Opinion
Case No. 94-C-1020-BU.
March 31, 1997
ORDER
This matter comes before the Court upon the motions of Defendants, Baxter Healthcare Corporation and Baxter International, Inc., for summary judgment pursuant to Rule 56, Fed.R.Civ.P. For the reasons stated below, the motions are denied.
The motion of Defendant, Baxter Healthcare Corporation, is also made on behalf of Defendants, American Hospital Supply Corporation, Inc. and American Heyer-Schulte Corporation. According to the record, American Hospital Supply Corporation, Inc. and American Heyer-Schulte Corporation no longer exist. Baxter Healthcare Corporation and its parent, Baxter International, Inc., defend this action in their place.
I.
On October 14, 1982, Plaintiff, Patricia Quillin, underwent surgery to implant an Angelchik Anti-Reflux Prosthesis around her gastroesophageal junction (where the esophagus enters the stomach). The prosthesis, which was originally manufactured by Heyer-Schulte Corporation, was surgically inserted in connection with a hiatal hernia repair. In the fall of 1993, Plaintiff started developing multiple complaints, including weakness of extremities and symptoms compatible with multiple sclerosis and Sjorgren's syndrome. On June 29, 1994, the prosthesis was removed. Upon removal, the tip of the prosthesis was noted as being broken in one area.
The Angelchik Anti-Reflux Prosthesis is "C"-shaped and is composed of a pliable silicone elastomer shell filled with highly cross-linked silicone gel. A reinforced Dacron tie-strap is affixed to the outer circumference of the prosthesis. Once the prosthesis is surgically placed around the gastroesophageal junction, the tie-scrap is tied to secure the prosthesis around the gastroesophageal junction.
Heyer-Schulte Corporation was operated as a wholly-owned subsidiary of American Hospital Supply Corporation between 1974 and 1982. On December 16, 1982, it became an unincorporated division of American Hospital Supply Corporation and ceased its separate corporate existence. Thereafter, it was known as American Heyer-Schulte, an unincorporated division of American Hospital Supply Corporation.
Thereafter, Plaintiff brought this action against Defendants, claiming her injuries resulted from silicone gel entering her body from the ruptured prosthesis. Plaintiff seeks damages against Defendants under the theories of negligence, strict liability, negligent misrepresentation, negligence per se through adulterated device, fraudulent misrepresentation, breach of implied warranty, breach of express warranty, breach of warranty of fitness for a particular purpose, intentional infliction of emotional distress and negligent infliction of emotional distress. Plaintiff's husband, Riley Quillin, also pleads a derivative common-law tort claim against Defendants alleging that he suffered loss of consortium.
The primary issue before the Court is whether Plaintiffs' state common-law claims against Defendants are preempted by the Medical Device Amendments of 1976 ("MDA") ( 21 U.S.C. § 360c, et seq.) to the Food, Drug and Cosmetic Act, ( 21 U.S.C. § 301, et seq.). The United States Supreme Court recently addressed whether state-common law claims are preempted under the MDA inMedtronic, Inc. v. Lohr, ___ U.S. ___, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996). In that case, the Supreme Court held that the plaintiff's claims were not preempted. Defendants argue that theMedtronic decision is not dispositive because the medical device at issue in that case reached the market through the "substantially equivalent" process, rather than the premarket approval process. Plaintiffs, however, contend that the Supreme Court's analysis in Medtronic is applicable to this case and supports a finding of no preemption.
II.
Congress enacted the MDA in the midst of rising concern regarding the safety and effectiveness of the growing number of medical devices being introduced into the marketplace.Medtronic, 116 S.Ct. at 2246. The MDA gives the Food and Drug Administration ("FDA") broad powers to classify and regulate medical devices. Under the MDA, the FDA must assign a medical device to one of three statutorily delineated categories. Class I devices are those devices which present no unreasonable risk of illness or injury. They are subject only to "general controls" on manufacturing processes. Id. at 2246; 21 U.S.C. § 360(a)(1)(A). Tongue depressors are one example of a Class I medical device. Class II devices include items such as tampons and oxygen masks. Use of Class II devices involves some risk of injury and are subject to "special controls," including performance standards, use guidelines and post-market surveillance programs. Id.; 21 U.S.C. § 360(a) (1) (B). Class III devices are devices which either "`present a potential unreasonable risk of illness or injury,' or which are `purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health.'" Id. at 2246 (quoting 21 U.S.C. § 360(a) (1) (C)). They include the Angelchik Anti-Reflux Prosthesis, as well as pacemakers, heart valves and replacement joints. Because of their inherent dangerousness, Class III devices are subject to the most stringent FDA regulation.
