular expertise in FDA regulations, so he was responsible for creating a memo detailing what American Home should have included in its [warning] labels under those regulations versus what it actually had."
Rush notes that the three-man team also "poured over deposition testimony from American Home's key witnesses and helped each other decide which potential witnesses would be most likely to admit the company's liability during trial. Someone would say, 'Okay, we can get this out of this witness.' Then we'd bounce ideas off of each other and decide whether calling that person would be a good move."
The three lawyers also shared trial exhibits "here and there," says Rush. "This didn't save much money, but it was another time-saver."
Buying Discovery Documents
If you're a solo who prefers working alone, Lopez suggests cutting down on trial preparation by purchasing discovery documents from lawyers involved in multi-district litigation: These lawyers compile national databases of key evidence in pharmaceutical litigation.
"This usually costs you between six and nine percent of your case [earnings], but you couldn't do this on your own without spending hundreds of thousands of dollars on [discovery battles]," says Lopez.
He adds that lawyers who want documents related to Rezulin or Propulsid cases can call attorneys involved in multi-district litigation or ATLA. Propulsid, a remedy promoted for infant gastric reflux, allegedly killed eight babies - and Lopez notes that discovery in Propulsid litigation is "heating up."
Rush also encourages others to purchase discovery documents. He bought them from the firm that won the first fen-phen verdict, and he says it saved him from sifting through the mountain of irrelevant material he believes American Home Products would have dumped on him during discovery. The documents also contained evidence of the company's liability which bolstered Rush's "bad company" argument and helped persuade the company to settle.
Furthermore, it also saved him countless hours of depositions.
"For about $6,000, I got the benefit of things such as not having to take days and days worth of depositions. They were there in the documents and I could just read them," says Rush. He notes that buying evidence from individual attorneys with their own databases is less costly than going through nationally compiled ones.
Time and Money
But even with these case-management techniques, lawyers who take on a pharmaceutical mass tort case must be prepared to commit a great deal of time and money.
"You have to be willing to take it all the way to trial and verdict - and appeals, if necessary - and to retry it if you have to," says Rush. "You're going to have to match them expert for expert and transcript for transcript. You can never let them think they can out-man you, out-gun you or out-spend you. And there's no substitute for trial experience in these cases."
Lopez warns that a pharmaceutical case will require a third to a half of a small firm's manpower.
"Those attorneys could be generating revenue for the firm, but if they're devoting their time to a [pharmaceutical] case, they won't see a dollar for about three years," he says. "So if your trough is full, that's okay, but if it isn't, think twice."
Rush devoted thousands of hours and invested about $100,000 in the fen-phen suit over a two-year period. He also had to put other cases on the back burner during the six months prior to trial.
Choosing Your Battles
According to Lopez, one of the most important strategies in mass tort litigation is to file your best cases first because these are the cases that will be heard first - and they will set the tone for future settlement negotiations.
"That's a lot more important than getting as many cases filed as you can, because the one thing that drives settlements is when verdicts start coming down heavily versus the defense," he says. "And the heavier the verdicts, the greater the settlements will be in all cases that follow."
The strongest cases are those with solid evidence that the medication caused the injury, that the company knew it could cause this type of injury and that the company failed to warn the public of the risk.
In fen-phen litigation, for example, the strongest cases generally involved plaintiffs who suffered from primary pulmonary hypertension (PPH) - a rare, often fatal heart disease that has been linked to fen-phen. And the first fen-phen case Lopez's firm filed was on behalf of a woman in her mid-30s who had suffered PPH taking the drug.
"The disease was almost non-existent among those in her age range, and there was a fairly clear temporal relationship to her taking diet drugs," says Lopez. "That case not only settled about a week before trial, but it helped settle a number of cases after that. PPH cases were golden cases."
Rush, the Philadelphia solo, agrees. In his fen-phen suit last summer, Rush says he had strong evidence linking his client's PPH to fen-phen use as well as interoffice memos and e-mails that revealed:
American Home knew there was a link between valvular heart disease and Pondimin (the "fen" in the fen-phen combination) as early as 1994, but didn't tell doctors or note this in warning labels until the summer of 1997;
The company had put together a marketing team - referred to as a "swat team" in interoffice memos - that determined that sales would suffer if they warned the public about the link between Pondimin and PPH; and
- American Home fought the FDA's efforts to strengthen warning labels.
- As soon as Rush showed American Home defense lawyers his trial preparation, he says they "made me an offer I couldn't refuse." He settled with the company
- for a confidential amount and then proceeded to trial against his client's physician.
- Strong causation and failure to warn are equally important in other pharmaceutical mass torts.
Rezulin, a drug designed to stabilize diabetes, has allegedly caused liver toxicity, congestive heart failure and even death among its users. Plaintiffs' attorneys say the drug's manufacturer, Warner-Lambert of Morris Plains, N.J., knew about the potentially lethal side effects long before it fought for FDA approval. Not only did the pharmaceutical giant fail to share this knowledge with the FDA, it also failed to warn the public of the risks when the drug went on the market, they claim.
But while the FDA has already established that Rezulin can cause liver failure, damage and elevated liver enzymes in the blood, there still isn't any scientific research that definitively links Rezulin to cardiovascular problems. So many plaintiffs' attorneys are planning on filing liver cases first, and waiting to file heart cases.
"Liver cases are strong because diabetics don't inherently have liver problems," says Jeb Wait, a Houston plaintiffs' lawyer who's also a physician. "I feel very strongly that liver cases will be easier to prove than heart cases because diabetics inherently have heart problems. It's therefore going to be tougher to prove that a plaintiff's cardiovascular problems weren't caused by the disease itself."
For this reason, plaintiffs' lawyer Joseph Santoli says he's not taking any heart damage or heart failure cases.
"We've been approached with between 200 and 300 claims alleging Rezulin caused heart failure and death, but haven't agreed to take any of those cases," says Santoli, who practices with a two-lawyer firm in Ridgewood, N.J.
