Hannan v. Boston Scientific Corporation

Background

Tami Hannan and Daniel Hannan filed an amended complaint alleging that Boston Scientific’s Obtryx Transobturator Mid-Urethral Sling System was implanted in Tami Hannan during surgery on or about December 3, 2012. They alleged that the product caused significant pain, expense, embarrassment, disfigurement, and other harm. Their amended complaint asserted seven causes of action: product liability based on defective manufacture and design; product liability based on failure to warn; negligence; breach of express warranty; negligent misrepresentation; violation of California’s Unfair Competition Law; and loss of consortium.

Boston Scientific moved to dismiss under Federal Rule of Civil Procedure 12(b)(6), which tests whether a complaint alleges legally sufficient claims. The court also applied Federal Rule of Civil Procedure 9(b) to the negligent-misrepresentation claim because that claim involves alleged fraud-like conduct and therefore must describe the alleged misconduct with particularity.

Rulings on the Claims

First Claim: Defective Manufacture and Design

The court granted the motion to dismiss the first claim. It held that California law does not permit strict-liability design-defect claims against manufacturers of implanted medical devices. The court also concluded that, to the extent the plaintiffs intended their design-defect theory to be a failure-to-warn theory, it duplicated their separate failure-to-warn claims and still did not state a strict-liability design-defect claim.

The plaintiffs also failed to identify a manufacturing defect in the particular Obtryx Sling implanted in Tami Hannan. Their allegations described alleged problems with the entire product line rather than a deviation in the specific implanted product. The court therefore concluded that the manufacturing allegations effectively advanced a design-defect theory.

The strict-liability design-defect claim was dismissed with prejudice. The strict-liability manufacturing-defect claim was dismissed with leave to amend.

Second Claim: Strict-Liability Failure to Warn

The court denied the motion to dismiss the second claim. It applied California’s learned-intermediary doctrine, which means that for an implanted medical device the manufacturer’s warning duty runs to the patient’s physicians rather than directly to the patient.

The court found that the plaintiffs had plausibly alleged that Boston Scientific failed to provide adequate warnings to Tami Hannan’s implanting physicians. The allegations addressed warnings and instructions concerning the risks and benefits of the pelvic mesh products, the product’s directions for use, physician training, and marketing. The second claim therefore remained pending.

Third Claim: Negligence

The court granted in part and denied in part the motion to dismiss the negligence claim. The plaintiffs asserted negligent design, negligent manufacturing, and negligent failure-to-warn theories.

The negligent failure-to-warn theory survived. The court found that the plaintiffs identified Tami Hannan’s physicians, alleged that Boston Scientific failed to adequately warn or instruct them, and identified subjects that the warnings allegedly omitted. The court also found that the alleged injuries were sufficiently connected to the alleged product defects at the pleading stage.

The negligent manufacturing-defect theory did not survive because the plaintiffs did not allege that the specific Obtryx Sling implanted in Tami Hannan was negligently manufactured. That claim was dismissed with leave to amend. The negligent design-defect theory survived because the plaintiffs identified alleged design problems with Boston Scientific’s pelvic mesh products and alleged that the Obtryx Sling was one of those products.

Fourth Claim: Breach of Express Warranty

The court granted the motion to dismiss the express-warranty claim and dismissed it with leave to amend. The plaintiffs alleged that Boston Scientific represented that its products were safe, effective, and fit for their intended purposes. But they did not identify the written representations made to Tami Hannan’s physician or allege how that physician relied on them. The court held that these allegations were insufficient under the learned-intermediary doctrine and California warranty law.

Fifth Claim: Negligent Misrepresentation

The court granted the motion to dismiss the negligent-misrepresentation claim and dismissed it with leave to amend. The claim was subject to Rule 9(b), which requires specific allegations about the who, what, when, where, and how of the alleged misrepresentation or omission. The plaintiffs referred generally to an overall deceptive campaign concerning the Obtryx Sling but did not identify a specific deceptive event or circumstance.

Sixth Claim: Unfair Competition

The plaintiffs agreed to dismiss their claim under California Business and Professions Code section 17200 and any related request for attorney’s fees. The sixth claim was dismissed with prejudice.

Seventh Claim: Loss of Consortium

The court denied the motion to dismiss Daniel Hannan’s loss-of-consortium claim. The claim depends on an actionable tort injury to the spouse, but the court found that some of Tami Hannan’s tort claims remained plausible. The loss-of-consortium claim therefore also survived the motion to dismiss.

Disposition and Amendment

The court denied dismissal of the second claim and the seventh claim. It granted dismissal of the first claim, with the strict-liability design-defect portion dismissed with prejudice and the strict-liability manufacturing-defect portion dismissed with leave to amend. It granted in part and denied in part dismissal of the third claim, with the negligent-manufacturing portion dismissed with leave to amend. It granted dismissal of the fourth and fifth claims, each with leave to amend, and dismissed the sixth claim with prejudice.

The plaintiffs were ordered to file any amended complaint within 21 days. Any amended complaint had to state the remaining product-liability theories separately, and no new parties or causes of action could be added without the court’s permission or Boston Scientific’s agreement.