Kubicki ex rel. Kubicki v. Medtronic, Inc.

Citation: 293 F. Supp. 3d 129Docket: Civil No. 12–cv–734 (KBJ)

Court: Court of Appeals for the D.C. Circuit; February 4, 2018; Federal Appellate Court

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Ketanji Brown Jackson serves as a United States District Judge.

The document outlines a products-liability case involving Caroline Kubicki, a Type-I diabetic who experienced a hypoglycemic event while using a Medtronic insulin pump and infusion set. Key sections include:

1. **Caroline's Injuries**: Detailed information on the hypoglycemic event and the specific Medtronic devices involved, including their design, operation, and regulatory background.
2. **Infusion Set Recalls**: Notable recalls of the infusion set in 2009 and 2013, including a return and replace recall and an FDA warning letter.
3. **Procedural History**: Initially, plaintiffs sued Medtronic; after amending their complaint, they also included claims against Unomedical related to the infusion set.
4. **Motions for Summary Judgment**: Both Medtronic and Unomedical filed motions for summary judgment, which are addressed in subsequent sections.
5. **Causation Ruling**: The current record does not support granting summary judgment on causation; parties can revisit this after expert discovery.
6. **Timeliness Ruling**: Legal principles on statutes of limitations, discovery rule, and relation back doctrine are discussed. Claims against Unomedical are deemed untimely, while claims against Medtronic are considered timely.
7. **Preemption Ruling**: Most state law claims against Medtronic regarding the MMT-522 pump are preempted by the Medical Device Amendments, as they do not align with federal requirements. However, claims regarding the MMT-396 infusion set are not preempted.
8. **Learned Intermediary Doctrine and Warranty Claims**: Medtronic is not entitled to summary judgment on failure to warn claims, but it is on the breach of express warranty claim. While punitive damages claims are currently premature, they remain a potential remedy.

The introduction emphasizes the tragic nature of Caroline's experience with the devices designed to manage her diabetes.

Caroline, a 19-year-old sophomore at George Washington University, suffered severe hypoglycemia in September 2007, resulting in a traumatic brain injury that left her in a persistent vegetative state. Her parents, John and Karen Kubicki, have initiated a lawsuit against Medtronic, Inc., and its subsidiaries, as well as Unomedical Devices SA de CV and its affiliate, following the use of the Medtronic MiniMed Paradigm® Insulin Pump Model MMT-522 and Quick-set Infusion Set Model MMT-396. The amended complaint consists of 25 state law claims organized into five categories: 

1. **Negligence Claims (Counts I-V)**: Allegations of common law negligence regarding the design, manufacturing, and inadequate consumer instructions related to the insulin devices.
2. **Strict Liability Claims (Counts VI-X)**: Claims asserting the devices were sold in a defective and unreasonably dangerous condition.
3. **Express Warranty Claims (Counts XI-XV)**: Assertions of breaches of express warranties relied upon by Caroline and her family.
4. **Failure to Warn Claims (Counts XVI-XX)**: Allegations that the defendants did not adequately warn users or the FDA about the foreseeable harms of the devices.
5. **Punitive Damages Claims (Counts XXI-XXV)**: Claims for punitive damages based on the defendants' alleged malicious and reckless behavior.

Fact discovery has been completed, but expert discovery is still pending. The Kubickis have narrowed their claims against Unomedical to the failure to warn allegations. Currently, two motions for summary judgment have been filed by Medtronic and Unomedical, which the plaintiffs oppose without filing a cross-motion for summary judgment.

Medtronic contends that the plaintiffs, the Kubickis, cannot prove causation since Caroline was not wearing her insulin pump during the hypoglycemic incident. Additionally, Medtronic asserts that the plaintiffs' common law tort and express warranty claims are entirely preempted or barred by statutes of limitations, and argues it is entitled to summary judgment on punitive damages due to a lack of evidence for intentional wrongdoing. Unomedical raises similar defenses, claiming its failure to warn allegations are untimely and preempted, and echoes Medtronic’s arguments regarding causation and punitive damages.

The court has reviewed the defendants' summary judgment motions, including prior rulings, and has decided to grant in part and deny in part Medtronic's motion while granting Unomedical's motion in full. Specifically, the court finds that neither defendant is entitled to summary judgment on causation prior to expert discovery. However, Unomedical is granted summary judgment based on the statute of limitations. Summary judgment for Medtronic will be granted concerning claims linked to the MMT-522 Pump (except for manufacturing defect claims) and certain failure to report claims related to the MMT-396 Infusion Set due to federal preemption. Medtronic's motion for summary judgment on the breach of warranty claim is also granted, as the statements do not constitute an actionable warranty, and the claim for punitive damages is dismissed due to D.C. law not recognizing it, though the court finds the issue of punitive damages premature until expert discovery is completed. The court will allow Medtronic to seek summary judgment on causation following expert discovery. A separate order will follow this memorandum. 

Caroline, diagnosed with Type I diabetes at age six, began using an insulin pump in March 2001 after struggling to manage her blood glucose levels with insulin shots, having experienced three hypoglycemic events before receiving the pump.

In October 2006, Dr. Paresh Dandona prescribed Caroline the MMT-522 Pump and MMT-396 Infusion Set. On September 8-9, 2007, Caroline experienced a hypoglycemic event after spending the evening with her roommate, Magdelena Posthumus, who observed Caroline napping, eating, and returning to bed. Caroline's blood sugar was measured at 77 mg/dL around 7:02 p.m., and she administered six units of insulin at approximately 8:30 p.m. Posthumus left the dorm at 11:00 p.m. and found Caroline unresponsive the next morning, displaying distress symptoms. Posthumus notified resident advisors and called 911, reporting Caroline was unconscious and vomiting. Emergency personnel found her blood sugar at a critical low of 20 mg/dL. Despite receiving glucose injections at the scene and at GW Hospital, Caroline's condition did not improve, and a CT scan indicated she suffered from diffuse cerebral edema. As a result, Caroline now resides in a nursing facility in a persistent vegetative state with no chance of recovery. The glucometer data indicated significant fluctuations in her insulin levels prior to the incident, ranging from 43 mg/dL to 568 mg/dL. Important data from the MMT-522 Pump was lost when Mr. Kubicki removed its battery, believing it would not affect the stored data.

Joint non-destructive testing of Caroline's pump showed no defects. The MMT-396 Infusion Set used by Caroline was discarded shortly after her injury, preventing further testing. Following a hypoglycemic event, the Kubickis sought information on the cause of Caroline's low blood sugar, consulting her doctors, who recommended preserving the MMT-522 Pump for testing, suspecting an insulin overdose.

The MMT-522 Pump is an FDA-regulated insulin delivery device that monitors blood glucose and administers insulin based on user programming. It operates by delivering a basal rate of insulin and allows users to give bolus doses as needed. The insulin is stored in a cylindrical reservoir within the pump and delivered via the MMT-396 Infusion Set, which consists of a tube with a needle for insertion into the body.

Proper operation requires careful steps to refill the insulin reservoir, including disconnecting the infusion set and ensuring the p-cap connector remains dry. The p-cap connector is vital to the case's products-liability claims, featuring one-way vent openings covered by a PTFE membrane that equalizes pressure in the reservoir, preventing complications during insulin administration. The connector's design integrates two materials: PTFE on the top and polyester on the underside.

Medtronic developed a vented p-cap design for its insulin pumps to ensure watertight functionality. The vents are crucial for maintaining proper internal pressure in the reservoir, which directly affects insulin delivery rates. If vents become blocked, increased pressure can lead to unscheduled insulin delivery, even if the pump isn’t programmed to do so.

