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$5.5 Million Medical Malpractice Verdict and Award of Interest Upheld Against Delaware Doctor and Christiana Care Health Services, Inc. Who Failed to Manage the Doctor’s Study at Christiana Hospital

John Houghton, and Evelyn Houghton v. Nadiv Shapira, M.D., and Christiana Care Health Services, Inc., Civil Action No. N11C-06-092 MJB (Del. Super.), affirmed by Shapira v. Christiana Care Health Services, Inc., 99 A.3d 217 (Del. Supr. 2014)

On August 7, 2014, the Delaware Supreme Court upheld a jury verdict with interest totaling over $5.5 million in favor of our medical malpractice clients.

Background

In December 2009, our client, a 72 year old retired pipefitter and plumber, was admitted to Christiana Hospital after falling off a ladder. He fractured three ribs and did not need surgery. The plan was to treat his pain and discharge him in a few days.

Although Plaintiffs’ experts testified that oral pain medication would have been sufficient to treat our client’s rib fracture pain, on his second day at Christiana Hospital, Dr. Shapira, a thoracic surgeon, treated his rib fracture pain with an On-Q catheter made by the I-Flow Corporation (“I-Flow”). Each On-Q catheter has small holes like a garden hose and is surgically inserted over the ribs and is supposed to drain numbing medication over the injured ribs (“On-Q”). Dr. Shapira surgically inserted two On-Q catheters under Mr. Houghton’s skin and over his ribs. The On-Q catheters came out one day later, and Dr. Shapira surgically reinserted them. This time, one catheter inserted by Dr. Shapira instead of going up and over our client’s ribs went down and through his chest wall and perforated some of his internal organs in breach of the standard of care. Dr. Shapira failed to realize what he did. Two days later, our client underwent the first of several surgeries to save his life, and spent 49 nights recovering in a hospital and rehab facility, instead of a few days.

Subsequently, we filed a medical malpractice lawsuit in Delaware Superior Court, alleging that Dr. Shapira negligently failed to obtain informed consent before performing the On-Q procedure and that Dr. Shapira negligently performed the procedure. We also alleged that Christiana Care Health Services, Inc. (“Christiana”) was liable because Dr. Shapira was its agent. Additionally, we alleged that Christiana itself was negligent for failing to properly manage a study of the On-Q procedure being undertaken by Dr. Shapira at the hospital and in approving his “expedited review” application to conduct the study. We asserted a loss of consortium claim on behalf of our client’s wife.

The Trial

During the 8 day jury trial, we presented evidence that the On-Q procedure had not been approved by the FDA and was thus an “Off-Label” use. Our experts testified that the On-Q was not the standard of care for treating rib fracture pain. The standard of care was pain medication and if necessary, an epidural. In addition, we presented evidence that Dr. Shapira had an independent interest in the On-Q procedure. Specifically, we showed that Dr. Shapira: (a) was under contract with and being paid by the On-Q manufacturer, I-Flow, to promote the On-Q for this “Off-Label” use by other physicians; (b) created a database at Christiana to collect information about his patients’ responses to the On-Q procedure; (c) requested and received approval from Christiana’s Institutional Review Board (“IRB”) to study the effectiveness of the On-Q procedure using the patient data he was collecting; (d) was writing articles on his on-going study which he submitted first to I-Flow and then to peer review journals; (e) was required to, but did not disclose to Christiana his business relationship with I-Flow; and (f) was the only physician in Delaware to ever use the On-Q for rib fracture pain.

During the trial, we also showed that Christiana: (a) had knowledge of Dr. Shapira’s study; (b) was required to investigate Dr. Shapira’s relationship with I-Flow (but did not); and (c) was required to instruct Dr. Shapira to inform patients that the On-Q was not the standard of care, that he was performing a study, and that he was being paid by the On-Q manufacturer, I-Flow.

The Jury Award and Award of Costs, Pre-Judgment and Post-Judgment Interest

On November 14, 2012, the jury returned a damages verdict in favor of our clients finding both Dr. Shapira and Christiana liable. The jury awarded $3.75 million in damages to our client and $650,000 to his wife for loss of consortium. The jury apportioned 65% of the total liability to Dr. Shapira, and 35% to the hospital.

Subsequently, the Superior Court awarded our clients costs, pre-judgment and post-judgment interest totaling over $1,100,000.

The Delaware Supreme Court Affirms

In July 2013, Christiana appealed, and Dr. Shapira cross-appealed. On August 29, 2014, the Delaware Supreme Court affirmed the entire judgment in favor of Plaintiffs.

Informed Consent Claim

In its opinion, the Supreme Court first examined our client’s informed consent claim, and noted that the jury could have found that Dr. Shapira breached the standard of care on two grounds. To begin with, Dr. Shapira admitted that he did not present our client with the option to receive an epidural rather than undergo the On-Q procedure, thereby failing to meet his obligation under Delaware’s informed consent statute to disclose “alternatives to treatment . . . which a reasonable patient would consider material to the decision whether or not to undergo the treatment. . . .”

The Court also found that the trial court properly allowed us to present evidence to the jury that Dr. 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 Court ruled that Dr. Shapira’s relationship with I-Flow (and his failure to disclose that relationship) was relevant to the jury’s determination of whether Dr. Shapira met the standard of care for informed consent. According to the Court, the conflict information was relevant because it related to the issue of risks and alternatives. Specifically, Dr. Shapira was making a name for himself and earning money by promoting the On-Q procedure and gathering data about the procedure’s efficacy, and the conflict created a risk that Dr. Shapira wanted to perform the procedure because it would benefit him personally, and not because it was the most appropriate procedure. Likewise, the conflict created a risk that Dr. Shapira did not disclose or consider all reasonable alternatives.

Thus, the Delaware Supreme Court held that, under these circumstances, the conflict of interest evidence was relevant to the informed consent claim and admissible.

Evidence of the Procedure’s “Experimental” Nature

The Delaware Supreme Court also ruled that the trial court did not err by permitting our expert witnesses to testify at trial that the On-Q procedure was experimental while prohibiting four defense witnesses (who were all Christiana trauma surgeons) from testifying that the procedure was not experimental. According to the Court, the trial court correctly ruled that the question of whether a procedure is experimental is an opinion requiring specialized knowledge and cannot be given unless the witness is qualified as an expert. The Court concluded that Defendants’ argument lacked merit because only our witnesses were qualified as experts on this issue.

Jury Instruction on Proximate Cause

The Delaware Supreme Court also concluded that the trial court’s jury instruction on proximate cause was proper. The jury was instructed that:

Proximate cause is a cause that directly produces the harm, and but for which the harm would not have occurred. A proximate cause brings about, or helps to bring about, the plaintiff’s injuries, and it must have been necessary to the result. There may be more than one proximate cause of an injury.

On appeal, the Court rejected the Defendants’ argument that the inclusion of the phrase “or helps to bring about” rendered the instruction legally incorrect because it was inconsistent with the ‘but for’ causation standard that the Delaware Courts have adopted. According to the Court, it is settled law that the phrase “helps to bring about” can be part of an accurate statement of the “but for” causation standard.

Court Opinions can be found below:
Houghton Superior Court decision.pdf
Houghton Supreme Court decision.pdf

Posted by Randall E. Robbins a Delaware injury lawyer with experience helping clients who have suffered hospital related injuries due to medical negligence.