Lowery v. Sanofi-Aventis LLCLowery v. Sanofi-Aventis LLC
This matter is before the court on Defendant Genzyme Corporation‘s Motion for Summary Judgment. (Doc. # 49). The Motion has been fully briefed. (Docs. # 50, 62, 67). After careful review, and for the reasons discussed below, the court concludes that Defendant‘s Motion (Doc. # 49) is due to be granted.
This case presents issues about the admissibility of expert testimony, the causation requirements in a toxic tort case with complicated medical and technical issues, and the limiting effect of federal regulations on state-law claims. In the context of these issues, the court must determine if there is a factual issue to present to a jury for determination. This case also stands as a reminder that although some cases seem viable upon their initial presentment, they can fall apart when the legal standards affecting expert testimony are applied and Congress‘s policy choices come in to play.
Here, Plaintiff Ralph Lowery, a patient with an arthritic knee, received an injection of a medical device manufactured by Defendant Genzyme Corporation to relieve pain in his knee from arthritis. But, as it turns out, the lot from which that injection was drawn was contaminated with bacteria. Almost immediately after receiving the injection, Plaintiff experienced increased pain in his arthritic knee. He then filed this action claiming that the device caused him to suffer from septic arthritis. On the surface, this claim may seem meritorious. After all, the device was cоntaminated with bacteria.
But, that is not the whole story. Plaintiff retained experts, which is necessary in a case like this. It was critical for Plaintiff‘s experts to be qualified and for them to provide reliable expert opinion testimony
There is another problem. The defective product at issue is a Class III medical device, a product that is heavily regulated in every aspect of its design, manufacture, and sale. In fact, the product is scrutinized so much for safety and effectiveness that, once it is approved by the Food and Drug Administration, no one, especially the manufacturer, can alter the device‘s design or manufacture unless it receives prior approval from the FDA certifying that the device will remain safe and effective with the proposed changes. To enforce this policy, Congress has prohibited the states (or any other authority) from interfering with the federal regulatory scheme by imposing on device manufacturers requirements that are different from or in addition to the federal requirements. Because that is exactly what Plaintiff seeks to do here -- to impose such different or additional obligations on Defendants -- his claims are preempted.
Although this case started out with promising facts for Plaintiff, for the reasons explained in detail below, the legal and evidentiary standards that must be applied prove to be an insurmountable barrier to his recovery. Defendant is due summary judgment in this case.
I. Factual Background
The facts set out in this opinion are gleaned from the parties’ submissions and the court‘s own examination of the evidentiary record. All reasonable doubts about the facts have been resolved in favor of Plaintiff. See Info. Sys. & Networks Corp. v. City of Atlanta, 281 F.3d 1220, 1224 (11th Cir. 2002). These are the “facts” for summary judgment purposes only. They may not be the actual facts that could be established through live testimony at trial. See Cox v. Adm‘r U.S. Steel & Carnegie Pension Fund, 17 F.3d 1386, 1400 (11th Cir. 1994). For summary judgment purposes, the facts that have been excluded under the court‘s Daubert memorandum opinion are not analyzed. See Rubens v. Mason, 387 F.3d 183, 188 (2d Cir. 2004) (“[I]n deciding a motion for summary judgment, a court may rely only on material that would be admissible at trial.“).
A. Production of Synvisc-One Lot 7RSL021 and Plaintiff‘s Contaminated Injection
Defendant manufactures Synvisc-One -- a Class III medical device used to treat “pain [caused by] osteoarthritis (OA) of the knee” -- at its facility in Ridgefield, New Jersey. (Doc. # 50-1 at 11, 13). Devices and drugs do not just enter the market without significant regulatory scrutiny. Under FDA regulations, Medical devices fall into three categories. One of those categories is Class III medical devices. Class III devices are subject to the highest scrutiny. Riegel v. Medtronic, Inc., 552 U.S. 312, 317 (2008) (citing
An overview of the manufacturing process is helpful to understand the issues in this case.1 Although certain steps in the process undergo “terminal sterilization,” Defendant manufactures the final Synvisc-One product by “aseptic processing,” which means that the processing does not actively sterilize but preserves the sterile status of a material. (Id. at 16, 19). Terminal sterilization “is the final step” in a sterilized process. (Doc. # 50-7 at 19). The difference between an aseptic process and a sterilized process is that an aseptic process “reduces” the “risk of the presence of microorganisms” while a sterilized process produces “the absence of viable organisms.” (Doc. # 50-7 at 19). Defendant preserves the sterile environment by manufacturing Synvisc-One in “strictly controlled environments.” (Doc. # 50 at 9, ¶ 11) (citing id. at 17-19, 24). Controls for aseptic processing include the use of “clean rooms” by controlling personnel movement, using personal protective equipment, air filtering, and specific ventilation to control air movement in the rooms. (Doc. # 50-3 at 26). Water is introduced to the manufacturing process via a Water for Injection (“WFI“) system.2 Synvisc-One‘s PMA specification requires Defendant to test the WFI system daily and before each use of the system. (Id. at 28).
Synvisc-One is comprised of two components: Hylan A-10 fluid and Hylan B-10 gel. (Id.). Both components are subject to “endotoxin, bioburden, and sterility testing” during their respective manufacturing processes. (Id.). Although Defendant “terminally sterilize[s]” the gel before combining it with the fluid, the fluid cannot be terminally sterilized. But, the fluid is otherwise filtered for contaminants. (Id.).
