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Medical Malpractice and Product Liability: Lack of Informed Consent
Failed medical device and percutaneous discectomy procedure for disc herniation
| Disposition:
(Settlement/Arbitration/Trial) |
Arbitration |
Date: |
12/30/2003 |
Type of Case: |
Product Liability |
Allegation(s): |
Failure to obtain consent for experimental procedure |
Result: |
$495,000 + $675,000 (settlement) |
Case Name: |
Susan Klug v. Roe Hospital and Roe Inc (settlement), James F. Marino, M.D. (arbitration) |
Facts: |
On Jan. 9, 2001, plaintiff Susan Klug, 33, a software engineer, agreed to allow orthopedic surgeon James F. Marino, a founder of ROE, Inc. manufacturers and marketers of surgical equipment, perform a percutaneous lumbar discectomy on her to treat her disc herniation at the L5-S1 level of her lumbosacral spine. She claimed that she agreed to this procedure because Marino explained that it would be less invasive than other procedures and would be a two-hour outpatient procedure with a fast recovery. Marino also informed her that he would be using Roe Inc's devices during the surgery.
On Jan. 10, Marino performed the surgery at Roe Hospital. In addition to Marino, the operating room was also filled with Roe, Inc.'s employees who set up and "directed" the experimental equipment, took notes and snapped photographs of Mrs. Klug undergoing the procedure that used the company's patented equipment.
During the operation, the percutaneous procedure was unsuccessful because Marino could not reach the L5-S1 level. He then attempted an experimental transiliac approach to L5-S1 (a Roe, Inc. "open project"), which involved coring through Klug's hip bones (iliac crests) for percutaneous access to L5-S1. That procedure failed. Marino then abandoned the percutaneous procedure altogether and attempted an "open procedure." Klug claimed that Marino then performed the discectomy at the wrong level, L4-5, where he removed a healthy disc instead and left the injured disc at L5-S1 in place.
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| Injury/Injuries: |
Injuries: bulging disc, lumbar; depression; drop foot; post-traumatic stress disorder; radiculopathy.
Klug claimed that her life has been devastated by the results of the surgeries performed on her. She claimed that she has permanent loss of motion and strength in her right foot and ankle which translates to a foot drop. She also noted that abnormal EMG studies confirm L5 radiculopathy and she continues to have lower back pain that is worse than before the surgery. An MRI taken on 12/16/02 confirmed a moderate far lateral disc bulge on the right side at L5-S1 and mild left paramedial disc bulge at the same level. Additionally, Klug claimed to suffer from depression, pain disorder and PTSD as a result of the surgeries.
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| Contentions: |
Klug sued Roe Inc., alleging strict products liability, defective design and failure to warn. Additionally, she sued ROE, Inc. under an agency theory with regard to the Roe Inc. employees who were present and/or participated in the surgery and who were actively involved in creating, developing, testing and marketing the surgical equipment. Klug also brought allegations of fraud by concealment, as well as battery against Roe Inc. for the acts of its employees and Marino.
Klug also sued Roe Hospital, alleging negligent assistance in the surgical procedures, failure to disclose the experimental nature of the procedures and allowing non-licensed personnel to assist in the surgery.
Lastly, Klug went into arbitration with Marino, alleging medical malpractice, lack of informed consent, negligence per se and battery.
Klug contended that Roe Inc. designed and manufactured the equipment used during her surgery. She claimed that the equipment used in her surgery was investigational, experimental and that one device in particular was part of an ongoing investigational/clinical study.
Klug contended that the experimental transiliac approach to L5-S1 was performed without her knowledge or consent. She also argued that because this procedure failed, Marino performed the "open procedure" which was substantially different from the surgery to which she consented.
Roe, Inc. and Roe Hospital contended that they were not negligent, that their products were not defective in design and that there was no connection between their products and Klug's injuries. In effect, they argued that Klug's injuries were caused by Marino's negligence.
Marino contended that the percutaneous and transiliac approach failed because the equipment he was using failed to perform as expected. He further claimed he did not have to obtain Klug's informed consent to perform the other procedures inasmuch as the situation constituted a "medical emergency."
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| Special Notes: |
Plaintiff settled the product liability action as against Roe, Inc. for $650,000, and her action against Roe Hospital for $25,000 in May 2003.
Following the October Arbitration hearing, Klug received an award of $600,000 in gross economic damages, with a $405,000 set-off from the prior settlements, for a net economic damage award of $195,000. Non-economic damages were awarded in the amount of $300,000. Marino filed a motion to periodicize, and Klug filed a cost memo in the amount of $19,921.92. The parties agreed that the motion would be withdrawn and the claim for costs would be waived conditioned on immediate payment of $495,000 from Marino to Klug. The arbitration matter thus settled for $495,000 on Dec. 30, 2003.
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