Searching over 5,500,000 cases.

Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

Steele v. DePuy Orthopaedics

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


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



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.


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 ...

Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.