Ali v. Allergan USA, Inc.
| Decision Date | 23 August 2012 |
| Docket Number | NO. 1:12-CV-115 (GBL/TRJ),1:12-CV-115 (GBL/TRJ) |
| Court | U.S. District Court — Eastern District of Virginia |
| Parties | SARA ALI, et al., Plaintiffs v. ALLERGAN USA, INC., Defendant. |
THIS MATTER is before the Court on Defendant Allergan USA, Inc.'s ("Allergan") Motion to Dismiss Amended Complaint. This case is brought by a medical patient against the manufacturer of a medical device for an alleged malfunction of the device and for alleged misrepresentations in marketing materials for the device.
There are four issues before the Court. The first issue is whether Plaintiffs Sara and Daniel Ali's ("Plaintiffs") Amended Complaint contains sufficient pleading of claims under Virginia law that are not preempted by the Medical Device Amendments ("MDA") of the federal Food, Drug, and Cosmetic Act ("FDCA"). The Court holds that Plaintiffs' state law claims as pled in the Amended Complaint cannot avoid preemption by the MDA. The Amended Complaint does not present factual allegations demonstrating that the manufacturer, Allergan, violated federal law in the manufacture, labeling, or marketing of the device at issue in this case. Such pleading is required to state "parallel" claims based on state law that do not impose dutiesdifferent from or in addition to the federal requirements on the device and thereby avoid preemption. For these reasons, the Court grants Allergan's Motion to Dismiss Amended Complaint as to all causes of action.
The second issue is whether Plaintiffs' fraud claims meet the particularity pleading requirement set forth in Rule 9(b) of the Federal Rules of Civil Procedure. The Court holds that Plaintiffs' cause of action for fraud by negligent misrepresentation is not supported by sufficient pleading of the particular content and circumstances of the alleged misrepresentations to satisfy Rule 9(b). Thus, Plaintiffs' negligent misrepresentation cause of action must be dismissed for insufficient pleading.
The third issue is whether the Virginia Consumer Protection Act ("VCPA") provides a private cause of action for Allergan's alleged misrepresentations about the device where the device is regulated by the FDA. The Court holds that the VCPA does not cover federally regulated medical devices and, therefore, dismisses Plaintiffs' VCPA claims with prejudice.
The fourth issue is whether Plaintiffs' adequately plead false advertising claims under Virginia's false advertising statute. The Court holds that Plaintiffs' false advertising cause of action must be dismissed for Plaintiffs' failure to identify a false promise or statement of fact made by Allergan in advertising for the device.
The Court dismisses the causes of action set forth in the Amended Complaint without prejudice, with the exception of the VCPA cause of action, which is dismissed with prejudice. Plaintiffs may seek leave to amend their pleading and submit an amended pleading for the Court's consideration if they are able to provide sufficient factual matter to state their claims in accordance with this opinion.
Pursuant to Rule 201 of the Federal Rules of Evidence, and upon Allergan's motion, the Court takes judicial notice of several documents issued by the United States Food and Drug Administration ("FDA") and Department of Health and Human Services ("HHS").1 These documents, presented in Allergan's Exhibits A, C, E, and F, pertain to FDA approval of the LAP-BAND Adjustable Gastric Banding System ("LAP-BAND"),2 the medical device at issue in this case. The Court considers the facts presented in these documents in connection with Defendant's Motion to Dismiss Amended Complaint.
The LAP-BAND is a Class III medical device3 manufactured and marketed by Allergan. "The device is a permanent implant placed around the upper portion of the stomach to reduce theamount of food that can be ingested[,] resulting in reduced calorie intake and weight loss." Def.'s Ex. F at 3; see also Def.'s Ex. C at 7. It is "restricted to prescription use" and "indicated for use only in severely obese patients who have failed more conservative weight-reduction alternatives, such as supervised diet, exercise and behavior modification programs." Def.'s Ex. A at 1, 3. In 2001, the CDRH determined that there was sufficient pre-clinical and clinical data establishing the safety and effectiveness of the LAP-BAND to warrant FDA approval. Def.'s Ex. C at 24. The FDA approved the device "for use in weight reduction for severely obese patients ... in accordance with its labeling." Id. at 23.
Contemporaneously with its approval of the LAP-BAND, the FDA noted several potential adverse effects of the device on health, including the risk that the band would erode while implanted. Id. at 9-10. The FDA determined that 89% of subjects in the United States clinical trial reported at least one adverse event, though "[m]any adverse events were mild and required no intervention." Id. at 10. Only 1% of subjects experienced band erosion, which was "resolved with explanation of the device" in each case. Id. at 22; see also Def.'s Ex. F at 11 (). The FDA issued several warnings and precautions concerning use of the LAP-BAND, including warnings that "[e]xplant and replacement surgery may be indicated at any time" as well as warnings specifically about the risk of band erosion. Def.'s Ex. C at 2-7. The FDA warned of several ways that the risk of band erosion could be increased, including the use of anti-inflammatory agents by the patient and certain surgical procedures. Id.
