Smith v. Depuy Orthopaedics Inc

Citation: 552 F. App'x 192Docket: No. 13-2148

Court: Court of Appeals for the Third Circuit; January 13, 2014; Federal Appellate Court

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Michael Smith appeals the denial of his motion for a continuance under Federal Rule of Civil Procedure 56(d) regarding his products liability case against DePuy Orthopaedics, Inc. and related entities (collectively, Defendants). Smith underwent two knee surgeries, receiving components of the Defendants’ P.F.C. Sigma Knee, which were FDA-approved through the premarket approval (PMA) process. Defendants sought summary judgment, claiming Smith's allegations were preempted, while Smith requested additional discovery through a cross-motion for a continuance. The District Court denied Smith's motion and granted summary judgment in favor of the Defendants. 

The Defendants manufacture the RP Knee, part of the LCS Total Knee System, regulated under the Medical Device Amendments. The RP Knee received FDA approval in 1985, and the P.F.C. Sigma Knee, introduced in 1996, was approved via the 510(k) process. Defendants later submitted PMA applications to update the RP Knee with new components, resulting in FDA approvals in 2000 and 2006. Smith's first surgery took place on October 15, 2007, where the RP Knee and P.F.C. Sigma components were implanted. Following ongoing issues, including chronic pain and confirmed loosening of the implant, Smith underwent a second surgery on July 20, 2009, where some original components were retained, and new components were added from the P.F.C. Sigma Knee. The appellate court will affirm the district court's ruling.

In 2010, Smith reported a condition involving a 'snapping behind the patella-femoral joint' and subsequently filed a complaint against Defendants for state law violations. A Magistrate Judge mandated the filing of summary judgment motions regarding preemption by August 24, 2012, while staying discovery except for specific manufacturing records requested by Smith. In response to Smith’s request for documents related to the approval and manufacture of surgical components, Defendants supplied over 3,000 regulatory documents pertaining to the P.F.C. Sigma Rotating Platform Total Knee System. On the deadline of August 24, 2012, Defendants filed for summary judgment, claiming Smith’s allegations were preempted. Smith requested two adjournments for the return date of September 17, 2012, which were granted, pushing it to October 29, 2012. The day before submitting his opposition to the summary judgment, Smith sought additional documents concerning components from a second surgery. He then filed his opposition and a cross-motion under Rule 56(d) for a continuance to conduct further discovery. The District Court granted Defendants’ summary judgment, ruling that Smith’s state law claims were preempted under Riegel due to FDA PMA approval of the device, and denied Smith's cross-motion, citing deficiencies in his affidavit under Rule 56(d). An appeal regarding the denial of the cross-motion ensued. The District Court held jurisdiction under 28 U.S.C. § 1332, and the appeal was reviewed under 28 U.S.C. § 1291, with the standard of abuse of discretion applied to the denial of additional discovery. A district court is permitted to grant summary judgment prior to completion of discovery if the opposing party had an adequate opportunity to obtain discovery, as outlined in Rule 56(d), which provides options for deferral or allowance of discovery based on a showing of need.

A party seeking further discovery in response to a summary judgment motion must submit a compliant affidavit detailing the specific information sought, how it would prevent summary judgment, and reasons for its prior unavailability. Failure to comply with this requirement is typically detrimental to claims of insufficient discovery on appeal. In this case, Smith contended that the District Court erred by granting summary judgment before he could obtain discovery related to components from his second surgery, necessary to ascertain their compliance with the PMA process and FDA approval. However, Smith's declaration lacked the necessary explanation of how the requested discovery would affect the summary judgment outcome, resulting in non-compliance with Rule 56(d).

Consequently, Smith could not leverage the claimed lack of discovery to overturn the District Court's ruling. The components in question were linked to previously approved FDA components of the PMA-approved RP Knee, indicating that no further discovery was necessary to establish PMA preemption. The District Court had already allowed limited discovery, and Smith's late request for additional regulatory documents—made just before his opposition brief was due—was deemed insufficient to warrant a continuance. Thus, the District Court acted within its discretion in denying the continuance and ruling on the summary judgment motion based on the available record. Furthermore, Smith did not challenge the finding that the components from the P.F.C. Sigma Knee were integrated into the RP Knee and received PMA approval, which undermined his argument on appeal. The court affirmed the District Court's denial of Smith's cross-motion for a continuance.

The application to the FDA outlines modifications to tibial tray stem lengths and locations, enabling compatibility with both LCS Complete and Rotating Platform bearings, as well as P.F.C. Sigma RP bearings. The claims presented under New Jersey’s Products Liability Act include allegations of manufacturing and design defects, failure to warn, negligence, breaches of express and implied warranties, negligent misrepresentation, fraudulent concealment, fraud and deceit, and a claim under the Virginia Consumer Protection Act. The Supreme Court's decision in Riegel establishes that state law claims are preempted when federal requirements exist, and claims are based on state laws that diverge from federal ones regarding safety and effectiveness. 

Smith sought additional discovery, arguing that documents provided by the Defendants indicated only 510(k) clearance for components, contradicting their assertion of inclusion in the PMA process. The District Court clarified that Smith misinterpreted the situation: the PMA Supplements relevant to the LCS Total Knee System incorporated components from the P.F.C. Sigma Knee previously cleared via the 510(k) process, thus subject to federal preemption. Smith failed to justify delaying the Defendants' summary judgment motion. Although he contended he could not ascertain whether the components from his second surgery had PMA approval, chart stickers indicated their relation to the P.F.C. Sigma Knee, and the Supplements confirmed that all components and bearings associated with it received PMA approval. Various case precedents were cited to support this interpretation of FDA approval.