Opinion
23-CV-1622 (AT) (OTW)
02-01-2024
DAVID N. SHEINFELD, Plaintiff, v. B. BRAUN MEDICAL INC., et al., Defendants.
REPORT & RECOMMENDATION TO THE HONORABLE ANALISA TORRES
ONA T. WANG, UNITED STATES MAGISTRATE JUDGE.
I. INTRODUCTION
Plaintiff David N. Sheinfeld (“Plaintiff”) brings this action pro se against B. Braun Medical Inc. (“Braun Medical”) and Aesculap Inc. (“Aesculap”) for failure to warn, design defects, and manufacturing defects in connection with an artificial disc replacement medical device for patients with degenerative disc disease. (ECF 1). Defendants moved to dismiss for failure to state a claim under Fed.R.Civ.P. 12(b)(6) and 12(b)(2). (ECF 9). Defendants' motion has been referred to me for a Report & Recommendation. (ECF 14). For the following reasons, I respectfully recommend that Defendants' motion to dismiss be GRANTED.
II. BACKGROUND
On November 25, 2019, Plaintiff underwent spinal disc replacement surgery using the activL Artificial Disc Class III medical device (“activL Device”). (ECF 1 at ¶3). The surgery was deemed a success and Plaintiff was released after one night of observation. Id. On January 28, 2020, Plaintiff attended a follow-up appointment, and the device was observed to be stable and safe. Id. at ¶ 4.
On February 25, 2020, Plaintiff attended another follow-up appointment. Id. at ¶ 5. His surgeon, Dr. Sravisht Iyer, determined that the activL Device had migrated approximately one millimeter from the prior visit. Id. Finding that there was a risk of catastrophic injury, Dr. Iyer performed corrective surgery on February 28, 2020, to fuse the activL Device in place. Id. at ¶¶ 5-6. The corrective surgery was successful. Id. at ¶ 6.
On April 14, 2020, Plaintiff underwent further corrective surgery because of a failure of fusion hardware separate from the activL Device. Id. at ¶ 7.The surgeon who performed the surgery, Dr. Ronald Childs, told Plaintiff at a follow-up examination that the original migration of the activL Device was due to a failure of the device, and not related to the actions of his previous surgeons. Id.
Plaintiff concedes that this fusion hardware failure was not the fault of either Defendant. (ECF 1 at ¶ 7).
Plaintiff filed his Complaint pro se on February 24, 2023, alleging that the failure of the activL Device to stay in place after the first surgery was due to negligence in its design or in its manufacture; or, in the alternative, that Defendants failed to adequately warn consumers about the risk of implant migration. (ECF 1). Defendants filed their motion to dismiss on April 13, 2023. (ECF 9). On January 3, 2024, the motion was fully briefed. (ECF 31).
On December 21, 2023, the Court directed Plaintiff to file his surreply, if any, to Defendants' reply in support of their motion to dismiss by January 12, 2024. (ECF 30). Plaintiff filed his surreply on January 3, 2024. (ECF 31).
III. ANALYSIS
A. Standard of Review
Under Fed.R.Civ.P. 12(b)(6), dismissal must be granted where the complaint fails to contain “enough facts to state a claim to relief that is plausible on its face.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007). The Court is limited to the complaint's factual allegations, documents attached to the complaint, matters of judicial notice, and documents which the plaintiff relied on in filing the complaint. Brass v. Am. Film Techs., Inc., 987 F.2d 142, 150 (2d Cir. 1993).
Where, as here, the plaintiff is proceeding pro se, the complaint is to be “liberally construed.” Erickson v. Pardus, 551 U.S. 89, 94 (2007). This includes drawing all reasonable inferences in the plaintiff's favor and reading the allegations to “raise the strongest claims that the allegations suggest.” Grimes v. Fremont Gen. Corp., 785 F.Supp.2d 269, 282 (S.D.N.Y. 2011). In the pro se context, the Court may also consider materials outside of the complaint, “in particular, materials that a pro se plaintiff attaches to his opposition papers.” Ceara v. Deacon, 68 F.Supp.3d 402, 410 (S.D.N.Y. 2014) (citations omitted). Although the Court accepts the plaintiff's factual allegations as true when deciding a motion to dismiss, the Court does not need to accept “labels and conclusions” or “assertion[s]' devoid of ‘further factual enhancement.' ” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009).
