"The urologist contended that, at all times, he was willing to undergo any training program that the manufacturer or distributor recommended and that he used the microwave device at all times exactly as instructed by the proctor and by the literature given to him," writes Acacia Brush Perko, Esq.
In the 1990s, the plaintiff, a male computer consultant in his mid-60s, started having mild lower urinary tract symptoms with urination one to three times nightly and minimal urinary bladder residual. His prostate was enlarged by ultrasound examination, but since his symptoms were not progressive, the defendant urologist advised him that surgical intervention was not warranted.
In early 2003, the defendant medical device manufacturer received FDA approval to distribute a device that used microwaves emitted from one portion of a catheter inserted into the patient’s bladder to burn out portions of the prostate from the inside, a procedure designed to remove prostatic tissue obstructing the flow of urine without a surgical procedure.
After FDA approval, the defendant distributor approached the urologist and sold him one of the devices. The defendant proctor performed two microwave prostate removals with the urologist, and then issued a certificate on behalf of the manufacturer and distributor, indicating that the urologist had been fully trained and was competent to use the device without further supervision.
Also see: Lack of emergent VCUG leads to costly settlement
The urologist then performed an unsupervised microwave prostate removal on the plaintiff using the device. The plaintiff left the urologist’s office in considerable pain and then experienced massive urinary incontinence, requiring the use of a diaper.
Two additional surgeries performed
Over the next 6 months, the urologist performed two other surgeries on the plaintiff, seeking to dilate strictures of the urethra.
The plaintiff alternated between frank urinary incontinence, requiring diapers, and bladder outlet obstruction, requiring self-catheterization.
The plaintiff then sought further opinions, and it was determined that his external urethral sphincter was damaged beyond repair and that he needed the implantation of a prosthetic urethral sphincter and resection of the portion of the urethra that appeared irreversibly strictured.
Claiming physical damages, the plaintiff sued the urologist for medical malpractice (negligent treatment), the manufacturer and distributor for product liability (design defect, negligence, fraud, failure to adhere to FDA requirements of approval), and the proctor for negligent training.
The defense disputed the allegations.
The urologist contended that, at all times, he was willing to undergo any training program that the manufacturer or distributor recommended and that he used the microwave device at all times exactly as instructed by the proctor and by the literature given to him.
The manufacturer and distributor contended that the FDA did not explicitly require the exclusion of patients with prior strictures.
The manufacturer and distributor also contended that the Supremacy Clause precluded the claiming of any design defects in a lawsuit brought under state law when the FDA had approved the design and in fact precluded any lawsuits in tort under state law. The only recourse for the plaintiff, according to the manufacturer and distributor, was a complaint regarding noncompliance with FDA conditions of approval with the FDA having exclusive jurisdiction over any such litigation.
The manufacturer and distributor also claimed that the educational materials had been sent to and received by the urologist and that he was competent to proceed using the product without further supervision.
Before trial, the urologist settled out for $200,000. A week before trial, the judge granted the remaining defendants’ summary judgment, ruling that the Supremacy Clause, combined with FDA approval of the product and education program, pre-empted any and all state causes of action in tort.
The plaintiff appealed. Just before the reply brief was due, the manufacturer and distributor resolved the case for $195,000 with the plaintiff.
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LEGAL PERSPECTIVE: The judge and jury have different functions. Judges decide matters of law, and juries decide questions of fact. The civil rules allow a party to move for summary judgment prior to trial, asking the judge to rule that there is no genuine issue of material fact and that they are entitled to judgment as a matter of law. If granted, a case will not proceed to trial.
Here, the remaining defendants, the manufacturer and distributor, moved for summary judgment, which was granted. The plaintiff appealed that decision to the higher court, asking the appellate court to reverse the trial court’s decision. If successful, this would have resulted in a remand and trial.
Faced with the potential of protracted litigation, a likely sympathetic plaintiff, and the uncertainty of what a jury would do with the facts of the case, the manufacturer and distributor chose the safe bet of a settlement short of trial.