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Steele v. DePuy Orthopaedics

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW JERSEY CAMDEN VICINAGE


November 20, 2003; as amended December 11, 2003.

WILLIAM C. STEELE, ET AL., PLAINTIFFS,
v.
DEPUY ORTHOPAEDICS, INC., DEFENDANT.

The opinion of the court was delivered by: Kugler, United States District Judge

FOR PUBLICATION

OPINION

In this product liability case, Plaintiffs William C. Steele and his wife Linda G. Steele filed suit, individually and on behalf of a class of similarly situated persons, against Defendant DePuy Orthopaedics, Inc., the manufacturer of an artificial knee joint prosthesis known as the "LCS-P/S Total Knee System" ("LCS-P/S Knee"). Plaintiffs assert state-law claims of negligent design, manufacturing, warnings, and labeling, as well as strict liability, breach of express and implied warranty, and fraudulent concealment by DePuy regarding the safety and efficacy of the LCS-P/S Knee.

DePuy moves for summary judgment, arguing that Plaintiffs' state-law claims are preempted by the 1976 Medical Device Amendments ("MDA") to the Food, Drug and Cosmetic Act ("FDCA"), 21 U.S.C. §§ 360 et seq., specifically, 21 U.S.C. § 360k(a), because the LCS-P/S Knee received premarket approval ("PMA") by the United States Food and Drug Administration ("FDA"). DePuy also moves to strike, or in the alternative requests that the Court disregard, the affidavits of Dr. Charles H. Kyper pursuant to Fed. R. Evid. 702 and Fed. R. Civ. P. 56(e).

For the reasons expressed below, DePuy's motion for summary judgment is (1) granted with respect to Plaintiffs' state-law claims of negligent manufacturing, design, warning and labeling, strict product liability, and breach of implied warranty of merchantability and fitness for a particular purpose, and (2) denied with respect to Plaintiffs' state-law claims of breach of express warranty and fraudulent concealment. The Court also grants DePuy's motion to strike Dr. Charles H. Kyper's affidavits.

I. FACTUAL BACKGROUND

A. The Parties

Plaintiff William C. Steele ("Steele") suffers from degenerative osteoarthritis in his knees. To alleviate the pain and discomfort associated with that disease and to increase Steele's mobility, doctors implanted the LCS-P/S Knee *fn1 in his knees. Defendant DePuy Orthopaedics, Inc. ("DePuy") designs, manufactures, distributes, and markets the LCS-P/S Knee, and its predecessor, the LCS-Knee.

Following his operation, Steele began to suffer "acute pain and swelling" and "hemarthrosis," or a "hemorrhage in a joint," in his knees. He alleges that his orthopedic surgeon, Dr. Stephen J. Zabinski, spoke with a sales representative of DePuy regarding Steele's post-operative complications. Steele claims that in response to those complaints, DePuy's sales representative "admitted" that the LCS-P/S Knee contained a design defect and had been withdrawn from the market for that reason.

Steele underwent surgery for the removal of the "tibial insert component" of the LCS-P/S Knee in his right knee. He maintains that he continues to suffer "pain, swelling, hemarthrosis and loss of mobility in his right knee," and likely will undergo surgery to extract the remainder of the LCS-P/S Knee in the right knee. As noted, Steele brought this class action against DePuy asserting state-law claims of negligence, strict product liability, breach of express and implied warranty, and fraudulent concealment regarding the safety and effectiveness of the LCS-P/S Knee's "tibial insert components." The class consists of "all citizens and residents of the United States who have had one or more LCS-P/S Knees surgically implanted in their bodies, together with their spouses." To date, the class has not been certified.

B. The MDA and the PMA process

In 1976, Congress enacted the Medical Device Amendments of the FDCA in response to public concern about the safety and effectiveness of medical devices. The MDA grants the FDA broad authority to regulate medical devices and establishes a regulatory framework that classifies medical devices intended for human use into three categories or classes "based on the risk that they pose to the public." Medtronic, Inc. v. Lohr, 518 U.S. 470, 476 (1996). Class I devices are those devices that present no unreasonable risk of illness or injury and are subject only to minimal regulation by "general controls." 21 U.S.C. § 360c(a)(1)(A). Class II devices, which present a greater risk of harm than Class I devices, may be marketed without advance FDA approval but require manufacturers to comply with federal performance regulations known as "special controls." 21 U.S.C. § 360c(a)(1)(B). Class III devices are devices that either (1) "present[] a potential unreasonable risk of illness or injury," or are (2) "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[.]" 21 U.S.C. § 360c(a)(1)(C)(ii)(I-II). The parties do not dispute that the LCS-P/S Knee, and its predecessor, the LCS-Knee, are Class III devices under the FDCA.

Before a Class III device can be marketed to the public, the manufacturer must provide the FDA with "reasonable assurance" that a device is both safe and effective. 21 U.S.C. § 360c(a)(1)(C)(i). The manufacturer may furnish those assurances through the FDA's premarket approval process. 21 U.S.C. § 360e(a). The rigorous and exhaustive PMA process requires manufacturers to "submit detailed information regarding the safety and efficacy of their devices, which the FDA then reviews, spending an average of 1,200 hours on each submission." Lohr, 518 U.S. at 477. *fn2 See 21 U.S.C. § 360e(c)(1)(A)-(G); 21 C.F.R. § 814.20. Typically, the FDA refers the device to an independent panel of experts, which prepares a report and recommendation on whether to approve the device. See 21 U.S.C. § 360e(d)(2). If the FDA determines that the manufacturer has provided reasonable assurances that the device is safe and effective for its intended use, then the agency issues an order that permits the manufacturer to market the device as approved. It does so after a manufacturer demonstrates that the manufacturing and processing methods and facilities conform to FDA requirements, and that the proposed labeling of the device is not false or misleading. 21 U.S.C. § 360e(d)(2). Thereafter, the manufacturer may not alter the approved labeling, product design, or manufacturing process in any way that would affect the safety or effectiveness of the device. 21 C.F.R. § 814.80.

