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.

Young v. Bristol-Myers Squibb Co.

United States District Court, N.D. Mississippi, Greenville Division

February 22, 2017

KAMILAH YOUNG PLAINTIFF
v.
BRISTOL-MYERS SQUIBB COMPANY; ASTRAZENECA PLC; ASTRAZENECA LP; ASTRAZENECA PHARMACEUTICALS LP; and ASTRAZENECA AB DEFENDANTS

          MEMORANDUM OPINION AND ORDER

          DEBRA M. BROWN UNITED STATES DISTRICT JUDGE.

         This products liability action is before the Court on the motions to dismiss of: (1) Bristol-Myers Squibb Company, and AstraZeneca Pharmaceuticals LP, Doc. #7; and (2) AstraZeneca AB, AstraZeneca LP, and AstraZeneca PLC, Doc. #20.

         I

         Procedural History

         On April 27, 2016, Kamilah Young filed a complaint in the Circuit Court of Sunflower County, Mississippi, against Bristol-Myers Squibb Company, AstraZeneca PLC, Astrazeneca LP, AstraZeneca Pharmaceuticals LP, and AstraZeneca AB. Doc. #2. In her complaint, Young seeks to recover for injuries and damages caused by her ingestion of Farxiga, a drug researched, developed, sold, and/or marketed by the various defendants. Id.

         On May 31, 2016, Bristol-Myers Squibb Company and AstraZeneca Pharmaceuticals LP (“Removing Defendants”) removed the state court action to this Court. Doc. #1. Approximately one week later, on June 7, 2016, the Removing Defendants filed a motion to dismiss Young's complaint under Rule 12(b)(6) of the Federal Rules of Civil Procedure. Doc. #7. Young responded in opposition to the motion to dismiss on June 21, 2016, Doc. #17; and the Removing Defendants replied on June 29, 2016, Doc. #18.

         On July 7, 2016, AstraZeneca AB, AstraZeneca LP, and AstraZeneca PLC (“Non-Removing Defendants”), filed a document “join[ing] and rely[ing] on” the Removing Defendants' motion to dismiss and reply.[1] Doc. #20. Young responded in opposition to this filing on July 21, 2016, Doc. #29; and the Non-Removing Defendants replied on August 1, 2016, Doc. #32.

         II

         Relevant Standard

To survive a motion to dismiss [for failure to state a claim], a complaint must contain sufficient factual matter, accepted as true, to state a claim to relief that is plausible on its face. A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged. The plausibility standard is not akin to a probability requirement, but it asks for more than a sheer possibility that a defendant has acted unlawfully. Where a complaint pleads facts that are merely consistent with a defendant's liability, it stops short of the line between possibility and plausibility of entitlement to relief.

Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (internal citations and punctuation omitted) (citing Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555-58 (2007)). Under this standard, a court must “accept all well-pleaded facts as true, viewing them in the light most favorable to the plaintiff.” New Orleans City v. Ambac Assurance Corp., 815 F.3d 196, 199-200 (5th Cir. 2016) (internal quotation marks omitted). However, “a plaintiff's obligation to provide the grounds of his entitlement to relief requires more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do so.” Twombly, 550 U.S. at 555.

         III

         Factual Allegations

         A. Farxiga Development and Effects

         At some point before 2014, Bristol-Myers Squibb and the AstraZeneca Defendants were involved in the research, development, and testing of Farxiga, a sodium-glucose cotransporter 2 (“SGLT-2”) inhibitor designed to treat type-2 diabetes. Doc. #2 at ¶¶ 3-16, 23-24. SGLT-2 inhibitors inhibit renal glucose reabsorption with the goal of lowering blood glucose. Id. at ¶ 32. When taken, SGLT-2 inhibitors cause the kidneys to excrete, rather than metabolize, glucose. Id.

         Because Farxiga, like other SGLT-2 inhibitors, prevents absorption of glucose, the “body's primary fuel, ” the bodies of patients on the medication break down fat instead. Id. at ¶ 33. When fat is broken down, acids called ketones are introduced into the body's blood stream, creating the potential for acidosis (excessive blood acidity). Id. at ¶ 33. Generally, to maintain blood-acid balance, the body excretes excess ketones through urination. Id. at ¶ 35. Accordingly, a patient suffering from ketoacidosis (excessive blood acidity caused by ketones) will generally report high blood-glucose levels and frequent urination. Id. at ¶ 34. However, “because Farxiga places the kidneys under duress by expelling significant amounts of glucose that has not been metabolized through the urinary tract, Farxiga users are often unable to obtain blood-acid balance without medical intervention.” Id. at ¶ 35.

