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Byron Smith, Individually and As Personal Representative of the Estate of India N. Smith, et al. v. St. Jude Medical Cardiac Rhythm Management Division

March 13, 2013


The opinion of the court was delivered by: Catherine C. Blake United States District Judge


Plaintiffs Byron Smith, individually and as personal representative of the estate of India N. Smith, and Carrie Youngbar, individually and as parent and next friend of India N. Smith, (collectively "Plaintiffs") have sued St. Jude Medical Cardiac Rhythm Management Division ("St. Jude") and Lifewatch Services, Inc. ("Lifewatch") for claims arising out of the death of their three-year-old daughter. St. Jude and Lifewatch have filed individual motions to dismiss the complaint. [ECF Nos. 14, 22]. The issues have been fully briefed, and a hearing was held on February 27, 2013. For the reasons articulated below, St. Jude's motion will be granted. Lifewatch's motion will be granted in part, and the case will be stayed pending Plaintiffs' compliance with the Maryland Health Care Malpractice Claims Act.

I.Factual Background

India Smith was born on June 30, 2005, to Byron Smith and Carrie Youngbar. Compl. ¶ 3. In her first few months of life, India was diagnosed with a serious heart condition. Compl. ¶ 12-13. She began treatment with Dr. Mubadda Salim, a pediatric cardiologist at the University of Maryland Medical School Department of Pediatric Cardiology. Id.

On November 4, 2005, doctors implanted India with a St. Jude Model 5380 Cardiac Pulse Generator ("the St. Jude pacemaker"). Compl. ¶ 14. At follow-up appointments, Dr. Salim noted that, because of India's particular condition, the ventricular threshold for pacing of her pacemaker was higher than the normal threshold. Compl. ¶ 17. Due to the increased threshold, the expected battery life of the pacemaker decreased from the anticipated "normal" battery life of four years down to two years. Id.

On May 3, 2007, India suffered cardiac symptoms, and doctors found a fractured ventricular lead in her pacemaker. Compl. ¶ 20. India underwent a lead replacement at this time. Id. Following the lead replacement, Dr. Salim noted that the ventricular capture rate of India's pacemaker had decreased. Compl. ¶ 23.

In late 2007, Dr. Salim explained to Plaintiffs that the pacemaker would signal when the battery had reached a level of depletion, thus indicating the need for replacement. Id. Dr. Salim noted that once the signal occurred, there still would be plenty of battery life remaining to allow for elective replacement of the pacemaker without endangering India. Id.

On May 12, 2008, Dr. Salim first discussed with Plaintiffs the timing to replace the battery in India's pacemaker. Compl. ¶ 25. Dr. Salim asked Plaintiffs to increase the frequency of the telephone interrogations of the pacemaker to every six weeks, but assured Plaintiffs that the pacemaker would continue to function as they evaluated when to schedule replacement of the battery. Id.

Six months later, on November 10, 2008, Dr. Salim told Plaintiffs that the pacemaker battery had a remaining useful life of about nine months. Compl. ¶ 26. Dr. Salim informed Plaintiffs that India would be scheduled in the next year for replacement of her pacemaker. Id. Dr. Salim also ordered monthly telephone interrogation of India's pacemaker by Lifewatch. Id.

Pursuant to Dr. Salim's order, Lifewatch was to call India's home every 30 days to interrogate her pacemaker over the phone to determine how it was functioning and how much battery life was remaining. Id.

On February 9, 2009, Dr. Salim noted that India had a normal physical evaluation. Compl. ¶ 28. He assured Plaintiffs that the pacemaker's battery had a life expectancy of about six months, and he anticipated replacement in late summer or early fall of 2009. Id. Dr. Salim continued to order monthly telephone monitoring of India's pacemaker by Lifewatch. Id. According to the complaint, however, Lifewatch's last monitoring call occurred on April 14, 2009. Id.

On May 11, 2009, Dr. Salim told Plaintiffs that the battery replacement likely would occur in September. Compl. ¶ 29. Dr. Salim again stated that India's needs would continue to be met by the pacemaker until then. Shortly after this appointment, when Plaintiffs arrived home, they received an urgent message from Dr. Salim's office. Compl. ¶ 30. By telephone, Dr. Salim explained that he had forwarded the latest interrogation results to the St. Jude company representative with whom he worked. Id. Based upon that conversation, Dr. Salim now believed that the remaining battery life on the pacemaker was much shorter than he had realized. Id. Dr. Salim requested to see India in early June to meet with the St. Jude representative and to schedule an elective battery replacement. Id.

On May 27, 2009, India died following a cardiac incident. Compl. ¶ 32. As part of the protocol for managing recently deceased pacemaker patients, hospital staff removed India's pacemaker and returned it to St. Jude for testing. Compl. ¶ 36.

According to the complaint, the pacemaker could not be tested at St. Jude until its battery was replaced. Compl. ΒΆ 37. Also according to the allegations in the complaint, investigative reports by St. Jude and an autopsy performed on May 28, 2009 by the Office of the Chief Medical Examiner for the State of Maryland revealed ...

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