Saturday, February 21, 2009

Past Time to Right a Wrong

Remember Riegel v Medtronic and the Supreme Court decision exonerating Medtronic because their heart catheter was FDA approved? Well, Medtronic is back in the news. It should be apparent to anyone who reads the NYT’s article Lawmakers Seek to Return Right to Sue Device Makers -, that enough is enough.

Because of the Supreme’s misguided Riegel decision, injured Americans throughout the country have had their cases tossed out of court. Bills have been written to end this insanity, but have not yet passed. Congress needs to pass them, now, before anymore women are burned internally, hearts are shocked or torn apart, and defective implants and treatments go horribly wrong.
Please read the Times piece and come back and tell us your thoughts.


  1. Dianne, I agree, Congress needs to do its job and make law. If they don't The Supreme Court will.
    What are they waiting for? The right time? Public opinion? The Supreme Court's decision? The end of the financial tragedy? Is everything besides the bailout going to be put on hold for the next 2-6 years?

    The Supreme Court's job is not to decide that rights such as the right to have your grievance heard before a court of our peers should be eliminated. I am not a constitutional lawyer but it seems that this kind of decision should be made by Constitutional amendment or Congressional law making.

    Some advice - When looking at trying to change such fundamental civil rights, it would be advisable that you do it in such a way that the American public doesn't find out about it (a la Daniel Troy) otherwise it's not likely to happen.

  2. Jaynesday, yes, but Congressional law and Constitutional amendmendments still must be constitutional. Nobody has the right to deny our right to a day in court, not even Mr. Troy.

  3. Coupla' points.

    The preemption issue is not a Constitutional one, or--if it is--it may lean in favor of the feds. The relevant Const. provision is the supremacy clause, which says the feds can preempt states under certain circumstances (e.g., whether slavery is OK, width of railroad tracks, building nukes, etc..)

    So, while the right to a day in court may apply in criminal matters (I need to check), I don't think there is anything in the Const. that applies to that right in the civil damages arena.

    The MDA (Med. Device Act) had an explicit preemption provision saying that states could not impose different requirements on devices than the FDA. This has logic in the sense that you probably wouldn't want a Michigan Device Agency to require more--or less--from a pacemaker, say, than what is federally mandated.

    The key issues are whether (a) civil liability constitutes competing regulation, especially when it is based on the alleged fraud, negligence, or similar (and thus outside the immediate question of FDA approval); and (2) whether state tort law constitutes a competing regulatory scheme at all. The SC has been divided on the second question.

    Obviously, preemptors hang their argument on the second issue especially.

    Meanwhile the FDCA, the law which governs drugs, is different from the MDA, and has no explicit preemption or not-preemption clause one way or other.

    Because Congress passed the MDA in its current form, it ought to be easier to amend in a way that negates the presumption of preemption than the FDCA.

  4. re: above, and as I should have known, the right to a trial is the core of the 6th amendment and concerns criminal accusations (not civil) and is a right given to _defendants_, not plaintiffs. Here is the text of the 6th, all of which terms have had much commentary:

    In all criminal prosecutions, the accused shall enjoy the right to a speedy and public trial, by an impartial jury of the State and district wherein the crime shall have been committed, which district shall have been previously ascertained by law, and to be informed of the nature and cause of the accusation; to be confronted with the witnesses against him; to have compulsory process for obtaining witnesses in his favor, and to have the Assistance of Counsel for his defence.

  5. Well, you learn something every day....Apparently the 7th amendment does cover civil trials, but they are limited to issues on the fed level (not "private plaintiffs) as I understand it. Perhaps a real lawyer will help us.

    Here is some interesting text on the "jury of peers' notion, which is not in the Constitution.

    Jury of Peers

    People often say "I have a right to have my case heard by a jury of my peers!" when there is no such right in the Constitution. The Constitution does take up the issue of juries, however. It is the nature of the jury which is not in the Constitution. In Article 3, Section 2, the Constitution requires that all criminal trials be heard by a jury. It also specifies that the trial will be heard in the state the crime was committed. The 6th Amendment narrows the definition of the jury by requiring it to be "impartial." Finally, the 7th Amendment requires that certain federal civil trials guarantee a jury trial if the amount exceeds twenty dollars.

    Note that no where is a jury "of peers" guaranteed. This is important for some historical and contemporary reasons. Historically, the notion of a peer is one of social standing - in particular, in a monarchy such as the one the United States grew up from, commoners would never stand in judgement of lords and barons. Along these same lines, since suffrage and jury service have always been closely tied (and in the beginnings of the United States it was typical for only white, male, property-owners to be allowed the vote), any combination of gender, race, and economic status would be judged by only one kind of jury, hardly by "peers."

