Cynthia Garey v. Abbott Laboratories

I. FACTUAL BACKGROUND

In 2006, Philip Garey, the husband of Plaintiff Cynthia Garey and father of Plaintiffs Shannon Garey, Erin Kelley, and Megan Mackelvie, received an implantable cardiac defibrillator (ICD) to address an arrhythmia. Dkt. 1-1 (Compl.) ¶¶ 5, 23. ICDs correct both fast and slow heart rates and contain a defibrillator that can shock the heart to enable an appropriate rhythm to take over. Id. ¶ 2. In 2015, after the battery in his 2006 ICD began to fail, Mr. Garey underwent surgery to implant a new ICD manufactured by Abbott. Id. ¶ 24. Although the lead that connected the ICD to Mr. Garey’s cardiac tissue had been recalled in 2011, it was left in place during the 2015 surgery. Id. ¶¶ 6, 24. In 2016, Abbott issued a global medical device advisory and recall for the 2015 ICD due to premature battery depletion. Id. ¶ 8. In 2017, Mr. Garey was informed that the recalled lead was failing and that he would again need surgery. Id. ¶ 25. On April 12, 2017, the FDA sent a letter to Abbott warning that the ICD software was not fully verified during the final configuration test procedures. Id. ¶ 10. On May 19, 2017, Defendant Dr. Raymond Schaerf performed…