(If, after reading his report, you hunger to hear more from him (and get a free breakfast), you can stop by the National Conference on the Impact of U.S. and State Supreme Courts on American Business [http://www.directorsroundtable.com/currentevents/showEvent.php?eventID=175 ] on Thursday morning in Los Angeles, where he will be discussing – what else? – Wyeth v. Levine.)
Here’s his report:
I spent my morning at the U.S. Supreme Court listening to oral argument in Wyeth v. Levine. Some in the media have labeled this closely watched case “the business case of the century,” and although that description is overblown (even if it only means “in the last eight years”), it is without a doubt the most significant case in recent memory involving the prescription drug industry. It may have a lasting impact on many other industries regulated by the federal government as well. And the case raises compelling issues of federalism and federal preemption, intriguing questions about the degree of deference to be afforded various positions of the FDA, and a number of other interesting issues. All in all, not a bad way to start the day. I’m delighted to share the experience with you.
A few caveats. This report is being generated from memory and my notes. No transcript is yet available. And it is sometimes hard to hear at the Court. In order to get this to you quickly, I dictated it on the way to the airport. Some of the questions and exchanges may be hard to decipher - they certainly are for me. Sometimes that is the nature of oral argument.
A little background about the case to begin with. As virtually all readers of this blog must surely know by now, the case began on April 7, 2000, when Diana Levine sought treatment for a migraine headache and associated nausea at a Vermont health clinic. She was given Demerol (for the migraine) and Wyeth’s anti-nausea drug Phenergan by an injection into a muscle (which the Phenergan label says is the “preferred method” of administration). Sometime later that day, she returned to the clinic complaining that she was still ill. A physician’s assistant, hoping to give swifter and more effective relief, then administered a second dose of both drugs. This time she used a method called “IV push,” which involved injecting the drugs from a syringe into the tubing of an IV infusion line leading to a needle inserted in Levine’s forearm.
The Phenergan label repeatedly warns in very strong terms that great care must be used when administering the drug intravenously to avoid getting the drug into the arteries, because that can result pain, severe irritation of the arteries, and gangrene requiring amputation. Unfortunately for Levine, the physician’s assistant not only got the drug in Levine’s artery, she administered twice the recommended dose, did it more quickly than directed by the label, and failed to stop when Levine complained of severe pain, even though the label directed her to stop immediately if the patient complains of pain in order to see if the drug is getting into an artery. As a consequence, Levine contracted gangrene and her forearm was amputated.
Levine settled with the health clinic and its employees, and her case against Wyeth went to trial in a Vermont state court. Her lawyer tried the case on the theory that the Phenergan label should have said that the drug should not be administered intravenously at all, or at a minimum, not by IV push. The jury returned a multi-million dollar verdict. Wyeth argued at trial and on appeal that Levine’s claim was preempted by federal law. The Vermont Supreme Court disagreed, and the U.S. Supreme Court granted review to address whether the FDA’s labeling judgments preempt state-law tort claims premised on the theory that a different label should have been used.
In the Supreme Court this morning, Seth Waxman argued for the petitioner, Wyeth. He split his time with the government, with Ed Kneedler of the Solicitor General’s office arguing for the United States. David Frederick argued for Levine. The courtroom was packed, as you might expect.
Waxman began by stating that this was a start case of conflict preemption. He noted that the FDA repeatedly had approved intravenous Phenergan injection, including by the IV push method. Justice Kennedy interrupted to note that Wyeth argued it was impossible to comply with both federal and state law. Kennedy said he did not understand that position because it would be possible to come up with label language that satisfies both. Waxman responded that Kennedy had addressed the impossibility standard of implied preemption. The question is whether Wyeth could use the FDA required label (which includes IV push) and at the same time use a label that says you should not use IV push.
Justice Ginsberg interjected that the Vermont jury did not seem to say that intravenous use of the drug across the board was not permissible, it only seemed to object to IV push. (It actually is not clear what the Vermont jury decided – see footnote 2 to the Vermont Supreme Court opinion.) Justice Ginsberg wanted to know if the FDA ever considered the risks and benefits of IV push versus IV drip administration. That was a question that was repeated throughout the argument.
Waxman said yes the FDA did consider the two, that the FDA was aware of the risks of all forms of administration including IV push. He pointed to four separate references in the label that only apply to IV push administration.