The MMT-522 Pump and MMT-396 Infusion Set are part of Medtronic's diabetes management devices. The FDA approved a precursor device, the Guardian Continuous Glucose Monitoring System, in June 1999, but this did not include an insulin pump. Medtronic launched its "Paradigm" insulin pump system in 2001 and received 510(k) approval for the Paradigm MMT-515 Insulin Pump in May 2004. In October 2005, Medtronic sought approval for modifications to this pump and the Guardian RT sensor to facilitate data communication between them, which was granted on April 7, 2006, resulting in the Paradigm Real Time System that includes the MMT-522 Pump. The MMT-396 Infusion Set, which features the vented p-cap, received FDA clearance through the 510(k) process on June 7, 2001. Medtronic designed the p-cap, while Unomedical handled the design and manufacture of the rest of the infusion set components, with Unomedical's name appearing on the product packaging and instructions. Unomedical's involvement was limited to assembling the infusion set with the p-cap provided by Medtronic.

Both the MMT-522 Pump and MMT-396 Infusion Set are prescription-only devices, requiring physician supervision for use. There were recalls related to the infusion sets in 2009 and 2013, with a significant recall on June 29, 2009, of the "Lot 8" batch due to a silicone lubricant that could clog vents, potentially causing incorrect insulin delivery.

Patients with impacted infusion sets were advised against using them and instructed to return these sets to Medtronic for replacement. The MMT-396 Infusion Set used by Caroline during her injury was not part of the Lot 8 recall, which had assured users that all other Medtronic infusion sets were safe. Medtronic did not reference Unomedical, the manufacturer of the infusion sets (excluding the p-cap), in the Lot 8 recall materials. Four years later, on June 7, 2013, Medtronic issued a Class I recall of its Paradigm infusion sets, including the MMT-396, due to risks of insulin delivery errors if the reservoir or p-cap became wet during refilling. This recall was prompted by user practices observed on YouTube, specifically the horizontal holding of the reservoir that could block vents with fluid. Medtronic's notification urged users to keep the insulin vial upright and ensure dryness before connecting components. Unomedical A/S was identified as a manufacturer in this recall. Medtronic described the issue leading to the 2013 recall as a "temporary blocked vent," emphasizing its rarity and the low incidence of related complaints (less than 100 per year out of 425,000 users). Medtronic characterized the recall as a voluntary corrective action. Following this, on September 19, 2013, the FDA issued a warning letter to Medtronic after finding violations of current good manufacturing process regulations concerning its Paradigm insulin pumps during an inspection of its Northridge facility.

The FDA identified multiple deficiencies in Medtronic's practices, particularly its failure to comply with 21 C.F.R. 820.100(a), which mandates the establishment of corrective and preventative action procedures. Specific failures included inadequate identification of corrective actions for the Paradigm Insulin Infusion Pumps (MMT-5XX, 7XX) and a lack of thorough complaint evaluations, leading to incomplete records regarding investigations. The FDA categorized the Paradigm insulin pumps as "adulterated" under 21 U.S.C. 351(h) and "misbranded" under section 502(t)(2) due to 13 Good Manufacturing Practice (CGMP) violations, although these violations did not relate to the temporary-block-vent condition of the MMT-396 Infusion Set mentioned in the Kubickis' complaint. The FDA criticized Medtronic's reporting failures in a 2013 letter, particularly regarding incidents of insulin overdoses from the pump.

In a separate legal context, on September 2, 2010, the Kubickis filed a lawsuit against Medtronic in the Superior Court of the District of Columbia on behalf of Caroline. This initial complaint was dismissed without prejudice after a tolling agreement, and upon its expiration, the Kubickis refiled their complaint. The claims included negligence, strict liability, misrepresentation, fraud, breach of warranties, deceptive trade practices, and failure to warn, specifically regarding the "Medtronic MiniMed Paradigm® Insulin Pump Model MMT-522," without mentioning the MMT-396 Infusion Set. Medtronic subsequently removed the case to federal court on May 8, 2012, and moved to dismiss the complaint, arguing lack of particularity in fraud claims, duplication of warranty claims, and preemption. The court partially granted the motion, dismissing the fraud and implied warranty claims without prejudice but allowed the remaining claims based on FDA violations to proceed, ruling that they survived preemption challenges under Rule 12(b)(6).

The Court allowed Medtronic the opportunity to renew its express preemption challenge after discovery, indicating that while the Plaintiffs' pleading is currently adequate for a motion to dismiss, they are expected to clarify the connection between common law duties and federal requirements as the case advances. The Court dismissed Medtronic's implied preemption argument, emphasizing that the Plaintiffs are not basing their claims on alleged violations of FDA regulations, which is prohibited, but rather on traditional state tort law. 

On January 10, 2014, the Kubickis submitted an amended complaint, which added Unomedical as a defendant and included specific allegations regarding defects in the MMT-396 Infusion Set. Despite Medtronic's objections, the Court permitted this amendment. Following this, both Medtronic and Unomedical filed pre-discovery dispositive motions, which the Court denied, directing the parties to conduct fact discovery and allowing the defendants to respond to a proposed second amended complaint after discovery.

After the fact discovery period ended, the Kubickis filed a second amended complaint asserting various causes of action, including negligence, strict liability, breach of express warranties, failure to warn, and punitive damages, with multiple counts for each theory of liability against all five defendants: Medtronic, Inc., Medtronic Diabetes, Medtronic MiniMed Inc., Unomedical Devices SA de CV, and Unomedical Devices A/S. The claims against Medtronic relate to both the MMT-522 Pump and the MMT-396 Infusion Set, while the claims against Unomedical are specifically focused on the MMT-396 Infusion Set.

The Kubickis filed negligence claims against Medtronic, alleging violations of various duties related to the design and marketing of the MMT-522 Pump and MMT-396 Infusion Set. These claims include failing to act with reasonable care in design, providing adequate instructions and warnings, documenting complaints about unintended insulin overdelivery, and manufacturing the devices, all paralleling federal regulations (21 C.F.R. 820.30, 801, and 803). The same allegations were made against Unomedical concerning the MMT-396 Infusion Set.

In their strict liability claims, the Kubickis contend that Medtronic sold the insulin pumps and infusion sets in a defective and unreasonably dangerous condition due to inadequate labeling, instructions, warnings, improper design and manufacture, and failure to report complaints. Similar allegations were made against Unomedical for the MMT-396 Infusion Set.

The Kubickis also assert breach of warranty claims against Medtronic, stating that the MMT-522 Pump and MMT-396 Infusion Set were guaranteed to be free from defects for specified periods. They allege that Medtronic misrepresented the safety of the devices based on design modifications intended to prevent vent blockage. Unomedical is accused of breaching its three-day warranty and making similar promotional claims about safety.

Both Medtronic and Unomedical have moved for summary judgment on the Kubickis' Second Amended Complaint, with Medtronic arguing that (1) there is no evidence of causation, (2) the claims are preempted, and (3) the statute of limitations bars the claims.

Medtronic seeks summary judgment on the punitive damages claim, asserting a lack of evidence for intentional wrongdoing. Unomedical also requests summary judgment, citing the statute of limitations and implied preemption, while contending that its alleged misconduct does not meet the threshold for punitive damages. During a hearing on November 3, 2016, Plaintiffs indicated they were abandoning all claims against Unomedical except for failure to warn under negligence and strict liability theories. 

The legal standard for summary judgment under Federal Rule of Civil Procedure 56 requires the court to grant judgment if there is no genuine dispute of material fact and the movant is entitled to judgment as a matter of law. A material fact affects the suit's outcome, and a genuine dispute exists if a reasonable jury could find for the nonmoving party. The moving party must demonstrate the absence of any genuine dispute, after which the nonmoving party must present specific facts indicating a genuine issue for trial. The nonmoving party cannot rely on mere allegations or denials but must provide affirmative evidence.

In addressing causation, Medtronic argues that there is insufficient evidence to support a jury finding that either the MMT-522 Pump or the MMT-396 Infusion Set caused Caroline's injuries, claiming that records show she was not connected to the pump during her hypoglycemic incident, thus negating any potential causation.