After Defendant produces and tests the individual components, it combines them during the “bulk blending” step into fifty-liter or one hundred fifty-liter vessels. (Id. at 28-29). At this stage, Defendant retains samples of the bulk for future investigations and fills the product into individual syringes. (Id. at 30). All these processes are subject to strict “in-process controls” laid out in “standard operating procedures, which are reviewed and approved by the FDA as part of the PMA process.” (Docs. # 50-3 at 24, 30; 50-1 at 64, 66).
Defendant then conducts two different tests on the product before distributing it. (Docs. # 50-3 at 30; 50-6 at 51). These tests are required by the procedures in the PMA specifications. (Docs. # 50-3 at 30; 50-6 at 51). The first test is the “sterility test,” which detects the presence of microbial growth in the product. (Docs. # 50-7 at 21-22; 50-6 at 45). At the time Defendant made Lot 7RSL021 (“the Lot“), it tested for sterility using a fourteen-day incubation period. (Docs. # 50-3 at 45; 50-7 at 20-21). The second test is an endotoxin test, which requires that endotoxins in the product be below a threshold quantity.3
Defendant manufactured the Lot оn May 23, 2017 and kept samples from the bulk blending step in the event future testing became necessary.4 (Doc. # 50-3 at 33). The Lot was filled into individual syringes on June 15, 2017, and it entered into its sterility and endotoxin protocols. (Id. at 34). The Lot passed both tests: the endotoxin results were below the threshold amount and there
was “no growth” in the sterility testing.5 (Doc. # 50-1 at 16). The Lot then went through a second round of testing in September 2017. (Doc. # 50-3 at 34). As part of this “stability testing,” Defendant conducted another round of endotoxin testing and sterility testing. (Id.). The results were again within release specifications. (Doc. # 50-1 at 28).
On November 1, 2017, Dr. Stephen T. Ikard injected Synvisc-One from the Lot into Plaintiff Ralph Lowery‘s right knee to treat Plaintiff‘s knee pain associated with osteoarthritis. (Doc. # 50 at 8, 10; 56 at 3). Plaintiff began experiencing pain and swelling in his right knee by the time he returned home. (Docs. # 56 at 7; 56-6 at 9). Three days later, Plaintiff went to an emergency room because he continued experiencing pain and swelling in his right knee. (Doc. # 62 at 9) (citing Doc. # 62-5). Dr. William McKibbin, an orthopedic specialist, operated on Plaintiff‘s knee, removed a “dark thick yellow fluid,” sampled cultures, and made the initial clinical diagnosis that Plaintiff had septic arthritis. (Docs. # 62-6 at 1; 50-11 at 3). The day after his initial treatment and procedure, Plaintiff followed up with Dr. Albert T. White, an infectious disease specialist. (Docs. # 58-17; 58 at 9). Dr. White‘s assessment was that it was “most likely septic arthritis.” (Doc. # 58-17 at 5). Based on all the facts available to Dr. Ikard, he said that a “reasonable physician [could] conclude” that Plaintiff suffered “septic arthritis from a сontaminated lot of Synvisc.” (Doc. # 62-18 at 71). He also said in a sworn statement that “it very possibly could have been infected.” (Doc. # 58-3 at 28-29).6
B. Investigation of The Lot and Findings
On November 10, 2017 -- ten days after Plaintiff‘s Synvisc-One injection -- Defendant became aware of “a higher number of adverse events” for the Lot. (Doc. # 50-1 at 3). These adverse events triggered an internal investigation. (Doc. # 50-1 at 3). At that time, Defendant retested the retained bulk samples collected from the Lot. (Id. at 32-33). Defendant‘s endotoxin retest failed on November 21, 2017, and the sterility retest showed positive microbial
Defendant conducted an investigation to determine the cause of the recall and produced an Investigation Report. (Docs. # 50 at 12; 50-1). While not an exhaustive list, Defendant investigated the rates of adverse events, previous endotoxin and sterility testing, the manufacturing record and testing data for the Lot, the manufacturing environment, and changes to the manufacturing process from 2016 onward. (Doc. # 50 at 13, ¶ 28) (citing Doc. # 50-1). Defendant concluded that the Lot was uniformly contaminated with Methylobacterium thiocyanatum; the contamination was an isolated incident; the root cause was not identified, but it was likely from “incidental contamination” or from the WFI system; and there were no deviations from manufacturing or testing processes in Synvisc-One‘s PMA or other federal requirements that would have caused the contamination. (Docs. # 50-1 at 77-78; 50-3 at 38; 50-2 at 72; 62-10). The uniform contamination “could only occur if ... the bulk was contaminated.” (Docs. # 50-1 at 78; 62-10 at 104-105). The Investigation Report stated that the contamination posed a “high risk” because of the combination of the frequency of the adverse events and the nature of the events observed. (Doc. # 62-10 at 106-107). However, the report did not identify what condition or harm patients were at a “high risk” for. (Id.). Defendant‘s Health Hazard Report indicated that ”Methylobacterium thiocyanatum ... are unusual pathogens that rarely cause human infections .... [But the] [r]isk ... includes septic arthritis.” (Doc. # 62-17 at 4, 30).
