John Muldoon v. DePuy Orthopaedics, Inc.

Background

John Muldoon’s Second Amended Complaint asserted claims arising from a 2007 left total hip replacement. The complaint alleged that a ceramic-on-metal implant containing DePuy-manufactured components broke down, released toxic cobalt-chromium metal ions and particles, and caused injuries, pain, missed work, and the need for revision surgery in 2014. The complaint asserted eighteen causes of action against numerous defendants; thirteen were asserted against the DePuy Defendants.

The DePuy Defendants moved to dismiss all claims against them under Federal Rule of Civil Procedure 12(b)(6), which tests whether a complaint alleges enough facts to support a legally recognized claim. Claims sounding in fraud also had to meet Rule 9(b), which requires the circumstances of the alleged fraud to be stated with particularity.

Federal preemption

DePuy argued that the entire action was barred by federal preemption because the Food and Drug Administration had approved the Pinnacle CoMplete Acetabular Hip System through the premarket approval process. Muldoon disputed that he received that system. The court found that the complaint alleged that individually approved components were implanted in Muldoon but did not establish that those components were the same as the later-approved Pinnacle CoMplete system. Because resolving that issue required deciding a factual dispute, the court declined to dismiss the action on preemption grounds. It stated that the issue might be revisited on summary judgment.

Claim-by-claim rulings

Negligence

The court held that Muldoon adequately alleged harm and causation by alleging that the metal portion of the prosthesis broke down, released metal debris into his body, caused pain and missed work, and required replacement of the hip. The court also found that the alleged degradation of the product was sufficient at the pleading stage to allege a breach of duty. DePuy’s motion to dismiss the negligence claim was DENIED.

Manufacturing defect

The court found sufficient allegations that the implanted components broke apart, created metallic debris, or became loose or detached; that Muldoon suffered harm; and that the defect caused that harm. DePuy’s motion to dismiss the manufacturing-defect claim was DENIED.

Design defect

Applying California law, the court held that strict-liability design-defect claims against manufacturers concerning implanted medical devices are barred. DePuy’s motion to dismiss the design-defect claim was GRANTED, and the claim was DISMISSED WITH PREJUDICE because amendment would be futile.

Failure to warn

DePuy relied on the learned-intermediary doctrine, under which a manufacturer may satisfy its duty to warn end users by adequately warning the physician or other intermediary under the circumstances described by California law. The court found a factual dispute about whether DePuy adequately warned the surgeon, Dr. David Dodgin, and concluded that the issue could not be resolved on a motion to dismiss. DePuy’s motion to dismiss the failure-to-warn claim was DENIED without prejudice to considering the argument on summary judgment.

Failure to test

The court held that California law does not recognize strict liability for failure to test as an independent cause of action. It explained that testing theories may be pursued as part of negligence, design-defect, manufacturing-defect, or failure-to-warn claims. DePuy’s motion to dismiss the failure-to-test claim was GRANTED, and the claim was DISMISSED WITH PREJUDICE.

Express and implied warranty

The court held that California law generally requires contractual privity for the warranty claims at issue. Muldoon’s complaint did not allege that he purchased the components directly from DePuy or that he relied on specific statements from DePuy that could support an exception for an express warranty claim. DePuy’s motions to dismiss the express-warranty and implied-warranty claims were each GRANTED WITH LEAVE TO AMEND. The court specified that an amended complaint alleging direct purchase must include documentary proof or specific payment details. For the express-warranty claim, Muldoon could alternatively allege specific statements from DePuy and explain who made them, when and where they were made, how they were presented, and how he relied on them.

Intentional and negligent misrepresentation

The court held that the complaint’s general references to marketing materials and statements that the components were safe, effective, and high-quality did not satisfy Rule 9(b). The complaint did not identify the specific materials, their contents, or facts showing direct contact between DePuy and Muldoon. DePuy’s motions to dismiss the intentional-misrepresentation and negligent-misrepresentation claims were GRANTED WITH LEAVE TO AMEND, allowing Muldoon to allege specific misrepresentations.

False Advertising Law, Consumer Legal Remedies Act, and Unfair Competition Law

The court found that the false-advertising, Consumer Legal Remedies Act, and Unfair Competition Law claims were inadequately pleaded because they did not identify the particular advertisements or marketing materials, when and where the statements were made, who communicated them, or how they were communicated. The court also found that statements describing the components as safe, effective, and high-quality were generalized statements that constituted nonactionable “puffery.” DePuy’s motion to dismiss these three claims was GRANTED WITH LEAVE TO AMEND. For the Consumer Legal Remedies Act claim, the court additionally held that Muldoon had not adequately alleged that he was a consumer who entered into a consumer transaction with DePuy; amendment required purchase documentation or specific payment details.

Civil RICO

The court held that Muldoon had not adequately pleaded a civil claim under the Racketeer Influenced and Corrupt Organizations Act. The complaint did not allege the DePuy-Dr. Dodgin enterprise described in Muldoon’s opposition, did not plead a pattern of racketeering activity or predicate acts with the required particularity, and did not identify the California tort or torts supporting the alleged injury to business or property. The court nevertheless concluded that alleged medical expenses, lost wages, and lost earning capacity could potentially satisfy the injury requirement if properly connected to a qualifying property interest and the alleged conduct. DePuy’s motion to dismiss the civil RICO claim was GRANTED WITH LEAVE TO AMEND.

Punitive damages

The court declined to dismiss or strike Muldoon’s request for punitive damages at the motion-to-dismiss stage. Because the failure-to-warn claim remained and could theoretically support punitive damages, DePuy’s motion concerning that remedy was DENIED.

Judicial notice and final disposition

The court GRANTED DePuy’s request for judicial notice of an FDA safety and effectiveness document concerning the Pinnacle CoMplete system. It also GRANTED Muldoon’s request for judicial notice of an FDA document concerning withdrawal of the Pinnacle Complete Acetabular Hip System.

Overall, Judge Phyllis J. Hamilton’s order GRANTED IN PART and DENIED IN PART DePuy’s motion to dismiss. Muldoon could file an amended complaint within 28 days, and the order stated that no new parties or causes of action could be added without permission or the agreement of all defendants.