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Medical Malpractice Quiz
Will Unapproved Anchor Sink Surgeon?
Lorne Sheren
Publish Date: October 10, 2007   |  Tags:   Medical Malpractice-Legal

While pitching in his league's championship game, "Slider" Johnson feels a snap in his right shoulder followed by excruciating pain. An ER doc reduces the dislocated shoulder, but things go from bad to worse for Mr. Johnson. His pitching shoulder dislocates three more times during the next four months, the last two times with no associated movement. He finds himself in constant pain and fear that his shoulder will dislocate.

 Case Points

  • A surgeon implants a non-FDA approved anchor during arthroscopic rotator cuff repair and subacromial decompression.
  • The anchor comes loose and, despite a second arthroscopy, irreparably damages the patient's articular surface.

 Case Question

  • Does using an investigational device without the full understanding and written consent of the patient constitute negligence?

A salesman in the OR
Slider agrees to his orthopedist's recommendation: arthroscopic rotator cuff repair and subacromial decompression. An outpatient facility specializing in orthopedic surgery hosts the procedure. An interscalene block for post-op pain management supplements general anesthesia.

At the urging of an orthopedic implant salesman, the surgeon uses a "new and improved" anchoring system. The salesman tells the surgeon that the anchor is strong and easy to install. The salesman is present during the procedure and instructs the surgeon as to the proper use of the new anchor. The procedure is successful and Slider is sent home to recuperate.

Pop goes the shoulder
Two months later, while undergoing physical therapy, Slider feels a pop in his shoulder. The therapist refers him to his orthopedist, who rightly suspects that the repair has failed. Driven by constant pain and limited shoulder mobility, Mr. Johnson reluctantly agrees to an arthroscopy.

The second arthroscopy reveals that the anchor had come loose and had damaged the articular surface of the shoulder joint. The repair is difficult because of the recent surgery. The surgeon shaves the articular surface, but it remains damaged in spite of the surgeon's efforts to resurface the humeral head.

The surgeon does his best, but Mr. Johnson is left with limited range of motion in his right shoulder. This limitation interferes with his work as a police officer. He is reassigned to desk duty - at the same salary he earned when he was a patrolman - and his career as an amateur baseball pitcher is clearly over.

Feeling like a guinea pig
Mr. Johnson hires a medical malpractice lawyer, who discovers during a review of his client's medical records that the FDA had never approved the anchor used in the first repair. The anchor is listed as an investigational device.

Outraged that he'd been the "subject of an experiment," Mr. Johnson brings suit against the surgeon for using an unapproved device without his consent, against the manufacturer for allegedly failing to inform the surgeon of its unapproved status and against the outpatient surgical center for failing to have a protocol in place to ensure that only approved devices are implanted.

Which, if any, of these three defendants is responsible for Mr. Johson's disability? You'll find the answer at writeOutLink("www.outpatientsurgerymall.net",1).

Answer and Explanations
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