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.

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. 

Pennsylvania learned intermediary case discussion

Gaining experience for the care and feeding of the information on this blog has been an interesting experience.  Getting a voice, and creating a personality for the blog will be an on-going evolution of styles and ideas.  My goal is to provide timely information about medical device litigation issues, and other interesting tidbits about the medical device industry.  To do so, I try to review new news and cases at least once a day.  Some days have a number of items to choose from, and some have none - and in 2008, there has been very little in the reported case law, and on the internet having to do with the issues that I want to address. 

The Beck Herrmann blawg on Drug and Device Law is impressive for the quality of its writing, and for the personality of the authors that comes through with almost each post.    Their excellent recent discussion of the trial court's decision in the HRT litigation is of significant interest (though it is not an appellate decision), in particular for its discussion of the learned intermediary rule.   While a pharmaceutical case, the discussion is equally applicable to devices and therefore is discussed here.

I have reviewed learned intermediary matters in other postings here.  Medical device litigation falls into what I will call the retail litigation (non-mass tort cases) and the multiple case litigation.  Beck/Hermann are right that in mass tort cases, the learned intermediary doctrine helpful, but is a silver bullet only for the individual or retail case.  But for that particular individual case, it is effective and can end the case.  Using and understanding the principles of this doctrine are crucial.

Medical device litigation is no different than other litigation in the sense that the alleged wrong-doing must have caused harm.  Someone who runs a stop sign is not liable in tort unless the running of the stop sign caused harm.  The learned intermediary doctrine arises in the context of claims of inadequate warnings.  A doctor who is aware of the risks of the use of a product, yet uses the product with knowledge of those risks, does, and should, insulate a device company from liability, even if plaintiff claims that the risks are not appropriately set forth in the product documentation.

In Pennsylvania HRT case that Beck/Herrmann discuss one of the issues was the learned intermediary doctrine.  This doctrine is a causation doctrine - did running the stop sign (the alleged inadequate warning) cause the harm (the injuries alleged by plaintiff)?    The court held that because the prescribing physicians had actual knowledge of the risk that plaintiff claimed should have been warned about, and still prescribed the medication, plaintiff could not prove causation. 

The court made a number of common sense observations that apply to the application of this rule:

• In deciding whether to prescribe a product, a physician is obligated to take into account what the physician knows from experience, the information provided by the company, the patient's individual condition, and make a reasoned judgment about whether to prescribe the drug or device taking all of those factors into account.
• Under Pennsylvania law, the plaintiff must prove that the physician would have altered his prescribing behavior if the warning sought to be given, was in fact given.
• In response to plaintiff's request that a 'heeding presumption' (a rebuttable presumption that the physician would not have administered the product if the sought after warning was given) be used, the court declined to do so because Pennsylvania is not one of the states that utilizes this weakened version of the learned intermediary doctrine.  The court reviewed several prior Pennsylvania cases discussing this issue.
• The duty to warn in a drug/device case runs to the prescribing physician, and not to the patient or to the public at large.
• The physician testified that he was specifically aware of reports in the literature about the possibility of the association of the risk that was complained of to the drug, yet he chose to prescribe it anyway, and would even today.
• Thus, the court concluded that additional information to the physician would not have altered the behavior, and therefore there was a failure of causation.

This case contains a good map for counsel on both sides of drug/device cases where the learned intermediary doctrine is at issue.  It lays out the law in a clear and concise way, and also the types of questions that should be posed to  prescriber, whether that doctor is a defendant or not.

Texas learned intermediary medical device decision

The Texas Court of Appeals in Fort Worth reversed a jury verdict in favor of the plaintiff against Ethicon in late December on learned intermediary grounds.  Read case here.

The medical device at issue was a surgical stapler made by Ethicon and used during colon surgery on the plaintiff. The surgeon used the device to cut out a piece of bowel that needed to be removed, and then sewed the remaining ends of the bowel back together.  The surgeon testified that he tested to make sure that gas and fluid could pass through the opening, and that there was no leaking.  The bowel ends eventually came apart and caused a bad infection which required additional surgeries and hospitalization to correct.

Plaintiff brought a medical malpractice lawsuit and a product liability lawsuit against Ethicon.  She settled with all defendants except for Ethicon before trial. 

At trial, the jury awarded the plaintiff more than $500,000.

The appellate court reversed the verdict and held for Ethicon.  It came to this conclusion because there was no proof that if the warning which the plaintiff claims should have been given would have stopped the surgeon from using the stapler.  The surgeon testified that he was aware of the risks of using the stapler that plaintiff claims should have been given,.  Therefore, the court held that as a matter of law, the product warning could not be considered a competent producing cause of the injuries.

Plaintiff's expert claimed that there should have been warnings that even if properly applied, staples can come apart and cause the difficulties that the plaintiff had here.  The surgeon testified that he did not need Ethicon to tell him this because he knew it already, and that leaks can come from any number of reasons.  Even had Ethicon specifically told him this, he would not have stopped him from using the device. 

The rule articulated by this court is one that makes sense and that other jurisdictions use as well.  If a physician is aware of the risks of the use of a device, even if not specifically warned about by the company, then plaintiff has not been able to establish causation, one of the necessary elements of a claim.

 

Consumer's Union urges advertising changes for medical devices

The following guest post was prepared by Steven Vahidi, another Goldberg Segalla lawyer in our medical device group.  This post is Mr. Vahidi's personal opinion and is not that of the law firm, or its clients.:

Consumers Union, the publisher of Consumer Reports, recently sent a letter to the FDA petitioning the Commissioner to require Medical Device Manufacturers who advertise implantable devices such as replacement knees, hips and heart valves to warn consumers “about the very real danger of health care-acquired infections that can and do result from surgery and follow-up care…which can and do[es] cause death or serious morbidity and expense.”

Will a warning that surgery has a risk of infection be a surprise to anyone?  Given that hospitals and surgeons are in the practice of having their patients sign lengthy consent forms warning of the possible side-effects and complications of surgery – including infection – it seems that including a warning about “serious morbidity and expense” in medical device advertising will discourage people who need implants from consulting with physicians to have an informed discussion about the risks and benefits of obtaining them.  Surely, that is not Consumer Union's goal. 

In its petition, Consumer Union expresses concern about the "system of payments between many device companies and surgeons creat[ing] financial incentives to conduct [unnecessary] surgery."  That concern is a wholly separate concern than the medical balancing that must go on between a patient and her physician before undergoing treatment, such as that with an implantable device.

But, from a defense perspective, at the end of the day, no matter what the content may be of DTC advertising, the implantation of the device is a decision between the physician and the patient after the physician has had a full discussion of the risks, benefits and alternatives of the treatment.  It is this required conversation between physicians and patients that is at the heart of the the learned intermediary doctrine (manufacturers of prescription drugs and medical devices discharge their duty to warn patients by providing warnings to the prescribing physician). 

Consumers Union even wants to go one step further and have the warning include “the expected life span of the device before failure occurs.”   Again, from a defense perspective, some might argue that such a “warning” might be considered an express warranty creating an additional cause of action for plaintiffs in instances where the life of the device falls short of the “expected life span.”

One would think that the public policy should be to encourage patients to have discussions with their physicians about possible medical interventions that may be appropriate for them.  The risk benefit discussion is an individual one depending upon the unique circumstance of the individual patient.  Scaring patients away from talking to their physician in this author's view should not be a part of public policy.

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.