Pursuant to section 515 of the Food, Drug, and Cosmetic Act ("FDCA"), codified at 21 U.S.C. § 360e, the LAP-BAND first obtained FDA premarket approval ("PMA") for commercial distribution on June 5, 2001, subject to certain ongoing conditions. Def.'s Ex. F at 5; see alsoDef.'s Ex. A. These conditions include restrictions on the labeling of the device to that specifically approved by the FDA. Defs.'s Ex. A at 1, 3. The FDA also prohibits advertisements and other descriptive material recommending or implying that the LAP-BAND may be used in any way not included in the FDA-approved labeling for the device. Id. at 3. Importantly, the manufacturer is required to submit a PMA supplement for FDA review and approval before making any change or modification to the LAP-BAND, which might affect its safety or effectiveness. Id.; see also Def.'s Ex. E at 3. The modified device is subjected to testing to determine whether it remains safe and effective. Defs.'s Ex. A at 3; see also 21 C.F.R. § 814.82(a)(2) (2012).
The manufacturer is also required to submit annual post-approval reports identifying changes to the device affecting its safety or effectiveness, labeling changes, new indications for use of the device, changes in the performance or design of the device, the use of a different manufacturing or packaging facility, and similar changes. Defs.'s Ex. A at 4; see also 21 C.F.R. § 814.39. Published and unpublished reports or studies on the device must be identified and summarized in these annual reports. Defs.'s Ex. A at 4. The manufacturer must also prepare and submit to the FDA reports of adverse reactions, device defects, and any corrective action taken to address such problems. Id. at 5, 6; see also 21 C.F.R. §§ 803.50-803.52.
Since the initial PMA of the LAP-BAND, the device has obtained FDA approval of PMA supplements, and the conditions of approval remain in effect. See Def.'s Ex. E. Allergan has most recently agreed to conduct post-approval studies to evaluate the long-term effectiveness of the LAP-BAND and the incidence of adverse effects. Id. at 2.
Plaintiffs allege the following facts in their Amended Complaint.
On December 17, 2009, Sara Ali underwent bariatric surgery at the Inova Fair Oaks Hospital located in Fairfax, Virginia. Am. Compl. ¶ 18. During Ms. Ali's surgery, a LAP-BAND manufactured and marketed by Allergan was surgically inserted in her, and Ms. Ali was discharged on December 21, 2009. Id. at ¶ 19. On December 23, 2009, Ms. Ali was admitted to Reston Hospital Center in Reston, Virginia, complaining of difficulty breathing and swallowing, and it was determined that she required a second surgery. Id. at ¶ 20. During this second surgery, the original LAP-BAND was explanted and replaced by another LAP-BAND, which was also manufactured and marketed by Allergan. Id.
On April 15, 2011, Ms. Ali was admitted to Inova Fair Oaks Hospital again because she was experiencing severe abdominal pain in her lower abdominal quadrant. Id. at ¶ 21. On April 19, 2011, an esophagogastroduodenoscopy ("EGD") was performed on Ms. Ali, and it was determined that the LAP-BAND implanted on December 23, 2009, had eroded. Id. The LAP-BAND was surgically removed on April 20, 2011, by Dr. Hazim Elariny. Id. at ¶ 22. During the surgery, Dr. Elariny discovered a dense extensive inflammatory mass extending from the left upper quadrant to the right lower quadrant surrounding the tubing of the LAP-BAND, phlegmon formation, and multiple abscesses. Id. at ¶ 23. Dr. Elariny performed a blunt dissection and electrocautery of the inflammatory mass, a gastronomy involving removal of the LAP-BAND, and a saline washing and draining of the abdominal cavity. Id. at ¶ 24. Ms. Ali suffered and continues to suffer from complications arising from the erosion of the LAP-BAND. Id. at ¶ 25.
Plaintiffs allege that, in electing the implantation of the LAP-BAND as a weight loss measure, Ms. Ali and her physician relied upon representations made by Allergan in its labeling and marketing of the device that turned out to be false. Id. at ¶ 27. These representations included the following, inter alia: the LAP-BAND was tested and found to be safe and effective; theLAP-BAND was the safest and healthiest weight loss surgery; the LAP-BAND had the...
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