Lowery v. Sanofi-Aventis LLC

• Decision Date: 09 March 2021
• Docket Number: Case No.: 7:18-cv-00376-RDP
• Parties: RALPH LOWERY, Plaintiff, v. SANOFI-AVENTIS LLC, et al., Defendants.
• Court: U.S. District Court — Northern District of Alabama

RALPH LOWERY, Plaintiff,
v.
SANOFI-AVENTIS LLC, et al., Defendants.

Case No.: 7:18-cv-00376-RDP

UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF ALABAMA WESTERN DIVISION

March 9, 2021

MEMORANDUM OPINION

This case is before the court on Defendant Genzyme Corporation's Motion to Exclude Testimony of Plaintiff Ralph Lowery's Expert Catherine E. Patterson (Doc. # 51) and Defendant's Motion to Exclude Testimony of Plaintiff's Expert Charles Abney (Doc. # 55).¹ The motions are fully briefed (Docs. # 52, 56, 60, 61, 63, 64).² After careful review, and for the reasons discussed below, the court concludes that Defendant's Motions (Docs. # 51, 55) are due to be granted.

I. Background

Plaintiff advances six claims in this case based on the allegation that he suffered injuries after Defendant's medical device, Synvisc-One, was injected into his right knee. (See Doc. # 35). Plaintiff's device came from Synvisc-One production Lot 7RSL021 ("Lot") that Defendant voluntarily recalled after it discovered that the Lot was contaminated with Methylobacterium

Page 2

thiocyanatum. (Doc. # 50 at 6). Plaintiff alleges that the contaminant caused septic arthritis (i.e., a joint infection) in his right knee and other injuries resulting from the onset of septic arthritis, including hearing loss, reduced mobility, and a shortened lifespan. (See Docs. # 35, 60). He also alleges that the Lot was contaminated because of several deficiencies in Defendant's manufacturing process and that those deficiencies rise to the level of violations of federal requirements.

To establish that the bacteria caused septic arthritis and other injuries, Plaintiff seeks to admit the testimony of Dr. Charles Abney. And, to establish that Defendant's manufacturing processes and facilities violated several federal requirements imposed on Defendant, Plaintiff seeks to admit the testimony of Dr. Catherine E. Patterson. Defendant challenges the admissibility of both witnesses' opinion testimony.

A. Plaintiff's Medical History and the Synvisc-One Injection

Plaintiff is a 70-year-old male with a history of knee problems. (Doc. # 56-3 at 12).³ On November 1, 2017, Plaintiff visited Dr. Stephen Ikard and reported he was having a pain level of "8/10" and walking with a cane. (Doc. # 56 at 7). Dr. Ikard injected a dose of Synvisc-One from the Lot into Plaintiff's knee to treat his pain associated with osteoarthritis. (Doc. # 50 at 8). Plaintiff experienced pain and swelling in his right knee by the time he returned home. (Doc. # 56 at 7) (citing Doc. # 56-6 at 9). Three days later, Plaintiff went to an emergency room because he continued to experience pain and swelling in his right knee with a pain level of "6/10." (Docs. # 56 at 18; 62 at 9; 62-5). Plaintiff received antibiotics about five hours before Dr. William McKibbin, an orthopedic specialist, operated on his knee. (Doc. # 56 at 3-4, 18). Dr. McKibbin removed fluid from Plaintiff's knee that he described as a "dark yellow thick fluid," sampled

Page 3

cultures, and took a "gram stain" to check for organisms in the fluid. (Id. at 18). He also made the initial clinical diagnosis that Plaintiff had septic arthritis. (Doc. # 62-6 at 1). Based on all the facts available to him, Dr. Ikard stated in his deposition that a "reasonable physician [could] conclude" that Plaintiff suffered "septic arthritis from a contaminated lot of Synvisc." (Doc. # 62-18 at 71). He also said in a statement that "it very possibly could have been infected." (Doc. # 58-3 at 28-29).⁴

The day after his initial treatment and procedure, Plaintiff followed up with Dr. Albert T. White, an infectious disease specialist. (See Docs. # 58-17; 60 at 9). Dr. White reviewed Plaintiff's record -- which by then included the negative results on the samples taken during surgery⁵ -- and prescribed Vancomycin for six weeks. (Doc. # 56-4 at 18-19). Dr. White's assessment was that Plaintiff "most likely [suffered from] septic arthritis." (Doc. # 58-17 at 5). In February 2018, Plaintiff, again, visited Dr. Ikard. (Doc. # 56 at 8). At this time, Plaintiff stated this his pain was at a level of "4/10." (Doc. # 60-2 at 30). In February 2018, Dr. Ikard noted that "there were some questions whether or not this was actually a pseudoseptic reaction or truly a septic joint" and discussed this possibility with Plaintiff.⁶ (Id. at 32-33).

