Glennen v. Allergan, Inc.
| Citation | 247 Cal.App.4th 1,202 Cal.Rptr.3d 68 |
| Decision Date | 29 April 2016 |
| Docket Number | A145367 |
| Court | California Court of Appeals |
| Parties | Ashley GLENNEN, Plaintiff and Appellant, v. ALLERGAN, INC., Defendant and Respondent. |
Casey, Gerry, Schenk, Francavilla, Blatt & Penfield LLP, Jeremy Robinson, Wendy M. Behan, Law Office of Mitchel J. Olson, J.D., M.D., Mitchel J. Olson, San Diego, Counsel for Plaintiff and Appellant Ashley Glennen.
King and Spalding LLP, Ethan P. Davis, San Francisco, Jeffrey S. Bucholtz, Norton Rose Fulbright U.S. LLP, Lesley Swanson, Jan Dodd, Los Angeles, Counsel for Defendant and Respondent Allergan, Inc.
, J.
Plaintiff Ashley Glennen sued defendant Allergan, Inc. (Allergan),1 alleging she suffered complications after Allergan's LAP–BAND Adjustable Gastric Banding
System (Lap–Band) was surgically implanted in her body. She appeals from the judgment rendered after the trial court sustained Allergan's demurrer to her second amended complaint (SAC) without leave to amend. She contends the court erred in concluding her claim that Allergan failed to adequately train physicians in the use of the Lap–Band is preempted by federal law. We affirm.
We take the factual material from plaintiff's SAC and from matters subject to judicial notice. BioEnterics was a subsidiary of Inamed Corporation, a company that merged with Allergan in 2006. In March 2000, BioEnterics applied for Food and Drug Administration (FDA) premarket approval to manufacture and market the Lap–Band. The Lap–Band BioEnterics' application was based on the Lap–Band's designation as a Class III device under the Medical Device Amendments to the Food, Drug, and Cosmetic Act (FDCA). (52 Stat. 1040, as amended, 21 U.S.C. § 301 et seq.
) BioEnterics received premarket approval for the Lap–Band on June 5, 2001. In the letter notifying BioEnterics of this approval, the FDA indicated that the Lap–Band's labeling must “specify the requirements that apply to the training of practitioners who may use the device as approved in this order....” A brochure prepared by BioEnterics provides that surgeons planning laparoscopic placement must, among other things, “[h]ave extensive advanced laparoscopic experience ...[;] [¶] [h]ave previous experience in treating obese patients and have the staff and commitment to comply with the long-term follow-up requirements of obesity
procedures[;] [¶] [p]articipate in a training program for the LAP–BAND System authorized by BioEnterics Corporation or an authorized BioEnterics distributor (this is a requirement for use).” The brochure also states that surgeons were required to be observed by “qualified personnel” during their first band placements, to have the equipment and experience necessary to complete the procedure via laparotomy if required, and to report on their personal experiences using the device.2 Furthermore, the FDA approval letter obligated the manufacturer to ” (Italics added.)
In January 2003, plaintiff underwent a surgical procedure to implant a Lap–Band. The Lap–Band eventually eroded into both her stomach and her liver. The erosion into the stomach caused a portion of her stomach to die. Additionally, the tubing attached to the Lap–Band became entangled with her small intestine, resulting in the death of a portion of her small intestine. The erosion into the liver caused the Lap–Band to become firmly adhered to her liver. During surgery to remove the Lap–Band she suffered a massive hemorrhaging from her liver, causing her to experience profound hypotension and systemic shock.3 As a result, plaintiff suffered brain damage.
In September 2012, more than nine years after the procedure, plaintiff filed a complaint alleging several causes of action against Allergan and other defendants.
In December 2012, plaintiff filed a first amended complaint.
On April 12, 2013, plaintiff filed her SAC, alleging a single cause of action against Allergan for negligence.
On July 9, 2013, the trial court granted Allergan's demurrer to the SAC without leave to amend.
On April 14, 2015, judgment after demurrer was entered in favor of Allergan. Notice of entry of judgment was served on May 19, 2015. Plaintiff thereafter filed a timely appeal.
(Coleman v. Medtronic, Inc. (2014) 223 Cal.App.4th 413, 421–422, 167 Cal.Rptr.3d 300
(Coleman ).)
