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Congress Moves To End Medical Device Immunity

Posted by Jane Akre
Friday, March 06, 2009 12:53 PM EST
Category: Major Medical, Protecting Your Family
Tags: Federal Preemption, Surgical Mesh, medical Devices, Diana Levine, Supreme Court, Tort Reform, Dangerous Products, Product Liability

Will medical devices be address by Congress next?


Suzanne McClain's case against mesh maker has been hurt by the Riegel decision.

Suzanne McClain


IMAGE SOURCE: Suzanne McClain, Courtesy, Suzanne McClain 

IMAGE SOURCE: Wikimedia Commons, Supreme Court, author: Ken Hammonds


Are Medical Devices Next?

The Supreme Court decision this week for Diana Levine, concludes that consumers do have a right to sue if they are injured by an FDA approved drug or by the makers’ failure-to-warn label.

But this decision flies in the face of last year's high court decision over medical devices. 

In Riegel v. Medtronics, the justices ruled 8-1 that patients cannot sue medical device makers when they are injured by a product approved by the FDA.  The court looked to a preemption clause in a 1976 medical device federal law.

The next step may be in the hands of Congress.

Medical Device Safety Act of 2009

The Levine outcome has energized the efforts to address medical devices that harm consumers.  Thursday legislation was submitted on the Medical Device Safety Act by Sen. Edward M. Kennedy (D-Mass.) and in the House by Rep. Frank Pallone (D-NJ) and Henry Waxman (D-CA).

The Medical Device Safety Act “puts safety first and eliminates the blanket immunity that medical device companies currently enjoy thanks to an unfortunate Supreme Court decision last year,” Pallone said, according to Reuters. Pallone chairs the House Energy and Commerce subcommittee on health. 

Supporters say it is needed.

Even with FDA approval, many dangerous medical devices have been approved.

The precedent-setting Riegel case was brought by the widow of Charles Riegel. He was injured when a Medtronic balloon catheter burst while being inserted in his chest during an artery-clearing procedure.   

The ruling in Riegel gave immunity to manufacturers making Class III devices such as heart defibrillators and breast implants, because they allegedly undergo a stricter scrutiny.

But a GAO report issued in January said many of the older medical devices were grandfathered in under federal regulations and have not been closely reviewed for safety under the premarket approval process.   

In a statement, Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed), said the bill does not improve patient safety.  

"It will, however, restrict patient access to essential medical technologies, produce a chilling effect on medical innovation, create more lawsuits and ultimately result in higher health care costs for all Americans."

The implications of Riegel may be even more far reaching.

Suzanne McClain of Maben, Mississippi, says because of Riegel, she’s had difficulty finding representation in her surgical mesh case against Ethicon (Johnson and Johnson).

Surgical mesh is used to treat incontinence and it is a Class II device. Class I and II medical devices do not have to be approved for safety. Instead manufacturers must claim they are “substantially equivalent” to a device already on the market before being cleared for sale.

In McClain’s case, her doctor told her last year that the mesh has eroded through her vaginal wall. Surgery has been unable to extract any more than one-third of the petroleum-based mesh.

Her concern today is that it might migrate.

For McClain, it doesn't seem to matter that Class I and Class II devices were not included in the Riegel decision. 

"I can’t find an attorney because no one will take it on because of that Supreme Court ruling,” she told IB News.

The Medical Device Safety Act, if approved, would nullify the Riegel v. Medtronic decision providing consumers with the same rights to hold a manufacturer accountable over defective heart stents as they now have when they claim injury from dangerous drugs or an inadequate warning label.   

"Congress must make clear that big corporations do not have a right to 'hit and run' by causing serious health damage and then walking away from legal responsibility," says Nan Aron, President of Alliance for Justice, a coalition of consumer and advocacy organizations in a statement. 

"Passage of the Medical Device Safety Act will protect the victims of unsafe products and ensure that manufacturers have a strong incentive to make safe products in the first place."  #


Anonymous User
Posted by Connie Rensing
Friday, March 06, 2009 10:46 PM EST

I believe in this woman and how many others are suffering from this quick fix that is ruining their lives. I have knowm Suzanne since the early 80's and I'm so proud of her that she is working day and night for the saftey and health for so many other women that have suffered thru this and still suffering. She is a wife and mother that has dedicated herself to her life and family and now to the thousands of others that have gone under this horrible discrase of a botched surgery. Something must be done to radicate this hugh injustice to women . The very least that is exceptable would to be to find a solution to their suffering.

Connie Rensing

Anonymous User
Posted by JILL PAUL
Sunday, March 08, 2009 5:42 PM EST

Please sign and post comments on "The Medical Device Safety Act Petition" started by Josephine McKee. Your support is imperative if we want to get the "Medical Device Safety Act" passed by Congress and the Senate in the very near future. This will negate FDA Preemption on faulty medical devices and make medical manufacturers' responsible and accountable for their products - not the FDA.

Anonymous User
Posted by Suzanne McClain
Monday, March 09, 2009 12:25 AM EST

This was such an important ruling and though it only covers medications approved by the FDA at this time, it puts us one step closer to having the Supreme Court Ruling of February 20, 2008 overturned. This is the case of Riegel vs. Medtronics in which the Supreme Court in an 8-1 vote ruled that one could not file suit against the manufacturer of a Class III device that was approved by the FDA. There is substantial confusion about this ruling, and as a result it seems lawyers are unwilling to take on any cases against manufacturers of medical devices, as they are uncertain as to if they even have a chance to win, and a trial against a pharmaceutical giant can be quite costly.