         In the general population, ketoacidosis is rare for type-2 diabetics and “much more common” in type-1 diabetics. Id. at ¶ 38. This discrepancy is caused by the fact that type-1 diabetics, like Farxiga patients, are unable to metabolize glucose. Id.

         B. Farxiga Approval and Marketing

         On January 8, 2014, the United States Food and Drug Administration approved Farxiga for treatment of type-2 diabetes. Id. at ¶ 23. Following approval, the defendants each participated in the manufacturing, marketing, distribution, and sale of Farxiga. Id. at ¶ 28. Although Farxiga was indicated for only glycemic control in adult type-2 diabetics, the defendants marketed Farxiga for other purposes, including weight loss and blood pressure reduction. Id. at ¶ 37.

         On May 15, 2015, the FDA issued a Public Health Advisory linking SGLT-2 inhibitors, including Farxiga, to diabetic ketoacidosis, a condition which can result in organ failure and death. Id. at ¶ 39. On December 4, 2015, the FDA, which had also received reports linking Farxiga to kidney injuries, including renal failure, required the defendants to change the Farxiga warning label to warn of ketoacidosis and urosepsis. Id. at ¶¶ 40-41. Before and after the FDA's advisories, the defendants “aggressively promote[d] Farxiga” and “did nothing to alert United States consumers, and health care professionals of the risks associated with Farxiga.”[2] Id. at ¶¶ 42-43.

         C. Young's Use of Farxiga

         In or about May 2015, Young was prescribed Farxiga and began taking it as prescribed. Doc. #2 at ¶ 49. On or about May 31, 2015, Young fell ill with ketoacidosis. Id. at ¶ 54. On June 22, 2015, Young suffered renal failure and was hospitalized for approximately ten days. Id. at ¶¶ 54-55. This action followed.

         IV Analysis

         In her complaint, Young asserts ten causes of action against the defendants based on: (1) strict liability (Count One); (2) manufacturing defect (Count Two); (3) design defect (Count Three); (4) failure to warn (Count Four); (5) negligence (Count Five); (6) breach of express warranty (Count Six); (7) breach of implied warranty (Count Seven); (8) negligent misrepresentation (Count Eight); (9) fraud (Count Nine); and (10) “violation of consumer protection laws” (Count Ten).

         A. Common Law Claims (Counts One, Five, Seven, Eight, and Nine)

         As an initial matter, the defendants argue in their motion that the Mississippi Products Liability Act subsumes Young's common law claims so as to require dismissal of the claims based on strict liability, negligence, breach of implied warranty, negligent misrepresentation, and fraud. Doc. #8 at 5-8.

         The MPLA, which applies “in any action for damages caused by a product, including, but not limited to, any action based on a theory of strict liability in tort, [and] negligence or breach of implied warranty, except for commercial damage to the product itself” provides, in relevant part:

The manufacturer, designer or seller of the product shall not be liable if the claimant does not prove by the preponderance of the evidence that at the time the product left the control of the manufacturer, designer or seller:
(i) 1. The product was defective because it deviated in a material way from the manufacturer's or designer's specifications or from otherwise identical units manufactured to the same manufacturing specifications, or
2. The product was defective because it failed to contain adequate warnings or instructions, or 3. The product was designed in a defective manner, or 4. The product breached an express warranty or failed to conform to other express factual representations upon which the claimant justifiably relied in electing to use the product; and
(ii) The defective condition rendered the product unreasonably dangerous to the user or consumer; and
(iii) The defective and unreasonably dangerous condition of the product proximately caused the damages for which recovery is sought.

Miss. Code Ann § 11-1-63(a). Though the defendants argue that Young's claims for strict liability, negligence, breach of implied warranty, negligent misrepresentation, and fraud should be dismissed as subsumed by the MPLA, dismissal is not required merely because a claim falls under the MPLA's purview.

