The Court of Appeal of the State of California First Appellate District Division Five (“California Appellate Court”), in its opinion filed on June 13, 2018, reduced the punitive damages award by a California jury from $70 million to $19.7 million (i.e., two-times the amount of the compensatory damages award) in a case where the plaintiff alleged that the defendants’ surgical stapler was defectively manufactured and they failed to warn of certain defects in the stapler which resulted in her rectrum being stapled shut during surgery.
The Surgical Stapler
The PPH03 Hemorrhoidal Circular Stapler (“stapler”) manufactured by Ethicon Endo-Surgery LLP (“Ethicon”), a subsidiary of Johnson & Johnson Health Care Systems, Inc., is inserted into the patient’s rectum during hemorrhoid surgery and when the surgeon squeezes the firing lever, a blade cuts out a ring-shaped portion of tissue and a circular line of staples fix the remaining tissue within the anal canal. A cracking noise from the breaking of a washer alerts the surgeon that the stapler has fired. The stapler’s instructions direct surgeons not to fire the device more than once and warn that additional firings could result in tissue damage.
The plaintiff alleged that after her surgeon fired the stapler during her surgery, the surgeon could not remove the device. Believing that the stapler had not fired the first time, the surgeon decided to fire the stapler again to free the device (the only other option would have been to cut it out). Using all of her strength, the surgeon fired the device a second time and was then able to remove it.
The surgeon examined the plaintiff and saw some loose staples, but believed the surgery was successful. It was subsequently discovered that the plaintiff’s rectum had been stapled closed during the surgery. As a result, the plaintiff had a colostomy, followed by multiple surgeries unsuccessfully attempting to repair her rectum and reverse the colostomy. The plaintiff has a permanent colostomy bag which has severely impaired her quality of life.
In August 2012 (seven months after the plaintiff’s surgery), Ethicon voluntarily recalled certain lots of the stapler. The FDA’s recall notice identified the reasons for the recall as follows: “Users have difficulty firing the stapler devices, resulting in incomplete firing stroke and incomplete staple formation. Failure to complete the firing stroke of the stapler can result in severe pain, sphincter dysfunction, rectal wall damage, sepsis, bleeding, and occlusion of the rectal canal. Failure to complete the firing stroke can also result in poor staple formation, dehiscence of the rectal wall staple line and bleeding. This product may cause serious adverse health consequences, including death.” After the 2012 recall, Ethicon adopted a pass/fail force to fire requirement for all staplers coming off its assembly line: any stapler with a force to fire measurement greater than the maximum specification is rejected and not released for sale.
The California jury found Ethicon was liable for manufacturing defects, failure to warn, and negligence; it found Ethicon not liable for design defects and found the surgeon was not negligent. The jury awarded the plaintiff approximately $525,000 in economic damages and $8 million in past and future noneconomic damages. The plaintiff’s husband was awarded $1.3 million for his past and future loss of consortium damages.
The jury found Ethicon acted with malice and, following a bifurcated trial on the amount of punitive damages, awarded the plaintiffs $70 million in punitive damages. The defendants filed an appeal.
California Appellate Court Opinion
The California Appellate Court held that the trial court erred in admitting Ethicon’s files and records about other stapler incidents as evidence that the stapler used in the plaintiff’s surgery was defective; however, the error was harmless in light of evidence of the 2012 recall, the admission of which Ethicon did not challenge on appeal.
The California Appellate Court explained that the plaintiff’s theory was that the stapler used in her surgery was one of the defective staplers subject to the 2012 recall. The 2012 recall notice identified the problem as physicians having “difficulty firing the stapler devices, resulting in incomplete firing stroke and incomplete staple formation,” which “can result in . . . occlusion of the rectal canal.” The plaintiff submitted evidence that the stapler used in her surgery came from a lot later subject to the 2012 recall, and the plaintiff’s expert opined that the surgeon’s experience with the stapler used in the plaintiff’s surgery was consistent with the defective staplers recalled in 2012.