There are three Nonconforming Reports (“NCRs“) in Defendant‘s internal investigation “being associated with the Lot.” (Doc. # 62-10 at 45). Although the NCRs were upstream (that is, during the manufacturing of the gel component of Synvisc-One), they did not implicate Methylobacterium thiocyanatum, and any gel would have been “sterilized ... killing any organisms present” before the bulk blending step. (Docs. # 50-1 at 19-20; 62-12 at 61). Defendant‘s FDA-approved procedures allow for them to retest “retained bulk samples” “in the event of an excursion or NCR as necessary.”7 (Doc. # 62-12 at 17) (emphasis added). In explaining whether there was an excursion or NCR that made testing necessary (pursuant to its own FDA-approved procedures), Robert Darius, Defendant‘s head of Good Manufacturing Practices (“GMP“) compliance, stated that “there wouldn‘t be a reason to [re]test.” (Docs. # 62-12 at 17; 50-1 at 3).
The FDA began a year-long inspection of the Ridgefield facility approximately two weeks after the first adverse events were reported. (Doc. # 50-8). The FDA conducted a comprehensive observation
There are two aspects of the FDA‘s inspection report released on February 27, 2018 that are relevant to this case. First, the FDA found that “this facility is considered to be in a minimally acceptable state of compliance with regards to current [GMPs].” (Doc. # 62-3 at 1). Second, the FDA issued a Form FDA 483 (“483 Report“) “for [a] ... deficiency.” (Id.). The 483 Report explained that Defendant‘s “[l]aboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality[,] and purity.” (Doc. # 62-3 at 29). Specifically, the FDA found that Defendant‘s “endotoxin results might be invalid for the final release and stability studies.” (Id.) (emphasis added). With respect to accurate endotoxin results, Defendant pooled together samples in such a manner that it “[did] not accurately reflect” the “maximum valid dilution” of the samples. (Id. at 30). James Assini, Associate Director of Quality Assurance for Defendant, put it simply by explaining that by “not pooling ... [manufacturers] are trying to ensure that a single unit with endotoxin is not diluted to the point where it would not be detected if it were pooled with other samples.” (See Doc. # 67 at 12) (citing Doc. # 50-7 at 10). Artificially low endotoxin concentrations “can lead to false negative results.” (Id.). Assini admitted that Defendant‘s endotoxin testing method “was a misinterpretation” of the “FDA guidance for industry Pyrogen and [E]ndotoxin testing.” (Docs. # 62-4 at 29; 62-15; 50-2 at 47).8 Again, it is undisputed that the Lot was “[u]niformly contaminated.” (Doc. # 62 at 9, ¶ 3). If the contamination is uniform, “the testing of one syringe individually or [a] pooled syringe ... would have [made] no difference in the results generated.”9 (Doc. # 50-7 at 12).
II. Standard of Review
Under
Once the moving party has met its burden with a “properly supported motion for summary judgment,”
The substаntive law will identify which facts are material and which are irrelevant. See id. 248. All reasonable doubts about the facts and all justifiable inferences are resolved in favor of the non-movant. See Allen v. Bd. of Pub. Educ. for Bibb Cty., 495 F.3d 1306, 1314 (11th Cir. 2007); Fitzpatrick v. City of Atlanta, 2 F.3d 1112, 1115 (11th Cir. 1993). A dispute is genuine “if the evidence is such that a reasonable jury could return a verdict for the nonmoving party.” Anderson,
477 U.S. at 248. If the evidence is merely colorable, or is not significantly probative, summary judgment may be granted. See id. at 249.
“[A]t the summary judgment stage the judge‘s function is not himself to weigh the evidence and determine the truth of the matter but to determine whether there is a genuine issue for trial.” Id. “Essentially, the inquiry is ‘whether the evidence presents a sufficient disagreement to require submission to the jury or whether it is so one-sided that one party must prevail as a matter of law.‘” Sawyer v. Sw. Airlines Co., 243 F. Supp. 2d 1257, 1262 (quoting id. at 251-52); see also LaRoche v. Denny‘s, Inc., 62 F. Supp. 2d 1366, 1371 (S.D. Fla. 1999) (“The law is clear that suspicion, perception, opinion, and belief cannot be used to defeat a motion for summary judgment.“).
The Eleventh Circuit has interpreted Celotex to require that, as to issues on which the nonmovant would bear the burden of proof at trial, a
moving party is not required to support its motion with affidavits or other similar material negating the opponent‘s claim in order to discharge this initial responsibility. Instead, the moving party simply may show [ ]—that is, point[ ] out to the district court—that there is an absence of evidence to support the non-moving party‘s case. Alternatively, the moving party may support its motion for summary judgment with affirmative evidence demonstrating that the non-moving party will be unable to prove its case at trial.
Fitzpatrick, 2 F.3d at 1115 (quoting U.S. v. Four Parcels of Real Property, 941 F.2d 1428, 1437 (11th Cir. 1991)). And, where the moving party has met this initial burden by showing that there is an absence of evidence supporting the nonmoving party‘s case, the nonmoving party must
respond in one of two ways. First, he or she may show that the record in fact contains supporting evidence, sufficient to withstand a directed verdict motion, which was “overlooked or ignored” by the moving party, who has thus failed to meet the initial burden of showing an absence of evidence. Second, he or she may come forward with additional evidence
sufficient to withstand a directed verdict motion at trial based on the alleged evidentiary deficiency.
Id. (internal citations omitted).