         By its express terms, the MPLA applies to “any action for damages caused by a product.” Miss. Code Ann. § 11-1-63(a). Although “[t]he statute clearly contemplates suits may be brought under the statute, ” the MPLA “does not preclude or bar an action, although it clearly creates what some may argue to be formidable obstacles for a plaintiff to overcome in order to prevail.” R.J. Reynolds Tobacco Co. v. King, 921 So.2d 268, 273 (Miss. 2005). Accordingly, common law claims based on damages caused by a product are subsumed by the MPLA and must be analyzed under the statute. Elliott v. El Paso Corp., 181 So.3d 263, 269 (Miss. 2015). Common law claims for damages caused by a product which seek to impose liability outside the MPLA's framework must be dismissed for failure to state a claim. See id. (“Plaintiffs' negligence and strict-liability-based products-liability claims against CPChem, Tri-State, and TGP must be analyzed under the MPLA. To the extent that Plaintiffs purport to make common-law negligence or strict-liability claims based on damages caused by odorant fade, we find that those claims fail as a matter of law.”).

         Practically, where a common law claim is subsumed by the MPLA and is brought alongside products liability claims based on the same theory of recovery, the proper course is to dismiss the common law claim to the extent it is duplicative of the parallel products liability counts. See, e.g., Cross v. Laboratories, No. 1:05-cv-170, 2014 WL 11430933, at *3 (N.D. Miss. May 12, 2014) (“Plaintiffs' claims for negligence and warranty/misrepresentation are duplicative and subsumed by the MPLA and are dismissed. All claims under the MPLA shall remain viable at this juncture ....”); Arnoult v. CL Med. SARL, No. 1:14-cv-271, 2015 WL 5554301, at *3 (S.D.Miss. Sep. 21, 2015) (“Plaintiff's negligence claims against Uroplasty are governed by the MPLA, and Count 3 of the Complaint is subsumed by Counts 1 and 2.”) (internal citation omitted). To the extent a subsumed common law count is asserted “as an independent tort claim outside the scope of the MPLA, ” the count must be dismissed for failure to state a claim.” Id. (“The Court grants Uroplasty's motion to dismiss Count 3 insofar as it is asserted as an independent tort claim outside the scope of the MPLA.”).

         1. Strict Liability (Count One)

         There is no dispute that a claim for strict liability based on damage caused by a product is subsumed by the MPLA. Miss. Code Ann § 11-1-63(a). Young's claim for strict liability includes allegations regarding: (1) defective design; (2) failure to warn; and (3) defective manufacture. Doc. #2 at ¶¶ 73-74, 81-82. In this regard, her strict liability claim in Count One is subsumed by Count Two (manufacturing defect), Count Three (design defect), and Count Four (failure to warn). Accordingly, Count One will be dismissed as duplicative of Young's product liability claims. To the extent Count One attempts to impose liability on other grounds, it will be dismissed for failure to state a claim.

         2. Negligence (Count Five)

         Claims for negligence are also subsumed by the MPLA. Miss. Code Ann § 11-1-63(a). Young's claim for negligence includes allegations regarding: (1) defective design; (2) failure to warn; and (3) defective manufacture. Doc. #2 at ¶¶ 135, 138-40. In this regard, the claim is subsumed by Count Two (manufacturing defect), Count Three (design defect), and Count Four (failure to warn). Accordingly, to the extent Young's negligence claim in Count Five is subsumed by the product liability claims, Count Five will be dismissed as duplicative. To the extent Count Five attempts to impose liability on other grounds, it will be dismissed for failure to state a claim.

         3. Breach of Implied Warranty (Count Seven)

         Claims for breach of implied warranty are subsumed by the MPLA. Miss. Code Ann. § 11-1-63. Young's claim for breach of implied warranty in Count Seven alleges that the defendants breached the implied warranties of merchantability and fitness for particular purpose because Farxiga “was unduly dangerous and caused undue injuries ....” Doc. #2 at ¶ 174. In this regard, the claim is subsumed by Count Three (design defect). Accordingly, to the extent the claim is subsumed by the product liability claims, Count Seven will be dismissed as duplicative. To the extent Count Seven attempts to impose liability on other grounds, it will be dismissed for failure to state a claim.

