Thursday, November 01, 2007

Guided Tour of Defense briefs in Riegel v. Medtronic

The Supreme Court briefing is now complete in Riegel v. Medtronic. For preemption wonks like us, that’s sort of like being a kid in a candy store – so we’ve taken a good look at what have to be the best and most state of the art defense preemption arguments around for those of us who defend medical device companies. We’ll tell you right now, we haven’t been disappointed.

We hope you won’t be either, so we’re going to give our readers a guided tour. The tour starts, as it should, with the defendant Medtronic’s brief. Medtronic is rightly known in our business as “The Preemption Company.” Win or lose, Medtronic has defined the state of the art in medical device preemption for quite some time. The Riegel brief shows that Medtronic’s lost none of its preemption edge.

First impression? Look at the facts (br. at 8-9). This is a borderline ridiculous product liability case. The device, a cardiac balloon catheter, was misused – and we’d have to say abused. It was inserted into a patient with a “heavily calcified” (from the medical records) coronary artery despite an explicit warning not to use this particular catheter on “calcified’ blockages. Reading between the lines, we’d guess that the reason for that warning is that calcifications tend to be hard and have sharp edges. The business end of the device, after all, is still a balloon. On top of that, the surgeon then overinflated the device by two atmospheres.

The result? Predictable. The balloon burst.

From what the highly abbreviated facts indicate, we can see that there might be a malpractice case on such facts. That only a product liability suit was filed in Riegel speaks volumes about how out of control product liability truly is.

Turning to the preemption battle, we were struck by how limited a universe of products we’re talking about. The FDA grants less than 50 PMAs a year, according to the 2005 stats Medtronic cites (br. at 4). Even as to Class III (the most potentially risky and thus the most highly regulated) medical devices, there are way more FDA clearances under §510k on the basis of “substantial equivalence” to prior products (over 3000) than there are PMAs. For all intents and purposes Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), killed preemption in the §510k situation.

Still, we can see why industry likes §510k – it’s quicker, cheaper, and the approval rate is almost 90% – even if there’s no preemption protection. Reading Medtronic’s description (pp. 5-7) of the PMA process (and it should know, since it has so many PMA devices), it’s a wonder that even 40+ devices successfully run this gauntlet every year. The FDA really does examine everything. At bottom, that’s the practical basis for broad preemption in the PMA context. Almost everything about this kind of device really is the product of the FDA’s affirmative judgment about a particular device. And the “conditions of approval” the FDA imposes means that manufacturer can’t change anything that affects device safety after approval without going back to the FDA. Br. at 8.

Unfortunately, because there are relatively few PMA devices, even if Medtronic wins everything in Riegel, there’s still going to be plenty of medical device product liability litigation.

Rats.

But that’s just the way things are after Lohr. Unlike some folks we could name (but won’t), we don’t subscribe in the least to the “God bless those who sue our client” philosophy. That’s why we spend our own time putting the word out on this blog. That’s why we fight the good fight in groups like PLAC and ALI – all on our own dime. If we were running things, we’d want preemption of just about all product liability claims except manufacturing defects – and we’d want a really strong FDA keeping watch over the rest.

Anyway, within the universe of PMA products, the Medtronic brief methodically goes through (pp. 17-19) the legal and practical reasons why the FDA is all over this type of application, and how a PMA device manufacturer can’t so much as sneeze without prior FDA approval. It debunks (p.19. n.3) the idea that a PMA is some sort of “one and done” process, by explaining how the FDA retains extensive post-approval authority (reporting, inspection, and change approval) over PMA devices.

Medtronic then knocks down (pp. 20-25) each of five arguments against preemption based upon Lohr. First, the requirements of the PMA process are necessarily more device-specific than those of the §510k process in Lohr by virtue of the exponentially more extensive FDA review. Second, preemption is not limited to what’s in FDA regulations, since the term “requirements” is used separately from the term “regulations” – and Agency approval of a PMA application itself imposes requirements specifically upon the approved device. Third, the FDA does not have to originate preemptive requirements to impose them, since the Agency can (and often does) tell manufacturers to modify their submitted designs, labels, or manufacturing processes. Nothing in the statute or in precedent requires administrative origination (as opposed to administrative adoption) for there to be preemption. Fourth, the specific PMA process, rather than the form letter transmitting that approval, establishes preemption. Fifth, the PMA process brings to bear the FDA’s expert judgment on matters of safety and efficacy, so the Agency’s prohibition upon post-approval changes is imposed precisely for safety and efficacy related purposes.