The parties have raised two issues for the court to resolve at summary judgment: (1) whether Defendant is entitled to summary judgment as a matter of law because there is not a genuine dispute of material fact; and (2) the scope of preemption with respect to Plaintiff‘s claims. These two issues are separate but not in complete isolation. Nonetheless, because preemption is a constitutional issue, the court “first analyze[s] whether each claim can stand under state law, and only then decide the preemption questions where necessary.” Godelia v. Doe 1, 881 F.3d 1309, 1317 (11th Cir. 2018). Thus, the court will address Plaintiff‘s claims under state law before addressing any preemption issues and address preemption issues only in the alternative.
III. Analysis
Defendant moves for summary judgment under
A. Plaintiff‘s Claims Fail Under Alabama Law
Plaintiff asserts six separate claims: (1) Strict Liability10; (2) Alabama Extended Manufacturers Liability Doctrine (“AEMLD“); (3) Negligence and Wantonness; (4) Breach of Implied Warranty; (5) Breach of Express Warranty; and (6) Failure to Comply with [GMPs]. (Doc. # 35). Defendant is due summary judgment on Counts One through Five because Plaintiff has failed to establish causation. (See Doc. # 72). Count Four and Count Five also fail because Plaintiff did not provide notice to Defendant as required under Alabama law. And, Plaintiff concedes that “Failure to Comply with [GMPs]” is not a “viable cause of action in Alabama,” (Doc. # 62 at 33 n.10). Thus, Summary Judgment is due to be granted on the claim made in Count Six. The court
1. Plaintiff Has Not Establishеd a Prima Facie Case on Any of His Claims Because He Has Failed to Establish Medical Causation
Plaintiff‘s claims under Alabama law asserted in Counts One through Five fail because (1) Plaintiff has not pointed to any
Pharm. Corp., 2017 WL 553134, at *6 (N.D. Ala. Feb. 10, 2017) (compiling product liability cases in Alabama and the Eleventh Circuit requiring expert testimony to prove medical causation). Indeed, while expert testimony is not required in every case, the “interaction between a complex and technical medical device and the unique physiological and medical circumstances of the patient in which it is implanted is a subject on which no ordinary juror could rationally be expected to have knowledge.” Hughes v. Stryker Corp., 423 F. App‘x 878, 879 (11th Cir. 2011). Thus, here, in the absence of viable expert testimony, the jury would be left to “speculate” without adequate guidance as to the cause of the injury. Id.; Jones, 2017 WL 553134, at *6 (citing Lowery v. Bisbee, 623 So. 2d 1047, 1049 (Ala. 1993)).
To be sure, in this context there must be expert testimony supporting two types of causation: general and specific.11 General causation is established by “laying a scientific groundwork” that the toxin in question “can cause the harm plaintiff alleges.” Chapman v. Procter & Gamble Distrib., LLC, 766 F.3d 1296, 1303 (11th Cir. 2014) (emphasis in original). Specific causation requires a court to evaluate whether the expert‘s methodology reliably supports the conclusion that the substance did cause the plaintiff‘s specific injury. Id. (internal citations omitted).
a. General Causation
Plaintiff points to Defendant‘s Health Hazard Evaluation and Investigation Report, Dr. Minerva Perrin‘s deposition testimony, and Dr. Ikard‘s deposition testimony to establish general causation. (See Doc. # 62 at 35-37). For the reasons explained below, none of these establish general causation.
Even if Defendant‘s documents can be said to be a legally sufficient substitute for expert testimony to establish general causation, the contents of them do not establish it.12 For example, the Health
Finally, as a last-ditch effort, Plaintiff cites a single statement by counsel that Dr. Ikard assented to in his deposition: “a reasonable physician [could] conclude that this was ... septic arthritis from a contaminated lot of Synvisc.” (Doc. # 62 at 36) (citing Doc. # 62-18 at 71). This conclusory statement does not lay “any scientific groundwork” for the conclusion that Methylobacterium thiocyanatum causes septic arthritis. McClain, 401 F.3d at 1252.
b. Specific Causation
Even if Plaintiff could establish general causation, he is also required to establish specific causation. This is an even more significant undertaking in this case, and one that Plaintiff has been unable to accomplish. Plaintiff relies on the opinions and statements of two physicians for specific causation: Dr. Abney and Dr. Ikard. As discussed in detail in the court‘s memorandum opinion and order (Doc. # 72), Dr. Abney‘s opinion that Plaintiff suffered from septic arthritis because of Methylobacterium thiocyanatum in the Lot is inadmissible.
Contrary to what Plaintiff represents as a “fact,” Dr. Ikard‘s testimony does not establish a genuine dispute as to whether Methylobacterium thiocyanatum caused septic arthritis in Plaintiff‘s right knee. Dr. Ikard‘s most favorable statement for Plaintiff is that his (Plaintiff‘s) knee “very possibly could have been infected.” (Doc.
Further, to the extent that Plaintiff relies solely on Dr. Ikard‘s clinical impression during Plaintiff‘s treatment to establish specific causation, a treating physician‘s testimony is limited to his factual observations and is not expert causation evidence. United States v. Henderson, 409 F.3d 1293, 1300 (11th Cir. 2005); Rondini v. Bunn, 2020 WL 136858, at *3 (N.D. Ala. Jan. 13, 2020). Thus, Plaintiff‘s claims necessarily fail under state law. Defendant‘s motion for summary judgment is due to be granted as to all of Plaintiff‘s claims.
