McClellan v. I-Flow Corp.
| Decision Date | 23 January 2015 |
| Docket Number | Nos. 11–35109,11–35134.,s. 11–35109 |
| Citation | 776 F.3d 1035 |
| Parties | Christina McCLELLAN, Plaintiff–Appellant, v. I–FLOW CORPORATION, a Delaware corporation; DJO, L.L.C., a Delaware corporation; DJO Incorporated, a Delaware corporation; Pacific Medical, Inc., a California corporation, Defendants–Appellees. Christina McClellan, Plaintiff–Appellee, v. I–Flow Corporation, A Delaware corporation, Defendant–Appellant, and DJO, L.L.C., a Delaware corporation; DJO Incorporated, a Delaware corporation; Pacific Medical, Inc., a California corporation, Defendants. |
| Court | U.S. Court of Appeals — Ninth Circuit |
OPINION TEXT STARTS HERE
R. Daniel Lindahl, (argued), Lindahl Law Firm PC, Portland, OR, Leslie W. O'Leary, (substituted for R. Daniel Lindahl), Portland, OR, Jeffrey B. Wihtol, Law Offices of Jeffrey B. Wihtol, Portland, OR, for Plaintiff–Appellant/Cross–Appellee.
Andrew G. Klevorn, (argued) Katten Muchin Rosenman, LLP, Chicago, IL, and James W. Joseph, Elmer Stahl LLP, Chicago,IL, Eric J. Neiman, George S. Pitcher, Williams, Kastner & Gibbs, PLLC, Portland, OR, for Defendants–Appellees/Cross–Appellants I–Flow Corp.
Richard H. Nakamura, Jr., (argued) Morris Polich & Purdy LLP, Los Angeles, CA, Patrick Lysaught, Baker Sterchi Cowden & Rice, LLC, Kansas City, MO, Roger G. Perkins, Morris Polich & Purdy LLP, San Diego, CA, for Defendants–Appellees/Cross–Appellants DJO, LLC and DJO, Inc.
Appeal from the United States District Court for the District of Oregon, Ann L. Aiken, Chief District Judge, Presiding. D.C. No. 6:07–cv–01309–AA.
Before: ALFRED T. GOODWIN, HARRY PREGERSON, and MORGAN CHRISTEN, Circuit Judges.
Christina McClellan appeals the judgment entered in favor of defendant-appellees after a jury trial. Defendant I–Flow Corporation cross-appeals the district court's denial of costs. We vacate and remand for a new trial, and dismiss I–Flow's cross-appeal as moot.
McClellan underwent two surgeries to repair her anterior labrum, located in the shoulder. After each surgery, she was prescribed continuous infusion of a painkiller, delivered through a PainBuster continuous infusion pump device. I–Flow manufactured the PainBuster and defendants DJO, LLC and DJO Incorporated (collectively, DJO) distributed and sold the PainBuster.1 A continuous infusion pump contains a portable medication reservoir attached to a catheter that delivers the medication to the site—here, to the shoulder joint.
During her recovery from the second surgery, McClellan's physician diagnosed her with chondrolysis of the shoulder. This condition meant that McClellan suffered the loss of articular cartilage in her main shoulder joint (the glenohumeral joint). Articular cartilage provides a slick surface allowing bones to move easily. In McClellan's case, it specifically allows the “ball-and-socket” of the glenohumeral joint to move properly. She suffered a complete loss of articular cartilage, resulting in a spontaneous fusion of her shoulder due to the ball and socket growing together into a single bone. She has no motion in the joint and can move her shoulder only a few degrees. McClellan's condition is not treatable.
McClellan filed suit, alleging state common law claims for negligence and strict products liability. She advanced two theories of liability: (1) I–Flow negligently failed to warn that its pain pump should not be used in intra-articular spaces such as the glenohumeral joint; and (2) I–Flow was strictly liable for selling a product that was unreasonably dangerous due to a lack of adequate warnings. Prior to submission of the case to the jury and in denying McClellan's motion for a new trial, the district court declined to give certain requested instructions, reasoning that they were preempted by federal law.
The PainBuster is regulated under the Medical Device Amendments of 1976(MDA) to the Food, Drug & Cosmetics Act (FDCA).2 The MDA requires that manufacturers provide the U.S. Food and Drug Administration with “reasonable assurance of the safety and effectiveness” of a device prior to marketing and sale. 21 U.S.C. § 360c(a)(1)(A)(i), (B), (C)(i). This reasonable assurance process is known as “premarket approval.” Medtronic, Inc. v. Lohr, 518 U.S. 470, 477, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996). However, devices already on the market prior to 1976 are allowed to remain on the market without approval until the FDA completes an evaluation. Id. at 478, 116 S.Ct. 2240.