Justice Alito asked how it was possible for the FDA to determine that IV push administration is safe and effective. He noted that the drug is not life-saving it only relieves nausea. The implication was that in his mind the risks clearly outweigh any benefits. (We hear more from Alito before the end of the argument.) Waxman responded that the record shows that the FDA clearly considered the issue.
Justice Ginsberg correctly noted that Waxman had not answered the question. She wanted to know how the benefit of IV push could outweigh the substantial risk. Waxman noted that the label is addressed to physicians so that they can make their own decisions. Taking away treatment options is not always better. The FDA has to make a risk-benefit analysis.
Chief Justice Roberts then changed the subject and asked Waxman to address the distinction between the medical device field – where there is an expressed preemption provision – and prescriptions drugs, where there is not. Waxman began addressing the similarities in the extensive approval process and the FDA’s balancing of risks and benefits. Roberts noted that when the FDCA was passed there was an established background of state involvement drugs, while in medical devices that was not the case. That might explain why there is an express preemption provision in the medical device amendments. Waxman countered that when Congress enacted the 1938 Act, there were not situations where a state jury was imposing different labeling positions than the FDA. Waxman noted that Wyeth is not seeking field preemption, nor seeking to preclude tort remedies for conduct that precludes federal law. But that the existence of conflict preemption does not rise or fall on the existence or lack of existence of an express preemption clause – or of a savings clause.
Souter then asked a series of questions. He said that he understands that the company could go back at any time to ask the FDA to change the label. But Wyeth did not do so. Where is the conflict? Souter continued, by noting that Wyeth is not saying that it tried to give the kind of warning the Vermont jury wanted but that the FDA would not allow it. Instead, he noted, Wyeth’s argument is whatever is on the label is the standard against which a conflict must be judged. In other words, if there is a difference between the FDA label and what the jury wanted, there is a conflict. Waxman affirmed that Souter had actually stated Wyeth’s argument. We can’t have a world, he said, where the day after the FDA says you may distribute this drug with this label, the manufacturer can run in and change the label. Nor could a state legislator require a company to do so. That would be preempted.
Ed Kneedler then began his argument. Justice Ginsberg immediately asked him to clarify whether the FDA had changed its policy on preemption. She noted that some briefs had indicated that the FDA believed that tort suits are a helpful adjunct to the FDA’s efforts to protect consumers. Kneedler noted that the FDA had not taken a position as a general matter that a manufacturer may change a label without new risk information.
Scalia then asked what would happen if a jury concludes that there is new information that if properly considered by the FDA would have resulted in a label change. Would there be a tort remedy if the FDA did not go to the manufacture with that information, and ask for a label change? Kneedler responded that such a claim would not be preempted. He then moved to a discussion of the anti-depressant fact pattern, where the FDA had rejected efforts to change the label. There would be preemption in that situation, he argued. But if the matter was never brought to the FDA’s attention, there would be no preemption.
Scalia then asked what happened if the manufacturer brings the information to the FDA’s attention (and presumably ask for a label change) but the FDA does not act. Can the manufacturer be subject to suit in that instance? Yes, Kneedler responded there would be no actual conflict in that instance. He then added, that is likely that the FDA would act.
Ginsberg challenged him on that point, asking why that would be likely. She noted that there are more than 11,000 approved drugs and asked if the FDA really is monitoring them all. Kneedler responded by pointing out the additional post-market powers given to the FDA by FDAAA.
Breyer then asked a series of questions directed at identifying what is and is not “new” information. For example, he wanted to know if a certain additional number of people get gangrene, why isn’t there a duty on the manufacturer to strengthen the label? The gist of Kneedler’s response was that by “new” he meant a new risk or a risk of greater severity. Breyer then raised a point that he returned to a number of times. It is his view that the CBE regulation doesn’t say anything about new information. And it is his view of the record that at trial, no one addressed the question about whether or not there was new information. That, suggested Breyer, should end the case. And we would go on to the next case (presumably to decide the preemption issue with a fuller record).
Scalia noted that new information was not brought up by either side and clearly did not buy the notion that it is the burden of the drug company to show a lack of new information.
Roberts then asked a question that was repeated a number of times during the course of the argument. Did the FDA specifically address the benefits and risks of IV push versus intravenous administration generally. Kneedler said yes.
