A Senate hearing will address allegations of payments by medical device companies to physicians and hospitals (read here). This issue has been partially explored previously in this blog, read here. Officials from some of the companies which have been in the news lately will be testifying. More to follow after the news reports of the hearing are published.
This post has nothing specific to do with device litigation.
It involves an amazing opinion by Judge Starcher of the West Virginia Supreme Court. It astounds for the level of incivility between colleagues on the bench, and for its attacks on the principal of one of the parties to the litigation. It is hard to imagine these gentlemen being in the same room now, never mind that they are colleagues on the bench and must work together. Read it here. This is the same court that produced the aberrant decision with regard to the learned intermediary doctrine not being a viable defense in the state of West Virginia (read that case here)
The Massey v. Caperton case is apparently a notorious case in West Virginia. The judges apparently have personal relationships, and allegations of financial relationships with some of the parties involved. Three of the five judges have been asked to recuse themselves. One has now done so, and in a most public and colorful way has called on one of his colleagues to do the same.
The opinion is worth a read for those concerned about civility in litigation, and avoiding the appearance of impropriety in our judicial system. This one is really quite amazing.
The wake of Reigel continues. Injected into the midst of a presidential campaign, the decision in Reigel is being targeted by Congressional Democrats. Read here an article outlining some of the comments and efforts to date. Senator Kennedy's are astonishing - he says that PMA approval will be a green light to shoddy practices for device manufacturers. Does he really believe the things that he says?
The hysteria in the plaintiff's bar and some of the media and politicians about this decision is not surprising but is disappointing. The ruling simply says that for the class of devices that get the most scrutiny, if the rules are followed, and the FDA is not defrauded, then those companies are protected from state court tort lawsuits. What is wrong with that?
The preemption wars front is now not only in our courthouses but also in political campaigns and in Congress.
The FDA today released a draft guidance document on the issue of the dissemination of medical literature about off label uses of drugs and devices. You can find the FDA statement here, and the draft guidance here. The public comment period ends, and you may start the process of commenting by clicking here.
Henry Waxman, late of Roger Clemens bashing and Brian McNamee annointing, has previously been critical of this anticipated draft guidance (See Rep. Waxman's web site here) and we can expect more criticism.
What does the guidance say? First, it covers drugs, devices and biologics. The agency expresses the public health benefit of dissemination of medical literature to the medical community. A countervailing consideration is that inappropriate promotion of a drug/device for an unapproved purpose makes the device adulterated and misbranded.
How do you strike the balance? Physicians are free to use approved devices in accord with their judgment (subject of course to good and accepted medical practice) and they may write in the medical literature about their experience. If a manufacturer is going to disseminate literature that is 'off label' the agency recommends best practices, some of which are highlighted below:
Who knows whether this idea will eventually work, but a product is being developed for a knee brace that will generate electricity. Step by step every person generates power that in theory can be harnessed for good use.
Here is a link to an article (read here) about such a knee brace. The concept came from car manufacturers using ways to have the friction from the use of brakes create electricity. As a person walks electricity is created.
The trick for this product development is to use this brace to save and use electricity for such things as pacemakers, insulin pumps, etc. The article even talks about potential military applications for soldiers to help them create and store power, and perhaps limit the need for batteries.
I love the ingenuity of this industry.
Read here an article in the Corporate Crime Reporter which discusses criticism of the FDA for failing to debar convicted felons - and the post talks about a specific conviction reportedly related to the performance of a clinical trial - after conviction. An interesting point is that the debarment provisions are apparently only available as to the manufacturers of generics, and not brand names.
Given all of the recent discussions about inadequate funding of the FDA, it is a delicious irony that the congressman quoted in the post indicates that the FDA budget will be cut if it does not debar felons. In other words, it may not have enough money to do its job properly, so let's punish it for not having enough money by cutting its funding further. Washington DC is a strange place indeed.
The post is based on a House sub-committee report by the Republican Committee members, and a link to the report is contained in the post.