Medtronic presents several alternative explanations for Caroline's sudden drop in blood sugar, including inadequate monitoring, hypoglycemia unawareness, insufficient food intake, excessive exercise, patient dosing error, or a combination of these factors. An affidavit from Dr. Helena W. Rodbard, a retained expert for Medtronic, supports these causation claims. However, the Court has previously ruled that presenting Dr. Rodbard's assessment before the formal expert-discovery phase was premature, leading to the striking of certain causation-related claims from Medtronic's submissions.

Currently, the Court assesses whether Medtronic is entitled to summary judgment on causation based on the incomplete existing record. A genuine dispute exists regarding whether Caroline was connected to her insulin pump during the hypoglycemic incident, making summary judgment inappropriate at this stage. Medtronic argues for summary judgment, citing evidence suggesting Caroline was not using her insulin pump at the time of the event. This includes testimony from Caroline's roommate, Magdelena Posthumus, who reported that the pump was found on Caroline's desk rather than attached to her. Additionally, Posthumus's statements to a 911 dispatcher implied uncertainty about Caroline's use of the device. Reports from responding police officers further corroborate that there was no indication the insulin delivery device was attached to Caroline.

Caroline's medical records indicate that her insulin pump was found disconnected on her desk when Posthumus discovered her unresponsive body, though it remains uncertain if Posthumus was responsible for this disconnection. The plaintiffs contest Medtronic's assertion by characterizing Posthumus's testimony as inconsistent and unreliable, noting her inability to recall details about the pump and her call to 911. They argue that Posthumus's late-night activities may have impaired her memory. The plaintiffs further assert that Posthumus could not rule out the possibility that the pump was under Caroline's pajamas and did not notice its location on the desk until after others had entered the room. They interpret Caroline's medical records as evidence that she was using the pump at the time of her hypoglycemic episode, highlighting that the pump was covered in vomit, suggesting it was with her during the incident. Additionally, they reference observations from a resident advisor and a paramedic that may imply the pump was still attached to Caroline. The Kubickis emphasize that Caroline typically did not remove her pump at night. In contrast, Medtronic counters that the plaintiffs misinterpret the evidence and provides alternative readings of the testimonies and records.

Posthumus was the sole witness regarding Ms. Kubicki's activities on the relevant night, stating that Ms. Kubicki was asleep when she left and remained so until the following morning when she found Ms. Kubicki in distress. The court noted insufficient evidence to definitively prove that Ms. Kubicki was not connected to her insulin pump that night, as evidence suggests both possibilities. Credibility assessments and evidence weighing are jury responsibilities, not functions of a judge during summary judgment. The court's role is to determine if a genuine trial issue exists. The record allows a jury to infer either that the insulin pump contributed to Ms. Kubicki's injury or that it was unused on her desk when discovered. The timeline presents a significant gap with no eyewitness testimony, as Posthumus was out and then asleep, leaving unanswered questions about the pump's involvement. Expert testimony may be necessary to clarify if Ms. Kubicki was using the pump during the critical timeframe. Overall, the evidence does not sufficiently negate the existence of a factual issue for trial regarding the use of the insulin pump at the time of the injury.

The ongoing dispute between the parties revolves around competing interpretations of evidence and witness credibility, leading to unresolved causation questions that must be determined by a jury, not the Court. The Court references relevant case law, emphasizing that proximate causation is generally a factual issue for the jury, citing cases like *In re Fort Totten Metrorail Cases* and *Ferebee v. Chevron Chem. Co.*. The Court's ruling on causation is limited to the current summary judgment motions, with expert discovery anticipated to clarify these issues further. Expert testimony is deemed crucial in complex medical product liability cases under D.C. law, particularly for claims involving permanent injuries or multiple causation factors.

Additionally, the Court acknowledges a separate issue regarding the timeliness of the plaintiffs' product-liability claims, which are subject to a three-year statute of limitations per D.C. Code § 12-301. There is consensus among the parties that the claims related to the MMT-522 Pump are timely, while the dispute centers on the timeliness of claims concerning the MMT-396 Infusion Set, introduced six years post-injury. The Court will require the parties to propose a schedule for expert discovery, allowing Medtronic to renew its summary judgment request on causation afterward.

Infusion set-related tort claims by the Kubickis against Unomedical are deemed untimely, as they could have been discovered shortly after Caroline's injury in 2007, with no prior notice to Unomedical until the amended complaint was filed six years later. Conversely, claims against Medtronic regarding the MMT-396 Infusion Set are not time-barred because they relate back to previously timely claims concerning the MMT-522 Pump.

The discussion references the statute of limitations, which sets a time limit for filing legal claims, emphasizing that claims filed beyond this period are generally barred. The text outlines that statutes of limitations aim to prompt timely notice for defendants and prevent stale claims. It also explains the discovery rule, which can extend the period when a claim is considered to have accrued, starting not at the time of injury but when the plaintiff becomes aware (or should reasonably be aware) of the injury, its cause, and evidence of wrongdoing. Additionally, the relation back doctrine is mentioned, allowing amendment of claims if a connection to the original timely claims is established, ensuring the defendant is aware of the claims.

The discovery rule established by the District of Columbia Court of Appeals states that the statute of limitations for negligence claims begins when a plaintiff has inquiry notice of potential wrongdoing. This hinges on what the plaintiff knows or should have known regarding the defendant's fault. Even if the plaintiff does not fully understand the extent of the injury's cause, the statute of limitations still applies. Plaintiffs are required to investigate their claims with reasonable diligence; failure to do so can result in a presumption of inquiry notice. The reasonableness of a plaintiff's investigation is assessed objectively.

Once a plaintiff becomes aware of an injury, its cause, and evidence of wrongdoing, they must file their claim within the applicable limitations period, starting from the time they gain this knowledge. It is the defendant's responsibility to prove that the plaintiff has not acted reasonably in investigating the claim.

In terms of amending pleadings, Federal Rule of Civil Procedure 15(c) allows for an amendment to relate back to the date of the original filing if it arises from the same conduct or occurrence as the original complaint. The plaintiffs argue their amendment regarding the Infusion Set is timely under this rule, as it does not introduce new legal theories but stems from the same underlying conduct. While both the discovery rule and the relation back doctrine concern knowledge of the claim, they focus on different parties: the discovery rule pertains to the plaintiff's knowledge, while the relation back doctrine involves whether the defendant had adequate notice of the claim.

The key issue is whether the original complaint sufficiently informed the defendants of the liability basis that would later be presented in the amended complaint. The relation back doctrine requires that notice to the defendant is pertinent, as demonstrated in Hartley v. Wilfert and Dover v. Medstar Wash. Hosp. Ctr., where the court ruled that claims regarding D.C.'s overtime statute did not relate back to earlier claims due to a lack of notice about wage violations. For relation back to apply, the original and amended complaints must share a common core of operative facts, as established in Mayle v. Felix.

In this case, the plaintiffs named Unomedical as a defendant on January 10, 2014, over six years after an incident involving Caroline's hypoglycemic event. They argued that their claims related to the MMT-396 Infusion Set were timely because they could not have linked Caroline's injury to the infusion set until a recall in June 2013. However, the court disagreed, asserting that the plaintiffs could have reasonably discovered the potential connection to the infusion set much earlier. The insulin-delivery device's complex nature, with identifiable components, would have prompted a reasonable plaintiff to investigate the source of the insulin overdose immediately after the injury. The Kubickis were aware of the interconnection between the MMT-522 Pump and the MMT-396 Infusion Set, making it unreasonable for them to initially file a complaint focused solely on the pump without addressing the infusion set.

Karen Kubicki's subjective belief that the insulin-delivery product was a single unit is irrelevant to the legal analysis. The standard for the discovery rule is objective. The court concludes that a reasonable plaintiff, given the circumstances and diligent investigation, would recognize the insulin pump and the infusion set as distinct components. This conclusion is reinforced by a physician's advice to the Kubickis to retain all items used by Caroline following her injury, which highlighted the need to investigate further. Additionally, a reasonable plaintiff would have consulted the product packaging, which indicated that the infusion set tubing was separate from the pump, thus clarifying their distinct nature.