At the time Plaintiff received his injection in November 2017, he was also suffering from

Page 4

hearing loss and wore hearing aids. (Docs. # 56 at 20; 56-3 at 12). Plaintiff alleges that his Vancomycin antibiotic treatment prescribed by Dr. White following the removal of the fluid from his knee caused additional hearing loss. (Doc. # 56 at 20). Plaintiff visited his primary otolaryngologist (i.e., "ear, nose and throat" (ENT)), Dr. Craig M. Benoit, on May 18, 2018. (Docs. # 56 at 20-21; 56-20 at 3). According to the records from that visit, Plaintiff did not indicate that he was suffering any further hearing loss. (Docs. # 56 at 20-21; 56-20 at 3). On November 19, 2018⁷ -- approximately one year after starting his antibiotic treatment -- Plaintiff visited Dr. Lee Loftin, another ENT. (Doc. # 58-20). Dr. Loftin's initial clinical impression was that Plaintiff "appear[ed]" to suffer hearing loss from Vancomycin. (Doc. # 58-8 at 5). Dr. Loftin noted that Plaintiff experienced hearing loss between an audiogram administered in August 2016 and the one he administered in November 2018. (Docs. # 58-8 at 2; 56-22). Dr. Abney testified that there is medical literature concluding that Vancomycin can contribute to hearing loss. (Doc. # 60 at 26). Dr. Abney did not conduct any hearing tests but instead relied on (1) Plaintiff's observations that his hearing loss worsened after starting his Vancomycin treatment and (2) certain clinical impressions. (Docs. # 60 at 25; 60-1 at 23).

B. Expert Testimony of Dr. Charles Abney

Plaintiff retained Dr. Abney -- a medical doctor and attorney -- to offer expert testimony in this case regarding medical causation. Dr. Abney practices in family medicine as a hospitalist. (Doc. # 50-12 at 11). In that role, he "is devoted to adult medical services." (Doc. # 60 at 7). He regularly treats osteoarthritis and often interacts with patients "needing total joint replacement" and refers those patients to an orthopedic surgeon for diagnosis and treatment. (Id. at 8). By his estimates, he has seen "at least 150,000 patients as a physician." (Id.).

Page 5

Dr. Abney produced a four-page report in this case opining on issues ranging from infectious disease to orthopedics to otolaryngology. (Doc. # 50-11). Dr. Abney's relevant opinions and conclusions can be summarized as follows:

[1] Mr. Lowery had septic arthritis of the right knee resulting from intraarticular injection of a contaminated lot of Synvisc One;

[2] given the administration of antibiotics to Mr. Lowery approximately 5 hours before the tissue and synovial samples were taken, these samples would not be reliable sources for microbial culture;

[3] Mr. Lowery suffered aggravated hearing loss from IV Vancomycin use and literature links hearing loss to prolonged Vancomycin use;

[4] Mr. Lowery is no longer a candidate for a total knee replacement because of the septic arthritis;

[5] Mr. Lowery will no longer be able to meaningfully mobilize without a walker and eventually will require a wheelchair; and

[6] limited mobility will reduce Mr. Lowery's lifespan.⁸

(Doc. # 60 at 11) (citing Doc. # 58-14) (formatting modified).

C. Synvisc-One and Lot 7RSL021 Production⁹

Synvisc-One is an FDA-approved Class III medical device that is a gel-like "viscosupplement" injected into a patient's knee to relieve pain. (Doc. # 62-12 at 20). Importantly, and unlike most other consumer products, medical devices are subject to strict regulation enforced by the Food and Drug Administration ("FDA"). New Class III medical devices are approved for public use through the FDA's "premarket approval" ("PMA") process. (Doc. # 50-3 at 11, 15).

Page 6

The subjects for review in the PMA process include, among other matters, clinical studies and their data related to the device's safety and effectiveness and the processes employed in its manufacture. (Id.). On average, approval occurs only after the FDA spends around 1,200 hours reviewing an application. See Riegel v. Medtronic, Inc., 552 U.S. 312, 317-18 (2008) (internal citations omitted).

Once the FDA grants this approval, the manufacturer cannot make any "changes in design specifications, manufacturing processes, labeling, or any other attribute[] that would affect safety or effectiveness" without first obtaining FDA approval for such changes. Frey v. Bayer Corp., 2020 WL 5995587, at *1 (M.D. Ga. Oct. 9, 2020) (citing id. at 319). It follows that Synvisc-One has design and manufacturing process specifications approved by the FDA in its PMA application and that it cannot deviate from those absent prior FDA approval. The reason that a manufacturer cannot deviate from the approved specifications without prior FDA approval is because the approved specifications "provide a reasonable assurance of safety and effectiveness." Riegel, 552 U.S. at 317. Incorporated into the manufacturing specifications are the Current Good Manufacturing Practices ("GMPs") that manufactures must comply with -- and cannot deviate from -- in producing these medical devices. 21 C.F.R. § 820.1(a)(1); see Herrnandez v. Stryker Corp., 2014 WL 7044171, at *3 (W.D. Wash. Dec. 11, 2014) (citing Horowitz v. Stryker Corp., 613 F. Supp. 2d 271, 278-79 (E.D.N.Y. 2009)).

Synvisc-One is manufactured using aseptic processing, which means that the processing does not actively sterilize; it merely preserves the sterile status of a material. (Doc. # 50-3 at 16, 19). To preserve the sterile nature of the device, Defendant manufactures Synvisc-One in "strictly

Page 7

controlled environments."¹⁰ (Doc. # 50 at 9, ¶ 11) (citing id. at 17-19, 24). Water is introduced to the manufacturing process via the Water for...