March 23, 2015

FreeStyle test strips and blood glucose meter blamed in diabetic woman’s wrongful death suit

pRODUCTrECALLThe parents of Abbie Harper have filed suit against Abbott Laboratories, alleging the company’s FreeStyle test strips and blood glucose monitor system their daughter was using to manage her diabetes contributed to her death in November 2013.  Harper was a second-year student at The University of Chicago Law School. The suit was filed by Ken and Leyanne Harper in December 2014 in Cook County Circuit Court (note: the Harper family is not represented by The Cochran Firm, D.C.).

Abbie Harper was using the FreeStyle test strips and blood glucose monitor in conjunction with an Insulet Omnipod insulin pump, a medical device which adheres to the body and delivers required amounts of insulin.  Abbott laboratories recalled the test strips just four days after Abbie Harper’s death.

The Harpers named Insulet, the maker of the Omnipod, as a co-defendant in the suit, claiming the companies knew or should have known the Abbott diabetes test strips were not compatible with the Insulet Omnipod insulin pump.  The suit claims Abbie Harper died as a result of the Abbott FreeStyle test strips were providing erroneously low blood glucose results which caused her to receive too little insulin from the Insulet Omnipod insulin pump.  After two days without receiving enough insulin, Abbie Harper died from complications associated with low glucose levels.

Urgent Class I recall issued for Abbott FreeStyle test strips

Since Abbie Harper’s tragic death in November 2013, Abbott Laboratories issued a pair of recalls for its FreeStyle test strips used to manage diabetes.  The Food and Drug Administration (FDA) classified the recalls as Class I, the most serious designation given to recalls.  Class I recalls are issued to medical devices whose continued use will likely lead to serious injury or death.  The recall for the Abbott FreeStyle test strips was initially issued in November 2013 and expanded to all versions of the Abbott FreeStyle test strips in late January 2014.

At the time, Abbott Laboratories waited two months to send out letters warning users of its FreeStyle test strips of the recall and danger of being given erroneously low glucose levels by the device.  Another recall for the FreeStyle test strips was issued in the Spring of 2013.  In 2010, Abbott recalled 359 million test strips after experiencing a similar issue of patients being issued inaccurate blood glucose levels.

The tragic case and product recall draws similarities Alere’s recall of its INRatio home PT/INR monitor system and test strips. In December 2014, the FDA issued a Class I recall for the Alere INRatio PT/INR monitoring system, which is used by patients taking the anticoagulant drug warfarin to manage the clotting effectiveness of their blood. Patients were receiving erroneously low readings from the Alere INRatio which showed their PT/INR levels to be in a therapeutic range when their blood was actually many times thinner, putting them at risk for serious bleeding events and hemorrhagic stroke. According to the FDA, at least three deaths and six serious injuries are linked with the defective Alere INRatio monitor system and test strips.