2. Breach of Express and Implied Warranties
Plaintiff‘s warranty claims fail because Plaintiff has not provided the notice of a breach of warranty to Defendant that is required under Alabama law. In a personal injury case, as the Eleventh Circuit has noted, “[t]he Alabama courts have held that notice of breach is a condition precedent to bringing a breach of warranty action ... which must be affirmatively pleaded in the complaint.” Hart v. Yamaha-Parts Distributors, Inc., 787 F.2d 1468, 1474 (11th Cir. 1986) (emphasis added) (citing Parker v. Bell Ford, Inc., 425 So. 2d 1101, 1102 (Ala. 1983); Lindsey v. International Shoe Co., 233 So. 2d 507, 509 (Ala. Civ. App. 1970) (“the giving of notice must be affirmatively pleaded in the complaint“)); Smith v. Apple, Inc., 2009 WL 3958096, at *2 (N.D. Ala. Nov. 4, 2009) (reasoning that “general awareness of defects” was insufficient to satisfy notice requirement where plaintiff failed to plead notice in complaint). Plaintiff has neither alleged nor shown that it provided Defendant with the required notice. (See Doc. # 35 at ¶ 30).
Plaintiff argues that the notice requirement for a breach of warranty claim was eliminated by the Supreme Court of Alabama in Simmons v. Clemco Indus., 368 So. 2d 509, 514 (Ala. 1979). This argument fails for two reasons. First, a reading of Simmons does not support that broad assertion. Simmons only eliminated the notice requirement for warranty “beneficiaries,” not “buyers.” Id.; see Hart, 787 F.2d at 1474 (recognizing that Simmons distinguishes buyers from beneficiaries in the notice statute); see, e.g., Hobbs v. Gen. Motors Corp., 134 F. Supp. 2d 1277, 1283 (M.D. Ala. 2001) (citing Simmons, 368 So. 2d at 509) (“There are Alabama cases which have abrogated the notice requirement
is due summary judgment on Plaintiff‘s claims for Breach of Implied Warranty and Breach of Express Warranty.14
The court separately addresses the question of causation related to Plaintiff‘s Breach of Implied and Breach of Express Warranty claims. Plаintiff argues that “the importance of the implied warranty claims cannot be overstated. ... [I]t does not require expert testimony to prove it.” (Doc. # 62 at 34). Plaintiff is correct that he does not have to present expert testimony to prove Defendant‘s breach of the warranty. See Tucker v. Gen. Motors Corp., 769 So. 2d 895, 899 (Ala. Civ. App. 1998). However, the same cannot be said in relationship to the causation of the medical damages he alleges. See
In the alternative to its state-law arguments, Defendant asserts preemption defenses to Plaintiff‘s claims. (Doc. # 50 at 19-33). The court will address these defenses with a full view of Eleventh Circuit case law as its guide. After careful review, and taking fully into account Eleventh Circuit precedent, the court concludes that Defendant is due summary judgment on all counts for an alternate reason: even if his state-law claims were viable, they are preempted by federal law.
1. The Court‘s Preemption Approach
Preemption finds its authority in the Supremacy Clause.
In the context of this cаse, the Eleventh Circuit case law presents an interesting fork in the road. Although it makes sense for a court of appeals to wade into the question of preemption only if a plaintiff‘s claims fail under state law, a district court, when called upon to rule on a motion to dismiss or a motion for summary judgment, finds itself in a different position.17 Where a defendant
raises an alternative ground for summary judgment (such as here, preemption), it would be a disservice to the parties (not to mention the court, as a matter of judicial economy) not to address all alternative grounds for its ruling. For example, if the district court did not address in the alternative a meritorious preemption argument and the court of appeals ultimately disagreed with its conclusion that the state-law claims were inviable, the case would have to be remanded for further briefing and a ruling on the preemption defense. If faced with a meritorious preemption argument on remand,
The court is aware of the admonition by the panel in Sharp that indicates that “it was inappropriate for the district court to reach preemption after finding that the state law claims were not viable.” Sharp, 2020 WL 7647511, at *1 n.2. But, the court is not bound by Sharp, an unpublished decision. And, with respect, Sharp does not take into account either the practicalities of district court practice (noted above) or the mandate of
Further, the Eleventh Circuit‘s decision in Sharp actually proves this point. Although the Eleventh Circuit reversed and remanded the case because the district court erred in determining that the plaintiff failed to state a claim under state law, the Eleventh Circuit also noted that the district court‘s preemption analysis was incorrect and provided guidance on this issue for remand. Sharp, 2020 WL 7647511, at *1 n.2. As it turns out, if the district court had remained silent on the alternative argument, it may have taken the same erroneous preemption approach on remand. And, that may have, in turn, necessitated a second appeal, a second reversal, and a second remand. With these pragmatic concerns in mind, this court proceeds (albeit with some trepidation) to analyze Defendant‘s preemption defense as an alternative ground for granting summary judgment.
2. The FDA Regulatory Scheme and Preemption
Congress passed the Medical Device Amendments (“MDA“) of 1976 to the Federal Food, Drug, and Cosmetic Act (“FDCA“) giving the FDA regulatory authority over medical devices. Riegel, 552 U.S. at 316 (citing
The approval process for medical devices is rigorous and requires the FDA to spend (on average) over 1,200 hours reviewing each application. Riegel, 552 U.S. at 317-18 (internal citations omitted). Unsurprisingly then, an application includes large amounts of data on the effectiveness and safety of the device under review, descriptions of facilities, manufacturing specifications, processes for device production, and proposed product labeling. Id.;
The court begins its analysis by examining the scope of preemption. As already discussed, a Class III device is subject to “rigorous” scrutiny before the FDA approves it for commercial use. Riegel, 552 U.S. at 312, 316. Congress, recognizing that a manufacturer cannot deviate from requirements in the PMA and MDA, enacted an express preemption provision that applies to Class III devices after their approval:
[N]o State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement—
(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and
(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.
