Last year, the Supreme Court ruled in favor of federal preemption in Riegel v. Medtronic. The ruling protects medical device makers from state-law claims for injuries or damages caused, as long as the devices receive premarket approval from the FDA (DISCLOSURE: I do work for a drug and device manufacturer. It should go without saying, but all opinions expressed about the effects of this ruling and the government’s policies on this subject are my own).
Some Congressional Democrats are seeking to reverse these protections through legislation. Again, I don’t expect many people to feel bad for drug and device makers, but such an attack on the industry should be noted, along with potential consequences.
Legal and regulatory clarification is needed in many areas of the health care industry to reduce costs. Removing these protective barriers for the industry would be a gift to prosecuting tort lawyers, and would be a step in the wrong direction for health care reform. Increased liability and murkier legal and regulatory systems would only add costs to manufacturers, which will hurt the overall market with potentially higher prices and less innovation.
A recent blog post at the Corner explains how the stimulus is also hostile to the health care market. The advisory board the stimulus creates will have negative effects on drug and device makers, as we can confidently predict that the recommendations will not be favorable. It’s no secret why the industry was lobbying against this provision.
The increase to welfare programs like Medicaid, for which everyone unemployed will be eligible thanks to the stimulus, could also do manufacturers a disservice. As government increases its control of health care, they will attempt to negotiate below-market prices for goods and services, driving down profits for manufacturers and hurting innovation. It’s likely that Democrats will continue to push policies that punish brand name manufacturers, who already endure significantly more oversight to ensure product safety than generics do.
President Obama is supposed to address health care in his upcoming discussions about the budget. One thing being mentioned, as I’ve been warning, is a cut to Medicare Advantage. See my earlier posts to familiarize yourself with this topic. While we should welcome a debate on health care, we should be cognizant that the left’s policy is one of hostility towards drug and device manufacturers, and is therefore bad for the health care marketplace.
UPDATE: A court ruling in California a few months ago opened up brand name drug makers to liability for products made by generic manufacturers. Generic drug makers are also lobbying Congress for a distinct advantage of market exclusivity when patent terms expire.
This report by the Pacific Research Institute summarizes the changes that the new administration has already made to health care.