691 N.E.2d 738 | Ohio Ct. App. | 1997
Lead Opinion
[EDITORS' NOTE: THIS PAGE CONTAINS HEADNOTES. HEADNOTES ARE NOT AN OFFICIAL PRODUCT OF THE COURT, THEREFORE THEY ARE NOT DISPLAYED.] *806 In this consolidated appeal, appellants Geneva Dutton, Kathleen Goodmote, and Laurie Quaint challenge the trial court's grant of summary judgment in favor of AcroMed Corporation, the manufacturer of "VSP Bone Plates" and "VSP Bone Screws." Dutton, Goodmote, and Quaint ("appellants") each claimed damages for injuries allegedly sustained as a result of the surgical implantation of VSP bone plates and screws into the pedicles of their spines. Appellants contend that their state law claims for strict product liability and negligence against AcroMed Corporation ("AcroMed") are not preempted by the Medical Devices Amendments of 1976,1 which preclude the imposition of any "requirement" under state law that is "different from, or in addition to" federal requirements.
On June 26, 1996, the United States Supreme Court announced its decision in Medtronic, Inc. v. Lohr.2 As a result of this decision, AcroMed withdraws its arguments that appellants' manufacturing and design defect claims are preempted but continues to maintain that appellants' failure-to-warn and fraud claims are preempted.3 Consequently, this court must decide whether summary judgment was appropriately granted in favor of AcroMed on appellants' state law claims for failure to warn and fraud. Last, this court must decide whether summary *807 judgment was properly granted in favor of defendant Arthur D. Steffee, M.D. on Laurie Quaint's fraud claim.
In introducing the MDA, Senator Edward Kennedy, the bill's sponsor, stated, "The purpose of this legislation is to protect the health and safety of the American people * * *. [T]he legislation is written so as the benefit of the doubt is always given to the consumer * * *. [I]t is the consumer who pays with his health and his life for medical device malfunctions."7 The report of the Senate Committee on Labor and Public Welfare indicates that the medical device legislation was prompted by the Dalkon Shield litigation. The report explains that the Health Subcommittee believed that medical device legislation was urgently needed because of the health hazards posed by unregulated intrauterine devices.8
The Act's legislative history also shows that Congress was concerned with the issue of interstate commerce as the House Committee on Interstate and Foreign Commerce debated the effect that differing state regulations would have on such commerce. The House Report indicates that "[t]he Committee recognize[d] that if a substantial number of differing requirements applicable to a medical device [were] imposed by jurisdictions other than the federal government, interstate commerce would be unduly burdened."9 *808
Less rigorous than the premarket approval process, the premarket notification procedure under Section 510(k) of the Federal Food, Drug, and Cosmetic Act allows the manufacturer to market, without further regulatory analysis, a new device that is "substantially equivalent" to a device already on the market, including a device that was grandfathered into the market by virtue of having been first sold prior to May 28, 1976.14 A finding of substantial equivalence does not connote FDA approval of the device but, rather, permits the manufacturer to immediately market the device.15 Critical to a determination of substantial equivalence is whether the manufacturer's labeling is consistent with the device's proposed use as stated in its application.16
Not desirous of undergoing this procedure, AcroMed met with FDA personnel to discuss its options. Upon the advice of the FDA, AcroMed submitted separate Section 510(k) applications for its cancellous bone screw and nested bone plate, specifically omitting any statement that the devices could be used as a spinal fixation device. Moreover, proposed labeling that made any reference to spinal *809 use would have been fatal to a finding of substantial equivalence, and, therefore, these references likewise were omitted. The applications, as modified, were found to cover devices that were substantially equivalent to devices already on the market and were, consequently, cleared for immediate marketing.
In the MDA, preemption is controlled by Section 360k, subsection (a), which provides:
"(a) General rule. Except as provided in subsection (b), 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 —
"(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 Act."
