I previously discussed the possibility that legislation would be enacted providing that FDA approval would shield drug manufacturers from tort liability. In particular, I wondered whether new legislation would insulate Merck from liability for Vioxx-related heart attacks and deaths by virtue of FDA approval of the drug.
Rea, in comments, pointed out that such a liability shield is already in place in Michigan. Michigan statute MCL 600.2946(5) provides:
In a product liability action against a manufacturer or seller, a product that is a drug is not defective or unreasonably dangerous, and the manufacturer or seller is not liable, if the drug was approved for safety and efficacy by the United States food and drug administration, and the drug and its labeling were in compliance with the United States food and drug administration's approval at the time the drug left the control of the manufacturer or seller."
In any health care lawsuit, the amount of noneconomic damages recovered, if otherwise available under applicable Federal or State law, may be as much as $250,000, regardless of the number of parties against whom the action is brought or the number of separate claims or actions brought with respect to the same occurrence.
The term `health care lawsuit' means any health care liability claim concerning the provision of health care goods or services ... brought in a State or Federal court ... against a ... manufacturer ... or seller of a medical product, regardless of the theory of liability on which the claim is based ..
If that bill passes, non-economic damages will be limited to $250,000 in Vioxx cases.
In addition, S. 607 also prohibits the award of punitive damages for any drug, such as Vioxx, that received FDA approval:
No punitive damages may be awarded against the manufacturer or distributor of a medical product based on a claim that such product caused the claimant's harm where--(A)(i) such medical product was subject to premarket approval or clearance by the Food and Drug Administration...
Those limitation are particularly significant with regard to Vioxx. Vioxx is a pain reliever often prescribed for arthritis. Many arthritis sufferers, and presumably many Vioxx users, are older and may be at or near retirement age. Retired people do not have much earned income. Lost earnings damages in a Vioxx case are likely to be relatively small.
Vioxx is claimed to cause heart attacks and sudden cardiac deaths. In the event of sudden cardiac death, there will be few if any medical expenses.
Thus, of the elements of damage available in a sudden cardiac death of a retired person due to Vioxx, the lost wages are likely to be small, medical expenses may be non-existent, punitive damages are barred, and the non-economic damages will be limited to $250,000. Not to worry, Merck will still have to pay for the funeral.
Limiting Merck's liability for non-economic damages in Vioxx litigation is not without irony.
One of the main elements of non-economic damages is pain and suffering. A person suffering a non-fatal heart attack as a result of Vioxx is likely to endure a substantial amount of pain and suffering.
One justification put forth for limiting pain and suffering awards is that the amount of the award is subjective. Tort reformers often argue that there is no empirical measure of the monetary value of pain and suffering. As a result, they argue, pain and suffering awards look more like a lottery than a measurement of compensation.
When we want empirical measurements of value, usually we look to markets. Markets express the collective opinion of the value of a good or service. Where can we look for a market-based value of pain and suffering?
Well, Vioxx was prescribed, in part, to relieve the pain of arthritis. Merck offered Vioxx for sale and consumers decided whether or not the pain relief it provided was worth the price. Those transactions establish a market price for relief of arthritis pain. If pain and suffering is not capable of empirical measurement through markets, then Merck would have had no customers for Vioxx.
Thus, the very existence of a market for Vioxx undercuts the premise of the argument for a statutory limit on pain and suffering damages.
As I said, the Vioxx example is not without irony.
DM, what are your thoughts on the Michigan statute? First, if the FDA's approval process will be the last hurdle of 'safety,' is that so bad, as long as the FDA remains scientifically rigorous? Second, 600.2946 wouldn't protect Merck if new research subsequent to the FDA approval revealed problems with Vioxx that Merck ignored; or am I mistaken?
Posted by: Peatey at November 22, 2004 02:30 PMIf the FDA process was rigorous, and if the drug companies were forthcoming with info to the FDA, and if the FDA was not subject to political pressures and/or captive of the industry, and if the FDA continued monitoring fater approval, I think that FDA approval would be very good evidence that a drug was not defective and therefore that no liabiity should attach to its sale. Unfortunately many of the above are just not so.
Posted by: dwight at November 22, 2004 02:46 PM