The Legal Examiner Mark The Legal Examiner Mark The Legal Examiner Mark search twitter facebook feed linkedin instagram google-plus avvo phone envelope checkmark mail-reply spinner error close
Skip to main content

Last week, the new Medical Device Liability Bill was up for debate within Congress’ House and Energy Subcommittee. This new legislation is intended to undo the U.S. Supreme Court’s decision in Riegel v. Medtronic, Inc. In Riegel, the Supreme Court immunized certain manufacturers of medical devices by protecting them from state law product liability claims. This precludes approximately 10 million patients from claims against the manufacturer of their implanted devices when the devices were approved by the FDA.

Expectedly, pro tort reform associations such as American Tort Reform Association (ATRA) have begun marketing against passage of the new bill. In their latest press release, ATRA makes several bold claims, including: (1) the legislation’s intent is to only further trial lawyer fees; (2) this bill will allow claims that could bankrupt reputable companies; and (3) the bill would undo “longstanding law”. As a proponent of the bill, it’s clear to me that these claims are without merit.

First, the argument that pro-consumer legislation is really just pro-trial lawyer legislation is incredulous. This is nothing more than ARTA’s attempt to play to the stereotype of a trial attorney as reason to prevent victims from being made whole. Trial lawyers have, directly and indirectly, brought about increased safety measures and forced manufactures to be more conscientious of consumer safety.

Second, ATRA claims that the bill could allow excessive claims that would bankrupt the industry. The intention of product liability lawsuits, like most all other forms of personal injury litigation, is to make the injured victim whole again. Often people will hear of lawsuits with huge punitive damage awards. These punitive damages are sometimes greater than the compensatory damages themselves, and are intended to do as its name implies – punish the defendant. However, they are only available in extreme cases. In other words, the vast majority of product liability cases results in compensating the plaintiff for their injury, and are not intended to “bankrupt” any company (or for that matter, actually do bankrupt such a company).

Third, to call the decision of Riegel “longstanding” is beyond a stretch of the imagination. Riegel was decided February 20, 2008. In the decision, the Medical Device Amendments of 1976 was construed to spare medical device manufactures from claims of flawed design or labeling. While the decision has already precluded at least 1,400 lawsuits against manufacturers, the decision has created law that is far from longstanding.

The intent of this legislation is to undo the Supreme Court’s overreach into product liability lawsuits. Riegel has precluded otherwise legitimate claims, a preclusion not consistent with any other tort law. In the more recent decision of Wyeth v. Levine, the Supreme Court held that manufacturers could be held liable for mislabeled or defective drugs regardless of FDA approval.

In contrasting these two decisions, the current state of American law is this: If someone were to be seriously hurt or killed because of an FDA-approved drug was mislabeled, they are allowed to seek compensation. But if this person were injured by a mislabeled FDA-approved medical device, they would be precluded from bringing suit. Where is the consistency, or for that matter, the justice in that?

21 Comments

  1. Gravatar for Darren McKinney

    First, Don, the word is "incredible," not "incredulous."

    Second, as plaintiffs' lawyers are wont to do, Don, you've exaggerated the "bold" claims in ATRA's May 12 news release.

    We didn't say that the "legislation’s intent is to only further trial lawyer fees." We said it's "little more than an effort to stimulate the economy for personal injury lawyers." Trial lawyers spend more than any other special interest to elect the members of Congress they prefer, and now those grateful lawmakers are repaying the favor.

    As far ATRA's assertion that "personal injury lawyers threaten manufacturers of critical medical technologies ― and thus the health of patients who benefit from them ― with speculative, potentially bankrupting lawsuits filed invariably in some of the nation’s least fair civil courts," it's a matter of public record. And your spinning response omits mention of multibillion-dollar class actions. Did you forget about them?

    Lastly, Don, I don't know how you define "longstanding," but I dare say that most folks would be comfortable defining a 33-year-old law that had been upheld by lower federal courts several times and then by the Supreme Court (8-1) last year as "longstanding" law.

    The bottom line is that it's impossible to argue credibly that countless lay judges and juries, operating under 50 different sets of state tort law and under the influence of self-interested trial lawyers, can analyze and regulate the design and safety of scientifically complex medical technologies better than dedicated experts at the FDA.

    If trial lawyers are truly interested in consumer and patient safety, Don, why won't you join ATRA in calling for improving reforms at the FDA?

