Medical Devices: Law, Trends and Oddities

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

Rhode Island forum shopping rewarded in medical device case

One of the vexing problems facing defendants in medical device (and pharmaceutical, for that matter) litigation is being dragged into a court that has limited contact with the case.  Worse still is being dragged into states that have no connection to the litigation.  Alas, that is an issue for another day.

The simple question of whether a court should hear a case, as opposed to technically being able to hear a case, has a fancy Latin name - forum non conveniens.

What happened in the case at issue?  Defendant manufactured an over the counter medical device used in preparation for surgery.  A number of cases have been filed against the company in different states.   The decision was rendered on January 22, 2008 in a Rhode Island Superior court (read here).

The cases in Rhode Island involve two Massachusetts plaintiffs and a New Hampshire plaintiff who sued the manufacturer (resident in Virginia) and their pharmacy for a product purchased in the pharmacies' Massachusetts and New Hampshire stores.

The natural question is, what the heck does this dispute have to do with Rhode Island?  Well, it seems that if the cases were brought where the manufacturer resides, or where the plaintiffs reside, the claims would be barred by the statute of limitations.  They were too late!

According to the opinion, Rhode Island has not recognized the forum non coveniens doctrine.  Even if it did, this court held that the case would not be transferred to another state, even under condition that the statute of limitations not be asserted as a defense in the appropriate states.

How do we get to Rhode Island?  One of the two pharmacies has its corporate headquarters there, and the other pharmacy used to have it there.  The court felt that was enough of a connection, when coupled with Rhode Island's proximity to Massachusetts and New Hampshire, to keep the cases there.

The fact of the matter is that the cases were brought there because they were not timely commenced where they live, and because Rhode Island is thought by some to be a more favorable place for plaintiffs in personal injury actions.  Yes, the cases technically could be brought in Rhode Island because the pharmacies sold the product.  Indeed, part of the court's reasoning was that evidence could be more easily obtained as to the pharmacies.  This is a reason that is hard to understand since the pharmacies are parties and will have to produce discovery anyway.  Most courts, when engaging in a forum non conveniens analysis, weigh non-party discovery (such as in this case, the access to physicians and medical and employment records in the plaintiffs home states) more heavily than discovery as to parties.

The analysis and reasoning are not what disturbs about this case; the analysis is routine, and arguably could have gone either way.  Rather, it is that the case is an illustration of the attempts by some courts to keep cases that really belong elsewhere.  While a conflict of laws analysis will now need to be entertained to evaluate which states' statute of limitations applies, if anyone thinks that this court will apply another state's statute of limitations, then I have a bridge to sell.

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.

Off label use of biliary stents

According to NewsWise (read here),  the American Journal of Therapeutics has an article (I could not find a link to the actual article on line) that the vast majority (more than 80%) of adverse events reported for biliary stents are the result of off label use for peripheral vascular disease. 

This points up the need for controlled studies of the safety and effectiveness of such stents for peripheral vascular disease.  The study reported that more than 1 million such stents were inserted off label. 

This study also highlights the potential issues related to, and the potential exposure for the off label use of devices.  Since I started this blawg, the FDA has warned about the off label use of liver ablation devices (read here) and cautioned physicians to follow labeling and instructions for use.  There are also potential new FDA rules for how companies may provide information about off label uses of approved devices (read here).

One million biliary stents being used off label is a lot.  80% of reported adverse events related to off label use is very high.  The law is favorable to companies on off label use, but they will need to continue to be good corporate citizens for this protection to continue.   Further, as  alluded to in a different post, it would seem that the physicians using such devices off label ought to be providing a full and complete informed consent to their patients about what they are doing, and what is an approved use and what is not.

As the months go by, and this blawg matures, this topic of off label use and promotion will be an interesting one to follow.

Family alleges toothpaste killed hyper-allergic girl

A friend sent me a link to the following article for this blawg, which I would place in the oddity category. 

