Pharma vs. Devices – FDA, Supreme Court and Liability Whiplash

Whiplash. I don’t know what else to call it when the US Supreme Court does a near 180° reversal on a decision from just a year ago on medical product liability. Consider the following…

On February 20th, 2008, the US Supreme Court ruled in favor of Medtronic in the case Riegel v. Medtronic. The case involved a cardiac catheter, which ruptured during surgery. Medtronic asserted (and the Court agreed) that, because the company had received premarket FDA approval for the device, the company was immune from suit in state courts. The prevailing argument was, in essence, that the rigor of the federal review and approval process trumped the individual’s right to seek judgment using the state courts.

Many supported the notion of keeping federally-regulated medical devices above the reach of state courts, but at the same time questioned whether the FDA was really capable of the safety rigor that the Court attributed to it.

Fast-forward one year to March 4th, 2009. On this day the US Supreme Court ruled in Levine v. Wyeth in favor of the plaintiff, a musician who lost her hand after an anti-nausea medication was injected arterially, contrary to the warnings on the drug packaging. Levine had prevailed in a state court, winning a judgment against Wyeth, a judgment which the pharmaceutical maker appealed all the way up the Supreme Court, and lost.

The warning for the medication, mandated and provided by the FDA for the package insert, was apparently not compelling enough for the Court. And despite its timeliness, the arguments in support of the Medtronic verdict do not appear to carry the same weight they did only 12 months ago as the Court cited the lack of FDA resources (compared to the 11,000 approved pharmaceuticals on the market) as a reason why the FDA should not be expected to police post-market medication safety.Is the Court acknowledging that the FDA has experienced a regulatory-capability meltdown in the past year akin to what we’ve seen in the financial markets?

I can imagine a scene in which there are two doors into the FDA, one labeled ‘drugs’ and one labeled ‘devices’. The applicants cued up in the ‘devices’ line are chatting and laughing with one another. They know that FDA approval is their ticket, a virtual ‘get out of product-liability free’ card. The applicants in the other line, however, are being browbeaten by attorneys and insurance adjusters. The applicants are sweating through their third shirt of the morning and the packaging designers are showing off the new microwave-sized box needed to include the encyclopedic disclaimers and cautions for each vial of product.

The Court has effectively bracketed the problem, but failed in both instances to provide a workable solution. Manufacturers, even those subject to the rigors of burdensome premarket approvals, should not be absolved of liability for their product. And manufacturers who play by the rules and include the FDA provided warnings in their packaging should not be held liable for a perceived insufficiency of the cautionary statements.

I don’t expect that the attorneys representing the medical manufacturers will be wearing neck-braces the next time they argue before the US Supreme Court, but I suspect that they’ll all be maneuvering carefully, seeking not to exacerbate the legal-whiplash with which they’re already afflicted.

Tobias Gilk is President and MRI Safety Director for Mednovus, Inc.

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  1. Talk about opening a can of worms . . .
    FDA is having a public hearing on 11/12 and 11/13/09 to discuss promoting FDA-regulated medical products using the Internet and Social Media Tools.
    SUMMARY: The Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER), in collaboration with FDA’s Center for Biologics Evaluation and Research (CBER), Center for Veterinary Medicine (CVM), and Center for Devices and Radiological Health (CDRH), is announcing a public hearing to discuss issues related to the promotion of FDA-regulated medical products (including prescription drugs for humans and animals, prescription biologics, and medical devices) using the Internet and social media tools. FDA is seeking participation in the public hearing and written comments from all interested parties, including, but not limited to, consumers, patients, caregivers, health care professionals, patient groups, Internet vendors, advertising agencies, and the regulated industry.
    This meeting and the written comments are intended to help guide FDA in making policy decisions on the promotion of human and animal prescription drugs and biologics and medical devices using the Internet and social media tools. FDA is seeking input on a number of specific questions but is interested in any other pertinent information participants in the hearing would like to share.
    Dates and Times: The public hearing will be held on November 12 and 13, 2009, from 8 a.m. to 5 p.m. each day. Submit written or electronic registration by close of business on October 9, 2009. Written and electronic comments will be accepted until February 28, 2010.
    Location: The public hearing will be held at the National Transportation Safety Board Conference Center, 429 L’Enfant Plaza, SW., Washington, DC 20594, 202-314-6305; Metro: L’Enfant Plaza station on the yellow, green, orange, and blue lines; see: http://ntsb.gov/events/newlocation.htm .
    74 FR 48083 — Sep. 21, 2009 FDA source: http://www.FederalRegister.com

