On last night's Fox Business show (airs again tonight at 10pm ET, Saturday at 9 pm & 12 midnight, and Sunday at 10 pm), I gave trial lawyer Mark Lanier a hard time about the consequences of some of his many lawsuits. For example, Lanier secured a $4.8 Billion settlement with Merck over its arthritis drug Vioxx, which the company had pulled from the market voluntarily over concerns it might increase the risk of heart attacks...but the FDA said the drug's benefits outweighed the risks and should be available to consumers. Merck declined to put it back on the market, a move I suggested was motivated by Lanier's lawsuits.
But Lanier made other claims on the show that I had not heard before, arguing that Merck knew of adverse effects and did not share that knowledge with customers or the FDA. Lanier said:
My response to Merck was just tell us the truth. If you know the drug will increase your risk of a heart attack by seven fold, warn me. Because I have a right to know what you know. What Merck said is no, we’re going to keep that knowledge. They didn’t tell the FDA everything. They didn’t tell the public hardly anything and it wasn’t until some renegade doctors got a hold of some statistics that the truth came out.
So, I invited Merck to watch the program and send us a response. Here's some of what they wrote:
Mr. Lanier is pulling numbers out of the sky for dramatic effect. Merck is not aware of any Vioxx study that shows a 7-fold difference in cardiovascular events and the scientific evidence does not support that claim.
Merck studied Vioxx extensively before and after it came to market. Vioxx was one of the most studied drugs in history. ... In total, Merck conducted about 130 studies involving more than 50,000 patients, comparing Vioxx to NSAIDs (Note: common painkillers like aspirin, ibuprofen and naproxen) or a placebo.
The FDA approved Vioxx four times. ... Regulatory agencies in more than 70 countries approved Vioxx because they determined it to be a safe and effective drug and an important medical advance for patients with chronic pain.
Additionally, we think it is important to point out that Merck believed in the safety of Vioxx and disclosed what it learned rapidly and widely. The data from Merck’s studies were shared with the FDA, which repeatedly approved the medicine as safe and effective. In fact, the VIGOR study, for example, was a matter of extensive public debate throughout the medical, scientific and regulatory communities. As science progressed, the FDA updated the Vioxx label.
Merck also pointed out that Lanier's big Texas verdict -- a jury awarded $253 million to the widow of a man who died of a heart arrhythmia while on Vioxx -- was overturned on appeal:
The Texas appellate court threw out the verdict in its entirety because the evidence was insufficient and ordered judgment entered for Merck. ... The court concluded that there was not sufficient evidence supporting the jury’s verdict and that Vioxx did not cause the death of Robert Ernst. Plaintiff filed a motion for rehearing. That motion was denied. Plaintiff has now filed a petition for review before the Texas Supreme Court.
Meanwhile, Vioxx remains unavailable to consumers.