MARSHALL v. ZIMMER, INC. ( 2020 )

IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA RICHARD A. MARSHALL et al., : Plaintiffs : CIVIL ACTION □ ZIMMER, INC. et al., No. 18-3363 Defendants : MEMORANDUM PRATTER, J. sepremperS 2020 In this defective medical device case, the Marshalls allege that the Zimmer Defendants (collectively, “Zimmer’”) are responsible for complications Mr. Marshall suffered a knee replacement surgery. During that surgery, a NextGen RHK knee replacement system manufactured and sold by Zimmer was implanted in Mr. Marshall’s left leg. The stash Ils assert the system was defective, and thus caused Mr. Marshall’s catastrophic injuries. seni that the Marshalls cannot create a triable issue of fact with respect to a product defect, Zimmer seeks summary judgment on all of the plaintiffs’ claims. The Marshalls concede that their claims rise and fall on whether they can present expert testimony with respect to their allegations of a product defect. The Court has given the Marshalls multiple opportunities to find an expert to support their claims, but the Marshalls seem to have come up short. Thus, the Court must decide whether the Marshalls can proceed on the present record. For the reasons that follow, the Court will grant the defendants’ motion for summary judgment. BACKGROUND! I. Factual Background a. General information about the NextGen RHK knee replacement system The NextGen RHK knee replacement system has been made for clinical use since 2002. The replacement system is a hinge knee system that is intended as a “last resort” or “salvage” implant system for patients with particularly challenging orthopedic presentations. The system assists patients who require additional stabilization, in part due to previously failed surgeries related to resolving knee complications. Declaration of Anthony M. DiGioia III, M.D. (“DiGioia Decl.”), at (34-8. . The knee replacement system is comprised of several components, including a femoral component, a hinge pin, a hinge post, a hinge post extension, an articular surface, and a tibial baseplate. All of the metal components of the system are manufactured from Zimaloy ® Cobalt- Chromium-Molybdenum Alloy. The polyethylene components are made of ultra-high-molecular- weight polyethylene. The following image is a pictorial representation of the at-issue knee system: The following facts are undisputed by the parties unless otherwise noted. The Court observes that the Marshalls fail to rebut Zimmer’s statement of material facts in accordance with this Court’s pretrial rules and procedures in several ways. To the exten? the Marshalls have not rebutted the Zimmer’s factual averments with record support, the Court considers Zimmer’s assertions of material facts undisputed. Any other unsupported factual assertions, advanced by either party, are treated as merely conclusory. . 2 Polyethylene Box Insert Hinge Pin with Hinge Pin Plug {DANBPS} {Comet -Cuonis- Hoty team alloy and UEMAPS) Femoral gel. Fenoral Component . pe aaaN oe! Screw ja aa raat oe ce eee COED) ning el fi ot ry. Sed _ ee ‘am aD (Gctalt-Cront- _ Oe en quant") Alto) oe Oe ie Component eee Component ee manne Bushing re (Ccralt-Chrontus- □ (UaNaPR} aot Plug ok (UHH# Front View Lateral View b. Mr. Marshall’s history of left knee complications Mr. Marshall has a long history of medical complications related to his left □□ He had at least six procedures leading up to the surgery at issue in this litigation. At age 21, Mr. Marshall had a left knee arthrotomy. Five years later, after developing a staph infection in the| same knee, he had an arthroscopy. In 2005, he underwent total knee replacement, followed by an ee and drainage to treat post-surgical hematoma. Mr. Marshall suffered from a patella fracture and had an extensor mechanism allograft the following year. Two years later, Mr. Marshall had his prior knee prosthesis removed.” He also underwent an insertion of an antibiotic spacer block to treat an infection that had formed in his knee. In Decezaber of 2008, he had a new antibiotic spacer block inserted into his left knee. The Marshalls assert that Mr. Marshall’s surgeon tid not complete the total knee revision, but they do not cite to the record for this averment. 