Medical Devices: Law, Trends and Oddities

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. 

SJ granted to health care providers in Louisiana medical device case

Congratulations to my friend Bruce Cranner from the Frilot firm in New Orleans. Bruce advised today that he and his firm were successful in receiving summary judgment in favor of health care defendants in a medical device case in Orleans Parish in Louisiana on February 1, 2008. The case is Adelman-Chester v. Kent, 98-18330. I have a copy of the decision and will email (click here to request) to anyone that wants it, but as I am still new to the blogosphere, I have not figured out yet how to make documents that I have available to readers.

Plaintiffs claimed that the defendant dentist, the LSU School of Dentistry and LSU were liable in strict products liability for Vitek TMJ implants and injuries that they allegedly caused. The allegations outlined in the court’s opinion are those traditionally made against a manufacturer of a medical device, and not as to health care providers. It was also claimed that the providers and the manufacturer were involved with a joint venture together so as to cause the dental providers to be liable for the product.

The court found that there was no reason to impose liability upon the defendants on any legal ground, and granted summary judgment.

There had been an innovative settlement in the case that I will discuss in a subsequent post.  Summary judgment was obtained as to those plaintiffs who did not agree to the settlement terms.

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.

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 .....

Latex glove summary judgment decision in New York

A Southern District of New York federal judge has partially dismissed a latex glove product liability case brought against a cooperative of glove distributors.  The decision breaks little new ground but addresses the discovery rule in statute of limitations, breach of warranty statute of limitations and warnings preemption.

The court held that the negligence, strict products liability and failure to  warn claims were time barred as the first symptoms had developed more than three years (the applicable NY statute of limitations) before the action was commenced.  However, with regard to the breach of warranty claims, the applicable statute of limitations was 4 years from the date of tender of the product, and that the timing of the development of symptoms is irrelevant to the warranty statute of limitations.

The court also held that the FDA's promulgation of the Latex Labeling Rule effective 9/30/98 preempted any state law claims that the labeling was inadequate from that date forward.   Any timely asserted state law warning claims prior to that date were permitted to proceed.

The case name is MORGAN v.ABCO DEALERS, INC., Steriltx (U.S.A.), Inc., and Sintex, Inc., No. 01 Civ. 9564(PKL). The decision is by US District Court for the Southern District of New York, Judge Leisure on December 11, 2007.  The Westlaw cite is Slip Copy, 2007 WL 4358392 (S.D.N.Y.). 

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.