« January 2008 | Main | March 2008 »
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 NY Times reports of the amendment of a complaint to add claims that the inventor of a spinal device misled the FDA about safety and effectiveness in obtaining approval for the device (read here). This is one of the cases alluded to in the NY Times in a recent article about accusations that the financial interests of physicians inappropriately influences safety and effectiveness clinical studies. Read here about my prior post on this article.
The amendment comes in the wake of the momentous decision of the Supreme Court earlier in the week preempting state court lawsuits against the manufacturers of Class III approved medical devices. There have been numerous postings about the decision, and I commend readers to the series of posts at the Beck Hermann blog (read here).
I bring this action to your attention because already it seems that the plaintiff's bar is taking up the exception to preemption articulated by Justice Scalia in Reigel to the effect that state law is not preempted if the state law allows for remedies in the event that the device company misled the FDA. I wrote about the likelihood that this will become a new battleground in medical device cases in my post about the decision yesterday (read here).
The attorney for the plaintiff in the case discussed in the Times article names two factors that distinguish his case from Reigel. One, he says that the product was not manufactured the way that it was supposed to. This seems to be a manufacturing defect claim, which would probably not be affected by the Reigel decision.
The other theory is more troubling. He states that the financial interests of the investigators raises questions about the validity of the data provided to the FDA. This thesis is at the center of my criticism of the earlier Times article. Where is the beef - where is the evidence of an improper influence on the data? The Times article, which relied heavily on this case, did not point out any instance in which the results were affected by such an interest. If this theory is afforded validity, then the preemption protections afforded by Reigel will be gutted as all Class III cases involving any kind of financial interest by any clinical investigator will be subject to suit. Surely, that is not what the Supremes intended by their decision earlier this week.
The following is a guest post on the Reigel case from a sometime, and hopefully more regular, contributer to this page. Steve Vahidi is one of our Goldberg Segalla lawyers.
Regular readers of this blog are aware that Mike pays quite a bit of attention to the preemption provision of the MDA for Class III PMA medical devices as interpreted by the courts at the state and Federal level.
Yesterday, the Supreme Court of the United States issued an Opinion in the much-watched case of Riegel v. Medtronic, Inc. (No. 06-179). The Court’s 8 to 1 Decision (or 7-2, depending on how Justice Stevens’ concurrence is interpreted) is a major victory for manufacturers of Class III PMA medical devices and a crushing blow for plaintiffs’ attorneys.
The Court, led by Justice Scalia, upheld the Second Circuit’s finding of preemption, and in doing so brought the Eleventh Circuit, as well as four circuits which have not addressed this issue, in line with the majority of the federal circuit courts who have held that the PMA process constitutes a federal “requirement” specifically applicable to Class III devices. State common law claims for negligence and strict liability would conflict with this federal requirement because such claims are “different from, or in addition to,” the requirements imposed by the FDA during the PMA process.
In the twelve years since Medtronic v. Lohr, 518 U.S. 470 (1996) when the Court last addressed the meaning of the term “requirement” and the scope of the MDA, the majority of justices recognizing that state common law causes of action are “requirements” (and thus are preempted) has increased from 5-4 to 8-1. This increase is in despite of the loss of Chief Justice Rehnquist and Justice O’Connor, both of whom were in the 5-4 majority in Lohr. This is a truly positive development.
Based on the questions asked by the Justices at oral argument in Riegel, it appeared that Justices Scalia, Thomas and Breyer (who felt that there was preemption in Lohr) would be joined by Chief Justice Roberts and Justice Kennedy, forming a new five person majority. Justice Ginsburg’s questions predictably echoed the petitioner’s arguments and telegraphed that she opposed preemption. Justice Stevens wrote the opinion in Lohr and finding no preemption applied. It was unclear how the other two would rule. Justice Souter appeared ambivalent and Justice Alito Alito was an unknown because of their lack of participation in questioning.The 8-1 decision exceeded even the most optimistic of predictions and may be a sign of more good things to come for manufacturers of medical devices and pharmaceuticals.
Justice Scalia appears to lay the ground work by using language in the Opinion that could immediately be applied in pharmaceutical failure-to-warn cases:
The FDA requires…pre-market approval to be made with almost no deviations from the specifications in its approval application, for the reason that the FDA has determined that the approved form provides a reasonable assurance of safety and effectiveness.
Scalia went on to site two instances where statutes regarding “labeling and packaging” for insecticides and “advertising or promotion” of cigarettes were held to preempt state common law claims. In doing so, Scalia indicated that in the scope of the MDA (and other Federal regulatory schemes) permitting states legislatures to impose common law duties would “make little sense” and disrupt the Federal government’s ability to effectively regulate, thus necessitating preemption. With regard to tort claims, the Court went even further and stated that “tort law, applied by juries under a negligence or strict liability standard, is less deserving” of exclusion from federal preemption than state medical device laws.
Justice Stevens' concurrence rejected the idea that the preemption provision of the MDA was meant to bar all state regulatory action and tort remedies but found that in the Riegel’s claims "are predicated on New York common-law duties that constitute requirements with respect to the device at issue that differ from federal requirements relating to safety and effectiveness."
Dissenting, Justice Ginsburg relied her interpretation of Congress’ intent in enacting the MDA and found that Congress did not intend broadly to preempt state common-law suits grounded on allegations independent of FDA requirements. She wrote that it is "difficult to believe that Congress would, without comment, remove all means of judicial recourse."
