Not surprisingly, the editors of The New England Journal of Medicine say 'yes.' Preemption, you may recall, is the notion that FDA approval supercedes state law claims challenging safety, efficacy, or labeling. Drugmakers and the FDA argue that preemption exists by maintaining the agency’s actions are the final word on safety and effectiveness.
This fall, the US Supreme Court will hear a case that could determine whether patients can sue a drugmaker through state law when a product has already been approved by the FDA. And in an editorial, the NEJM editors offer a cautionary note.
"Drug and device companies have chosen an inauspicious moment to attack the right of patients to seek redress," they write. "A series of pivotal reports on patient safety from the Institute of Medicine, as well as numerous articles in scholarly journals, has put the issue of patient safety in the national spotlight. Although frivolous lawsuits should not be condoned, product-liability litigation has unquestionably helped to remove unsafe products from the market and to prevent others from entering it. Through the process of legal discovery, litigation may also uncover information about drug toxicity that would otherwise not be known. Preemption will thus result in drugs and devices that are less safe and will thereby undermine a national effort to improve patient safety.
"Owing in part to a lack of resources, approval of a new drug by the FDA is not a guarantee of its safety. As the Institute of Medicine has reported, FDA approval is usually based on short-term efficacy studies, not long-term safety studies. Despite the diligent attention of the FDA, serious safety issues often come to light only after a drug has entered the market. The FDA which, unlike most other federal agencies, has no subpoena power, knows only what manufacturers reveal.
"Why should doctors be concerned about preemption? In stripping patients of their right to seek redress through due process of law, preemption of common-law tort actions is not only unjust but will also result in the reduced safety of drugs and medical devices for the American people. Preemption will undermine the confidence that doctors and patients have in the safety of drugs and devices. If injured patients are unable to seek legal redress from manufacturers of defective products, they may instead turn elsewhere."
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Two comments that I find most interesting in this article are:
1. "Preemption will undermine the confidence that doctors and patients have in the safety of drugs and devices."
2. "If injured patients are unable to seek legal redress from manufacturers of defective products,they may instead turn elsewhere."
I don't think either one of these issues has been anticipated by those that forge the preemption excuse. Justice in Michigan has warned prior of the self destructive results of preemption.
Item 2. is a very ominous statement and leaves some question as to where the harmed will turn. There are a lot of possiblities but as we all know the fury of someone who is harmed will only intensify if they are are told "tough luck buddy".
Have a Happy 4th!
Doctors seem to worry about much more as well.....
So, You Want To Be A Doctor…..
Lately in the media, others have said and appear to express concern about the apparent shortage of primary care doctors in particular. Typically, the main reason stated and speculated for this decline of this health care profession that historically has been the apex of our health care system is lack of pay of this specialty when compared with other specialties chosen by potential physicians while in training. Yet considering the additional attention of shortages of students in some medical schools as well, one may ask the question as to whether or not people want to be any type of doctor in the first place in the United States. About one third of their lives are spent achieving the requirements of this profession. Reasons for not choosing to enter this profession are several and valid and include the following: There is the issue of long hours- with primary care in particular because of the apparent lack of doctors of this specialty. Such doctors may be over-worked without an expected pay reflecting the work they do. Furthermore, those doctors employed by health care systems are required to see a certain number of patients a day, and receive a monetary bonus if this expectation is exceeded. It seems that most doctors are members of such health care systems. So burnout never anticipated certainly may occur. And I consider such a requirement mandated by health care systems demeaning to this profession, and leave the doctor without the control that the doctor is entitled to due to their training and experience, and this competes with the other adversary of doctors, which is managed care. In fact, even government healthcare programs provide financial incentives in relation to the pay-for-performance system to improve the quality of care. However, the recent increase in hospitalists, who are those doctors that are usually Internal Medicine doctors who care for patients presently under hospital care, and they have lessened the load for all doctor specialties for the work they do that the admitting doctors would have to do without their presence. This in itself makes a doctor possibly more effective and efficient in their practice outside of the medical institution. All doctors, I presume, face a high degree of emotional and physical stress associated with their profession, as stated in the previous paragraph, for example. And this is not to mention the incredible stress associated with patient care in the first place, with some patient cases causing more stress than others. Patient care duty is a noble and great responsibility. Doctors, due to the changes that have occurred recently in the U.S. health care system, not only have the issue of money to deal with, but also a loss of autonomy regarding patient care combined with loss of respect that may be due in large part to the others previously mentioned who dictate how they practice medicine. Ironically and often, these others who direct these doctors are not as qualified as the doctor in the first place. This is complicated by the perception that the public, with some who view doctors as having the easy life with their pay and profession, which does not seem to be the