(May 22, 2012) A woman who claims that she was burned by a hyrdro thermablator (HTA) did not support her claims with evidence, so the Ohio magistrate judge has recommended the manufacturer, Boston Scientific Corp., be granted summary judgment on the woman’s claims. In accordance with the Federal Rules of Civil Procedure 56, summary judgment shall be granted if there is no genuine issue of material fact, and the party requesting summary judgment is entitled to judgment as a matter of law.
On May 4, a judge for the U.S. District Court for the Northen District of Ohio adopted the magistrate judge’s recommendation that Boston Scientific be granted summary judgment. Boston Scientific, in its motion for summary judgment, argued that the HTA System user’s manual and other literature warn that a risk associated with this procedure is “a potential for leakage of hot fluid, which may result in thermal injury to the surrounding tissue.”
The Boston Scientific Hydro Thermoblator circulates heated saline in the uterus to eliminate and/or reduce menstrual bleeding, which is a minimally invasive alternative to a hysterectomy. The woman bringing this lawsuit was treated with the hydro thermablator by her doctor in 2008, and alleges that during the “heating and circulation phase of the procedure, the HTA malfunctioned, and began leaking hot fluids,” which resulted in burns to her vaginal introitus, outer vaginal area, and buttocks.
During the procedure, the HTA sheath is inserted and sealed into the uterine cavity, allowing saline to circulate through the sheath and into the uterine cavity at increasing heat, ultimately reaching 194 degrees fahrenheit, for approximately ten minutes, where saline kept at room temperature is used to flush and cool the treated area.
In addition, Boston Scientific relied on the Medical Device Amendments (MDA) to the Food Drug and Cosmetics Act, stating that the victim’s claims are preempted. This provision uses a two-part test, which requires courts to determine whether the federal government has established requirements applicable to the device at issue, and if so, whether the common-law claims are based upon state requirements as to the device that is different from, or in addition to, the federal ones, and that relate to safety and effectiveness.
The victim’s response was that Boston Scientific did not comply with federal regulations in designing and manufacturing the HTA, and because of this failure to comply, her claims should not be preempted. She alleged that in 2009, Boston Scientific recalled certain HTA units for a circuit board defect that could result in a failure of the system pump, leading to patient injury from hot fluid leaks.
However, despite this victim’s claims, the magistrate judge determined that she failed to support these allegations with any evidence; therefore, there is no genuine issue of material fact that she presented to prevent the judge from granting Boston Scientific’s motion for summary judgment. Even though the victim was informed that Boston Scientific planned on filing a motion for summary judgment, she conducted no discovery, which could help her overcome this dispositive motion. Because of these reasons, the victim’s lawsuit was dismissed, as Boston Scientific’s motion for summary judgment was granted.