In the words of Ted Olson, the Bush Administration's Former Solicitor General, who now represents Medtronic: "When judges make laws, they become impossible to change through the legislature."
"And too much power in judges is not good," he warned, during an October 4, 2004, interview on PBS Online News Hour.
The Court granted certiorari in the Riegel case to decide whether the express preemption provision of the Medical Device Amendments to the Food, Drug, and Cosmetic Act preempts state-law claims seeking damages for injuries caused by medical devices that received pre-market approval from the Food and Drug Administration.
The stakes could not be higher, because a favorable ruling for Medtronic could mean the end of legal recourse for persons injured by defective devices. The list of names on amicus briefs arguing against preemption includes 30 state attorneys general, the Public Health Advocacy Institute, the Prescription Access Litigation and Community Rights Counsel, Consumers Union and the American Association for Justice, the AARP, the National Women's Health Network, the National Research Center for Women and Families and the US Public Interest Research Group.
Their briefs point out that Congress knows full well how to preempt state law tort remedies and could have easily drafted the legislation to include a clear statement preempting all state tort remedies as applied to medical devices but "declined to do so."
The majority of Americans do not want Congress to eliminate state tort damage remedies, and requiring clarity in preemption provisions forces politicians influenced by special interests to ignore the interests of the voting public to be held accountable. "If our federal representatives truly want to repeal time-honored common law remedies for corporate malfeasance," the amicus brief states, "let them say so clearly and directly, and then face the political consequences."
The requirement that preemption provisions be unambiguous "helps to ensure that those legislators face the appropriate consequences in subsequent elections," the brief notes.
"Without a requirement for clarity," they explain, "federal legislators might be tempted to enact an ambiguous provision with the hope that the courts would resolve the ambiguity in favor of preemption, thereby satisfying the special interests while maintaining plausible deniability with their constituents."
The brief also points out that, "Courts are institutionally ill-positioned to untangle the countless compromises made during the legislative process in an effort to resolve ambiguities in a preemption provision."
Ms Riegel is facing a stacked deck in the Supreme Court itself. The nine member panel now consists of 7 justices chosen by Republican Presidents and 2 appointed by President Clinton. Four justices were appointed by the Bush clan, 2 were chosen by President Reagan and President Ford appointed one.
On top of those odds, Medtronic's attorney, Ted Olson, is the former boss of the Deputy Solicitor General representing the Bush Administration, Edwin Kneedler, and they used to file amicus briefs together in the Supreme Court seeking favorable rulings for the pharmaceutical industry.
However, the fact remains that Congress decides whether federal regulations preempt state tort claims, and the Court has received an amicus brief from former FDA official William Schultz, of the Zuckerman Spaeder law firm, filed on behalf of two of the longest-serving members of Congress, who say Congress did not intend to include common law tort actions within the category of state requirements subject to preemption by the MDA.
Massachusetts Senator Ted Kennedy has served in the Senate since 1962. While chairman of the Subcommittee on Health, Labor and Public Welfare in 1974-1976, he was the sole sponsor of the Senate bill that resulted in the passage of the MDA.
California Congressman Henry Waxman, chairman of the Government Reform and Oversight Committee, which has investigative authority over all government agencies, has served in the House of Representatives since 1974. In 1976, Rep Waxman supported the MDA and participated in the debates on the bill.
Combined, these two men have more than 75 years of experience enacting legislation, and if anyone can explain the meaning of "intent," as that term applies to the FDA legislation at issue in this case, it's these two guys.
Their brief points out that Congress was fully aware of the widespread lawsuits involving devices when the MDA was enacted, and "if Congress had intended to preempt state tort law suits it would have explicitly done so."
The brief provides a lengthy discussion of the "intent" of Congress in passing the legislation. "At the time the MDA was enacted in 1976," they write, "the terminology used in the preemption provision was understood by Congress not to encompass product liability litigation."
They note that the enactment of § 360k(a) was the first time that Congress included a specific preemption provision and that it was the result of concern about California's medical device regulation, the Sherman Food, Drug, and Cosmetic Law adopted in 1970, and not products liability lawsuits against device makers.
