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.

McLeod v. Sandoz Inc.

United States District Court, D. South Carolina, Florence Division

March 23, 2018

James E. McLeod and Glenda McLeod, Plaintiffs,
v.
Sandoz, Inc., Defendant.

          ORDER

          R. Bryan Harwell United States District Judge

         This matter is before the Court on Defendant Sandoz, Inc.'s [ECF No. 24] motion to dismiss the amended complaint. For the reasons stated below, the Court grants Defendant Sandoz, Inc.'s motion to dismiss.[1]

         Background

         This case arises from Plaintiff James E. McLeod's use of the pharmaceutical drug amiodarone for treatment of his non-life threatening atrial fibrillation. Plaintiffs allege that after ingesting amiodarone, which was manufactured by Defendant Sandoz, Inc. (“Sandoz”), McLeod developed and was diagnosed with shortness of breath and chronic obstructive and progressive pulmonary disease. [Amended Complaint, ECF No. 23, at ¶ 18]. The amiodarone tablets were manufactured and sold by Sandoz as a generic version of Wyeth's Cordarone®.

         Plaintiffs generally allege that Sandoz failed to adequately warn Plaintiff of the risks associated with the off-label use of amiodarone to treat non-life threatening atrial fibrillation, particularly the risk of pulmonary toxicity-lung disease. Plaintiffs contend Sandoz failed to adequately warn when it failed to provide a Medication Guide with Plaintiff's prescription. Plaintiffs allege the risks of amiodarone were disclosed in the Medication Guide and had the Plaintiff received the Medication Guide, he would have been aware of the serious lung related side effects and would not have taken amiodarone. Id. at ¶¶ 38-39. Plaintiffs also generally allege that Sandoz fraudulently marketed amiodarone for the off-label use of treating non-life threatening atrial fibrillation.

         Plaintiffs filed their Complaint on May 23, 2016, alleging claims against Defendant Sandoz, Inc. for: 1) strict products liability - failure to warn; 2) negligence - failure to warn; 3) negligence -“off label” marketing and sale; 4) negligence per se - “off label” marketing/sale and failure to provide Medication Guide; 5) fraud and deceit; and 6) loss of consortium.

         In an Order dated March 31, 2017, the Court dismissed Plaintiffs' claims for 1) strict products liability - failure to warn; 2) negligence - failure to warn; 3) negligence - “off label” marketing and sale; and 4) negligence per se - “off label” marketing/sale and failure to provide Medication Guide. See [Order, ECF No. 21]. Specifically, the Court held that Plaintiffs' failure to warn claims based on the failure to provide a Medication Guide were impliedly preempted under Buckman v. Plaintiffs' Legal Comm., 531 U.S. 341 (2001) and 21 U.S.C. § 337(a) because the requirement to provide a Medication Guide to distributors is based solely on the requirements of the FDCA and related regulations, and there is no parallel duty to provide a Medication Guide under South Carolina law. In a footnote, the Court noted that Plaintiff's claims relating to the failure to provide a Medication Guide were also due to be dismissed because, pursuant to the learned intermediary doctrine, the manufacturer's duty to warn extended only to the prescribing physicians, not the patient. The Court also held that Plaintiffs' negligent "off-label" promotion claim was impliedly preempted under Buckman.

         The only claims that were not dismissed were Plaintiffs' fraudulent off-label marketing claim and the loss of consortium claim. However, as to the fraudulent off-label marketing claim, the Court found that the original Complaint failed set forth facts sufficient to establish causation in light of the learned intermediary doctrine because: 1) Plaintiffs had not alleged that Plaintiff's prescribing physicians were unaware of the warnings set forth in the Medication Guide or the risk of pulmonary toxicity or lung problems possibly resulting in death; and 2) Plaintiffs had not alleged that the prescribing physicians would have changed their decision to prescribe amiodarone had they been aware of the risk of pulmonary toxicity or lung problems resulting in death. The Court permitted Plaintiffs to amend their fraudulent off-label marketing claim to state facts sufficient to establish causation under the learned intermediary doctrine. The Court also advised Plaintiffs that any amendment to their fraudulent off-label marketing claim must comply with the specificity requirements for fraud claims under Rule 9(b) of the Federal Rules of Civil Procedure.