The plaintiffs' argument that they lacked knowledge of a defect in the infusion set until after a recall in June 2013 misinterprets the law regarding the statute of limitations for products liability claims. A plaintiff only needs to suspect wrongdoing to trigger the statute, not to have definitive knowledge of causation. The Kubickis had suspicions regarding the insulin delivery mechanism as early as 2010, which should have prompted them to investigate and potentially file claims for all components involved.

Moreover, their failure to timely assert product-liability claims meant they did not include Unomedical, the manufacturer of the infusion set, as a defendant in their action. Despite Karen Kubicki's unawareness of Unomedical's involvement, an objectively reasonable plaintiff would have been able to discover potential claims against the manufacturer based on the product's packaging, which explicitly identified Unomedical as the assembler of the infusion set.

Unomedical's name is present on the MMT-396 Infusion Set, highlighting the Kubickis' failure to investigate the potential sources of the product linked to Caroline's injury. The Kubickis had a clear obligation to investigate all manufacturers involved, particularly since they knew that the infusion set was made by someone other than Medtronic. This situation placed them on "inquiry" notice, as established in Berkow v. Lucy Webb Hayes Nat'l Training Sch., indicating that their knowledge of one party's misconduct should have prompted further investigation into potential co-defendants. The court found no justification for the Kubickis to neglect investigating other manufacturers when filing their products-liability lawsuit in 2010. The MMT-396 Infusion Set works in conjunction with the MMT-522 Pump, and the connections between the components were public knowledge at the time of Caroline's injury. The Kubickis' intent to sue only Medtronic, despite evidence of Unomedical's involvement, was unreasonable. The plaintiffs’ reliance on dissimilar cases, such as Lee v. Wolfson, is misplaced because those circumstances differ significantly from the current case, where immediate suspicion of a defect required broader investigation into all manufacturers involved.

Lee's claims against the manufacturer did not accrue until the recall notice was issued, as the court determined that the plaintiff could not reasonably know of any wrongdoing related to the parking brake at the time of her injury, especially since no defect was identified during investigations. In contrast, the Kubickis' allegations involved a suspected defect in the insulin-infusion system used by Caroline, which required them to conduct a timely inquiry into all components of that system. Legal precedent indicates that a claim accrues when the injury is known or should have been known in relation to the alleged negligence. Unlike Lee, where the plaintiff lacked awareness of wrongdoing, the Kubickis were aware of a potential product defect from the beginning, establishing their obligation to investigate. A similar case, Colarossi v. Schmid Laboratories, demonstrated that a claim accrues when a plaintiff is aware of a possible cause for their injury, which was the case for the Colarossi plaintiff who learned of a potential link between her IUD and her injuries in 1978. The court ruled the claim was untimely due to her failure to investigate the correct manufacturer before filing suit, emphasizing the necessity of due diligence. The same principle applies to the Kubickis, who had a duty to investigate their claims promptly.

The Kubickis were aware of possible wrongdoing by the manufacturers of Caroline's insulin-delivery system in 2007, following Caroline's injury and advice from her physician linking the injury to the insulin-delivery system (MMT-522 pump and MMT-396 Infusion Set). By 2010, when they filed a lawsuit against Medtronic, they had established this connection, indicating that their product-liability claims accrued at the latest by that year. The 2009 recall of certain MMT-396 Infusion Sets did not affect this timeline, as Medtronic assured the safety of other lots. Although the Kubickis argued that these assurances led them to overlook potential claims against the MMT-396 Infusion Set, the recall notice, which detailed a defect that could cause insulin over-delivery, should have prompted further investigation into the system's components. Consequently, a reasonable plaintiff, having knowledge of the risks, would likely have pursued claims against all manufacturers involved, including Unomedical.

Additionally, the Kubickis attempted to invoke the "relation back" doctrine under Federal Rule of Civil Procedure 15(c)(1)(B) to argue that their claims related to the MMT-396 Infusion Set should be considered timely despite potentially being discoverable earlier. However, this assertion hinges on whether the claims arose from the same conduct or occurrences outlined in the original pleading.

Plaintiffs assert that the Second Amended Complaint merely expands upon the original factual allegations regarding the Infusion Set without introducing new legal theories. However, the Court determines that the infusion set-related claims against Unomedical cannot relate back to the original complaint for statute of limitations purposes. According to Rule 15(c)(1)(B), relation back is only permissible if the defendant received sufficient notice of the facts and claims prior to the statute of limitations expiration. The general rule prohibits the addition of new parties after the limitations period has expired, as new defendants typically lack awareness of original claims. Rule 15(c)(1)(C) provides exceptions for adding new parties if they received notice within the service timeframe and knew or should have known they would be included but for a mistake regarding party identity. Relation back under this rule hinges on the knowledge of the party to be added, not the amending party. The rule aims to prevent unfair consequences from non-prejudicial mistakes. The Kubickis failed to present evidence to refute Unomedical's claim of lack of awareness of the litigation until 2014 and did not demonstrate that the omission was due to clerical error or confusion among related corporate entities. Thus, Unomedical is entitled to repose as it was not named in the lawsuit before the statute of limitations expired.

An amended complaint adding a new defendant can relate back to a prior complaint if the defendants are closely related and represented by the same counsel, as long as the new defendant had notice of the claims. In this case, the Kubickis failed to allege specific product defects concerning the MMT-396 Infusion Set until 2014, which meant Unomedical could not reasonably anticipate liability for Caroline's injuries prior to that time. Consequently, the relation back doctrine does not apply for their claims against Unomedical. 

Conversely, claims against Medtronic are deemed timely because Medtronic was part of the original action, thus differing significantly from Unomedical's situation. Under Federal Rule of Civil Procedure 15(c)(1)(B), the court assesses whether the amended claims arose from the same conduct outlined in the initial pleading, which would have put Medtronic on notice. Medtronic contends that the initial complaint did not provide notice of potential claims related to the infusion set, asserting that introducing a new device represents a substantial alteration and a new legal theory. However, Medtronic acknowledges that both the MMT-522 Pump and MMT-396 Infusion Set work together to deliver insulin, and that both devices are marketed under its name. Therefore, Medtronic's claim of lack of notice regarding the infusion set claims is deemed unconvincing, especially given the initial complaint's assertion that Caroline was injured due to an insulin overdose linked to the MMT-522 Pump.

Technical issues with insulin pumps, particularly concerning the MiniMed Insulin Pump, have been reported, including excessive insulin delivery leading to hypoglycemia. On September 9, 2007, Caroline Kubicki was found unresponsive due to her malfunctioning pump. Had she been aware of the true risks, including the potential for severe hypoglycemia and resulting brain injury, she likely would not have used the device. Medtronic was aware of product-related deficiencies that could cause serious injuries. The plaintiffs' amendment to the complaint, which included claims about the MMT-396 Infusion Set, does not introduce a new legal theory but instead refines existing allegations. The relation back doctrine applies, allowing the amendment to relate to the original complaint since Medtronic had sufficient notice of the claims. The court finds that the infusion set claims are timely due to their connection with the initial allegations regarding the insulin pump. Additionally, Medtronic's argument for dismissal based on preemption—where state law conflicts with federal law—is based on the Supremacy Clause, which mandates that conflicting state laws yield to federal law.

Congress has authorized the FDA to regulate medical devices, which raises issues of express and implied preemption regarding state law claims. Express preemption occurs when federal law explicitly prohibits state law claims, while implied preemption arises when federal regulation is so comprehensive that it suggests Congress intended to leave no room for state regulation. Medtronic asserts that Section 360k(a) of the Medical Device Amendments (MDA) to the FDCA expressly preempts the Kubickis' claims related to the MMT-522 Pump and implies preemption for claims regarding both the pump and the MMT-396 Infusion Set, as they seek to enforce FDA regulations instead of independent state duties. The Kubickis counter that their claims do not expressly preempt because they align with federal requirements and are independent state law claims, not infringing on the FDA's authority. The court finds that all claims concerning the MMT-522 Pump are expressly preempted, except one manufacturing defect claim, while most claims related to the MMT-396 Infusion Set are not impliedly preempted, except for a claim regarding Medtronic's failure to report adverse events to the FDA. Thus, the case will proceed with a manufacturing defect claim for the MMT-522 Pump and most claims against Medtronic concerning the MMT-396 Infusion Set. The MDA, enacted in response to issues with state regulation of medical devices, expanded the FDCA's regulatory framework to encompass medical devices.