If a manufacturer intends to modify a Class III device and that modification affects the safety and effectiveness of the device, the manufacturer must submit a PMA supplement for FDA approval. *fn3 21 C.F.R. § 814.39; see also 21 C.F.R. § 814.37 (permitting manufacturer to submit amendments to PMA or PMA supplement before approval). According to FDA regulations, changes that may affect the safety and effectiveness of the device include but are not limited to (1) new indications for use of the device, (2) labeling changes, (3) the use of a different facility or establishment to manufacture, process, or package the device, (4) changes in sterilization procedures, (5) changes in packaging, and (6) changes in the performance or design specifications, circuits, components, ingredients, principle of operation, or physical layout of the device. 21 C.F.R. § 814.39.

Three exceptions exist to allow a manufacturer to market a medical device without premarket approval. First, Congress incorporated a "grandfathering" provision in the MDA 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 for the device. See 21 U.S.C. § 360e(b)(1)(A); 21 C.F.R. § 814.1(c)(1). Second, an investigational device exemption ("IDE") permits manufacturers to market "a device that otherwise would be required to comply with a performance standard or to have premarket approval to be shipped lawfully for the purpose of conducting investigations of that device." 21 C.F.R. § 812.1. An IDE allows a manufacturer to use a device in clinical studies in order to collect information regarding the safety and effectiveness of the device. See 21 U.S.C. § 360j(g)(1).

Finally, "to prevent manufacturers of grandfathered devices from monopolizing the market while new devices clear the PMA hurdle, and to ensure that improvements to existing devices can be rapidly introduced into the market, the Act . . . permits devices that are `substantially equivalent' to pre-existing devices to avoid the PMA process." Lohr, 518 U.S. at 478 (citing 21 U.S.C. § 360e(b)(1)(B)). "Although `substantially equivalent' Class III devices may be marketed without the rigorous PMA review, such new devices, as well as all new Class I and Class II devices, are subject to the requirements of § 360k." Id. Section 360k "imposes a limited form of review on every manufacturer intending to market a new device by requiring it to submit a `premarket notification' to the FDA (the process is also known as a `§ 510(k) process,' after the number of the section in the original Act)." Id. As noted by the Supreme Court, "[t]he § 510(k) notification process is by no means comparable to the PMA process; in contrast to the 1,200 hours necessary to complete a PMA review, the § 510(k) review is completed in an average of only 20 hours." Id. at 478-79.

C. PMA review of the LCS-Knee and PMA supplement review of the LCS-P/S Knee
1. PMA review of the LCS-Knee

In 1980, DePuy began the multi-year approval process for the LCS-Knee by filing an IDE application with the FDA. That application included all relevant publications and research studies concerning the proposed device and its materials and design, a detailed proposal for the method and manner of conducting clinical studies including the methods and materials to be used for informed patient consent, and a description of the proposed product and its manufacturing processes and controls. After the FDA accepted DePuy's IDE application, certified orthopaedic surgeons conducted clinical studies on the LCS-Knee. Those studies, which were monitored by FDA-certified investigators, involved surgical implantation of the knee prosthesis on patients.

DePuy filed a PMA application for the LCS-Knee in 1983. That application consisted of more than 2000 pages, and included the design, manufacturing, and quality control procedures for the device, as well as an analysis of the data from the clinical studies involving the device. As part of the application process, the FDA required mechanical testing of the device by an independent third-party. In 1984, the FDA's independent advisory panel recommended approval of the LCS-Knee, and following further investigations and a review of the labeling of the device, the FDA approved the LCS-Knee for commercial distribution. It subsequently published a summary of the safety and effectiveness of the LCS-Knee in the Federal Register.

2. PMA supplement review of the LCS-P/S Knee

In response to "interest from the orthopedic surgical community for a posterior-stabilized knee with design features of the LCS product line," DePuy began the design work on the LCS-P/S (posterior stabilized) Knee in 1997. One year later, DePuy filed a PMA supplement application for the LCS-Knee, requesting approval for the addition of "posterior stabilized femoral and tibial bearing components and rotating platform (RP II) tibial trays and bearing components to the LCS Total Knee System." According to DePuy, the PMA supplement for the "posterior-stabilized components" contained the design rationale for the added components, fully dimensioned engineering drawings and photographs of all of the components, manufacturing process specifications, materials specifications, and sterilization and packaging specifications. The application also contained changes in the surgical technique necessitated by the components, along with draft labeling in the form of a package insert, representative copies of the packaging specifications and copies of the outer package labels.

The FDA evaluated DePuy's PMA supplement through a program known as "Real-Time" review. *fn4 Shortly thereafter, the FDA approved DePuy's PMA supplement. *fn5 That approval was subject to the FDA's "Conditions of Approval," as well as other general labeling and marketing restrictions set forth in 21 C.F.R. § 801.109. The FDA's document entitled "Conditions of Approval" required DePuy to submit the LCS-P/S Knee's proposed labeling before marketing, to limit advertising to the approved labeling, to submit a PMA supplement for review and approval before making any modifications affecting the safety or effectiveness of the device, to submit post-approval reports, and to report any incidents of adverse reaction to, or known defect of, the approved device. Pursuant to the FDA's request, DePuy subsequently submitted an amendment to the PMA supplement that included FDA-approved labeling for the LCS-P/S Knee.

In 2000, the FDA issued an "Enforcement Report" indicating that DePuy had voluntarily recalled the "PS Tibial Insert" of the LCS-P/S Knee.

