Court: District Court, S.D. Texas; March 23, 2016; Federal District Court
Defendant Medtronic, Inc. filed a Motion for Judgment on the Pleadings under Rule 12(c) of the Federal Rules of Civil Procedure, which the Court granted in full, resulting in the dismissal of Plaintiff Ronnie Morgan's claims with prejudice. Morgan's lawsuit, based on Texas state law, included allegations of negligence, strict liability, and breach of warranties related to the SynchroMed II Implantable Infusion System, which he claims malfunctioned and caused him to experience withdrawal symptoms. The case was initiated in state court on January 15, 2015, asserting seven causes of action, including negligence and various forms of strict product liability. Medtronic removed the case to federal court, raising defenses such as federal preemption and failure to provide required pre-suit notice for warranty claims. The Court found no issues of material fact and determined that Medtronic was entitled to judgment as a matter of law, agreeing that the SynchroMed II Pump is a Class III PMA device and that Morgan’s lack of pre-suit notice precludes his warranty claims. The standard for granting a motion under Rule 12(c) aligns with that for a motion to dismiss, requiring acceptance of the complaint's factual allegations as true and evaluating if the claimant is entitled to present evidence in support of his claims.
To prevent dismissal, a plaintiff must present sufficient factual allegations to establish a claim for relief that is plausible on its face, as mandated by legal precedent. The standard of plausibility goes beyond mere accusations and requires factual content from which a court can reasonably infer the defendant's liability. Claims that only suggest the possibility of liability do not meet the threshold for plausibility. Courts will not accept conclusory allegations or unwarranted inferences as true. A complaint may be dismissed if it omits necessary elements for relief. When evaluating a motion to dismiss, courts generally rely on the complaint and any pertinent documents attached to it or referenced within. The court may also take judicial notice of public records, including state court filings. In the context of a motion under Fed. R. Civ. P. 12(c), which seeks to resolve undisputed material facts, the court has discretion regarding the inclusion of evidence outside the pleadings. If such evidence is considered, the motion must be treated as one for summary judgment under Rule 56, allowing all parties to provide relevant material.
Medtronic's 12(c) Motion includes two key documents: the SynchroMed II Programmable Drug Infusion System Premarket Approval Database Listing and the SynchroMed Premarket Approval Database Listing, both of which are public records that the Court can consider without converting the motion to one for summary judgment. These documents, referenced in Morgan's Original Complaint, are critical as they confirm the SynchroMed II Pump is a Class III, PMA approved medical device. Medtronic asserts that Morgan's claims should be dismissed on two grounds: first, they are expressly preempted under 21 U.S.C. § 360k(a) due to state-law bases, and second, they are impliedly preempted under 21 U.S.C. § 337(a) regarding enforcement of federal law. Additionally, Medtronic argues that Morgan's breach-of-warranty claims fail due to noncompliance with Tex. Bus. Com. Code § 2.607(c)(1) pre-suit notice requirements. In response, Morgan contends that the motion is premature as pleadings are not closed, citing that his case originated in state court, which required only notification of his claim. He argues that discovery is necessary to support his claims and asserts he has provided sufficient factual allegations to establish a product liability claim for a manufacturing defect. The excerpt also outlines the Medical Device Amendments (MDA) enacted in 1976, which grant the FDA authority to regulate medical devices, classify them into three categories, and establish rigorous approval processes for Class III devices like the SynchroMed II Pump. Moreover, the MDA includes an express preemption provision preventing states from imposing additional requirements on the device concerning safety or effectiveness, a principle affirmed by the Supreme Court in Riegel v. Medtronic, Inc.
The court evaluates express preemption of state-law claims against the federal regulatory framework for medical devices, specifically the Medtronic SynchroMed II Pump. The analysis follows a two-step test established in *Riegel v. Medtronic, Inc.* First, the court confirms that the SynchroMed II Pump is a Class III medical device requiring premarket approval, satisfying the initial step that federal requirements are established. Second, the court finds that Morgan's state-law claims impose requirements that differ from, or add to, federal standards, thus meeting the conditions for express preemption. The court notes that state claims related to negligence, strict liability, and implied warranty are considered additional requirements under the Medical Device Amendments (MDA). Morgan alleges the device is defective, which pertains to safety and effectiveness; however, these claims do not parallel federal requirements as defined by the FDA regulations. Consequently, the court concludes that Morgan's claims are expressly preempted by federal law, justifying a judgment on the pleadings.