The FDCA categorizes medical devices into three classes based on risk, with Class III reserved for those posing the highest risk of illness or injury. New medical devices post-1976 fall under Class III, requiring a stringent premarket approval (PMA) process, wherein manufacturers must demonstrate the device's safety and effectiveness to the FDA. The FDA evaluates applications by balancing the probable health benefits against the risks of injury or illness. Approved devices must not undergo design or labeling changes without further FDA approval, maintaining strict adherence to the approved specifications. Any modifications require a supplemental PMA application, assessed under criteria similar to the initial application. Manufacturers of PMA devices have specific post-approval reporting obligations regarding incidents that may cause serious injury or death, which must be reported within 30 days of awareness. To alleviate delays in device improvements, the MDA allows devices deemed "substantially equivalent" to existing ones to bypass the PMA process. A new device is considered substantially equivalent if it has the same intended use as a predicate device and either matches its technological characteristics or proves to be as safe and effective. The FDA has a defined process for substantial equivalence reviews.

The 510(k) process is a premarket notification submitted by manufacturers to the FDA when introducing a new medical device, which must state the device's intended use, identify predicate devices, and propose a classification. This process is significantly faster than the Premarket Approval (PMA) process, averaging only 20 hours compared to 1,200 hours for PMA reviews, focusing on whether the new device is substantially equivalent to an existing one rather than on safety and efficacy. Due to its minimal information requirements and quick processing times, the 510(k) process is favored by manufacturers, leading to its widespread use for bringing new devices, including high-risk Class III devices, to market. In 2005, for instance, the FDA authorized 3,148 devices via the 510(k) pathway while approving only 32 through PMA.

Additionally, manufacturers that pursue the PMA process benefit from express preemption of certain state law claims under the Medical Device Amendments (MDA). According to 21 U.S.C. § 360k(a), states cannot impose requirements differing from federal regulations regarding device safety or effectiveness. The Supreme Court has established a two-part test for evaluating the applicability of state law claims under this statute, requiring courts to determine if federal requirements exist for the device and whether state claims impose additional or different requirements related to safety and effectiveness. It is well established that FDA premarket approval via the PMA process fulfills the first part of this inquiry.

Premarket approval under the Medical Device Amendments (MDA) imposes strict requirements, as the FDA mandates that approved devices must adhere closely to their application specifications. In contrast, devices approved through the Section 510(k) substantial equivalence process are not subject to the same stringent federal requirements, and thus, the first part of the Supreme Court's express preemption test is not applicable to them. 

State common law claims, such as negligence and strict liability, can be classified as "requirements" under the MDA’s express preemption clause. Current disputes often hinge on whether state claims impose obligations that diverge from or exceed federal standards. While the MDA's express preemption clause offers some protection to manufacturers of PMA-approved devices, it does not grant absolute immunity from all state law claims. Manufacturers remain liable if a claim is based on their violation of federal regulations, as parallel state claims do not add to federal requirements. 

For a plaintiff to successfully argue that a state law claim is parallel to federal requirements and thus not preempted, they must (1) identify specific federal regulations violated by the manufacturer, (2) specify a state law claim that parallels those federal requirements, and (3) demonstrate a causal connection between the violations and the alleged injury. The burden to invoke the MDA’s express preemption clause lies with the device manufacturer.

Federal preemption serves as an affirmative defense that defendants must assert and substantiate. Upon doing so, the burden shifts to the plaintiff to show that their state law claims are genuinely parallel to federal requirements and that the breach of these duties caused their injury. This framework was illustrated in Carter v. Novartis Consumer Health, Inc., which applied to an FDCA express preemption clause concerning prescription drugs. To prove that state law claims are not expressly preempted, plaintiffs must identify the specific federal requirement at issue, the corresponding state law claim, and establish causation. The court in Wolicki-Gables v. Arrow International emphasized that state and federal requirements are not genuinely equivalent if a manufacturer could be liable under state law without violating federal law.

Implied preemption, unlike express preemption, derives from legislative intent to allocate regulatory authority exclusively to federal entities. Under the FDCA, the FDA has the sole authority to investigate potential violations of medical device regulations, applicable whether a device was approved through the PMA process or the 510(k) process. Cases such as Martin v. Medtronic and Jones v. Medtronic illustrate that implied preemption can bar state law claims, including warranty claims related to PMA-approved devices and those approved via the 510(k) process.

In Buckman Company v. Plaintiffs' Legal Committee, the Supreme Court determined that if proving a defendant's liability under state law necessitates demonstrating a violation of the FDCA, then the state law claim intrudes upon the FDA's exclusive enforcement authority, thereby becoming impliedly preempted. However, the Court acknowledged that implied preemption is not absolute; plaintiffs can base a state tort claim on an FDCA violation if the claim is rooted in traditional state tort law predating federal laws. Conversely, if a state law claim hinges on the existence of the FDCA, it is considered impliedly preempted.

The court in Riley v. Cordis Corp. addressed the doctrines of express and implied preemption in relation to the Medical Device Amendments (MDA) to the Federal Food, Drug, and Cosmetic Act (FDCA). Express preemption prohibits plaintiffs from imposing additional requirements on a device approved through the Premarket Approval (PMA) process, but allows for the enforcement of genuinely parallel state law requirements. Implied preemption prevents plaintiffs from enforcing FDCA requirements unless there is a corresponding preexisting state law claim, regardless of the device's approval process.

In this case, the parties dispute whether Medtronic's MMT-522 Pump qualifies as a PMA-approved device, which would trigger express preemption. They also disagree on (a) the identification of specific federal requirements that could support a parallel state claim, (b) whether the plaintiffs' claims are genuinely parallel to federal requirements, and (c) the causation of Caroline Kubicki's injury by the alleged violations of state and federal law.

The court determined that Medtronic was entitled to summary judgment based on express preemption for all tort claims related to the MMT-522 Pump, except for the manufacturing defect claim, which requires further expert evaluation. The court concluded that the MMT-522 Pump, having received FDA approval through the PMA process, is subject to the MDA's express preemption. Additionally, it found that the plaintiffs failed to identify specific FDA requirements for their parallel state law claims or did not demonstrate the existence of genuinely equivalent claims.

The FDA approved the MMT-522 Pump as a PMA supplement, but plaintiffs argue that the approval does not cover the pump in isolation, as it was part of a broader Real Time System that included a blood glucose sensor. They contend that Medtronic cannot invoke the express preemption doctrine for the MMT-522 Pump alone. However, federal district courts in Duggan and Bentzley have rejected similar arguments, affirming that while the entire Paradigm Real Time System received premarket approval, the MMT-522 Pump should not be viewed as separate from the system. The plaintiffs claim that only the communication capabilities between the pump and sensor were approved, but courts have consistently ruled that premarket approval extends to all components of the approved device. The legal interpretation aligns with the statutory definition of a "device," which includes any component or accessory, confirming that the MMT-522 Pump is part of the PMA-approved device. Thus, the court supports the notion that the pump falls under the umbrella of the premarket approval received by Medtronic.

