Medical Devices: Law, Trends and Oddities

Indictments in wake of banned Miracle Machine

The Seattle Times, continuing its reporting on the rightfully besieged 'Miracle Machine', reports today that  a couple who ran a 'clinic' out of their home using the energy 'medical device' for 'bogus treatment' of hepatitis and other diseases, has been indicted for felony counts involving fraud.  One patient of this so-called clinic died during treatment - he had testicular cancer, refused surgery recommended by his medical doctor, and underwent the energy treatments instead.  The clinic operator had no health care license or degree. 

I have posted several times about this 'Miracle Machine' (here and here and here) and the recent news stories about it.   I commented on potential civil liability exposure for the purveyors of this machine, and now we see that there are criminal exposures as well.   

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.

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.). 

Medical device removal remand decision in New Jersey

This post is probably of interest only to lawyers and law professors, and the parties to the case, of course.   The issues involve the sometimes arcane questions that arise with removal to the federal courts of diversity jurisdiction cases (cases between citizens of different states) and federal question cases. 

The case is a medical device products liability case brought in state court in New Jersey.  The case was removed (transfered) to federal court by one of the defendants.  Plaintiff (a California resident) asked the federal court in New Jersey to remand (transfer back) the case to the New Jersey state courts.

The defendant argued that removal, was appropriate for two reasons. First, they argued that as the defendant had not yet been served, even though it was a forum defendant (meaning that its principal place of business was in New Jersey), under the language of the removal statutes, removal was appropriate.  Defendant tried to take advantage of language in the removal statute that says that a forum defendant who has been 'properly named and served'  cannot remove.  The forum defendant had not yet been served.  It nonetheless removed the case urging that the federal court therefore had jurisdiction. 

Nice try, and good attempt at lawyering.  However, the district court reasoned that the intent of the statute was to limit access to the federal courts in removal cases.  Therefore, even if the forum defendant had not been served, the court held that removal is not appropriate, and remanded the case to state court.

The defendant made another valiant, but ill-fated attempt to save jurisdiction in federal court.  It argued that because the plaintiff claimed fraud on the FDA as a cause of action, the case in reality was a federal question case.  The federal question alleged was based in essence on preemption grounds  The court rejected that argument and held that there was no federal question jurisdiction because the claims were at their heart state court claims.

The case name is DeANGELO-SHUAYTO v. ORGANON USA INC., Organon Pharmaceuticals USA Inc., Organon International Inc., and Akzo Nobel NV, Civil Action No. 07-2923 (SRC).  The decision is by US District Court for the District of New Jersey, Judge Chesler on December 12, 2007.  The Westlaw cite is Slip Copy, 2007 WL 4365311 (D.N.J.)  

Mssrs. Beck and Hermann also commented on this decision yesterday in their Drug and Device Law blawg. 

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.

"Danger: Avoid Death" label wins Wacky Warning contest

An organization called Michigan Lawsuit Abuse held a contest for the dumbest product warnings.  They all are winners.  This is slightly, but not entirely, off topic. 

As reported by Yahoo here are some of the winners.  And, here is a link to the Wacky Warning web site.

• "Danger: Avoid Death" on a small tractor.
• "Do not iron while wearing shirt" on an iron-on tee shirt transfer image.
• "Do not put child in bag" on a storage bag on a baby stroller.
• "Caution: safety goggles recommended" on a letter opener.

and last but not least:

• "The Vanishing Fabric Marker should not be used as a writing instrument for signing checks or any legal documents."

Ya gotta love it.

On that note, off to go watch the Giants struggle through another game.

Dubious claims for "Miracle Machine" removed from websites

The Seattle Times continues its investigative reports on the supposed 'Miracle Machine' with a report today that the machines discussed in previous posts (December 7, 2007 and December 9, 2007) have had the dubious claims about their use removed from websites that sold the devices.  The claims about these devices are now limited to stress relief - whatever that means.  Claims that they can cure cancer and AIDS have been removed.

The vendors of these devices would seem to me to have opened themselves for potential exposure for unproven claims that have been made in the past.  Claims concerning such 'snake oil' devices serve no useful purpose, and can cause people to question claims made by the legitimate medical device community. 

One day, it may be shown that such 'energy devices' are safe and efficacious.  Until that is done, it is good to see that vendors are no longer making unproven health claims.

Medical device blog now two weeks old

I am now two weeks into this blawg and so far have found it to be fun and rewarding.  My goal is still to try to post something useful daily, and no less than every other day.  As I explore this area, I will add links to other blogs that should be of interest to those who look at these pages.  I have been in touch with some who have similar interests, and have found their thoughts and feedback to be of great help.

I expected that there would be more reported decisions in the case books about medical device cases than there have been.  I plan to review pertinent ones as they are reported.  If anyone wishes to bring cases to my attention, please feel free to do so.

As reflected in the postings, the main areas of interest that I have seen to date seem to be in preemption, off-label use and ergonomics and human factors.  I realize that this is just based on the last two weeks, and am interested in how this will change as time goes by.

Have a great weekend all.

Mike Shalhoub, Goldberg Segalla, LLP, mshalhoub@goldbergsegalla.com

Medical device website worth bookmarking

There is a website for all things medical device by DeviceSpace, a division of Biospace. The site looks like it will be a superb resource for reviewing medical device topics.  It is organized by technology, device , company and news.  Worth taking a peak at.

FDA warns on off label use of ablation device

The FDA has issued a Public Health Notification relative to the off label use of an ablation device due to several reported patient deaths.  The approved use of the devices, which destroy/ablate tissue by the use of high heat, includes the treatment of non-resectable liver cancer and for pain associated with bone metastasis. 

Some surgeons have been using the devices for the treatment of lung cancer, and it is in this context that the deaths have occurred. 

Off label use is legal; however, it must be remembered by physicians, and in my view disclosed to patients, that the device has not been  studied by the manufacturer, and approved by the FDA for safety and efficacy. 

Due to the reported deaths, the FDA specifically cautions physicians to follow the instructions for use, and that there are clinical trials available for patients to enroll in.   The FDA Notification also reminds the health care practitioners of their responsibility to  report adverse events to the FDA.

For a related posting about proposed new rules for manufacturers and how and when they may provide information about off label use of medical devices, see one of the first posts in this blawg from last week.