Presenting Evidence of the Risk of the Procedure

A common scenario in a medical malpractice case involves a patient who undergoes a medical or surgical procedure and is injured as a result of a complication that occurs during or following that procedure. Last month, we discussed the fact that the defendant certainly should be permitted to offer evidence, given a proper foundation, that the plaintiff's injuries could have occurred in the absence of negligence. This is necessary to counter the possible impression of the jury that the mere occurrence of the complication is evidence of negligence. Conversely, the defendant should not be permitted to offer evidence that might lead a jury to improperly infer that the mere fact that a complication is a known risk of the procedure is evidence that the defendant was not negligent in causing that complication. The discussion concludes herein.

Statistical Data

The defense should be precluded from offering statistical data regarding the incidence of complications, unless the underlying studies evaluated the causes of the complications and the percentage caused by negligent care. In Holley v. Pambianco, 270 Va. 180, 184-5 (2005), the Supreme Court of Virginia explained why such statistics are useless and potentially misleading. In that case, plaintiff Danny Holley suffered a colon perforation following a colonoscopy and polyp removal. The defense offered testimony showing that between one and 13 patients per 10,000 undergoing this procedure will have a colon perforation. The witnesses acknowledged, however, that the statistics contained no breakdown between perforations that resulted from negligence and those that did not. The court, faced with this evidence, found that “[t]he statistical evidence was so misleading that, for all the jury could determine, each of the perforations of the colon contained in the statistics may have been due to a physician's negligence ' . We conclude that such raw statistical evidence is not probative of any issue in a medical malpractice case and should not be admitted.” Id.

The exclusion of this type of statistical evidence is necessary because the incidence of complications tells the jury nothing about the extent to which these complications occur as a result of, or in the absence of, negligence. In our example, the jury would be left to speculate whether some, all or none of the 2% of cases in which patients suffered nerve damage following low back surgery were the result of substandard care. And, as the court in Holley pointed out, this evidence is not only irrelevant, it is also potentially misleading.

It is very common for the defense to offer this type of statistical data, and it should almost never be admitted because few if any studies analyze the frequency of complications caused by malpractice. Since this type of data is so commonly offered, it is essential for plaintiffs to file a motion in limine in order to educate the court about the impropriety of this evidence.

Another Case in Point

Another Virginia court has taken this concept one step further. In Boyer v. Dabinett, 74 Va. Cir. 19 (2007), the trial court, in ruling on motions in limine to exclude the admission of certain studies into evidence, held that statistical data is only admissible if it includes a calculation of the degree of accuracy of the data. “If measures of statistical confidence are not expressed in the article, the data cannot be scientifically assessed, and the results, although neatly presented mathematically, are purely a collection of figures based on personal observations specific only to the group studied. Any inference drawn from such data about the population in general or to a specific case is the author's guesstimate based on his personal experience and not a scientific estimate.” Id. at 21-2. Following this reasoning, even if there is data that addresses the causes of complications from a particular procedure, unless there is a calculation of the margin of error of such data, it should be excluded.

Patients Do Not Consent to Negligence

Defendants often attempt to get risk-of-the-procedure evidence in front of the jury by offering testimony from the defendant or the plaintiff about the informed consent discussion, and by offering the signed consent form. Obviously, if the complaint contains a count for lack of informed consent, this evidence is essential. In fact, if the discussion at issue in the informed consent claim included mention of the statistical risk of a complication, that should also be admissible even though the data does not distinguish between negligent and non-negligent causes. That is because it is the overall risk that the patient is weighing, without regard to why the complication may occur. However, in the absence of an informed consent claim ' as in our example above ' this evidence should be excluded.

The cases that address this issue have excluded the consent discussion on the grounds that it is both irrelevant and unduly prejudicial. See, e.g., Hayes v. Camel, 283 Conn. 475 (2007); Wright v. Kaye, 267 Va. 510 (2004); Waller v. Aggarwal, 116 Ohio App. 3rd 355 (1996). Whether the plaintiff was advised of the risks of the procedure has no probative value on the issues of standard of care or causation. Even if the evidence of the risks might be admissible with a proper foundation to show that injury may occur without negligence, it is not material whether the plaintiff was advised of those risks.

On the other hand, the information is highly prejudicial because the jury might well conclude that the plaintiff assumed the risk of injury even though that is not a defense to malpractice. As stated by the Virginia Supreme Court in Wright v. Kaye, 267 Va. 510, 529 (2004), “Knowledge by the trier of fact of informed consent to risk, where lack of informed consent is not an issue, does not help the plaintiff prove negligence. Nor does it help the defendant show he was not negligent. In such a case, the admission of evidence concerning a plaintiff's consent could only serve to confuse the jury because the jury could conclude, contrary to the law and the evidence, that consent to the surgery was tantamount to consent to the injury which resulted from that surgery. In effect, the jury could conclude that consent amounted to a waiver, which is plainly wrong.”

Conclusion

The defendant should be able to offer evidence that a particular injury can occur from a procedure even if the standard of care is not breached. However, there must be a valid scientific basis for this evidence. Raw statistical data showing merely the incidence of complications is irrelevant and misleading. Evidence that the plaintiff was advised of the risk of complications is also not relevant in the absence of an informed consent claim, and it is unduly prejudicial. These issues need to be raised by way of motions in limine in order to ensure that improper evidence is not presented to the jury.

Christopher D. Bernard, a member of this newsletter's Board of Editors, is a partner at Koskoff, Koskoff & Bieder in Bridgeport, CT. His practice is primarily devoted to medical malpractice cases, including birth injuries, surgical errors, hospital negligence and physician malpractice. He is listed in The Best Lawyers in America and is a member of the Birth Trauma Litigation Group of the Association of Trial Lawyers of America.