         4. Negligent Misrepresentation (Count Eight) and Fraud (Count Nine)

         In a products liability action, negligent misrepresentation and fraud claims are subsumed by the MPLA unless the claims are “unrelated to the [product's] alleged defects.” Elliott, 181 So.3d at 269. Young, citing this provision, contends that her “claims for Fraud and negligent misrepresentation are governed by the common law, not the MPLA.” Doc. #17 at 18. However, both claims seek to recover for damages caused by the allegedly defective Farxiga and, therefore, fall within the MPLA's ambit. See Doc. #2 at ¶¶ 195, 214. In this regard, the claims are subsumed by Count Three (design defect) and Count Four (failure to warn) and must be dismissed as duplicative. To the extent Counts Eight and Nine attempt to impose liability on other grounds, they will be dismissed for failure to state a claim.

         5. Summary

         Young's common law claims for strict liability, negligence, breach of implied warranty, negligent misrepresentation, and fraud are subsumed by the MPLA. To the extent these common law claims are duplicative of Young's product liability claims, the common law claims must be dismissed as duplicative. To the extent the common law claims are asserted as independent torts, they must be dismissed for failure to state a claim.

         B. Design Defect (Count Three)

         The defendants argue that Young's claim for defective design must fail because Young has failed to plead a feasible design alternative and because federal law preempts the design defect claims.

         1. Preemption

         “Under the doctrine of federal preemption, a federal law supersedes or supplants an inconsistent state law or regulation.” United States v. Zadeh, 820 F.3d 746, 751 (5th Cir. 2016). Under the doctrine of conflict preemption, federal law will supersede or supplant state law “when compliance with both [the] state and federal law is impossible.” Id. “Federal preemption is an affirmative defense that a defendant must plead and prove.” Fisher v. Halliburton, 667 F.3d 602, 610 (5th Cir. 2012).” Accordingly, “[u]nless the complaint itself establishes the applicability of a federal-preemption defense - in which case the issue may properly be the subject of a Rule 12(b)(6) motion - a defendant should ordinarily raise preemption in a Rule 12(c) motion for judgment on the pleadings or a Rule 56 motion for summary judgment.” Id. (internal footnotes omitted).

         The defendants argue that federal law preempts Young's design defect claims because Young “alleges that Defendants should have designed Farxiga differently. ... [B]ut, critically, federal law prohibits Defendants from changing the design of Farxiga in a meaningful way without prior FDA approval.” Doc. #8 at 21.

         Today, pharmaceutical design defect claims are evaluated primarily against the framework set forth in Mutual Pharmaceutical Co., Inc. v. Bartlett, under which a court begins by identifying a defendant's state and federal law duties and then asks whether it is possible to comply with both duties. 133 S.Ct. 2466, 2475-77 (2013). In Bartlett, the United States Supreme Court considered whether a design defect claim brought under New Hampshire state law against a generic drug manufacturer was preempted by federal law. The Supreme Court held that, under New Hampshire state law, a manufacturer must “ensure that the products they design, manufacture, and sell are not ‘unreasonably dangerous.'” Id. at 2474. It further noted that under the risk-utility approach used in New Hampshire, a manufacturer could satisfy this duty “either by changing a drug's design or by changing its labeling.” Id. Because federal law prevents a generic drug manufacturer from changing the drug's design or its label, the Supreme Court concluded that federal law preempted the plaintiff's state law claims. Id. at 2476-77.

         a. State Law Duties

         Under Mississippi law, a manufacturer has a duty to manufacture a product which is not defective and “unreasonably dangerous.” Miss. Code Ann. § 11-1-63. “In most cases, the unreasonable danger presented by a product's design is the factor that makes the design defective.” Williams v. Bennett, 921 So.2d 1269, 1274 (Miss. 2006). Unreasonable danger, in turn, is determined under the risk-utility approach utilized by most courts in the country. See Smith v. Mack Trucks, Inc., 819 So.2d 1258, 1262-64 (Miss. 2002).

Under the risk-utility theory, a plaintiff may recover for any injury as a result of the use of a dangerous product, provided that the utility of the product is outweighed by its danger. In balancing a product's utility against the risk of injury it creates, the factors to be considered are:
(1) The usefulness and desirability of the product-its utility to the user and 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.