Medical Devices: Law, Trends and Oddities

Preemption - Kent v. Warner Lambert affirmed

The US Supreme Court this morning affirmed the Second Circuit in the Kent v. Warner Lambert case (read here) in a per curium opinion.  The Chief Justice did not participate and the court was evenly divided 4 - 4.  Therefore, without an opinion, or a decision by the Supreme Court on the merits, the 2d Circuit's decision was affirmed. 

The issue in this case had to do with fraud on the FDA claims.  A Michigan product liability reform statute prohibits suits on approved drugs or devices unless there has been fraud on the FDA.  A fraud suit was brought and the defendants moved to dismiss on the grounds that such a claim is preempted based on an earlier decision of the US Supreme Court in Buckman v. Plaintiff's Legal Committee (read here).  The trial court agreed, but was reversed by the Second Circuit in an opinion that remains the law in the Second Circuit (read here).  The Sixth Circuit has addressed the same issue and come to a different conclusion (read here).

The Second Circuit held that because the fraud exception to immunity from suit was statutory, then there was no preemption.  The Sixth Circuit disagrees.

The Supreme Court was unable to reach a majority opinion to resolve the conflict, so the Second Circuit opinion was affirmed.

More analysis will follow later.

Georgia medical device case - defect, breach of contract and learned intermediary

Product defect claims and learned intermediary claims are addressed in a case in the federal district court in Georgia. The product, a surgically implanted nerve stimulator, is a Class III device. The case is Tricket v. Advanced Neuromodulation Systems, Inc., 527 F.Supp.2d 625 (D. GA. 2008).

The claims made are traditional product liability claims for a medical device case.  Interestingly, there is no discussion of preemption in the decision, even though the device is a Class III device. 

Plaintiff suffered from chronic pain and the neurostimulator was implanted to help her pain.  Plaintiff did initially get some relief (she also had a successful trial period), but began to experience problems.  She was not happy with the amount of time the battery took to recharge, and also that she was getting an on/off sensation.  The battery was replaced, and then she began to experience electrical jolts.  No explanation could be found, and the entire system was replaced.  She continued with the same problems after the replacement system was implanted. 

One of the causes of action was for a breach of contract based on statements made by the defendant in connection with the replacement procedures.  The defendant had promised to reimburse for medical expenses, but then apparently did not do so,  Hence the breach of contract claimed.  The defendant claimed that the representations were not contractual obligations.  The court found that there was a question of fact and allowed the contractual claims to survive summary judgment.

As for the product defect claims, defendant claimed that the plaintiff had not identified a specific defect in the product, and that there was no proof of causation.  The judge held that under Georgia law, proof of a specific defect is not required - just that the 'device did not operate as intended'.  The court then analyzed the proof and allegations and found that there was a question of fact as to whether the device operated as intended.

The case also presented learned intermediary issues.  Georgia follows traditional law to the effect that the manufacturer owes a duty to warn to the physician, and not to the patient.   There is no mention of the on off sensation described by the patient in the warnings, and it had never been reported before.  Nonetheless, the court felt that there was a question of fact as to the adequacy of the warning as to this issue. 

However, as to the jolting sensations claim, summary judgment was granted based on the learned intermediary doctrine because the warnings did in fact address this specific issue.  In addition, the implanting physician was aware of the specific risk at issue.

Texas preemption and fraud decision in medical device case

In a Texas federal district court, summary judgment has been granted to defendants in a Class III medical device case on preemption grounds.  The devices at issue were hip implant components and bone cement used in the procedure.  Scott v. Pfizer, Inc., Slip Copy, 2008 WL 508641 (E.D.Tex.). 

One defendant sought to dismiss malice/fraud and misrepresentation allegations on the ground that they were not specifically pleaded.  The court dismissed those allegations because they did not meet a "who, what, when and where" pleading specificity standard.  The manufacturer of the implant has also moved for summary judgment on the other claims of the plaintiff, but that motion has not yet been decided.

