Was fetus’ wrist injured during cesarean delivery?

DEFENDANTS’ DEFENSE According to Bayer, Yasmin is safe, and remains on the market. It was an appropriate drug to treat her irregular bleeding.

VERDICT Claims against the medical center that referred the patient to the ObGyn were settled for $2.5 million before trial. A $14 million Illinois verdict was returned against the ObGyn, for a total award of $16.5 million.

Who is at fault when pelvic mesh erodes?

In January 2011, an ObGyn implanted the Gyne­care TVT Obturator System (TVT‑O; Ethicon) during a midurethral sling procedure to treat stress urinary incontinence (SUI) in a woman in her 60s. Shortly thereafter, the ObGyn left practice because of early-onset Alzheimer’s disease, and the patient’s care was taken over by a gynecologist.

At the 2-month postoperative visit, the gynecologist found that the mesh had eroded into the patient’s vagina. The gynecologist simply cut the mesh with a scissor, charted that a small erosion was present, and prescribed estrogen cream.

The patient continued to report pain, discomfort, pressure, difficulty voiding urine, continued incontinence, vaginal discharge, scarring, infection, odor, and bleeding.

PATIENT’S CLAIM The polypropylene mesh used during the midurethral sling procedure has been shown to be incompatible with human tissue. It promotes an immune response, which stimulates degradation of the pelvic tissue and can contribute to the development of severe adverse reactions to the mesh. Ethicon negligently designed, manufactured, marketed, labeled, and packaged the pelvic mesh products.

DEFENDANTS’ DEFENSE Proper warnings were provided about the health risks associated with polypropylene mesh products. The medical device was not properly sized.

VERDICT A Texas jury rejected the patient’s claims that Ethicon did not provide proper warnings about the sling’s health risks and declined to award punitive damages.

However, the jury decided that the mesh implant was defectively designed, and returned a $1.2 million verdict against Ethicon.

Was suspected bowel injury treated properly?

A 40-year-old woman was referred to an ObGyn after reporting abnormal uterine bleeding to her primary care physician. The patient had very light menses every few weeks. The ObGyn performed an ablation procedure, without relief. A month later, the ObGyn performed robot-assisted laparoscopic hysterectomy. The next day, the patient reported abdominal pain. Suspecting a bowel injury, the ObGyn ordered a CT scan; the bowel appeared normal, so the ObGyn referred the patient to a surgeon. During exploratory laparotomy, the surgeon found and repaired a bowel injury. The patient developed significant complications from a necrotizing infection that included respiratory distress and ongoing wound care.

PATIENT’S CLAIM Conservative treatment should have been offered before surgery. The ObGyn should have waited longer after the ablation procedure before doing the hysterectomy. The ObGyn should have checked for a possible bowel injury before closing the hysterectomy.

PHYSICIAN’S DEFENSE The bowel injury is a known complication of the procedure and was recognized and repaired in a timely manner.

VERDICT A Kentucky defense verdict was returned.

Pap smear improperly interpreted: Woman dies from cervical cancer

A 37-year-old woman underwent a pap smear in 2008 that was read by a cytotechnologist as normal. Two years later, the patient was found to have a golf-ball–sized cancerous tumor. She died from cervical cancer in 2011.

ESTATE’S CLAIM The cytotechnologist was negligent in misreading the 2008 Pap smear. If treatment had been started in 2008, the cancer could have been resolved with a simple conization biopsy.

DEFENDANTS’ DEFENSE The Pap smear interpretation was reasonable. The cancer could not have been diagnosed in 2008. The patient was at fault for failing to follow-up Pap smears during the next 2 years.

VERDICT After assigning 75% fault to the cytotechnologist and 25% fault to the patient, a Florida jury returned a $20,870,200 verdict, which was reduced to $15,816,699.

Disastrous off-label use of anticoagulation

When a pelvic abscess was found, a 50-year-old woman was admitted to the hospital for treatment. She was taking warfarin due to a history of venous thromboembolism.

Before the procedure, her physicians attempted to temporarily reverse her anticoagulation by administering Factor IX Complex (Profilnine SD, Grifols Biologicals). The dose ordered for the patient was nearly double the maximum recommended weight-based dose. Almost immediately after receiving the infusion, the patient went into cardiopulmonary arrest and died. An autopsy found the cause of death to be pulmonary emboli (PE).

ESTATE’S CLAIM An excessive dose of Profilnine caused PE. At the time of the incident, Profilnine was not FDA approved for warfarin reversal, although some off-label uses were recognized in emergent situations, such as intracranial bleeds.

DEFENDANTS’ DEFENSE The case was settled during the trial.

VERDICT A $1.25 million Virginia settlement was reached.