Greene v. Nevro Corporation

CourtDistrict Court, M.D. Louisiana
DecidedJanuary 31, 2025
Docket3:23-cv-01648
StatusUnknown

This text of Greene v. Nevro Corporation (Greene v. Nevro Corporation) is published on Counsel Stack Legal Research, covering District Court, M.D. Louisiana primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Greene v. Nevro Corporation, (M.D. La. 2025).

Opinion

UNITED STATES DISTRICT COURT

MIDDLE DISTRICT OF LOUISIANA

ASHLEY PAGE GREENE CIVIL ACTION VERSUS NO. 23-CV-1648-JWD-RLB NEVRO CORPORATION, ET AL.

RULING ON NEVRO CORPORATION’S MOTION TO DISMISS PLAINTIFF’S FIRST AMENDED COMPLAINT

Before the Court is Nevro Corporation’s Motion to Dismiss Plaintiff’s First Amended Complaint (Doc. 10) (“Motion”) brought by defendant Nevro Corporation (“Nevro” or “Defendant”). It is opposed by plaintiff Ashley Page Greene (“Greene” or “Plaintiff”). (Doc. 23.) Nevro filed a reply memorandum. (Doc. 25.) Oral argument is not necessary. The Court has carefully considered the law, facts in the record, and arguments and submissions of the parties and is prepared to rule. For the following reasons, the Motion is granted, and Greene is given twenty- eight (28) days within which to amend her complaint. I. ALLEGATIONS IN THE COMPLAINT This is a medical product liability case combined with a medical malpractice case. In her Complaint,1 Greene alleges that on or about December 7, 2022, neurosurgeon and defendant Charles Bowie, M.D. (“Bowie”) surgically implanted into Greene’s spine a spinal cord stimulator (“stimulator”) designed and manufactured by Nevro. (Doc. 1 at 2, ¶ 4.) She alleges that following the surgery, she suffered extreme pain and increasing difficulty maintaining balance (id. ¶ 5) but, despite the surgical removal of the device (id. at 3, ¶ 8), she eventually “suffered severe, permanent

1 Plaintiff’s First Amended Complaint (Doc. 7) merely corrects the name of the defendant neurosurgeon and incorporates by reference all other allegations of the original Complaint (Doc. 1.) Therefore, all references are to the original Complaint. nerve damage (neuropathy), cannot walk on her own or drive, ride in a car for more than an hour, has lost feeling in her legs and feet, lost her job, and is unable to live on her own” (id.). Greene alleges the medical negligence of Bowie caused the injuries and damages complained of. (Id. at 3–4, ¶¶ 11–12.)2 With respect to Nevro, Greene alleges: 14. In addition [, or in] the alternative, Plaintiff alleges that the spinal cord stimulator manufactured by Defendant Nevro Corporation was unreasonably dangerous and defective as defined by the Louisiana Products Liability Act [La. Rev. Stat. Ann. § 9:2800.51 et seq. (“LPLA”)] in its design and/or manufacture and/or for its failure to provide adequate warnings and instructions to users in its use and implantation all of which proximately caused Plaintiff’s injuries and damages, as aforesaid.

15. Further, after receiving notice of the untoward symptoms and findings post- operatively, Nevro, through its representative(s) for whom it is vicariously liable, failed to take any action to ensure that its spinal cord stimulator was not defective and the cause of Plaintiff’s injuries, including, but not limited to contact, with Dr. Bowie and/or Neuromedical Center staff to diagnose the cause of her progressive symptoms.

(Id. at 4, ¶¶ 14–15.)