However, this express preemption provision does not preempt state-law claims “premised on a violation of the FDA regulations; the state duties in such a case ‘parallel,’ rather than add to, federal requirements.” Id. at 312. Unsurprisingly, these state-law claims are called “parallel claims.” Mink, 860 F.3d at 1325-26 (internal citations omitted). When analyzing a claim for express preemption, the issue is whether a plaintiff‘s theories of liability and the facts supporting his or her cause of action, if enforced, would hold a defendant liable for violating requirements that are beyond the FDA‘s. See Purcel v. Advanced Bionics Corp., 2008 WL 3874713, at *3 (N.D. Tex. Aug. 13, 2008). Parallel claims may be based on any requirement, including device-specific requirements in the PMA and the generally-applicable GMPs. Mink, 860 F.3d at 1331.
There is also an implied preemption provision stating that “all such proceedings for the enforcement, or to restrain violations, of this chapter shall be by and in the name of the United States.”
These two preemption provisions, when considered together, leave only a narrow gap for a private litigant to bring a state-law claim related to medical devices. Indeed, the Eleventh Circuit has defined this “narrow gap“:
To make it through, a plaintiff has to sue for conduct that violates a federal requirement (avoiding express preemption), but cannot sue only because the conduct violated that federal requirement (avoiding implied preemption). Putting these ideas into practice, ... a plaintiff may proceed on her claim so long as she claims the ‘breach of a well-recognized duty owed to her under state law’ and so ‘long as she can show that she was harmed by a violation of applicable federal law.’
Mink, 860 F.3d at 1327 (emphasis added) (internal citations omitted) (quoting Bausch v. Stryker Corp., 630 F.3d 546, 558 (7th Cir. 2010)).
Not only must the claim be premised on a duty equivalent to one required by the FDA and cognizable under state law, but the claim must also be connected to the alleged injury. Kubicki on behalf of Kubicki v. Medtronic, Inc., 293 F. Supp. 3d 129, 172 (D.D.C. 2018); see id. at 1331 (citing Wolicki-Gables v. Arrow Int‘l, Inc., 634 F.3d 1296, 1301-02 (11th Cir. 2011)).
Once a defendant invokes preemption under the MDA, the burden falls on the plaintiff to show that his claims are not preempted. Kubicki, 293 F. Supp. 3d at 172. This is, by necessity, a high burden. The plaintiff must “set forth [evidence] pointing to specific PMA requirements that have been violated” and that those violations caused the plaintiff‘s injury. Wolicki-Gables, 634 F.3d at 1301 (emphasis added) (internal citations omitted); Godelia, 881 F.3d at 1319-20. In other words, if a plaintiff simply claims that a defendant violated a federal regulation without identifying (1) the specific facts showing how a defendant violated either a PMA specification or a specific GMP and (2) the specific facts showing that the violation caused the injury at issue, then that plaintiff fails to adequately assert a parallel claim. Wolicki-Gables, 634 F.3d at 1301 (internal citations omitted).
Here, the court concludes that regardless of whether Plaintiff has met his burden to establish that his claims are premised on binding federal requirements (and, to be clear, the court doubts that he has), all his claims are preempted because there is insufficient
3. Parallel Claims and Additional Requirements
There is a two-step inquiry for determining whether a claim is parallel or expressly preempted:
First, a court must determine whether the Federal Government has established requirements applicable to the device. If so, [second] the court must then determine whether the plaintiff‘s common-law claims are based upon state law requirements with respect to the device that are different from, or in addition to the federal ones, and that relate to the safety and effectiveness.18
Mink, 860 F.3d at 1326. The second step is that which is central to Defendant‘s summary judgment motion. Analyzing whether Plaintiff‘s claims are expressly preempted under
There are two types of requirements applicable to all medical devices. Rosen v. St. Jude Med., Inc., 41 F. Supp. 3d 170, 178 (N.D.N.Y. 2014). First, “[PMA] ... imposes ‘requirements’ under the MDA” that are “specific to individual devices.” Wolicki-Gables, 634 F.3d at 1301 (quoting Riegel, 552 U.S. at 323). Second, as already discussed, there are GMPs that manufacturers are requirеd to comply with, and they must not deviate from them.
Although preemption does not uniformly prohibit a plaintiff from relying on general requirements, establishing a parallel claim in that context is still a high bar. To assert a parallel claim, a plaintiff must “set forth” evidence of “specific violations” of “specific regulations.” Godelia, 881 F.3d at 1319-20 (distinguishing the holding in Wolicki from case where plaintiff connected “the violation of the specific federal regulations” to his claim) (emphasis added) (internal citations omitted); see Wolicki-Gables, 634 F.3d at 1301; Mink, 860 F.3d at 1331. Importantly, not only must a plaintiff show that a federal requirement has been violated but he must also “causally connect the simultaneous violations of federal and state law ... to the alleged injury.”19 Kubicki, 293 F. Supp. 3d at 172; see Mink, 860 F.3d at 1331 (citing Wolicki-Gables, 634 F.3d at 1301-02); Barnes v. Howmedica Osteonics Corp., 2010 WL 11565343, at *11 (N.D. Ala. Dec. 14, 2010) (granting summary judgment for defendant because plaintiff could not “demonstrate that the injury ... [he] sustained resulted from the federal violations“). And, once a defendant raises a preemption defense, the burden is on the plaintiff to show that his or her claims are parallel. Kubicki, 293 F. Supp. 3d at 172. Whether a claim is preempted is a “question of law, which may be decided on summary judgment.” Barnes, 2010 WL 11565343, at *2 (internal citations omitted).