The UK newspaper the Daily Mail is reporting (read here) that a British family believes that a 'repackaged' toothpaste caused anaphylactic shock in a young lady moments after she brushed her teeth.  She had suffered from asthma and severe allergies her entire life.  Although the coroner did not attribute her death to the toothpaste, another pathologist told the inquest hearing that toothpaste 'could cause severe reactions' and that toothpaste, mouthwash and tampons have been known to cause such reactions.  The coroner concluded that she died from a severe anaphylactic reaction and asthma, but did not link it to the toothpaste.

The family claimed that the packaging on her usual toothpaste had changed.  But the manufacturer said that the contents of the toothpaste had not changed since 2001.  The manufacturer also pointed out that they had only a handful of complaints and that they all were of a localized nature.

The media reporting is symptomatic of the challenges that the medical device industry faces every day with regard to bad things that happen in temporal relationship to the use of a product.  There is no evidence that an allergic reaction to toothpaste caused this death.  The coroner did not conclude that it did.  However, because the very understandably grief stricken family thought that there was a relationship, the media implied in its headline that there was a relationship.  The fact that the family believes that there might be a relationship between the toothpaste and her death is not evidence of such a relationship.

Another California state court medical device preemption decision

Preemption litigation for medical devices never rests.

In a second preemption decision in the last week, a California intermediate appellate court has upheld preemption for state tort claims for Class III PMA medical devices.  Jessen v. Mentor Corporation, --- Cal.Rptr.3d ----, 2008 WL 142824 (Cal.App. 2 Dist.).

At issue is a testicular prosthesis manufactured by Mentor, and which is a Class III medical device.  Contrary to the instructions for use, the device was not filled with saline prior to its placement in plaintiff's body.  Plaintiff claimed that it caused him pain and needed to be removed.

The appellate court upheld the application of preemption to this Class III device because of the PMA review process.  It reviewed the usual cases, and engaged in the usual discussion of the rigorous review that the FDA gives to Class III devices.  The court cited to the Blanco v. Baxter case from last week (discussed here) for the proposition that 'a majority of California and federal courts have concluded all state common law claims related to the safety or effectiveness of a device, other than those based on a violation of FDA requirements, are preempted."  The Jessen Court declined to follow another California intermediate court (Armstrong v. Optical Radiation Corp., 50 Cal. App.4th 5801 (1996) which had held that there was no preemption for Class III devices.

One interesting contention by plainitff in the case was that Mentor had not established that the testicular implant device at issue was not in fact a Class III device.  Apparently, there was a typographical error as to a citation in the motion papers, and the court rejected plaintiff's attempt to take advantage of it.  The main reason seems to have been that in fact the device was a Class III device, and plaintiff did not establish that it was not.  Of course, a different preemption analysis (likely no preemption) would flow if the device was not a Class III device.

Plaintiff also sought to show that the device did not comply with the FDA labeling requirements.  However, the requirement allegedly not met did not come into effect until 8 months after the plaintiff's surgery.  Therefore, the court felt that there was no proof that there was a failure to comply.

The preemption wars continue, as we await a decision in the Reigel case, as they will surely continue in some form or other thereafter.

 

FDA warns today of unretrieved medical device fragments

The FDA released a Public Health Notification today directed to health care practitioners about adverse events associated with unretrieved medical device fragments.  The FDA states that it receives more than 1000 adverse event reports each year of such fragments from more than 200 devices and across medical specialties. 

The FDA has a number of recommendations which are outlined below:

1. Use the device in accordance with labeled indications and the manufacturer’s instructions for use.
2. Inspect devices prior to use for damage or any out-of-box defects that might increase the likelihood of fragmentation.
3. Inspect devices immediately upon removal from the patient for any signs of breakage or fragmentation.
4. If the device is damaged, retain it to assist with the manufacturer’s analysis of the event.
5. Carefully consider and discuss with the patient (if possible) the risks and benefits of retrieving vs. leaving the fragment in the patient, including the following information:
   1. The material composition of the fragment (if known);
   2. The size of the fragment (if known);
   3. The location of the fragment;
   4. The potential mechanisms for injury, e.g., migration, infection;
   5. Procedures or treatments that should be avoided such as MRI exams in the case of metallic fragments. This may help to reduce the possibility of a serious injury from the fragment.

