Alexander Law Group announced that it has won a $9.8m judgment against Johnson & Johnson’s subsidiaries Ethicon Endo-Surgery, Inc. and J&J Healthcare Systems for injuries to its client caused by a defective Ethicon PPH 03 hemorrhoid stapler.
There was no offer of settlement.
The plaintiffs alleged, and the Alameda County Superior Court jury agreed, that during surgery on the plaintiff in January, 2012, the defective stapler misfired, sealing the client’s anal canal shut, leading her to suffer 21 days of emergency hospitalization, massive infection and major abdominal surgeries that resulted in a full laparotomy and a colostomy.
"This is a victory for all those who have been harmed by this known defective stapler," said Richard Alexander, managing partner for the Alexander Law Group. "Our outstanding team included lead attorney Nina Shapirshteyn, and she was assisted by counsel Annie Wu. They did an outstanding job poring through more than 45,000 pages of documents and presenting the facts to the jury. But regardless of the amount of the verdict, nothing can replace the harm done to our client by this defective product," Alexander added.
The primary plaintiff, Florence Kuhlmann, a retired San Jose police officer, continues to be plagued by external and internal scarring, continues to struggle with a deformed bowel, has been forced to wear a colostomy bag for the past four years and has had multiple medical procedures attempting to restore her damaged bowel and anal canal. Her husband, Dr. John Perkins, a Lawrence Livermore National Laboratory research scientist, was the other plaintiff.
"Our client has finally received justice," said lead attorney Nina Shapirshteyn, who has been named one of the nation’s outstanding trial lawyers. "We were able to overcome a multi-billion dollar company and its high-powered legal team because the jury understood how this company deceived and harmed both the doctor and her patient with this defective medical device."
The Ethicon PPH03 is used to allow general surgeons to perform a procedure known as a hemorrhoidoplexy that is not as drastic as a hemorrhoidectomy, which must be performed by a colorectal surgeon. Basically, the dangling hemorrhoids are pushed back up into the anus by the device, stapled against the rectal wall and then the excess hemorrhoidal tissues are cut above the staples by a circular knife in the device.
The jury found that the force to fire the stapler was in excess of its specifications and was caused by a defective manufacturing procedure that reduced the lubrication applied to the PPH 03, a defect which was known by Ethicon for more than 10 years before the product was recalled. Rather than changing the design and manufacturing process, Ethicon maliciously blamed the surgeons using the device when they reported repeated malfunctions.
During the procedure on the plaintiff, the surgeon, Dr. Rakhee Shah who was also a party to the lawsuit, inserted the PPH 03 and had difficulty firing it because of the lubrication defect. Not being able to remove the device, she fired it again, sealing the plaintiff’s rectal wall shut. The jury found Dr. Shah blameless because Ethicon and J&J Healthcare Systems never warned its customers that there were years of complaints from surgeons who used the device.
Eventually, Ethicon was forced to recall 144,693 PPH 03 units sold between 2011 and 2012 because of this dangerous defect. The stapler used on the plaintiff was from one of the lots later recalled.
The jury awarded the plaintiff and her husband $8.5 and $1.3 million respectively for past and future medical costs, pain and suffering, loss of consortium, embarrassment, humiliation and disfigurement.