David Frederick opened his argument by referring to the regulation (§201.80) that provides that labeling shall be revised to include a warning as soon as there is reasonable evidence of an association with a serious risk - causality need not be established. He began to argue that this required Wyeth to change its label.
Scalia interrupted, noting that the risks were already set forth in the label. Surely, he argued, the words of the regulation must mean serious risks not yet considered by the FDA. Frederick responded that the FDA never considered the risks of IV push versus intravenous administration generally. Roberts then asked about the four parts of the label that Waxman had indicated referred to IV push. When the FDA says it is safe under some circumstances, it must necessarily include an assessment or risk. Scalia jumped in to say that Frederick simply disagrees with the FDA’s judgment. Scalia said something like “if you say the FDA acted irresponsibly, then sue the FDA!” Scalia described the FDA’s label as "muscular” and said it made clear that serious risks attended IV push. Moreover, he said to Frederick, “your client’s physician did not follow the label, did he?” Frederick responded that the testimony at trial was that the physician had met the standard of care. Scalia noted that the level of drug administered was greatly in excess of that recommended. I believe Frederick contended in respond that the level of the drug did not add to the injury.
Scalia then asked Frederick if he had established that there were new problems that were not already considered by the FDA. The label, Scalia noted makes it very clear there was risks. Frederick’s response was that “that was not our burden.”
Scalia then noted that Wyeth had proposed a more restricted label and that the FDA had rejected it. Frederick pointed to footnote 1 of the Vermont Supreme Court opinion and said the proposed label did not address the IV push issue.
Roberts then said that he thought it was Levine’s theory that Wyeth should not suggest in a label that IV push administration is acceptable. Frederick contended that the jury did not prescribe a particular label, to which Roberts quipped that the jury did say that Wyeth had to pay millions of dollars.
Roberts and Scalia again pressed on whether the case turned on determining that there was a new risk. Frederick contended it did not.
Souter then asked a number of questions. He, too, wanted to know if Frederick accepted the notion that the obligation to seek a new label is keyed to the existence of new information. Frederick stated that it can be a new analysis of prior data. He claimed that Wyeth was aware of a lot of “unpublished information” that may have been known to the FDA but had not been synthesized for the FDA.
Alito then jumped in. Assume that the FDA considered the risks of IV push and said that it was okay. The next day the Levine incident happens. Is that case preempted? Frederick conceded that it was. So, Alito pressed, your argument is predicated on the existence of new information if the plaintiff can show new risk information, the plaintiff wins? In response, Frederick begins to discuss the CBE regulation.
Scalia noted that he envisioned a situation where drug manufacturers would keep changing the label in order to avoid liability. That, Frederick said would promote public safety. Not if the name of the game is balancing benefits and costs, countered Scalia. Plus you would eliminate needed drugs.
At this point, the argument took an odd turn. Frederick noted that § 352(f) says that a label is “misbranded” if it is not adequate for the safe use of a drug. This elicited a sharp response from Scalia, who wondered what good it would do for a company to have FDA approval, if that approval would not protect the company from a misbranding claim. After a series of exchanges involving Scalia, Souter, and Frederick, Souter dismissed the “misbranding” argument as a “theoretical concept.”
Stevens then asked what distinguished the case from one in which there is preemption. Here Frederick said that the difference that in this case there was no specific consideration and rejection by the FDA of a proposed warning. Roberts then rephrased the answer to say, essentially, “so if FDA considered the risks of IV push versus intravenous administration generally, you lose? If not, they lose? Frederick responded that you would search in vain for any consideration of IV push risks.
Ginsberg then asked Frederick to respond to Waxman’s statements about consideration of IV push in the label. Frederick responded that the FDA knew that IV risk was a method of administration. But, he contended, it did not consider the relative risks of IV push as compared to IV drip administration.
Souter then asked whether Frederick’s argument was that FDA could not have considered IV push, approved IV push (because the risks are so great)? Souter wanted to know, what evidence there was that FDA did consider it. Frederick said the correspondence is silent. But Scalia pointed out again that the label is not silent.
Kennedy asked if the court concludes that new information is what is required, and the label has to be changed, can the verdict in this case be sustained? Frederick said yes. And what of the Vermont Supreme Court opinion, asked Kennedy. Frederick only tried to defend the verdict.
