RESPONDENT: Medtronic, Inc.
LOCATION: Earthquake Park
DOCKET NO.: 06-179
DECIDED BY: Roberts Court (2006-2009)
LOWER COURT: United States Court of Appeals for the Second Circuit
CITATION: 552 US 312 (2008)
GRANTED: Jun 25, 2007
ARGUED: Dec 04, 2007
DECIDED: Feb 20, 2008
Allison M. Zieve - on behalf of the Petitioner
Edwin S. Kneedler - on behalf of the United States, as amicus curiae, supporting the Respondent
Theodore B. Olson - on behalf of the Respondent
Facts of the case
During Charles Riegel's angioplasty, his surgeon used an Evergreen Balloon Catheter to dilate his coronary artery. The catheter burst, causing extreme complications. Riegel sued the manufacturer, Medtronic, for negligence in the design, manufacture, and labeling of the device. Medtronic argued that Riegel could not bring these state-law negligence claims because they were preempted by Section 360k(a) of the Medical Device Amendments (MDA) to the Food, Drug, and Cosmetic Act. The MDA establishes a federal regulatory process for ensuring the safety of medical devices, and it provides that no state may set requirements that differ from or add to the federal ones. The District Court dismissed Riegel's claims as preempted by the MDA.
The U.S. Court of Appeals for the Second Circuit agreed that the suits based on medical devices like the Evergreen Balloon Catheter are preempted by the MDA. The catheter had been through the exceptionally rigorous "premarket approval" (PMA) process, by which federal regulators ensured that it met federal requirements. To allow state common-law suits for PMA-approved devices, the court ruled, would be to add a state requirement to the regulatory process despite the MDA's preemption clause.
Does Section 360k(a) of the Medical Device Amendments to the Food, Drug, and Cosmetic Act preempt state-law claims seeking damages for injuries caused by medical devices that received premarket approval from the Food and Drug Administration.
Media for Riegel v. Medtronic, Inc.Audio Transcription for Oral Argument - December 04, 2007 in Riegel v. Medtronic, Inc.
Audio Transcription for Opinion Announcement - February 20, 2008 in Riegel v. Medtronic, Inc.
This case comes to us on writ of certiorari to the United States Court of Appeals for the Second Circuit.
Like the previous two cases, it pertains to that considerable part of our business which consists of sorting out the relationship between federal law and state law.
This case involves the major federal statute governing medical devices known as the Medical Device Amendments Act of 1976.
Before that law was passed, regulation of medical devices was left almost entirely to the States and common law tort actions were the principle method of ensuring that manufacturers did not market dangerous or ineffective medical devices.
The Medical Device Amendments Act changed this.
It created a detailed scheme of federal oversight.
The law divides medical devices into three groups.
Class III, the group relevant to this case contains devices subject to particularly searching safety review, including the process known as pre-market approval.
Some Class III devices are exempt from the process, but manufacturers of the remaining Class III devices, which include the device at issue here, may not market their products until they receive approval from the Food and Drug Administration.
Manufacturers submit to the agency, what is typically a multivolume application, including among other things, a description of the devices designed and how it will be manufactured, a specimen of the device's proposed labeling and the contents of any -- any and all known studies concerning the device.
The Food and Drug Administration spends an average of 1200 hours reviewing each application.
It approves an application only if it finds there is a "reasonable assurance" of the devices' safety and effectiveness under the specifications in the application.
It lays the benefits of the device against its risks.
This means that it -- that it approves some devices that are very risky indeed, where for example, they provide the only hope for remedying an otherwise fatal condition.
Once a device has been approved, the manufacturer may not make changes that would affect the devices' safety or effectiveness without returning to the agency for another round of safety review.
When Congress added to the authority of federal regulators through the Medical Device Amendments, it took away authority from the States.
The law provides that no State shall "establish or continue in effect with respect to a device intended for human use" any requirement which is different from or in addition to any requirement applicable to the device under federal law and which relates to the safety or effectiveness of the device.
Thus, when the Federal Government requires that a device be marketed in -- in one form, a State may not require that the device be marketed in a different form.
In this case, petitioner, Donna Riegel and her husband Charles Riegel, filed a lawsuit against respondent, Medtronic Inc., under New York tort law.
Charles Riegel had been seriously injured when a catheter manufactured by Medtronic burst during heart surgery.
The catheter was a Class III medical device that had received pre-market approval from the Food and Drug Administration.
The Riegels contended that even if the catheter was manufactured in accordance with specifications that the agency had approved, the device was unsafe and improperly labeled under New York law.
They contended as relevant here that Medtronic was liable under the State's common law rules of strict liability, implied warranty, and negligence.
Mr. Riegel has since died and his wife presses his claims as administrator of his estate.
She argues that the preemption clause bars only state regulatory provisions and not common law claims.
The Second Circuit disagreed, and so do we.
The whole purpose of the Food and Drug Administration's review is to determine the appropriate balance between risks and benefits.
When state common law rules permit a jury to recalculate that balance, the federal scheme is frustrated, no less than when a state regulatory scheme takes the same action.
Indeed, leaving the recalculation to a jury on a case-by-case basis is arguably even worse.
Since the jury has before it, only the injured plaintiff and no one speaks for those who would be deprived of the benefits of the admittedly risky device, if manufacturers could not rely upon FDA approval.