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Sewell v. Mentor Worldwide, LLC

United States District Court, C.D. California

August 27, 2019

MARY SEWELL 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 13, 2019 Defendants Mentor Worldwide, LLC. (“Mentor”), NuSil LLC., and NuSil Technology LLC (“NuSil”) filed a motion to dismiss (Dkt. No. 12). Plaintiffs opposed the motion (Dkt. No. 14).

         Plaintiffs filed a Motion to Remand (Dkt. No. 15) and Defendants opposed the motion (Dkt. No. 19). The Court deemed the matter appropriate for resolution without oral argument, see Local Rule 7.15, and took the matter under submission on August 9, 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

         Mary Sewell and Tom Saunders are a married couple and citizens of Orange County, California. Compl. ¶ 1. Carole Little is a citizen and resident of El Dorado County, California. Id. ¶ 2. Julia Maceo is a citizen and resident of Sonoma County, California. Id. ¶ 3. Aurora Victoria Corona Cattuzzo and Michael Anthony Cattuzzo are a married couple and citizens of Sacramento County, California. Id. ¶ 4. Barbara Johncke and Anders Johncke are a married couple and citizens of Fairfield County, Connecticut. Id. ¶ 5. Marianne Curry and Joseph Zacharzuk Jr. are a married couple and citizens of Maui County, Hawaii. Id. ¶ 6. Tracie Leach and Gregory Leach are a married couple and citizens of Noble County, Indiana. Id. ¶ 7. Lenie Valerie is a citizen of Johnson County, Kansas. Id. ¶ 8. Deborah Michelle Destasio and Joseph Destasio are a married couple and citizens of Canadian County, Oklahoma. Id. ¶ 9. Stacey Holder and Mark Clark Holden are a married couple and citizens of Oklahoma County, Oklahoma. Id. ¶ 10. Sheila Mathis and Randy Mathis are a married couple and citizens of Young County, Texas. Id. ¶ 11. Kristina Ruiz and Steve Ruiz are a married couple and citizens of Utah County, Utah. Id. ¶ 12.

         Mentor is a limited liability company incorporated in Delaware with its principal place of business in Santa Barbara, California. Id. ¶ 13. Mentor manufactured the MemoryGel Implants at issue. Id. ¶ 14.

         NuSil LLC is a limited liability company incorporated in California with its principal place of business in Carpinteria, California. Id. ¶ 15.

         NuSil Technology, LLC is a limited liability company incorporated in Delaware with its principal place of business in Carpinteria, California. Id. ¶ 16. 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. ¶ 18.

         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”). See generally FAC. Under the MDA, medical devices, such as the MemoryGel Implants, are subject to three classifications and regulated accordingly. 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. The Food and Drug Administration (“FDA”) classified silicone breast implants as Class III devices. Id. Accordingly, the FDA requires manufacturers to meet certain requirements for Class III devices. 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.

         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. ¶ 92. On December 12, 2003, Mentor submitted a request to the FDA for PMA for its MemoryGel Implants. Id. ¶ 108. On November 17, 2006, Mentor received approval subject to certain conditions. Id. ¶ 109. 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..

         D. Plaintiffs' MemoryGel Procedures

         Sewell was implanted with MemoryGel Implants on January 3, 2006. Id. ¶ 28. Sewell alleges that following implantation she experienced fatigue, muscle pain and weakness, joint pain, swelling and stiffness, vision issues, light sensitivity, numbness, skin rashes, dizziness, nausea, chronic sore throats, chest pain, migraines. Id. ¶ 29. On March 13, 2017, Sewell underwent a bilateral explantation of her implants in Newport Beach, California. Id. ¶ 30. A gel bleed/rupture of Sewell's right implant was discovered during the procedure. Id. After explantation, various defects were found in Sewell's implants. Id. ¶ 31.

         Little was implanted with MemoryGel Implants in May 2007. Id. ¶ 33. Following implantation, Little developed a number of illnesses and symptoms including, among other things, rheumatoid arthritis, fatigue, joint pain and stiffness, memory loss, shortness of breath, cognitive dysfunction, chest pain, itching, nausea, dizziness, numbness, vision issues, light sensitivity, skin rashes, night sweats, dry eyes, metallic taste, poor wound healing, and hair loss. Id. ¶ 35. On February 27, 2017, Little underwent a bilateral explantation of her implants. Id. ¶ 36. A gel bleed/rupture of Little's implants was discovered during the procedure. Id. After explantation, various defects were found within Little's breast implants. Id. ¶ 37.

         Maceo was implanted with MemoryGel Implants in December 2006. Id. ¶ 39. Following implantation, Maceo developed a number of illnesses and symptoms including, among other things, rheumatoid arthritis, fatigue, joint pain and stiffness, muscle weakness, memory loss, shortness of breath, cognitive dysfunction, chest pain, itching, nausea, dizziness, numbness, vision issues, light sensitivity, skin rashes, night sweats, dry eyes, metallic taste, poor wound healing, and hair loss. Id. ¶ 40. On April 26, 2017, Maceo underwent a bilateral explantation. Id. ¶ 41. A gel/bleed rupture was discovered during the procedure. Id.

         Cattuzzo was implanted with MemoryGel Implants on May 21, 2007. Id. ¶ 43. Following implantation, Cattuzzo developed a number of illnesses and symptoms, including, among other things, rheumatoid arthritis, autoimmune disorders, fatigue, joint pain and stiffness, muscle weakness, memory loss, itching, and allergies. Id. ¶ 44. On August 21, 2017, Cattuzzo underwent a bilateral explantation of her implants. Id. ¶ 45. A gel bleed/rupture was discovered during the procedure. Id. After explantation, various defects were found within Cattuzzo's implants. Id. ¶ 46.

