Medical Devices: Law, Trends and Oddities

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. 

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.

Tennessee appeals court reverses defense win: prior incidents admissible; expert should have been able to testify

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.

Arkansas Supreme Court case rejects medical device preemption and learned intermediary defense

The Askansas Supreme Court ruled that summary judgment should not have been granted to a defendant in a medical device product liability case on February 7, 2008.  The case, Despain v. Bradford, can be found here.

The device company manufactured a hearing device which was implanted in the plaintiff's ear.  Plaintiff claimed that he suffered hearing damage as a result of interference between the magnet in the device, and equipment at the plaintiff's place of business.  The implant was removed shortly after being placed.

At issue on the appeal is whether the device was entitled to preemption and whether the learned intermediary rule barred recovery.  This young blog has had a number of preemption posts already which can be found here, and of course the we are awaiting a decision from the US Supreme Court in Reigel.

The device at issue is a Class III device, and therefore is the type of device that is under review by the Supreme Court in Reigel.  Nonetheless, this court rejected the idea that preemption should protect the manufacturer because it found that state tort claims do not impose an additional or different burden on the defendant.  The court felt that it was significant that the FDA did not initiate the design (which it would very rarely do in this author's opinion). 

The court felt that it was important that, in their view, the plaintff was not claiming that there should be a difference in the way that the product is manufactured.  However, when the court outlined the claims being made by the plaintiff, they included claims of improper design, amongst other things.  Thus, it is hard to see how the court could have reached that conclusion.

A lack of specific FDA regulations as to the type of device at issue was also felt to be significant by the court.

As to the rejection of the learned intermediary doctrine, the court did not reject the doctrine in principle.  Indeed, they implied that the doctrine is alive and well.  Rather, they felt that the plaintiff sufficiently raised a question of fact as to the adequacy of the warnings at issue.  The sufficiency issue had to do with the sufficiency of the warning against working near a magnetic field.  The warning did specifically mention that strong magnetic fields were to be avoided.  However, the court felt that there was a question of fact as to whether the physician is obligated to conduct a 'detailed investigation of the patient's workplace or other environment' before recomending implantation. 

Rhode Island forum shopping rewarded in medical device case

One of the vexing problems facing defendants in medical device (and pharmaceutical, for that matter) litigation is being dragged into a court that has limited contact with the case.  Worse still is being dragged into states that have no connection to the litigation.  Alas, that is an issue for another day.

The simple question of whether a court should hear a case, as opposed to technically being able to hear a case, has a fancy Latin name - forum non conveniens.

What happened in the case at issue?  Defendant manufactured an over the counter medical device used in preparation for surgery.  A number of cases have been filed against the company in different states.   The decision was rendered on January 22, 2008 in a Rhode Island Superior court (read here).

The cases in Rhode Island involve two Massachusetts plaintiffs and a New Hampshire plaintiff who sued the manufacturer (resident in Virginia) and their pharmacy for a product purchased in the pharmacies' Massachusetts and New Hampshire stores.

The natural question is, what the heck does this dispute have to do with Rhode Island?  Well, it seems that if the cases were brought where the manufacturer resides, or where the plaintiffs reside, the claims would be barred by the statute of limitations.  They were too late!

According to the opinion, Rhode Island has not recognized the forum non coveniens doctrine.  Even if it did, this court held that the case would not be transferred to another state, even under condition that the statute of limitations not be asserted as a defense in the appropriate states.

How do we get to Rhode Island?  One of the two pharmacies has its corporate headquarters there, and the other pharmacy used to have it there.  The court felt that was enough of a connection, when coupled with Rhode Island's proximity to Massachusetts and New Hampshire, to keep the cases there.

The fact of the matter is that the cases were brought there because they were not timely commenced where they live, and because Rhode Island is thought by some to be a more favorable place for plaintiffs in personal injury actions.  Yes, the cases technically could be brought in Rhode Island because the pharmacies sold the product.  Indeed, part of the court's reasoning was that evidence could be more easily obtained as to the pharmacies.  This is a reason that is hard to understand since the pharmacies are parties and will have to produce discovery anyway.  Most courts, when engaging in a forum non conveniens analysis, weigh non-party discovery (such as in this case, the access to physicians and medical and employment records in the plaintiffs home states) more heavily than discovery as to parties.

The analysis and reasoning are not what disturbs about this case; the analysis is routine, and arguably could have gone either way.  Rather, it is that the case is an illustration of the attempts by some courts to keep cases that really belong elsewhere.  While a conflict of laws analysis will now need to be entertained to evaluate which states' statute of limitations applies, if anyone thinks that this court will apply another state's statute of limitations, then I have a bridge to sell.

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.

 

Oregon removal remand decision

Removal continues to be a subject of litigation.  This will be particularly true for litigation where there is, or may be an MDL (Multi-District Litigation) in federal court.  It will also be particularly true in those states that have not yet moved to modern full and complete fact and expert discovery.  Amazingly there are still at least 3 states (NY, PA and OR) where there is not full and complete expert discovery, including depositions.  But, I digress.

In litigation involving a medical device made by Bard (a hernia patch), Bard and a hospital were sued in state court in Oregon.  They removed the case to federal court, and plaintiff moved to remand to state court because there was not complete diversity of jurisdiction.  And, there was not because the hospital was a resident of the state of Oregon.

At issue on the removal motion was the question of whether there was fraudulent joinder of the hospital in order to defeat diversity, and allow the case to stay in state court, with limited discovery, and out of the reach of the MDL.  Plaintiff claimed that there were potentially viable state law claims, and the court agreed.

The case is Snyder v. Davol, Inc., Westlaw Slip Copy, 2008 Westlaw 113902 (D. Or.).  The index number is CV 07-1081-ST.

One of the interesting things about the decisions was that there apparently was case law to the effect that a hospital could not be held strictly liable as the seller of a product under Oregon law.  However, it was not squarely on point, and dated to the 1980s and early 1990s.  Thus, the federal judge held that it could not be said unequivocally that Oregon would not allow such a claim (the overwhelming majority of states would not permit such a claim).  Thus, remand was found to be appropriate.