II. ARGUMENTS OF THE PARTIES

A. Nevro Nevro argues that because the stimulator is a Class III medical device approved by the FDA “through its rigorous pre-market approval process,” Plaintiff’s claims under the LPLA are preempted by federal law. (Doc. 10-1 at 7.) Therefore, all state law claims are preempted except to the extent that the claims “‘parallel’ the duties imposed by federal law.” (Id. at 8 (citing 21 U.S.C. § 360k(a); and then citing Naquin v. Medtronic, Inc., No. 20-30793, 2021 WL 4848838 at

2 The Court notes that Greene has filed a separate Louisiana Medical Review Panel proceeding against Bowie and Neuromedical Center, PLC in the Medical Review Panel proceeding entitled Ashley Greene v. The Neuromedical Center and Charles Bowie, M.D., PCF Number 2023-01161 (Docs. 14-5,14-6, and 14-7). Bowie and The Neuromedical Center, APMC, have filed a separate motion to dismiss. (Doc. 14.) *2 (5th Cir. Oct. 18, 2021) (quoting Riegel v. Medtronic, Inc., 552 U.S. 312, 321–22 (2008))).) To successfully plead a parallel claim, Plaintiff, at a minimum, must allege the violation of a specific FDA regulation and facts sufficient to permit a reasonable inference that such a violation occurred and that it caused the plaintiff’s injuries. (Id. at 10.) Here, Plaintiff has done neither and specifically, Plaintiff’s design defect claim, manufacturing defect claim, and inadequate warnings

claim all fail in this regard and therefore must be dismissed. (Id. at 10–14 (citations omitted).) Nevro insists that even without regard to the preemption issue, Plaintiff’s Complaint fails to “offer any factual allegations in support of [her] claims [under the LPLA] and, thus, fails to state a claim . . . on which relief can be granted.” (Doc. 10-1 at 1; see also id. at 3.) In the context of this products liability case, Nevro argues that the Complaint fails to offer any specific allegations as to how its stimulator was defective, what characteristics rendered it unreasonably dangerous, whether alternative designs existed, whether there was a likelihood that the product’s design would cause Plaintiff’s damage, and whether the gravity of that damage outweighed the burden on the manufacturer of adopting such alternative design. (Id. at 3–4 (citations omitted).)

Further, Nevro maintains that the Complaint’s LPLA’s claim is devoid of any allegations as to Nevro’s product specifications or performance standards and how this stimulator deviated from them (id. at 4–5), or how any alleged defect caused Plaintiff’s injuries (id. at 3–5). Similarly, Nevro contends that Plaintiff makes no allegations regarding what product characteristic required instructions or warnings and how, if at all, the warnings and labelling were inadequate or deficient. (Id. at 5–6.) Nor does the Complaint address in any way the learned intermediary doctrine and fails in her pleading obligations in that regard. (Id.) B. Plaintiff Plaintiff argues that Nevro’s preemption argument fails because Plaintiff’s “claims parallel claims for a manufacturer’s acts and omissions prohibited by FDA regulations.” (Doc. 23 at 1; see also id. at 5 (“A cause of action for product manufacturing defect inconsistent with a product’s FDA approved design may be asserted against the manufacturer who sold the product, in parallel

with a state products liability law.” (citations omitted)).) Regarding her alleged lack of any factual allegations, Plaintiff argues that she alleges that Dr. Bowie, her treating neurosurgeon, examined her “due to her progressive neurological decline . . . and in June or July 2023 advised Plaintiff that the cause of her symptoms was the spinal cord stimulator and that it should be removed immediately.” (Id. at 2–3 (citing Doc. 1, ¶ 6).) According to Plaintiff, “this factual allegation alone places Nevro on notice of a possible manufacturing defect in this particular device from which it would not be immune.” (Id. at 3.) Plaintiff complains that because of Louisiana’s short, one-year prescriptive period, Plaintiff “had no chance to examine [the stimulator] or even identify exactly what iteration of the device

was used in her case . . . [and further,] had no notice that the device was FDA approved until Nevro filed its Motion.” (Id. at 2.) Therefore, Nevro’s Motion unfairly “seeks to deny Plaintiff . . .

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Greene v. Nevro Corporation, Counsel Stack Legal Research, https://law.counselstack.com/opinion/greene-v-nevro-corporation-lamd-2025.