Last week we wrote about body part transplants. In legal terms, we asked whether body parts could be the basis of a product liability action. No, they cannot. In cinematic terms, we asked whether grafting a killer’s body part onto an otherwise good person can lead to mayhem. Yes, it can. At least that scenario is plausible enough to pass TwIqbal muster as that standard is applied by the less fussy courts. We’re not joking. It is an interesting thought-experiment to ask whether there are some courts that would wave such a claim through, permitting discovery as to whether a transplant could turn the poor plaintiff into a killer. The crazily-lenient court would sniff at our arguments, telling us that any weaknesses in plaintiff’s theory could be explored on cross-examination and pondered by a jury of someone’s peers.
We admit that our standard of plausibility is a tad tougher. It still drives us crazy that Steve Austin, The Six Million Dollar Man, supposedly could lift several tons with his bionic arm. The bionic arm was attached, of course, to a not-so-bionic torso, waist, and leg – wouldn’t those ordinary body parts be crushed by the load? Then there’s the metaphysical question as to whether transplants could be so extensive or fundamental as to render the recipient a different person. We’re pretty sure we encountered this issue in a story by Poe and a movie on Lifetime. We read one tale of a man who removed his artificial parts one-by-one (eye, nose, arm, leg, etc.) until there was virtually nothing left. We have seen something very like that during expert depositions.
The ancients puzzled over when a change in parts produced a different whole. In Plutarch’s Life of Theseus, Plutarch asked whether a ship that was restored by replacing each and every one of its wooden parts remained the same ship. In more modern times, there is the example of George Washington’s axe, which three times had its handle replaced and twice had its head replaced. Was it really the same axe? In his Essay on Human Understanding, Locke discussed the Principium Individuationis. If atoms are taken away or added, an object is no longer the same mass or body. And yet, living creatures are different. For them, identity depends not on a mass of the same particles, but on something else. An oak growing from a plant to a great tree and then lopped is still the same tree. Man is different still. Locke thought that for man self depends on consciousness, not substance. By that reasoning, when lawyers drone on at trial and render some of the jurors unconscious, they have effectively created a new jury. It might be intentional. Somehow, all of this made us think of the old Wendy’s “Parts is parts” commercial. And then we got hungry.
And now for the segue from what the DDL Daughter calls the Interesting Pause to what she calls the Boring Law Bits. The question of when or whether the whole becomes different because of a new sum of its parts applies to device components. Different devices are subject to different regulatory regimes and, consequently, to different legal standards. A class III device goes through the PMA process and enjoys preemption. A class II device goes through 510(k) clearance and enjoys quality time in a Parisian report and an MDL file. Preemption, sadly, will seldom extend its sweet embrace to a 510(k) device, no matter how much Bexis and logic and policy suggest otherwise. What if a device’s components are partly PMA and partly 510(k)? A Franken-device?! Something approximating that issue came up recently in Smith v. DePuy Orthopaedics Inc., 2014 U.S. App. LEXIS 718 (3d Cir. Jan. 7, 2014). Smith is an unpublished opinion, so you will likely have a problem wringing any precedential value out of it. But that doesn’t stop us from discussing it. It contains sound reasoning and ample cites, and you should hasten to transplant them into your briefs.
The plaintiff, Smith, sued for what he claimed was a knee replacement gone wrong. The Magistrate Judge asked for summary judgment motions from both parties on preemption, and then dismissed the case on the ground that the claims were preempted because the product went through the PMA process. That sounds like a proactive Magistrate Judge. We would be remiss not to acknowledge the heroic work being done by Magistrate Judges all over the place. It is a thankless job; or at least it was until right now: thank you. We say that even though some Magistrate Judges have put us through Discovery Hell and even though one ultra-soft Magistrate Judge vexed us in our prosecutorial salad days by granting bail to every criminal defendant who avowed that he or she was “honorable.” Apparently several of those defendants preferred to live out their honorable lives in other jurisdictions, in other countries, or in the wind – anywhere but the dark-paneled courtrooms where 12 citizens solid and true would scrutinize the peripatetic defendant’s crimes.