In 1978, the FDA promulgated regulations implementing and defining the scope of Section 360k.19 Under these regulations, Section 360k applies to any state requirement "having the force and effect of law (whether established by statute, ordinance, regulation or court decision)."20 These regulations, however, restrict Section 360k's preemptive effect so that a state requirement is preempted only when the FDA "has established specific counterpart regulations or * * * other specific requirements applicable to a particular device under the [A]ct, thereby making any existing divergent State * * * requirements applicable to the device different from, or in addition to, the specific [FDA] requirements."21 *810 In listing examples of requirements not preempted by the Act, the regulations specifically state that Section 360k "does not preempt State * * * requirements of general applicability where the purpose of the requirement relates either to other products in addition to devices."22
The United States Supreme Court recently addressed the preemptive effect of the MDA in Medtronic, Inc. v. Lohr.23 Relying on the regulations discussed above, the court opined that these regulations provide that "state requirements of `general applicability' are not pre-empted except where they have `the effect of establishing a substantive requirement for a specific device.'"24 In addition, the federal requirements must be "applicable to the device" and will preempt state law only if they are "specific counterpart regulations" or "specific" to a "particular device."25 Comparing the federal requirements for labeling with the state requirements regarding a manufacturer's duty to warn, the court concluded that the Lohrs' claims for failure to warn were not preempted. The court further opined that the federal requirement were not directed to a specific device or field of device regulation and the state requirements did not specifically relate to medical devices. To the contrary, the state requirements were found to be generally applied and, therefore, not within the preemptive scope of Section 360k.26
A careful review of the record demonstrates that the FDA required that AcroMed's labeling be consistent with its Section 510(k) application seeking a determination of substantial equivalence. If the labeling failed to be consistent with its application, then AcroMed would risk losing a determination of substantial equivalence and further risk marketability of its device. Hence, AcroMed was prohibited from labeling its device as it had requested, not because of any federal requirements regarding the device but, rather, because the requested labeling would be inconsistent with its application for premarket notification and, therefore, not substantially equivalent to any device already on the market. In such a case, AcroMed would be required to undergo premarket approval, a procedure that the record reflects it vehemently tried to avoid.
In contrast, the federal requirements for labeling are set forth in Section 801.109, Title 21, C.F.R., and are generic in purpose and scope; they are not directed to the regulation of any specific device. Moreover, the state requirements set forth in R.C.
We, therefore, find that appellants' failure-to-warn claims are not preempted by the MDA, and it was error for the trial court to grant AcroMed summary judgment on these claims.
"* * * negligently, and/or fraudulently represented that said bone plates and screws were safe and approved for use in the spine by the appropriate regulatory agency. Said representations were false and were made for the intent and purpose of inducing reliance on [FDA] approval in the medical community and patients such as Plaintiff. Plaintiff and her physician did in fact rely upon said misrepresentations and as a direct and proximate result suffered the injuries and damages herein described."
Consequently, we must determine whether appellants' fraud claims against AcroMed, as alleged, are preempted by the Act. As above, we are *812 compelled to conclude that appellants' fraud claims are not preempted by the MDA.
In order to reach the preemptive scope of Section 360k, a state requirement must not only be "different from, or in addition to" any federal requirement, it also must relate to the "safety or effectiveness of the device." In this case, appellants' fraud claims are based "on a more general obligation — the duty not to deceive."27 Because appellants' state law fraud claims do not relate to the safety or effectiveness of AcroMed's bone plates and screws, they are not within the preemptive scope of Section 360k.28 Consequently, appellants' state law fraud claims alleged against AcroMed are not preempted by the Act, and it was error for the trial court to grant AcroMed summary judgment on these claims.
We are mindful, however, that appellants may develop this theory of recovery on remand. In such a case, this court is of the opinion that the Medtronic court very specifically addressed this issue and determined that such a claim is not preempted by the Act. To the extent that appellants may allege a violation of a state-imposed duty that is "equal to, or substantially identical to, requirements imposed" under federal law, Section 360k affords no preemption.29
On the authority of Medtronic v. Lohr,30 appellants' claims against AcroMed are not preempted by the MDA as a matter of law. Consequently, the trial court erred in granting AcroMed's motion for summary judgment.
Accordingly, appellants' first assignment of error is sustained.