The Court rejects the Kubickis' argument that the FDA acknowledged only the Paradigm Infusion System, not the MMT-522 Pump, as approved through the PMA process. They cite a 2010 Citizen Petition requesting the FDA to clarify that approval was limited to the pump's data communication capabilities, which the FDA denied, affirming that both the 522 pump and the Guardian RT sensor received PMA approval as part of the Paradigm System. The Court finds no ambiguity in the FDA's statements and notes that the agency declined to amend its approval to exclude the pump, indicating its intention for the pump to remain included in the PMA approval. The Court aligns its conclusion with prior cases, Duggan and Bentzley, which also upheld the PMA approval for the MMT-522 Pump. Consequently, the Court determines that the pump received premarket approval, satisfying the first prong of the Riegel test for express preemption. Additionally, the Kubickis failed to establish that their state law claims are genuinely equivalent to specific federal requirements, as required to counter the express preemption claim, with their earlier attempts deemed inadequate.

The Court expects the Plaintiffs to clarify their claims regarding the connection between common law duties and federal requirements as the case progresses. If they fail to do so, the Defendants may raise preemption objections later. Medtronic's preemption arguments are recognized as valid. However, the mere FDA approval of a device does not automatically preempt all state law claims against it. A PMA-approved manufacturer is shielded from liability if compliant with federal law. The key issue is whether the state law claims made by the Kubickis against the MMT-522 Pump parallel federal requirements. They assert five categories of claims, including negligence and failure to warn, claiming these do not impose additional requirements beyond those of the FDA, as they are based on alleged violations of federal law. The federal standards cited include current good manufacturing practices (CGMP) and regulations regarding the monitoring and reporting of adverse events. The Plaintiffs reference a 2013 Warning Letter from the FDA indicating Medtronic's non-compliance with CGMPs and its failure to report adverse incidents related to the pump in a timely manner.

The Court determines that the Current Good Manufacturing Practices (CGMPs) cited by the Plaintiffs are inadequate to support a parallel state law claim related to the MMT-522 Pump. Specifically, the Plaintiffs' claims regarding negligent design, manufacturing, labeling, and breach of warranty do not align with the federal law requirement of reporting adverse incidents. The Plaintiffs reference multiple CGMPs, such as those mandating adequate personnel qualifications, design control procedures, and compliance with product specifications. However, Medtronic argues that these regulations are not device-specific and therefore cannot serve as a basis for a parallel state law claim under the Medical Device Amendments (MDA) preemption clause. This argument highlights a division in case law concerning whether CGMPs can substantiate a viable parallel claim against express preemption.

The Eighth and Eleventh Circuits have determined that plaintiffs cannot use Current Good Manufacturing Practices (CGMPs) to circumvent the Medical Device Amendments (MDA) preemption, as CGMPs are deemed too vague to establish specific federal requirements enforceable under state law. In contrast, the Fifth, Sixth, and Seventh Circuits have concluded that certain CGMPs can be sufficiently specific to support a parallel state law tort claim. Courts opposing the enforceability of CGMPs in this context argue that these regulations are general and apply broadly to the design, manufacture, and control processes for medical devices, thereby failing to provide the specificity needed for manufacturing defect claims. They highlight that CGMPs provide limited guidance on quality processes for specific devices, leaving manufacturers considerable discretion. Consequently, claims based on CGMP violations are often found to be preempted, as the regulations are too vague to establish a concrete standard of care. For a state law claim to survive preemption, a plaintiff must identify specific federal requirements applicable to the medical device that the manufacturer allegedly violated, ensuring the state claim does not impose additional standards beyond federal law.

The federal-requirement baseline must be specifically established, but Current Good Manufacturing Practices (CGMPs) provide only general guidelines for manufacturers, rather than enforceable duties. The FDA emphasizes that CGMPs are flexible and can be adapted to various devices, lacking detailed prescriptions for manufacturing a specific device. Consequently, federal regulations that do not provide specific production guidelines cannot serve as a benchmark for determining whether state law claims, which impose liability for manufacturing defects, establish parallel duties to federal law. In the case of Howard v. Sulzer Orthopedics, the court ruled that a negligence per se claim involving a specific GMP violation was not preempted, as the plaintiff identified a clear, enforceable GMP. Similarly, in Bausch v. Stryker Corp., the court noted the necessity of evaluating whether CGMPs prescribe sufficiently specific duties to assess state law claims. The court concluded that the cited CGMPs are often too vague to support a parallel state claim for defects or warranty breaches. For instance, 21 C.F.R. 820.25(a) requires manufacturers to ensure sufficient qualified personnel but does not specify required qualifications or ratios, highlighting the ambiguity in the regulations.

A court must evaluate whether common law negligence claims regarding the insufficient number of qualified employees can be limited to the scope of related federal regulations. In their amended complaint, Plaintiffs reference the Current Good Manufacturing Practice (CGMP) regulation, which mandates that manufacturers develop procedures to ensure device design meets intended use and user needs. However, this regulation lacks specificity on compliance requirements, making it difficult to compare with state law duties. Similarly, the non-CGMP regulations cited by Plaintiffs only require that labeling information be conspicuous and that manufacturers provide adequate usage instructions, which also lack detailed compliance criteria. As a result, there is no clear baseline for comparing state common law requirements, questioning the legitimacy of Plaintiffs' claims of parallelism.

The 2013 FDA Warning Letter to Medtronic, which cited violations of generalized CGMPs, does not substantively support Plaintiffs’ claims, as the violations were not directly related to the specific issues raised by the Plaintiffs, nor did the FDA detail the requirements necessary for compliance. Additionally, the letter did not address the non-CGMP regulations related to labeling and usage instructions. 

In contrast, Plaintiffs’ claims regarding Medtronic's failure to report incidents to the FDA under 21 C.F.R. § 803 are different due to the specificity of the reporting requirements outlined in that regulation. This section mandates timely reporting of certain events, providing a clearer standard for comparison with state law claims.

Reporting obligations under federal regulations require Medtronic to notify the FDA within 30 days of becoming aware that a device may have caused or contributed to a death or serious injury, or that a malfunction could likely result in such outcomes. Additionally, certain events necessitating remedial action to prevent substantial public health risks must be reported within five days. Specific information required in these reports includes detailed patient information, adverse event descriptions, and device specifications. Unlike more general guidelines, these reporting requirements are not vague and are enforceable.

Plaintiffs' preemption arguments falter as they fail to demonstrate any state common law claims that are equivalent to these federal regulations. During a court hearing, counsel for the Kubickis acknowledged the absence of any such D.C. law mandating similar adverse event reporting, effectively conceding that their state law failure to warn claims—based on Medtronic's alleged reporting failures—are preempted. The plaintiffs attempt to link Medtronic's reporting obligations to their failure to warn claims by arguing that inadequate tracking and timely reporting prevented the FDA from issuing necessary warnings about the risks of the insulin pump. However, there is no D.C. common law that imposes liability for failing to report adverse incidents to the FDA regarding approved medical devices.

Plaintiffs argue that Medtronic's noncompliance with federal reporting requirements equates to a failure to warn consumers under D.C. common law tort. This argument fails for two main reasons. First, it conflates state law with federal obligations; the duty to warn consumers about device-related risks is distinct from the federal requirement to report adverse events to the FDA, as the latter does not impose a duty to update consumer warnings. Plaintiffs have not identified any regulation that mandates manufacturers to warn consumers of adverse events post-approval. Second, the plaintiffs' claims rely on speculation regarding potential FDA actions had Medtronic complied with reporting requirements. There is uncertainty whether the FDA would have required updates to consumer warnings based on the reported incidents, thus undermining the assertion that Medtronic’s reporting failures equate to a failure to warn. The court also cites precedent from the In re Medtronic litigation, which found that similar state law claims imposed additional requirements that are preempted by federal law, emphasizing that any claims regarding defective labeling based on new information discovered post-approval fall under the preemptive scope of Riegel. Ultimately, the court does not accept the argument that Medtronic's reporting failures are parallel to the claims of inadequate warnings under D.C. law, as they would necessitate warnings beyond those approved by the FDA.