Maybe I am naive because I have represented physicians and hospitals and medical device companies for years. Almost without exception, the goal of every person that I have met - and medical device companies are made up of people - has been to create as safe and as effective a product as possible, and for patients to be able to receive the very best care as possible. Of course, medical device companies are run for profit. Evidence of the particular genius of our economic system is that for-profit companies are able to develop the life saving and enhancing products that they do.
It is very easy to demagogue the fact that device companies can be very profitable, and throw up the mantra of Michael Moore and his ilk, and my colleagues in the plaintiff's bar - that profits are put over safety.
Comes now the New York Times, and not for the first time, in an article on January 30, 2008 (read here) in which financial ties of clinical trial investigators to the devices that they investigate are criticized. Where is the evidence in the article by this Times' reporter that results were affected by financial ties?
The Drug And Device Law blog by Beck/Hermann has an extensive, and excellent, post on this topic (read here). Mssrs. Beck and Hermann make many of the points that I would have, and in a more colorful way. Thus, I will not belabor their post as it is so good.
However, there are two points that I will not let pass.
The cynical part of me looks to the glaring and obvious issue that confidential documents were leaked to the reporter and form the basis of the article. Obviously, the device company and its attorneys did not leak the materials. Who does that leave? Hmmmmmm? What is the redress for companies that are put in the position that the manufacturer here was?
The article, like a good plaintiff's attorney would, raises a lot of innuendo about financial ties but provides no proof whatsoever that they results of the studies were altered as a result of those ties. My opinion? The surgeons involved will not as a group risk their professional lives to promote a product that does not work. Why? First, there is my belief that they, like the device companies, want to do good. Second, if they are using products that do not work, then their results, and their reputations, and eventually their practices will suffer. For those of you that think that all behavior is governed by profits, when their practices suffer, their profits will suffer. They will no longer be perceived as the premier surgeons that they are, and their opportunities to participate in clinical trials will suffer. They will make less money.
Maybe there are surgeons who will behave in the manner that the reporter seems to think - but all of them in a clinical study of this sort? That is incredibly difficult to believe. Of course, there are bad apples in every walk of life. But, to accuse the surgeons of the motives and behaviors that the Times does in the article, without proof, and based only on the words of the paid expert for the attorney for a plaintiff is irresponsible.
It does make for good press though, I suppose.
The FDA released a Public Health Notification today directed to health care practitioners about adverse events associated with unretrieved medical device fragments. The FDA states that it receives more than 1000 adverse event reports each year of such fragments from more than 200 devices and across medical specialties.
The FDA has a number of recommendations which are outlined below:
The Notification encourages Medwatch reporting as well.
inspection of the product before implantation, and after explantation would seem to be a no-brainer. Same for following instructions for use.
Sending the product to the manufacturer is a very good step to take as it can and does greatly assist with ascertaining the cause(s) of the problem, and with developing methods for preventing the problem in the future. Often, for medical legal reasons, a hospital may be reticent to send the device back, but the better practice would be to have it sent back for analysis and evaluation.
An informed consent discussion with the patient is always a good idea.
The Atlanta Journal-Constitution reports that Cryolife Inc was sued last week in state court in Georgia by an Atlanta area man who claims that a allograft meniscal implant that he received during knee surgery caused an infection that has left him with permanent injuries. Early news reports do not identify the organism. The company has hotly disputed the claims, and takes the position that it followed appropriate protocols and standards, and that it reported the case to the FDA when it learned of it. It states that there is a risk of infection with this surgery that should be a part of the informed consent discussion that the patient has with the physician.
Unfortunately, it is an easier target because of earlier settled lawsuits related to a tissue recall and a claim that infection caused death.
The lawsuit is interesting for several reasons.
In an ironically argued opinion piece, three physicians argue today in the New England Journal of Medicine (Read here) that the Supreme Court should reject preemption in the Reigel case (See my prior posts here, and here and here). These physicians argue in essence that rejecting preemption will make health care safer. Upholding preemption is on very sound legal and public policy grounds. I do not agree with that the rejection of preemption will result in better health care, and the physicians have not made any more than a conclusory argument that it does. The supreme irony here is that the physician lobby has argued for years, and I agree with them here, that medical malpractice lawsuits do not make health care safer, only more expensive. As to the medical device field, these three physicians feel otherwise.
