Medical Device Litigation History and Primer
1976 through Reigel v. Medtronic
Guest post provided by Denver personal injury attorney Beth Klein
Background of the Act
The Food & Drug Administration (“FDA”) governs medical devices for use and sale in the United States. The FDA was given power over medical devices in the 1976 Medical Device Amendments to the Food, Drug, & Cosmetic Act, 21 U.S.C. section 360c et seq. (AMDA@). The purpose of the MDA was to provide reasonable assurance of safety and effectiveness for all medical devices.
Classes and Categories
Devices are categorized into three classes (I, II, and III) based upon the amount of risk involved in the use of that device. 21 U.S.C.A. section 360c(a).
– Class I devices present no unreasonable risk of illness or injury and are subject to Ageneral controls,@ 21 U.S.C. section 360c(a)(1)(A).
– Class II devices B which need more assurances of safety and effectiveness because they are potentially more harmful B are subject to performance standards known as Aspecial controls.@ 21 U.S.C. section 360c(a)(1)(B).
– Class III medical devices are those devices which present a potentially Aunreasonable risk of injury@ or which are Apurported or represented to be for a use in supporting or sustaining human life@ or for a use Awhich is of substantial importance in preventing impairment of human health.@ 21 U.S.C. 360c(a)(1)8.
– Class III devices, in contrast, are subject not only to the general controls and performance standard requirements, but also must undergo, baring certain exceptions, an extensive pre-market approval (APMA@) process Ato provide reasonable assurance of its safety and effectiveness@ before they can be sold to the general public. 21 U.S.C. section 360c(a)(1)(c).
Exceptions to PMA Process
Most Class III devices on the market have received pre-market approval under one of three exceptions to the PMA requirement. The first exception is a statutory Agrand fathering@ provision that allows pre-1976 devices to remain on the market without FDA approval until such time as the FDA initiates and completes the requisite PMA. The second exception permits devices that are Asubstantially equivalent@ to pre-existing devices to avoid the PMA process. 21 U.S.C. section 360e(b)(1)(B). Products that are Asubstantially equivalent@ are subject to a limited form of review known as a Section 510(k) process (A510(k)@). Devices that represent innovative technology may be marketed under the third exception known as the Ainvestigational device exception@ (AIDE@). This allows for experimental and unapproved devices to be utilized in human trials. A device used under the IDE exemption need not comply with pre-market approval requirements during the experimental trial period. 21 U.S.C. section 360j(g); 21 C.F.R. sections 812-813.
The principle of preemption arises from the Supremacy Clause of the Constitution which states that Athe laws of the United States . . . shall be the supreme Law of the Land . . . any Thing in the Constitution or laws of any State to the Contrary notwithstanding.@ U.S. Const. Art. VI, cl.2.
Congress may preempt state law, and its intent controls. If the statute contains an express pre-emption clause, the Court focuses on the plain wording of the clause. Such is the case with medical devices because the MDA expressly preempts any state requirement that adds to or is different from an FDA requirement. 21 U.S.C. section 360k(a). Any State or political subdivision of a State may establish or continue in effect any requirement with respect to a medical deviceY having the force and effect of law (whether established by statute, ordinance, regulation, or court decision).@ 21 C.F.R. section 808.1(b).
Consistent with the language of the MDA, the Courts engage in a two-step process. They first determine whether the FDA has established specific federal requirements applicable to the device at issue. If a A specific federal requirement@ has been established, the next step is to determine whether each of the common law claims adds to or differs from the federal requirement. If the common law claim imposes new or different requirements upon the manufacturer, the claim will fail.
Preemption and the PMA Process
When a product is approved through a PMA process, pre-emption applies because a specific federal requirement has been established upon which state common law would be considered an additional requirement.@ Mitchell v. Collagen Corp., 126 F. 3d 902 (7th Cir. 1997) (Collagen injection product approved through PMA, preemption applies); Martin v. Medtronic, Inc., 254 F.3d 573 (5th Cir. 2001)(lead wire in pacemaker approved through PMA, preemption applies).
The Medtronic cases illustrate how the Circuits arrived at different conclusions concerning the same device approved through a PMA process. The approval process for the Medtronic pacemakers was complicated. Medtronic was granted an IDE from the PMA process to permit clinical trials of the Model 4003 pacemaker, a predecessor of the Model 4004M. Following clinical trials Medtronic submitted the Model 4003 to the FDA for a complete PMA review. Model 4003 received PMA approval. Two years later, Medtronic submitted a PMA supplement to the FDA for the Model 4004M. The FDA approved the Model 4004 PMA Supplement, and afterward and FDA inspection revealed a significant risk of failure in the 4004M.