  2. Good points, but how will we expose fraud without litigation? Some will be obvious but others will not.
    I admit that litigation has its problems. But fixing that problem by elimination of litigation only deals with the issues on one side of the fence.
    How would you prevent individuals/corporations and the industry from taking advantage of an environment where they are more or less free to let their self interests rule their decision making?

  3. Many perfectly good drugs have been driven off the market by litigation. Bedectin for nausea comes to mind. Since no alternative for first trimester nausea is known, our hospitalizations for dehydration are twice those in Europe. Vioxx was approved by the Canadians after American litigation. I think it is safe, and I still use it on myself.
    I am concerned, Axiomatic, that we are mixing drug company fraud, with should be a crime, with criminal sanctions and “failure to warn” liability for drug companies selling products which the FDA has determined are safe and effective and whose warnings have been reviewed. The way you are looking at this, there is virtually nothing a drug company can do to insulate itself from eye-popping awards for bad outcomes they had no part in.
    The area where the risk premium is most obvious is vaccines, where the usual tort laws needed to be suspended to find suppliers for these vital “drugs”. If you look into this I think you will find, most of the cost of a vaccine is for liability protection.
    So much for the argument that the Trial bar has any interest in the “greater good”.
    If we are going to have entitlement health care, because they do in Europe, remember, there is essentially no tort liability in Europe. Maybe tort liability is not necessary to have a safe medical system.

  4. Thank you, John Graham. I should probably correct myself to ask ‘why’ preemption should be applied to devices and not pharmaceuticals? (setting aside, for the moment, your point as to the constitutionality of preemption) The relationship between manufacturer, patient and regulatory bodies are strikingly similar.
    Perhaps we should start by renaming the agency FDDA to put drugs and devices on comparable footing, then look to legal structures that treat all medical products (with which we treat patients) in a similar way.

  5. Christopher,
    Just interested – how much has litigation added to the average cost of drugs? Any estimate about how many people have not had the benefit of a drug because of the frivolous litigation of a few selfish consumers? These kind of unproven, emotional claims have been thrown around much too long. Maybe you could give us some real facts and figures.
    Opposed to your 12 retired jurors, we have a pharmaceutical company well into development of a new drug that decides no one will ever know that a bad trial result has been realized, if they just don’t report it to the FDA. It happens much more than it should. This can be documented.

  6. So, let me see if I have this: twelve retired workers on a jury presented with a single instance of drug tragedy like this one, isolated from the beneficial value of the drug can overturn the experts at the FDA and prevail in state court. But when we have our Extraordinary Committee on Medical Efficacy, deciding what drugs and treatments can be performed in this country, no appeal will be possible. So the experts chosen by the president for political reasons will be way smarter than the career scientists at the FDA, right?
    One hundred dollar aspirins are going to be a bargain soon.

  7. Thank you for the clarification, Axiomatic. Rule of law seems to the uninitiated more of a tendency than a requirement. How is it even plausible that a seventh warning would have had a different result when every healthcare worker, even the nurse involved in this tragic accident, already knows that intra-arterial injection is disastrous? Under of our system with no adult supervision of state courts, I gather that wrongly decided state cases are not the provence of the Supreme Court.
    Could a drug company decide that the legal climate in a particular state was so slanted in favor of the plaintiff bar that they would no longer sell their product in that state. If the state were small, like Vermont, for example, the revenue loss would be slight. The gesture might restore a little common sense to jury verdicts. Somehow, I bet Vermont would rediscover the interstate commerce clause or some other mumbo jumbo and force Wyeth to restore sales.
    It seems that one’s appetite for states rights depends entirely on what is on the menu.
    The logical extension of the monotonous uninterrupted expansion of medical liability will be strict liability. If you think malpractice insurance is expensive now, just wait until that happy day arrives.
    Someday, as a society, we are going to be forced to limit liability, for all things medical. Someday we are going to have to transfer medical care and medical products from tort law to contract law, with specified damage limits.
    I am not holding my breath.

