Vieira v. Mentor Worldwide, LLC

• Citation: 392 F.Supp.3d 1117
• Decision Date: 01 August 2019
• Docket Number: Case No. CV 19-04939-AB (PLAx)
• Parties: Nicole VIEIRA, an individual; Emilia Barozzi, an individual; Plaintiffs, v. MENTOR WORLDWIDE, LLC; NuSil, LLC; NuSil Technology, LLC; and Does 1-100, inclusive, Defendants.
• Court: U.S. District Court — Central District of California

392 F.Supp.3d 1117

Nicole VIEIRA, an individual; Emilia Barozzi, an individual; Plaintiffs,

v.MENTOR WORLDWIDE, LLC; NuSil, LLC; NuSil Technology, LLC; and Does 1-100, inclusive, Defendants.

Case No. CV 19-04939-AB (PLAx)

United States District Court, C.D. California.

Signed August 1, 2019

Amanda Deanne McGee, Jennifer A. Lenze, Lenze Lawyers PLC, Manhattan Beach, CA, Edward Eugene Angwin, Angwin Law Firm, Los Angeles, CA, Lowell W. Finson, Finson Law Firm LLC, Marina del Rey, CA, for Plaintiffs.

Dustin B. Rawlin, Pro Hac Vice, Tucker Ellis LLP, Cleveland, OH, Monee Takla Hanna, Tucker Ellis LLP, Los Angeles, CA, Melissa J. Fassett, Price Postel and Parma LLP, Santa Barbara, CA, for Defendants.

ORDER DENYING PLAINTIFFS' MOTION TO REMAND AND GRANTING DEFENDANTS' MOTION TO DISMISS

HONORABLE ANDRÉ BIROTTE JR., UNITED STATES DISTRICT COURT JUDGE

Before the Court are two motions filed by the Parties.

Defendants Mentor Worldwide, LLC ("Mentor"), NuSil, LLC, and NuSil Technology, LLC ("NuSil Technology") (collectively, "Defendants") filed a Motion to Dismiss ("MTD," Dkt. No. 12). Plaintiffs Nicole Vieira ("Vieira") and Emilia Barozzi ("Barozzi") (collectively, "Plaintiffs") filed an opposition ("Opp'n.," Dkt. No. 16) and Defendants filed a reply (Dkt. No. 17). The Court heard oral argument on July 12, 2019 and took the motion under submission.

Plaintiffs filed a Motion to Remand (Dkt. No. 18). Mentor opposed the motion (Dkt. No. 24) and filed supplemental authority in support of their opposition (Dkt. No. 26). The Court took the motion under submission on July 31, 2019. For the following reasons, Plaintiffs' Motion to Remand is DENIED and Defendants' Motions to Dismiss is GRANTED .

I. BACKGROUND

This lawsuit revolves around injuries Plaintiffs allegedly suffered after surgically receiving Mentor's MemoryGel Silicone Breast Implants

("MemoryGel Implants"). Plaintiffs plead the following in their First Amended Complaint ("FAC," Dkt. No. 1, Ex. A).

A. The Parties

Vieira is a citizen and resident of Solano County, California. FAC ¶ 1. Barozzi is a citizen and resident of Arapahoe County, Colorado. Id. ¶ 2.

Mentor is a limited liability company incorporated in Delaware with its principal place of business in Santa Barbara, California. Id. ¶ 3. Mentor manufactured the MemoryGel Implants at issue. Id. ¶ 4.

NuSil LLC is a limited liability company incorporated in California with its principal place of business in Carpinteria, California. Id. ¶ 6. NuSil Technology is a limited liability company incorporated in Delaware with its principal place of business in Carpinteria, California. Id. ¶ 7. NuSil LLC and NuSil Technology are silicone raw material suppliers and allegedly manufactured, produced, supplied, and shipped the silicone used in the MemoryGel Implants. Id. ¶ 9.

B. FDA Regulation of Silicone Breast Implants

In 1976, Congress passed the Medical Device Amendments ("MDA") to the Federal Food, Drug, and Cosmetic Act ("FDCA"). Id. ¶ 36. Under the MDA, medical devices, such as the MemoryGel Implants, are subject to three classifications and regulated accordingly. Id. ¶ 37. Class I devices require the least and most general oversight, Class II devices are reviewed according to more stringent "special controls," and Class III devices receive the most oversight and require rigorous premarket review and approval. Id. The Food and Drug Administration ("FDA") classified silicone breast implants

as Class III devices. Id. ¶ 38. Accordingly, the FDA requires manufacturers to meet certain requirements for Class III devices. Id. On April 10, 1991, the FDA published a final regulation under Section 515(b) of the FDCA requiring that manufacturers of silicone breast implants submit pre-market approval ("PMA") applications with data showing a reasonable assurance of safety and effectiveness of the implants by July 9, 1991. Id. ¶ 39.

C. Mentor's FDA Approval

In order to eventually seek PMA for its MemoryGel Implants, Mentor was required to first provide the FDA with sufficient information regarding the safety and efficacy of the medical device. Id. ¶ 46. On December 12, 2003, Mentor submitted a request to the FDA for PMA for its MemoryGel Implants. On November 17, 2006, Mentor received approval subject to certain conditions. Id. ¶¶ 62-63. One of the conditions imposed on Mentor required it to conduct six post-approval studies¹ to further characterize the safety and effectiveness of MemoryGel Implants. Id. ¶ 63.