Defendants argue that Plaintiff's Complaint should be dismissed on three grounds: (1) Plaintiff's state tort claims are preempted by the Medical Device Amendments of 1976, 21 U.S.C. § 360k(a); (2) Plaintiff fails to state a claim under New York law; and (3) Plaintiff has failed to establish personal jurisdiction as to Defendant Braun Medical.
B. Federal Preemption
Under the Supremacy Clause of the Constitution, U.S. Const. art. VI, cl. 2, federal law may “preempt,” or “set aside,” state law in certain circumstances. Barnett Bank of Marion Cnty., N.A. v. Nelson, 517 U.S. 25, 30 (1996). Here, the relevant form of preemption is “express preemption, where Congress has expressly preempted local law[.]” Buono v. Tyco Fire Products, LP, 78 F.4th 490, 495 (2d Cir. 2023) (internal quotation marks omitted).
In 1976, Congress amended the Federal Food, Drug, and Cosmetic Act (“FDCA”). These “Medical Device Amendments” (“MDA”) provide that:
Except as provided in subsection (b), no 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.
21 U.S.C. § 360k(a). The Supreme Court has held that the MDA expressly preempt state requirements that (1) relate to the safety and effectiveness of a medical device; and (2) impose standards “different from, or in addition to” federal requirements. Riegel v. Medtronic, Inc., 552 U.S. 312, 323-30 (2008). “State ‘requirement[s]' subject to preemption include common-law causes of action for negligence and strict liability.” A.F. by & Through Fogel v. Sorin Grp. USA, Inc., 346 F.Supp.3d 534, 540 (S.D.N.Y. 2018) (citing Riegel, 552 U.S. at 323-34).
Every Class III medical device undergoes a “rigorous regime” of premarket approval (“PMA”) to ensure the device's “safety and effectiveness.” Riegel, 552 U.S. at 317-18. “The [PMA] process includes review of the device's proposed labeling,” including a determination “that the proposed labeling is neither false nor misleading.” Id. (citing 21 U.S.C. § 360e(d)(1)(A)). In Riegel, the Supreme Court held that PMA approval for a Class III device constitutes a “requirement” applicable to that device. Id. at 321-23. Accordingly, “[s]tate common-law tort claims are expressly preempted . . . to the extent that they [ ] relate to the safety and effectiveness of a PMA-approved device[.]” Simon v. Smith & Nephew, Inc., 990 F.Supp.2d 395, 402 (S.D.N.Y. 2013) (citing Riegel, 552 U.S. at 323-30).
However, the FDCA “does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations; the state duties in such a case ‘parallel,' rather than add to, federal requirements.” Riegel, 552 U.S. at 330 (quoting Medtronic, Inc. v. Lohr, 518 U.S. 470, 495 (1996)). This exception applies “only in a narrow set of circumstances: where the defendant allegedly violated FDA regulations, but the violation is not itself the basis of the claim.” Simon, 990 F.Supp.2d at 402 (citation omitted). “[T]o state a parallel claim plaintiff must ‘set forth facts pointing to specific [premarket approval] requirements that have been violated,' and link those violations to his injuries.” Gale v. Smith & Nephew, Inc., 989 F.Supp.2d 243, 249 (S.D.N.Y. 2013) (quoting Wolicki-Gables v. Arrow Int'l, Inc., 634 F.3d 1296, 1301 (11th Cir. 2011)).
The activL Device went through the PMA process for FDA approval. See ECF 9-2. Thus, the device is subject to federal requirements. Here, because Plaintiff's claims arise out of the alleged failure of the activL Device, they relate to the safety and effectiveness of a medical device. Accordingly, they meet the first part of the Supreme Court's two-part requirement for MDA preemption. See Riegel, 552 U.S. at 323-30.
The next inquiry, then, is whether his claims meet the second requirement of the Supreme Court's preemption test by seeking to impose standards “different from, or in addition to” federal requirements imposed. In order for Plaintiff's claims to avoid preemption and survive a motion to dismiss, he must plead that his state law claims both parallel federal requirements, and arise out of specific federal violations.