  8. Christopher George,
    Now that the decisions are rendered, it’s almost irrelevant whether the harm was a result of defective product or defective delivery of care. The lasting legal precedent of who can be held responsible _if_ there is a defective medical product at some point in the future is likely to be significant to a greater number of people than direct effects of this single decision.
    If FDA preemption is THE issue, how are we supposed to reconcile the Wyeth decision with the Medtronic decision?
    Was preemption law a year ago, but not now? I get that pharmaceuticals and devices are different things, but for me the underlying issue is the 3-way relationship between medical manufacturers, the public, and the FDA. Through that lens, the fundamental relationships in these two cases are comparable and I can’t wrestle the disparate legal decisions into a coherent logic.

  9. The Food Drug & Cosmetics Act and the Safe Medical Device Act are written differently: The former does not assert pre-emption and the latter does. It’s really no mystery why the Supreme Court decided differently. An interesting question is: Does the Constitution give Congress the power to assert pre-emption? In Wyeth v. Levine, Clarence Thomas said “no”.
    I’m very uncertain about pre-emption. From a utilitarian perspective, I think it’s ok but not ideal. From a constitutional perspective, I agree with Thomas.
    It brings me into conflict with most other conservatives. See http://tinyurl.com/dfofl2.

  10. Christopher –
    It was decided that this case would be heard by the Supreme Court to defend or defeat the concept of FDA Preemption (in essence). I agree that it was not a very good one due the drug administration issue but regardless, deciding for Wyeth would have been a decision for FDA Preemption, deciding for Levine was a decision against FDA Preemption.
    My argument was pointed at the real question at issue – FDA Preemption.

  11. I don’t understand how “making products that can never be questioned” relates to these cases. The products were mis-used! There is nothing the matter with either of these products.

  12. There are problems here with both sides of this issue. What about frivolous lawsuits, what about conflicting requirements, what about unsafe drugs and untrustworthy corporations? The answer to all of this is complicated and no one is completely sure about the best answer.
    One thing is for sure, a simple concept like preemption is much to one sided to answer all the concerns as it attempts to do.
    We must never allow corporations to produce products that can never be questioned directly by the consumer in a court of law. It is bad for the consumer and ultimately bad for the producer.
    The best answer for all of these issues is more than a one word answer.

  13. In both of these cases the product was mis-administered. The Medronic balloon was inflated above the pressure for which it was rated; the drug was mis-administered by the nurse.
    In both cases, the fault lay with the doctor or nurse using the product, not the product. There is no “failure to warn” here. The balloon was over inflated. Every balloon, when overinflated enough will burst. The injection was made into an artery. It was an error, but it wasn’t the drug company’s error, it was the nurse’s error.
    I don’t understand why this blog is not in favor of pre-emption in these cases. Every drug, no matter how long it has been safely used will now be more expensive to cover tort costs from freak mis-use of their products. Mis-use is completely out the manufacturer’s control.

  14. While it is at odds and kooky, the law is the law–devices and drugs are handled differently. I dont think it is “strange” then that the rulings turned out the way they did.
    Congress will need to legislate the change for devices, which they are working on now. I believe a bill is in the works.

  15. Federal government approval is a minimum requirement. As we all know even in the case of best FDA intent, they have to make a call on risk and reward. The states may not agree to the same risk and reward ratio.
    So they should have the freedom. Now, I am not for lawsuites unless there was a criminal intent to hide and mislead.