Confidential

Facts

The plaintiff, a man in his 60s, had mild symptoms of prostatism for years, with urination 1-3 times nightly, and minimal urinary bladder residual. His prostate was enlarged to ultrasound examination, but since his symptoms were not progressive, the defendant urologist in this case advised him that his symptoms did not warrant the risks of surgical intervention (TURP).

In early 2003, defendant manufacturer received FDA approval to distribute a device designed to remove prostatic tissue which was obstructing the flow of urine without a surgical procedure. This machine was said to remove part of the prostate in the course of an office procedure.

After FDA approval of the machine, defendant manufacturer and defendant distributor approached defendant urologist and sold him one of these machines. Defendant "proctor" performed two microwave prostate removals with defendant doctor, then issued a certificate on behalf of defendant manufacturer and defendant distributor, indicating that defendant urologist had been fully trained and was competent to use this device without further supervision.

On July 11, 2003, defendant urologist performed prostate removal on plaintiff. This was the first unsupervised procedure he had ever done.

From the time the plaintiff left defendant urologist's office that day, in considerable pain, he experienced massive urinary incontinence, requiring the use of a diaper. This did not abate until about six weeks later, when a stricture in the urethra caused complete bladder outlet obstruction, and plaintiff had to be seen multiple times for insertion of a catheter to empty his bladder.

Over the next six months, defendant urologist performed two further surgeries on plaintiff, seeking to dilate strictures of the urethra. The plaintiff alternated between frank urinary incontinence, requiring diapers, and bladder outlet obstruction, requiring frequent self-catheterization. The plaintiff then sought further opinions from UCLA, where it was determined that plaintiff's external urethral sphincter was gone, and that he needed the implantation of a prosthetic sphincter and resection of the portion of the urethra that appeared irreversibly strictured. This surgery restored 90 percent of plaintiff's control over urination. He was rendered impotent by the initial microwave procedure.

PLAINTIFF'S CONTENTIONS:
As to defendant urologist, the plaintiff contended that given the absence of progression of symptoms of prostatism and the absence of any symptoms that plaintiff felt were significant, no prostate procedure should have been done. The training given to the urologist, two procedures under supervision, was inadequate to warn the urologist about the ways the device operated. Finally, the urologist failed to notice migration of the catheter outward to a position in which the device would burn the urethra rather than the prostate.

As to defendant manufacturer and distributor, the plaintiff contended that FDA conditions of approval were granted as to patients who were clinically similar to those in the clinical trial submitted to the FDA, which excluded patients who previously had had urethral strictures. The plaintiff was one such patient and should, on that basis, not have had this procedure; this information was not conveyed to defendant urologist. Further, the FDA required the delivery to urologist of written information guides which were never delivered to defendant urologist and a meaningful educational program before issuing certificates of competence, which program was never carried out. Finally, though approved by the FDA, there was a substantive design defect in the device, in that it had no markings on the catheter to permit the urologist to know where the segment lay, and to ascertain migration of the catheter during the procedure, which might harm the urethra. The migration of the catheter by one centimeter would move the device from a position next to the prostate to one, which was below the prostate but opposite the external urethral sphincter muscle.

As to defendant proctor, the plaintiff contended that though assigned by manufacturer and distributor to make sure that the FDA required educational program was fully implemented before issuing a certificate of competence, proctor spent less than one full hour with defendant urologist and then issued a certificate of competence, permitting urologist to proceed with further prostate resections unsupervised. Though he knew that none of the patients in the FDA feasibility study have had prior strictures, and that the device was not cleared of use in such patients, he had already used it in such patients without complications, and told defendant urologist the product was safe to use on such patients.

DEFENDANTS' CONTENTIONS:
Defendant urologist asserted that at all times he was willing to undergo any training program the manufacturer or distributor recommended, and that he used the microwave apparatus at all times exactly as instructed by the proctor and by the literature he had reviewed.

Defendant manufacturer/distributor contended the FDA did not explicitly require the exclusion of patients with prior strictures. Further, the Supremacy Clause precluded the claim of a design defect in a lawsuit brought under state law when the FDA had approved the design, and in fact precluded any lawsuits under state law. The only recourse for the plaintiff was a complaint regarding non-compliance with FDA conditions of approval, with the FDA having exclusive jurisdiction over any such litigation. Further, the educational materials had been sent to and received by the urologist and he was competent to proceed using the product without further supervision.

Settlement Discussions

The plaintiffs made demands at mediation of $200,000 from the urologist and $200,000 from the manufacturer and distributor. Initially, the urologist settled out for $200,000. Defendant manufacturer and distributor and proctor failed to settle the case at first, and brought a motion for summary judgment grounded solely in the argument that the FDA approval process pre-empted all state law claims. The judge granted this motion, thereby disposing of the entire case.

Result

Settlement for a total of $395,000; $200,000 from the urologist; $195,000 from the manufacturer and distributor of the microwave appratus after plaintiff filed his appeal.

Other Information

The plaintiff filed his appeal, claiming that all claims save those of design defect were not pre-empted by the FDA approval, and claims relating to design defect may or may not be pre-empted. After plaintiff filed his appeal, defendant manufacturer settled for $195,000. Defendant disputes plaintiff's characterization of its brief and the settlement process.