All the marbles may now reside at the United States Supreme Court, since the Court granted certiorari in Riegel, see our prior post, but the pendency of Supreme Court review doesn’t seem to have weakened the force of the arguments in favor of preemption in cases involving pre-market approved (“PMA”) medical devices. Instead, the hits just keep on coming.
The latest is Blunt v. Medtronic, Inc., 2007 Wisc. App. Lexis 667 (Wis. App. July 31, 2007). Now, Wisconsin isn’t exactly the most defendant-friendly jurisdiction in the country (Bexis, wearing his Thomas and Kriefall scars, agrees). For one thing, it’s way down at the bottom – and we don’t mean alphabetically – of our roster of states that have adopted the learned intermediary rule. So when a Wisconsin state court lets loose with an excellent preemption decision, we figure it’s worth taking a look.
Blunt involved a claimed defect in a cardiac defibrillator – one of those implanted gadgets that stands by to stabilize heart rhythm (love that word, unique in the English language with more syllables than vowels) in people with chronic heart problems. As best we can tell (we’re not representing Medtronic in these types of cases), it’s not one of those defibrillators involved in the now mostly settled federal MDL. See here for what we’ve had to say about that.
It’s also a case where the defendant got sued for doing the right thing. Medtronic’s quality control procedures caught a “potential [electrical] shorting problem” in the defibrillator’s battery. They better than fixed it, and got the FDA to approve a new, improved model. After that, they notified everybody who’d received the original model of the possible problem. This plaintiff – who, frankly, should consider himself lucky – never experienced any problems with his defibrillator at all. His surgeon simply replaced it as a precaution. All these facts are at: 2007 Wisc. App. Lexis 667, at *2-3.
So the guy isn’t really injured. These things have to be replaced periodically anyway (no battery lasts forever), so his replacement surgery merely happened earlier than it would have otherwise. Nonetheless, he sues, making the usual strict liability and negligence allegations we’ve come to know and love.
Bad move. Medtronic isn’t known as the “preemption company” for nothing. Medtronic not only seeks to have the action dismissed on preemption grounds, but it goes about the process in the right way. Before it makes its motion, Medtronic makes sure that it has a rock solid record to present to the court. Instead of leaping right in to a motion to dismiss, Medtronic takes the additional time and effort needed to move for summary judgment – with the entire regulatory history of the device properly before the court. 2007 Wisc. App. Lexis 667, at *4. This may be the most important lesson of Blunt – preemption is important enough to take the time and spend the money to do it right. That certainly helped Medtronic in the inevitable appeal in Blunt.
The Blunt opinion itself reads like a primer on medical device preemption. The court goes through the FDA’s maze of device classifications, id. at *5-6, and explains how PMA is the most “rigorous” (a preemption code word) form of FDA approval. Id. at *6. The court notes why this is true. PMA requires:
- [S]ubmission of a detailed application, including clinical data, manufacturing processes, and proposed labeling. A PMA application must include the following:
- A complete description of the device, its functional components, and the principles of its operation;
- A complete description of the methods, facilities and controls used for the manufacture, processing, packaging and storage of the device of sufficient detail so that the FDA can make a knowledgeable judgment about the quality control used in the manufacture of the device;
- A complete description of the properties of the device relevant to diagnosis and treatment of a disease or medical condition;
- The results of all nonclinical laboratory studies (including microbiological, toxicological, immunological, biocompatibility, stress, wear, shelf life);
- The results of all clinical studies;
- The results of all published reports concerning the safety and effectiveness of the device; and
- Copies of all proposed labeling, instructions, literature and advertising.
2007 Wisc. App. Lexis 667, at *8-9 n.3 (quoting Medtronic’s brief). Hey, that’s pretty good in and of itself. We can tell you that any time a court chooses to quote your brief – with attribution – as fact rather than argument, you’re doing something right.