The device implanted in me is a Class II device, and received FDA approval through the 510K process. A process so severely flawed, that a manufacturer only has to show “substantial equivalence” to a product already on the market. The problem with this process is that when these manufacturers cite substantial equivalence to a device, called a predicate device, and the predicate device is pulled from the market, the FDA neglects to take any/all devices that had used this predicate device to gain approval off the market too.

In my case, the device implanted in me gained approval using the ProteGen sling and was approved on January 28, 1998. The manufacturer of the ProteGen Sling pulled their device from the market under a firm initiated recall via a letter to the FDA on January 22, 1999 stating “Use of ProteGen in the treatment of female urinary incontinence is associated with higher than expected rate of vaginal erosion and dehiscence, and does not appear to function as intended.”

The ProteGen Sling recall is documented on the March 17, 1999 FDA Enforcement Report. It took nearly two months after the FDA received the letter from the manufacturer stating the problems with their device to list this product as a recalled product on their enforcement report, a report that is published weekly. Doesn’t common sense dictate that this should have been done immediately? Wouldn’t the next logical step by the FDA have been to pull all devices that used the ProteGen Sling as its predicate device? If they had done so, the device that was implanted in me in 2004 would no longer have been on the market to harm me and countless others.

How many people have actually heard of the FDA’s MAUDE Database? Until I was harmed, I had never heard of this before. The issue I have with this database is, that it is not uniform. You must conduct searches in many different ways in order to attain the largest number of adverse events. And why, when a manufacturer acquires a product from another company, are the adverse events not combined regardless of what manufacturer you type into the database. This happened to me too, and I only accidently found out that Ethicon had acquired the TVT from another company, and that there were a substantial number of adverse events on file in regards to this other company, as well as Ethicon all before I ever even had my surgery. Had I known this, I never would have allowed this device to be implanted within me.

I was never made aware of the major complications that could arise as a result of the implantation of Ethicon’s Gynecare Tension Free Transvaginal Taping (TVT) System, nor does their “Essential Product Information” pamphlet address the type of complication I have encountered, erosion, or any of the vast array of complications others have encountered. Because of this inadequate warning label, and the fact that my doctor never provided it to me in the first place, I feel that the manufacturer, the FDA and my doctor are all responsible for my injuries, and I should have the right to hold them all accountable.

Thank you Ms. Akre, for shedding a little light on my situation. I am eternally grateful.

Ms. Levine, I am so happy for the fact that you will finally be receiving justice, but what a price you had to pay for it. What a price we are all paying for the approvals of a flawed Government Agency, and the money hungry manufacturers of these products. How they sleep at night, I will never know.

Anonymous User
Posted by JILL PAUL RN
Sunday, March 15, 2009 7:59 PM EST

I've been told that it could take "ONE YEAR" to pass/fail legislation on The Medical Device Safety Act in Congress and the Senate which was reintroduced on March 5, 2009. Please, Congressmen/Women and Senators, act on this bill immediately to protect and save lives of our innocent US citizens and restore their rights. Also, those who has read this comment, go into the "Medical Device Safety Act Petition" and add your name in support of this very important Bill - S504/HR 1346. You can also find it by typing LINK is imperative that all who have been injured by a medical device, add their names to this very important petition. Congress and the Senate are watching. Thank you.

Anonymous User
Posted by JILL PAUL RN
Monday, March 16, 2009 2:37 PM EST

The "Medical Device Safety Act Petition" can be found at: LINK

Please show your support of the Medical Device Safety Act S540/HR 1346 which can be found at LINK , by adding your comments & signature of this important petition. Thank you.

Anonymous User
Posted by Lorraine
Monday, March 16, 2009 6:23 PM EST

Thank you Jane for this article and also I second Suzanne's Comment fully! as below 2nd posting down ....

Please read her post also
Posted by Suzanne McClain
Monday, March 09, 2009 12:25 AM EST

Plus this is my Comment.....

I have been seriously harmed by the Ethicon Gynecare TVT Secure, it has ruined my life to the extent of loosing my home, career, my business, it has effected my family life and not knowing what the future holds, I am now housebound and registered disabled. I live in the UK. I have signed the petition today.


I long for the day the FDA and the MHRA in the UK wake up and see what suffering is going on everywhere from this dreadful Mesh they are implanting in people everyday!

Anonymous User
Posted by lyn
Tuesday, March 17, 2009 4:27 PM EST

how many more women have to suffer the terrible complications of this awful tvt mesh .I am in constant pain, although partial removal a few months ago,i am still suffering.I fear what will happen next ,as some of the tape could not be found.being in constant pain,just what is going on inside of me?? My life has been ruined.i have become a nervous wreck! I live in fear,i have never been so scarred in my life.and neither have members of my family.

Anonymous User
Posted by JILL PAUL RN
Tuesday, March 17, 2009 7:08 PM EST

I encourage each and every one of you to 1) write to your respective Congressmen/Women and Senators expressing support of Bill S504/HR 1346 and 2) send the petition to at least 10 people in your email address book to sign on your behalf showing their support of those who have been injured by a faulty medical device. Again, the Medical Device Safety Act Petition can be found at: LINK Together, we can "conquer", alone, we cannot. Thank you.

Comments for this article are closed.

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