Da Vinci robot maker faces more problems despite defense verdict

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June 20, 2013

Da Vinci robot maker faces more problems despite defense verdict 

Alyssa E. Lambert

A jury found that Intuitive Surgical Inc., the da Vinci surgical system maker, was not negligent in training a doctor who seriously injured a man while using the robot during a prostate removal. But the company faces new problems inside and outside of the courtroom.

A Washington state jury found that Intuitive Surgical Inc. (ISI), the da Vinci surgical system maker, was not negligent in training a doctor who seriously injured a man while using the robot during a prostate removal. Plaintiff attorneys handling litigation against the embattled manufacturer say the defense verdict will not affect the pending products liability cases and is not a win for ISI, which faces new problems inside and outside of the courtroom. (Est. of Taylor v. Intuitive Surgical, Inc., No. 09-2-03136-5 (Wash., Kitsup. Co. Super. May 23, 2013).)

In 2008, Scott Bildsten performed a prostatectomy on Fred Taylor using the da Vinci system. Taylor sustained serious injuries, including kidney failure and brain damage, and died in 2012 from heart failure allegedly related to his injuries. The plaintiffs alleged that the company improperly marketed the surgical system, failed to provide adequate warnings regarding its use, and failed to properly train Bildsten and the hospital staff.

At trial, ISI pinned the blame on Bildsten, who used the da Vinci unsupervised for the first time and reached a confidential settlement with Taylor’s estate before the trial. After five weeks, the jury reached a 10-2 verdict.

Richard Friedman of Bremerton, Wash., who represents the Taylor family, said he will appeal the verdict. “This was a very difficult case, and most of the cases people are going to have are going to be easier than this one,” he said. “The doctor was told not to operate on overweight patients, and he did it anyway, and that was a hard fact to get around.”

Birmingham, Ala., attorney Francois Blaudeau, who represents plaintiffs in several da Vinci actions, said that the verdict will not affect the products liability cases.

“The Taylor case has been mischaracterized by the press as having some effect on the other cases pending, but those other cases involve product defects in the monopolar scissors and insulation defects in the shaft and other portions of the instrument that have caused various injuries,” said Blaudeau, who is also a practicing gynecological surgeon. “The Taylor case is very limited to the negligent training claim, so there was an empty chair issue, and the defendant’s attorneys took advantage of that. But there is an issue with the training of surgeons, and we do think that issue will come up in other cases.”

Two weeks before the verdict, the California-based manufacturer issued an urgent medical device notification to its customers that certain 2009 and 2010 versions of the robots’ cautery monopolar scissors, which are used to cut and coagulate tissue during hysterectomies, prostatectomies, and gastric bypasses, may develop microscopic cracks. These cracks may cause the scissors to leak electrical energy and burn tissue during surgery. ISI said that replacements were to be available soon, but it did not recall the crack-prone scissors. This defect is alleged in some of the pending products liability cases.

Birmingham, Ala., attorney Nolan Awbrey, who is working with Blaudeau, said ISI’s notification raises a “significant issue.” He added that “while it doesn’t apply in every case, it is going to affect certain cases—how we evaluate them and how we approach them.”

ISI reported the scissor problem to the FDA, which is reviewing it. The FDA was already investigating the robots due to an increase in the number of adverse event reports (AER) associated with them, as Trial News previously reported. The number of AERs for accident burns, punctures, and other robot-related injuries increased 34 percent from 2011 to 2012.

While ISI continues to fight the products liability lawsuits—it has been named in 26 according to a first-quarter 2013 financial statement filed with the U.S. Securities and Exchange Commission (SEC)—a group of shareholders is now accusing it of securities fraud.

In April, a plaintiff filed a class action in federal district court in California on behalf of all investors who bought ISI shares between Oct. 19, 2011, and Apr. 18, 2013, alleging the company and its officers and directors made materially false and misleading statements regarding the surgical systems’ supposed safety and effectiveness in violation of the Securities Exchange Act of 1934 and SEC Rule 10b-5. The purported class claims these false statements concealed problems with the robots and misled investors about the company’s financial prospects, causing ISI stock to trade at artificially inflated prices, and that senior executives sold shares of personally held stock during the class period for more than $218.6 million in proceeds. (Abrams v. Intuitive Surgical, Inc., No. 5:13-cv-01920-EJD (N.D. Cal. filed Apr. 26, 2013).)

Friedman said many people were misled by the company’s actions, but he thinks the tide is turning in the plaintiffs’ favor.

“Intuitive did a beautiful job of marketing in this,” he said. “But we are going to see a lot of successes before too long.”

August 8, 2013 UPDATE:

Regulatory problems continued to plague ISI in July when the FDA announced a Class II recall of 30 da Vinci devices that may not have been tested properly. Class II recalls are issued when a product “may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.” On June 27, ISI notified its customers that factory testing on four different da Vinci components—the dual camera controller, the instrument control box, the Si surgeon side cart, and the Si vision system cart—in 30 devices may not have met compliance standards.

On July 18, ISI disclosed that following an FDA inspection of the company’s facilities in April and May, it received a warning letter on July 16 for its failure to report certain device corrections and removals or patient adverse events associated with them. The FDA detailed its inspection observations in a Form 483, a precursor to the warning letter. The form notes that, for example, in October 2011 ISI notified customers that the robots were not cleared for use in thyroidectomies, but some were used for the procedure anyway. The company received 13 complaints and was aware of five medical device reports about adverse events but never reported this information to the FDA.

The agency also observed that ISI did not have adequately established procedures for design changes. It did not document its decision to add a thyroidectomy function to the device’s general laparoscopy clearance through the FDA’s 510(k) “Letter to File” procedure, which allows for minor device modifications to be made via letter rather than submitting a new 510(k) application. A new application is required for changes or modifications that could significantly affect the device’s safety or effectiveness or if the device is to be marketed for a new or different indication, but this was not done.

ISI also failed to document surgeons’ need to scrape the device’s instruments against each other to clean them during surgery, resulting in holes and tears in the protective tip covers and patient injuries. The FDA has asked ISI to take corrective action and intends to conduct a follow-up inspection after those steps have been taken.


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