On the somewhat less controversial point of whether state tort suits constitute conflicting “requirements,” Medtronic discusses (pp. 28-33) several cases in which a majority of the Court has made precisely this point. It then dispatches the same old plaintiffs’ arguments that they’ve trotted out unsuccessfully time after time since first losing this issue in Cipollone v. Liggett Group, Inc., 505 U.S. 504 (1992): (1) that the term “requirements” generally should be limited to “positive” state “enactments” (a weird argument, which gets weirder as time goes on since tort reform statutes govern product liability in more and more states); (2) that “requirements” in the context of the Medical Device Amendments means only positive enactments (implausible because Congress preceded that word with the very broad article “any”); (3) that a savings clause expressly limited to reimbursements in recall situations doesn’t apply to the entire act; and (4) implications from what wasn’t said in legislative history – complete with examples where legislative silence hasn’t precluded preemption as to other similarly worded statutes.

Medtronic then explains (pp. 34-38) how state tort claims that might start out “general” get converted by the litigation process into state requirements that govern “specific” devices. This is really common sense, since the litigation process can hardly do otherwise. No matter how broad the allegations that a plaintiff might pleat in the initial complaint, there has to be a trial before the defendant can be liable. At that trial, the plaintiff will put on experts who will (as long as they get paid) testify in excruciating detail just what exactly our clients did wrong. Without this type of expert testimony, plaintiffs can’t make out a jury submissible case. That same process of taking general allegations and fitting them to the facts of a particular case is how – for preemption purposes – initially “general” tort allegations end up tailored to “specific” devices before liability is (or can be) imposed.

For those of you who are looking at the preemption clause, 21 U.S.C. §360k(a), and are scratching your heads over what “specificity” has to do with the price of eggs, it comes from an FDA regulation where the Agency put a “gloss” on the statute that the Lohr court accepted. Medtronic uses (pp. 38-39) this same regulation , 21 C.F.R. §808.1(d), and the FDA’s administrative discussion when that regulation was adopted 42 Fed. Reg. 30,383, 30,384 (intended to preserve state law that only “incidentally” regulated devices) to show how plaintiff’s arguments about what specificity entails would effectively have the regulation nullifying the preemption clause in the statute itself, since there are few, if any, state common-law claims that would be uniquely applicable to a single medical device.

That done, Medtronic gets to the “easy part” (our words): that the tort claims in Riegel are “different from or in addition to” the FDA’s requirements (pp. 40-42). Plaintiffs don’t really have a contrary argument, so they tried – for the first time in front of the Supreme Court – to turn Riegel into a non-compliance case. After the usual waiver arguments, Medtronic points out that there’s no “genuine equivalence” here because the record shows no noncompliance, and the plaintiffs’ theories would have to change what the FDA in fact approved. There’s also a long, rather technical footnote (br. at 46 n.12) about why Bates v. Dow Agrosciences LLC, 544 U.S. 431 (2005), isn’t relevant since EPA in Bates wasn’t purporting to evaluate substantively the manufacturer’s statements.

Finally, Medtronic closes strong, with policy reasons supporting preemption. We’ve heard all this before – about uniformity, about states conflicting amongst themselves, about why we create agencies like the FDA in the first place – but Medtronic says it so well that its arguments bear repeating:

[L]ay juries are singularly ill-equipped to evaluate the safety and effectiveness of medical devices, and, for that reason, Congress gave the FDA exclusive responsibility for making such determinations. When the FDA evaluates a device’s safety and effectiveness, it takes a broad public health view, balancing not just the risks and benefits that would be experienced by a particular patient, but the risks and benefits that would be experienced by large classes of patients. A jury, in contrast, decides a particular case in isolation, without considering the wider policy implications of its decision.

Br. at 45.

Medtronic’s main thrust is be the various practical reasons why it was a good idea – from the standpoint of both device safety and availability – not to let plaintiffs usurp the functions of the FDA to set the country’s standards for what’s safe enough and effective enough to be sold. Medtronic points out that this isn’t just industry special pleading, since doctors agree that excessive product liability inhibits innovation and keeps older, less safe devices from being replaced by newer, better models. Br. at 48 (quoting AMA Board of Trustees report). Finally, Medtronic points out (br. at 48-50) that opening up PMA devices to all manner of product liability claims leaves manufacturers with no incentive to choose the a rigorous PMA process that directly assesses safety over a §510k procedure that doesn’t even focus on device safety. It goes to show that, while plaintiffs like to talk about safety, in the end they’re all – and only – about liability.