The other defendant who manufactured the bone cement moved for summary judgment on preemption grounds.  The bone cement was a device that was grandfathered in as a Class III device with the inception of the Medical Device Act in 1976.  There was a recent Louisiana case that granted preemption for a product in a similar posture that I discussed in a earlier post (read here).  The Texas court agreed that preemption should apply to this device.  This decision was made before the Supreme Court ruled in the Reigel case a couple of weeks ago.

Plaintiff also claimed that there was a violation in the manufacturing processes of the defendant and sought to raise a question of fact as to the claim of a manufacturing defect.  The defendant offered proof that the product was manufactured properly, and that it met the manufacturing specifications.  In the absence of contrary proof, the court held that summary judgment should be granted because plaintiff could not show that there was in fact a manufacturing defect. 

Post Reigel - congressional effort begins

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.

Wake of Reigel - medical device complaint amended to add claims that FDA was misled

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.

Medical Device Preemption: Guest Post by Vahidi

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. 

Medical device preemption decision issued

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.

Speaking for the Court, Justice Scalia was clear: Medical devices that have received pre-market approval (Class III devices) are entitled to preemption protecting the product from state court tort claims. The decision was 8 – 1, with Justice Ginsburg dissenting. Justice Stevens concurred in part, and most importantly concurred with respect to the concept that state tort law imposes different and additional requirements to the federal regulatory scheme. Thus, on this critical issue, the Court’s opinion was 8 -1.

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.

Louisiana medical device preemption upheld

Congratulations to my friends at Abbott, Simses & Kuchler for their successful representation of DuPont for a Mentor medical device product.  On preemption grounds, a federal judge in the Western District of Louisiana dismissed a state law based product liability claim against Mentor for a medical device (a paste made up of half Teflon and half glycerine) used for stabilization of vocal cords to assist in voice functionality. 

The case is Mathis v. E.I. DuPont De Nemours & Co. and Mentor Corporation, Civ. 06-0825, and can be found at Westlaw,  Slip Copy, 2008 WL 162156 (W.D.La.).

The preemption twist in this case is that the device at issue was approved by the FDA as part of a NDA (New Drug Application) in 1972.  The Medical Device Amendments were not enacted until 1976. It is those amendments that contain the express preemption provision for medical devices.  The 1976 amendments contained a provision  that deemed devices that went through the NDA process to be Class III devices. Thus, the device at issue is deemed to be a Class III device for the purposes of the FDA regulatory scheme.

Summary judgment was sought on preemption grounds.  The court reviewed traditional preemption law for these kinds of cases.  It specifically analyzed two Fifth circuit cases which reviewed PMA devices and preemption (Martin v. Medtronic, Inc., 254 F.3d 573, 577 (5th. Cir.2001) and Gomez v. St. Jude., 442 F.3d 919 (5th Cir.2006).

The court focused on the level of FDA scrutiny in the NDA process and in the process following the adoption of the Medical Device Amendments.  In light of the level of FDA involvement and scrutiny, the court felt that preemption was appropriate.  Specific failure to warn claims were made, and the court felt that as the FDA was significantly involved in their development, that preemption was appropriate.

The preemption wars continue while we await a decision in the Reigel case.

Another California state court medical device preemption decision

Preemption litigation for medical devices never rests.

In a second preemption decision in the last week, a California intermediate appellate court has upheld preemption for state tort claims for Class III PMA medical devices.  Jessen v. Mentor Corporation, --- Cal.Rptr.3d ----, 2008 WL 142824 (Cal.App. 2 Dist.).

At issue is a testicular prosthesis manufactured by Mentor, and which is a Class III medical device.  Contrary to the instructions for use, the device was not filled with saline prior to its placement in plaintiff's body.  Plaintiff claimed that it caused him pain and needed to be removed.

