Jacob v. Mentor Worldwide, LLC, Case No. CV 19-01484-AB (PLAx)
| Decision Date | 01 August 2019 |
| Docket Number | Case No. CV 19-01484-AB (PLAx) |
| Court | U.S. District Court — Central District of California |
| Parties | Tammi JACOB et al; Plaintiffs, v. MENTOR WORLDWIDE, LLC; NuSil, LLC; NuSil Technology, LLC; and Does 1-100, inclusive, Defendant. |
Jennifer A. Lenze, Amanda Deanne McGee, Lenze Lawyers PLC, Manhattan Beach, CA, Lowell W. Finson, Finson Law Firm LLC, Marina del Rey, CA, for Plaintiffs.
Monee Takla Hanna, Tucker Ellis LLP, Los Angeles, CA, Dustin B. Rawlin, Pro Hac Vice, Tucker Ellis LLP, Cleveland, OH, Melissa J. Fassett, Timothy E. Metzinger, Price Postel and Parma LLP, Santa Barbara, CA, for Defendant.
ORDER DENYING PLAINTIFFS' MOTION TO REMAND AND GRANTING DEFENDANTS' MOTIONS TO DISMISS
Before the Court are three motions filed by the Parties.
Defendants, Mentor Worldwide, LLC. ("Mentor"), NuSil LLC., and NuSil Technology LLC ("NuSil") filed motions to dismiss (Dkt. Nos. 19, 23). Plaintiffs Tammi Jacob ("Jacob"), Kate Nunn ("Nunn"), Aluvia Solano ("Solano"), Mary Watson ("Watson"), and April Zimmerman ("Zimmerman") (collectively, "Plaintiffs") opposed the motions (Dkt. Nos. 34, 35), and Defendants replied (Dkt. Nos. 37, 38).
Plaintiffs filed a Motion to Remand (Dkt. No. 21). Mentor opposed the motion (Dkt. No. 33) and Plaintiffs replied (Dkt. No. 39). The Court heard oral argument on July 12, 2019 and took the motions under submission. For the following reasons, Plaintiffs' Motion to Remand is DENIED and Defendants' Motions to Dismiss is GRANTED.
This lawsuit revolves around injuries Plaintiffs allegedly suffered after receiving surgical implants of Mentors' MemoryGel Silicone Breast Implants ("MemoryGel Implants"). Plaintiffs plead the following in their Complaint ("Compl.," Dkt. No. 1, Exhibit A).
Jacob is a citizen and resident of Los Angeles County, California. Compl. ¶ 1. Nunn is a citizen and resident of Collin County, Texas. Id. ¶ 2. Solano is a citizen and resident of Bernalillo County, New Mexico. Id. ¶ 3. Watson is a citizen of Saline County, Arkansas. Id. ¶ 4. Zimmerman is a citizen of Jackson County, Missouri. Id. ¶ 5.
Mentor is a limited liability company incorporated in Delaware with its principal place of business in Santa Barbara, California. Id. ¶ 6. Mentor manufactured the MemoryGel Implants at issue. Id. ¶ 7.
NuSil LLC is a limited liability company incorporated in California with its principal place of business in Carpinteria, California. Id. ¶ 8.
NuSil Technology, LLC is a limited liability company incorporated in Delaware with its principal place of business in Carpinteria, California. Id. ¶ 9. 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. ¶ 11.
In 1976, Congress passed the Medical Device Amendments ("MDA") to the Federal Food, Drug, and Cosmetic Act ("FDCA"). Id. ¶ 41. Under the MDA, medical devices, such as the MemoryGel Implants, are subject to three classifications and regulated accordingly. Id. ¶ 42. 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. ¶ 43. 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. ¶ 44.
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. ¶ 51. On December 12, 2003, Mentor submitted a request to the FDA for PMA for its MemoryGel Implants. Id. ¶ 67. On November 17, 2006, Mentor received approval subject to certain conditions. Id. ¶¶ 68. 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. ¶ 68.
Jacob was implanted with MemoryGel Implants in November 2006. Id. ¶ 21. Jacob alleges that following implantation she developed pain and swelling of her breasts, experienced fatigue, muscle pain, muscle weakness, joint pain, stiffness and swelling, vision issues, light sensitivity, numbness, dizziness, nausea, memory loss, shortness of breath, cognitive dysfunction, chest pain, migraines, itching, chronic sore throats, night sweats, and hair loss. Id. ¶ 22. In July 2018, an MRI scan revealed Jacob's right breast implant had ruptured ; Jacob underwent a bilateral explantation of her implants on August 6, 2018. Id. ¶ 23. After explantation, various defects were found within Jacob's right breast implant. Id. ¶ 24.
Nunn was implanted with MemoryGel Implants in December 2014 and December 2015. Id. ¶ 25. Following the implantation, Nunn began to experience, among other things, pain and swelling of the breasts, edema, and muscle pain. Id. ¶ 26. On September 17, 2018, Nunn underwent an explantation of her right breast implant. Id. ¶ 27. A gel bleed/rupture was discovered during the procedure. Id. After explantation, various defects were found within Nunn's right breast implant. Id. ¶ 28.
Solano was implanted with MemoryGel Implants for her left and right breast on April 19, 2011 and August 9, 2011 respectively. Id. ¶ 30. Following implantation, Solano developed a number of illnesses and symptoms. Id. ¶ 31. On December 13, 2016, Solano underwent an explantation of her ruptured left breast implant. Id. ¶ 31. After explantation, various defects were found within Solano's left breast implant. Id. ¶ 32.
Watson was implanted with MemoryGel Implants in February 2012. Id. ¶ 33. Following the implantation, Watson began to experience, among other things, fatigue, muscle weakness, joint stiffness, shortness of breath, itching, dizziness, and night sweats. Id. ¶ 34. On January 24, 2017, Watson underwent a bilateral explantation of her implants. Id. ¶ 35. A gel bleed/rupture was discovered during the procedure. Id. After explantation, various defects were found within Watson's right breast implant.
Zimmerman was implanted with MemoryGel Implants on June 8, 2012. Id. ¶ 37. Following the implantation, Zimmerman began to experience, among other things, fatigue, cognitive dysfunction, muscle pain and weakness, joint pain, stiffness, and swelling, memory loss, shortness of breath, chest pain, nausea, dizziness, fevers, numbness, vision issues, light sensitivity, silicone toxicity, hair loss, dry eyes, dry mouth, chills, sore throat, skin rash, and a metallic taste in her mouth. Id. ¶ 38. In May 2017, an MRI scan revealed Zimmerman's right breast implant had ruptured ; Zimmerman underwent explantation of her implants on June 21, 2017. After explantation, various defects were found within Zimmerman's right breast implant. Id. ¶ 39.
On February 27, 2019, Plaintiffs filed a complaint 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. On February 28, 2019, Mentor filed a notice of removal in this Court and then filed a motion to dismiss Plaintiffs' complaint pursuant to Federal Rule of Civil Procedure 12(b)(6). Plaintiffs filed a motion to remand.
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).
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) ().
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