Justice Scalia replied that the text of the preemption clause does exactly that and “[t]he operation of a law enacted by Congress need not be seconded by a committee report on pain of judicial nullification.”
This Opinion should help stem the tide of claims against manufacturers of Class III devices that have undergone the PMA process.
A day late and hopefully not a dollar short. I have had limited computer internet access for the past two days.
Naturally, as these things go, yesterday, on a day that I was traveling and unable to get to a computer to post, the Supreme Court issued its highly anticipated decision in Reigel (read here). Some comments. More to follow later.
The law of the land is now clear. Unlike the opinion in the Lohr case, the Reigel opinion is not fractured and split. Of course, in Lohr, the Court rejected preemption for Class II medical devices, which undergo a less intensive FDA review and ultimately achieve approval premised on a finding of substantial equivalence.
Any state law tort claims ‘different than, or in addition to’ FDA rules are now barred under Reigel. However, as Justice Scalia expressly observed, the plaintiff’s bar has been left with an out – state laws which “provid[e] a damages remedy for claims premised on a violation of FDA regulations” are ‘parallel’ requirements and not different requirements, and thus are not preempted. We can expect that the plaintiff’s bar will now recast claims as to Class III devices into claims that the FDA regulations were not followed. This will be a more limited volume of cases, but it will not prevent the mass tort, aggregation of claims. Until the parameters of this exception articulated by the Court have been tested in the courts, the high volume cases will continue to place large risks on medical device companies. It will be interesting to see how this plays out.
Justice Ginsburg’s dissent observes that the Court’s decision in Reigel does not address the situation of what happens if a defect in a Class III device becomes apparent only after the device has been approved. It seems to me that if that happens, and if the FDA regulations pertaining to handling the ‘defect’ once it becomes apparent still boils down to whether the device company follows federal law in connection with dealing with the defect. If it does not follow the FDA regulatory scheme, it is exposed under the exception to the preemption doctrine articulated by Justice Scalia.
I have to go run to a meeting, and will post further about my thoughts on this important decision, and what it bodes for the Kent v. Warner Lambert case that will be dealt with by the Court later in this Term.
As I have written before, the preemption wars continue.
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.
An intermediate Tennessee appellate court reversed a jury verdict in favor of a medical device manufacturer and ordered a new trial on two grounds:
1. The trial judge should have permitted the admission of reports of other incidents;
2. The trial judge should not have excluded the plaintiff's expert from testifying.
The case is Sparks v. Mena, Slip Copy, 2008 WL341441 and can be found here.
The case began as a combined medical malpractice and medical device case - a common tactic by the plaintiff's bar to try to enhance the chances of a plaintiff's verdict with the hope that the parties will blame each other. However, the surgeon and hospital won summary judgment, and that decision was not appealed. The case went on to trial, and the device company won.
What led to the case? The plaintiff was undergoing gall bladder surgery when a device used for the procedure inadvertently lacerated her aorta, causing her injury. The product liability claim was that the device (a trocar) was defective in that it was unreasonably dangerous. The trocar has a cutting blade to allow entry into the abdomen, and also a safety shield that is designed to spring forward and prevent further cutting once it has entered the abdomen. Plaintiff claimed that there was a defect in the trocar that prevented the shield from springing forward. The plaintiff's expert opined that a part in the trocar was bent when it left the manufacturer's hands preventing it from operating properly. Thus, the claim was a manufacturing defect.
After the incident, the trocar was forwarded to the manufacturer for analysis. The testing and analysis done was destructive in nature such in that part of the trocar was broken or bent by the manufacturer's tester.
Admissibility of other reports: At issue were 21 reports of incidents purported to be similar as the one at issue. The trial court had excluded all but 2 of those reports. In the two that were admitted the manufacturer's testers were able to replicate the incident as reported by the surgeon. The appeals court found that the trial judge used the wrong legal standard to determine if they were admissible. As to the replication issue, the court thought that the inability to replicate the did not make the reports inadmissible - the failure to replicate goes to the weight of the evidence, not to its admissibility. The court ruled that the evidence goes to the theory that the product is unreasonably dangerous, and to the defendant's knowledge of the allegedly dangerous condition.
However, it seems to me that since the claim was a manufacturing defect, and not a design defect, I am not sure how the prior incidents are relevant to a manufacturing defect claim. In the case in Tennessee, plaintiff was claiming that the device was manufactured improperly. The other cases do not bear on that issue one way or another.
Admissibility of expert testimony: Both the trial court and the appellate court felt that the proffered expert had expertise in the relevant field. The opinion is not clear as to why the court below barred the expert testimony, but it seems likely that it was because the expert could not demonstrate the reliability of his opinion as to the defect. The appeals court court felt that the expert should have been permitted to testify because he had sufficiently familiarized himself with the pertinent materials, including examine the remnants of the device, and disassembling an exemplar device. Based on this evidence, it seems difficult to see how he could opine as to the condition of the device when it left the defendants hands. However, as the defendant's employee damaged the device during testing, it seem to me that the court thought (without expressly saying so) that the plaintiff should have the benefit of the doubt, and the expert allowed to posit his theory.
Thus, this case should serve as a caution for manufacturers to take great care in their examinations of product returned to them for analysis.