In order to market a Class III device, a manufacturer generally must obtain premarket approval from the FDA. Premarket approval requires submission of a detailed application, including clinical data, manufacturing processes and proposed labeling. 21 U.S.C. § 360e(c). The process is intended to provide "reasonable assurance" that the device is both safe and effective. 21 U.S.C. § 360e(d) (2). The application is referred to a panel of qualified experts for study and submission of a report and recommendation respecting approval. 21 U.S.C. § 360e (c) (2). The FDA retains the right to withdraw its approval if it finds that a device previously approved is unsafe or ineffective. 21 U.S.C. § 360e(e).
Two important exceptions to the premarket approval requirement allow Class III devices to reach the marketplace without premarket approval review. First, a grandfather provision allows pre-1976 medical devices to remain on the market until such time as the FDA initiates and completes the requisite premarket approval process. 21 U.S.C. § 360e (b) (1) (A); 21 C.F.R. § 814.1 (c) (1). Second, the MDA allows devices that are "substantially equivalent" to preexisting devices to avoid the premarket approval process in order to permit them to compete with grandfathered devices. 21 U.S.C. § 360e (b) (1) (B).
Manufacturers of "substantially equivalent" Class III devices must submit to a limited form of review known as the "premarket notification" or the "510(k) process". This allows the device to be marketed without inquiry and without submitting much information if the FDA determines the device is substantially equivalent to a preexisting device. Medtronic, 116 S.Ct. at 2247. As noted by the Supreme Court in Medtronic, the section 510(k) process is limited in scope when contrasted to the premarket approval process. Whereas the premarket approval process requires about 1,200 hours of review, the section 510(k) process is completed in about 20 hours. Id. at 2247. The medical device in Medtronic reached the market through the "substantially equivalent" process.
III.
Before discussing the holding in Medtronic, the Court will briefly review the applicable principles of preemption. The doctrine of preemption, which is based upon the Supremacy Clause of the United States Constitution, provides that a state law is invalid to the extent it conflicts with federal legislation.Cipollone v. Liggett Group, Inc., 505 U.S. 504, 516, 112 S.Ct. 2608, 2617, 120 L.Ed.2d 407 (1992). Preemption occurs in several circumstances. A state law is preempted (1) when Congress expressly so provides, see, Jones v. Rath Packing Co., 430 U.S. 519, 525, 97 S.Ct. 1305, 1309, 51 L.Ed.2d 604 (1977); (2) when federal regulation of a legislative field is so comprehensive that there is no room for supplementary state regulation, see, Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230, 67 S.Ct. 1146, 1152, 91 L.Ed. 1447 (1947); and (3) when the state law is in actual conflict with a federal provision,see, Pacific Gas Elec. Co. v. State Energy Resources Conservation Dev. Comm'n, 461 U.S. 190, 204, 103 S.Ct. 1713, 1722, 75 L.Ed.2d 752 (1983).
In the MDA, Congress included an express preemption provision. Section 360k(a) of the MDA provides in pertinent part:
Except as provided in subsection (b) 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 —
(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.21 U.S.C. § 360k(a). Because an express preemption provision is provided, the scope of the statutory language need only be considered. See, Cipollone, 505 U.S. at 517, 112 S.Ct. at 2618. The interpretation of the scope of the statutory language "does not occur in a contextual vacuum," but rather is guided by two presumptions "that Congress does not cavalierly preempt state-law causes of action" and "that `[t]he purpose of Congress is the ultimate touchstone' in every preemption case." Medtronic, 116 S.Ct. at 2250 (quoting Retail Clerks Intern. Ass'n, Local 1625 v. Schermerhorn, 375 U.S. 96, 103, 84 S.Ct. 219, 222, 11 L.Ed.2d 179 (1963)).