case presently. Another frequent occurrence is the doctor’s patient directing their care with their doctor from either DTC ads or researching medical disorders on the internet themselves. There are also reasons of malpractice insurance, which is why doctors choose to join health care systems, it is believed, to pick up the tab for this necessity, along with eliminating the concerns of running a practice in a private manner, which historically has been the case, as their offices are owned by the health care system as well. Yet having another pay their malpractice premium does not eliminate their concern about being sued for error perceived by one of their patients. To protect against this, defensive medicine is implemented by doctors, which basically involves copious amounts of documentation and ancillary diagnostic testing regarding the doctor’s adherence to recommendations and guidelines. It has been said that up to 90 percent of malpractice cases against a doctor are baseless and without merit, so they are unsuccessful for the plaintiff, yet this still affects the rate the doctor or another system has to pay for malpractice insurance of a wrongfully accused doctor. This is combined with the amount the doctor has to spend to defend themselves in such cases, which separates them from their focus on the restoration of the health of their patients completely. Furthermore, malpractice lawsuits cost about 100,000 dollars over the course of about 4 years for such cases. A tort reform in Texas in 2004 resulted in annual malpractice premiums reduced by about a third of what they were. Soon afterwards, claims against doctors remarkably dropped by about 50 percent. Some specialties of doctors pay more premiums for malpractice than others. For example, OB/GYN doctors have been known to pay around 300 thousand dollars a year for this insurance. Certain types of surgeons experience a similar high rate of malpractice premiums. Malpractice flaws are catalysts for doctors to practice the inappropriate defensive medicine mentioned earlier to avoid potential litigation, which is a waste of health care resources with ordering unneeded patient methods or procedures to cover themselves against such lawsuits. Also, about a third of the U.S. is insured by Medicare, which progressively has lowered what they will reimburse a doctor for regarding the care doctors give a patient they treat. This fact is recognized by other insurance companies who will eventually follow the recommendations of Medicare, usually, regarding the reimbursement issue, so it seems. This will lead to a doctor having to see even more patients in order to make it financially with their profession, as this has resulted in the overall income of a doctor experiencing a decline of about 10 percent over the last decade or so. Further complicating the financial state of a primary care doctors is that doctors normally have to pay off the debt acquired from attending medical school and training, which averages well over 100,000 dollars today after their training is completed. About 20 years ago, that debt was only about a fifth of what it is today. Paying this debt off is typically about 2 thousand dollars a month that doctors on average is what the doctors choose to pay in order to eliminate this debt in a timely fashion. Conversely, there are some who believe that doctors in the U.S. are over-paid. This may be true, but they are not absent of financial concerns as with any other profession. And as mentioned earlier, clearly doctors accept more responsibility involved with human health than other vocations, so this should be kept in mind perhaps more by others. Most doctors do not recommend their profession to others for such reasons stated in this article so far presently, and perhaps other reasons not mentioned. This is somewhat understandable, yet extremely unfortunate for the health of the public in the future. There have been cases where doctors do in fact change careers, and get into vocational fields such as medical communications or corporate medical companies. Also, expert witnessing is another consideration for those who choose to leave their profession. Finally, other choices considered include consulting and research. The training of doctors fortunately leaves them with options not involved directly with the flaws of medical care, but this is bad for us as citizens, overall. The etiology of their departure from their designed profession is largely due to the negative state of mind that occurs as a doctor in today’s health care system, which is expressed by them at times in apathy, cynicism, and vexation regarding their limitations coerced by others. Conversely, not all doctors are deities. Like others, some are greedy and corrupt, which complicates others in this profession. Personally, I believe that the intentions of most physicians are bonafide. Yet in time, due to the nature of the current health care system, doctors frequently and really do become cynical, demoralized and apathetic. This may be considered a significant concern to the well-being of those in need of restoration of their health, understandably. Not long ago, the medical profession that has been discussed had overt honor and a clear element of nobility. Such traits are not as visible or recognized anymore, which saddens many intimate with the profession and importance of public health that is needed by many. “In nothing do men more nearly approach the Gods then in giving health to men.” --- Cicero Dan Abshear Author’s note: What has been written has been based upon information and belief.
Needless to say (for tolks who've read me here), I was glad to see NEJM take so strong a stand against preemption. This is their second such editorial, the first in response to the Riegel case regarding devices, equally condemning.
I understand it in context, but I will say that I _am_ surprised to see NEJM take such a strong stand. Docs are not "naturally" used to defending trial lawyers (for a couple of the reasons that Dan suggests). The fact that they do so here (and also in JAMA) tells us something, I think, about what is at stake in preemption.
Re: Jaynesday's comment, yes, I was surprised to see their iteration of my own recurring warning that preemption will undermine trust in pharma in general, and severely so. As we've recently discussed re: the last Harris poll, there is not that much further down to go.
