Delaware doctor who failed to disclose risks of FDA unapproved surgery hit with $4.4 million malpractice verdict

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by Jim Orr

John Houghton fell from a ladder and suffered multiple rib fractures. He was admitted to Christiana Hospital in Newark, Delaware. Despite receiving oral pain medication, Houghton continued to experience severe chest pain. He was referred to Dr. Nadiv Shapira, a thoracic surgeon affiliated with Christiana Hospital. Shapira determined that Houston was a candidate for a procedure intended to treat pain caused by rib fractures known as an “On–Q procedure.”

The “On–Q procedure” involves the insertion of an On-Q catheter under the patient’s skin and over the ribs using a metal tunneling device. The catheter contains several holes, and, when liquid analgesic is infused through the catheter, it soaks the surrounding tissue. The goal is to continuously soak the nerves around the ribs with analgesic to relieve pain. However, the procedure has not been approved by the FDA and is thus an “off-label” use of the On–Q catheter.

After Houghton agreed to the On–Q procedure, Shapira inserted two On–Q catheters into Houghton’s rib fracture area on December 8, 2009. The next day, Houghton inadvertently removed the catheters. Shapira performed another surgery to insert two new On–Q catheters. One of those catheters became displaced and perforated some of Houghton’s internal organs. As a result, Houghton spent significant additional time in the hospital and underwent several surgeries to remove the catheter and repair the organ damage.

Houghton filed a medical malpractice lawsuit alleging that Shapira negligently failed to obtain informed consent before performing the On–Q procedure and that Shapira negligently performed the procedure. Houghton also alleged the hospital was liable because Shapira was its agent. Additionally, Houghton alleged the hospital itself was negligent for failing to properly manage a study of the On–Q procedure being undertaken by Shapira.

The jury returned a verdict in favor of Houghton, finding both Shapira and the hospital liable in negligence. The jury awarded $3.75 million in damages to Houghton and $650,000 to Evelyn Houghton for loss of consortium. The jury apportioned 65% of the total liability to Shapira, and 35% to the hospital.

On appeal, the defendants argued the evidence failed to support the jury’s finding on the informed consent claim against Shapira. Houghton’s informed consent claim had two components. First, Houghton alleged that Shapira breached the standard of care for informed consent by failing to adequately disclose the risks and alternatives of the On–Q procedure, including the fact that the On–Q procedure was “experimental” and that an epidural was a viable alternative. Second, Houghton alleged that Shapira breached the standard of care by failing to disclose significant personal conflicts of interest regarding the On–Q procedure, including his business relationship with I–Flow, the company behind On-Q. Rejecting Shapira’s appeal, the Delaware Supreme Court has affirmed the judgment in favor of Houston. Shapira v. Christiana Care Health Services, Inc., No. 392, 2013 (Del. August 07, 2014).

The Delaware Supreme Court noted that Shapira conceded at trial that he never presented Houghton with the option to receive an epidural rather than undergo the On–Q procedure. Delaware’s informed consent statute requires a physician to disclose “alternatives to treatment … which a reasonable patient would consider material to the decision whether or not to undergo the treatment….” Here, Shapira acknowledged that epidural anesthesia can be a “very effective” treatment method for rib fracture pain. Because receiving an epidural was a viable alternative to the On–Q procedure, and Shapira did not tell Houghton about it, the Delaware Supreme Court held that the jury could have reasonably found that Shapira breached the standard of care.

Furthermore, the court also held that Shapira’s relationship with I–Flow (and his failure to disclose that relationship) was relevant to the jury’s determination of whether Shapira met the standard of care for informed consent.

In 2007, Shapira had entered into a contract with the On–Q’s manufacturer, I–Flow Corporation, to promote the procedure. Also in 2007, Shapira created a database to collect information about his patients’ responses to the On–Q procedure. Then, in 2009, Shapira requested and received approval from the hospital to study the effectiveness of the On–Q procedure using the patient data he was collecting. Shapira did not disclose anything about his relationship to I-Flow to Houghton.

The Delaware Supreme Court ruled that Shapira’s relationship to I–Flow related directly to the procedure he performed. According to the court, Shapira was making a name for himself, and earning money, by promoting the On–Q procedure, and was gathering data about the procedure’s efficacy. Shapira therefore had a strong incentive to play down the risks of the On–Q procedure and play up the problems with alternative treatments. In sum, there was a risk that Shapira wanted to perform the procedure because it would benefit him personally, and not because it was the most appropriate procedure. Thus, the Delaware Supreme Court held that, under these circumstances, the conflict of interest evidence was relevant to the informed consent claim and admissible. Accordingly, the trial court properly permitted the jury to consider this evidence when reaching its determination as to whether Shapira met the standard of care under the informed consent statute.

The Delaware Supreme Court also rejected other arguments raised on appeal regarding jury questions and evidentiary rulings. The entire judgment in favor of the Houghtons was affirmed.

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* Michael Heygood, James Craig Orr, Jr. and Eric Pearson are all Board Certified in Personal Injury Trial Law — Texas Board of Legal Specialization.

** Michael Heygood, James Craig Orr, Jr. and Eric Pearson were selected to the Super Lawyers List, a Thomson Reuters publication, for the years 2003 through 2014.