IV.
In Medtronic, the Supreme Court addressed the preemptive scope of section 360k(a) with respect to state-law claims against the manufacturer of a Class III device marketed pursuant to the substantial equivalence process. The plaintiff and her husband filed suit against the defendant alleging claims of negligence and strict liability under Florida state law after the plaintiff was implanted with a pacemaker manufactured by the defendant, which contained an allegedly defective lead. The pacemaker lead was exempted from the premarket approval process under the section 510(k) process for substantially equivalent devices. After defendant removed the case to federal court, the defendant moved for summary judgment urging that the claims were preempted under section 360k(a). The district court initially denied the motion. However, shortly after its decision, the Eleventh Circuit Court of Appeals in an unrelated case held that section 360k(a) required preemption of at least some of the claims. The district court thereafter reconsidered its prior ruling and dismissed the plaintiff's complaint. The Eleventh Circuit reversed, in part, holding that the plaintiffs' negligence design claims and their strict liability claim arising from unreasonably dangerous design were not preempted by the MDA. The Eleventh Circuit upheld dismissal of the plaintiffs' negligent manufacturing and negligent failure to warn claims on preemption grounds.
In a five to four decision, the Supreme Court concluded that none of the plaintiff's state-law claims were preempted. The Court, in reaching its decision, relied on the MDA's purpose and legislative history, as well as the FDA's interpretative regulations in holding that the MDA did not preempt the plaintiffs' common law claims. With respect to the design defect claims, the Court determined that the section 510(k) process imposed no federal "requirement" with respect to the design of the device and therefore concluded that those claims were not preempted. Id. at 2254-55. In reaching its decision, the Court recognized that under the section 510k process, the pacemaker had never been formally reviewed for safety or equivalence; the focus of that procedure had been on equivalence, not safety.
As to the plaintiffs' state-law allegations that the manufacturer failed to comply with FDA requirements, the Court concluded that those claims were not preempted. The Court explained that the existence of a damages remedy "for violations of common law duties when those duties parallel federal requirements" does not necessarily mean that state law imposes a requirement different from or additional to the requirements imposed by the MDA. "[R]ather it merely provides another reason for manufacturers to comply with identical existing `requirements' under federal law." Id. In reaching its decision, the Supreme Court found that the ambiguity of section 360k(a) made it appropriate to defer to the assessment of the FDA that section 360k(a) does not preempt state-law "`requirements that are equal to, or substantially identical to, requirements imposed by or under the act.'" Id. at 2256 (quoting 21 C.F.R. § 808.1(d)(2)(1995)).
Regarding the plaintiffs' claims of negligent manufacturing and failure to warn, the Court deferred to the determination of the FDA that section 360k(a) preempts state requirements only when there exist "`specific counterpart regulations or . . . other specific requirements are applicable to a particular device'" under the MDA. Id. at 2257 (quoting 21 C.F.R. § 808.1(d)(1995)). According to the Supreme Court, the general requirements imposed pursuant to the MDA — the labeling and good manufacturing practice requirements found in 21 C.F.R. parts 801 and 820 — do not give rise to preemption of state-law claims. Moreover, in order to be preempted, state requirements must be "with respect to" medical devices, be "different from, or in addition to" federal requirements and relate "to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device." State requirements of "general applicability" are not preempted except where they have "the effect of establishing a substantive requirement for a specific device." Id. In Medtronic, the state requirement regarding negligent manufacturing was simply "the general duty of every manufacturer to use due care to avoid foreseeable dangers in its products." Id. at 2258. Similarly, the "failure to warn claim is the general duty to inform users and purchasers of potentially dangerous items of the risks involved in their use." Id. Thus, the Court found that the general state requirements were not developed "with respect to" a medical device and were not the "kinds of requirements" that would impede the implementation and enforcement of specific federal requirements. Id. at 2258.
