Medtronic Insulin Pump Blamed for NJ Death

(CN) - A New Jersey man who relied on a Medtronic device to administer the proper dose of insulin while he slept slipped into a fatal diabetic attack, his estate claims in court.

Diagnosed with Type 1 diabetes mellitus in the 1970s, Charles Slack Jr. had always been conscientious about monitoring his diet, visiting his doctor on a regular basis and keeping careful control over his insulin levels, according to the federal complaint filed Monday.

For the last several years of his life, Slack had relied on tried Medtronic's products to control his diabetes, his estate claims.

On April 15, 2013, Slack suffered a diabetic attack while he slept because "failed to receive the correct dose of insulin," the complaint states.

Though Slack had been correctly using the MiniMed insulin pump and the MiniMed Paradigm Quick-Set Infusion Sets in the days before that attack, his estate says "the pump, set and reservoir failed to take the necessary, expected and warranted steps to alert [Slack] of the failure."

The attack allegedly caused Slack's "body and mind to slowly and through intense agony, crawl into unconsciousness, with a lack of responsiveness and with a complete loss of control over his body."

Slack "was found, lying in his urine drenched bed, in a state of unconsciousness and unresponsiveness, yet alive," the complaint states.

The 57-year-old allegedly spent the next several weeks hospitalized in a coma but died on April 30.

Joann Hassan, as executrix of Slack's estate notes that the decedent's specific insulin pump was the "MiniMed Paradigm Real-Time Revel 523 System."

Medtronic touts its infusion sets as able to regulate the blood-sugar levels of diabetic consumers with accurate doses of insulin in "a steady trickle," according to the complaint.

The product is said to weigh only a few ounces and can be worn on a belt since the pump is about the size of a deck of cards.

Medtronic's purported integrity flies in the face, however, of criticism it received in 2009 from the Food and Drug Administration, for not reporting an insulin pump malfunction that caused an individual to be hospitalize, Hassan says.

The FDA also investigated and cited Medtronic for many problems at its manufacturing facility in Puerto Rico, including issues with its product testing, according to the complaint.

Hassan says Medtronic had been relying on individuals with high school educations and "some in-house training" to conduct such testing, and they were not adhering the necessary stringent testing procedures to determine product reliability.

Medtronic issuing its first Class 1 recall in June 2009 at the FDA's insistence, according to the complaint, but it issued more recalls over the next two years since there continued to be problems with the insulin-pump products that had the likelihood to cause serious injury or death if consumers continued to use the pumps.

Along with Medtronic Inc., Hassan's complaint names as defendants Medtronic Mini Med Inc., Unomedical Devices SA de CV, Unomedical A/S and Convatec Inc.

Hassan seeks punitive damages for breach of warranty, negligence, wrongful death and other claims.

She is represented by Daniel Baurkot with Pinczewski & Baurkot of Easton, Pa.

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