Searching over 5,500,000 cases.


searching
Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

Billetts v. Mentor Worldwide, LLC

United States District Court, C.D. California

August 27, 2019

BRITTANY BILLETTS et al; Plaintiffs,
v.
MENTOR WORLWIDE, LLC; NUSIL, LLC; NUSIL TECHNOLOGY, LLC; and DOES 1-100, inclusive, Defendant.

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

          HONORABLE ANDRÉ BIROTTE JR., UNITED STATES DISTRICT COURT JUDGE.

         Before the Court are two motions filed by the parties.

         On June 12, 2019 Defendants Mentor Worldwide, LLC. (“Mentor”), NuSil LLC., and NuSil Technology LLC (“NuSil”) filed a motion to dismiss (Dkt. No. 10). Plaintiffs Brittany Billets, Vivian Aguiar, Ann Delmonico, Cornelia Ditto and Leah Johnson (“Plaintiffs”) opposed the motion (Dkt. No. 20).

         Plaintiffs filed a Motion to Remand (Dkt. No. 16) and Defendants opposed the motion (Dkt. No. 18). The Court deemed the matter appropriate for resolution without oral argument, see Local Rule 7.15, and took the matter under submission on August 14, 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 receiving surgical implants of Mentors' MemoryGel Silicone Breast Implants (“MemoryGel Implants”). Plaintiffs plead the following in their Complaint (“Compl., ” Dkt. No. 1, Exhibit A).

         A. The Parties

         Billets is a citizen and resident of San Bernardino County, California. Compl. ¶ 1. Aguiar is a citizen and resident of Miami-Dade County, Florida. Id. ¶ 2. Delmonico is a citizen and resident of Newport County, Rhode Island. Id. ¶ 3. Ditto is a citizen and resident of Seminole County, Florida. Id. ¶ 4. Johnson is a citizen of Lee County, Mississippi. 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.

         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. ¶ 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.

         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. ¶ 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 studies[1] to further characterize the safety and effectiveness of MemoryGel Implants. Id. ¶ 68.

         D. Plaintiffs' MemoryGel Procedures

         Billets was implanted with MemoryGel Implants on August 15, 2013. Id. ¶ 21. Billets alleges that following implantation she experienced fatigue, muscle pain, muscle weakness, joint pain and swelling, vision issues, light sensitivity, numbness, skin rashes, dizziness, nausea, memory loss, shortness of breath, cognitive dysfunction, chest pain, migraines, silicone toxicity, night sweats, and hair loss. Id. ¶ 22. On May 26, 2017, Billets was diagnosed with a rupture of her right breast implant. Id. ¶ 23.

         Aguiar was implanted with MemoryGel Implants on September 8, 2016. Id. ¶ 24. Following implantation, Aguiar developed a number of illnesses and symptoms, including, among other things, pain and swelling of the breasts, seromas, and muscle pain. Id. ¶ 25. On February 15, 2018, Aguiar underwent an explanation of her implants. Id. ¶ 26. A gel bleed/rupture of Aguiar's right implant was discovered during the procedure. Id. After explanation, various defects were found within Nunn's right breast implant. Id. ¶ 27.

         Delmonico was implanted with MemoryGel Implants on July 22, 2010. Id. ¶ 28. Following implantation, Solano developed a number of illnesses and symptoms., including, among other things, pain and swelling of the breast, seromas, joint pain, swelling, stiffness and fatigue, muscle pain and weakness, memory loss, shortness of breath, cognitive dysfunction, migraines, chest pains, chronic sore throats, itching, nausea, dizziness, numbness in her extremities, issues with her vision, skin rashes, light sensitivity, silicone toxicity, night sweats, and hair loss. Id. ¶ 29. On April 28, 2017, Delmonico underwent an explanation of her implants. Id. ¶ 30. After explanation, various defects were found within Delmonico's right breast implant. Id. ¶ 31.

         Ditto was implanted with MemoryGel Implants on October 9, 2007. Id. ¶ 32. Following implantation, Watson began to experience, among other things, pain and swelling of the breasts, seromas, fatigue, joint pain, swelling and stiffness, muscle pain and weakness, and migraines. Id. ¶ 33. On October 12, 2017, Ditto underwent a bilateral explanation of her implants. Id. ¶ 34. A gel bleed/rupture was discovered during the procedure. Id. After explanation, various defects were found within Watson's right breast implant. Id. ¶ 35.

         Johnson was implanted with MemoryGel Implants on September 2, 2010. Id. ¶ 36. Following the implantation, Johnson began to experience, among other things, fatigue, cognitive dysfunction, muscle pain and weakness, joint pain and soreness, dry skin, dry eyes, easy bruising and slow healing wounds, shortness of breath, metallic taste, night sweats, skin rashes, insomnia, swollen and tender lymph nodes in the breast area, numbness, chest pain, fevers, chronic neck and back pain, light sensitivity, vision issues, migraines, chest inflammation, and hair loss. Id. ¶ 37. On October 20, 2017, Johnson underwent a bilateral explantation. Id. ¶ 38. A gel bleed/rupture was discovered. Id. After explantation, various defects were found within Johnson's right breast implant. Id. ¶ 39.

         E. This Action

         On February 22, 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 June 5, 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.

         II. LEGAL STANDARD

         A. Motion to ...


Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.