The Medtronic Court was divided as to whether state common-law damages claims could ever be preempted by the MDA. A majority of the Court held that such actions do impose "requirements" under the MDA and are therefore preempted when the other conditions are satisfied. Id. at 2262. The majority based this conclusion on its reading of Cipollone, in which the Court concluded that the phrase "requirement or prohibition" in section 5(b) of the Public Health Cigarette Smoking Act of 1969 necessarily included common-law claims. In that case, the Court noted that "`[state] regulation can be as effectively exerted through an award of damages as through some form of preventive relief. * * * [Citation].'" Cipollone, 505 U.S. at 521, 112 S.Ct. at 2260.
V.
Defendants argue that the premarket approval process required by the FDA for Class III devices constitutes a "specific" federal requirement "applicable to the device" which preempts Plaintiffs' state common-law claims. The Supreme Court in Medtronic did not address whether the premarket approval process is a specific federal requirement. While a majority of the circuit courts have held that the premarket approval process constitutes a specific requirement, the Court agrees with the Ninth Circuit Court of Appeals in Kennedy v. Collagen Corp., 67 F.3d 1453 (9th Cir. 1995), cert. denied, 116 S.Ct. 2579 (1996), that the premarket approval process does not qualify as a specific federal requirement. As stated by the Ninth Circuit in Kennedy:
[I]t makes little sense to hold that the FDA's premarket approval process qualifies as a `specific requirement applicable to a particular device.' 21 C.F.R. § 808.1(d). All Class III devices are required to obtain premarket approval before being sold in interstate commerce. 21 U.S.C. § 360e; 21 C.F.R. § 814.1. The fact that the premarket approval process involves specific requirements, see 21 C.F.R. § 814, 820, must not be confused with the premarket approval requirement itself acting as a specific requirement.Id. at 1459.
The Court finds the Court's reasoning in Kennedy persuasive and rejects Defendants' argument that the premarket approval process constitutes a "specific requirement applicable to a particular device."
In Kennedy, the Ninth Circuit found none of the plaintiff's claims against the manufacturer of collagen-based products preempted. The Seventh Circuit, however, in Mitchell v. Collagen Corp., 67 F.3d 1268 (11th Cir. 1995), cert. granted, 116 S.Ct. 2576 (1996), found similar claims against the same manufacturer preempted. After Medtronic, the Supreme Court denied certiorari in Kennedy, but granted certiorari in Mitchell and remanded the case for consideration in light ofMedtronic.
Defendants state in their briefing that they have complied with the good manufacturing practice regulations. In light of the Supreme Court's decision in Medtronic, the Court finds that these general requirements do not preempt Plaintiffs' manufacturing claims. Medtronic, 116 S.Ct. at 2258 ("the federal requirements reflect important but entirely generic concerns about device regulation generally, not the sort of concerns regarding a specific device or field of device regulation which the statute or regulations were designed to protect from potentially contradictory state requirements").
In their briefing, Plaintiffs concede that the FDA imposed five device-specific requirements relating to the labeling of the Angelchik anti-reflux device. Plaintiffs state that these requirements may preempt certain elements of their claims as they develop through the course of the litigation. Because the exact scope of this potential preemption cannot be defined until Plaintiffs' claims become better defined through discovery, Plaintiffs request that Defendants' motion be denied.
The Court need not address whether specific requirements have been established as to labeling. As discussed below, the Court concludes that the state requirements, including a claim for failure to warn, are not preempted under section 360k(a) as they are not "requirements with respect to a device."
VI.
Even if the premarket approval process or the labeling requirements discussed by Plaintiffs were specific federal requirements, the Court must consider whether the state requirements in this case are "with respect to" medical devices. The Medtronic Court held that common-law claims challenging the manufacturing and labeling of medical devices were not preempted as they were "general obligations" imposed by the state on manufacturers. They were not state requirements specifically developed "with respect to" medical devices. 116 S.Ct. at 2258. Upon review, the Court finds that Plaintiffs' common-law claims relating to manufacturing, design defect, failure to test and failure to warn are predicated upon general obligations applicable to all manufacturers and, under the holding inMedtronic, are not requirements specifically established for medical devices. The Court also finds that they are not the sort of state requirements section 360k(a) was intended to preempt.