The defense amici in Riegel amplify these arguments and present others. The PLAC (Product Liability Advisory Council) brief takes on the infamous presumption against preemption – pointing out that this is simply an argument that the Act’s express preemption clause should be read to mean something less than what it plainly states (PLAC br. at 5-8). PLAC puts presumptions back into proper perspective – that they are, at most, the apprentice – and cannot play the role of the sorcerer himself:

A presumption, if applicable at all, is no more than a tool for resolution of doubt. It operates at the margins of decision-making, where the Court must choose between equally plausible interpretations of a Congressional enactment – akin to the sandlot rule that a tie goes to the runner. If the call is that close, the Court might fairly presume that Congress would not cavalierly override state laws.

PLAC br. at 6. PLAC discusses the FDA’s early intervention – from the “conception of the new device” – to show that the FDA is anything but a “passive receptacle.” PLAC br. at 10. It sets out the PMA process step by step, including all the ways that a manufacturer can stray from the straight and narrow, and what can happen if it does. PLAC br. at 8-17.

PLAC also takes on the fundamentally illogical argument that a state-law judgment cannot be a “requirement” because the unfortunate defendant can simply pay judgments and proceed as before. That one’s always struck us as odd, since the same plaintiffs advancing it are simultaneously waxing eloquent out of the other side of their mouths about the value of tort liability in enhancing the everybody’s safety.

So much for consistency (but we knew that).

PLAC skewers this argument properly:


Because the requirements in the PMA are just that, “requirements,” this is usually the only choice for manufacturers, but it is neither a practical nor a tolerable one. The cost of litigation is staggering. . . . The risk of multiple damage awards, plus the cost and disruption of massive, intrusive, and interminable litigation create a hydraulic pressure to settle. Whether the companies settle or litigate, the costs are necessarily are reflected in the price of the device – and other products they make. That would further raise the escalating cost of health care and perhaps limit access to medical technology that FDA has found beneficial to the public health.
PLAC br. at 20-21. This argument is particularly apt since plaintiffs’ lawyers assiduously seek to turn every alleged medical device defect into a mass tort through indiscriminate solicitation. There is rarely “just one” plaintiff. That means that the first premise of the “just pay judgments” argument fails, because even if the manufacturer “voluntarily” chose to comply with a jury’s verdict, the next plaintiff would just come up with some different version of the supposed defect. PLAC br. at 22-23.

Finally, PLAC comes to the defense of the FDA (sort of). Criticisms of the FDA have no place in state-law-based litigation. It’s not the role of the states to disregard what a federal agency does because they don’t like the agency. Rather, the response is to get Congress either to strengthen the agency to do what it’s supposed to do, or do away with it altogether. Here, Congress in 2007 did just that (the former) – greatly augmenting the Agency’s post-marketing surveillance capabilities. It’s not for state-law plaintiffs to second guess Congress. That’s why the Founders put a Supremacy Clause in the Constitution in the first place. PLAC br. at 22-24.

Another amicus brief was filed by the Chamber of Commerce. Its main function is something after our own hearts – detailing for the court the FDA’s position in the various amicus briefs that the Agency has filed on relevant preemption questions. COC br. at 6-7.

The Chamber amplifies the point that Medtronic made about the ever increasing absurdity of any distinction between common law and “positive state enactments” – going into some detail about the increasing ubiquity of statutes governing tort and product liability. COC br. at 11-13. COC provides a nice citator of state tort reform statutes.

We don’t know whether it matters much for other cases, but the Chamber does an excruciatingly thorough “second bite at the apple” dissection of exactly where the same plaintiffs’ arguments that they’re regurgitating in Riegel were made and rejected in Lohr. COC br. at 12-15.

Probably the most interesting and different argument that the Chamber makes concerns the aforementioned “specificity gloss” that, by a 5-4 margin, the Supreme Court added to the statute in Lohr. After making the obligatory arguments that there is specificity in Riegel (COC br. at 20-26), the Chamber invites the Supreme Court to reconsider that aspect of its decision in Lohr, which, in effect, amended the statute judicially to add a device specificity requirement that Congress didn’t choose to include. COC br. at 26- 30. The Court probably won’t do this – but the Chamber cogently explains why it should. And if the Court does, well, we’ll all have the Chamber to thank.