Note also that it is not only those directly injured who may "turn elsewhere." When a Vioxx-scale disaster happens - and inevitably it will at some point - and it happens, in effect, "in the dark" - a great many people are likely to turn elsewhere. I think this means everything from significantly lower rates of compliance, to quack remedies, to an even greater reliance on alternative therapies (some of which are of proven efficacy), to no therapy at all.
In all events, a disaster indeed.
p.s. For those who have written here (and there are many elsewhere) that the civil liability system is only about "greedy trial lawyers," I wonder how they understand why the most respected voices in mainstream medicine - NEJM and JAMA = would take such strong stands against it?
I also wonder how the docs here feel when they read this in NEJM.
It is my position that application of the federal preemption doctrine in the context of lawsuits filed for legal compensation involving a drug injury or medical device harm is bad public policy.
I have previously set forth some of my reasons for this position in a March 2008 post at my blog, Drug Injury Watch:
http://www.drug-injury.com/druginjurycom/2008/03/issue-should-we.html
More recently, Justinian Lane has written two good articles on this subject at the Tort Deform blog:
http://www.tortdeform.com/archives/2008/07/the_trasylol_story_illustrates.html
http://www.tortdeform.com/archives/2008/06/critiquing_the_economic_argume.html
As for the preemption of medical device lawsuits, thankfully on June 26, 2008 Congressmen Henry Waxman (D-Calif.) and Frank Pallone (D-N.J.) along with 62 bipartisan supporters introduced HR 6381, the Medical Device Safety Act of 2008. This bill, if enacted into law, would reverse the U.S. Supreme Court's Riegel ruling in favor of Medtronic and restore the legal rights of any patient harmed by a defective and unsafe medical device product.
I encourage all interested citizens to contact their representatives in Washington and ask those lawmakers to support this type of federal legislation.
Hi Tom - Good to see you here. As you may know, Pharmalot has covered the preemption issue very closely, citing major articles (Kessler/Vladeck, for example), hearings (including access to streaming here), and so on.
So, however they come down on the issue, most folks on this site are very well informed, which is great.
I second Tom's call to action regarding your legislatures. But it's just as important to contact the presidential candidate you're supporting to ask them to support the legislation as well, since the odds are it will be our next president who is presented with this legislation.
Re: Justinian's point, I fully agree - it is important that voters know where _every_ candidate stands on preemption. There would be nothing better, from my perspective, than a full and open debate about this cricial issue, in every village and farm.
It is, perhaps, finally just beginning to get the some attention. But there is much more to do. Most people are not aware of the issue at all. And, if they are aware, they generally don't believe it _could_ be true that, for example, companies would be fully shielded from civil liability, even if felony fraud was committed in that company's dealings with the FDA. That disbelief is one of the lessons from living with preemption for thirteen years in Michigan.
Believe it. Those who defend preemption would certainly seem to prefer it all happened quickly, quietly, and in the dark.
Let's turn on the light. Full and open discussion has to be good for everyone, and not only on this issue.
"Full and open discussion has to be good for everyone, and not only on this issue."
This reminds me of the movie Borat. There's a scene when an American guy is telling Borat that in this country, women get to choose who they have sex with. The American says, "This is a good thing!" Borat replies, "It's not good for me!"
In this case, Borat is of course the pharmaceuticals...
I believe that many doctors favor preemtion and would stop at nothing to avoid involvement, to avoid having to defend their concerns. It adds to the wall that keeps patients from being safe. How can they practice if they believe the tools of their trade are faulty? Maybe to lose faith in FDA approved drugs means that they can't trust their own advice. For that reason, I believe they do not report reactions properly. And for that reason, it is imparative that FDA listens to patients even if their doctors are mute.
For the doctors that are willing to speak out, good for you, and I wish you were nearby.
Just a Thought - No doubt docs vary in why and how much they fill out Medwatch reports. It's an awful system, but it's what we have.
Still, I think the key point in this story is that the New England Journal of Medicine has published its second, strong editorial condemning preemption - directly, definitively, unambiguously. And they did so for many of the reasons you describe.
HAPPY BIRTHDAY AMERICA!
Excerpts from President Ronal Reagan’s First Inaugural Address.
"We are a nation that has a government—not the other way around. And this makes us special among the nations of the Earth. Our Government has no power except that granted it by the people. It is time to check and reverse the growth of government which shows signs of having grown beyond the consent of the governed.
It is no coincidence that our present troubles parallel and are proportionate to the intervention and intrusion in our lives that result from unnecessary and excessive growth of government. It is time for us to realize that we are too great a nation to limit ourselves to small dreams. We are not, as some would have us believe, doomed to an inevitable decline. I do not believe in a fate that will fall on us no matter what we do. I do believe in a fate that will fall on us if we do nothing. So, with all the creative energy at our command, let us begin an era of national renewal. Let us renew our determination, our courage, and our strength. And let us renew our faith and our hope."