II. SUMMARY JUDGMENT STANDARD

Summary judgment is proper "if the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to judgment as a matter of law." Fed. R. Civ. P. 56(c). An issue is "genuine" "if the evidence is such that a reasonable jury could return a verdict for the nonmoving party." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). A fact is "material" if it may affect the outcome of the suit under the applicable law. Id. In deciding whether there is a disputed issue of material fact, a court must view the facts and all reasonable inferences in a light most favorable to the nonmoving party. Id. at 250.

The moving party always "bears the initial responsibility of informing the district court of the basis for its motion, and identifying those portions of the `pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any,' which it believes demonstrate the absence of a genuine issue of material fact." Celotex Corp. v. Catrett, 477 U.S. 317, 323 (1986). However, where the nonmoving party bears the burden of persuasion at trial, "the burden on the moving party may be discharged by `showing'--that is, pointing out to the district court--that there is an absence of evidence to support the nonmoving party's case." Id. at 325. The non-moving party "may not rest upon the mere allegations or denials of" its pleadings and must present more than just "bare assertions, conclusory allegations or suspicions" to establish the existence of a genuine issue of material of fact. Fed. R. Civ. P. 56(e).

III. MOTION TO STRIKE

As a threshold matter, the Court must determine whether to strike, or in the alternative disregard, the affidavits of Dr. Charles H. Kyper pursuant to Fed. R. Evid. 702 and Fed. R. Civ. P. 56(e).

In opposition to DePuy's motion for summary judgment, Plaintiffs submit affidavits *fn6 by Dr. Charles H. Kyper, currently the principal consultant at Kyper & Associates, a medical device consulting firm, and formerly an employee with the FDA in different capacities from 1966 to 1994. Plaintiffs contend that Dr. Kyper's affidavits are offered "to demonstrate, with facts, the vast difference between a full PMA review (original LCS-Knee) . . . and the cursory and perfunctory Real-Time review" of the LCS-P/S Knee. Plaintiffs also argue that Dr. Kyper's affidavits establish that the "FDA's Real-Time review of the LCS-P/S Knee was equivalent, in terms of length and thoroughness, to the § 510(k) process which was found by the majority of the Supreme Court in [Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996)] to have no preemptive effect." DePuy counters that Dr. Kyper's "interpretation and application" of "selected FDA regulations" to the facts of this case "is a matter of law solely within the province of this Court and not within the proper scope of expert opinion" pursuant to Fed. R. Evid. 702. DePuy further argues that because Dr. Kyper lacks personal knowledge regarding the FDA's Real-Time review of the PMA supplement for the LCS-P/S Knee, the Court should strike his affidavits pursuant to Fed. R. Civ. P. 56(e).

In deciding a motion for summary judgment, the Court may consider evidence that would be admissible at trial. Rule 56(e) of the Federal Rules of Civil Procedure provides that an affidavit "shall be made on personal knowledge, shall set forth such facts as would be admissible in evidence, and shall show affirmatively that the affiant is competent to testify to the matters stated therein." See also Local Civ. R. 7.2(a) (stating that "[a]ffidavits shall be restricted to statements of fact within the personal knowledge of the affiant," and "[a]rgument of the facts and the law shall not be contained in affidavits").

The parties do not dispute that the FDA approved DePuy's PMA supplement for the LCS-P/S Knee. Rather, they disagree on whether that approval imposes specific federal requirements on the LCS-P/S Knee for purposes of triggering preemption under Section 360k(a) of the MDA. However, whether the FDA's approval of a PMA supplement imposes requirements on a particular device is a question of law to be determined by the Court, not a question of fact for the jury. Consequently, Dr. Kyper's opinion regarding the nature and scope of the FDA's Real-Time review of the LCS-P/S Knee would neither assist the trier of fact to understand evidence, nor help the jury to determine a fact in issue. See Fed. R. Evid. 702 (providing that expert opinion is admissible "[i]f scientific, technical, or other specialized knowledge will assist the trier of fact to understand evidence or to determine a fact in issue").

Further, Dr. Kyper's assessment of the FDA's approval of DePuy's PMA supplement lacks the requisite personal knowledge required by Fed. R. Civ. P. 56(e) and Local Civ. R. 7.2(a). Although Dr. Kyper attests that the information provided in his affidavits is based on personal knowledge, his affidavits do not indicate that he participated in the FDA's approval of the LCS-P/S Knee. Dr. Kyper's affidavits reveal that he merely reviewed correspondence between the FDA and DePuy and other related FDA materials, and based on that information only, concluded that certain deficiencies and misrepresentations made by DePuy existed in the FDA's review of the device. Dr. Kyper fails to present any evidence that he participated in the FDA's review of the LCS-P/S Knee. Moreover, his affidavits fail to indicate that he contacted the FDA to confirm the truth and accuracy of the information contained in the FDA's correspondence with DePuy. Finally, Dr. Kyper's original affidavit is replete with recitations and legal interpretations of FDA regulations regarding medical devices. Thus, because Dr. Kyper's affidavits contain unsubstantiated conclusory statements regarding the adequacy and extent of the FDA's review of DePuy's PMA supplement for the LCS-P/S Knee, coupled with rote recitations and legal interpretations of FDA regulations, the Court declines to consider them in deciding the instant motion. DePuy's motion to strike is granted.

IV. PREEMPTION

The Supremacy Clause of the United States Constitution provides that the "Laws of the United States . . . shall be the supreme Law of the Land." U.S. Const. art. VI, cl. 2. Accordingly, any "state law that conflicts with federal law is `without effect.'" Cipollone v. Liggett Group, Inc., 505 U.S. 504, 516 (1992) (citation omitted). Federal law may preempt, and thereby displace, state law in one of three ways: (1) "`express preemption,' which arises when there is an explicit statutory command that state law be displaced; (2) `field preemption,' which arises when federal law so thoroughly occupies a legislative field as to make reasonable the inference that Congress left no room for the States to supplement it; and (3) `conflict preemption,' which arises when a state law makes it impossible to comply with both state and federal law or when state law stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress." St. Thomas--St. John Hotel & Tourism Ass'n, Inc. v. Government of the United States Virgin Islands, 218 F.3d 232, 238 (3d Cir. 2000) (internal quotations and citations omitted).