Mandating additional warnings from manufacturers that exceed FDA-approved device labels is preempted under Section 360k(a) of the Medical Device Amendments (MDA). This section prohibits state law claims that assert a manufacturer has a post-sale duty to warn based on new injury reports related to the medical device. The Kubickis’ claims regarding the pump's failure to warn hinge on the assertion that Medtronic should have provided further warnings and recalled the device after discovering its deficiencies post-approval. However, the MDA's preemption clause prevents any court or jury from imposing liability under these circumstances. 

Moreover, any state law claim suggesting Medtronic failed to provide warnings beyond those mandated by the FDA, or that it neglected to recall the product without adhering to the PMA supplement process, introduces requirements that conflict with federal standards. The court reaffirmed that preemption applies when a manufacturer cannot alter warnings or instructions approved by the FDA. 

Conversely, claims against Medtronic regarding the design, manufacture, and labeling of the MMT-396 Infusion Set are not subject to express preemption since it was approved via the 510(k) substantial equivalence process. Therefore, the Kubickis can pursue their state law tort claims related to the MMT-396 Infusion Set, provided these do not encroach on FDA enforcement authority. The Federal Food, Drug, and Cosmetic Act (FDCA) grants exclusive enforcement powers to the federal government, not private litigants. Earlier, the court determined that the Kubickis’ claims associated with the MMT-522 Pump were not impliedly preempted, allowing for the possibility of litigation.

Plaintiffs are asserting state law breach claims that parallel federal regulations, which means their claims are not impliedly preempted under Buckman, as they do not seek to enforce federal regulations directly. The court has previously determined that the Kubickis' claims related to pump devices are expressly preempted, leaving only the question of implied preemption regarding their state law claims against Medtronic for the MMT-396 Infusion Set. Established precedent allows state law tort claims concerning 510(k) devices to proceed if they are grounded in traditional state tort law that predated federal enactments. Conversely, implied preemption may apply if federal laws are a critical element of the case. The Supreme Court's decision in Buckman highlighted that a "fraud-on-the-FDA" claim, which relies on the federal approval process, is impliedly preempted. As such, state law claims that effectively seek to enforce the FDCA cannot stand. However, the court concluded that the Kubickis' claims regarding the negligent design, manufacture, and labeling of the Infusion Set exist independently of the FDCA, aligning with the Supreme Court's indication that such claims can proceed even if federal regulations exist. The claims are characterized as those that would also be valid in the absence of federal law, thus not subject to implied preemption.

Negligence and strict liability claims were not impliedly preempted, as plaintiffs based their claims on traditional state law and did not claim fraud against the FDA. Although the plaintiffs acknowledged the absence of a common law claim for failing to report adverse events to the FDA under District of Columbia law, their failure to warn claim against Medtronic, alleging a breach of "a duty of reasonable care" to warn about the MMT-396 Infusion Sets, survives the preemption argument. D.C. law recognizes tort claims against manufacturers for not warning consumers of known product defects, supporting the viability of the Kubickis' claims regarding the MMT-396 Infusion Set. The court determined that Medtronic is entitled to summary judgment on express preemption grounds for all claims related to the MMT-522 Pump, except for the manufacturing defect claim, and on implied preemption for the non-existent claim regarding failure to report adverse events involving the MMT-396. However, implied preemption does not bar the Kubickis' claims related to the design, manufacture, and labeling of the MMT-396 Infusion Set, nor their failure to warn claims.

Regarding the learned intermediary doctrine, Medtronic argued that its duty to warn only extends to physicians, who act as intermediaries between the manufacturer and patients. This doctrine posits that if a manufacturer adequately informs the prescribing physician of product dangers, it is not required to warn each patient.

Dr. Dandona, Caroline's physician, testified that he did not read or rely on the warnings provided for the MMT-522 Pump and MMT-396 Infusion Set, indicating that even if the warnings had been adequate, it would not have changed his decision to prescribe the devices. Medtronic argues that this aligns with the learned intermediary doctrine, asserting that because Dr. Dandona did not consider the warnings, the company cannot be held liable for any alleged failure to warn, as there was no causal link to Caroline's injury.

However, the Court rejects Medtronic's argument, emphasizing that for the learned intermediary doctrine to exonerate a manufacturer, the warnings must be adequate. Existing case law supports that if a warning is inadequate or misleading, the manufacturer remains liable for injuries to the user. The adequacy of Medtronic’s warnings is still in dispute, which prevents granting summary judgment in favor of Medtronic.

Additionally, while it is noted that a physician's reliance on warnings is crucial for determining causation, mere inadequacy of a warning is insufficient for liability under the learned intermediary doctrine; the warning must also be a "producing cause" of the injury. The Court highlights that Dr. Dandona’s testimony suggests he was not responsible for reviewing Medtronic’s materials or instructing patients on device usage, further complicating the issue of causation and leaving genuine material facts unresolved.

Dr. Dandona's role involves establishing the policy for pump installation and appropriate infusion rates, while the technical aspects and patient instructions are delegated to pump trainers. The record indicates that Dr. Dandona did not review the instructions provided by Medtronic for the insulin-delivery device, which raises concerns about their adequacy. Under District of Columbia law, there is a presumption that the pump trainers would have read and relied on the manufacturer's instructions. However, there is no evidence confirming whether the trainers did so, leaving open the possibility that their instructions to Caroline were inadequate and contributed to her injury. Consequently, the court suggests that the pump trainer, rather than Dr. Dandona, serves as the relevant "learned intermediary" in the failure to warn claim, thus maintaining a causal link between the inadequate instructions and Caroline's injury.

Regarding the breach of express warranty claim against Medtronic, the plaintiffs allege that the company made misleading statements about the safety and functionality of the MMT-396 Infusion Set in its advertising, including claims about design modifications that were supposed to enhance safety but failed to do so. Medtronic argues that these statements do not constitute an actionable warranty, warranting summary judgment in their favor.

Medtronic's infusion sets feature patented tubing designed to be clog and kink resistant, ensuring safe insulin delivery. The court grants Medtronic summary judgment on the express warranty claims, finding that the statements cited by the plaintiffs do not constitute an enforceable warranty under District of Columbia law. To establish a breach of warranty claim, a plaintiff must demonstrate that the defendant violated an express promise about the product. An enforceable express warranty arises from factual affirmations or descriptions that become part of the sales agreement, as outlined in D.C. Code 28:2-313(1). However, mere affirmations of product value or opinions do not create a warranty, and claims based solely on broad promotional statements are insufficient to support a breach of warranty. The court highlights that the plaintiffs' reliance on general claims regarding the infusion set's design does not equate to a specific, fact-based promise of performance. For instance, statements about reducing clogging and ensuring safe delivery were deemed too generalized to constitute actionable warranties. The court cites similar cases where general advertising claims were classified as "puffery" rather than enforceable warranties. Thus, the plaintiffs' claims fail as a matter of law due to the nature of the statements in Medtronic's advertising materials.

To establish an enforceable express warranty, a manufacturer must provide specific, verifiable statements about a product's performance, rather than general praise. For example, in *City of Wyoming v. Procter & Gamble Co.*, statements labeling wet wipes as "flushable" were deemed sufficient to create an express warranty. Conversely, Medtronic's marketing claims regarding the MMT-396 Infusion Set are categorized as "puffery," lacking the specificity required for a warranty. This distinction is supported by the case of *In re General Motors Corp. Anti-Lock Brake Products Liability Litigation*, where broad claims about vehicle safety systems were dismissed as non-actionable puffery, as consumers could not rely on them as factual guarantees. Similar dismissals occurred in cases involving vague positive statements about products or services that lacked measurable claims. Thus, the Court concludes that Medtronic's advertising does not constitute an enforceable warranty. Additionally, while Medtronic seeks summary judgment on the punitive damages claims, the Court finds it premature to dismiss the possibility of punitive damages entirely.