Please follow Toms call and contact your representatives to support HR 6381, the Medical Device Safety Act of 2008. Your voice can make a difference.
"I do not believe in a fate that will fall on us no matter what we do. I do believe in a fate that will fall on us if we do nothing."
Happy 4th to a strong and free America. Thanks Carol for your inspirational message. Wisdom and inspiration like this stands in stark contrast to the confused, self service of our current political and social environment. We really need to cut through the b*ll some times to see our way clear to the fresh air of common sense. We can fight from now 'till doomsday about minute details on both sides of the aisles we've constructed but that only serves to propogate the norm. Addressing the root cause of our misdirection is the way to take care of the problem.
Moving away from a politically controled FDA and Supreme Court is the first step.
In 2006, my husband after an otherwise unremarkable stress test, was diagnosed as having an asymptomatic heart blockage in his LAD. He was subsequently operated on by his cardiologist who we subsequently found out, was an "interventional" cardiologists, and had two stents implanted.
When I confronted the Dr. and asked why he had not done a bypass--or recommended one--he only told me that "the stents will take care of the problem." Since there was no problem with the stents, I let it go--but I immediately went to the site Angioplasty.org, where what I learned about stents made the hair stand up on my head.
I begged my husband to change doctors, and begged in vain. My husband looked it like he was "saved" from the dreaded bypass by this wonderful man.
I began to relax when none of the bad things that I'd been learning from A.org, happened. Meanwhile my husband retired from his job and the next year--during another stress test--another blockage was discovered. Once more, two more stents were installed (All 4 stents are drug-eluting. Cypher).
I asked the Doctor, why not bypass? It's obvious that these stents aren't anything but bandaids, putting off the actual solution to my husband's CAD until he's older and sicker and way less able to withstand surgery. The doctor shrugged and said, "a lot of people have way more stents than just four. Your husband is 67 and he's doing real good."
Well--now my husband isn't doing so good. He's lucky to be alive. In 2008 yet another blockage was discovered--this one in a branch of the circumflex down to the LAD. "It's too small for the drug eluting stents" said the doctor "so I'm going with the bare-metal stents. Less complications that way." By now I was terrified. I was right.
My husband had the new bare-metal stents installed with the "kissing-stent" technique. I demanded that my husband attend Cardiac Rehab--"good idea" the Dr. agreed. And so he began rehab. He got up to 2.6 on the treadmill--and then had a heart attack. He suffered an acute STeMI, and the only reason that he's still here today is that it happened in the same hospital where he was operated on to start with. From the start of the pain that radiated from his left arm, to 15 minutes after that--he was in the Cath Lab, getting his baremetal stents seated more firmly against his artery.
No bypass. Of course. Even though a minimally invasive bypass has been developed--my husband will hear nothing either against the stents that caused his heart attack, nor against the Dr. who installed them. The two of them--the Dr. and my husband--are good with the idea of the stents--even though the last two almost killed my husband and the first four are in line to do the same thing, through a phenomenon known as late-stent stenosis (that's when drug-eluting stents stop eluting).
I don't think that I'll have my beloved husband for long. So I have this advice for people--find out if your cardiologist is an "interventional" one: those are the ones who insist on these deadly band-aids. If that's the kind of cardiologist you have--find another one who will do the new, minimally invasive bypass.
It's pretty terrible, waking up a few times a night to see if my husband's still breathing. He's a relatively young-looking, formerly vigorous man. This isn't how I envisioned our retirement!
I hope that all of you who are either offered or inveigled into accepting stents, realize that if you need them, you need a bypass. That to postpone the bypass is bad for two reasons: One, the stent might kill you and, two, when you finally DO have to have the bypass, you'll be much older and sicker than you are now--partially due to the stents. Please consider that, and act accordingly.
The rest of you--have a great retirement. Good luck to all.
By the way--this skinned and gutted FDA 'pre-approves' (and has for years) all medical devices. There is no room for independent testing in this FDA.
Now comes the news that some infant formula has 'chemicals used to make plastics' in it, which has sickened 50 Chinese babies and killed one. This reminds me of the dog food recall of last year--that dog food was ALSO found to have been contaminated with "chemicals used to make plastics." How long before American babies are dying from "unexplained renal shut-down"? For all I know, they might be dying from the same formula that the Chinese babies are dying from.
This FDA--does no testing. It 'pre-approves' anything and everything that comes across its desk. That's what it does--in this era of 'privatization'--that's all it's going to do.
Good luck to all of us. We need it now more than ever before.