"The legislative history demonstrates that Congress included section 360k in the MDA for one specific reason," the brief states, "to reconcile the new federal regulatory scheme with device regulatory schemes that states had adopted in the absence of federal regulation."
"There is no suggestion anywhere in the legislative history to suggest that Congress even considered preempting state tort suits," the senior lawmakers write, "much less that it intended to preempt such suits."
According to the Congressmen, there is no indication in the hearings, the Committee Reports or the debates on the House or Senate floor that even one member of Congress believed that section 360k would bar state common law remedies against device makers.
Mr Kneedler formed a tag-team with his old boss, Mr Olson, during oral arguments to the Court on December 4, 2007, in an all out push for a favorable ruling for Medtronic, and Mr Olson took the lead.
Mr Olson tried to make the argument to Justice Ginsburg that the preemption provision in the MDA, Section 360k(a)(1), was put in place by Congress.
Justice Ginsburg said, "what it was intended to do was to cut State pre-market approval, where States like California came in when there was a Federal void and said we shouldn't let the manufacturers put out whatever they'd like. Let's have a pre-market approval."
"And the argument is," she told Mr Olson, "as you well know, which was presented in Senator Kennedy's brief, that's what we meant to do with the preemption provision."
"Nothing more," Justice Ginsburg stated.
Chief Justice Roberts asked Mr Olson how newly discovered flaws were dealt with and whether preemption would apply in cases where the FDA had not considered a risk.
For example, he said, "where you have this catheter, and the FDA didn't look at the possibility of allergic reactions to the balloon plastic, and all of a sudden it turns out to be a serious problem."
"How can you say that that's preemptive?" he asked.
"This is a continuous process," Mr Olson said, "Information must be given by the manufacturer. There is a process by which doctors report consequences to the FDA. Citizens may report information. This is a continuous jurisdiction."
Justice Kenney asked whether the manufacturer is free to continue selling the device after there are newly discovered risks "pending the FDA's acting on the same information?"
Mr Olson stated, "yes," and "let me explain why I think that is important to this case."
If that information is in the possession of the FDA, he said, "The FDA can suggest to the manufacturer -- it can require the recall. It can change warnings. It can do all of those things. But what it is doing, because it's continuously involved in the process."
But Justice Kennedy pointed out that all this takes time. "Let's assume that we know it's going to take six months for the FDA to do this," he said. "The manufacturer knows that there's a real problem."
"He can continue to sell in the face of the knowledge of the real problem?" he asked.
"What I'm suggesting," Mr Olson replied, "is that the FDA can act as promptly or as slowly."
"I was asking you about the manufacturer's duty pending the FDA's action," Justice Kennedy stated.
"It's dependent upon the manufacturer providing information to the one centralized agency," Mr Olson replied.
Justice Stevens told Mr Olson to suppose that the manufacturer did not provide the information to the FDA. "Would the preemption nevertheless exist?" he asked.
"Yes, Justice Stevens," Mr Olson said.
Justice Stevens noted that, at least as a theoretical possibility, there could be a newly discovered risk that the FDA never knew about and asked, "nevertheless, the claim would be preemptive?" he asked.
"Yes," Mr Olson said.
"And that's a judgment that Congress made," Mr Olson stated, "because with the -- the manufacturer then would be violating the law, failing to tell the FDA what was going on, perhaps committing fraud, and be subject to criminal penalties, recall penalties, civil penalties, and that sort of thing."
Justice Souter pointed out that Mr Olson did not answer the question posed by Justice Kennedy. "His question was," he said, "what if the manufacturer has learned that there is -- that there's a problem that somebody hadn't anticipated? The manufacturer has told the FDA, and the FDA has not yet acted."
"Leave open the question of whether the FDA is slow or whether it just takes time, but there's a -there's a hiatus here," Justice Souter told Mr Olson. "And an injury occurs because of marketing that took place during the hiatus."
"Does preemption still apply?" he asked. "Yes, it does," Mr Olson replied.
"And the reason for that," he stated, "is that someone must make a judgment. That - the information that the manufacturer may have learned may be -- have some aspect of the safety or effectiveness of the device, but it still might be the best product available."