3 c. Mr. Marshall's experience with the NextGen RHK knee replacement system and post-surgery complications Mr. Marshall had surgery on his left knee in 2009 at Pennsylvania Hospital? in Philadelphia to address severe arthritic disease and his previcusly failed knee procedures. The surgery involved a revision of his left knee as well as the re-implantation of knee components (i.e. of the Zimmer NextGen RHK knee replacement system). During that procedure, Mr. Marshall also had extensor allograft reconstruction. □ Initially, after his 2009 surgery, Mr. Marshall had no complaints. However, according to Zimmer, Mr. Marshall began to complain of knee pain around December 2010. Mr. Marshall asserts he experienced pain sooner than that date. During that same year, he was advised to see an amputation specialist. . Mr. Marshall’s discomfort and knee complications progressed, and in 2015, Dr. Gwo-Chin Lee performed yet another surgery on Mr. Marshall’s left knee. This surgery was a total knee anthroplasty and reconstruction of the extensor mechanism disruption. A problematic component was removed. Dr. Lee reconstructed the extensor mechanism with a al allograft. During the surgery, Dr. Lee also found “complete emeaen of the quad tendon,” sig can bone loss, and a □ large amount of metallosis within the joint. DiGioia Decl. at’§ 30. Mr. Marshall alleges that as result of the implant of the defective Zimmer knee replacement system, his left knee developed metallosis, anc he suiiered catastrophic injuries, which required a revision procedure. At some point prior to January 2014, Mr. Marshall was also diagnosed with 3 Zimmer asserts prior to the removal of this action from state court, Hospital was dismissed from the case because the plaintiffs failec to secure a certificate of merit from an expert necessary to proceed on their claims against the hospital. The Marshalls do not contest this. 4 The Marshalls assert metallosis is a contamination of the joint with metallic debris. □ Non-Hodgkin’s lymphoma. According to Zimmer, while Mr. Marshall’s medical records do not contain complete information regarding Mr. M2zshall’s diagnosis and treatment of the disease, Mr. Marshall contends that the loosening and metz:losis in his left knee after the Zimmer device was implanted contributed to the development of hi; lymphoma. Mr. Marshall’s left leg has been amputated. The Marshalls assert his amputation was a direct result of the surgery and the defective Zimmer medical device. d. Expert evidence in support of the defendants’ motion for summary judgment Mr. Marshall has not proffered a medical expert in support of his claims.> The Zimmer Defendants rely on their defect and causation expert, Dr. Anthony M. DiGioia, an orthopedic surgeon with approximately 32 years of experience and who reportedly has performed several thousand total knee replacements. Dr. DiGioia opines that the loosening and metallosis, and the eventual need for revision surgery in Mr. Marshall’s knee were caused ly patient factors specific to Mr. Marshall, not any defect in the NextGen RHK system. According to this defense expert, loosening and metallosis can happen with any system, particularly in very challenging complex revision cases like Mr. Marshall’s, which can result in wear. Dr. DiGioia contends that Mr. Marshall’s medical records show that the device was loose at least six years before it was revised in 2015. Dr. DiGioia believes that Mr. Marshall developed loosening due tc his prior loss of bone stock, loss of his extensor mechanism, and then, secondarily, due to his smoking and failure to follow medical advice following the 2009 surgery. That is, regardless of the system implanted, according to the defense expert, Mr. Marshall would have developed locsening of his left knee, which led to his metallosis, and “one cannot conclude that the NextGen RHK components implanted in Mr. Marshall were 5 The Court details in another section of this Memorandum attempts the Marshalls have made to obtain an expert to support their claims. defective merely because he developed loosening, wear, metallosis, and eventually needed a revision procedure.” DiGioia Decl. at Dr. DiGioia also — that while the system is reserved for the most challenging orthopedic patients, it has enjoyed a high clinical success rate. In his practice, he has used the medical device challenged by the plaintiffs bui has never seen any metal wear in his patients with the medical device suggestive of a defect; nor has he observed any defect otherwise. In the literature he reviewed, Dr. DiGioia also found ao proof that the NextGen RHK components are at risk for developing metallosis due to design defect. Based on his review of Zimmer’s discovery responses, he has not seen information suggesting a link between the device and any later developed metallosis in a patient other than Mr. Marshall. II. Procedural Background A detailed summary of the procedural history of this case is helpful to the Court’s determinations today. . The case has neon pending since 2017 where the plaintiffs initiated the action in the Court of Common Pleas of Philadelphia County. The L was removed in 2018. By scheduling order, to the extent that they would rely on them, the Marshalls were required to serve expert reports by July 15, 2019. Scheduling Order of January 14, 2019 (Doc. No. 16). In response to the absence of such service, Zimmer filed its first motion for summary judgment, contending that the Marshalls could not substantiate their state law claims scunding in negligence, strict liability, and breach of warranty with respect to the knee replacement system at issue. In response, the Marshalls sought additional time to find an expert who would