As to misrepresentation claims, the Court concludes that they are not preempted. Such claims are based upon a general obligation — "the duty not to deceive," see, Cipollone, 112 S.Ct. at 2624. The Court concludes that this duty is not preempted by section 360k(a). Similarly, the Court finds that the emotional distress claims are not preempted as they are predicated upon duties of general obligations. These state requirements escape preemption "because their generality leaves them outside the category of requirements that section 360k(a) envisioned to be `with respect to' specific devices."Medtronic, 116 S.Ct. at 2258.
The Court finds that the negligence per se claim is not preempted as it appears to be alleging violation of federal requirements. Such a claim is not "different from, or in addition to" the duties mandated by federal law." Id. at 2255-2256.
With regard to the implied warranty claims, the Court finds that the implied warranty claims are not preempted. AlthoughMedtronic did not address a claim for breach of implied warranty, the Court cited with approval an FDA regulation listing the Uniform Commercial Code as an example of the type of state regulation that is not preempted by section 360k. Medtronic, 116 S.Ct. at 2257 (citing 21 C.F.R. § 808.1(d) (1) (1995)).
Concerning the express warranty claim, Plaintiffs allege that Defendants expressly warranted that the silicone implants were of merchantable quality, fit and safe for human implantation, nontoxic and otherwise not injurious to the recipient's health and well-being. In Cipollone, the Court found that an express warranty that smoking did not "present any significant health consequences" was not preempted because the warranty was a "contractual commitment voluntarily undertaken" by the cigarette manufacturer. 505 U.S. at 525-26, 112 S.Ct. at 2262. The "requirements" imposed were not "imposed under State law," but rather "imposed by the warrantor." Cipollone, 505 U.S. at 525, 116 S.Ct. at 2622. In the instant case, the assertions forming the basis of Plaintiffs' claim appear to arise by Defendants' own express representations, not by a state-imposed duty. Therefore, the warranties are not state "requirements" and thus fall outside the scope of section 360k(a).
As to Mr. Quillin's consortium claim, the Court finds that the claim should be allowed to proceed since there is no preemption of Mrs. Quillin's claims.
VII.
In their motion, Defendants have raise two additional issues in regard to Plaintiff's claims. Defendants argue that Plaintiff's misrepresentation claims are subject to summary judgment as they lack the specificity required under Fed.R.Civ.P. 9(b). Defendants contend that Plaintiff has failed to identify (1) the persons who allegedly made misrepresentations to Plaintiff; (2) the occasion on which such statements were made to her and by whom; and (3) what affirmative misstatements or half-truths were directed to her and how. According to Defendant, Plaintiff's vague and conclusory allegations are insufficient to survive summary judgment. This Court disagrees.
The Court finds that the allegations in Counts III and V of the Second Amended Complaint meet the requirements of Rule 9(b). Plaintiff has alleged what the misrepresentations were: the silicone implants were safe; has alleged who made the misrepresentations: Defendants; and has alleged when the misrepresentations were made: prior to her surgery implanting the prosthesis. The Court finds that these allegations are sufficient to withstand summary judgment.
Defendant argues that Plaintiff's warranty claims are barred by the five-year statute of limitations set forth in Okla. Stat. tit. 12A, § 2-725(1). According to Defendants, the limitations period expired in 1987. Plaintiff concedes that section 2-725 (1) provides the governing five-year statute of limitations. However, Plaintiff argues that tolling provisions apply. Plaintiff contends that Defendants engaged in fraudulent concealment, thereby tolling the statute of limitations on Plaintiff's warranty claims.
The Court concludes that the tolling provisions do apply to the warranty claims. Okla. Stat. tit. 12A, § 2-725 (4). The Court also concludes that genuine issues of fact exist in regard to Defendants' defense of statute of limitations. Therefore, summary judgment is inappropriate.
VIII.
Based upon the foregoing, Defendant, Baxter Healthcare Corporation's Motion for Summary Judgment (Docket Entry #57) and Defendant, Baxter International, Inc.'s Motion for Summary Judgment (Docket Entry #61) are DENIED. This matter is hereby scheduled for a case management conference on April 24, 1997, at9:30 a.m.