Jacob v. Mentor Worldwide, LLC

• Court: U.S. Court of Appeals — Eleventh Circuit
• Writing for the Court: Brasher, Circuit Judge
• Citation: Jacob v. Mentor Worldwide, LLC, 40 F.4th 1329 (11th Cir. 2022)
• Decision Date: 20 July 2022
• Docket Number: 20-10132
• Parties: Lalitha E. JACOB, MD, Plaintiff-Appellant, v. MENTOR WORLDWIDE, LLC, Defendant-Appellee.

40 F.4th 1329

Lalitha E. JACOB, MD, Plaintiff-Appellant,v. MENTOR WORLDWIDE, LLC, Defendant-Appellee.

No. 20-10132

United States Court of Appeals, Eleventh Circuit.

Filed July 20, 2022

Thomas A. Burns, Shannon C. Reese, Counsel, Burns, PA, Tampa, FL, for Plaintiff-Appellant.

Dustin Bradley Rawlin, Nelson Mullins Riley & Scarborough, Cleveland, OH, Caycee Hampton, Joseph H. Lang, Jr., David J. Walz, Carlton Fields, PA, Tampa, FL, Jeffrey Charles Sindelar, Jr., Tucker Ellis, LLP, Cleveland, OH, for Defendant-Appellee.

Before Lagoa, Brasher, and Tjoflat, Circuit Judges.

Brasher, Circuit Judge:

The question in this appeal is whether a federal medical-device statute preempts state-law manufacturing defect claims. Lalitha Jacob received MemoryGel Silicone Gel Breast Implants made by Mentor Worldwide, LLC. After one of her implants ruptured, she sued Mentor pro se , alleging negligence and negligence per se, strict liability failure to warn, and strict liability manufacturing defect. The district court dismissed her complaint without prejudice and later dismissed her amended complaint with prejudice as preempted and foreclosed by Florida law. Jacob appealed. After careful review and with the benefit of oral argument, we conclude that Jacob's manufacturing defect claims are sufficiently pleaded to survive a motion to dismiss. We therefore reverse and remand.

I. BACKGROUND

Congress enacted the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act to "provide for the safety and effectiveness of medical devices intended for human use." Medtronic, Inc. v. Lohr , 518 U.S. 470, 474, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996) (quoting Medical Device Amendments of 1976, Pub. L. No. 94-295, 90 Stat. 539 ); see also 21 U.S.C. § 301 et seq . The Amendments establish three classes of medical devices—Class I, Class II, and Class III—based on the level of oversight required to ensure their safety. See 21 U.S.C. § 360c(a)(1). Classification is based on the level of risk posed by the device. Lohr , 518 U.S. at 476–77, 116 S.Ct. 2240. Class I devices involve the least risk and require only general regulatory controls. Id. Class II devices involve more risk and require both general and special regulatory controls. Id. Class III devices involve the most risk and require general regulatory controls and pre-market approval before being sold to consumers. Id.

Mentor's MemoryGel Silicone Gel Breast Implant is a Class III medical device that has been deemed safe and effective via the FDA's pre-market approval process. Once approved, the Amendments forbid unauthorized changes to "design specifications, manufacturing processes, labeling, or any other attribute, that would affect safety or effectiveness." Riegel v. Medtronic, Inc. , 552 U.S. 312, 319, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008) (citing 21 U.S.C. § 360e(d)(6)(A)(i) ). Makers of approved devices are also subject to ongoing reporting requirements related to device safety. See id. For example, a manufacturer must inform the FDA of studies of its devices and incidents of the device injuring consumers. Id. The FDA retains authority to withdraw its approval based on this information. Id.

In January 2007, Jacob was surgically implanted with Mentor's MemoryGel implants. Jacob alleges that after she received her implants she developed "severely disabling and life-threatening medical problems related to lupus-like syndrome. ..." Twelve years later, Jacob underwent surgery to remove her implants. At that point she discovered that her left implant had ruptured, creating "a severe systemic[-]chemical and heavy metal toxicity adversely affecting [her] entire body."

Jacob then sued Mentor in the United States District Court for the Middle District of Florida, asserting claims for (1) negligence and negligence per se, including negligent failure to warn and negligent manufacturing (Count I); (2) strict products liability—failure to warn (Count II); and (3) strict products liability—manufacturing defect (Count III).

Mentor moved to dismiss under Federal Rule of Civil Procedure 12(b)(6). Mentor argued that Jacob's claims were both expressly and impliedly preempted by federal law. Jacob filed a two-page response stating that she "strongly fe[lt] [her] case should not be dismissed" and that her medical issues "were very severe, life-threatening and totally different from the similar cases usually encountered in the courts across the country." She also filed an "addendum" to that response, stating that Mentor's product "failed" to "meet very basic standards of safety" because "the shell of the implants in question were porous ." She later filed another addendum stating that she was "personally aware of a case similar to [hers] that [had] passed ‘preemption’ in another state," and that "[t]he factors surrounding [her] case [were] equally strong, if not more."