Justice Kennedy asked whether a manufacturer is obligated to notify the FDA if it "finds just from its own laboratory experiments and not because of any data it's received from doctors and patients that there's a better way to do this."
And Mr Olson stated: "I don't think so, Justice Kennedy."
Justice Alito asked whether a person looking at the file for a PMA proceeding would be able to tell exactly which design features or risks were considered by the FDA.
"No, I don't think you could," Mr Olson responded.
Justice Alito asked Mr Olson if he knew "whether the PMA process in this case considered the design defect that the Petitioner seems to be relying on?"
"Well, all -- no," Mr Olson stated. "I don't know the answer to that specifically."
Justice Ginsburg asked Ms Riegel's attorney, Allison Zieve, to explain what was wrong with the label on the device.
Ms Zieve said the label was inadequate or misleading because in one place it lists among 12 precautions not to inflate the balloon above the burst pressure of eight, and in another place it has a chart that shows inflation up to 13, and at another place in the instructions, it says inflate to the nominal pressure.
At that point, Chief Justice Roberts cut her off with the statement: "So that's just like a car speedometer. I mean, the speedometer goes up to 120 miles and hour, but that doesn't mean you are supposed to drive it that fast."
But Ms Zieve was quick to respond and pointed out that, "the car doesn't come with a chart that shows you safe usage of up to 100 miles either."
Justice Kennedy asked her whether Medtronic was free to alter the label without the FDA's consent, and Ms Zieve said yes, under 814.39, "Medtronic could make changes to strengthen the warnings or clarify the instructions without prior approval."
Later in the hearing, Ms Zieve noted that there is testimony from the doctor in this case, and he thought that the label showed testing up to 13. "And that based on the directions, he thought that going up to 10 was fine and that it was standard use among the cardiologists," she told the justices.
Justice Kennedy asked the government's attorney, Mr Kneedler, to suppose a label is approved in a very specific form under the PMA and then a year later, it turns out, unforeseen by anyone, that doctors are just reading it the wrong way and it's dangerous.
"Can the manufacturer continue to sell new devices with the same labeling pending the annual report?" he asked.
Mr Kneedler said yes and began giving the usual long-winded answer, saying that there would be difficult judgments to make as to whether the injury was associated with a device or some other problem, at which time Justice Kennedy butted in and said, "Just take my hypothetical."
"I was going to say," Mr Kneedler continued right on, "it's possible that the labeling would be regarded as misleading for some reason."
"In that event," he said, "the manufacturer should apply to -- should submit what's called a supplemental PMA and request that the labeling be changed to clarify that."
Justice Kennedy again asked whether the manufacturer could continue to sell the device, "knowing that the label is being misconstrued by very good doctors pending FDA action?"
"Ordinarily, yes," Mr Kneedler answered.
"If there was -- if there was a very serious risk to health and safety -" he started to say, and Justice Kennedy cut him off again and said: "Yes, it's very serious."
"In that event," Mr Kneedler stated, "FDA has a variety of tools that it can take and so does the manufacturer."
He explained that one would be a "Dear Doctor" letter, "a notification to physicians or other users of a product that there may be some previously unrecognized problem or misrepresentation or what could be misconstruction of the label."
Justice Kennedy asked whether a failure to give that notice would subject a manufacturer to liability if the manufacture continued to sell the device.
Mr Kneedler said no, not state tort liability, and then swung into another long-winded answer about how the manufacturer could be subject to criminal penalties for either misrepresenting or withholding information if it did not report the problem to the FDA.
But the bottom line is, the answer is no, the citizen would be left with no recourse.
Chief Justice Roberts asked Ms Zieve whether her point was that a company does not have to sell a defective device just because it is approved.
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Houston attorney Andy Vickery says preemption is an assault on the rights of American citizens. "For 39 years through both Democratic and Republican administrations, the FDA took the stance that private tort litigation was a good thing," he notes.
"Prior to the Bush Administration," he says, "the FDA avoided getting involved in civil litigation and when it did, it was generally to protect consumers."
Attorney Robert Brava-Partain of the Baum, Hedlund, Aristei & Goldman law firm, also contends that the FDA has always protected consumers until "the Bush Administration shifted the focus towards the protection of the companies whose products the agency is supposed to be regulating."