    Today, the American ideal dictates that we are all peers of one another, that regardless of gender, race, religion, social status, or any other division (except age), we are all equal. In this ideal, since we are all peers, a guarantee of a jury of ones peers would be redundant. While some argue with this ideal, it is the most democratic way to approach the subject. Juries need only be impartial, and not made up of one's peers, else the jury system would be unworkable.

  6. And you mislearn something.

    The Seventh Amendment has some ambituities re: civil trails. Is there a lawyer in the house?

  7. I bet James could help us.

  8. A number of weeks ago James gave us a beautiful summary of product liability litigation history. A key paragraph was this - (bold added by me)

    The final case was Escola v Coca Cola Bottling (24 Cal. 2d 453) decided in 1944; in Escola, a California Waitress while handing a bottle of Coca Cola had the bottle explode in her hands causing a gash in her right hand that required immediate medical attention. Coca Cola’s defense was the product was outside their control and there was no way of knowing if the injury was caused by improper bottling practices or that the Plaintiff was somehow culpable. In their defense Coca Cola introduced evidence that the bottles were subjected to rigorous testing by the original manufacturer and that they had met their duty of care.The Court disagreed and held for the Plaintiff. In the majority opinion written by Justice Gibson, his opinion relied on the facts of the case and essentially ruled that because the bottle exploded an inference of negligence could be drawn to support the negligence verdict. However, it was Justice Traynor who wrote a concurring opinion, introduced the Doctrine of Strict Liability. In his opinion he wrote that changes in society made it impossible for an individual to have the knowledge and means required to challenge large corporations and as a matter of Public Policy essentially shifted the burden from the Plaintiff to the Defendant.

    In conclusion - whether or not we have a civil right to trial in product litigation we see that the issue was settled in law. Of course not to the liking of some industries, therein we have preemption.

  9. Well done, your Esquire.

    I think some states - e.g., North Carolina - have rejected "strict liability," but wudda I know.

  10. Justice, as you know, under “due process of law” and the 5th and 14th Amendments the rights of Americans are protected; in that light, I believe preemption is a Constitutional issue.

    From Wikipedia:
    Due process (more fully due process of law) is the principle that the government must respect all of the legal rights that are owed to a person according to the law of the land, instead of respecting merely some or most of those legal rights.

    The Fifth Amendment to the U.S. Constitution reads:

    “No person shall be ... deprived of life, liberty, or property, without due process of law ....”

    The Fourteenth Amendment to the U.S. Constitution reads:

    “nor shall any State deprive any person of life, liberty, or property, without due process of law ...”

    Preemption violates these rights. If it becomes the “law of the land,” the legal rights that were at one time promised to every individual, in this fabled land known as America, will be gone.


  11. The recalled product was Medtronic Inc. Sprint Fidelis® Defibrillator Leads, model numbers 6930, 6931, 6948 and 6949 manufactured from September 2004 through October 15, 2007:

    Here is a link to the premarket approval records (click on S029, S030. . .):

    The following changes were made to the leads:
    June 8, 2004: A polyurethane overlay was added.
    July 3, 2007: Design and manufacturing changes were approved to improve the df-1 leg strength and handling characteristics of the leads.

    When did the company become aware that the thin leads (cables) were prone to fractures (breaks)? Were improvements made to the leads? If so, how were the “improved” leads tested to assure the safety and effectiveness of the leads before they were sold?

    “The FDA requires that a device that has received premarket approval be marketed without significant deviations from the specifications in the device’s approval application, for the reason that the FDA has determined that those specifications provide a reasonable assurance of safety and effectiveness.” – Riegel v. Medtronic, Inc. (2007), found at

    Justice pointed out that states cannot impose different requirements on devices than the FDA; however did the FDA meet its own requirements in this case?

  12. Where is Joshua Sharfstein?

  13. David

    I have been not reading too many of the posts here lately, so I just came upon your post today and I thank you for the kind words. I enjoyed conducting the research for the litigation post I submitted and would like to help here but I am somewhat unsure of the question.
    Since I think the question involves when Federal Jurisdiction applies in civil matters, I have attached a link to an article which hopefully answers your question. The article indentifies the Federal issues which would be properly heard before a Federal Court, as well as the circumstances where a State civil action is heard in a Federal Court; the latter predominantly pertains to cases involving multiple jurisdictions.

    Hopefully, the link works, if not I will have to ask Harpy for advice.

    In addition, Tortquemada wrote that North Carolina has abandoned the Doctrine of Strict Liability; you are correct, the following is from the North Carolina’s General Statutes:
    § 99B 1.1. Strict liability.
    There shall be no strict liability in tort in product liability actions. (1995, c. 522, s. 1.)