The appellate court upheld the application of preemption to this Class III device because of the PMA review process.  It reviewed the usual cases, and engaged in the usual discussion of the rigorous review that the FDA gives to Class III devices.  The court cited to the Blanco v. Baxter case from last week (discussed here) for the proposition that 'a majority of California and federal courts have concluded all state common law claims related to the safety or effectiveness of a device, other than those based on a violation of FDA requirements, are preempted."  The Jessen Court declined to follow another California intermediate court (Armstrong v. Optical Radiation Corp., 50 Cal. App.4th 5801 (1996) which had held that there was no preemption for Class III devices.

One interesting contention by plainitff in the case was that Mentor had not established that the testicular implant device at issue was not in fact a Class III device.  Apparently, there was a typographical error as to a citation in the motion papers, and the court rejected plaintiff's attempt to take advantage of it.  The main reason seems to have been that in fact the device was a Class III device, and plaintiff did not establish that it was not.  Of course, a different preemption analysis (likely no preemption) would flow if the device was not a Class III device.

Plaintiff also sought to show that the device did not comply with the FDA labeling requirements.  However, the requirement allegedly not met did not come into effect until 8 months after the plaintiff's surgery.  Therefore, the court felt that there was no proof that there was a failure to comply.

The preemption wars continue, as we await a decision in the Reigel case, as they will surely continue in some form or other thereafter.

 

Califonia state court preemption decision

On January 11, 2008, a California intermediate appellate court upheld preemption in a medical device case in a case named Blanco v. Baxter Health Care, --- Cal.Rptr.3d ----, 2008 WL 108971 (Cal.App. 4 Dist.). 

Product at issue

Artificial mitral heart valve.   The valve at issue had been approved as an investigational device (IDE) in April 1984.  In 1985, the device began to go through the premarket approval process (PMA) for a Class III device.  The PMA was approved in August 1986.  In December 1987, plaintiff had the subject valve placed in her body.

In May 1988, having had 12 reported issues of valve leaflet fracture or escape, the manufacturer voluntarily suspended marketing of the device.  Two weeks later, the FDA reclassified the voluntary suspension as a Class I recall.

In April 1989, the FDA advised the manufacturer that the recall was completed. 

In February 1993, the manufacturer notified the plaintiff of issues related to the valve which was implanted in her body, but that it did not recommend explantation of the device.

In December 2002, the plaintiff died, and the autopsy found that two of the leaflets had escaped to one of the iliac arteries.  The cause of death was felt to be severe mitral valve regurgitation.

Lawsuit and status leading to appeal

Plaintiffs sued Baxter alleging negligence, strict products liability, and breach of express and implied warranty.

On a summary judgment motion brought by Baxter, the court held that preemption barred all of those claims because of the intimate involvement of the FDA in the PMA approval process and in the recall.  The trial court felt that to allow state tort liability would be to impose an additional and different requirement to the federal law which is not permitted under the preemption doctrine, as that doctrine is applied to medical devices.

Decision of appellate court

The court undertook a traditional analysis of preemption law, including a detailed analysis of the fractured US Supreme Court decision in Medtronic v. Lohr (and California preemption cases decided after the Lohr case.  Interestingly, both sides asked the court to take judicial notice of the amicus briefs filed in the Reigel case which the court declined to do.    

Imposing state tort liability would violate the preemption doctrine because to do so would impose requirements different and in addition to the federal requirements.  The court carefully analyzed the various claims made by the plaintiffs and explained why they are not applicable.  The decision provides a good roadmap and analysis of how courts should approach preemption cases.

The negligence claims were grounded in alleged negligence manufacturing and a negligent failure to warn.  The court found it significant that the plaintiff did not claim that the manufacturer failed to appropriately implement the PMA process or the recall.  As to the manufacturing and warning claims, plaintiff argued that a different manufacturing process and/or warning should have been used.  The court felt that any plaintiff award based on those theories would impose a state requirement in addition to or different than the state one.  Therefore, therefore, it held that preemption exists.

The strict liability claims were dismissed for the same reason.

The breach of implied warranty claim was dismissed because of a lack of privity of contract between the seller and the patient.

The preemption wars will continue .....