1. Plaintiff's manufacturing defect and design defect claims
As a threshold matter, Plaintiff did not respond to Defendants' arguments that his manufacturing defect and design defect claims should be dismissed. When a plaintiff has failed to respond to a defendant's argument that a claim should be dismissed, a court may find that the plaintiff has abandoned that claim. See Pincover v. J.P. Morgan Chase Bank, N.A., 592 F.Supp.3d 212, 227 (S.D.N.Y. 2022); Zoulas v. New York City Dep't of Educ., 400 F.Supp.3d 25, 47 (S.D.N.Y. 2019).
Even if Plaintiff has not abandoned these claims, however, the Complaint does not identify a specific federal manufacturing or design requirement that the activL Device failed to meet. To establish a prima facie case that a product was defectively designed, a plaintiff must plead sufficient facts to show that: “(1) the product as designed posed a substantial likelihood of harm; (2) it was feasible to design the product in a safer manner; and (3) the defective design was a substantial factor is causing the plaintiff's injury.” Colon ex rel. Molina v. BIC USA, Inc., 199 F.Supp.2d 53, 83 (S.D.N.Y. 2001). “To successfully plead a manufacturing defect claim, the complaint must allege both ‘that a specific product unit was defective as a result of some mishap in the manufacturing process itself, improper workmanship, or because defective materials were used in construction,' and ‘that the defect was the cause of plaintiff's injury.' ” Tears v. Bos. Sci. Corp., 344 F.Supp.3d 500, 510 (S.D.N.Y. 2018) (quoting Colon ex rel. Molina, 199 F.Supp.2d at 85).
Plaintiff asserts only that the activL Device performed “below any reasonable expectation” because “[i]f an FDA approved device is used as instructed and as intended, one has the right to assume that the device will perform as designed and not lead to potentially catastrophic injury.” Compl. at ¶ 8. Plaintiff argues that there are only two possibilities for why the activL Device did not attach properly after the first surgery. The first possibility is that the device was negligently designed. The second possibility is that it was negligently manufactured because it “may have shown the ability to successfully integrate into the bone in other cases but did not in this instance.” Id. at ¶ 9.
Plaintiff's circular arguments that the activL Device was negligently designed or negligently manufactured are not specific enough to avoid preemption and dismissal of these claims. See Simon v. Smith & Nephew, Inc., 990 F.Supp.2d 395, 403 (S.D.N.Y. 2013) (“To avoid preemption and satisfy the Twombly and Iqbal pleading standards, plaintiffs suing with regard to a PMA-approved device cannot simply make the conclusory allegation that defendant's conduct violated FDA regulations.”). Plaintiff's theory amounts to a res ipsa loquitor argument that, because the activL Device migrated after surgery, there must have been negligence in its manufacture or design. But Plaintiff does not plead that the activL Device, which was approved by the FDA through the PMA process, violates any specific federal requirement that could be the basis for a parallel state claim. Accordingly, Plaintiff's manufacturing defect and design defect claims should be DISMISSED on both preemption grounds, and failure to state a claim.
2. Plaintiff's failure to warn claim
Next, I will address Plaintiff's failure to warn claim. To prevail on a failure to warn claim, a plaintiff must establish “(1) a manufacturer has a duty to warn (2) against dangers resulting from foreseeable uses about which it knew or should have known, and (3) that failure to do so was the proximate cause of the harm.” State Farm Fire & Cas. Co. v. Nutone, Inc., 426 F. App'x. 8, 10 (2d Cir. 2011). A plaintiff's complaint must specify how the warning provided was inadequate. Reed v. Pfizer, Inc., 839 F.Supp.2d 571, 575 (E.D.N.Y. 2012); Oden v. Boston Scientific Corp., 330 F.Supp.3d 877, 891 (E.D.N.Y. 2018).
Plaintiff alleges that there was “a clear failure to properly warn the consumer by means of an overly broad and nonspecific warning in the Potential Risks and Adverse Effects in the Aesculap Patient Brochure [for the activL Device].” (ECF 1 at ¶ 8). Specifically, Plaintiff points to the statement that “movement of the implant out of place” is possible is a “generic catchall” that does not provide enough information for patients and doctors to make an informed decision about surgery. Id. at ¶ 9. Plaintiff alleges that his surgeons “may have been able to screen [him] more effectively as a candidate for this surgery” if they had had more information. Id.