    Respectfully,

    Darren McKinney

    Dir., Communications

    American Tort Reform Assoc.

    Washington

  2. Gravatar for Michael Bennett

    "The bottom line is that it's impossible to argue credibly that countless lay judges and juries, operating under 50 different sets of state tort law and under the influence of self-interested trial lawyers, can analyze and regulate the design and safety of scientifically complex medical technologies better than dedicated experts at the FDA."

    Cigarettes: There's an example of the great success of the FDA? Zyvox, Thalidomide, Neurontin, to name just a few more.

    How many people's lives have been ruined and how many have been killed as a consequence of manufacturers' negligence, greed and corruption enabled by the failures of the FDA? How can anyone argue against accountability and plaintiff attorneys and civil courts playing an important role in that unless they have a self-interest in doing so?

    Plaintiff attorneys have made phenomenal contributions to consumer rights and safety and to civil justice. What has the tort "reform" movement done, besides causing further injury to victims and protecting negligent individuals and corporations, in those regards?

    If you are unfortunate enough to become a victim, like millions of Americans become every year, I doubt that you will be seeking support from your "self-interested" colleagues at ATRA.

    My support goes to the victims' advocates...Trial Lawyers!

    Michael Bennett

    The Coalition For Patients' Rights

  3. Gravatar for Darren Wilson

    Dear Darren,

    Thanks for commenting here. You have a good first name, but I am not so sure about the validity of your argument, particularly your suggestion regarding the FDA's infallible ability to sufficiently evaluate, monitor and regulate hundreds of thousands (millions?) of products to adequately protect the American public from dangerous, defective, or completely ineffective drugs and medical products. While many products are safe and effective, I believe that thousands of Americans die or are severely harmed by products each year, and that many of those deaths and injuries are preventable.

    You say: "The bottom line is that it's impossible to argue credibly that countless lay judges and juries, operating under 50 different sets of state tort law and under the influence of self-interested trial lawyers, can analyze and regulate the design and safety of scientifically complex medical technologies better than dedicated experts at the FDA."

    (BTW, drug and device makers have their own "self-interested" lawyers, lobbyists, and PR people.)

    I appreciate the dedicated efforts of many of the hardworking people at the FDA and the insurmountable challenge they face. Remember that drugs and medical devices are developed and marketed for profit by extremely wealthy, powerful and influential corporations (who spend quite bit of their own money lobbying in support of their interests).

    Even with a record 20% increase (http://tinyurl.com/pe959z), the President's proposed budget for the FDA for 2010 is approximately $3.2 Billion:

    http://www.foodmanufacturing.com/scripts/ShowPR~RID~11298.asp

    This means that the FDA's entire proposed (though greatly increased) budget is a few hundred million dollars less than the the annual profits of a single well-known drug manufacturer: http://tinyurl.com/ojwgnm

    To suggest that the FDA has sufficient power and resources (without the help of the civil justice system) to regulate corporations in a way that will effectively protect Americans from harm does not hold water, in my opinion. I think we have seen proof of the failure of this argument in recent years, and I am not alone in that opinion.

    Do a search for "FDA whistleblowers" and you will find many articles like this one, written just last week:

    http://www.theepochtimes.com/n2/content/view/16742/

    More here: http://en.wikipedia.org/wiki/Criticism_of_the_Food_and_Drug_Administration

    Finally, I remain surprised that the same special interests who constantly argue for deregulation, and spend millions lobbying for, deregulation and "small government" are often those who are claiming that "government will manage this problem best" and that the American people should forego their right to a trial by jury and "stay out of it."

    To me, it sounds like you are advocating that a pack of wolves be put in charge of guarding the henhouse.

  4. Gravatar for Mike Bryant

    States have been able to do a lot of things to help consumers. The past administration did everything they could to strip those states rights. If you search "FDA" you will see that many of us have blogged on FDA reform.

  5. Gravatar for Darren McKinney

    Mr. Wilson,

    Perhaps you didn't read to the end of my previous comment wherein I readily acknowledge the human fallibility of the FDA and invite personal injury lawyers, the lawmakers they buy and others to join ATRA in advocating reform of the beleaguered agency.