In addition to this “grandfathering provision,” Congress also included a provision to increase competition and “to prevent manufacturers of grandfathered devices from monopolizing the market” while other manufacturers of similar devices are undergoing the process of providing the FDA with safety assurances. Id. This provision exempts a device from the “reasonable assurance of safety” requirement if the manufacturer shows that the device is “substantially equivalent” to a grandfathered device. 21 U.S.C. § 360e(b)(1)(B); Lohr, 518 U.S. at 478, 116 S.Ct. 2240.
This process is known as the 510(k) process (after the original section number). Lohr, 518 U.S. at 478, 116 S.Ct. 2240. The 510(k) process requires the manufacturer to submit a “premarket notification” to the FDA. 21 U.S.C. § 360(k); Lohr, 518 U.S. at 478, 116 S.Ct. 2240. The FDA then uses the “premarket notification” to verify that the device is “substantially equivalent” to a grandfathered device. Lohr, 518 U.S. at 478, 116 S.Ct. 2240. Once a manufacturer submits a 510(k) notification and the FDA finds the device to be substantially equivalent to a pre–1976 device, the device can be marketed without the manufacturer having made any additional showing regarding the safety and effectiveness of the device. Id.
In the discussion below, we first address and reject I–Flow's argument that we lack jurisdiction to hear this appeal. We then turn to McClellan's contentions. McClellan assigns four errors to the district court: (1) it wrongly refused to give jury instructions regarding negligence and federal standards because it incorrectly concluded they were preempted; (2) it improperly barred expert testimony as to safety standards; (3) it improperly barred expert testimony as to an association between pain pump use and chondrolysis; and (4) it improperly excluded certain documentary evidence as hearsay. Because we hold that the requested instructions were not preempted by the MDA and remand for a new trial, we decline to reach the evidentiary issues.
We have appellate jurisdiction. This court has a duty to ensure subject matter jurisdiction exists over an appeal. See, e.g., D'Lil v. Best W. Encina Lodge & Suites, 538 F.3d 1031, 1035 (9th Cir.2008). I–Flow argues that no final, appealable judgment exists in this case, 28 U.S.C. § 1291, because a judgment as to fewer than all parties may be appealed “only if the [district] court expressly determines that there is no just reason for delay,” Fed.R.Civ.P. 54(b). The judgment in this case did not so state. There was no need to do so.
The district court severed the claims against DJO, Inc. as its alleged liability would be wholly derivative of DJO, LLC's liability. I–Flow argues that this severance somehow left the claims against DJO, Inc. unresolved, thereby requiring the district court to expressly state that the judgment was appealable. But as McClellan points out, the judgment identifies I–Flow, DJO, LLC, and DJO, Inc. as defendants, and states that judgment was entered in favor of the defendants. That alone settles the issue, as judgment was entered as to all defendants. And even if it was not, given the alleged derivative liability of DJO, Inc., there can be no serious argument that judgment in favor of DJO, LLC and dismissal of the action could preserve DJO, Inc.'s alleged liability. We therefore proceed to the merits of the appeal.
McClellan challenges the district court's refusal to give a negligence per se instruction,3 an instruction as to considering statutes and regulations in determining reasonable care,4 and nine special instructions related to federal law.
The Supremacy Clause of the Constitution makes evident that “state laws that conflict with federal law are ‘without effect,’ ” Altria Grp., Inc. v. Good, 555 U.S. 70, 76, 129 S.Ct. 538, 172 L.Ed.2d 398 (2008) (citation omitted). There are three types of preemption: (1) express preemption, (2) field preemption, and (3) conflict preemption. Id. at 76–77, 129 S.Ct. 538; Hillsborough Cnty., Fla. v. Automated Med. Labs., Inc., 471 U.S. 707, 713, 105 S.Ct. 2371, 85 L.Ed.2d 714 (1985). The district court relied upon, and the parties discuss, only conflict preemption.
Conflict preemption is implicit preemption of state law that occurs where “there is an actual conflict between state and federal law.” Altria Grp., 555 U.S. at 76–77, 129 S.Ct. 538. Conflict preemption “arises when [1] ‘compliance with both federal and state regulations is a physical impossibility,’ ... or [2] when state law ‘stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.’ ” Hillsborough Cnty., 471 U.S. at 713, 105 S.Ct. 2371 (citations omitted). Only the latter flavor of conflict, obstacle preemption, is at issue here.
In evaluating whether federal law has preempted state law, we must (1) look to “the purpose of Congress [as] the ultimate touchstone,” while also (2) “start[ing] with the assumption that the historic police powers of the States were not to be superseded ... unless that was the clear and manifest purpose of Congress.” Wyeth v. Levine, 555 U.S. 555, 565, 129 S.Ct. 1187, 173 L.Ed.2d 51 (2009). The presumption against preemption “applies with particular force when Congress has legislated in a field traditionally occupied by the States.” Altria Grp., 555 U.S. at 77, 129 S.Ct. 538. With respect to express preemption, “when...
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