This case, asserting injuries allegedly stemming from an FDA-approved medical device, arises within a complex and highly regulated area of federal law pursuant to which the contours of permissible private enforcement suits are carefully circumscribed. The starting point is the federal Medical Device Amendments of 1976 (MDA), title 21 United States Code section 360c et seq.,4
which imposed a “regime of detailed federal oversight” over the market for medical devices. (Riegel v. Medtronic, Inc. (2008) 552 U.S. 312, 316, 128 S.Ct. 999, 169 L.Ed.2d 892 (Riegel ).) Regulation of medical devices, an expansive field encapsulating everything from “ ‘bedpans to brainscans' ” (Medtronic, Inc. v. Lohr (1996) 518 U.S. 470, 476, 116 S.Ct. 2240, 135 L.Ed.2d 700 (Lohr )), had traditionally been left largely to state supervision. However, rapid technological change and highly publicized instances of medical device failure led many to doubt the ability of the “common-law tort system to manage the risks associated with dangerous devices.” (Riegel, at p. 315, 128 S.Ct. 999.) In response to this “mounting consumer and regulatory concern” (Lohr, at p. 476, 116 S.Ct. 2240 ), Congress entered the field and enacted the MDA, which “intentionally ‘swept back some state obligations' in favor of uniform federal regulation.” (Walker v. Medtronic, Inc. (4th Cir.2012) 670 F.3d 569, 572, quoting Riegel, at p. 316, 128 S.Ct. 999.)
The MDA utilized a two-pronged approach to achieve its purpose. On the one hand, it imposed an intricate regulatory scheme to increase oversight and promote uniformity at the federal level. Correspondingly, as will be discussed below, it eliminated the potential for state enforcement interference by enacting an express preemption clause. (See § 360k.)
A key feature of the federal scheme is a graduated classification system designed to tailor the level of FDA oversight to the safety risks posed by a given medical device; the higher the safety risk, the more regulatory requirements apply. (See § 360c(a)(1)
.) Class I devices present the lowest safety risk and accordingly are subject only to “ ‘general controls,’ ” such as labeling requirements, imposed by the FDCA and the regulations promulgated pursuant to its authority. (Riegel, supra, 552 U.S. at p. 316, 128 S.Ct. 999.) Such devices need not adhere to device-specific regulations because general quality controls, applicable to “all finished devices intended for human use” (21 C.F.R. § 820.1 ) are “sufficient to provide reasonable assurance of the safety and effectiveness of the device.” (§ 360c(a)(1)(A)(i).)
The safety and effectiveness of Class II devices cannot be guaranteed by these generally applicable controls, and so these devices require further oversight, including device-specific “special controls,” such as the promulgation of performance standards, postmarket surveillance, patient registries, and the dissemination of guidelines. (§ 360c(a)(1)(B)
.) Where not even such special controls can ensure the device's safety, and where the device is either useful in supporting or sustaining human life, substantially important in preventing the impairment of human health, or presents an unreasonable risk of illness or injury, the device is given a Class III classification. (§ 360c(a)(1)(C)
.) Because of the risks associated with them, new Class III devices are required to go through a premarket approval (PMA) process “to provide reasonable assurance of [their] safety and effectiveness.” (Ibid. )
Premarket approval is a “ ‘rigorous process' ” (Riegel, supra, 552 U.S. at p. 317, 128 S.Ct. 999
), designed to fully vet and secure safety and effectiveness before a new Class III device may be introduced to the market. (Lohr, supra, 518 U.S. at p. 477, 116 S.Ct. 2240.) The PMA process for new devices is governed by section 360e, as well as regulations promulgated under its authority. Where PMA is required, the device's proponent must file with the FDA an application providing a wide variety of information: reports of all investigations into the safety and effectiveness of the device, a statement of its components, a full description of the methods used to manufacture and produce the device, device samples, and specimens of proposed labeling. (§ 360e(c)(1).) This application process typically requires a “multivolume application.” (Riegel, at p. 317, 128 S.Ct. 999.) The FDA review of each submission generally entails an average of 1,200 hours of study before possible approval. (Lohr, at p. 477, 116 S.Ct. 2240.)...
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