Back to Smith v. DePuy. There is also a procedural component to that case that is a wee bit interesting. The court stayed most discovery during the pendency of the motions. The plaintiff served additional discovery requests, sought a continuance, and submitted a declaration with its summary judgment cross-motion describing what discovery he sought and why it had not previously been obtained. But he failed to discuss how the discovery sought, if provided, would preclude summary judgment. That is, he failed to submit a declaration that complied with all the requirements of Fed.R. Civ.P. 56(d). Oops. No continuance. No additional discovery. No case. We have written about the requirement of Rule 56(d) before.
The key is the regulatory history of the device at issue. In 1985, the RP Knee went through the PMA process, which “provide[s] reasonable assurance of its safety and effectiveness.” In 1996, the defendant introduced the P.F.C. Sigma Knee, which was a fixed-bearing system containing: (1) a femoral piece; (2) a patella; (3) a tibial tray; and (4) a tibial insert. The FDA approved the P.F.C. Sigma Knee through the 510(k) Pre-Market Notification process. In February 2000, Defendants submitted a PMA application to the FDA to supplement the existing RP Knee with a new rotating platform, which was designed to be used with the 510(k)-cleared femoral and patella components of the P.F.C. Sigma Knee. Things are starting to get mixed up. Or are they? The FDA approved this application in March 2000, as a supplement to the LCS Total Knee System PMA. Soon after, in May 2000, the defendants submitted a PMA application to supplement the RP Knee to include the 510(k)-cleared rotating platform tibial trays and bearings from the P.F.C. Sigma Knee, thereby incorporating all components of the P.F.C. Sigma Knee into the RP Knee. The FDA approved that application in June 2000 as another supplement to the LCS Total Knee System PMA. In February 2006, Defendants submitted another PMA application to supplement the RP Knee, this time to notify the FDA that an inspection was being added to the manufacturing process for certain tibial trays. The FDA approved this application in February 2006.
On October 15, 2007, Smith underwent right knee replacement surgery and had the RP Knee—including the P.F.C. Sigma tibial insert, tibial tray, patella, and femoral component- implanted. In mid-2008, Smith allegedly experienced “chronic pain with swelling and locking of the joint.” In mid-2009, Smith underwent a revision of his loose knee implant. In 2010, Smith allegedly developed a “snapping behind the patella-femoral joint.” The cure for that sensation was apparently the filing of a legal complaint. The claims mostly fell under New Jersey’s Products Liability Act, alleging manufacturing defect, design defect, and failure to warn, as well as negligence, breach of express warranty, breach of implied warranty, negligent misrepresentation, fraudulent concealment, fraud and deceit. There was also a claim under the Virginia Consumer Protection Act. Why is that? We do not know. Nor does it matter.
After the district court dismissed his case, the plaintiff appealed, arguing that the district court abused its discretion by proceeding with summary judgment before the plaintiff received discovery on the components implanted during his second surgery. The plaintiff wanted to employ the discovery to determine which components went through the PMA process and which did not. Smith expected newly discovered documents to show only a 510(k) clearance for the components at issue, which would contradict the defendants’ declaration that these components were included in the PMA process.
The Third Circuit did not buy the plaintiff’s argument. As the court read the regulatory history, the PMA supplements to the LCS Total Knee System incorporated the components of the P.F.C. Sigma Knee that had previously been cleared through the 510(k) process, and thus those components were subject to the same PMA federal preemption. Moreover, because the components implanted during the second surgery all related to the P.F.C. Sigma femoral piece, tibial tray, and tibial tray bearings, which were approved by the FDA through the PMA process, and because those components are components of the PMA-approved RP Knee, no discovery was necessary to determine that these components were also subject to PMA preemption. That is double-barreled reasoning by the court. The parts are part of a whole that was covered by the PMA process, and that’s enough. But even if it isn’t, the particular parts at issue went through the PMA process. New discovery wouldn’t change any of that.
The Third Circuit observed that PMA preemption motions are often decided without discovery. The court also expressed annoyance that the plaintiff’s request for additional regulatory documents occurred just one day before his opposition brief was due and a month and a half after he received the defendant’s production. According to the Third Circuit, that delay, together with the failure to explain why the discovery was needed, provided the district court with sufficient grounds to deny the continuance motion. The summary judgment, therefore, was affirmed.
For those of you who read through this blogpost all the way, we congratulate you. You are the same person as when you started. Or maybe just an ounce smarter.