Stevens asked whether the case boiled down to whether there was new information. Or is it sufficient that it is a new judgment based on old information? Frederick said it could be either.
Frederick’s argument ended in a discussion with Kennedy and Breyer about whose burden it was to show new information. Kennedy referred to statutes in some cases that give a rebuttable presumption in favor of manufacturers whose labels comply with the FDA. And Breyer returned to his problem with the lack of evidence at trial about new information, one way or the other. That last point was answered by Waxman, who noted that the preemption issue was decided at summary judgment.
Handicapping the Justices
It is always hazardous to predict a case’s outcome based on what transpired at argument, but we might as well have some fun. I confess that – like you – I have not figured out what each of the justices was driving at during argument. Here’s my cut at the odds of getting a vote for preemption in this case from each justice. Remember, we need five.
Nothing too sophisticated here. I looked at how each of them voted in Geier (the leading “obstacle preemption” case) and Riegel (express preemption for medical devices), considered what each said in argument in Riegel, Kent, and today’s case, stirred it all up, and … we’re off:
Justice Ginsburg – Longshot
- Seems to already have made up her mind that FDA approval of a drug does not preempt state tort suits. Riegel at 1019.
- Joined Stevens in Geier dissent.
- Views regulatory compliance merely as a defense for jury to consider. Riegel Oral Argument at 9.
- Questions in Kent argument telegraphed vote against implied preemption of product liability claims predicated on fraud on the FDA.
- “The presumption against preemption is heightened where federal law is said to bar state action in fields of traditional state regulation.” Riegel at 1013.
- Concerned that FDA regulations provide no remedy for injured consumers. Kent Argument at 55; Riegel at 1015.
- Believes that FDA’s position on preemption is entitled to little weight because the agency has been inconsistent in its views. Riegel at 1016 fn. 8.
Justice Stevens – Probable Longshot
- Has written multiple opinions emphasizing presumption against preemption of state product liability law.
- Took narrow view of implied conflict preemption in Geier dissent.
- Skeptical of implied preemption in Kent argument.
- Also expressed concern in Kent argument that FDA cannot “give recovery to a class action of a couple of hundred plaintiffs who were injured.”
- Concurred narrowly in Riegel on ground that express preemption provision was controlling.
- Wrote Riegel opinion, which strongly endorsed rationale for preemption: “One would think that tort law, applied by juries under a negligence or strict-liability standard, is less deserving of preservation,” than state safety regulations because a jury “sees only the costs of a more dangerous design, and is not concerned with its benefits; the patients who reaped those benefits are not represented in court.”
- Found it “extraordinary” that “because of the judgment of . . . one jury, the manufacturer is placed at a risk in selling a device that scientists at the FDA have said is okay.” Riegel Argument at 19.
- May have less expansive view of implied preemption but joined Breyer in Geier majority.
- Joined Riegel majority.
- Expressed concern that tort suits will scare manufacturers from keeping medical devices on the market, leaving patients without any medical device until the FDA approves a new one. Riegel Argument at 18.
- Joined Riegel majority.
- Joined Breyer in Geier majority.
- Asked pro-defense questions in Kent Argument.
Justice Alito – Good Bet
- Joined Riegel majority.
- Suggested that fraud-on-the-FDA lawsuits would interfere with FDA’s ability to do its job. Kent Argument at 36.
- Joined Riegel majority.
- Wrote landmark implied preemption majority opinion in Geier.
- “You’ve got to get drugs to people and at the same time the drug can’t hurt them. Now, who would you rather have make the decision as to whether this drug, is on balance, going to save people, or on balance, going to hurt people? An expert agency, on the one hand, or 12 people pulled randomly for a jury role who see before them only the people whom the drug hurt and don’t see those who need the drug to cure them?” Kent Argument at 30.
- Joined Riegel majority.
- Authored implied preemption opinion in Freightliner (so we know he believes in it), but joined dissent in Geier.
- As is his custom, said nothing in today’s argument.
- Joined Riegel majority, but joined dissent in Geier.
- Appeared skeptical of implied preemption arguments in Kent.
For those of you who are counting, that’s more than five likely votes for preemption. The real questions are how broadly the opinion will be written, and how the Court will come out on the more nuanced list of issues that readers of this blog know are presented in this case. We’ll just have to wait and see.