The Notification encourages Medwatch reporting as well.

inspection of the product before implantation, and after explantation would seem to be a no-brainer.  Same for following instructions for use. 

Sending the product to the manufacturer is a very good step to take as it can and does greatly assist with ascertaining the cause(s) of the problem, and with developing methods for preventing the problem in the future.  Often, for medical legal reasons, a hospital may be reticent to send the device back, but the better practice would be to have it sent back for analysis and evaluation. 

An informed consent discussion with the patient is always a good idea.

Oregon removal remand decision

Removal continues to be a subject of litigation.  This will be particularly true for litigation where there is, or may be an MDL (Multi-District Litigation) in federal court.  It will also be particularly true in those states that have not yet moved to modern full and complete fact and expert discovery.  Amazingly there are still at least 3 states (NY, PA and OR) where there is not full and complete expert discovery, including depositions.  But, I digress.

In litigation involving a medical device made by Bard (a hernia patch), Bard and a hospital were sued in state court in Oregon.  They removed the case to federal court, and plaintiff moved to remand to state court because there was not complete diversity of jurisdiction.  And, there was not because the hospital was a resident of the state of Oregon.

At issue on the removal motion was the question of whether there was fraudulent joinder of the hospital in order to defeat diversity, and allow the case to stay in state court, with limited discovery, and out of the reach of the MDL.  Plaintiff claimed that there were potentially viable state law claims, and the court agreed.

The case is Snyder v. Davol, Inc., Westlaw Slip Copy, 2008 Westlaw 113902 (D. Or.).  The index number is CV 07-1081-ST.

One of the interesting things about the decisions was that there apparently was case law to the effect that a hospital could not be held strictly liable as the seller of a product under Oregon law.  However, it was not squarely on point, and dated to the 1980s and early 1990s.  Thus, the federal judge held that it could not be said unequivocally that Oregon would not allow such a claim (the overwhelming majority of states would not permit such a claim).  Thus, remand was found to be appropriate.

Cryolife sued in state court in Georgia for allograft implant

The Atlanta Journal-Constitution reports that Cryolife Inc was sued last week in state court in Georgia by an Atlanta area man who claims that a allograft meniscal implant that he received during knee surgery caused an infection that has left him with permanent injuries.  Early news reports do not identify the organism.  The company has hotly disputed the claims, and takes the position that it followed appropriate protocols and standards, and that it reported the case to the FDA when it learned of it.  It states that there is a risk of infection with this surgery that should be a part of the informed consent discussion that the patient has with the physician.

Unfortunately, it is an easier target because of earlier settled lawsuits related to a tissue recall and a claim that infection caused death.

The lawsuit is interesting for several reasons.

• Settlement of high profile allegations like those related to inappropriate information provided to the FDA for the recall in 2002 can create an atmosphere where it is easier to believe allegations like those made in the new plaintiff's complaint, even if the allegations are completely unrelated and have nothing to do with one another.
• Cases are settled for many reasons, and are even settled when there is no basis for the lawsuit at all.  They are settled for economic reasons.  They may be settled through an insurance company.  They may be settled because of the time and expense of defending a case.  However, the settlement of a case can sometimes be used against a company in a PR war at a later date (and that is precisely what is occurring here).  The company settled a Minnesota wrongful death case for undisclosed amounts.  The settlement is presented as if it were an admission of wrongdoing, which is an extremely unlikely scenerio.  Media reports about this new lawsuit include the fact of the prior settlement, making the reader make an implicit leap that there must have been fire where there were allegations of smoke.
• Finally, the lawyer for the plaintiff makes the following statement:  ; "the tragic thing is, surgeons have no responsibility for any of this".  Why is it tragic if someone did nothing wrong that they have no responsibility?  When did we get to the point that it is considered 'tragic'  not to have responsibility without fault?