Wednesday, December 05, 2007

Riegel - Our Intrepid Correspondent Reports

We were too busy - and none of our clients would pay for it in any event - so we didn't attend yesterday's Supreme Court oral argument in Riegel v. Medtronic. But fortunately for us, and by extension all of you reading this, one of our old friends (and a dedicated reader) was there - Tom Parker, an Ohio lawyer we've worked with on important medical device cases for years.

Here's what he has to say about the Riegel oral argument:

[It's all Tom from here on, until further notice - except for our bracketed comments, of course]

The oral argument in Riegel v. Medtronic was presented by Alison Zieve for petitioners and by Ted Olson for Medtronic. I believe Edwin Kneedler presented the Solicitor General’s argument, also supporting preemption.

Petitioners’ Argument

Ms. Zieve spoke for six or seven minutes before encountering her first question. As she argued that device manufacturers should not be able to obtain PMA approval and sell – without risk of liability – devices that later proved to have problems, the Chief Justice asked whether the problems she spoke of would not be addressed by FDA after reports of such problems would be given to FDA through the MDR process. She agreed FDA could act in that way but contended in such circumstances FDA would be in a passive role; not the active protector of public health.

Justice Scalia then asked his first of about ten questions. He asked Zieve if the device could be changed by the manufacturer once a problem was discovered. Zieve indicated it could under the PMA Supplement process; she also stated some more minor changes could be made without FDA’s advance permission.

Justice Kennedy asked whether in a state law tort claim the jury can perform the same risk/benefit evaluation assigned to FDA under the statute. He asked whether a jury could, for example, adequately assess the benefits to the public from being able to continue to utilize a device in which there was, say, a 1% risk of injury. He asked whether FDA did such balancing in the PMA evaluation process. [Bloggers' note - that sounds like a vote (#1) for the good guys] Zieve tried to fall back on Lohr at that point; Scalia cut her off and indicated that Lohr was not of much analytical help because of the absence of a safety and efficacy determination in the 510k situation.

Justice Ginsberg then asked a question on a point that she came back to at least three or four times. She wanted to know whether tort suits compromised FDA’s ability to regulate in the drug product setting. Zieve said no and quickly pointed out that the MDA was enacted because of a void in FDA regulation of medical devices until 1976, when, in specific response to California device regulation initiatives the MDA was enacted. She argued that drugs had, in contrast, been regulated for several decades prior to the enactment of the MDA and, in the absence of state regulatory activity, Congress had felt no need to include a preemption provision in the drug portion of the FDCA.

Scalia then asked whether it was Zieve’s position that states could issue regulations pertaining to drugs so long as they did not conflict with FDA’s regulations. Zieve agreed. And then he asked whether it was her position that states could do the same in regard to medical devices.

Ginsberg asked whether a manufacturer who proposed a change to a device, which change was rejected by FDA, would have a defense in a product liability suit alleging that the failure to make a device with the proposed design provided a basis for liability. Zieve said she thought the manufacturer should be able to assert a defense of compliance with the PMA. [Bloggers' note - if we run into Public Citizen representing a plaintiff in the future, we'll make sure to remind them of this]

Scalia then followed up and asked if the manufacturer could be held liable for not making a change to a device that FDA had rejected. Ginsberg followed up to ask whether that was the circumstance in which preemption should apply. Zieve said it should (a strange answer since it effectively conceded the federal requirement issue and the state tort suit requirement issue). [Bloggers' note - this is precisely the situation in prescription drugs with suicide and SSRI's (certain antidepressants) - we'll be sure to remind Public Citizen of that, as well]

Justice Ginsberg then asked “if FDA said a device manufacturer should include ‘X’ in a device design and the manufacturer did so, would that entity not be protected by preemption against a claim that the manufacturer should have done ‘Y’ in order to avoid a contention that the X-including device was a defective design. Zieve agreed that such an affirmative requirement imposed by FDA would provide a basis for preemption. [Bloggers' rhetorical question - And Zieve was arguing for plaintiffs?]

The Chief Justice then asked if it wasn’t petitioners’ position that devices which did not use an allegedly improved design (such as a feasible alternative design normally posited by a plaintiff’s expert and alluded to in Ginsberg’s X and Y hypothetical) should be removed from the market (implicitly even though the original design still held PMA approval). Zieve seemed to beg the question by asserted that manufacturers do not withdraw products from the market just because of the threats posed by tort liability suits. The Chief Justice asked again, “But don’t you want such devices off the market if safer alternative designs exist?” Zieve stated that is the usual desire.