         Johncke was implanted with MemoryGel Implants on February 7, 2008. Id. ¶ 47. Following implantation, Johncke developed a number of illnesses and symptoms, among other things, arthritis symptoms, chronic fatigue, joint pain and stiffness, fibromyalgia, muscle weakness, memory loss, cognitive dysfunction, debilitating migraines, numbness, light sensitivity, night sweats, autoimmune disorders, and hair loss. Id. ¶ 48. On August 25, 2017, Johncke underwent a bilateral explantation. Id. ¶ 49. A gel bleed/rupture was discovered. Id. After explantation, various defects were found within Johnson's right breast implant. Id. ¶ 50.

         Curry was implanted with MemoryGel Implants on April 11 2007. Id. ¶ 51. Following implantation, Curry developed a number of illnesses and symptoms including, among other things, tremors and other central nervous system problems, neurocognitive issues, fatigue, Hashimoto's thyroiditis, endocrine system disorders, vision problems, dry eyes, headaches, neck and shoulder pain, elbow and thumb pain, breast pain, breathing difficulties, and articular problems. Id. ¶ 52. On May 5, 2017, Curry underwent a bilateral explantation. Id. ¶ 53. A gel bleed/rupture was discovered in Curry's left breast implant. Id. After explantation, various defects were found within Johnson's right breast implant. Id. ¶ 55.

         Leach was implanted with MemoryGel Implants in 2006. Id. ¶ 56. Following implantation, Leach developed a number of illnesses and symptoms including, among other things, rheumatoid arthritis, fatigue, joint pain and stiffness, muscle weakness, memory loss, cognitive dysfunction, chest pain, itching, nausea, dizziness, numbness, vision issues, light sensitivity, skin rashes, and hair loss. Id. ¶ 57. On March 20, 2017, Leach underwent a bilateral explantation. Id. ¶ 58. A gel bleed/rupture was discovered in Curry's left breast implant. Id. After explantation, various defects were found within Curry's implants. Id. ¶ 59.

         Lenie was implanted with MemoryGel Implants on July 29, 2008. Id. ¶ 60. Following implantation, Lenie developed a number of illnesses and symptoms including, among other things, fatigue, muscle pain and weakness, joint pain, swelling and stiffness, ocular migraines, memory loss, shortness of breath, dizziness, numbness, vision issues, light sensitivity, skin rashes, and night sweats. Id. ¶ 61. On September 26, 2017, Lenie underwent a bilateral explantation. Id. ¶ 62. A gel bleed/rupture was discovered in Lenie's left breast implant. Id. After explantation, various defects were found within Lenie's implants. Id. ¶ 63.

         Destasio was implanted with MemoryGel Implants on September 6, 2007. Id. ¶ 64. Following implantation, Destasio developed a number of illnesses and symptoms including, among other things, lupus, rheumatoid arthritis, fatigue, muscle weakness, joint pain and stiffness, memory loss, itching, nausea, dizziness, vision issues, light sensitivity, skin rashes, night sweats, dry eyes, and chronic pain. Id. ¶ 65. On February 23, 2017, Destasio underwent a bilateral explantation. Id. ¶ 66. A gel bleed/rupture was discovered in Destasio's right breast implants. Id. After explantation, various defects were found within Destasio's implant. Id. ¶ 67.

         Holden was implanted with MemoryGel Implants on August 27, 2013. Id. ¶ 68. Following implantation, Holden developed a number of illnesses and symptoms including, among other things, fatigue, muscle weakness, joint pain and stiffness, memory loss, itching, skin rashes, autoimmune dysfunction, and hair loss. Id. ¶ 69. On November 10, 2017, Holden underwent a bilateral explantation. Id. ¶ 70. A gel bleed/rupture was discovered in Holden's left breast implant. Id. After explantation, various defects were found within Holden's implants. Id. ¶ 71.

         Mathis was implanted with MemoryGel Implants on January 7, 2007. Id. ¶ 71. Following implantation, Mathis developed a number of illnesses and symptoms including, among other things, rheumatoid arthritis, fatigue, joint pain and stiffness, muscle weakness, memory loss, shortness of breath, cognitive dysfunction, chest pain, itching, nausea, dizziness, numbness, vision issues, light sensitivity, skin rashes, night sweats, dry eyes, metallic taste, poor wound healing, and hair loss. Id. ¶ 73. On May 16, 2017, Mathis underwent a bilateral explantation. Id. ¶ 74. A gel bleed/rupture was discovered in Mathis's left breast implant. Id. After explantation, various defects were found within Mathis's implants. Id. ¶ 75.

         Ruiz was implanted with MemoryGel Implants on May 27, 2010. Id. ¶ 76. Following implantation, Mathis developed a number of illnesses and symptoms including, among other things, rheumatoid arthritis, fatigue, joint pain and stiffness, muscle weakness, memory loss, shortness of breath, cognitive dysfunction, chest pain, itching, nausea, dizziness, numbness, vision issues, light sensitivity, skin rashes, night sweats, dry eyes, metallic taste, poor wound healing, and hair loss. Id. ¶ 77. On December 27, 2016, Ruiz underwent a bilateral explantation. Id. ΒΆ ...


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