    Moreover, in addition to calling for FDA reform in letters to the editor in both The New York Times and The Wall Street Journal in recent months, ATRA's May 12 news release concluded thusly:

    “The desire to compensate individuals who have suffered is understandable, and certainly the FDA is not without its bureaucratic shortcomings. But its experts are still far better suited to regulate the safety and effectiveness of medical devices than are lawsuits driven by personal injury lawyers. Congressional leaders would be well-advised to abandon this latest gift to the politically powerful litigation industry and instead seek broad, bipartisan support for strengthening and reforming the FDA, as needed."

    So you see, your straw man argument, claiming that tort reformers hail the FDA as "infallible" (your word), is demonstrably false and barely worthy of refutation. But I had a few spare moments.

    Darren McKinney

    ATRA

  6. Gravatar for Don Greiwe

    Darren M.,

    In response to your reply, “incredulous” is the appropriate word for the sentence, not “incredible” as you suggest. I invite you to consult a dictionary as to the definition of incredulous. In the context of the sentence, it means “expressive of disbelief.” Other appropriate sentences with the word “incredulous” would be “he had an incredulous stare after I lied to him,” or, “I have an incredulous disposition after reading a statement by someone who refers to trial attorneys as ambulance chasers.”

    I do find your response to be both incredible and incredulous.

    To your second comment, I fail to see a distinction between what was said in the original post and your claim that “trial lawyers spend more than any other special interest to elect the members of Congress they prefer, and now those grateful lawmakers are repaying the favor” (quoted verbatim to avoid any misunderstanding). To state trial lawyers that self-servingly promote consumer-protection laws for the sole sake of turning a profit is, well… incredulous.

    Your suggestion that trial lawyers outspend the U.S. Chamber of Commerce and its local chapters, business associations, special interest groups, and Tort Deformers is not worthy of a response. Your lobbying efforts aside, the country has been through the Bush years favoring business and has seen the economy of this country fall to a resounding thud. Protectionism of the sort favored by the Republican guard of the Bush Administration has not worked. This great country was grown on a capitalistic society, which included the protections of the U.S. Constitution and its amendments. It will, despite your efforts to change it, continue to protect the weak against the strong. It will be done with attorneys who contract with clients for a fee agreement that allows these individuals to fairly and honestly take on your manufacturers whose products have caused serious injury or death.

    The ruling of the Supreme Court in Riegel in 2008 regarding federal preemption is new and far from “longstanding”. Never before has any court interpreted the law to go as far as was done in Riegel where it was ruled that FDA approval alone immunized device manufacturers from certain tort claims made under “longstanding” state law.

    The Seventh Amendment of the U.S. Constitution guarantees a trial by jury in most civil cases. It empowers individuals with the ability to force corporations like those you represent to be held accountable for the wrongs they commit in the pursuit of profit (and many times, excessive profit). Trial by jury is the purest form of democracy. To suggest that the jury system has failed the people of this country is clearly wrong and misguided. Additionally, the law of punitive damages does not allow for the bankrupting of a company by a judgment based upon such damages as you incorrectly assert. You would know that to be true if you were familiar with the law.

    Lastly – many trial attorneys, including myself and colleagues, believe that reform is indeed needed at the FDA. However, the FDA has a difficult enough job without having the American Tort Reform Association telling it how to do its job. There are signs that the new administration will bring this reform, but it will take time before we see tangible results. There are legitimate accusations of corruption within the FDA, as one of my colleagues wrote about. These stories of impropriety are exactly why the Court got Riegel wrong.

  7. Gravatar for Michael Bennett

    ATRA's interest in FDA reform is a transparent attempt to make them seem like consumer advocates. Nothing more.

    "Most sorts of diversion in men, children and other animals, are an imitation of fighting"

    ~Jonathan Swift

  8. Gravatar for Darren McKinney

    Don:

    I don't know what dictionary you've got on your desk nor where you went to school, but you're simply wrong on the meanings of "incredible" and "incredulous." A perciever is incredulous; that which he percieves is incredible. Simple as that.

    And speaking of incredible, your claim to be looking out for the interests of the little guy is as about as incredible as they come. Do you have any sense of how many mom & pop shops are shut down each year thanks to the meritless slip & falls with which your kind clog our courts? Or how much such lawsuits cost taxpayers, consumers and employees? Do you care?

    I don't know you personally, Don, so I suppose you may very well care. (I hope so.) But certainly you'd concede that many personal injury lawyers care only about bullying and extorting quick settlements from English as Second Language entrepreneurs, other small busninessmen and women, and even large corporations when they think they can get away with it (see, for example, the thousands of asbestos and silica case frauds uncovered by various judges in the past few years).