Of the three parts that make up the activL Device, the Complaint states that one part required three revision surgeries in 2020, while the other two parts “have shown a pattern of adverse event reports over multiple years.” (ECF 1 at ¶ 11). In his Complaint, Plaintiff does not provide any additional detail on this alleged “pattern of adverse event reports,” nor is there any indication of whether the need for three revision surgeries imposed an additional federal requirement to change the warning provided with the activL Device.
Plaintiff responds to Defendants' motion to dismiss by providing more detail on how the warnings accompanying the activL Device were inadequate under federal law: “If the [instructions for use] had contained an adequate warning that migration of <3 mm may not require immediate surgical intervention, but rather further monitoring, the subsequent surgeries [following his first disc replacement surgery] might have been avoided.” (ECF 16 at 11). Plaintiff points to the Summary of the Safety and Effectiveness Data (“SSED”) which he argues distinguishes “between a device that migrates <3mm and a device that migrates >3mm.” See ECF 16 at 10, Ex. 6.This raises an inference, Plaintiff argues, “that a device that migrates <3mm is less significant, and a successful device integration with the spine can still possibly be achieved.” (ECF 16 at 10). Without this information, Plaintiff's surgeon determined out of caution that a revision surgery was necessary. Id. In his response to Defendants' reply, Plaintiff includes more SSED data that ostensibly shows that there were several instances of implant migration that did not require surgical intervention during the activL Device trial period. (ECF 31 at 7-8).
“The Summary of Safety and Effectiveness Data (SSED) is a document mandated by the Food, Drug and Cosmetic Act subparagraph 520(h)(1)(A) to be publicly available upon issuance of an approval order of a premarket approval application (PMA)[.]” Available at https://www.fda.gov/media/113810/download#:~:text=The%20SSED%20is%20an%20FDA,approve%20or%20deny %20the%20PMA. The Court takes judicial notice of the SSED because it is from an official government source. See Fed. R. Evid. 201(b)(2).
Plaintiff's failure to warn claim should be dismissed for two reasons. First, as Plaintiff admits in his Complaint, the activL Device Potential Risks and Averse Effects statement expressly warned that migration of the device after surgery was possible. Although Plaintiff cites to FDA regulations and guidance on labeling for medical devices, he fails to explain why not distinguishing between >3 mm and <3 mm of movement constitutes a violation of those regulations. None of the passages Plaintiff cites in his surreply support his assertion that the activL Device instructions for use were required to contain “‘examples' regarding the level of acceptable migration.” See ECF 16. Nor is his “inference” that a migration of <3 mm is “less significant” than >3 mm anything more than speculation. The additional SSED data Plaintiff includes in his response to Defendants' reply is similarly unhelpful because it does not address whether this data had to be included in the activL Device warning materials. All this data shows is that there were some instances of implant migration during the trial period that did not require surgical intervention, not that Defendants failed to warn about actual known dangers.
This leads to the second reason Plaintiff's claim should be dismissed. Even if Plaintiff could point to a federal regulation requiring warnings about migration to be more specific than what was provided with the activL Device, he cannot show that the lack of a more specific warning caused his injury. Plaintiff's assertions that his surgeon “might” not have decided that surgery was necessary had the labeling contained more information is pure conjecture. While it is true that, as Plaintiff admits, “[t]here are no guarantees in the medical world” (ECF 31 at 6), and that he need not prove his allegations with certainty at the pleading stage, a failure to warn claim must plead enough facts for the Court to draw an inference that the inadequate warning was the proximate cause of Plaintiff's injuries. Nowhere in Plaintiff's filings does he plead any facts that lead to a reasonable inference that his doctor would not have performed the fusion surgery had the activL Device warnings been more detailed. The closest Plaintiff comes is asserting that “[a]voidance of surgical intervention . . . was achievable had this warning and guidance been provided to Dr. Iyer.” (ECF 31 at 8). Accordingly, Plaintiff does not plead sufficient facts to show that the device's warning was the proximate cause of his injuries. Plaintiff's failure to warn claim should be DISMISSED.
