The usual claim against a manufacturer in a product liability case is that the product is defective, either as designed or as manufactured, or that there was a failure to warn of something known about the product.
A 61-year-old Kentucky man was suffering from kidney stones in 2007. His urologist scheduled an extracorporeal shock wave lithotripsy procedure to break up the stones.
The next day, the patient returned for a ureteroscopic procedure with a basket device passed through the ureter, and the broken stone pieces were collected. During the procedure, the basket device broke off and became lodged in the ureter. The patient was immediately sent to the hospital and received aggressive care, but he eventually lost his left kidney.
The patient sued the urologist, claiming that it was negligent to use the basket device in anatomy that was already inflamed from the ESWL procedure the day before. The physician countered that there was no negligence and that the injury was due to a stricture of the ureter, and the complication was appropriately managed.
Legal Perspective: In addition to suing the urologist for negligence, the patient also named the manufacturer of the basket device as a defendant in the case. The usual claim against a manufacturer in a product liability case is that the product is defective, either as designed or as manufactured, or that there was a failure to warn of something known about the product.
In this case, the manufacturer filed a motion for summary judgment, most likely claiming there were no facts to support that the product was defective, and they were released from the case. The matter was ultimately tried solely on the claim that the physician used the device in a negligent fashion during the ureteroscopic procedure. The jury returned a defense verdict.
Blood vessels injured during abdominal sacrocolpopexy
A 72-year-old woman developed prolapse of her uterus, bladder, and other pelvic organs and went to a Michigan urologist, who performed an abdominal sacrocolpopexy. While attempting to gain access to the sacral prominence, the median sacral vein tore and expanded to involve the inferior vena cava (IVC) and left iliac vein. Massive bleeding occurred and multiple units of blood were transfused. The vascular injuries were successfully repaired with the assistance of a general surgeon. The patient was hospitalized for 16 days and needed home health care and physical therapy, but eventually recovered and returned to work.
The woman sued the urologist and claimed that he was negligent in overaggressive manipulation of the median sacral vein, causing it to tear at the insertion site with the IVC and/or iliac vein. She claimed she had a prolonged recovery period due to the negligence.
The physician argued that vessel injury and bleeding of this type are known complications of the operation and were recognized and managed appropriately in a timely manner. The jury returned with a defense verdict.
Perforation of bladder occurs during cystoscopy
A Michigan woman who suffered from recurrent bladder cancer was 84 years of age when she underwent a cystoscopy performed by her urologist. She was also undergoing chemotherapy at the time.
Several weeks following the procedure, she was diagnosed with a bladder perforation and became septic. She was hospitalized and then transferred to rehabilitation for 9 months before dying from complications from overwhelming sepsis.
A lawsuit was filed on her behalf and claimed that the bladder was lacerated during the cystoscopy and that the woman would have survived if not for the negligence.
The physician denied that the bladder was perforated during the procedure, and argued that a bladder perforation was a known complication of a cystoscopy. Additionally, he maintained that bladder cancer chemotherapy agents can be irritating to exposed tissue and may have caused the perforation. A defense verdict was returned.
Hemorrhaging results in DIC during prostatectomy
A 68-year-old New York man underwent a radical retropubic prostatectomy in 2005. The operation was performed by his urologist, and during the procedure significant bleeding occurred and the patient developed disseminated intravascular coagulation (DIC). The surgery was stopped and blood, blood products, platelets, and resuscitative fluids were provided; the patient was stabilized; and the surgery was completed. He remained hospitalized for several weeks.
The man filed a lawsuit claiming he subsequently developed erectile dysfunction and urinary incontinence. The incontinence eventually resolved but his ED persisted. He alleged the urologist was negligent in failing to properly perform the procedure and failing to appropriately manage the complications. Specifically, he claimed that poor intraoperative suturing caused excessive bleeding, which led to DIC. He also alleged lack of informed consent in that the physician did not disclose that the prostatectomy could cause ED or incontinence, and he argued that he could have had close monitoring of his grade-6 cancer or that a less invasive prostatectomy could have been attempted. Further, he complained that the DIC was not properly treated, leading to weeks of treatment in the hospital.
The defense claimed the hospital staff adequately treated his DIC; he was stabilized in the operating room; and surgery was completed. They also argued that the risks of the operation were properly discussed, the procedure was appropriate for his condition, and the patient had ED prior to the procedure. A defense verdict was returned.
Bleeding following ureteral stent placement
A 60-year-old Ohio man underwent a procedure for removal of kidney stones with placement of a ureteral stent. He was placed on heparin after the procedure to prevent clotting at the site of the stent. The patient had continued bleeding at the stent site, a clot developed, and he subsequently died from a pulmonary embolism (PE).
A lawsuit was filed on behalf of his estate and claimed that the urologist, pulmonologist, and cardiologist failed to timely diagnose and treat the arterial bleeding and clot formation that caused his death from the PE.
The defense argued that the bleeding was caused by the administration of heparin and that the patient’s symptoms were appropriately and promptly diagnosed and treated and that his death was due to a known risk of the procedure. A defense verdict was returned.