Then the court gets right to the point. Preemption is primarily a federal law issue and PMA preemption has been litigated extensively in the federal courts. The overwhelming weight of federal appellate precedent holds that the FDA’s PMA process involves extensive “requirements” (another preemption code word) that are “specifically” (another code word) applicable to the approved device. 2007 Wisc. App. Lexis 667, at *9-10. The court cites a bunch of cases, which put the tally at 9 to 1 in favor of the good guys: Riegel v. Medtronic, Inc., 451 F.3d 104 (2d Cir. 2006); Gomez v. St. Jude Medical Daig Division, Inc., 442 F.3d 919 (5th Cir. 2006); McMullen v. Medtronic, Inc., 421 F.3d 482 (7th Cir. 2005); Cupek v. Medtronic, Inc., 405 F.3d 421 (6th Cir. 2005); Horn v. Thoratec Corp., 376 F.3d 163 (3d Cir. 2004); Brooks v. Howmedica, Inc., 273 F.3d 785 (8th Cir. 2001); Martin v. Medtronic, Inc., 254 F.3d 573 (5th Cir. 2001); Kemp v. Medtronic, Inc., 231 F.3d 216 (6th Cir. 2000); Mitchell v. Collagen Corp., 126 F.3d 902 (7th Cir. 1997); contra Goodlin v. Medtronic, Inc., 167 F.3d 1367 (11th Cir. 1999).
If anything, the law is even more solidly behind the defense position on PMA preemption than Blunt lets on. For one thing, the Ninth Circuit is generally thought as being on board, although the decision came in an odd context. See Papike v. Tambrands, Inc., 107 F.3d 737, 741 (9th Cir. 1997) (tampon case). For another, Blunt isn’t the only state appellate court to find claims involving these devices preempted. See Worthy v. Collagen Corp., 967 S.W.2d 360 (Tex. 1998); Fry v. Allergen Medical Optics, 695 A.2d 511 (R.I. 1997); Green v. Dolsky, 685 A.2d 110 (Pa. 1996); Troutman v. Curtis, 143 P.3d 74 (Kan. App. 2006); Baker v. St. Jude Medical, S.C., Inc., 178 S.W.3d 127 (Tex. App. 2005); Steele v. Collagen Corp., 63 Cal. Rptr. 879 (Cal. App. 1997); Mears v. Marshall, 944 P.2d 984 (Or. App. 1997).
The court next examined Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), the most on-point United States Supreme Court decision in the area. Lohr involved the same statute, but a different, less “rigorous” form of FDA medical device approval. Fortunately for the PMA device manufacturers (and unfortunately for just about everybody else – including Medtronic in that case) the Court in Lohr specifically distinguished the PMA process from the lesser procedure that the Lohr Court ultimately found incapable of generating preemptive requirements due to its lack of specificity. 2007 Wisc. App. Lexis 667, at *11-13.
The Blunt court also paid attention to what the FDA had to say about medical device preemption, and quoted extensively from the amicus brief that the FDA filed in the Horn case, advocating preemption. 2007 Wisc. App. Lexis 667, at *11-12, 18-20. While we’re OK with that, we’re realists as well. Any precedent in favor of deferring to administrative agencies when they say things we like can come back and bite us in the future when the agency in question – under new management, so to speak – says something we won’t like.
We just have to try to make hay while the sun shines, and that’s what happened in Blunt.
The Blunt court looked over the preemption precedent and determined that it was more persuaded by the majority position on PMA preemption than by the sole dissenting view expressed in Goodlin. 2007 Wisc. App. Lexis 667, at *13-14.
Every case, however, has its own little factual twists and turns. That’s why you can never “mail it in” in the law business, especially with preemption in product liability cases. Plaintiff made the argument that Medtronic should not have the benefit of preemption – essentially because it had gone and done the right thing. In the Through-the-Looking-Glass world of plaintiff logic, no good deed (or bad deed, or any deed at all) can go unpunished. Plaintiff argued there was no preemptive conflict because Medtronic had already gotten the FDA to approve a “better battery version” of the device. 2007 Wisc. App. Lexis 667, at *14. There couldn’t possibly be a conflict with the FDA’s approval of the newer model, plaintiff argued. Id. But that wasn’t the device at issue.