Because Plaintiff's Complaint should be dismissed on Rule 12(b)(6) grounds, it is unnecessary to reach Defendants' Rule 12(b)(2) argument that this Court cannot exercise personal jurisdiction over Defendant Braun Medical. However, the facts in Plaintiff's Complaint and his opposition papers suggest that Braun Medical may be subject to personal jurisdiction as the parent company of Aesculap. See ECF 1 at ¶¶2-3 (identifying Aesculap as a “subsidiary” of Braun Medical). In addition, in his response to Defendants' motion to dismiss, Plaintiff asserts that when he contacted Aesculap in advance of filing this lawsuit he was contacted directly by Braun Medical's legal team. (ECF 16 at 14, Ex. 7). Although “a parent company is not automatically liable for the acts of its wholly-owned subsidiary,” Manchester Equip. Co., Inc. v. Am. Way, 60 F.Supp.2d 3, 6 (E.D.N.Y. 1999), a parent-subsidiary relationship may, in some cases, allow for the exercise of personal jurisdiction by association when the parent exercises significant control over the subsidiary. SPV Osus Ltd. V. UniCredit Bank Austria, No. 18-CV-3497 (AJN), 2019 WL 1438163, at *8 (S.D.N.Y. Mar. 30, 2019). As at least one district court in the Second Circuit has found, “[G]eneral counsel for one corporation acting as an attorney for an affiliate shows a significant level of control over the day-to-day operations of the affiliate.” Knapp v. Consolidated Rail Corp., No. 89-CV-1034S, 1992 WL 170891, at *5 (W.D.N.Y. Jul. 7, 1992).
IV. CONCLUSION
For the foregoing reasons, I respectfully recommend that Defendants' motion to dismiss be GRANTED in its entirety.
Because Plaintiff is proceeding pro se, I also recommend that he be given an opportunity to request to file a proposed amended complaint pleading a manufacturing defect claim within 30 days of Your Honor's final disposition of this motion.To the greatest extent possible, Plaintiff's amended complaint must allege facts to support both that:
I find that amendment would be futile as to Plaintiff's design defect and failure to warn claims. Amendment would be futile as to Plaintiff's design defect claim because, as discussed above, the activL Device went through the PMA process for FDA approval. Accordingly, any design defect claim would seek to impose a state requirement that is “different from, or in addition to” the FDA's federal requirements. Amendment would also be futile as to Plaintiff's failure to warn claim because the activL Device brochure states that “movement of the implant out of place” is possible. (ECF 1 at ¶10). The Court is not aware of any authority, and Plaintiff has not provided any authority, for the proposition that an adequate warning on a medical device must provide strict parameters for when surgical intervention is or is not necessary. As Plaintiff admits in his response to Defendants' motion to dismiss, “[T]here is some discretion left to the doctors as to when intervention is appropriate[.]” (ECF 16 at 9). In addition, Plaintiff is unable to plead with requisite certainty that the fusion surgery was unnecessary, or that a more specific warning would have led his doctor to draw the conclusion that the surgery was unnecessary.
a) the specific activL Device implanted in his spine was defective as a result of some mishap in the manufacturing process itself, improper workmanship, or because defective materials were used in construction; and
b) the defect was the cause of his injury.
The Clerk of Court is respectfully requested to mail a copy of this Order to the pro se Plaintiff at the address listed on the docket.
V. OBJECTIONS
In accordance with 28 U.S.C. §636(b)(1) and Fed.R.Civ.P. 72(b), the parties shall have fourteen (14) days (including weekends and holidays) from receipt of this Report to file written objections. See also FED. R. CIV. P. 6. A party may respond to any objections within fourteen (14) days after being served. Such objections, and any responses to objections, shall be addressed to the Honorable Analisa Torres, United States District Judge. Any requests for an extension of time for filing objections must be directed to Judge Torres.
FAILURE TO FILE OBJECTIONS WITHIN FOURTEEN (14) DAYS WILL RESULT IN A WAIVER OF OBJECTIONS AND WILL PRECLUDE APPELLATE REVIEW. See Thomas v. Arn, 474 U.S. 140, 155 (1985); IUE AFL-CIO Pension Fund v. Herrmann, 9 F.3d 1049, 1054 (2d Cir. 1993); Frank v. Johnson, 968 F.2d 298, 300 (2d Cir. 1992); Wesolek v. Canadair Ltd., 838 F.2d 55, 58 (2d Cir. 1988); McCarthy v. Manson, 714 F.2d 234, 237-38 (2d Cir. 1983).