Drug Trials on Trial
National Law Journal
By Tresa Baldas
July 18, 2005
Clinical drug trials are triggering an increasing number of lawsuits, ranging from wrongful death claims to the right to continue receiving drugs, according to attorneys on both sides of the litigation.
Also, plaintiffs have expanded their targets to include just about anyone associated with a clinical trial: doctors, universities, research institutions, drug companies, clinical trial review boards-even patent holders of certain medical devices.
And it's a big target to start with: There are about 50,000 clinical trials currently under way in the United States, mainly used to test experimental drugs and medical devices.
"I'm getting more and more calls from clients about it," said Nancy Sher Cohen, a shareholder in the Los Angeles office of Heller Ehrman who has resolved a number of clinical trial lawsuits on behalf of biotech companies in the last year. "It's become a much more fertile area than it was two to three years ago."
Some believe that public mistrust of the medical community is driving the litigation.
"For many years there weren't a lot of challenges to clinical trials. They were seen as truly good, as kind of mom-and-pop-and-apple-pie, and that scientists were here to help people . . . but people don't see the truly good anymore," said Jan Murray, partner in the Cleveland office of Squire, Sanders & Dempsey, who counsels more than a dozen biotechnology drug sponsors and clinical trial sites like hospitals. "[The public is] questioning the motives of the pharmaceutical companies. And they're questioning if the FDA is seeking to protect the companies."
Mark Gately, a partner in the Baltimore office of Washington-based Hogan & Hartson, said that in the last four months alone he's handled three major clinical trial lawsuits on behalf of Thousands Oaks, Calif.-based Amgen Inc., a biotech company that was sued over a Parkinson's drug experiment and a blood-disorder drug.
"I'm starting to feel like I know more about clinical studies than anything else," Gately said. "I think this is just the tip of the iceberg.
"I think you're going to get patients coming in like this: 'We don't care what the risk of the drug is, we'll take a chance.' And then you'll get the other side saying, 'You should have stopped this earlier,' " Gately added.'Mere Guinea Pigs?'
Most recently, Amgen sparked national attention in the medical community when it won two back-to-back drug lawsuits in Kentucky and New York involving an experimental drug for Parkinson's disease.
In a twist from the typical clinical trial lawsuits-where patients sue because something goes wrong-the plaintiffs in these cases sued because they were denied continued access to an experimental drug they felt was beneficial.Avoiding a Lawsuit
In the course of a year, attorney Natasha Leskovsek, a Food and Drug Administration specialist at Heller Ehrman, counsels more than 100 pharmaceutical companies on how to to avoid getting sued. In particular, she aims to help them establish solid consent forms that companies hope will be lawsuit-proof. It's these consent forms, she noted, that often get researchers and drug companies into trouble. "The most basic rule of the consent form is it has to be written at a fifth-grade level. You have to think about the ordinary patient you're trying to recruit to your study," said Leskovsek, noting that none of her clients has thus far been sued, but they're constantly on guard for it. Attorney John Serio, senior counsel to Brown Rudnick Berlack Israels of Boston, also advises the clinical research community on regulatory matters. He represents both drug companies and medical-device companies, both of which, he said, have been put on guard by the plaintiffs' bar. Like Leskovsek, Serio believes a concrete consent form will help keep companies out of legal trouble. He offers four tips to establishing a strong informed consent document:
- Write it for people with a limited education and avoid using complex terms and legalisms.
- Make sure it complies with federal regulations and point out any potential adverse reactions.
- Inform participants of alternative treatments.
- Include Health Insurance Portability and Accountability Act language to assure the patient that their information is confidential.
- "What this is really about is the rights of patients in clinical trials," said Alan Milstein of Sherman, Silverstein, Kohl, Rose & Podolsky in Moorestown, N.J., the plaintiffs' attorney in the Amgen litigation. Milstein is also handling about a half-dozen other clinical trial lawsuits.
