You Be the Judge: Device Advice

A routine prostate surgery, assisted for the first time by robotic device, led to fatal complications. Who was in the wrong?

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After being diagnosed with prostate cancer, Fred Taylor was scheduled for a routine prostatectomy at Harrison Medical Center in Silverdale, Washington. On September 8, 2008, his surgeon, Dr. Scott Bildsten — who had done more than 100 traditional open prostate surgeries without complication — performed his first robotic-assisted prostatectomy.

The operation did not go well: What should have been a 5-hour operation turned into a 14-hour disaster for Taylor, who suffered a cascade of complications — kidney failure, stroke, and sepsis, among others.

At 280 pounds, the 67-year-old retiree was obese and had undergone coronary bypass and three lower abdominal surgeries. Still, Taylor was active and liked to fish, swim, and golf.

After surgery, his life changed.

The debilitating procedures left him largely sedentary, increasing strain on his heart. Taylor succumbed to heart failure and died on August 25, 2012. Before his death, Taylor filed suit against Bildsten, his medical practice, and Harrison. Later, Taylor added Intuitive Surgical Inc. (ISI), the maker of the da Vinci robotic device Bildsten used to remove his prostate. After his death, his wife Josette proceeded with the lawsuit. Before trial, she settled with Bildsten and Harrison but proceeded against ISI for claims of product defect, breach of warranty, breach of contract, violation of the Washington Product Liability Act (WPLA), negligence, and product liability. The trial court granted summary judgment in favor of ISI on all claims except for Taylor’s failure-to-warn claim under the WPLA.

According to Josette Taylor, the chain of events leading up to her husband’s death began long before his surgery. First, contrary to what Harrison was led to believe by ISI, the da Vinci device was not subjected to FDA’s rigorous pre-market approval process. Instead, it was cleared for use because it was “substantially equivalent” to an existing device. Second, ISI did not warn the hospital about the dangers of the device. Third, ISI knew that small to mid-sized regional hospitals like Harrison would not buy the expensive ($1.8 million) surgical system if significant, costly training was required because it would reduce a hospital’s productivity. So, ISI recommended only two supervised surgeries before surgeons could use the da Vinci solo. Finally, the technology was so complex that Harrison and physicians had to rely on ISI for instruction and proper usage, and it did not provide adequate training to Bildsten and failed its duty to warn Harrison about product dangers.

ISI contended that during training it did warn Bildsten about the dangers, and had provided both Bildsten and Harrison with its user manual listing all warnings, including that the device should not be used to perform prostate surgery on obese patients or on patients who had undergone lower abdominal surgery. ISI argued that it had no duty to warn the hospital because medical device makers satisfy their duty to warn patients of the risks by providing warnings to doctors prescribing the products.

How Would You Rule?

The Washington Supreme Court held that ISI failed to warn the purchasing hospital of the dangers of the da Vinci device. The Court stated that the purpose of product liability laws is to protect purchasers of the product. In this case, the purchaser is not the doctor, but the hospital.

—Taylor v. Intuitive Surgical Inc., February 9, 2017

 

Featured image: Shutterstock.com.

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