Finding preemption in the Medtronic cases, in Kemp v. Medtronic, 231 F.3d 216 (6th Cir. 2000), the Sixth Circuit found that the PMA process constituted a specific federal requirement for the device at issue based upon its holding in Martin v. Telectronics Pacing Systems, Inc., 105 F.3d 1090 (6th Cir. 1997)(The application and approval process under the IDE is device specific). This Court also held that even though the IDE process and the PMA process were not identical, the two processes were not materially different and therefore, preemption applied.
The Eleventh Circuit in Goodlin v. Medtronic, 167 F.3d 1367 (11th Cir. 1999), also addressed the extent to which state law claims are preempted with respect to a medical device approved under the PMA process but reached a different conclusion. The Eleventh Circuit did not find that the state claims were preempted.
The Eleventh Circuit interpreted Medrontic v. Lohr, 116, S. Ct. 2240 (1996), as meaning that a state law claim would be preempted if three requirements were met: (1) the imposition of a specific federal requirement that (2) applied to a particular device and (3) focused on the safety and effectiveness of the device.@ Goodlin, 167 F.3d 1372. The Court found that the FDA had not imposed any specific requirement on Medtronic. ANeither the FDA=s actual review of a device and its supporting information nor the agency=s eventual approval of the device imposes any ascertainable requirement upon the device.
Pre-emption and the 510(k) Process
The 510(k) review process is the clearest exception to preemption. The 510(k) process involves a limited form of review known as Apremarket notification.@ This process averages only 20 hours of review as opposed to some 1200 hours in the PMA process. The focus on the 510(k) review is on Aequivalence@ and not safety.
Medrontic v. Lohr, 116, S. Ct. 2240 (1996) is the seminal case on this issue. This case holds that the MDA does not preempt common law suits for medical devices that are marketed under the 510(k) process. The Section 510(k) process does not establish a specific federal requirement, and therefore, common law duties do not add an additional or different Arequirement.
Preemption and Other Approval Processes
Issues arise when a product is approved through an
other process such as an IDE or a 510(k) process. To further complicate the issue, at times, certain components of a product are approved through a 510(k) process while the remainder of the product is marketed under an IDE. Other issues arise when there are design changes, and components are approved for use through PMA Supplements.
Preemption and PMA Supplements
In In Re: Medtronic Polyurethane, 96 F. Supp. 2d 568 (U.S. Dist. ED Texas 1999), the Court found that it was irrelevant that the Medtronic 4004 was approved through the supplemental PMA process and granted summary judgment against Plaintiffs based upon preemption.
Preemption and the IDE Process
Blinn v. Smith & Nephew Richards, Inc., 55 F. Supp. 2d 1353 (MD Fla. 1999), involved orthopedic bone screws that were implanted in the pedicles of the spine in spinal fusion surgeries. These screws were intended to stabilize the spine to allow spinal fusion to take place; the screws failed. These screws had been approved for market under an IDE. The Blinn Court held that failure to warn claims were pre-empted.
Chambers v. Osteonics Corporation, 109 F. 3d 1243 (7th Cir. 1997), involved hip implants approved under an IDE process which allegedly did not contain the correct quality of metal in compliance with ASTM standards. The negligent manufacturing claim survived because the claim did not impose any greater requirements on Osteonics than the FDA itself.
Martin v. Telectronics Pacing Systems, Inc., 105 F.3d 1090 (6th Cir. 1997), involved the implantation of the ATP4210 Pacemaker, one of fifty experimental devices, approved for use under and IDE with a Y adapter component that was approved under the 510(k) process. The Plaintiffs argued that that Y adapter alone was defective and should be exempt from preemption since the Y adapter was approved through a 510(k) process. Unfortunately, the Court viewed the Aproduct as a whole@ as an approved investigational device based upon a concession by the Plaintiffs in earlier proceedings, and dismissed the case.
Fraud on the FDA
The thrust of this claim is that the manufacturer made fraudulent representations to the FDA in the course of obtaining approval to market the product. Plaintiffs contend that had the representations not been made, the FDA would not have approved the devices, and Plaintiffs would not have been injured.
The Seventh Circuit has strongly maintained that claims alleging fraud committed through representations made to the FDA during the PMA process are preempted. See Mitchell, 126 F. 3d at 914. The Sixth Circuit also followed the reasoning in Mitchell and held that claims for fraud on the FDA were preempted in Kemp, 213 F. 3d at 236.