    Just a guess but NC has an overwhelming Republican Legislature?


  14. Justice
    Thought you might find the following language from Rice v Santa Fe Elevator Corp (331 U.S. 218, 1947) interesting:

    “Congress legislated here in a field which the States have traditionally occupied. See Munn v. Illinois, 94 U. S. 113; Davies Warehouse Co. v. Bowles, 321 U. S. 144, 321 U. S. 148-149. So we start with the assumption that the historic police powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress. Napier v. Atlantic Coast Line R. Co., 272 U. S. 605, 272 U. S. 611; Allen-Bradley Local v. Wisconsin Employment Board, 315 U. S. 740, 315 U. S. 749. Such a purpose may be evidenced in several ways. The scheme of federal regulation may be so pervasive as to make reasonable the inference that Congress left no room for the States to supplement it. Pennsylvania R. Co. v. Public Service Comm'n, 250 U. S. 566, 250 U. S. 569; Cloverleaf Butter Co. v. Patterson, 315 U. S. 148. Or the Act of Congress may touch a field in which the federal interest is so dominant that the federal system will be assumed to preclude enforcement of state laws on the same subject. Hines v. Davidowitz, 312 U. S. 52. Likewise, the object sought to be obtained by the federal law and the character of obligations imposed by it may reveal the same purpose. Southern R. Co. v. Railroad Commission, 236 U. S. 439; Charleston & W. C. R. Co. v. Varnville Co., 237 U. S. 597; New York Central R. Co. v. Winfield, 244 U. S. 147; Napier v. Atlantic Coast Line R. Co., supra. Or the state policy may produce a result inconsistent with the objective of the federal statute. Hill v. Florida, 325 U. S. 538. It is often a perplexing question whether Congress has precluded state action or, by the choice of selective regulatory measures, has left the police power of the States undisturbed except as the state and federal regulations collide. Townsend v. Yeomans, 301 U. S. 441; Kelly v. Washington, 302 U.S. l; South Carolina Highway Dept. v. Barnwell Bros., 303 U. S. 177; Union Brokerage Co. v. Jensen, 322 U. S. 202.”

    I don't recall if this case was cited in the Wyeth Briefs.


  15. Thanks James, I knew you would come through.
    I guess the question for me is this. Why are we in a position in the first place that Congress has to legislate the end to preemption? Not having a deep background in these matters it appears that preemption took an uncommon path to get to where it is today.
    I understand that the Bush administration's hatred of trial lawyers (support of industry) was the force behind the introduction of preemption. I presume though that industry experts provided the real legal tools (above or below board) that accomplished the deed. It's the legal tools that I question.

    As I recall Daniel Troy's movement out of industry, into the FDA and back to industry may have allowed some "unusual" events to take place.
    But did anyone really have the legal right to do what was done or are these things just political tennis balls that will be volleyed with each change of administration?

    From your last post James it appears that law is far from settled on what is state and federal jurisdiction. A weakness in the law that allows manipulative folks to take advantage?

    I hope that there is enough support from both parties to settle this matter once and for all. I fear that since so few voters know about preemption and also don't realize the less than stellar performance of our pharma industry, politicians may not act in our best interests in the long run. Big pharma money may hold sway.

    We've had some very bad incidences in pharmaceutical safety but nothing that has tripped the interest into the public outcry zone. Until that unfortunate time, will it will be safe for politicians to fill their pockets and act like they "just couldn't see this thing coming". A bit cynical I know but returning to my original question, how could all this legally happen?

  16. David

    The issue of preemption extends far beyond the pharmaceutical industry, which is why I provided the subsequent post in which I copied a quote from Rice v Santa Fe Elevator. The Santa Fe case was cited in numerous subsequent Supreme Court decisions, most notably Cipollone v Liggett Group (505 U.S. 504 1992) and Silkwood v Kerr McGee (464 U.S. 238 1984).
    In Cipollone the Court considered several issues, including an individual's right to bring a State Tort claim.
    The Court upheld Cipollone on this issue however, on three additional issues the Court Ruled against the Plaintiff. The majority ruling premised a good part of its decision on the language cited in the Rice Decision.
    What is particularly interesting about the Cipollone decision was the Concurrence and Dissent by Justice's Kennedy and Souter; both Justice's, along with Justice Blackmun, concurred with the majority but believed the decision should have expanded the Plaintiff's right to pursue the additional claims rejected by the majority, including a Failure to Warn Claim.
    I included the Silkwood case only due to its notoriety; the issue was primarily one of punitive damages. Kerr-McGee believed punitive damages were preempted by Federal law and the Appellate Court agreed with Kerr-McGee. However, in a 5-4 decision the Appellate Court Decision was reversed.



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