    I'm not saying, nor is anyone I know in the tort reform community saying, that plaintiffs' lawyers can't and don't serve a higher purpose than their own enrichment often enough. And we certainly don't want to change the Constitution when it comes to the right to a trial by jury. But we would like judges and prosecutors to crack down further on those shysters who repeatedly abuse our civil justice system for their own benefit (see Scruggs, Lerach & Weiss). And we stand by our unassailable position that even a flawed FDA is far better suited to regulate medical devices consistently than are lay judges and juries in 50 states when goaded by self-interested trial lawyers.

    Finally, at least the American Tort Reform Association is quite credible when it comes to truthfully stating whose interests we represent. Our name is straightforward, too, unlike that of the euphemistic and focus group-tested American Association for Justice, formerly and more transparently known as the Association of Trial Lawyers of America. Certainly ATRA's name leaves no one incredulous.

    It's been fun, fellas, but I really should get back to work. Keeping up with all of your get-rich-quick schemes in 50 states is a fulltime job. But let me know if you ever want to play four-on-one again. I'm a good sport. Have a lovely holiday weekend.

    Yours,

    Darren

  9. Gravatar for Jim Clark

    Darren-

    Did you get the memo from President Obama today? He issued a Directive to the Heads of All Executive Branch Departments and Agencies regarding federal preemption of state causes of action. A major blow to ATRA and a major victory for the American consumer public. Enjoy....

  10. Gravatar for Suzanne McClain

    Darren M,

    As a woman who was injured by a medical device, I take personal offense to your comments. It has taken a year to even find a law firm who is handling cases pertaining to the type of device that was implanted in me.

    You said "the FDA is not without its bureaucratic shortcomings. But its experts are still far better suited to regulate the safety and effectiveness of medical devices than are lawsuits driven by personal injury lawyers."

    These so called experts are approving Class II Medical Devices for implantation into one's body within 90 days, and with no clinical trials required under the 510K process. The manufacturer simply has to cite "substantial equivalency" to a similar medical device already on the market, called a "predicate device" to obtain this approval.

    However, when the predicate device is pulled from the market, whether by the FDA or via a firm initiated recall, (the former of which happened in my case) citing their product is "associated with higher than expected rate of vaginal erosion and dehiscence, and does not appear to function as intended" these "experts" (your word, not mine) leave on the market devices that had used this predicate device to gain approval. Think they're so smart now?

    My life is destroyed. My husband's life is destroyed. No one bothered to tell me that this device, approved by the FDA had no clinical trials, and that in fact by having this very device implanted, I actually entered in to a clinical trial. Those of us that had this device implanted are the studies. I didn't sign up for this and never agreed to allow my body to be used to further science, a science that isn't working. I was in effect, used as a guinea pig.

    Worse than this, is the fact that the device implanted in me has been used time and again as the predicate device to approve additional devices, when in all actuality this device itself, by virtue of the device the manufacturer chose to cite as its substantial equivalent being defective and pulled from the market is faulty too.

    I don't put much stock in the FDA. They can't even maintain a uniform database. I am speaking about the MAUDE Database in case your wondering.

    You have some audacity to point fingers at personal injury attorneys. Perhaps you should take a deeper look at the FDA, the doctors and the pharmaceutical companies who, for the most part are all in bed together.

    Laws need to be passed banning all doctors from owning stock in a pharmaceutical companies, including the doctors who are scientists working for the FDA, as well as banning pharmaceutical companies from providing "kick-backs" to doctors in any way, shape or form. These kick-backs are the incentive for many doctors to violate their "Hippocratic Oath" in which they vowed to never intentionally harm anyone.

    I want my life back! Can your "experts" give that to me? Neither can the lawyers, but they can fight for justice on my behalf.

    Oh, and by the way, this comment, "It's been fun, fellas, but I really should get back to work. Keeping up with all of your get-rich-quick schemes in 50 states is a fulltime job. But let me know if you ever want to play four-on-one again. I'm a good sport. Have a lovely holiday weekend" made you look like a pompous a**!

    Lastly, since your arguing the dictionary, "fulltime" is not a word in itself. It is two independent words, which when used together must be hyphenated.

Comments are closed.

Of Interest