Scalia then observed – in relation to the safer alternative design issue – that it is not realistic to expect individual juries in the states to weigh the risks and benefits of particular device designs and alleged improvements thereto. [Bloggers' note - that sounds like another vote (#2) for the good guys]

Breyer asked what the specific defect in the Evergreen Balloon Catheter was. Zieve pointed out that the specific allegations of defect had not been fleshed out in the record below. But Justice Breyer pressed Zieve until she answered, in essence, that the device should not have been able to explode if over-pressurized. He got her to admit that she was suggesting a different type of material or different material properties should have been incorporated in the design. He observed these are precisely the kind of things that FDA should govern. [Bloggers' note - that sounds like another vote (#3) for the good guys]

Justice Ginsberg tried to rescue Zieve by asking what the defects were in the catheter labeling. [Bloggers' note - that sounds like a vote (#1) against the good guys] Zieve indicated that the labeling was ambiguous because while there was an indication that the device’s pressure limit was 8 atmospheres, there were other places that discussed the impact on the device of being inflated to 13 atmospheres during testing. The Chief Justice compared this to having a speedometer on an automobile that indicated a car could travel 120 mph; he noted that such information on the speedometer did not equate to a manufacturer recommendation that the vehicle actually be driven at that speed. [Bloggers' note - that sounds like another vote (#4) for the good guys]

Justice Kennedy then asked whether Medtronic could change the labeling to clarify any confusion relating to the pressurization issue. Zieve pointed to the portion of 814.39 which allows certain labeling changes to be made immediately. [Bloggers' note - that's the device equivalent of the CBE regulation (21 C.F.R. §314.70) for drugs]

Breyer then expressed concern with the general way things progress in a tort case. A client who has been injured appears in a lawyer’s office. The counsel, with no knowledge of the product or defect, is convinced there must be a product defect because device users should not be injured. Armed with that belief, the lawyer files suit and proceeds to conduct exhaustive discovery in search of a theory of defect. (As an aside, we deal with this all the time in the front lines of medical product litigation). Zieve responded to this concern by indicating that in many situations, the defect is well known – as in cases of recalled products. By implication, she seemed to admit the theory of defect in the case at bar was hazy.

Medtronic’s Argument

Ted Olson began his argument by picking up on Justice Kennedy’s opening question, pointing out that it is indeed FDA and not state juries which should be the centralized arbiter of what is appropriate – based on their expert judgment – in medical device design and labeling.

Justice Ginsberg jumped right in asking him why we should believe medical device regulation would be any more harmed by tort cases than drug regulation is. [Bloggers' note - definitely a vote against] Olson indicated that the MDA has different language than the drug portion of the FDCA, reflecting Congress’ considered judgment that states should not regulate medical device design and labeling. Ginsberg, picking up on petitioners’ argument, asked him to concede that the MDA preemption clause was only needed because of the efforts being made in California to regulate devices. Olson argued that the current concern is different. He said if there was a state PMA process, then there would at least be an approval application, containing detailed product information and the device manufacturer would be able to have a detailed give and take with the regulatory body, presumably leading to a considered judgment. He indicated that in the typical jury case, no such considered judgments are made and there is no ability to balance the larger risk/benefit issues Congress has mandated FDA to consider.

The Chief Justice asked, “What if FDA gets it wrong and a device does not perform as expected? What then?” Olson indicated that the agency’s involvement in the process is continuous. It considers reports of citizens, physicians, device manufacturers, and others. FDA also reviews annual and other filings reflecting device performance in order to determine an ongoing position relative to a particular device.

Justice Kennedy asked whether a device manufacturer may continue to sell a device even after learning of a product performance problem; and, if so, whether it would still enjoy preemption protection. Olson said yes, they may still sell and, yes, there would still be preemption. But he also indicated that because of the real time interaction between the manufacturer and the agency, decisions are made on an ongoing basis as to whether the device should be recalled, whether Dear Doctor letters should be issued, etc.

Justice Stevens wanted to know whether the manufacturer would still enjoy preemption if it did not report its problems to the agency. Olson said it would but it would subject itself to a broad and severe array of enforcement sanctions. [Bloggers' note - this is the fraud on the FDA issue presented by the pending Kent case]

Justice Souter asked if a manufacturer would even enjoy preemption for claims brought by people who were injured by a device during the ‘hiatus’ period between when the manufacturer learned of a possible device problem, reported it to the agency and was awaiting agency action. Olson indicated that preemption would apply but that in the actual world of device regulation, the interactions between FDA and the manufacturers minimized any such hiatus periods. Moreover, FDA’s control over the field – via preemption – is significantly better than ceding such authority to state-law juries.

Justice Alito asked whether it is possible to tell from the record of proceedings what design issues were considered by FDA at the time of PMA approval. Olson said he did not believe it was in the detailed way the justice’s question implicated. He went on to say that subjecting FDA to such intrusions on its processes by tort litigants seeking to prosecute device claims is one of the things that should be avoided.

Justice Ginsberg asked Olson if the litigant would have a claim if the device manufacturer failed to comply with FDA requirements. Olson said such a claim would not be preempted. Roberts asked him again if he agreed that such claims are not preempted, and Olson repeated it and added that negligent manufacture and breach of warranty claims are not preempted. Justice Ginsberg followed up again on this same issue. [Bloggers' note - we would have preferred a caveat, that the plaintiffs must be interpreting the FDA requirements the same way the FDA does; we've had cases where the plaintiffs claim violations by having their experts interpret FDA regulations in bizarre and novel ways]

During a brief lull, Olson made a conflict preemption argument, comparing the issues in this case to those addressed in Geier, stating that it is as essential to preserve the centralized, expert balancing of issues in the medical device context as it was in motor vehicle regulation.

