ATLANTIC CITY, N.J.-Jurors in the latest Vioxx trial heard videotaped testimony yesterday from a doctor who said he wouldn't have prescribed the painkiller for his patient, a plaintiff in the trial, if Merck & Co. sales representatives had warned him of its safety problems in one of their more than 200 visits to his office.
What jurors didn't hear is that the doctor, John Braun, took Vioxx for nearly two years to treat his own neck pain, suffered a heart attack-and now is suing Merck himself.
Dr. Braun, an internist from Oradell, N.J., is part of a small but potentially damaging group among the 9,650 plaintiffs Merck is facing for its handling of Vioxx-physicians who accepted the company's assurances that the painkiller was safe, took it themselves, and now are in a position to testify about Merck's aggressive marketing techniques.
Dr. Braun's case, filed in the same court that is hearing this week's trial, hasn't yet been scheduled.
Lawyers for both sides agreed to exclude his heart attack from his testimony yesterday because it could unfairly influence jurors, but his answers offer a glimpse into the arguments he and other doctors will be able to make in their own trials.
Dr. Braun testified that he saw the plaintiff, John McDarby, over a dozen times between 1998 and 2003 and prescribed Vioxx for his arthritis, which he said was effective in treating the pain. Dr. Braun said if Merck representatives had mentioned the drug's risks, he wouldn't have prescribed the drug to his patient who was male, in his 70s and diabetic, all of which increase the risk of a heart attack.
"My job as a doctor is to try and prevent heart attacks," he testified in the video.
"Why would I give him another risk factor?"
Doctors have played a critical but often behind-the-scenes role in the Vioxx saga. Because their prescription pads were the link between the drug maker and drug takers, Merck courted doctors to put their patients on Vioxx. Now, amid the litigation following the drug's withdrawal from the market, doctors have been key in explaining to juries that if they had known about Vioxx's heart risks, they wouldn't have prescribed it.
In addition, some doctors have said in interviews that adequate warnings would have prevented them from taking the drug themselves. "For these doctors, it's a double trauma," says Samuel L. Davis, an attorney representing Dr. Braun and two other doctors. "Not only have they and their families been put at risk, but the patients that they've taken an oath to do no harm to have been put at risk."
Merck says it properly disclosed everything it knew about Vioxx's safety profile and pulled the drug off the market in 2004 as soon as data from a study showed a link to increased heart-attack risks. "The data was certainly out there with 300,000 letters, medical conferences and articles," says Merck spokesman Chuck Harrell.
"We'll have to look at what [the physician plaitiffs] knew and when they knew it." The company declined to say how many doctors have brought Vioxx related lawsuits against Merck. Under cross-examination by Merck lawyers yesterday, Dr. Braun said he read a 2001 article in the Journal of the American Medical Association that raised questions about Vioxx's heart safety, but he didn't discuss the article or the cardiovascular risks with the drug representatives.
Still, Dr. Braun says he and other doctors were steered off course by the Vioxx sales representatives who visited them. In his opening arguments in the Atlantic City trial, plaintiff's attorney Mark Lanier said that Merck targeted doctors who they wanted to write more Vioxx prescriptions, a practice the company called "blitzing." Dr. Braun was among the blitzed, with Vioxx reps paying him 220 visits during the nearly five years the drug was on the market.
"I was never, ever warned about the cardiovascular risks of Vioxx," Dr. Braun said in an interview. "When I asked about risks, [Vioxx drug representatives] showed me a risk profile that said that taking Vioxx had less risks than placebo."
Dr. Braun says he was suffering from pain from a disk in his neck when he started taking samples of Vioxx in November 2002. He didn't stop until his August 2004 heart attack. He was 50 years old at the time and says he had no significant cardiovascular risk factors. His heart attack caused him to collapse, and he had to be shocked eight times to be revived, he says, adding that doctors found a clot in one of his main arteries.
"I woke up in the hospital six days after my heart attack," he said, was out of work for six weeks,
and now works less than he used to.
Legal experts say that being both doctor and plaintiff is a tricky proposition. In the doctors' favor is the fact that they thought the drug was safe enough to take themselves. "It strengthens the doctor's case. It's a true form of reliance, relying on it for their patients and themselves," says Edward Sherman, professor at Tulane Law School in New Orleans.
But doctors' additional access to health information increases the burden to be informed, say defense attorneys not involved in the case. "The physician is responsible to know the risks of the medications prescribed and can't blindly rely on the representations of a sales representative," says Peter L. Bicks, a defense attorney with Orrick, Herrington & Sutcliffe LLP.
Stephen Chenen, a 65-year-old retired internist suing Merck over his heart attack, alleges that Merck engaged in deceptive behavior over the drug. "Enron cooked the books. Merck cooked the science," he says.
A Merck spokesman maintains that the company handled the drug appropriately and repeated its intention to defend itself against each case individually in court. So far, Merck has won two cases and lost one.
Dr. Chenen took Vioxx for about three years for joint pain he had from athletic injuries. He says he was a mild smoker at the time of his heart attack in April 2002, which was when Merck updated the Vioxx label to include study results that suggested it could cause heart attacks. Dr. Chenen is represented by Ellen Relkin of Weitz & Luxenberg, which also represents Mr. McDarby.
Dr. Chenen says Vioxx sales reps visited his offices several times a week, and that he allowed them in because he treated a working-class population to whom he gave the free samples the representatives provided to him. "At that time, the big push was about the safety of Vioxx," he says, adding that he was never warned about heart risks.
Doctors and sales representatives have a complex relationship. Doctors say they rely on drug representatives to be forthcoming with all the available information about a drug, and also for free drug samples. But both parties have taken a few black eyes over incentives offered by drug makers to health-care professionals, such as payments for giving company-sponsored seminars.
According to a document introduced in the McDarby case, Merck said that doctors who needed to be "neutralized" should be offered such speaking fees. Under scrutiny from watchdog groups, doctors and drug companies alike are scaling back on such freebies.
The pharmaceuticals industry trade group in 2004 issued guidelines restricting such practices. And No Free Lunch, a nonprofit organization developed to encourage doctors to sever their ties with the pharmaceutical industry, encourages doctors to strip their offices of all promotional materials, even the mugs and pens that bear branded drug names. Dr. Braun says that in light of his experience, he no longer allows any Merck representatives-for any drug-into his office.