DePuy moves for summary judgment, arguing that Plaintiffs' state-law claims are expressly preempted by the MDA because those claims would impose requirements different from, or in addition to, the specific federal requirements imposed on the LCS-P/S Knee by FDA regulations. *fn7 The MDA contains the following preemption provision:

[N]o 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). The FDA regulations interpreting Section 360k(a) provide in part:

State or local requirements are preempted only when the Food and Drug Administration has established specific counterpart regulations or there are other specific requirements applicable to a particular device under the act, thereby making any existing divergent State or local requirements applicable to the device different from, or in addition to, the specific Food and Drug Administration requirements. There are other State or local requirements that affect devices that are not preempted . . . because they are not "requirements applicable to a device" within the meaning of section [360k(a)] of the act. The following are examples of State and local requirements that are not regarded as preempted . .
(1) Section [360k(a)] does not preempt State or local requirements of general applicability where the purpose of the requirement relates either to other products in addition to devices (e.g., requirements such as general electrical codes, and the Uniform Commercial Code (warranty of fitness)), or to unfair trade practices in which the requirements are not limited to devices.
(2) Section [360k(a)] does not preempt State or local requirements that are equal to, or substantially identical to, requirements imposed by or under the act.
21 C.F.R. § 808.1(d). Although at first glance the language of Section 360k(a) might seem fairly straightforward, that section has spawned a legion of cases attempting to determine its preemptive scope.

A. Medtronic v. Lohr

In Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), the plaintiffs brought suit against the manufacturer of a Class III pacemaker device that had been approved as a device "substantially equivalent" to a pre-existing device, asserting state-law claims of negligence and strict liability. In a five-to-four decision, the Court held that the plaintiffs' claims were not preempted by the MDA.

Based on the statutory language and the FDA's regulations interpreting the scope of Section 360k(a), the Court established certain guideposts for determining whether state-law claims are preempted by the MDA. The Lohr majority *fn8 stated that state requirements must be "with respect to" medical devices, "different from, or in addition to," federal requirements, and must relate "to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device." Id. at 500. In addition, state requirements of "general applicability" are not preempted except where they have "the effect of establishing a substantive requirement for a specific device." Id. Federal requirements must be "applicable to the device," and preempt state law only if the FDA has established "specific counterpart regulations" or other "specific" regulations applicable to a particular device. Id. Once a court identifies the relevant federal and state requirements, it must conduct "a careful comparison" between those requirements "to determine whether they fall within the intended pre-emptive scope of the statute and regulations." Id. Applying those principles, the Lohr Court unanimously concluded that the plaintiffs' negligent design claims were not preempted because the Section 510(k) premarket notification process did not impose federal requirements on the design of the pacemaker. Id. at 492-94; Id. at 513 (O'Connor, J., concurring in part and dissenting in part). The Court explained that FDA approval under that process did not "require" the pacemaker to take "any particular form for any particular reason," and therefore "the agency simply allowed the pacemaker, as a device substantially equivalent to one that existed before 1976, to be marketed without running the gauntlet of the PMA process." Id. at 493-94. Next, the Court unanimously concluded that "[n]othing in § 360k denies [a state] the right to provide a traditional damages remedy for violations of common-law duties when those duties parallel federal requirements." Id. at 495; Id. at 513 (O'Connor, J., concurring in part and dissenting in part).

The Court sharply divided, however, on whether the plaintiffs' state-law manufacturing and labeling claims were preempted by the MDA. With respect to the nature of the federal requirement, the majority found that the federal manufacturing and labeling requirements applicable to all medical devices reflected "important but entirely generic concerns about device regulation generally, not the sort of concerns regarding a specific device or field of device regulation that the statute or regulations were designed to protect from potentially contradictory state requirements." Id. at 501. Accordingly, the Court explained that the "generality of those requirements make this quite unlike a case in which the Federal Government has weighed the competing interests relevant to the particular requirement in question, reached an unambiguous conclusion about how those competing considerations should be resolved in a particular case or set of cases, and implemented that conclusion via a specific mandate on manufacturers or producers." Id.

Similarly, with respect to the nature of the state requirement, the Court concluded that the plaintiffs' general state common-law claims were not "specifically developed" "with respect to" the pacemaker, and thus "escape[d] pre-emption, not because the source of the duty is a judge-made common-law rule, but rather because their generality leaves them outside the category of requirements that § 360k envisioned to be `with respect to' specific devices such as pacemakers." Id. at 501-02. Justice O'Connor, writing on behalf of the Chief Justice, Justice Scalia, and Justice Thomas, primarily disagreed with the plurality's conclusion that the plaintiffs' claim survived preemption "insofar as they would compel [the manufacturer] to comply with requirements different from those imposed by the FDCA." Lohr, 518 U.S. at 513 (O'Connor, concurring in part and dissenting in part). Justice O'Connor stated that the plaintiffs' "claims regarding manufacture would, if successful, impose state requirements `different from, or in addition to,' the FDA's `extensive federal manufacturing and labeling requirements[.]" Id. at 514.

Justice Breyer, concurring in part and concurring in the judgment, agreed with Justice O'Connor's conclusion that state common-law damages actions impose requirements on a particular device, and are therefore preempted where such requirements would differ from those imposed by the FDCA. Lohr, 518 U.S. at 504. However, Justice Breyer agreed with the plurality that the FDA's manufacturing and labeling requirements imposed on the pacemaker, "even if numerous," were not "`specific' in any relevant sense," and therefore did not preempt state-law claims of general applicability. Id. at 507 (Breyer, J., concurring in part and concurring in the judgment). Finding that "no actual conflict" existed "between any federal requirement and any of the liability-creating premises of the plaintiffs' state-law suit," Justice Breyer concurred with the Court's judgment that the plaintiff's state-law claims were not preempted by the MDA. Id. at 507-08.