The California Appellate Court further held that the trial court did not abuse its discretion in finding much of the evidence of other stapler incidents sufficiently similar to the plaintiff’s surgery to be relevant on the issue of whether Ethicon had notice that the stapler was defective and/or its inspection and quality control processes were inadequate.
In California, a plaintiff may recover punitive damages “where it is proven by clear and convincing evidence that the defendant has been guilty of oppression, fraud, or malice . . . .” (Civ. Code, § 3294, subd. (a).) “‘Malice’ means conduct which is intended by the defendant to cause injury to the plaintiff or despicable conduct which is carried on by the defendant with a willful and conscious disregard of the rights or safety of others.”
Malice does not require actual intent to harm. Conscious disregard for the safety of another may be sufficient where the defendant is aware of the probable dangerous consequences of his or her conduct and he or she willfully fails to avoid such consequences. Malice may be proved either expressly through direct evidence or by implication through indirect evidence from which the jury draws inferences. To establish malice, it is not sufficient to show only that the defendant’s conduct was negligent, grossly negligent or even reckless. There must be evidence that the defendant acted with knowledge of the probable dangerous consequences to the plaintiff’s interests and deliberately failed to avoid these consequences.
A corporate employer may be liable for punitive damages if “an officer, director, or managing agent of the corporation” committed, authorized, or ratified the malicious conduct. Civ. Code, § 3294, subd. (b).
The California Appellate Court stated that there was evidence that Ethicon knew, when it designed the stapler, that excessive force to fire posed a risk to patient safety, and even if Ethicon inadvertently failed to implement a control plan for force to fire when it began manufacturing staplers, Ethicon received numerous reports over the years which either indicated an excessive force to fire or identified issues which could be attributable to excessive force to fire.
The California Appelllate Court stated that the jury could conclude that these reports notified Ethicon of force to fire issues, yet Ethicon failed to ensure that a control plan was in place to monitor force to fire. Despite knowing the risks of excessive force to fire and knowing that insufficient lubrication would increase the force to fire, Ethicon failed to conduct tests before changing the method of applying lubrication to staplers. Taken together, the California Appellate Court held that this evidence is sufficient to support the jury’s determination that Ethicon acted with malice.
With regard to the amount of the jury’s punitive damages award, the California Appellate Court stated that courts apply a three-factor weighing analysis looking to the nature and effects of the defendant’s tortious conduct and the state’s treatment of comparable conduct in other contexts. The constitutional guideposts for reviewing courts are: (1) the degree of reprehensibility of the defendant’s misconduct; (2) the disparity between the actual or potential harm suffered by the plaintiff and the punitive damages award; and (3) the difference between the punitive damages awarded by the jury and the civil penalties authorized or imposed in comparable cases.
The California Appellate Court stated that the most important indicium of the reasonableness of a punitive damages award is the degree of reprehensibility of the defendant’s conduct. The California Appellate Court concluded that Ethicon’s degree of reprehensibility, while not negligible, is only moderate. In light of Ethicon’s moderate degree of reprehensibility and the plaintiff’s substantial noneconomic compensatory damages award, the California Appellate Court held that $70 million in punitive damages is a constitutionally excessive award.
The California Appellate Court held: “the constitutional maximum in this case is two times the compensatory damages award, approximately $19.6 million … The award of punitive damages is modified to two times the compensatory damages award. The judgment is otherwise affirmed.”
Source Kuhlmann v. Ethicon Endo-Surgery LLC, A147945.
If you or a loved one suffered harm due to a defective medical device, you should promptly consult with a medical device claim lawyer in your U.S. state who may investigate your defective medical device claim for you and represent you in a claim against a medical device manufacturer, if appropriate.
Visit our website to find medical device lawyers in your state who may assist you or call us toll-free in the United States at 800-295-3959.
Turn to us when you don’t know where to turn.