FREQUENTLY ASKED QUESTIONS ABOUT F.D.A. PREEMPTION
1. Aren’t there unjustified lawsuits against drug and medical device companies?
Answer: Of course. We do not take any position on the merits of cases – that is for a judge and jury to decide. We only argue for the right to a day in court. Keep in mind that compliance with F.D.A. regulations is already, and rightfully, part of a company’s defense against any accusations of wrong-doing. Keep in mind, also, that judges decide whether there may be merit enough in a case to move it forward; it does not happen automatically. In addition, we support a number of proposals that would limit truly exploitative lawsuits; for example, capping punitive damages, weeding out unjustified cases, and making sure that injured victims get their rightful share of any damages awarded.
2. I have heard that lawsuits suppress new drug and device development, lead to a chaos of conflicting safety standards, and cause companies to defensively add warnings which needlessly scare off patients. Aren’t these assumptions true?
Answer: Actually, there is no empirical evidence that supports any of them. They are purely hypothetical, perhaps imaginary.
3. Don’t lawsuits challenge F.D.A.’s authority and expertise as far as assessing the risks and benefits of a drug or device?
Answer: No. In the great majority of cases, lawsuits complement F.D.A’s efforts to have the most accurate information about risks and benefits. Until the Bush administration, that was F.D.A.’s own position. A former F.D.A chief counsel described civil liability and F.D.A. regulation as “complementary systems of consumer protection.” F.D.A. preemption boils down to throwing one of those systems away.
4. Wouldn’t F.D.A. reform solve the problem?
Answer: No. First of all, there are a number of potential delinquencies that may be relevant in civil litigation but entirely outside F.D.A.’s jurisdiction; for example, bribing or threatening research scientists. Second, it is inevitable that, after approval, companies will learn new information about a drug or device before the F.D.A. does. Lawsuits come into play when companies fail to report such information to F.D.A. in an appropriate and timely fashion. Just as in Watergate, the relevant questions are: What did a company know? When did they know it? What did they do?
5. Do you represent, or are in any way supported by, trial lawyers?
Answer: No. None of us are trial lawyers nor does our organization receive support of any kind from trial lawyers. Defenders of preemption typically accuse those who disagree with them as part of a “greedy trial lawyer” conspiracy. We view that tactic as hate-mongering.
6. So what is your goal?
Answer: Our goal is policy that best balances the rightful claims of patients, drug and device companies, and the F.D.A.. Some of us are stockholders in drug and device companies. We view F.D.A. preemption as very bad for those businesses just as it is very bad for civil rights and public health.
7. How can I help?
Answer: One of the greatest challenges is that most of the movement toward preemption is happening “in the dark.” The media has been very slow to report on it, and most politicians have avoided it. Thus, it has been left to citizens like ourselves to carry the ball.
Review the materials under “Resources” and see what you think. Under “links,” you can find the link to write a letter to your own Representative and Senators. A template of a letter is also provided if that can be useful. Sign our petition and pass it on to as many people as you know. Raise the issue with your friends and certainly with anyone in the media.
Citizen groups like ours have had an impact. In Michigan, where there has been a preemption law for thirteen years, the State House voted to repeal it 70-39, with strong bipartisan representation. The Senate is still to act, but we are on our way. In any case, what happens now is not about this or that individual state. If the Supreme Court affirms full F.D.A. preemption, and Congress fails to act, it will become the law of the land.