B. Post-Lohr & whether PMA and PMA supplement review imposes federal requirements on the LCS-P/S Knee.
Based on the tenets articulated by the Lohr Court, this Court must first determine whether FDA approval of DePuy's PMA supplement imposes specific federal requirements on the LCS-P/S Knee. *fn9 This is a close question. First, although the Court in Lohr attempted to articulate general guideposts for determining the preemptive scope of Section 360k, it did not address a central issue in this case: whether PMA and/or PMA supplement approval of a Class III medical device by the FDA imposes requirements on a particular device within the meaning of the MDA and the FDA's regulations interpreting the scope of Section 360k(a).

In the wake of Lohr, courts have divided sharply on this issue. A majority of federal circuit courts and state courts of last resort have held that the PMA process imposes specific federal requirements on a medical device so as to trigger preemption of state-law claims. See, e.g., Brooks v. Howmedica, Inc., 273 F.3d 785, 795-96 (8th Cir. 2001) (en banc), cert. denied, 535 U.S. 1056 (2002); Martin v. Medtronic, Inc., 254 F.3d 573, 584 (5th Cir. 2001), cert. denied, 534 U.S. 1078 (2002); Kemp v. Medtronic, Inc., 231 F.3d 216, 226-27 (6th Cir. 2000), cert. denied, 534 U.S. 818 (2001); Mitchell v. Collagen Corp., 126 F.3d 902, 911 (7th Cir. 1997), cert. denied, 523 U.S. 1020 (1998); see also Horn v. Thermo Cardiosystems, Inc., 229 F. Supp. 2d 381, 390 (M.D. Pa 2002); Enlow v. St. Jude Med., Inc., 210 F. Supp. 2d 853, 858-62 (W.D. Ky. 2001); In re Medtronic Polyurethane Insulated Pacing Lead Prod. Liab. Lit., 96 F. Supp. 2d 568, 570 (E.D. Tex. 1999); Easterling v. Cardiac Pacemakers, Inc., 986 F. Supp. 366, 373-75 (E.D. La. 1997); Richman v. W.L. Gore & Assocs., 988 F. Supp. 753, 758 (S.D.N.Y. 1997); Milkiewicz v. Baxter Healthcare Corp., 963 F. Supp. 1150, 1156 (M.D. Fl. 1996); Worthy v. Collagen Corp., 967 S.W.2d 360, 376 (Tex.), cert. denied, 524 U.S. 954 (1998); Fry v. Allergan Med. Optics, 695 A.2d 511, 516 (R.I.), cert. denied, 522 U.S. 952 (1997); Green v. Dolsky, 685 A.2d 110, 117-18 (Pa. 1996), cert. denied, 520 U.S. 1168 (1997). On the other hand, a minority of courts have found that the PMA review process is not device-specific, and therefore does not preempt state-law claims. See, e.g., Goodlin v. Medtronic, Inc., 167 F.3d 1367, 1375-80 (11th Cir. 1999); Woods v. Gliatech Inc., 218 F. Supp. 2d 802, 808 (W.D. Va. 2002); Webster v. Pacesetter Inc., 171 F. Supp. 2d 1, 10-12 (D.D.C. 2001); Haidak v. Collagen Corp., 67 F. Supp. 2d 21, 28-29 (D. Mass. 1999); Lakie v. SmithKline Beecham, 965 F. Supp. 49, 53-54 (D.D.C. 1997); Weiland v. Telectronics Pacing Sys., Inc., 721 N.E.2d 1149, 1152 (Ill. 1999);.

Prior to Lohr, the Third Circuit Court of Appeals had found that PMA approval of a Class III medical device imposes specific requirements on a particular device sufficient to preempt state-law claims. Michael v. Shiley, Inc., 46 F.3d 1316, 1324 (3d Cir.), cert. denied, 516 U.S. 815 (1995). There, the recipient of a defective heart valve brought suit against the manufacturer of that device for negligent design, strict liability, breach of express and implied warranty, fraud-on-the-FDA, and common-law fraud by the manufacturer. Id. at 1321. The heart valve had received PMA approval. However, the Court of Appeals noted that because the device "was one of the first medical devices to be approved" under the MDA, the manufacturer's PMA application did not receive "the same organized and comprehensive evaluation that might be expected today." Id. at 1320. In determining whether the FDA had imposed requirements on the heart valve, the court found that although the FDA's "generally applicable" labeling and manufacturing regulations did not "rise to the level of specificity present in the case of some other devices regulated by the FDA," those regulations nonetheless presented "`specific requirements applicable to a particular device under the act.'" Id. at 1324. Although the majority in Lohr rejected Shiley's conclusion that the FDA's "generally applicable" labeling and manufacturing regulations found in 21 C.F.R. §§ 801.1-801.16 and §§ 21 C.F.R. 820.1-820.198 present specific requirements applicable to a particular device, Lohr did not address whether PMA and/or PMA supplement approval imposes requirements on the device sufficient to trigger preemption under Section 360k(a). Complicating the matter further, since Lohr the Third Circuit has not addressed this question.

Not surprisingly, DePuy argues that Shiley, as well as a majority of pre- and post-Lohr decisions in other jurisdictions instruct that PMA and PMA supplement approval impose requirements on a Class III medical device such as the LCS-P/S Knee. Plaintiffs counter that Lohr, as well as post-Lohr Third Circuit decisions suggest that their claims are not preempted by the MDA. Specifically, Plaintiffs contend that Hawkins v. Leslie's Pool Mart, Inc., 184 F.3d 244 (3d Cir. 1999); In re Orthopedic Bone Screw Prods. Liab. Litig., 193 F.3d 781 (3d Cir. 1999) (Bone Screw II); and In re Orthopedic Bone Screw Prods. Liab. Litig., 159 F.3d 817 (3d Cir. 1998) (Bone Screw I), rev'd, Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (2001), are both dispositive of the instant motion, and are "directly in opposition to the legal theory DePuy advances for express preemption." *fn10 This Court finds Plaintiffs' arguments unpersuasive.

