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. 

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.

Knee implant medical device case dismissed

The Sixth Circuit dismissed a product liability design defect and failure to warn case brought against Zimmer which had manufactured a knee replacement system. 

In Yanovich v. Zimmer Austin, Inc.,  2007 WL 4163860, plaintiff (the person suing) produced a single expert, whose field of expertise was in polymer engineering.  This expert was not a medical doctor, and did not offer any opinions as to whether the claimed defect was a proximate cause of plaintiff's injuries.

Typically, to be able to prevail, a plaintiff must prove a defect under the law, and must prove that the defect actually caused the injuries alleged.  This is basic fairness and common sense.

Zimmer moved for summary judgment, basically arguing that they felt that there were no issues for a jury to decide.  Zimmer argued that there was no proof that the product was defective, and that there was no proof that the alleged defect actually caused injury.  Plaintiff opposed the motion, and raised new claims that Zimmer claimed were not a part of the expert's opinions offered during discovery.

The appeals court considered the additional evidence offered by the plaintiff even though the court below did not. 

No manufacturing defect

In considering that evidence, the court felt that there was a fact question as to whether there was a difference between the product's specifications and a portion of the knee replacement system removed from the plaintiff.  However, this was insufficient to allow a jury to consider the plaintiff's lawsuit.

The court felt that the inquiry needed to go further and reviewed the question of whether the difference was 'material'.  In reviewing materiality, the court found it significant that the expert did not test whether the difference in hardness (the specification discrepancy at issue) would result in a difference in failure of the implant.  The court also observed that the expert did not rule out other possible causes of the failure (a necessary step in order to allow circumstantial evidence to prove a defect).

Therefore, the court felt that there was nothing for a jury to need to decide as to a manufacturing defect claim.

No design defect

The court also rejected design defect claims because the expert failed to research or make an analysis of the foreseeable risks versus benefits of the design at issue.

No warnings defect

Applying the 'learned intermediary doctrine' the court held that there was no failure to warn because the warnings provided to physicians was adequate.  The rule for drugs and medical devices in all states, except for a recent aberrant decision in West Virginia, is that the manufacturer has a duty to warn the physician, and not the patient, because in the case of drugs, the physician is making the prescription, and in the case of devices, is using the device. 

Discussion

I use this case a baseline for a discussion of other similar cases in the future.  Essential to the proof of claims against device companies is proof of a defect (was it manufactured properly?  Was it designed properly?).  It is also essential that it be proved that the defect caused injury.  The appellate court here did not have to decide whether plaintiff raised a question of fact as to that issue because it determined that there was no product defect.  Warnings must adequately advise the physician of the risks and the use of the product.   Finally, it is essential that the opinions offered by 'experts' be grounded in sound science, and in the facts and circumstance of an individual case.  The court in this case felt that this was not the case with the plaintiff's expert's opinions.  The need for scientific rigor is based on fundamental fairness.