Plaintiffs allege that Medtronic's actions regarding the implicated medical devices were malicious, willful, and lacked regard for safety, warranting punitive damages. However, punitive damages are recognized in the District of Columbia only as a remedy, not as an independent cause of action. Consequently, Medtronic's motion for summary judgment on Counts XXI, XXII, and XXIII of Plaintiffs' Second Amended Complaint is valid. The court clarifies that this decision does not prevent Plaintiffs from pursuing punitive damages later, as the case record is still developing and expert discovery has yet to occur. Medtronic's assertion to preemptively dismiss the punitive damages claim is rejected, and the court will consider this matter further as the case progresses. While the case involves serious allegations related to a widely marketed insulin-delivery device, the court finds some claims against Unomedical timely and agrees with Defendants on certain claims while disagreeing on others. Specifically, Unomedical is granted summary judgment on all claims against it based on timeliness, while Medtronic is granted summary judgment on all claims regarding the MMT-522 Pump, except for the manufacturing defect claim.

Plaintiffs allege that Medtronic did not report adverse events related to the MMT-396 Infusion Set, violating state law, and assert breach of warranty claims alongside a separate claim for punitive damages. The Court identifies genuine issues of material fact concerning Plaintiffs' claims of negligent design, manufacture, labeling, and failure to warn regarding the MMT-396 Infusion Set, particularly regarding causation. Consequently, Unomedical's Motion for Summary Judgment is granted, while Medtronic's Motion is granted in part and denied in part. The parties must submit a joint proposed schedule for expert discovery. Medtronic's motion references an expert declaration by Dr. Helena W. Rodbard, which discusses potential alternative causes of a plaintiff's injuries, but the Court previously allowed the Plaintiffs to strike parts of this declaration pending expert discovery. The document outlines that individuals with Type I diabetes require insulin for glucose processing, emphasizing the importance of insulin delivery systems. It also mentions a specific alarm code from the pump, which may relate to insulin delivery. Medtronic states that the FDA advised using the PMA Supplement process for device changes, as they were significant enough not to be considered substantially equivalent to existing devices. Additionally, the FDA’s warning letter noted a defect related to moisture ingress that could lead to pump failure.

The ultrasonic window welding process has been identified as the root cause of stress cracks leading to leaks in medical devices, negatively impacting their functionality. Plaintiffs do not assert that Caroline's injury stemmed from any "overlay leak." A 2013 Warning Letter criticized Medtronic for inadequate investigation of pump-related complaints, highlighting issues such as weak adhesive bonds and loose motor support disks, none of which were linked to the failure to investigate temporary blocked vent problems. The Federal Food, Drug, and Cosmetic Act (FDCA) prohibits the misbranding of medical devices in interstate commerce, detailing criteria for misbranding, including defective labeling and failure to comply with adverse event reporting requirements. U.S. District Judge Colleen Kollar-Kotelly oversaw the case until its transfer in July 2013. Flextronics International USA, Inc. was initially included as a defendant but was later voluntarily dismissed. Unomedical has aligned its arguments with Medtronic's regarding causation, which is the primary focus of the current analysis. The ruling addresses whether Caroline was connected to the insulin pump during the hypoglycemic incident, specifically disputing Medtronic's claims that she did not experience a temporary blocked vent and that such a blockage could not have caused her injury. Since expert discovery is ongoing, the court will only consider evidence regarding Caroline's connection to the pump at the time of her injury. The plaintiffs’ cited cases regarding reliance on the defendants' safety information are deemed inapplicable, as the court noted the significance of a confidential relationship in such determinations.

No fiduciary or confidential relationship exists in this case, and there is no latent product defect that emerged after the limitations period. The injury was immediately evident, with the plaintiffs aware of the insulin-delivery system's potential role in the injury by at least 2010. Class I medical devices are minimally regulated and present no unreasonable risk, while Class II devices, which are potentially more harmful, are subject to federal performance regulations but do not require pre-market approval. Class III devices present unreasonable risks or are critical for human health. The Supreme Court's decision in Lohr clarifies that the FDA's 510(k) substantial equivalence process prioritizes equivalence over safety, meaning that such approval does not necessitate particular forms to trigger express preemption. The Court found it consistent with congressional intent for state law claims to proceed against devices reviewed only under the 510(k) process. Medtronic's argument for summary judgment based on the absence of evidence for a manufacturing defect in the MMT-522 Pump was rejected, as the plaintiffs have not yet conducted necessary testing, making it premature to dismiss their claims regarding deviations from manufacturing specifications that could have caused the injury.

If the destructive testing of the pump reveals no manufacturing defect during the expert discovery process, Medtronic can renew its argument regarding preemption of the manufacturing defect claim. The recent case cited by Plaintiffs, Brackin v. Medtronic, does not change this conclusion. In Brackin, the court could not determine if the pump received premarket approval at that early litigation stage, and the case involved the MMT-523 Pump, not the MMT-522 Pump at issue here. Unlike in Brackin, there is unrefuted evidence that the MMT-522 Pump received premarket approval as part of the Real Time System. Furthermore, Brackin's reasoning is not binding and is unpersuasive, particularly if it suggests that a PMA-approved system can be dissected into components for preemption analysis. Plaintiffs incorrectly argue that the Court's prior ruling on the motion to dismiss precludes Medtronic from raising the preemption issue now. The Court's earlier opinion clarified that any preemption findings should not be interpreted as dismissing the need for Plaintiffs to identify a federal requirement that Medtronic allegedly violated, which must parallel a valid state law duty. Plaintiffs have confirmed that their claims are based solely on post-approval violations of federal law, which the Court accepts as binding for the future of this litigation, acknowledging that such claims would be preempted under Riegel. Relevant regulatory requirements emphasize the need for manufacturers to maintain appropriate design procedures and conduct documented reviews during device development.

Participants in design reviews must include representatives from all relevant functions, an independent individual, and necessary specialists, per id. 820.30(f). Manufacturers are required to establish procedures for design verification to ensure that design outputs meet input requirements, documenting all verification details in the Design History File (DHF) as outlined in id. 820.70(g). Additionally, manufacturers must ensure that manufacturing equipment meets specified requirements for design, construction, and maintenance (id. 820.72(a)), and that inspection, measuring, and testing equipment is suitable and routinely calibrated and maintained (id. 820.90(a)). Procedures for managing nonconforming products must include identification, documentation, evaluation, segregation, and disposition, with evaluations documented (id. 820.100(a)). Corrective and preventive action procedures must also be established (id. 820.198(a)). Manufacturers are responsible for maintaining complaint files and have procedures for receiving and evaluating complaints, including documentation for decisions not to investigate (id. 820.198(b)). The cited cases, Hughes v. Boston Scientific Corp. and Stengel v. Medtronic Inc., highlight complexities in preemption analyses related to PMA-approved devices, particularly in distinguishing between claims based on violations of the FDCA and those concerning failure to warn about device risks, as the legal implications vary significantly based on the nature of the claims.

The courts of appeals have differing views on whether state law failure to report claims are implicitly preempted by federal law. The Sixth and Eighth Circuits have ruled against allowing such state law tort claims, arguing they infringe upon the FDA's exclusive authority under the Federal Food, Drug, and Cosmetic Act (FDCA). In these circuits, failure to submit FDA-required reports is seen as a potential fraud on the agency, invoking the Supreme Court's ruling in Buckman. Conversely, the Fifth, Seventh, and Ninth Circuits have determined that state law failure to report claims are not preempted, as they arise from an alleged breach of state law duties rather than an implied federal right of action. The D.C. Circuit has not addressed this issue, and the current Court finds no need to intervene, particularly since the Plaintiffs concede there is no common law claim for failing to report adverse events in this jurisdiction. The only plausible failure to warn claim remaining in the Plaintiffs' complaint is the allegation that Medtronic failed to warn consumers about foreseeable harm associated with its product. Additionally, the Court previously ruled that any warranty claims related to the MMT-522 Pump are expressly preempted. The Kubickis' warranty claims based on advertising differ from their claim regarding an express warranty in the product packaging of the MMT-396 Infusion Set, which they appear to have abandoned, as they have not contested Medtronic's assertion that the relevant infusion set lots lacked any warranty.