 |
 |
to fill out a simple form to connect to Classified Postings in your area.
|
|
|
|
|
Calise v. Ethicon6/29/2004
Dena Calise appeals from the judgment in favor of Ethicon, Inc. and its parent, Johnson & Johnson (collectively referred to as Ethicon), on her complaint for false advertising. She claims Ethicon's marketing materials for its Vicryl sutures are likely to mislead the consumer about the absorption rate of the sutures, and she contends the evidence introduced at trial establishes this deceptive tendency as a matter of law. The trial court found otherwise, and we affirm.
FACTS
Dena Calise brought this action against Ethicon for false advertising concerning the absorption rate of its Vicryl sutures. Ethicon's advertisements claimed Vicryl sutures had an "unsurpassed absorption rate" and were "predictably absorbed in 56 to 70 days." In comparison, Ethicon claimed the absorption rates of an "other synthetic absorbable suture" and "chromic gut" were "between 60-90 days," and "after 90 days," respectively.
Calise alleged the advertisements would make a potential user believe "there is scientific corroboration that all significant traces of the suture material, when used in human surgery, will completely dissolve within 70 days . . . all of the scientific corroboration for the `70 days' figure is based upon animal studies where the sutures were not tied or knotted as in human surgery." Calise also alleged "a medically significant percentage" of the Vicryl suture will remain in the body for more than 70 days.
The case was tried without a jury. The evidence showed that Ethicon used the "predictably absorbed" claim in "various promotional items and web sites." Ethicon also claimed in its package inserts that absorption of Vicryl sutures was "essentially complete" in 56 to 70 days. Calise introduced several studies in which different suture materials were implanted in rats or rabbits and then tested after various periods of time to see how long they remained in the body.
Dr. Frederick Hetzel, Calise's expert, reviewed the studies and testified the data did not support Ethicon's claims that the Vicryl sutures are either "essentially absorbed" or "predictably absorbed" in 56 to 70 days. He also criticized the data because the studies were not performed with knots in the sutures, which is the typical way sutures are used in humans. Hetzel, a forensic consultant with respect to failed medical devices who holds a Ph.D. in organic chemistry, had not done any of his own experiments but "evaluated the language of the advertising claims against the data reported . . . ." He was not a surgeon and had not conducted any survey of surgeons to determine whether they would consider the advertising claims misleading. Dr. Melvin Shiffman, Calise's treating physician, testified he was a surgeon and had used Ethicon sutures for "as long as he can remember." Although he testified the absorption rate of a suture is important to a surgeon, he did not testify the advertising claims at issue would be likely to mislead a surgeon.
Thomas Barbolt, a senior research fellow with Ethicon who holds a Ph.D. in experimental pathology and toxicology, testified for Ethicon. Disagreeing with Hetzel, Barbolt testified that the Vicryl sutures break down through a process of "bulk hydrolysis," which means the material is quickly hydrated throughout and results in a "degradation of the material [that] is independent of the amount of material that's there." The significance of this phenomenon is that the presence of knots in the sutures does not delay the rate at which the material is absorbed by the body. Barbolt testified the phrase "essentially absorbed" means that 10 percent of the suture material remains. As to the phrase "predictably absorbed," Barbolt stated, "I think it
Page 1 2 3 4 5 California Classifieds
Classified Postings
|
| |
to fill out a simple form to connect to Classified Postings in your area.
|
|