R.C.
The Ohio Supreme Court, in Browning v. Burt,33 elaborated on the meaning of the term "medical claim" as it is used in R.C.
"A careful reading of R.C.
Count four of Quaint's complaint, her purported fraud claim, incorporates the allegations of counts one through three and the following allegations:
"18. At all times herein relevant, Defendant Steffee is a doctor, licensed to practice medicine in the State of Ohio and holding himself out as a specialist in orthopedic surgery.
"19. Defendant Steffee negligently and/or intentionally made misrepresentations concerning Federal Drug Administration approval of said devices [VSP bone plates and bone screws] in the spine, which representations were relied upon by plaintiff. In fact, these devices were never approved by the Federal Drug Administration for use in the spine, and Defendant Steffee knew or should have known of this fact. Plaintiff did not learn that these devices were not *814 Federal Drug Administration approved until such information was made public in December, 1993.
"20. Defendant Steffee, in using these devices in Plaintiff'sspine, breached the standard of care for surgeons under the sameor similar circumstances and in so doing, proximately causedPlaintiff the injuries and damages herein described." (Emphasis added.)
We perceive these allegations as setting forth a "medical claim," as defined by R.C.
Accordingly, appellant's second assignment of error is overruled.
Judgment affirmed in part,reversed in partand cause remanded.
HARPER, P.J., concurs.
PATTON, J., concurs in part and dissents in part.
Dissenting Opinion
On May 16, 1996, the majority denied appellee Arthur Steffee's motion to dismiss and then granted appellant Geneva Dutton's motion to amend her notice of appeal. These motions had been referred to the merit panel for consideration but were granted prior to hearing without benefit of oral argument. At the time, I believed the majority improvidently denied the motion to dismiss and dissented without opinion from the majority's actions due to its extraordinary haste to rule on the motion. I now take this opportunity to dissent in part.
App.R. 3(D) states:
"Content of the notice of appeal. The notice of appeal shall specify the party or parties taking the appeal; shall designate the judgment, order or part thereof appealed from; and shall name the court to which the appeal is taken. The title of the case shall be the same as in the trial court with the designation of the appellant added, as appropriate." *815
The purpose of the App.R. 3(D) notice requirements is to advise a party to the appeal of what judgment appellants are undertaking to appeal. Maritime Mfgs., Inc. v. Hi-SkipperMarina (1982),
The majority erred by denying Steffee's motion to dismiss because appellant's notice of appeal did not, either specifically or inferentially, refer to the summary judgment granted to Steffee. The trial court granted summary judgment to both Acromed and Steffee in the same half-sheet journal entry. However, appellant's notice of appeal specifically indicated its desire to appeal from only the judgment for the "[c]orporation on the issue of federal preemption."
Clearly, the notice of appeal referred to Acromed only and, by direct implication, did not purport to appeal from any order relating to Steffee. In fact, appellant conceded this point at oral argument, maintaining only that she meant to include Steffee in the notice of appeal, but failed to do so.
Appellant's concession necessarily admits that this court lacks jurisdiction to hear her appeal against Steffee. In fact, by granting appellant's motion to amend her notice of appeal (which she did by subsequently including Steffee), the majority, too, in effect conceded the defective nature of appellant's notice of appeal. However, once Steffee raised his motion to dismiss the appeal, we lacked authority to do anything other than rule on our own jurisdiction to hear the appeal. Our lack of jurisdiction in similar circumstances has been repeatedly noted by this court. See, e.g., State v. Standberry (Feb. 15, 1996), Cuyahoga App. No. 69079, unreported, at 4, 1996 WL 65875;Chotkevys v. Seman (Sept. 21, 1995), Cuyahoga App. No. 67812, unreported, at 3, 1995 WL 558871.
I believe the majority acted rashly by denying the motion to dismiss and subsequently permitting appellant to amend her notice of appeal, especially since it did not explain its reasons for denying the motion to dismiss. However well intentioned the majority's actions, it cannot exercise jurisdiction where none exists. For these reasons I would have granted Steffee's motion to dismiss the appeal. *816