Thus, a plaintiff who simply claims that a defendant violated a federal regulation, without identifying the specific facts showing (1) how the defendant violated either a PMA specification or a specific GMP and (2) that the violation caused an injury, fails to adequately assert a parallel claim. Godelia, 881 F.3d at 1319-20; Wolicki-Gables, 634 F.3d at 1301 (internal citations omitted). A plaintiff must show that the claim is “genuinely equivalent.” Wolicki-Gables, 634 F.3d at 1300 (emphasis in original) (quoting McMullen v. Medtronic, Inc., 421 F.3d 482, 489 (7th Cir. 2005)). A claim is genuinely equivalent only if the defendant “could [not] be held liable under the state law without having violated federal law.” Id. In other words, a plaintiff “cannot simply incant the magic words [that Defendant] violated FDA regulations in order to avoid preemption.” Id. This is important, because without specifically establishing a “federal-requirement baseline,” there is a high risk that a claim untethered to the established baseline would operate to “demand[] ... more of the manufacturer than the federal law requires.” Kubicki, 293 F. Supp. 3d at 180.
4. Plaintiff‘s Claims are Preempted
Defendant argues that Plaintiff‘s state-law claims are preempted by federal law. Defendant is correct for two reasons.
First, despite Plaintiff characterizing his claims as premised on “[Defendant‘s violation] of the relevant federal requirements,” there is nothing in the
a. Negligence, Wantonness, and AEMLD
Plaintiff asserts a Negligence and Wantonness claim for failure to exercise due care by not complying with several federal requirements.21 (See Doc. # 62 at 20-21, 23). Under Alabama law, a violation of a federal requirement supports a negligence per se claim. Allen v. Delchamps, Inc., 624 So. 2d 1065, 1067 (Ala. 1993) (holding that plaintiff had adequately stated a parallel negligence claim based on sale of food with substance in violation of FDA requirement). Such a claim is not impliedly preempted because it does not seek to privately enforce a duty owed to the FDA. And, a negligence claim premised on manufacturing defects is not expressly preempted if the defects are a result of violations of federal requirements. Godelia, 881 F.3d at 1319.
Plaintiff also asserts a claim under the AEMLD. To establish an AEMLD violation, a plaintiff must show:
(1) he suffered injury or damage[] to himself or his property by one who sells a product in a defective condition unreasonably dangerous to the plaintiff as the ultimate user or consumer, if
(a) the seller is engaged in the business of selling such a product, and
(b) it is expected to and does reach the user or consumer without substantial change in the condition in which it is sold.
Casrell v. Altec Indus., Inc., 335 So. 2d 128, 132 (Ala. 1976); see Heard v. FCA US, LLC, 2020 WL 1285743, at *2 (N.D. Ala. Mar. 16, 2020) (internal citations omitted). Importantly, while this is not a “no fault regime,” a manufacturer is deemed to be have “conducted himself unreasonably in placing a product on the market which will cause harm.” Atkins v. Am. Motors Corp., 335 So. 2d 134, 139-140 (Ala. 1976). A plaintiff has established a prima facie AEMLD claim if there is evidence from which a fact finder could infer that plaintiff‘s injuries were caused by a defective product. Rudd v. Gen. Motors Corp., 127 F. Supp. 2d 1330, 1345 (M.D. Ala. 2001) (Internal citations omitted). A product may be defective because of a manufacturing defect, which occurs when a product deviates from its intended design.22 McDaniel v. Mylan, Inc., 2019 WL 11638407, at *6 (N.D. Ala. Dec. 16, 2019); Schwartz v. Volvo N. Am. Corp., 554 So. 2d 927, 941 n.5 (Ala. 1989).
b. FDA Guidance Documents
Plaintiff argues that Defendant violated a federal requirement because Defendant
c. Endotoxin Testing Methods23
Plaintiff alleges that Defendant violated federal requirements because of what he argues are deficient endotoxin testing methods. (Doc. # 62 at 14-15). Specifically, he alleges Defendant breached its duty to exercise due care by conducting endotoxin testing in a manner noted as deficient in the FDA‘s 483 Report and by violating the “FDA‘s GMP Guidance on Endotoxin Testing,” which “could lead to false negative test results.” (Doc. # 62 at 22).