First, Bone Screw I and Bone Screw II are inapposite to the instant case because those cases dealt with medical devices approved as devices "substantially equivalent" to pre-existing devices, not the PMA and PMA supplement processes at issue. Second, Hawkins also is distinguishable. That case addressed whether a plaintiff's failure-to-warn claim against the manufacturer of chlorinator tablets was preempted under an express provision of the Federal Insecticide, Fungicide, and Rodenticide Act ("FIFRA"), 7 U.S.C. § 136 et seq. Hawkins, 184 F.3d at 246. Because the statutory language and regulatory scheme of the FIFRA differs from that of the FDCA, Hawkins does not control the disposition of the instant motion.

Based on the Third Circuit's decision in Shiley, which found that the PMA process imposes requirements on a Class III medical device, and the reasoning expressed by a majority of courts in other jurisdictions following Lohr, which support that view, see, e.g., Martin, 254 F.3d at 584, Kemp, 231 F.3d at 226-27, Mitchell, 126 F.3d at 911, this Court finds that FDA approval of the PMA supplement for the LCS-P/S Knee imposes specific federal requirements applicable to that device sufficient to trigger preemption under Section 360k(a). The Seventh Circuit, for example, has observed that PMA of a product's design, testing, intended use, manufacturing methods, performance standards and labeling, is "specific to the product," and therefore preempts state-law claims that would impose requirements "different from, or in addition to" the agency's determination on those matters. Mitchell, 126 F.3d at 913. Similarly, the Fifth Circuit has held that the PMA process imposes specific requirements as to the labeling, manufacturing, and design of a Class III medical device. Martin, 254 F.3d at 581, 583-84 (reaffirming its pre-Lohr decision in Stamps v. Collagen Corp., 984 F.2d 1416, 1422 (5th Cir.), cert. denied, 510 U.S. 824 (1993)); see also Kemp, 231 F.3d at 226-28 (finding PMA and PMA supplement approval of Class III pacemaker constitute specific requirement invoking preemption under § 360k).

Recently, in Horn v. Thermo Cardiosystems, Inc., 229 F. Supp. 2d 381 (M.D. Pa 2002), the recipient of a Class III heart pump brought suit against the manufacturer of that device for negligence, strict liability, and breach of implied warranties of merchantability and fitness for a particular purpose. Id. at 384-85. Relying on an "overwhelming weight of authority," id. at 383, and citing evidence of extensive and continuous review of the device by the FDA, id. at 386-88, the Horn court concluded that "the PMA process is a specific federal requirement applicable to" the device. Id. at 390. The court also noted that its decision was "consistent with pre-Lohr Third Circuit law, which decrees that the PMA is a federal requirement that triggers MDA preemption." Id. (citing Shiley, 46 F.3d at 1324).

Here, DePuy has demonstrated that the FDA rigorously and continually regulated the labeling, marketing, and design of the LCS-Knee and its successor, the LCS-P/S Knee. Although the requirements imposed by the PMA and PMA supplement processes are applicable to many Class III devices, the absence of regulations that relate specifically, or refer directly, to the LCS-P/S Knee does not preclude a finding that the FDA has imposed requirements applicable to the subject device. Unlike the "entirely generic" federal labeling and manufacturing applicable to all medical devices, see Lohr, 518 U.S. at 493, 501, PMA and PMA supplement approval require a manufacturer to demonstrate with particularity that the device is both safe and effective for its intended use. Indeed, prior to the FDA's approval of DePuy's PMA supplement for the LCS-P/S Knee, the agency reviewed and evaluated the specific design, manufacturing, and labeling of that device, see 21 U.S.C. §§ 360e(c), 360e(d)(2), and specifically determined that the device was both safe and effective "with respect to the persons for whose use the device is represented or intended, with respect to the conditions of use prescribed, recommended, or suggested in the labeling of the device," and after "weighing any probable benefit to health from the use of the device against any probable risk of injury or illness from such use." 21 U.S.C. § 360c(a)(2). Moreover, the FDA continually monitored and imposed restrictions on the design, labeling, and marketing of the LCS-P/S Knee. See 21 C.F.R. § 814.39; see also 21 C.F.R. § 803.1 (requiring manufacturer to report "deaths and serious injuries" related to the operation of the device, to "maintain adverse event files," and to submit to FDA "specified follow-up and summary reports"). Following FDA approval of the LCS-P/S Knee, DePuy could not change the design, manufacturing, labeling, packaging, or quality control methods without further FDA approval. The Court finds that the FDA's approval of DePuy's PMA supplement for the LCS-P/S Knee evinces a situation where "the Federal Government has weighed the competing interests relevant to the particular requirement in question, reached an unambiguous conclusion about how those competing considerations should be resolved in a particular case or set of cases, and implemented that conclusion via a specific mandate on manufacturers or producers." Lohr, 518 U.S. at 501. Accordingly, consistent with pre-Lohr Third Circuit case law and a majority of post-Lohr courts in other jurisdictions, the Court finds that the FDA's approval of the PMA supplement for the LCS-P/S Knee imposes specific requirements on that device sufficient to trigger preemption under Section 360k(a).