Justice Ginsberg wondered what incentive manufacturers would have to continue to improve a device that was PMA approved if it was insulated from liability. Olson stated that FDA has the authority to withdraw device approval if a newer, safer design was created.

Justice Kennedy asked if a manufacturer is obligated to notify FDA of newer designs they may developed in their own laboratories. Olson stated that they were not so obligated but that the forces of the marketplace would give the manufacturers the necessary incentive to continue to innovate and introduce new products. The Chief Justice asked if the manufacturer would not have an obligation to report new product design developments – from its own studies – in the device annual report. Olson picked up on this cue and indicated again that the whole relationship between FDA and the device manufacturer involves an elaborate process for the exchange of information, all of which leads to enhanced device regulation and improved devices. Olson referred to a Warner Lambert case as a point of comparison. [Bloggers' note - that would be the Kent case]

Scalia asked whether tort suits can regulate medical devices appropriately. Olson said no.

Stephens asked about FDA’s change of position on preemption. Olson said there was a considered change in position, in part resulting from the FDA’s experience in the aftermath of Lohr and in the development of preemption law in the federal circuits.

Olson concluded by arguing that the MDA reflected Congress’ intention to repose device regulation exclusively with the experts at FDA, whose job it was to balance competing interests on a centralized basis. He stated that giving juries control over device design and labeling would result in fewer devices being made available and in less safe devices.

The Solicitor General’s Argument

The Solicitor General began by asserting that in petitioners’ view, the day after a PMA was approved, a state could issue comprehensive device regulations purporting to make them parallel to the federal requirements, which could completely disrupt the plan established by Congress.

Ginsberg asked again for a comparison of the impact of drug litigation upon federal regulation of drugs to the impact of potential device litigation upon FDA’s control of medical devices. She wanted to know what the difference was between drugs and devices. The SG stated that, for one, medical devices are tangible things that involve engineering, blueprints, components and the like. Drugs, on the other hand, are chemical compounds which are not as easily second guessed from a design standpoint.

Justice Scalia quickly interjected that the legislation involving drugs and that dealing with medical devices came from different congresses. “Why would we expect them to be the same?”

Justice Ginsberg asked about FDA’s change in position on preemption. The SG stated that the originally-stated position was issued at the time FDA issued a draft regulation that opposed PMA preemption. He noted that FDA subsequently had the benefit of a number of years of device regulation experience and no longer felt it was the correct position. He also noted the withdrawal of that draft regulation.

Justice Kennedy asked whether a manufacturer could still sell a device if it happened that a series of well intended doctors all misread a particular device label, and did so in a way that led the use of the device to cause injury. The SG said yes, the device could still be sold and preemption would still apply. Justice Kennedy asked whether the manufacturer could change the label on an immediate basis in such an event. The SG said various things could be done to change the content of communications to the users/purchasers, ranging from Dear Doctor letters, notices, etc. Justice Kennedy asked if a manufacturer was subject to liability in that instance. The SG said, “Not in state court,” but yes in FDA enforcement proceedings.

Justice Souter asked if there would have been any need to have the words “in addition to” in the MDA preemption clause if not to stop state tort law regulation of devices. [Bloggers' note - that's a good-guy friendly question, maybe indicative of the critical fifth vote, but we won't call this one quite yet] If not for that purpose, he asked, couldn’t Congress have only preempted state requirements that were “different from” the federal requirements. The SG agreed that those added words implied an intention to broaden, rather than narrow the application of preemption.

The SG concluded his argument by pointing out that preemption should not turn on whether FDA had passed upon a particular design or defect issue. He stated that allowing that to be the determining factor would generate discovery into the workings of the PMA review process, which discovery would be excessively intrusive.

Petitioners’ Rebuttal

In her rebuttal, Ms. Zieve argued that only specific positive state regulations should be preempted, and that is probably what Congress intended in including the preemption clause in the statute. Souter asked, “Where should we draw the line?” In the ensuing exchange, Zieve allowed that it was petitioners’ position that the line is between positive enactments and jury determinations.

The Chief Justice asked, “Didn’t five justices of this court already rule otherwise?” Zieve stated that five justices did not rule on that issue in Lohr, basically contending that was not a ‘holding’ of the court. [Bloggers' note - this is a pretty poor response, since not only were there five votes to the contrary in Lohr (as the Chief observed), but also a contrary majority in Bates]

For Zieve’s final point, she stated that device manufacturers are able to make labeling changes of he sort asked about by Justice Kennedy under 814.39.

[That's the end of Tom Parker's report]

Thanks a bunch, Tom.

Anyway, after that report, we're cautiously optimistic that there will be a pro-preemption ruling in Riegel. We see Justices Roberts (C.J.), Scalia, Kennedy, and Breyer all pretty firmly in the pro-preemption camp, with Souter leaning in that direction. Justice Ginsberg's is in the opposite camp, probably joined by Justice Stevens (given his past track record on tort preemption). That leaves Justices Thomas (a pro-preemption vote in Lohr), and Alito (a Bush II appointee), whom we can't really predict on the basis of the oral argument.

That's our view. What do you think?

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