by Christopher T. Kirchmer
One of the biggest issues we face when trying to explain how dangerous drugs and devices make it to the market is overcoming the general belief that the Food & Drug Administration (FDA) is much more powerful and effective than it truly is. Several different Government Accountability Office (GAO) reviews of the FDA have found it lacks the staffing, power, and procedures to adequately protect the public. Contrary to what most people believe, the FDA does not do any testing. Instead, it must rely on the truthfulness and accuracy of the information provided to them by the drug and device companies seeking to market new products.
The truth is that many drugs and devices make it to market without ever having undergone clinical trials. Once a drug or device makes it to the market, the FDA is tasked with trying to keep up with the safety record of those drugs or devices, but the GAO has said that, “FDA lacks reliable, readily accessible data on tracked safety issues and post market studies needed to meet certain post market safety reporting responsibilities and to conduct systematic oversight.” Together, all of that means that drugs and devices can make it to the market without adequate safety testing and then may not be reliably watched for signs of danger.
Unfortunately, there is a disturbing trend among some judges and in the Congress to force the public to rely exclusively on the FDA to protect the public from dangerous drugs. They do this by reducing or limiting the individual citizen’s right to hold drug and device companies accountable when they maneuver a dangerous drug or device. When drug and device manufactures move to put a product on the market, billions of dollars are on the line. One thing we know about human nature is that when the incentives are large, there will be those that bend or break the rules to get an advantage. We see it in schools, sports, financial markets, and big business.
In truth, the FDA has never been strong enough to sufficiently protect the public from overly aggressive drug and device manufacturers. In the new climate of increasing deregulation, I do not expect that to change. Wherever you stand on deregulation, the one thing we should all be able to agree on is that there has to be a way to hold companies who cheat - companies who put dangerous drugs and devices on the market – responsible for those actions. That is not a Republican or a Democratic ideal. It is a human ideal. When you harm another, whether through a criminal act or simple negligence, you should be held to account if you do not voluntarily hold yourself to account.
When I was young, I was taught that if I borrowed the neighbor’s shovel and I chipped the blade, I should not return a broken shovel. Instead, I should take responsibility for my mistake and buy the neighbor a new shovel. If I did not do that voluntarily, my parents assuredly would have held me to that account. Members of Congress from both sides of the aisle need to be reminded that the citizens’ Seventh Amendment right to a civil jury trial to redress wrongs committed against them was one of the fundamental rights placed in the Bill of Rights for a reason. It is essential for a fair and orderly democratic society that values individuals over corporate and governmental powers.
Kirchmer has worked at Provost Umphrey since 1995 and is board certified in Personal Injury Trial Law. He primarily handles mass tort litigation, specifically defective medical devices and drugs, on behalf of the firm. He is currently serving on the Plaintiffs Steering Committees for the Bard and Cook IVC filter litigation. He has been recognized as a Best Lawyer in America by U.S. News & World Report for the past two years.