D. Plaintiffs' MemoryGel Procedures

Vieira was implanted with MemoryGel Implants on April 16, 2007. Id. ¶ 19. Vieira alleges that following implantation she developed Hashimoto's disease

, experienced fatigue, memory loss, hair loss, light sensitivity, skin rashes, vision issues, numbness, dizziness, nausea, chronic sore throats, chest pain, migraines, joint pain, stiffness and swelling, muscle pain and weakness.²

Id. ¶¶ 20-21. Vieira was unaware as to what triggered her symptoms. Id. ¶ 21. Vieira's injuries caused her to be bedridden; she subsequently moved to her parent's household in Vacaville, California for home care. Id. ¶ 22. On June 27, 2016, Vieira underwent a bilateral explantation of her implants in Los Angeles, California. Id. ¶ 23. A gel bleed was discovered in the right implant during the procedure. Id. Within six months of explantation, Vieira saw relief of approximately 80% of her symptoms and is now in remission from her Hashimoto's disease. Id. ¶ 24.

Barozzi received MemoryGel Implants on April 12, 2012. Id. ¶ 26. Barozzi alleges that following implantation, she developed a rash on her chest and abdomen along with dry eyes and mouth, experienced recurrent sore throats, ear infections, and bladder infections

. Id. ¶ 28. Barozzi's pain increased over time. Id. Barozzi also developed rheumatoid arthritis, experienced fatigue, joint pain and stiffness, muscle weakness, memory loss, shortness of breath, cognitive dysfunction, chest pains, itching, nausea, dizziness, numbness, vision issues, light sensitivity, night sweats, metallic taste, poor wound healing, and hair loss. Id. ¶ 27. Barozzi was unaware as to what caused her injuries. Id. ¶ 28. On August 2, 2016, Barozzi underwent a bilateral explantation of her implants. Id. ¶ 29. A gel bleed was discovered during the procedure. Id. ¶ 29. After explantation, various defects were found in Barozzi's implants. Id. ¶ 30.

E. This Action

Plaintiffs filed a FAC in the Los Angeles County Superior Court asserting causes of action for: (1) negligence/negligence per se; (2) failure to warn; and (3) manufacturing defect. Defendants filed a notice of removal in this Court and then filed a motion to dismiss Plaintiffs' FAC pursuant to Federal Rule of Civil Procedure 12(b)(6) for failure to state a claim. Plaintiffs filed a motion to remand.

II. LEGAL STANDARD

A. Motion to Dismiss Under 12(b)(6)

Federal Rule of Civil Procedure 8 requires a plaintiff to present a "short and plain statement of the claim showing that the pleader is entitled to relief." Fed. R. Civ. P. 8(a)(2). Under Rule 12(b)(6), a defendant may move to dismiss a pleading for "failure to state a claim upon which relief can be granted." Fed. R. Civ. P. 12(b)(6).

To defeat a motion to dismiss under Rule 12(b)(6), the complaint must provide enough details to "give the defendant fair notice of what the ... claim is and the grounds upon which it rests." Bell Atl. Corp. v. Twombly , 550 U.S. 544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007). The complaint must also be "plausible on its face," allowing the court to "draw the reasonable inference that the defendant is liable for the misconduct alleged." Ashcroft v. Iqbal , 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009). "The plausibility standard is not akin to a ‘probability requirement,’ but it asks for more than a sheer possibility that a defendant has acted unlawfully." Id. at 678, 129 S.Ct. 1937. Labels, conclusions, and "a formulaic recitation of the elements of a cause of action will not do." Twombly , 550 U.S. at 555, 127 S.Ct. 1955.

When ruling on a Rule 12(b)(6) motion, "a judge must accept as true all of the factual allegations contained in the complaint." Erickson v. Pardus , 551 U.S. 89, 94, 127 S.Ct. 2197, 167 L.Ed.2d 1081 (2007). But a court is "not bound to accept as true a legal conclusion couched as a factual allegation." Iqbal , 556 U.S. at 678, 129 S.Ct. 1937 (internal quotation marks omitted).

B. Leave to Amend

Should a court dismiss certain claims, "[l]eave to amend should be granted unless the district court ‘determines that the pleading could not possibly be cured by the allegation of other facts.’ " Knappenberger v. City of Phoenix , 566 F.3d 936, 942 (9th Cir. 2009) (quoting Lopez v. Smith , 203 F.3d 1122, 1127 (9th Cir. 2000) (en banc)); see also Knevelbaard Dairies v. Kraft Foods, Inc. , 232 F. 3d 979, 983 (9th Cir. 2000) ("An order granting such a motion must be accompanied by leave to amend unless amendment would be futile").

C. Removal

Federal courts are courts of limited jurisdiction and possess only that jurisdiction as authorized by the Constitution and federal statute. Kokkonen v. Guardian Life Ins. Co. of Am. , 511 U.S. 375, 377, 114 S.Ct. 1673, 128 L.Ed.2d 391 (1994). Under 28 U.S.C. § 1441(a), a party may remove a civil action only if the district court has original jurisdiction over the issues alleged in the state court complaint. There is a strong presumption that the Court is without jurisdiction until affirmatively proven otherwise. See Fifty Assocs. v. Prudential Ins. Co. of America , 446 F.2d 1187, 1190 (9th Cir. 1970). When an action is removed from state court, the removing party bears the burden of demonstrating that removal is proper. Gaus v. Miles, Inc. , 980 F.2d 564, 566 (9th Cir. 1992).

Under the diversity statute, 28 U.S.C. § 1332, a federal district court has original jurisdiction when the parties are completely diverse and the amount in controversy exceeds $75,000. See 28 U.S.C. § 1332. Pursuant to 28 U.S.C. § 1441(a) and (b), a...