"Are [patients] getting things that are at the whims of the company?" Milstein said. "Are they mere guinea pigs? Or are they real participants?"
Amgen had halted the Parkinson's drug trial last year, citing data that suggested the drug may cause brain damage.
But many patients felt the drug was beneficial, so they sued Amgen, hoping a judge would force the company to give them the drug.Two Big Decisions
On July 8, U.S. District Judge Joseph M. Hood in Kentucky ruled in Amgen's favor, finding that the company had the right to terminate the trial of a drug that it considered potentially harmful. Abney v. Amgen, No. 5:05-CV-254 (E.D. Ky.).
In a similar lawsuit in New York on June 6, U.S. District Judge P. Kevin Castel issued a similar ruling in Amgen's favor. The judge found that Amgen was under no contractual obligation to continue supplying the drug, and that the informed-consent forms signed by the patients acknowledged Amgen's right to stop the trial. Suthers v. Amgen, No. 05-CV-4158 (S.D.N.Y.).
Gately, the defense counsel in both Amgen cases, believes they have precedential value.
"The legal argument was, 'Who gets the right to make a decision to stop a trial: the patient or the sponsor?' " he said. "Both judges found it was the sponsor's right, and that's probably the most important precedent."
Plaintiffs in the New York case have sought an appeal, according to Milstein. No appeal plans have yet been announced in the Kentucky litigation.A Patient's Rights
Seattle attorney David Breskin of Short Cressman & Burgess believes that more clinical trial lawsuits are on the horizon because the public has, as he sees it, "become more aware of the rights of research subjects in clinical trials."
He speaks from experience.
Breskin is currently appealing a 2004 jury verdict that cleared the Fred Hutchinson Cancer Research Center of alleged negligence in the deaths of four patients who participated in a medical experiment 20 years ago.
However, the jury found the cancer center, referred to as "the Hutch," negligent in the death of a fifth patient, and awarded more than $1 million to his family. That verdict is on appeal. Dagosto v. Fred Hutchinson Cancer Research Center, No. 02-2-06303-9SEA (King Co., Wash., Super. Ct.).
Breskin represented the spouses of five patients who died in the drug trial, known as Protocol 126, and asked jurors to award them $3 million to $5 million each. They died of "graft failure," a fatal complication that occurs rarely in a conventional bone-marrow transplant.
According to Breskin, the Hutch allegedly didn't fully explain the risks of the experiment to his clients, and duped the patients into taking part in an experimental drug when they thought they were going to participate in the center's famous bone-marrow transplant treatment.
"It was sort of a bait and switch. They expected one thing and Hutch gave them something totally different," Breskin said.Patients Knew the Deal
But the Hutch's lawyer, George Mernick, a partner at Hogan & Hartson, said the patients knew what they were getting into, arguing that they had provided informed consent when they enrolled in the experiment, and knew it carried risks.
"The strongest argument was that the people who participated in this trial made informed decisions," Mernick said.
"And once the jury concluded that the relevant information had been provided to these patients before they said yes and agreed to enroll in this study, I think the jury then very readily accepted the notion that research medicine carries risks with it," Mernick said.
Mernick went on to say, "Let's face it, most cancer trials don't work. If they worked, we could have cured cancer right now. None of them is the magic bullet."
During closing arguments, Mernick stressed to the jury that a guilty verdict could stunt science.
"I said, 'Well, think about the message the plaintiffs are asking you to send to medical researchers: Don't take chances. If there's a slightest risk that it might not work, don't try it,' " Mernick said.
But clinical trial litigation isn't about halting science, argues Stephen Hanlon, partner in charge of pro bono work in the Washington office of Holland & Knight, who has handled clinical trial litigation. It's about making sure researchers get things right and protecting patients' rights, he said.
"The individual's right to choose is more important than the advancement of medical science," Hanlon said. "When those two things start to clash, the individual's right to choose trumps it."