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Hrymoc v. Ethicon

Dr. Bruce Rosenzweig, an expert in uro-gynecology, reviews records to conclude the manufacturer failed to properly inform physicians of the potential hazards of its pelvic mesh product.

The Expert: Dr. Bruce Rosenzweig, an expert in uro-gynecology, reviews records to conclude the manufacturer failed to properly inform physicians of the potential hazards of its pelvic mesh product.

By Dr. Gary F. Gansar, MD, FACS
Senior Physician Medical Director, AMFS

In a New Jersey state court case from 2017, urogynecologist Dr. Bruce Rosenzweig testifies for the plaintiff, who claimed that defectively designed pelvic mesh was causing her chronic pelvic pain. In this video, the doctor goes over Ethicon’s label warnings to both doctors and patients, concluding during this product liability case that these informational tools were inadequate.

He notes that the patient and doctor’s instructions from 2008 and 2015 differed substantially. There were additional instructions in 2015 that were not mentioned in 2008. For instance, there was a caution about “foreign body response” that could result in extrusion, erosion, exposure, or fistula formation. These are not transitory effects. Chronic pain is mentioned in the second set of instructions, not in the first. In the first instruction sheet there was a caution about “transitory” leg pain that would respond to aspirin. In the second set of instructions, this had evolved to chronic leg pain.

Voiding dysfunction was also mentioned as a possibility originally, but was couched in terms that made it seem like it was due to a surgeon’s error in judgment, which can occur if the mesh was placed it too tightly. After seven years of use, the newer instructions recognized that this problem of voiding dysfunction may occur without a technical issue during its placement and, indeed, can occur any time after placement.

Pain with intercourse is listed as a possible complication only in the latter instructions. It was not mentioned in 2008. Similarly, muscular pains were mentioned earlier as an acute and transient problem, but by 2015 this was recognized as a chronic risk. Due to the less than optimal experience with this mesh reconstruction, the more recent instructions admit that it may take more than one surgical placement to correct the original problem. The former instructions said nothing about this, and of course it therefore does not explain how difficult the operation to remove this mesh becomes once foreign body reaction and scarring around the mesh have occurred.

The mesh was released on the market in January 2004. By 2008, many of these complications were well known, but the expert says they were not clearly elucidated or in some cases even mentioned in the 2008 instructions. He explains that (as a defense witness had apparently earlier testified), these problems were well known to the manufacturer and they should have been enumerated in the 2015 instructions as well as in the 2008 version.

The expert concludes by pointing out that the patient information documents do not cover these significant complications and in his opinion, they should. He feels that the patient needs to be apprised of the same risks that the doctor is aware of. However, he concludes, if the manufacturer does not provide the information even to the operating surgeon, and that surgeon may thus be unaware of the reported complications that have occurred prior to 2004 until 2015, the manufacturer has neglected its duty to the patient.

The jury agreed with the expert, handing down a $15 million verdict.

About the Author Dr. Gary F. Gansar, MD, FACS

Gary Gansar, MD, is residency-trained in general surgery. He served as Chief of Surgery and Staff at Elmwood Medical Center and on the Medical Executive Committee at Touro Infirmary and Mercy Hospital in New Orleans, LA. Dr. Gansar was Board Certified in general surgery while in active practice. He joined AMFS in 2015 as a Physician Medical Director.

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