Jump to Navigation

Restore Medical Device Product Liability Lawsuits: Contact Your Legislators

Austin Kirk

Legislation has been introduced in the Senate and House of Representatives which would restore the ability of consumers to hold manufacturers of medical devices accountable through product liability lawsuits for injuries caused by defective products like heart defibrillators, artificial valves, artificial knees and hips. To show your support for this bill, it is important to act now and contact your legislators.

>>Contact Your Senators
>>Contact Your Representative

The Medical Device Safety Act of 2009 was introduced in the U.S. House and U.S. Senate to reverse a decision by the U.S. Supreme Court last year in Riegel v. Medtronic, which held that product liability lawsuits challenging the safety or effectiveness of medical devices are pre-empted by federal law if they are approved by the FDA.

Corporations which manufacture defective medical devices and dangerous drugs have been arguing for years that they should be insulated from liability for injuries caused by their products so long as the FDA approved the products. However, in reality, the FDA is not equipped to be the last line of defense for product safety, and their regulations should be viewed as the floor, not the ceiling.

Ultimately, responsibility for the safety of medical devices and prescription drugs should fall to the manufacturer, and a consumer should be entitled to compensation when a corporation fails to ensure that their product is safe and effective.

Earlier this month, in the case of Wyeth v. Levine, the U.S. Supreme Court came down on the side of the consumer, finding that makers of pharmaceutical drugs are not insulated from liability for faulty warning labels, regardless of whether the FDA approved the label.

However, the Riegel decision is continuing to present substantial hurdles for individuals injured by defective medical devices, such as the Medtronic Sprint Fidelis defibrillator lead that was recalled in 2007.

Although Medtronic was aware that the small wires they were selling to connect cardiac defibrillators to the heart were prone to fracture or break, they continued to allow the products to be implanted for months.

In January 2009, U.S. District Judge Richard H. Kyle in Minneapolis cited the Riegel decision as the basis of his dismissal of over 1,400 Medtronic lawsuits that had been filed on behalf of patients who were injured by the defective Medtronic defibrillator leads.

The legislation introduced by Sentator Edward Kennedy (MA-D), Rep. Frank Pallone (NJ-D) and House Energy and Commerce Chairman Henry Waxman (CA-D) could restore these lawsuits and protect other consumers injured by medical devices, by ensuring that they are able to hold the manufacturer responsible for a negligent design that results in a dangerous and defective medical device.

ACT NOW TO SUPPORT THE MEDICAL DEVICE SAFETY ACT

To preserve your right to pursue a product liability lawsuit for injuries caused by a bad medical device, it is important that you contact your Senators and Representative to make sure they understand the importance of supporting the Medical Device Safety Act.

The civil justice system and state court juries are an important safeguard to hold companies accountable for decisions which put profits ahead of consumer safety. Let your voice be heard.

>>Read More from American Association for Justice.

9 Comments Add Your Comments

  1. It would be great if someone could prepare a form letter to forward to your senator and house representatives. People are much more likely to send an email of support for the bill if a letter is prepared.

  2. It’s a shame when our government allows company’s like medtronic to sale defective material to the public that may cause harm or even death to any human being. What is the price of a life to our government officials on capital hill when U.S citizens are being killed by and american product made to save lives.Would this be listed as murder or assault on a person for the suffering of the use of there(medtronic) product.

  3. I have a Medtronic defibrilliator that was put in 02/09/2007 and the doctor contact me 10/2007 about the recall. The company did not contact me until 12/2007. They are not able to remove it, so now I will spend the rest of my life hoping and pray it does not go off due to the fracture wires. IHow do I feel? THIS IS MURDER. II have contact my senator and congress person…. To pass this law People by foreign for a reason….American products are not good..also breaking down…

  4. I am ashame of america we are always looking out for other countries and their people but in america the greed of large companies makes it like living in a 3rd world country, the lawmakers are just as greedy for lobbist that are killing people. Why cant we just be fair and do the right thing. What would Jeus do?

  5. All the above comments are true, I have personal written to several senators myself and mailed a copy to each, they don’t give a dam, like the wise has alway said it don’t hit home until is knots on your door.what medtronic and the FDA has allowed is truly unlawful , but all wants our votes ha,

  6. I am only learning about this bill right now because of a service learning project in my class for paralegal school. Does anyone know what the status of the bill is? I read on one of the websites that it has been killed because there was not enough support for it in Congress. I don’t know anyone personally that a faulty medical device has affected, but I have read a lot of the other comments left on websites about other people who have been personally affected. I think the bill should be brought up again, it is horrible that people who are sick are getting worse and sometimes dying because the medical companies are not standing behind their products. As far as I know everyother company has to stand behind their products otherwise they could have a suit filed against them so why not places that make medical equipment? I think this bill is a very important one and hopefully will get brought up again if it indeed has been passed on in Congress.

  7. I WAS HURT BY A TITANIUM ROD THAT CONNECTS MY HIP TOGETHER THE ROD BROKE IN HALF IN MY LEG I THINK ITS SICK HOW THESE BIG COMPANIES GET AWAY WITH FAULTY MEDICAL DEVICES THESE BAD DRUGS AND BAD PRODUCT ARE KILLING PEOPLE WAKE UP COGRESS DONT JUST STAND THERE AND WHAT PEOPLE DIE HOLD THESE BIG COMPANIES RESPONSIBLE FOR THERE ACTIONS…

  8. Could you please update your subscribers on how this bill is going. There are several of us who would like to know.

    • Austin Kirk says:

      @Bill – We will try to post a more detailed update, but there really has not been much progress to correct this injustice. Hopefully after the 2012 election we will see renewed efforts by legislators. Unfortunately, as this bill was being promoted to address the medical device pre-emption issue, the health care debate changed the political climate drastically, and following the 2010 elections there has been little chance of passing legislation to hold medical device manufacturers accountable.

Leave a Reply

  • Have Your Comments Reviewed by a Lawyer

    Provide contact information below and additional private comments if you want an attorney to contact you to review a potential case.
    The information below will not be published and will be confidential.
  • NOTE: Providing information for review by an attorney does not form an attorney-client relationship.

  • This field is for validation purposes and should be left unchanged.

Additional Information & Lawsuit Resources

Maryland Accident Lawyers

Our personal injury lawyers handle auto accidents, truck accidents and other serious cases.

Maryland Accident Information
Actos Bladder Cancer

Side effects of Actos, a popular diabetes drug, may increase the risk of bladder cancer.

Actos Bladder Cancer Lawsuits
Hip Replacement Lawsuits

Pursuing product liability lawsuiits for problems from a number of metal-on-metal hip systems.

DePuy ASR Hip Recall Info
Transvaginal Mesh Lawyers

Vaginal mesh used to repair POP and SUI can cause serious and severe complications.

Vaginal Mesh Lawsuit Info