FDA Recalls Diabetes Insulin Infusion Sets

By Staff Writer

In June, the FDA recalled Medtronic MiniMed Paradigm Insulin Infusion Sets distributed from December, 2001 through June, 2013. The Paradigm infusion sets are used by diabetes mellitus patients who require administered insulin to maintain acceptable blood glucose levels. The sets are made by a company called Unomedical in Denmark.

A serious safety issue can occur if insulin or other fluids come in contact with the inside of the tubing connector. If this occurs it can temporarily block the vents that allow the pump to properly prime. This can result in too much or too little insulin being delivered resulting in hypoglycemia or hyperglycemia which can be severe and lead to serious illness for diabetes patients. According to the World Health Organization, 347 million people worldwide have diabetes.

If you are a diabetes patient using this defective medical device and notice anything unusual during the infusion set prime process, such as the insulin continuing to drip from the tip of the infusion set cannula when priming has been completed, this may indicate that the connector vents are not working properly. If this occurs, do not insert the infusion setand immediately call the HelpLine at 1-888- 204-7616, for assistance.

If you are a patient who has suffered serious illness or injury due to this defective medical device, you may have a defective product claim.

Proving Your Claim

You will need to prove three things in order to win your lawsuit:

• you were injured
• the medical device was defectively designed or manufactured or defectively “marketed,” and
• the defect or improper marketing was the cause of your illness or injury.

How Long Do I Have To File A Lawsuit?

Every state sets time limits, called the “statute of limitations,” on filing product liability claims. You can find out the statute of limitation in your state by contacting an experienced product liability attorney.

Class Action Lawsuit

If other patients have been injured by the same medical device, you may be able to file a class action lawsuit. Sometimes, a class action has already been filed and you may be able to join in the lawsuit. The advantages of joining an existing class action lawsuit include:

• the lawyers for the class action lawsuit likely have expertise in bringing cases against large companies; they will become your lawyers as well
• there will be little or no upfront cost to you, and
• you will not have to figure out where to file your claim. You simply join the class action lawsuit.

You can bring your own lawsuit instead of joining the class action. If your injuries are different from other people in the class action, or if there are special circumstances in your case, this may be best.

Consult with a lawyer to find out if there is an existing class action concerning the medical device that injured you. If so, ask whether it is advisable for you to join. The initial consultation is usually free of charge. You can also contact the class action lawyers directly.

Getting Help

Medical device cases are complex. The legal and medical issues aren’t easily handled without an attorney. If you have questions or wish to retain a lawyer, consider contacting a lawyer who specializes in products liability and faulty medical device cases.

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