Having determined that PMA supplement approval imposes requirements on the subject device, the Court must determine whether Plaintiffs' state-law claims impose requirements different from, or in addition to, those requirements. *fn11

1. Negligence, Strict Liability, and Breach of Implied Warranty
Plaintiffs assert that DePuy defectively designed and manufactured the tibial insert components of the LCS-P/S Knee, and failed to provide users and medical providers with adequate warning regarding the defective, inherently dangerous, and unsafe condition of that device. DePuy argues that Plaintiffs' negligence, strict liability, and breach of the implied warranty of merchantability and implied warranty of fitness for a particular purpose claims, if successful, would impose requirements different from, or in addition to, the requirements imposed by the FDA through PMA and PMA supplement approval of the LCS-P/S Knee, and, therefore, are preempted by the MDA. This Court agrees.

The Third Circuit has held that state-law claims of negligent manufacture and design, strict liability, and breach of implied warranty may impose requirements different from, or in addition to, federal requirements imposed on a particular device by the FDA. Shiley, 46 F.3d at 1323, 1324; Gile v. Optical Radiation Corp., 22 F.3d 540, 541-42, 543-44 (3d Cir.), cert. denied, 513 U.S. 965 (1994). Specifically, the Third Circuit in Shiley held that because of the potential conflict between state- law negligence, strict liability, and breach of implied warranty claims with FDA labeling, design, and manufacturing requirements, those claims are preempted by the MDA. Shiley, 46 F.3d at 1324 (relying on Gile, 22 F.3d at 543-44). Critical to the disposition of this motion, then, is whether, and to what extent, if any, Lohr overruled Shiley and Gile on this issue.

A plurality in Lohr found that "few, if any, common-law duties have been preempted by [the] statute." Lohr, 518 U.S. at 502-03. However, the plurality stopped short of concluding that "common-law duties are never requirements within the meaning of 360k and that the statute therefore never pre-empts common-law actions." Id. at 502 (emphasis added). The majority also agreed that state-law requirements of "general applicability" are not preempted except where they have the "effect of establishing a substantive requirement for a specific device." Id. at 500. Five Justices disagreed with the plurality's conclusion that the MDA would "rarely" preempt state common-law actions. Id. at 504 (Breyer, J., concurring in part); Id. at 510, 511 (O'Connor, J., concurring in part and dissenting in part). Justice O'Connor stated that "state common-law damages actions do impose `requirements' and are therefore preempted where such requirements would differ from those imposed by the FDCA." Id. at 510, 511 (O'Connor, J., concurring in part and dissenting in part)(stating that "[w]hether relating to the labeling of cigarettes or the manufacture of medical devices, state common-law damages actions operate to require manufacturers to comply with common-law duties"). Agreeing with Justice O'Connor on that point, Justice Breyer stated that "a contrary holding would have anomalous consequences." Id. at 504 (Breyer, J., concurring in part). To illustrate that proposition, Justice Breyer offered the following hypothetical:

Imagine that, in respect to a particular hearing aid component, a federal MDA regulation requires a 2- inch wire, but a state agency regulation requires a 1-inch wire. If the federal law, embodied in the "2-inch" wire MDA regulation, pre-empts the state "1-inch" agency regulation, why would it not similarly pre-empt a state-law tort action that premises liability upon the defendant manufacturer's failure to use a 1-inch wire (say, an award by a jury persuaded by expert testimony that use of a more than 1-inch wire is negligent)? The effects of the state agency regulation and the state tort suit are identical.
Id. Thus, based on Justice Breyer's concurrence, five justices agreed that state-law damage actions can constitute requirements sufficient to trigger preemption by the MDA. Lohr, 518 U.S. at 509 (O'Connor, J., dissenting); Id. at 503 (Breyer, J., concurring in part). Given the Court's fractured decision on whether state-law duties of general applicability can impose requirements for purposes of preemption, and the fact that the majority agreed that state-law requirements of "general applicability" are not preempted except where they have the "effect of establishing a substantive requirement for a specific device," this Court does not believe that Lohr explicitly or implicitly overrules Shiley and Gile. Accordingly, state-law claims of general applicability may be preempted where they have the effect of establishing a substantive requirement for a specific device.

Plaintiffs' claims are predicated on DePuy's alleged inadequate design, manufacturing, and labeling of the LCS-P/S Knee. Although those claims are based on general duties not specifically developed "with respect to" the LCS-P/S Knee, to succeed on those claims, the jury would have to conclude that the LCS-P/S Knee contained inadequate labeling, or was unreasonably dangerous or defective, despite the FDA's determination on those matters. See, e.g., Shiley, 46 F.3d at 1324-25 (stating that jury's finding that manufacturer breached implied warranties was preempted because accepted standards for design and manufacture of products under state law may deviate from FDA's determinations in PMA process); Horn, 229 F. Supp. 2d at 390 (finding that "any judgment that the [Class III PMA-approved medical device] was unsafe or otherwise substandard would be in direct conflict--i.e., different from--the FDA's determination that the product was suitable for use"). For example, Plaintiffs contend that the LCS-P/S Knee was unsafe for its intended purpose and unreasonably dangerous to users. If successful, those claims would require a jury to conclude that the FDA's determination of the safety and efficacy of the device was insufficient, thereby imposing requirements different from, or in addition to, the FDA's determination on those matters. Such a ruling would have "the effect of establishing a substantive requirement" for the LCS-P/S Knee, and therefore is preempted. See Lohr, 518 U.S. at 500; see, e.g., Mitchell, 126 F.3d at 915 (finding that "state judgment for breach of implied warranty that rested on allegations about standards other than those permitted by the FDA would necessarily interfere with the PMA process and, indeed, supplant it"). The Court finds that Plaintiffs' negligence, strict liability, and breach of implied warranty claims impose safety and effectiveness requirements on the LCS-P/S Knee that, if successful, would differ from, or impose additional requirements to, those requirements established by the FDA on that device, and are, therefore, preempted by the MDA. Accordingly, DePuy's motion for summary judgment is granted with respect to Plaintiffs' negligence, strict liability, and breach of implied warranty claims.