         On April 14, 2017, Plaintiffs filed an Amended Complaint alleging claims for fraudulent off-label marketing and loss of consortium. [Amended Complaint, ECF No. 23]. In response, Sandoz filed a second motion to dismiss arguing that Plaintiffs disregarded the Court's directives and filed an Amended Complaint that contained many of the same deficiencies as the first complaint. Sandoz argues that Plaintiffs' Amended Complaint fails to establish causation under the learned intermediary doctrine. Sandoz also argues the Amended Complaint fails to meet the particularity requirements for fraud claims under Rule 9(b) of the Federal Rules of Civil Procedure. Sandoz further argues that Plaintiffs' Amended Complaint contains reworded claims that the Court clearly dismissed with prejudice.

         Even though Plaintiffs' Amended Complaint attempts to resurrect claims that were already dismissed with prejudice, the only claims properly before this Court at this time are Plaintiffs' fraudulent off-label marketing claim and the loss of consortium claim.

         In their fraudulent off-label marketing claim, Plaintiffs allege that Sandoz owed a duty to provide honest, accurate, and complete information to Plaintiff, his physicians, and the public. [Amended Complaint, ECF No. 23 at ¶ 89]. Plaintiffs allege that Sandoz misled and deceived Plaintiff, his physicians, and the public into believing that amiodarone was safe and effective for use in the treatment of atrial fibrillation. Id. at ¶ 90. Sandoz allegedly concealed and understated the health hazards and risks associated with the "off-label" use of amiodarone to treat non-life threatening atrial fibrillation. Id. at 92. Sandoz allegedly failed to fully inform Plaintiffs' physicians of the true defects in amiodarone. Id. at ¶ 95.

         Plaintiffs allege Sandoz concealed material facts they were obligated to disclose, including that amiodarone was not FDA approved for the treatment of atrial fibrillation, was not an appropriate "first line of treatment" for atrial fibrillation, is required to be accompanied by a Medication Guide intended to warn the consumer of the serious, life-threatening complications from the use of amiodarone, and was approved by the FDA only for limited use without any associated clinical trials. Id. at ¶ 99. Plaintiffs allege Sandoz engaged other medical professionals to deceptively promote the off-label use and purposely avoided detailed discussions of adverse reactions related to lung and vision injuries. Id. at ¶ 100. Plaintiffs allege the prescribing physicians justifiably and reasonably relied to their detriment on Sandoz's misrepresentations and omissions and their reliance on those misrepresentations and omissions proximately caused Plaintiff's injuries. Id. at ¶ 101.

         Rule 12(b)(6) Standard

         When deciding a motion to dismiss made under Federal Rule of Civil Procedure 12(b)(6), the Court must accept all well-pled facts alleged in the complaint as true and draw all reasonable inferences in the plaintiff's favor. Nemet Chevrolet, Ltd. v. Consumeraffairs.com, Inc., 591 F.3d 250, 253 (4th Cir. 2009). A complaint must state a “plausible claim for relief” to survive a 12(b)(6) motion to dismiss. Walters v. McMahen, 684 F.3d 435, 439 (4th Cir. 2012) (quoting Ashcroft v. Iqbal, 556 U.S. 662, 679 (2009)). The Court will not dismiss the plaintiff's complaint so long as he provides adequate detail about his claims to show he has a “more-than-conceivable chance of success on the merits.” Owens v. Baltimore City State's Attorneys Office, 767 F.3d 379, 396 (4th Cir. 2014) (citing Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007)). “Once a claim has been stated adequately, it may be supported by showing any set of facts consistent with the allegations in the complaint.” Twombly, 550 U.S. at 563. A complaint will survive a motion to dismiss if it contains “enough facts to state a claim to relief that is plausible on its face.” Id. at 570. ...


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.