The 483 Report makes clear that Defendant‘s endotoxin testing methods “do not include the establishment of scientifically sound and appropriate specifications and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity.” (Doc. # 62 at 13-14). Specifically, the FDA flagged Defendant‘s testing of “pooled sample[s] (three units),” which may dilute samples to the point that the endotoxin test “results might be invalid for the final release and stability studies.” (Docs. # 62 at 16; 62-3 at 29-30). Plaintiff asserts that Defendant was required to test each syringe individually. (Doc. # 62 at 15). Assini agreed that Defendant‘s practices were a result of a “misinterpretation of the guidance” and that a GMP requires “scientifically sound and appropriate specifications.” (Id. at 18) (emphasis omitted). However, nothing in the
The 483 Report and the guidance documents are of no moment, at least in the context of this case. There is only one deficiency purportedly linked to a GMP in the 483 Report: “laboratory controls do not include ... scientifically sound and appropriate specifications and test procedures.” (Doc. # 62 at 13-14) (citing Doc. # 62-3 at 79). This purported deficiency relates tо the requirement codified in
Plaintiff also contends (without support) that because Defendant “was incorrectly pooling the syringe ... instead of testing individual syringes ... [it] violated [the] FDA‘s GMP Guidance for Endotoxin Testing” (i.e., the GMP itself). (Doc. # 62 at 15) (emphasis added). However, as just noted, deviation from a guidance document by itself is not a violation of a GMP, and Plaintiff has not connected any such purported deviation to any specific binding requirement.
d. Additional Product Testing
Plaintiff also contends that Defendant‘s lack of additional testing was a violation of federal requirements. (Doc. # 62 at 20). But, Plaintiff‘s position does not find support in the
But, other than Plaintiff‘s conclusory assertion that Defendant was compelled to perform this testing, nothing in the
Plaintiff argues that Defendant was not prohibited from conducting additional
e. Adulteration and Contamination
In supporting his AEMLD and negligence claims, Plaintiff argues that the product was sold in a defective condition that was unreasonably dangerous because it was sold with Methylobacterium thiocyanatum and not according to PMA specifications, “rendering it unfit for human consumption.”26 (Doc. # 62 at 30). And, consequently Plaintiff argues, Defendant released the Lot in an “adulterated” condition, in violation of
The term “adulteration” is defined by statute.
Having said all that, the court readily acknowledges that whether Defendant released the Lot with a level of Methylobacterium thiocyanatum that was “out of the specification for its PMA” is at least a disputed fact. (Docs. # 62 at 13, 30, 32; 50-2 at 38-39). In Wolicki-Gables, the Eleventh Circuit said that “to properly allege parallel claims,” a plaintiff must “set forth facts pointing to specific PMA requirements that have been violated.” Wolicki-Gables, 634 F.3d at 1301; Godelia, 881 F.3d at 1319-20. As recently as three months ago, the Eleventh Circuit stated that a mаnufacturing defect claim premised on deviations from “consistent insulation diameters” in the PMA specification presents a sufficient parallel claim. Sharp, 2020 WL 7647511, at *2. As a condition of premarket approval of Defendant‘s device, it cannot “make, without FDA permission, changes in design specifications.” Riegel, 552 U.S. at 319. Thus, establishing the elements of his AEMLD claim that the Lot was “in a defective condition unreasonably dangerous,” or that Defendant was negligent per se, based on Defendant‘s failure to comply with the design specifications approved in the PMA, of which ”Methylobacterium is not a part of,” is not an additional requirement but a “duty ... parallel to the federal requirement.” (Doc. # 62-13 at 39). Mink, 860 F.3d at 1330. Nonetheless, this point is more academic than consequential here because Plaintiff‘s claims fail under both state law and preemption principles due to a lack of medical causation.
f. Breach of Implied Warranty
In Alabama, there is an implied warranty attached to a sale of goods promising that “the goods shall be fit for their ordinary purposes for which such goods are used.” Grubbs v. Medtronic, Inc., 2019 WL 3288263, at *4 (N.D. Ala. July 22, 2019). A breach of implied warranty claim requires that a plaintiff show “the existence of the implied warranty, a breach of that warranty; and damages proximately resulting from that breach.” Wilson v. Kidde Prod. Ltd, 2012 WL 3542210, at *8 (N.D. Ala. Aug. 14, 2012). Plaintiff brings a breach of implied warranty claim alleging that his Synvisc-One injection was “not fit for its intended purpose or use” making it “unmerchantable” for several reasons, including Defendant‘s testing deficiencies and because the injection was contaminatеd with Methylobacterium thiocyanatum. (Docs. # 35 at 5; 62 at 32-34).
There mere fact of contamination does not allow this claim to survive summary judgment. In Grubbs, the plaintiff brought a claim for breach of an implied warranty asserting the condition of the product, which was alleged to have been manufactured in violation of a federal requirement, rendered it unfit for its intended purpose. Id. The court held that this claim was not preempted because the claim was supported by Defendant‘s violation of a federal requirement. Id. Similarly here, Plaintiff alleges that the product was contaminated in violation of its PMA specification. However (and again), there is simply no
g. Breach of Express Warranty
Under Alabama law, an express warranty exists where the seller of a good makes “[a]ny affirmation of fact or promise made ... which relates to the goods and becomes part of the basis of the bargain ....” Grubbs, 2019 WL 3288263, at *4. Plaintiff argues that, although Defendant warranted that the Synvisc-One injection would “provide long-term relief” for arthritis, he suffered “adverse reactions.” (Doc. # 35). There is nothing in the
IV. Conclusion
For all the foregoing reasons, the court concludes that Defendant‘s Motion for Summary Judgment (Doc. # 49) is due to be granted. An Order consistent with this Memorandum Opinion will be entered.
DONE and ORDERED this March 9, 2021.
R. DAVID PROCTOR
UNITED STATES DISTRICT JUDGE