Shareholders have sued the maker of a surgical robot claiming the company has “grossly underreported” injuries and deaths attributed to the da Vinci.
The 67-page shareholder derivative complaint was filed by the city of Birmingham and Alabama’s Relief and Retirement System naming Intuitive Surgical of Sunnyvale, California, the maker of the device, reports Courthouse News.
The da Vinci robot is expensive, anywhere from $1 million to $2.3 million, and is the only product made by Intuitive, which also derives its profits from sales of the accessories to the device.
Intuitive’s chief financial officer and nine-member board of directors are all named in the lawsuit.
The da Vinci was originally approved by the U.S. Food and Drug Administration (FDA) under its 510(k) approval process. Initially the medical device was used for laparoscopic surgeries but the FDA expanded use of the da Vinci for some cardiac surgeries and certain urologic surgeries such as hysterectomy and prostatectomy.
Under FDA regulations, the manufacturer is supposed to alert the agency if there are any injuries or fatalities associated with a device as well as any company-initiated voluntary recalls. Upon a patient death, for example, the maker has 30-days to alert the FDA. It must investigate the death and report the circumstances back to the FDA.
In other words, it is entirely in the hands of the medical device company to report on itself.
What kind of complications went underreported? The da Vinci operates using tip covers fitted to the end of the surgical scissors. They are geared to prevent any electricity, used to cut tissue, from hitting tissue next to the surgical site.
According to the shareholders claim, Intuitive hid reports of the tip cover malfunctions “resulting in burning of the patient’s internal tissue.” CNBC reports that one patient said she suffered excrutiating pain following her uterine fibroid surgery when electrical burns perforated her small intestine. Another woman had her uterus burned by the da Vinci robotic tip.
There have also been several deaths. One woman, undergoing a da Vinci procedure for cervical cancer, died eleven days after suffering small bowel damage during the procedure.
Intuitive underreported these deaths or seriously misclassified them as “other” to the FDA’s MAUDE database of adverse events, says the complaint, and the company had knowledge of the defective tips years earlier but failed to report that information to the FDA.
A published article in the Journal for Healthcare Quality reported last September that this severe underreporting took place from January 2000 to August 2012. When the numbers were recalculated, there were actually 9,839 incidents and approximately 62 deaths or injury reports occurred from September 2012 to December 2013 alone.
Top executives also reportedly sold off stock when it traded at “an artificially inflated value” says the complaint, just as the FDA began its inquiry. After the FDA launched a safety probe into Intuitive, its stock price fell from $573 to $392 a share.
There are presently about 80 product liability lawsuits pending against Intuitive for its da Vinci robot medical device and the company has been sued by two insurers.
The Intuitive Surgical da Vinci robot was approved under the FDA’s 510(k) clearance process in April 2011. As we’ve reported here many time, the 510(k) has allowed thousands of medical devices onto the market with no clinical trials to assure human safety. Also approved via 510(k) was the recalled DePuy ASR, a metal-on-metal hip implant.
Instead of putting patient safety first, manufacturers currently operate under FDA guidelines that were established in 1997 that impose the “least burdensome” standard on industry, allowing it to bring new products to the market with the least amount of interference.
A 2011 Institute of Medicine report concluded that the 510(k) process needed to be abolished. Clearly that would be a step in the right direction for all consumers and patients.