The district court granted Mentor's motion to dismiss. It held that Jacob's failure to warn claims were preempted by federal law, explaining that "claims based upon failure to provide warning are preempted by federal law" and thus "cannot be sustained ...." It added that although Jacob's manufacturing defect claims purported to allege "parallel" violations of state and federal law and "may theoretically be sustainable," they were nonetheless dismissed because they suffered from procedural defects under Federal Rules of Civil Procedure 8 and 10. Though Jacob attached a supplement to her five-page complaint, the court held that the supplement did not meet Rule 8 ’s requirement that a complaint contain sufficient factual matter, accepted as true, to "state a claim to relief that is plausible on its face." The court also held that because the operative allegations in the complaint were not in numbered paragraphs, the complaint violated Rule 10(b).

The district court ordered that "to the extent" Jacob sought recovery for claims that were preempted, those claims were dismissed with prejudice. And to the extent that she sought recovery for claims that survived preemption, those claims were dismissed without prejudice under Rules 8 and 10 and should be realleged with greater clarity in an amended complaint. The court's dismissal order granted Jacob leave to amend.

Jacob then filed an amended complaint. In it, she alleged three new claims: violation of the FDA's pre-market approval (Count I), breach of implied warranty (Count II), and lack of informed consent—failure to warn (Count III). Mentor again moved to dismiss under Rule 12(b)(6), and the district court again granted Mentor's motion. As to Count I, violation of pre-market approval, the district court dismissed on preemption grounds. As to Count II, breach of implied warranty, the district court dismissed because a warranty claim requires privity of contract under Florida law, and Jacob did not allege that she bought her implants directly from Mentor. As to Count III, lack of informed consent/failure to warn, the district court held that "under the learned intermediary doctrine, a manufacturer's duty to warn runs only to the prescribing physician, not to the patient." And to the extent Jacob argued that Mentor had a duty to provide warnings broader than those approved by the FDA, any such claim was preempted. Jacob timely appealed.

II. STANDARD OF REVIEW

We review de novo a district court's dismissal of a complaint for failure to state a claim under Rule 12(b)(6). EEOC v. STME, LLC , 938 F.3d 1305, 1313 (11th Cir. 2019). Dismissal under Rule 12(b)(6) is appropriate when a plaintiff fails to allege facts sufficient "to raise a right to relief above the speculative level" or fails to "state a claim to relief that is plausible on its face." Bell Atl. Corp. v. Twombly , 550 U.S. 544, 555–56, 570, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007).

Because Jacob is a pro se litigant, we liberally construe her pleadings, holding them "to a less stringent standard than pleadings drafted by attorneys." Tannenbaum v. United States , 148 F.3d 1262, 1263 (11th Cir. 1998).

III. DISCUSSION

Jacob appeals the district court's dismissal of the manufacturing defect claims in Counts I and III of her initial complaint. We divide our discussion of her appeal into two parts. First, we address Mentor's argument that Jacob waived the "theoretically sustainable" manufacturing defect claims in her initial complaint by failing to replead them in her amended complaint. We conclude that she did not. Second, we address whether Jacob's pleadings stated a plausible claim against Mentor. We conclude that they do.

A. Jacob's Claims are not Waived

Jacob appeals the dismissal of the manufacturing defect claims in her initial complaint. Mentor argues that Jacob waived those claims when she omitted them from her amended complaint. Jacob replies that she did not waive the claims because, under our precedent, she was not required to replead claims that the district court held were meritless simply to preserve them for appeal. We agree.

Ordinarily, an amended pleading supersedes the former pleading. "[T]he original pleading is abandoned by the amendment, and is no longer a part of the pleader's averments against his adversary." Dresdner Bank AG v. M/V Olympia Voyager, 463 F.3d 1210, 1215 (11th Cir. 2006) (citation and quotation omitted). But we have also held that "a plaintiff does not waive his right to appeal the dismissal of a claim in the original complaint by amending the complaint and omitting the dismissed claim," provided that repleading the dismissed claim would have been futile. Reynolds v. Behrman Cap. IV L.P. , 988 F.3d 1314, 1319 (11th Cir. 2021) ; see also Dunn v. Air Line Pilots Ass'n , 193 F.3d 1185, 1191 n.5 (11th Cir. 1999) ("[W]e do not require a party to replead a claim following a dismissal under Rule 12(b)(6) to preserve objections to the dismissal on appeal" where "repleading would have been futile.").

Under our caselaw, we conclude that Jacob did not waive her right to appeal the district court's dismissal of her manufacturing...