California Court of Appeals – No Breach of Duty for Medical Device Representative in the Operating Room

The California Court of Appeals upheld a lower court’s finding that the presence of a medical device manufacturer’s sale representative in an operating suite does not alone give rise to a duty of care to the patient.  Smith v. St. Jude Med., Inc., 217 Cal. App. 4th 313 (Cal. Ct. App. 2013).  The court also upheld the finding that the manufacturer’s sales representative was not a proximate cause of the injury. 

In Smith, a woman died following cardiac pacemaker surgery from a perforated right atrium and ascending aorta, which caused an accumulation of blood around her heart. Plaintiffs brought a wrongful death action against the doctor who performed the surgery, various other defendants, St. Jude Medical, the manufacturer of the pacemaker leads and analyzer, and Jeremy Kosel, a St. Jude employee who supplied the pacemaker leads and tested them with St. Jude’s pacing system analyzer during the surgery.  

Kosel and St. Jude moved for summary judgment on the grounds that they did not owe a duty of care to the patient and were not a proximate cause of her injuries.  The evidence showed that Kosel was present in the operating room during the surgery but did not direct the surgeon on how or where to place the pacemaker leads. Kosel simply supplied the leads requested and then tested them with the analyzer once they were implanted.  Kosel read the numbers from the analyzer to the surgeon who then decided whether or not the implantation was successful.  Given that plaintiffs alleged that the injuries occurred from perforations in the atrium and aorta, not from the reading of the results from the analyzer, the court found there was no proximate cause or breach of the duty of care.  The court rejected plaintiffs’ characterization that the leads were placed at the direction of Kosel.  Plaintiffs appealed the lower court’s decision.

The lower court’s findings were upheld by the California Court of Appeals.  The Court of Appeals further determined that these were findings were appropriate at the summary judgment stage and were not questions of fact for the jury because there were no competing inferences regarding Kosel’s role in the surgery.  Kosel’s role was limited and did extend to directing the surgeon or making medical decisions. 

For a full copy of the opinion, click here.

Practical Tips:  1.  Consistent and effective training of personnel and risk management procedures are mandatory for those companies who have representatives in procedure and operating rooms in order to minimize risk.  2.  If enmeshed in litigation, it is important to affirmatively develop evidence that the medical device sales representative’s role in the operating room is limited and does not constitute care to the patient.  Doing so will assist in providing a basis for a court to grant summary judgment.

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