OK. Let’s see, that means that the moment a company makes an improvement to its product, all of its prior products automatically become “defective” by comparison. If all you’re interested in is transferring money from companies to consumers (while taking a “cut” of 33% or more), we suppose that’s great logic. The Medical Device Amendments, however, were passed with the intent to “protect innovations in device technology from being stifled by unnecessary restrictions.” H.R. Rep. No. 94-853, at 12. It’s harder to think of anything more anti-innovation than a theory of liability asserting that, because you improve your product, all your older models become defective.
Fortunately the court in Blunt was having none of it. The FDA had never recalled the original model, and at the time it was sold, that design continued to be sufficiently safe to satisfy the FDA:
In the instant case, a jury verdict in the Blunts’ favor would result in a jury finding that the original defibrillator. . .was defective, either in its design or manufacture. Such a conclusion runs contrary to the FDA’s approval of the original design as being safe to sell. Thus, the jury verdict would in effect threaten the federal premarket approval process by imposing on a manufacturer an obligation to modify what had previously been approved. While a common law tort suit may not traditionally fit into the term “state regulation” quite like a statute or regulation would, the practical effect of a jury verdict in this case would be the same.
2007 Wisc. App. Lexis 667, at *17 (emphasis added).
We think that the court got it exactly right. At the time it was sold, the original model of the device was good enough for the FDA under the Agency’s most “rigorous” form of approval. Good enough for the FDA is good enough. Competition in the marketplace is the best impetus to the innovation that the statute intended to foster. It’s the old adage about making a better mousetrap.
On the other hand, declaring the innovator’s prior products “defective” in light of an innovation is surely the the worst way imaginable to encourage innovation.
Indeed, the court went one better. Recognizing the argument for what it was, the court held that the plaintiff was in effect advocating mandatory redesign of devices and recall of FDA-approved products.
In order to avoid being held liable to patients who wished to remove or replace their [defibrillators], [defendant] would have little choice but to alter its product. Although altering the product would not be mandated explicitly by government, [defendant’s] lack of choice in the matter amounts, in my mind, to a requirement. . . . It would result in a jury finding that the FDA’s approval of the design was erroneous. It would usurp the power Congress gave to the FDA, and thus must be pre-empted.
2007 Wisc. App. Lexis 667, at *22-23.
That’s the good news. The bad news is that there’s a dissent – and because of the dissent, a probable further appeal. The dissent bought the plaintiff’s anti-innovation argument hook line and sinker. Because the defendant developed a new model of the product, all earlier versions automatically became “not so good” or “out of date.” 2007 Wisc. App. Lexis 667, at *25. The defendant was stuck with them. Its sale of FDA-approved product gets reduced to merely “clear[ing] its inventory.” Id. at *28. The dissent professes astonishment that – hypothetically – there would be preemption “even if the mortality rate were 80%.” Id. In reality, it’s the hypothetical the dissent poses that’s reductio ad absurdum. The FDA would never approve a device with that sort of mortality, and thus the question of preemption would never arise, and the hypothetical is meaningless.
As far as we’re concerned, the argument that a new model justifies liability because prior models are “out of date” only underscores the preemptive conflict inherent in this particular claim. Given that the Medical Device Amendments were explicitly enacted, in part, to “promote innovation,” any argument that penalizes innovation by declaring all of the innovator’s devices “defective” due solely to the fact of the innovation necessarily poses an “obstacle” to the full implementation of the goals of the federal act.
Our hope is that Chief Justice Roberts gets another opportunity to demonstrate the reputed pro-business” nature of the current Supreme Court before a further appeal has a chance of mucking up the great result in Blunt.