2. Breach of Express Warranty

DePuy argues that Plaintiffs' breach of express warranty claim is preempted under Section 360k(a). Relying on Shiley, 46 F.3d at 1325-27, Plaintiffs assert that their breach of express warranty claim is not preempted by the MDA.

In Shiley, the plaintiff brought a claim for breach of an express warranty based on statements made by the manufacturer on its packaging and labeling of the device. Id. at 1325. The court found that because express warranties "arise from representations of the parties," and therefore "do not result from the independent operation of state law," the MDA does not preempt state-law claims of breach of express warranty. Id.; accord Mitchell, 126 F.3d at 915. In other words, because a breach of express warranty claim "is not a product of state action," and hence, "not state imposed--the sine qua non of pre-emption under § 360k," that claim is not preempted by the MDA. Id. at 1328; see also Cipollone, 505 U.S. at 526 (noting that "`requirements' imposed by an express warranty claim are not `imposed under State law,' but rather imposed by the warrantor").

The court in Shiley also rejected the manufacturer's argument that because the labels on its product were approved by the FDA, any contract claims based on the representations made on those labels conflicted with the FDA's supervision over medical device labeling. 46 F.3d at 1327-28; but see Enlow v. St. Jude Med., Inc., 210 F. Supp. 2d 853, 861-62 (W.D. Ky. 2001) (finding Third Circuit's reasoning in Shiley "unpersuasive," and holding express warranty claim preempted by the MDA). First, the court noted that "[t]he fact that third parties dictate or define the terms of a contract does not undermine the doctrine that contractual duties arise from the mutual assent of parties to agreed upon language." Shiley, 46 F.3d at 1327. Second, the court found significant the manufacturer's "active" and "meaningful" participation in the development and design of the FDA-approved labeling. Id. at 1328. Finally, the court found that Section 360k did not preempt the plaintiff's express warranty claim to the extent that the claim sought to enforce the same requirements as imposed by the FDA. Id. In that regard, the court explained that "[b]ecause the obligations imposed arise from the FDA's own approved language, the resulting liability does not differ from or add to FDA regulation." Id.

Similar to the plaintiff in Shiley, Plaintiffs here argue that DePuy breached express warranties because the LCS-P/S Knee did not "conform to the representation defendant made in its promotional and advertising material[s][.]" *fn12 To the extent that Plaintiffs' breach of express warranty claim is predicated on DePuy's failure to adhere to FDA-approved packaging, labeling or advertising materials regarding the LCS-P/S Knee, Shiley instructs that those claims are not preempted under Section 360k(a). 46 F.3d at 1327-28. Furthermore, any express warranty claims that are based on representations made by DePuy concerning non-FDA approved promotional and advertising materials also are not preempted by the MDA because those claims arise out of a private contractual agreement rather than "a product of state action." Id. at 1328. Accordingly, DePuy's motion for summary judgment is denied with respect to Plaintiffs' breach of express warranty claims. *fn13

3. Fraudulent Concealment

New Jersey recognizes the common-law tort of fraudulent concealment. Rosenblit v. Zimmerman, 766 A.2d 749, 757-58 (N.J. 2001); Viviano v. CBS, Inc., 251 N.J. Super. 113, 123 (App. Div. 1991), cert. denied, 606 A.2d 375 (N.J. 1992). To succeed on that claim, a plaintiff must prove that: (1) the defendant had a duty to disclose information to the plaintiff; (2) the information was material; (3) the plaintiff could not readily have learned of the information without the defendant disclosing it; (4) the defendant intentionally withheld, altered, or destroyed the information; and (5) the plaintiff suffered harm by relying on the non-disclosure. Rosenblit, 766 A.2d at 758; Viviano, 251 N.J. Super. at 123.

DePuy argues that Plaintiffs' fraudulent concealment claim is preempted. Again, the Third Circuit's decision in Shiley, 46 F.3d at 1329-31, is instructive. There, the plaintiff alleged that the manufacturer of a defective heart valve had "sent cardiac surgeons and cardiologists a series of letters and other promotional materials which knowingly misrepresented the extent of the valve fracture problem and knowingly overstated the reduction in serious side effects achieved" by the heart valve. Id. at 1329. The court found that the plaintiff's "fraudulent promotion" claim was not preempted for two primary reasons. Id. at 1330-31. First, the court noted that unlike a strict liability claim, which is predicated on the duty to produce a safe product, a fraud claim is based "`on a more general obligation -- the duty not to deceive,'" id. at 1330 (quoting Cipollone, 505 U.S. at 528-29), and therefore does not "relate to the safety or effectiveness" of a particular device. Second, the court noted that the FDA had neither imposed specific requirements on the advertising or promotional materials for the device nor regulated or supervised the manufacturer's efforts to promote the device. Based on those circumstances, the court held that the plaintiff's fraud claim was not preempted.

Plaintiffs allege that DePuy "concealed information regarding the lack of safety and/or defective condition" of the LCS-P/S Knee from the recipients of that device and their medical providers. *fn14 Under Shiley's and Lohr's preemption framework, the Court must determine whether the FDA required DePuy to disclose information regarding the safety and effectiveness of the subject knee prosthesis. Because DePuy fails to identify whether the FDA has imposed requirements on DePuy regarding its obligation to disclose certain information to patients and other relevant parties, the Court cannot determine whether Plaintiffs' fraudulent concealment claim is preempted by the MDA. Accordingly, DePuy's motion for summary judgment is denied on Plaintiffs' fraudulent concealment claim.

V. CONCLUSION

DePuy's motion for summary judgment is (1) granted with respect to Plaintiffs' state-law claims of negligent manufacturing, design, warning and labeling, strict product liability, and breach of implied warranty of merchantability and fitness for a particular purpose, and (2) denied with respect to Plaintiffs' state-law claims of breach of express warranty and fraudulent concealment. The Court also grants DePuy's motion to strike Dr. Charles H. Kyper's affidavits.


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