Our good friends over at the Washington Legal Foundation also filed an amicus brief in Riegel. WLF takes the inventive approach of applying implied – rather than express – preemption analysis to the MDA. That’s not as far out in left (or should it be right) field as one might think at first blush, since Justice Breyer in Lohr invoked implied conflict preemption principles in his pivotal concurring opinion. 518 U.S. at 507-08. Back in 1996, we both participated in the amicus scrum in Lohr (that was in our Bone Screw salad days), and we remember that there was a division of opinion even then about which type of preemption was the best way to go. One of us was still at it five years later when Buckman (a Bone Screw case) came down.

It cannot be denied that, of the two, implied preemption fared much better from a defense perspective. So maybe WLF is right. In any event, their implied preemption argument is quite persuasive – at least to us:


[P]ermitting. . .injured plaintiffs to bring state-law suits alleging that a PMA medical device is defectively designed or improperly labeled would undermine FDA requirements mandating that the device be designed and labeled in that precise manner. If state officials have reason to believe that PMA medical devices being marketed within their jurisdiction are defective, they can go to FDA to report their concerns and urge FDA to exercise its power to prevent further marketing of the drug. But allowing States to go forward independently with proceedings designed to determine whether the FDA-mandated product design is defective is an invitation to chaos.
WLF br. at 19. See generally WLF br. at 18-23. One advantage of the WLF implied preemption approach is that it brings to bear the FDA’s views on implied preemption in the prescription drug field. WLF br. at 21-22.

WLF makes several of the well-established express preemption arguments too: (1) “requirements” includes common law torts (WLF br. at 10-13), (2) “requirements” includes state rules that have “general applicability” (WLF br. at 13), and (3) state second-guessing of FDA actions undercuts what Congress was trying to achieve when it passed the statute (WLF br. 14-15). We don’t mean to slight them by any means, but it’s the implied preemption brief that makes the WLF filing distinctive.

A fourth amicus brief was submitted in Riegel by Croplife America, the American Chemistry Council, and the Consumer Specialty Products Ass’n. These groups are interested in Riegel not particularly because of the FDCA, but because they’re regulated by FIFRA (that’s the EPA) and FIFRA has a very similar statutory preemptive language. The major FIFRA preemption decision, is of course, Bates. Thus the Croplife brief is the place to go for the most thorough discussion of all things Bates. Croplife br. at 9-12 (Bates does not exalt form over substance); 14-15 (Bates and the presumption against preemption), 15-16 (Bates and “requirements”); 17-20 (Bates and uniformity); 20-21 (Bates and remedies/immunity); 21-28 (Bates and parallel requirements).

While the Croplife brief isn’t nearly as much FDCA-oriented as the other filings, we’d recommend taking a look. Bates can come back to haunt our clients too – we’ve discussed on a couple of occasions how plaintiffs in FDCA case have advanced some pretty bizarre arguments based upon Bates.

So there you have it readers – our guided tour of the defense side briefs in Riegel. We’ll try to do the same thing in Kent when everything’s filed there as well.

3 comments:

Brian said...

Mark and Jim,
Great Blog and Happy Anniversary.

I enjoyed reading your post the "Guided Tour of Defense briefs in Riegel v. Medtronic" that it inspired me to respond.

You can read my post entitled "The Civil Justice Prosecutor's Perspective on Riegel v. Medtronic"
You can find it on my blog www.LaBovickInjuryLawBlog.com

I hope you enjoy reading it as much as I enjoyed writing it.

All the best,

Brian F. LaBovick, Esq.
www.LaBovickInjuryLawBlog.com

Heart Broken said...