In stark contrast the Third Circuit in In re Orthopedic Bone Screw Product Liability, 159 F. 3d 817 (3rd Cir. 1998) held that state law claims alleging fraud on the FDA are not foreclosed. Bone Screw, 159 F.3d at 829. Of import to the Third Circuit was 18 U.S.C. section 1001 which makes it a crime to make a fraudulent statement to a federal agency and 21 C.F.R. section 807.87(j) which requires every pre-market certification to contain a statement that the information contained therein is believed by the manufacturer to be truthful.
The Supreme Court granted certiorari limited to the following question: AWhether federal law preempts state law tort claims alleging fraud on the FDA during the regulatory process for marketing clearance applicable to certain medical devices.@ Buckman Co. v. Plaintiffs= Legal Committee, 531 U.S. 341, 148 L. Ed. 2d 854, 121 S. Ct. 1012 (2001).
AcroMed obtained approval of the bone screw for use in spines by misrepresenting the intended use in Buckman. In 1984 AcroMed sought a 510(k) approval for its bone screw device, indicating it for use in spinal surgery. The FDA denied approval on the grounds that the device lacked substantial equivalence to an approved device. In September 1985, AcroMed filed another 510(k) application indicating the intended use of the bone screw in spinal surgery. Again, the FDA did not approve the device for this use. In December 1985, AcroMed filed a three 510(k) petitions for the component parts and represented that the intended use was to be in long bones of the arms and legs B rather than spines. The FDA approved the three separate petitions. Eventually, the screws were implanted in spines contrary to the approved use and serious injuries resulted.
The Supreme Court held that state law fraud on the FDA claims were preempted and denied Plaintiffs the ability to seek a remedy where a device manufacturer misrepresented the intended use of a product to the FDA. The Court noted that the FDA was empowered to investigate suspected fraud, and citizens may report wrongdoing and petition the agency to take action. Of import was the fact that states do not traditionally regulate the FDA and these claims would be in conflict with the FDA=s responsibility to police fraud.
Justice Steven and Justice Thomas concurred in the judgment, but did not join the Court=s opinion. They felt that the result was too harsh, stating:
If the FDA determines both that fraud has occurred and that such fraud requires the removal of a product form the market, state damages remedies would not encroach upon, but rather would supplement and facilitate the federal enforcement schemeY. Under the pre-emption analysis the Court offers today, however, parties injured by fraudulent representations to federal agencies would have no remedy even if recognizing such a remedy would have no adverse consequences upon the operation or integrity of the regulatory process.
Manufacturing Defect Claims
Manufacturing claims can survive a preemption challenge. Several courts have found that preemption does not apply to claims that hinge on a defendant=s failure to follow FDA requirements regarding manufacturing, design or labeling. Martin, 105 F.3d 1101 (AAs indicated by [Lohr] and conceded by defendant, a claim that [the defendant] did not comply with [FDA] regulations governing its device would not be preempted.)
Fraudulent Concealment/Fraudulent Promotion
The question remains open as to whether a fraudulent concealment or fraudulent promotion claim will survive. In Michael v. Shiley, 46 F. 3d at 1316 (3rd Cir. 1995), the Plaintiff alleged that the manufacturer of a defective heart valve had Asent cardiac surgeons and cardiologists a series of letters and other promotional materials which knowingly misrepresented facts about the product. The Court found that the plaintiff=s fraudulent promotion claim was not preempted because the claim is based upon a duty not to deceive and there had been no specific requirements on the advertising or promotional materials for the device.
Another example can be found in Steele v. DePuy Orthopaedics, Inc., 2003 WL 22946150 (D.N.J.). In this case a knee implant, which failed, was approved under a PMA supplement. The Plaintiffs alleged that DePuy Orthopaedics had fraudulently concealed important information about the product from consumers. The Court ruled that Plaintiffs= fraudulent concealment claim survived. DePuy failed to identify whether the FDA imposed any obligation to disclose information to patients and relevant parties.
Reigel v. Medtronic, US Supreme Court, Feb. 20, 2008
On February 20, 2008, the United States Supreme Court issued an opinion consistent with Lohr. The opinion can be found at:
The Court examined a medical device that had obtained pre-market approval from the FDA. Quoting extensively from Lohr, Justice Scalia writing for the majority said. that
the common law claims were pre-empted only if they were different or in addition to requirements imposed by federal law. Parallel claims are not pre-empted, and states may provide for claims for damages based upon violations of FDA regulations.
Unfortunately, the Plaintiffs in Reigel did not raise the argument of parallel claims in the trial court, and the dismissal was affirmed since the argument was raised in the first instance on appeal.
In summary, the Reigel opinion simply restated the principles of pre-emption that were enunciated in Lohr. It is not a radical new shift for the Court, and it does not immunize medical device manufacturers in all cases. Manufacturers are still liable for failures to follow FDA regulations, manufacturing defects, and products approved through the 510K process.