In medical treatment, patients depend upon doctors and nurses to provide the best care available under the current standards of care. Patients also hope and expect the instruments and devices used by medical staff to work, aiding in their recovery. If one of these instruments or devices fails, a patient may experience a greater injury than the condition from which they suffered originally. When this occurs, civil relief is available through a product liability lawsuit, as seen in Albright v. Boston Scientific Corporation (15-P-633). The injured patient, a lady from Ohio, filed suit against the manufacturers of the pelvic mesh surgically implanted to treat her Pelvic Organ Prolapse (POP). The injured woman had the mesh implanted to assist with weakened tissue in her pelvic area after a previous surgery provided minimal to no relief. Her surgeon implanted one of BSC’s devices, which was advertised as safe for treatment of POP. The FDA had cleared the device for sale, but through the § 510(k) process in which the device is substantially equivalent to another already on the market. Under the § 510(k) process, the device does not have to undergo clinical tests for approval. At trial, the injured patient provided expert testimony that concluded the mesh oxidized and reacted with the patient’s tissue in an unexpected, untested way. The trial court, however, excluded two letters from the FDA sent to the manufacturer, as well as the medical application caution sent by the supplier of polypropylene material, which addressed some of the potential issues with the mesh.
The injured patient appealed the exclusion of this evidence, which was offered for the limited purpose of showing knowledge and notice on the part of the manufacturer that they were aware of potential problems with the mesh’s material. Both sides offered witness testimony and opinion as to what caused the injury to the patient and whether the manufacturer should have known of the risks, based on the type of materials used. The injured patient and the manufacturer also presented evidence regarding whether or not the manufacturer advised her surgeon of the known risks in its use.
The trial court used Ohio law in its ruling on the substantive claims. In Ohio, a manufacturer is liable for foreseeable harm stemming from a product defect that would have been avoided if reasonable care had been used. A manufacturer is not expected to completely ensure or guarantee the safety of its products, but it is expected to acknowledge and notify of any reasonably foreseeable risks.
The Supreme Court pointed out that the injured patient had the burden to prove the manufacturer created a product for which the foreseeable risks exceeded the benefits, and the jury was tasked with scrutinizing whether or not the mesh design was suitable or appropriate for its intended use to treat bladder POP. The court ruled that the exclusion of both the caution and the letters was prejudicial to the injured patient. Without these, the jury had an imbalance of information regarding the product to determine whether or not the manufacturer was liable. The court specifically pointed to the inclusion of the FDA’s approval of the product, which was heavily emphasized in closing arguments by the defendant’s counsel. The verdict in favor of the manufacturer was reversed and remanded for a new trial.
The Massachusetts personal injury attorneys at Karsner & Meehan can assist you with your product liability lawsuit. For a free, confidential consultation today, call our office at 508.822.6600.
More Blog Posts:
Appeals Court of Massachusetts Case Reveals The Difficulty People Face When Contesting a Will, Massachusetts Injury Lawyers Blog, March 3, 2016
Rear-end Collision Appellate Case Helps Illustrate Burden of Proof Considerations in Massachusetts Personal Injury Cases, Massachusetts Injury Lawyers Blog, February 3, 2016