Morgan's strict liability claims (Causes of Action 2, 3, and 4) are expressly preempted as they attempt to impose state law requirements that differ from federal standards established for the SynchroMed II Pump.
Cause of Action 2, alleging design defects, asserts that the pump was defectively designed and inadequately tested, failing to alert users when pain medication was depleted. The court finds this claim preempted under the Riegel framework, as federal regulations apply to the pump and Morgan does not assert that its design deviates from FDA approval. His claim would impose additional responsibilities on Medtronic beyond those mandated federally, leading to its dismissal.
In Cause of Action 3, Morgan's failure to warn claim contends that Medtronic did not adequately inform users of the pump's limitations. The court determines this claim is also preempted, as it seeks to impose labeling requirements that exceed federal regulations. Therefore, both claims are dismissed based on express preemption under 360k(a), affirming that state law cannot impose different or additional requirements on FDA-approved medical devices.
Morgan's manufacturing claim (Cause of Action 4) is expressly preempted due to federal requirements established for the SynchroMed II Pump, which received FDA approval. The Court references the Supreme Court's ruling in Riegel, which determined that deviations from premarket approval specifications constitute violations of the Medical Device Amendments (MDA). The Court finds that Morgan's claim imposes additional responsibilities on Medtronic beyond federal requirements, as Morgan fails to specify any deviation from FDA-approved plans. Consequently, this claim is preempted.
Additionally, Morgan's negligence claim is also expressly preempted. He alleges that Medtronic acted negligently by failing to ensure the pump notified users when medication was depleted and for not adequately testing the device before its release. The Court emphasizes that claims requiring proof of a safer alternative design impose different requirements than those established by the FDA through the Premarket Approval (PMA) process. Since Morgan's allegations suggest that Medtronic should have designed the pump differently, this negligence claim is similarly preempted. Ultimately, the Court concludes that Medtronic is entitled to judgment in its favor on both claims based on express preemption.
Morgan's warranty claims against Medtronic are preempted by federal law. He alleges breaches of express and implied warranties regarding the safety and effectiveness of the SynchroMed II Pump, claiming it was not safe for use and did not meet Medtronic's representations. Specifically, he argues that the device was unreasonably dangerous and unfit for its intended purpose. However, the court finds that these state law claims attempt to impose additional duties beyond those mandated by the FDA, which are expressly preempted under 21 U.S.C. 360k. Citing various precedents, the court concludes that Morgan's claims, including negligence and strict liability, cannot proceed as they conflict with federal regulations established during the FDA's premarket approval process. Additionally, even if Morgan's claims were tied to federal requirements, they would still be impliedly preempted under 21 U.S.C. 337(a), as only the federal government can enforce the FDCA and related regulations. Thus, the court grants Medtronic's motion for judgment on the pleadings.
Morgan's breach of warranty claims against Medtronic are dismissed due to his failure to provide the required pre-suit notice under Texas law. According to Texas Business and Commerce Code § 2.607(c)(1), a plaintiff must notify the seller of a breach within a reasonable time after discovering it, or they risk being barred from relief. Texas courts have consistently ruled that failure to give such notice is detrimental to warranty claims, as illustrated in cases like U.S. TireTech, Inc. v. Boeran, B.V. and McKay v. Novartis Pharm. Corp. Morgan did not assert compliance with the pre-suit notice requirement in his Original Petition, arguing instead that his case's origin in state court exempted him from this obligation. Ultimately, since Morgan did not notify Medtronic promptly regarding the alleged breach, his claims are dismissed with prejudice. The Court grants Medtronic's Motion for Judgment on the Pleadings, resulting in the dismissal of all claims against Medtronic.
Final judgment will be entered separately. Morgan's original lawsuit against Medtronic PS Medical, Inc. is challenged by Medtronic, which clarifies that it is Medtronic, Inc. that manufactures and sells the SynchroMed II Pump, the device associated with Morgan's alleged injury. Morgan fails to provide any facts disputing this claim, and the record supports Medtronic's assertion. The Court recognizes the SynchroMed II Pump as a Class III, PMA-approved medical device through judicial notice of FDA records. Morgan does not contest this classification. Judicial notice is appropriate for public government records not subject to reasonable dispute, as established in relevant case law. The Court affirms its recognition of the FDA information verifying the SynchroMed II Pump's status, referencing multiple precedents that support the dismissal of claims based on express preemption regarding strict liability and negligence claims against medical device manufacturers.
