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Albright v. Boston Scientific Corp.

Appeals Court of Massachusetts, Middlesex

September 13, 2016

DIANE ALBRIGHT
v.
BOSTON SCIENTIFIC CORPORATION.[1]

          Heard April 15, 2016

         Civil action commenced in the Superior Court Department on March 8, 2012.

         The case was tried before Diane M. Kottmyer, J.

          Jonathan D. Orent (Dennis A. Costigan with him) for the plaintiff.

          Robert T. Adams, of Missouri (Susan M. Donnelly Murphy with him) for the defendant.

          Present: Cypher, Katzmann, & Massing, JJ.

          KATZMANN, J.

         The plaintiff Diane Albright, an Ohio resident, brought this action in the Superior Court against defendant Boston Scientific Corporation (BSC), a Massachusetts-based company, seeking damages for injuries that she sustained after having BSC's "Pinnacle Pelvic Floor Repair" kit (Pinnacle device) surgically implanted to treat her pelvic organ prolapse (POP) condition.[2] BSC designed, manufactured, and marketed the Pinnacle device and sold it to the Ohio hospital where Albright's surgery took place. After a three-week trial, a jury found for BSC on Albright's claims of defective design and inadequate warning.

         On appeal, Albright challenges the exclusion of the medical application caution (caution) contained within the 2004 material safety data sheet (MSDS)[3] that had been provided to BSC by its supplier of the polypropylene material used to fabricate the mesh in the Pinnacle device. Albright offered the caution for the limited purpose of showing notice and knowledge on the part of BSC. Albright also claims error from the exclusion of two letters that the United States Food and Drug Administration (FDA) sent to BSC in 2012.[4] We conclude that, in the context of the case as it unfolded at trial, it was prejudicial error to exclude the proffered caution and FDA letters. The judgment in favor of BSC shall therefore be vacated and the case remanded to the Superior Court for a new trial.

         Background.

         There was evidence from which the jury could have found the following.[5]

         1. Surgeries.

         In 2008, Albright had surgery to treat POP symptoms involving her bladder. Dr. Jay Meyer performed a procedure[6] that did not involve the implantation of surgical mesh. Less than twelve months later, Albright experienced a recurrence of the bulging sensation in her pelvic area. During a follow-up visit with Dr. Meyer, Albright reported feeling "something give" in her pelvis after lifting a heavy table. Dr. Meyer advised Albright that if she could tolerate this sensation of a bulge or pressure in her pelvic area, surgery could be avoided. Albright was not able to do so; she met again with Dr. Meyer, voicing a desire to have "something done."

         Dr. Meyer informed Albright of an option to permanently implant a mesh device in her pelvic cavity to shore up weakened tissue. Albright agreed.[7] With the aid of an experienced colleague, Dr. Meyer performed the implant procedure at Mary Rutan Hospital, located in Bellefontaine, Ohio, on March 9, 2010. Mary Rutan Hospital had purchased the Pinnacle device from BSC on May 15, 2009. At the time, Dr. Meyer was pleased with the surgical outcome, commenting favorably that the Pinnacle device worked "as advertised."

         BSC marketed the Pinnacle device as a safe implant for use in the treatment of POP. The Pinnacle device is intended to shore up and repair tissue that holds and supports pelvic organs in place. The FDA had cleared the device for sale in the United States pursuant to the agency's § 510(k) process.[8]

         2. Postsurgery complications.

         Within six months, Albright experienced pain and discomfort when urinating and other "hard-to-describe" pain in her pelvic area. On examining Albright in September, 2011, Dr. Meyer found no indication of mesh erosion. He suspected that Albright might have interstitial cystitis.[9] No diagnosis was made linking Albright's symptoms and complications to the mesh. Similar findings were made by Dr. Andrew Hundley during visits with Albright in 2011 and 2012, and by Dr. Maurice Chung, a gynecologist who examined Albright in 2012 and 2014.

         Albright was also examined by Dr. Niall Galloway, a urologist and gynecologist affiliated with Emory University, and Dr. John Steege, a professor in the department of gynecology and obstetrics at the University of North Carolina. Drs. Galloway and Steege concluded that Albright was suffering from painful bladder syndrome and other complications due to the erosion and degradation of the mesh in her body.[10]

         3. Trial proceedings.

         Albright alleged that the Pinnacle device was defective due to a flawed design that failed to guard against the foreseeable risks of harm stemming from the mesh design. She also claimed that BSC had failed to adequately warn Dr. Meyer of the foreseeable risks that the Pinnacle device posed to her. BSC maintained that the Pinnacle device was safe for implantation inside Albright's body to treat POP. The jury never reached the disputed factual question whether the Pinnacle device caused Albright's injuries because of their finding that Albright had not shown by a preponderance of the evidence that the device was "defective" under Ohio law.

         a. Design.