Okay…so the Supreme Court says we cannot sue device manufacturers when their PMA products fail and cause harm. Wonder what their answer would be if asked “who foots the medical bills when it happens?” You make interesting comments about the circumstances of Mr. Riegel's unfortunate experience...perhaps it was medical malpractice...who knows? But, can we chat for a minute about the Medtronic Sprint Fidelis lead? I am the parent of a 12 year old whose heart device lead failed back in October. It failed within three years of its original implantation and caused him to have to undergo an additional surgery to replace the failed device. HUGE medical bills, and the device manufacturer offers virtually NO assistance with the bills. By the way, we discovered it had failed within one week of the FDA recall. Is it right for our medical insurance company to have to pay for the SAME surgery a second time because of an FDA recall/device failure? There is such a thing as Maximum Lifetime Coverage with insurance companies, and now, with the second surgery, our son has made a huge dent in his lifetime coverage. Good God…he’s only 12!!!! With the heart defect he has, HE NEEDS MEDICAL COVERAGE. Medical insurance keeps going up for all of us because of big device manufacturers whose products fail and they refuse to anti-up…just keep posting record profits. I understand that you defend the flip side of this...unnecessary law suits that only drive up the prices of necessary, life-saving devices. However, SOME circumstances DO warrant consideration for assistance with medical bills, etc. Shame on Medtronic for not taking a more "forthright" approach in doing the right thing for those who have truly suffered as a result of an "inept" product (the FDA would never have recalled it if circumstances didn't warrant), and shame on the Supreme Court for paving the road for increases in our insurance costs as a result of the Riegel v. Medtronic ruling. I am not talking about personal gain or trying to sue in order to pocket big bucks…I am talking about paying a kid’s medical bills when his heart device failed within its warranty period….i.e., "DOING THE RIGHT THING". I don't even want to begin to discuss what it "cost" our son...an academically advanced student who missed almost a month of school while out after surgery, grades dropping from A's to C's, having to make up missed work, the adolescent anguish of not wanting his friends at school to know he was having heart surgery for fear that he would be labeled as "different", AND THIS SURGERY WOULD NEVER HAVE TAKEN PLACE IF THE ORIGINAL LEAD HAD NOT FAILED. The FDA would never have recalled it if there weren't some concern for safety. What ever happened to the idea of making the “cost causer” pay? Any thoughts or suggestions? I know that you, yourself, are probably a "big guy" and you make a living supporting the even "bigger guys" on these issues, but do you think you could reach down deep within your heart and find some advice for "the little people"?

Heart Broken said...

Okay…so the Supreme Court says we cannot sue device manufacturers when their products fail and cause harm. Wonder what their answer would be if asked “who foots the medical bills when it happens?”
You make interesting comments about the circumstances of Mr. Riegel's unfortunate experience...perhaps it was medical malpractice...who knows. But, let's chat for a minute about the Medtronic Sprint Fidelis lead. I am the parent of a 12 year old whose heart device lead failed back in October. It failed within three years of its original implantation and caused him to have to undergo an additional surgery to replace the failed device. HUGE medical bills, and the device manufacturer offers virtually NO assistance with the bills. By the way, we discovered it had failed within one week of the FDA recall. Is it right for our medical insurance company to have to pay for the SAME surgery a second time because of an FDA recall/device failure? There is such a thing as Maximum Lifetime Coverage with insurance companies, and now, with the second surgery, our son has made a huge dent in his lifetime coverage. Good God…he’s only 12!!!! With the heart defect he has, HE NEEDS MEDICAL COVERAGE. Medical insurance keeps going up for all of us because of big device manufacturers whose products fail and they refuse to anti-up…just keep posting record profits. I understand that you defend the flip side of this...unnecessary law suits that only drive up the prices of necessary, life-saving devices. However, SOME circumstances DO warrant consideration for assistance with medical bills, etc. Shame on Medtronic for not taking a more "forthright" approach in doing the right thing for those who have truly suffered as a result of an "inept" product, and shame on the Supreme Court for paving the road for increases in our insurance costs as a result of the Riegel v. Medtronic ruling. I am not talking about personal gain or trying to sue in order to pocket big bucks…I am talking about paying a kid’s medical bills when his heart device failed within its warranty period. I don't even want to begin to discuss what it "cost" our son...an academically advanced student who missed almost a month of school while out after surgery, grades dropping from A's to C's, making up missed work, the adolescent anguish of not wanting his friends at school to know he was having heart surgery for fear that he would be labeled as "different", AND THIS SURGERY WOULD NEVER HAVE TAKEN PLACE IF THE ORIGINAL LEAD HAD NOT FAILED. The FDA would never have recalled it if there weren't some concern for safety. What ever happened to the idea of making the “cost causer” pay? Any thoughts or suggestions? I know that you make a living supporting the "big guys" on these issues, but do you have any advice for "the little people"?