Riegel v. Medtronic - the anti tort SC opinion and the federal pre-emption clause
In what is the most anti-tort opinion from the Supreme Court ever to hit the shelves of the Library of Congress Justice Scalia delivered a terrible and scathing opinion creating bonafide Federal preemption to regular tort claims. Here is the low down on Riegel vs. Medtronic: The Supreme Court agrees that the Federal Government has created a pre-emption clause within Federal Statute 21 U.S.C. Section 360. This means that if the Food and Drug Administration (FDA) give "Pre-market Approval (PMA) to any medical device and that device is defective and hurts, kills, infects or otherwise harms human beings (read: United States Citizens), that the human beings have the right to go scream in a bucket, because they can’t do anything about it. The FDA said the device was OK and that is the final word. No joke. The FINAL WORD! Sure the FDA may, eventually pull the product after a few hundred deaths, sure the FDA may fine or otherwise slap with figurative company wrist. However, you, the injured, dead or otherwise harmed individual or family, just need to ... learn to live with it.
The court, in its first few paragraphs, related the story of the Dalkon Shield, an intrauterine device that harmed thousands of women. The court made a broad accusation that the Dalkon Shield created a barrage of tort lawsuits that proved the common law tort system (read: American System of Justice) is defective and unable to properly handle tort claims related to medical devices. The court gave no basis for this opinion, except for the fact that there were many tort claims filed because thousands of woman here harmed by the Dalkon Shield. For most of America the Dalkon Shield cases were proof, similar to Ford Pinto cases, that Corporate profit motives outweigh human safety all too often, even with Federal oversight.
Are medical devices so special that they get special handling or special rules compared to any other "device" produced today. If the court system cannot properly handle medical devices then why it is able to handle front-end loaders that have a "device defect" that kills people. Why can the court properly handle tire defect cases, roof crush, seat belt failures, or any other "non-medical" device that harms people? It is illogical. The only logical position is that medical devices interact with the human body in a more intimate and significant way so they need additional protection from lawsuits. I feel the exact opposite. The fact that a medical device is such an intimate thing leads me to believe that the law should garner the human participant in using the medical device MORE not LESS protection from device defects.
The language of 21. U.S.C. section 360 states as follows:
Except as provided in subsection (b) see below of this section, no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement (emphasis added) -
(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and
(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter." Section 360k(a).
(The exception noted in subsection (b) allows the FDA some latitude in giving local and State government oversight in some limited instances, which were not covered by the court in the opinion.)
It is the "any requirement" language that created the interesting stretch. My reading of the statutory language reads that Congress attempted to prohibit States from creating additional legislative hurdles, which would prohibit medical devices that pass through the PMA process and get an FDA stamp of approval. There is nothing in the language of the above statute that indicates Congress intended to deny every single human being harmed by a PMA approved device redress from his or her injury in a court of law! The logical leap that the requirement of being responsible for harming folks is a part of the "any requirement" language is a stretch and an overly intricate reading of the statute. I might even agree in some part with the court if there was an iota of data or language in the legislative history to indicate that the drafters of the law contemplated such a use. There is, however, nothing in the text of the statute or the Congressional Records that indicates Congress every noticed or thought about the issue. It is apparent that the language of the statute became over broad because no one realized that "any requirement" included all common law general requirements of general tort responsibility. In other words, the general negligence laws of each state are being used as a "requirement" to deny a harmed person from bringing suit against a Class 3 medical device with PMA approval.
Justice Ginsberg noted this exact point in her dissent but was preempted in the argument by Justice Scalia in his controlling opinion with the indictment that the entire tort system is not deserving of "preservation" and that "juries...see(s) only the cost of a more dangerous design, and is not concerned with its benefits..."
Juries are given both sides of a matter. Drug and medical device companies spend significant money on hiring the best and brightest lawyers money can buy. The typical medical device case has a small law office representing the Plaintiff. The Plaintiff’s attorney usually attended a local or state college and a local law school. He or she may have graduated in the middle of their class and may have a paralegal and a legal secretary helping out on the case. I am sure the attorney is bright and passionate. If that attorney is lucky, he or she may even have an associate with the same legal pedigree. By contrast, the Drug or Medical Device Company has a team of legal scholars at their disposal. Most of their team, a team of maybe 10 or 20 attorneys and a cadre of paralegal assistants, investigators and legal secretaries all graduated at the top of their class from the best law schools in the nation. They are a highly trained and well-paid group of white shoe legal assassins. There is no doubt in my mind the battle is David vs. Goliath and the Plaintiff’s attorney is the David in this story. It is only the fact that the jury often finds truth and passion in the Plaintiff’s story that permits plaintiff’s to ever win a case. Justice Scalia’s argument relies on the myth that Plaintiff attorneys are a secret society of Svengali’s who use Jedi mind control to blind the jurors into believing their side of the case. That is just ridiculous and I am sure every egocentric defense attorney looks at Justice Scalia’s opinion as a direct insult.
The court directly took up the challenge that the legislature did not intentionally, without any comment, struck down any reference to public redress or access to the court system. Justice Scalia says that is "exactly what pre-emption clause for medical devices does by its terms. The operation of law enacted by Congress need not be seconded by a committee report on pain of judicial nullification... It is not our job to speculate on congressional motives."
Then why go out of your way to force the issue and push for Federal pre-emption?
A casual reader may think that the opinion is only about Medical Devices. However, how long will that last? How simple will it be for Congress to slip in Federal oversight preemption language into bill after bill until all torts are preempted by Federal oversight. It is against my Republican sensibilities to create Federal agencies to oversee private industry so that private industry can escape liability for harming the public with a faulty or defective product.
I am sure the burden on the court system will be greatly lightened when individuals can’t obtain help for their injuries. Certainly if we do not permit people to bring lawsuits there will be less lawsuits. However, what is the effect of that? I wonder who pay the medical costs associated with the injury. Will the person's health carrier have to pay? What if they do not have health insurance? Will the local hospital and doctors care for the person? How much is the Federal Government willing to spend to take care of those harmed by the negligence of corporations whose products are sold to our people, our children without the worry that the company can be held accountable for injuring those people? With regard to many medical devices, we are going to find out real soon.
Brian
Click here to read the Supreme Court decision for Riegel v. Medtronic, Inc., 552 U. S. ___ (2008)
