Medical Devices: Law, Trends and Oddities

New medical device trend? Green knees?

Who knows whether this idea will eventually work, but a product is being developed for a knee brace that will generate electricity.  Step by step every person generates power that in theory can be harnessed for good use.

Here is a link to an article (read here) about such a knee brace.  The concept came from car manufacturers using ways to have the friction from the use of brakes create electricity.  As a person walks electricity is created.

The trick for this product development is to use this brace to save and use electricity for such things as pacemakers, insulin pumps, etc.  The article even talks about potential military applications for soldiers to help them create and store power, and perhaps limit the need for batteries.

I love the ingenuity of this industry.

FDA criticized by Congress for failing to debar felons

Read here an article in the Corporate Crime Reporter which discusses criticism of the FDA for failing to debar convicted felons - and the post talks about a specific conviction reportedly related to the performance of a clinical trial - after conviction.  An interesting point is that the debarment provisions are apparently only available as to the manufacturers of generics, and not brand names.

Given all of the recent discussions about inadequate funding of the FDA, it is a delicious irony that the congressman quoted in the post indicates that the FDA budget will be cut if it does not debar felons.  In other words, it may not have enough money to do its job properly, so let's punish it for not having enough money by cutting its funding further.  Washington DC is a strange place indeed.

The post is based on a House sub-committee report by the Republican Committee members, and a link to the report is contained in the post.

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.

New York Times accusations against financial ties and medical device companies

Maybe I am naive because I have represented physicians and hospitals and medical device companies for years.  Almost without exception, the goal of every person that I have met - and medical device companies are made up of people - has been to create as safe and as effective a product as possible, and for patients to be able to receive the very best care as possible.  Of course, medical device companies are run for profit.  Evidence of the particular genius of our economic system is that for-profit companies are able to develop the life saving and enhancing products that they do.

It is very easy to demagogue the fact that device companies can be very profitable, and throw up the mantra of Michael Moore and his ilk, and my colleagues in the plaintiff's bar - that profits are put over safety.

Comes now the New York Times, and not for the first time, in an article on January 30, 2008 (read here) in which financial ties of clinical trial investigators to the devices that they investigate are criticized.    Where is the evidence in the article by this Times' reporter that results were affected by financial ties?   

The Drug  And Device Law blog by Beck/Hermann has an extensive, and excellent, post on this topic (read here).  Mssrs. Beck and Hermann make many of the points that I would have, and in a more colorful way.  Thus, I will not belabor their post as it is so good.

However, there are two points that I will not let pass.

The cynical part of me looks to the glaring and obvious issue that confidential documents were leaked to the reporter and form the basis of the article.  Obviously, the device company and its attorneys did not leak the materials.  Who does that leave?  Hmmmmmm?  What is the redress for companies that are put in the position that the manufacturer here was? 

The article, like a good plaintiff's attorney would, raises a lot of innuendo about financial ties but provides no proof whatsoever that they results of the studies were altered as a result of those ties.  My opinion?  The surgeons involved will not as a group risk their professional lives to promote a product that does not work.  Why?  First, there is my belief that they, like the device companies, want to do good.  Second, if they are using products that do not work, then their results, and their reputations, and eventually their practices will suffer.  For those of you that think that all behavior is governed by profits, when their practices suffer, their profits will suffer.  They will no longer be perceived as the premier surgeons that they are, and their opportunities to participate in clinical trials will suffer.  They will make less money.

Maybe there are surgeons who will behave in the manner that the reporter seems to think - but all of them in a clinical study of this sort?  That is incredibly difficult to believe.  Of course, there are bad apples in every walk of life.  But, to accuse the surgeons of the motives and behaviors that the Times does in the article, without proof, and based only on the words of the paid expert for the attorney for a plaintiff is irresponsible. 

It does make for good press though, I suppose.

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. 

Criticism by GAO of FDA inspections of medical device manufacturers

This post is being belatedly written as I have been quite busy with my day job.  I am on my way back from the DRI Products Liability seminar in Phoenix where I was a speaker, and am trying to catch up. 

For those who do not know, DRI is the largest organization of civil defense attorneys in the United States.  If you are interested in learning more about it, their website is www.dri.org. 

Back to the post.  The federal Government Accounting Office raised  concerns about the lack of oversight of foreign medical device manufacturers.  The concern is that they are not doing it, and that they do not have the funds to do it.(read here)

Some of the criticisms.  I raise these because they can directly impact the ability of medical device companies to attempt to use the FDA's oversight of its products and manufacturing as a defense in product liability cases.  The more it can be shown that the FDA is not able, by means of funding or will, to be involved in the oversight of the medical device industry, the more difficult it will be to try to use FDA involvement as a partial, or full defense in medical device cases. 

• There is criticism of a failure of the FDA to conduct biannual inspections of higher risk medical devices, even those manufactured domestically. 
• there is criticism of a paucity of pre-market inspections, which are noted to be even fewer in number than post-market inspections.  Some might argue that the pre-market inspections are just as, if not more important, than pre-market inspections.
• mechanisms for third party inspections should be utilized.

Rhode Island forum shopping revisited

A colleague in Rhode Island alerted me to another Rhode Island forum non conveniens case involving the same judge who decided the Paris case that I discussed in a recent post (read here).  The same judge and a very similar issue are involved in the Kedy case. 

The Kedy case was argued in the Rhode Island Supreme Court recently, and my colleague reports that the Supreme Court was hostile to the trial judge's view that there should be no forum non conveniens.  The decision which is being appealed, can be read here.  That case involved Canadian asbestos plaintiffs suing in Rhode Island state court.

The Kedy and Paris decisions are remarkably similar in their analysis of forum non conveniens and the reasons that Rhode Island is capable of handling the dispute.  However, the opinions have

one little itty bitty difference. 

In the second of the two cases, the judge ruled that even if Rhode Island recognized forum non conveniens, then she still would not transfer the cases.  One wonders if in deciding Paris, she was aware of the skepticism offered by the Supreme Court during argument of the earlier appeal, and if, in adding that caveat, she was attempting to make the Paris case appeal-proof.

The final result in Kedy will be interesting to watch because of the favor with which the Rhode Island courts are starting to be seen by the plaintiffs bar.

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.

FDA to act to prevent import of fraudulant medical devices

The Seattle Times has continued its excellent reporting (read here) on the issue of the importation of medical devices (read my prior posts here, and here and here, and here) that have not been approved as safe and effective.

This news article discusses testimony by the FDA Commissioner about what will be stepped up efforts to stop manufacturers from importing and selling such fraudulent devices into the United States.  The Seattle Times takes credit for spurring the FDA to take action in the wake of its series of articles on the so-called Miracle Machine.

More Congressional hearings are expected in March.  This article tries to make the point that the issue ties into the GOA report criticizing FDA for the limited extent of oversight of overseas device manufacturers that I wrote about earlier today (read here).  However, as these devices are not approved for use, the FDA would likely not be inspecting them in the first place.
 

Offbeat 'medical devices' discussed by Men's Health Journal

It is the end of a long week, and let's try something entertaining.

Mens Health Magazine wrote about as offbeat things to use to improve your health.

Click here is you want to see if:

• a trumpet can cure sleep apnea - better than CPAP?
• use text messages to quit smoking - beats the patch?
• use blue light to cure halitosis - bad breath
• Botox injection for an enlarged prostate?

Have a great weekend!

Mike