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.