A common scenario in a medical malpractice case involves a patient who undergoes a medical or surgical procedure and is injured as a result of a complication that occurs during or following that procedure. Last month, we discussed the fact that the defendant certainly should be permitted to offer evidence, given a proper foundation, that the plaintiff's injuries could have occurred in the absence of negligence. This is necessary to counter the possible impression of the jury that the mere occurrence of the complication is evidence of negligence. Conversely, the defendant should not be permitted to offer evidence that might lead a jury to improperly infer that the mere fact that a complication is a known risk of the procedure is evidence that the defendant was not negligent in causing that complication. The discussion concludes herein.

Statistical Data

The defense should be precluded from offering statistical data regarding the incidence of complications, unless the underlying studies evaluated the causes of the complications and the percentage caused by negligent care. In Holley v. Pambianco , 270 Va. 180, 184-5 (2005), the Supreme Court of Virginia explained why such statistics are useless and potentially misleading. In that case, plaintiff Danny Holley suffered a colon perforation following a colonoscopy and polyp removal. The defense offered testimony showing that between one and 13 patients per 10,000 undergoing this procedure will have a colon perforation. The witnesses acknowledged, however, that the statistics contained no breakdown between perforations that resulted from negligence and those that did not. The court, faced with this evidence, found that “[t]he statistical evidence was so misleading that, for all the jury could determine, each of the perforations of the colon contained in the statistics may have been due to a physician's negligence ' . We conclude that such raw statistical evidence is not probative of any issue in a medical malpractice case and should not be admitted.” Id.

The exclusion of this type of statistical evidence is necessary because the incidence of complications tells the jury nothing about the extent to which these complications occur as a result of, or in the absence of, negligence. In our example, the jury would be left to speculate whether some, all or none of the 2% of cases in which patients suffered nerve damage following low back surgery were the result of substandard care. And, as the court in Holley pointed out, this evidence is not only irrelevant, it is also potentially misleading.

It is very common for the defense to offer this type of statistical data, and it should almost never be admitted because few if any studies analyze the frequency of complications caused by malpractice. Since this type of data is so commonly offered, it is essential for plaintiffs to file a motion in limine in order to educate the court about the impropriety of this evidence.

Another Case in Point

Another Virginia court has taken this concept one step further. In Boyer v. Dabinett , 74 Va. Cir. 19 (2007), the trial court, in ruling on motions in limine to exclude the admission of certain studies into evidence, held that statistical data is only admissible if it includes a calculation of the degree of accuracy of the data. “If measures of statistical confidence are not expressed in the article, the data cannot be scientifically assessed, and the results, although neatly presented mathematically, are purely a collection of figures based on personal observations specific only to the group studied. Any inference drawn from such data about the population in general or to a specific case is the author's guesstimate based on his personal experience and not a scientific estimate.” Id. at 21-2. Following this reasoning, even if there is data that addresses the causes of complications from a particular procedure, unless there is a calculation of the margin of error of such data, it should be excluded.

Patients Do Not Consent to Negligence

Defendants often attempt to get risk-of-the-procedure evidence in front of the jury by offering testimony from the defendant or the plaintiff about the informed consent discussion, and by offering the signed consent form. Obviously, if the complaint contains a count for lack of informed consent, this evidence is essential. In fact, if the discussion at issue in the informed consent claim included mention of the statistical risk of a complication, that should also be admissible even though the data does not distinguish between negligent and non-negligent causes. That is because it is the overall risk that the patient is weighing, without regard to why the complication may occur. However, in the absence of an informed consent claim ' as in our example above ' this evidence should be excluded.

The cases that address this issue have excluded the consent discussion on the grounds that it is both irrelevant and unduly prejudicial. See, e.g. , Hayes v. Camel , 283 Conn. 475 (2007); Wright v. Kaye , 267 Va. 510 (2004); Waller v. Aggarwal , 116 Ohio App. 3rd 355 (1996). Whether the plaintiff was advised of the risks of the procedure has no probative value on the issues of standard of care or causation. Even if the evidence of the risks might be admissible with a proper foundation to show that injury may occur without negligence, it is not material whether the plaintiff was advised of those risks.

On the other hand, the information is highly prejudicial because the jury might well conclude that the plaintiff assumed the risk of injury even though that is not a defense to malpractice. As stated by the Virginia Supreme Court in Wright v. Kaye , 267 Va. 510, 529 (2004), “Knowledge by the trier of fact of informed consent to risk, where lack of informed consent is not an issue, does not help the plaintiff prove negligence. Nor does it help the defendant show he was not negligent. In such a case, the admission of evidence concerning a plaintiff's consent could only serve to confuse the jury because the jury could conclude, contrary to the law and the evidence, that consent to the surgery was tantamount to consent to the injury which resulted from that surgery. In effect, the jury could conclude that consent amounted to a waiver, which is plainly wrong.”

Conclusion

The defendant should be able to offer evidence that a particular injury can occur from a procedure even if the standard of care is not breached. However, there must be a valid scientific basis for this evidence. Raw statistical data showing merely the incidence of complications is irrelevant and misleading. Evidence that the plaintiff was advised of the risk of complications is also not relevant in the absence of an informed consent claim, and it is unduly prejudicial. These issues need to be raised by way of motions in limine in order to ensure that improper evidence is not presented to the jury.

Christopher D. Bernard, a member of this newsletter's Board of Editors, is a partner at Koskoff, Koskoff & Bieder in Bridgeport, CT. His practice is primarily devoted to medical malpractice cases, including birth injuries, surgical errors, hospital negligence and physician malpractice. He is listed in The Best Lawyers in America and is a member of the Birth Trauma Litigation Group of the Association of Trial Lawyers of America.