         Compared to other transvaginal surgical mesh devices on the market in 2009 for the treatment of POP, the Pinnacle device called for a sizable amount of dense mesh with small "pores" (i.e., openings in the mesh). The design premise for the Pinnacle device is that when implanted in the body, its mesh will promote tissue growth through the mesh pores, and, by doing so, this new growth will anchor and stabilize the device in the patient's body. BSC, however, did not conduct clinical tests to assess mesh shrinkage or degradation in the body.

         Experts for both sides addressed the scientific properties of BSC's polypropylene mesh. Janice Connor, the clinical programs director of BSC's urology and women's health division, testified that her review of scientific literature confirmed that mesh devices, like the Pinnacle device, were a safe and effective medical option for women, especially when compared to native tissue repair surgeries which resulted in a recurrence rate of thirty to seventy percent. Doreen Rao, an engineer in BSC's urology group, stated that polypropylene is "inert" and does not undergo changes once it is implanted in the human body.[11] On the other hand, Albright's experts focused on "oxidation, " the response of tissue cells to the presence of a foreign body, in this case the implanted Pinnacle device.

         Scott Guelcher, a chemical engineering professor and polymer chemist, explained what happens when tissue cells react to polypropylene material. Guelcher was among the first to discover that polypropylene materials, "which were normally considered stable, " did, in fact, degrade. Guelcher described this reactive process, testifying that human cells produce, or secrete, reactive oxygen species, which "settle on and attach to" the implant. The response of human cells to implanted material is a "surface-driven" effect. The cell-generated reactive oxygen species continuously break down and degrade the polypropylene mesh until it is destroyed or removed. This means that the oxidation process results in a "bigger problem" where there is more polypropylene surface, as is the case with the Pinnacle device, which uses relatively more mesh than other POP mesh devices. Guelcher added that polypropylene is one of the most easily oxidized materials, a fact that, in his view, is important to know for biomaterial design purposes.

         Dr. Thomas Barker, a professor of biomedical engineering at the university level, also testified for Albright. Dr. Barker described a further nuance to the chemical reactive process. Dr. Barker testified that, upon implantation of the mesh device, human cells populate "dense portions" of the mesh (i.e., where its fibers are in close proximity to one another). Tissue cells are activated to "apply force" and to pull on the mesh material. As a result, Dr. Barker testified, tissue then grows across mesh fibers ("fibrotic bridging"), rather than inside mesh pores, the latter of which is what the Pinnacle device is intended to promote. This fibrotic bridging process may form a scar around the implant, which can cause pain to the patient. Dr. Barker opined that there was a "mechanical mismatch" between the Pinnacle device and the anatomical space (the pelvic cavity) where the device is implanted. As opposed to hernia mesh on the abdominal wall, the implanted Pinnacle mesh has two millimeters of soft tissue to protect it from extruding into the patient's vaginal cavity (a complication about which Albright complains). This mismatch can lead to foreseeable biomedical risks, including mesh contracture, mesh shrinkage, and abrasions. Dr. Donald Ostergard, another of Albright's expert witnesses, testified at trial that the Pinnacle device was not appropriate for its intended use to treat POP because of the volume, weight, and pore size of its mesh. Albright's experts -- Guelcher, Barker, and Ostergard -- testified that, prior to marketing the Pinnacle device, BSC ignored or otherwise failed to account for the oxidation process as it affects the Pinnacle mesh when implanted to treat POP.

         b. Warning and directions for use.

         Albright presented expert evidence that BSC had failed to warn Dr. Meyer of the risk that the mesh's density and volume posed in terms of the frequency, permanence, and potential severity of complications caused by degradation of the mesh inside the body. This included painful bladder syndrome and pudendal neuralgia, as well as the harm that would follow from a procedure to remove some or all of the mesh to address such complications. BSC sought to show that the potential or anticipated risks associated with the Pinnacle device were fully disclosed in its directions for use (DFU). The DFU for the Pinnacle device identified incontinence, dyspareunia, erosion, extrusion, and contracture, among other risks. BSC's expert, Dr. Matthew Davies, testified that BSC had adequately warned Dr. Meyer of the risks in using its device.

         D ...


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