Medtronic Lawsuit: Hernia Mesh, MiniMed, and Infuse Cases

Medtronic is currently facing lawsuits and recent judgments across four broad fronts: a $382 million federal antitrust verdict handed down in February 2026, thousands of Covidien hernia mesh product liability claims consolidated in federal and state court, individual injury suits tied to MiniMed insulin pump recalls, and a running history of False Claims Act settlements over alleged kickbacks and off-label promotion. The company has also resolved earlier waves of litigation over the Sprint Fidelis defibrillator leads and the Infuse bone graft, and its own name sits on the 1996 Supreme Court decision that still governs when patients can sue medical device makers under state law. Here is where each of the major Medtronic lawsuits stands.

The $382 Million Applied Medical Antitrust Verdict

On February 5, 2026, a federal jury in the U.S. District Court for the Central District of California ordered Medtronic to pay $381,705,005 in damages to Applied Medical Resources Corporation after finding the company liable for federal and state antitrust violations.¹ The verdict followed a ten-day trial focused on the market for advanced bipolar surgical devices, which surgeons use to cut tissue and seal blood vessels.

Applied Medical, which sells a competing product called the Voyant Intelligent Energy System, filed the suit in February 2023. It alleged that Medtronic conditioned discounts and rebates on its broader surgical catalog on hospitals and group purchasing organizations also buying its LigaSure bipolar devices, making the Voyant economically impractical to adopt even where hospitals wanted it.² Applied Medical put Medtronic’s share of the advanced bipolar market above 70 percent. Medtronic argued the market should be defined more broadly to include ultrasonic and robotic devices, which would have reduced its share substantially. The jury adopted the narrower market.

The Federal Trade Commission had filed a unanimous amicus brief in July 2023 urging the court to reject Medtronic’s motion to dismiss, taking no position on the underlying facts but arguing that Medtronic’s proposed legal standards for exclusive-dealing and bundling claims were too strict.³

Medtronic has said it is disappointed with the outcome and intends to appeal.¹ As of April 2026, the company had filed post-trial motions asking the court to set aside the verdict, which Applied Medical opposed as a rehash of arguments already rejected.⁴ The damages could potentially be trebled under the Clayton Act, but that question had not been publicly resolved as of mid-2026.

Covidien Hernia Mesh Multidistrict Litigation

The largest active product liability exposure Medtronic faces came with its 2015 acquisition of Covidien. Thousands of patients have sued over Covidien-branded hernia mesh, alleging that the devices, particularly the polyester designs, cause chronic pain, infections, bowel obstructions, mesh migration, nerve damage, breakage, and fragmentation.⁵

In June 2022, the U.S. Judicial Panel on Multidistrict Litigation consolidated the federal cases into MDL No. 3029 in the District of Massachusetts before Judge Patti B. Saris. By late 2023, roughly 830 cases were pending in the federal MDL, more than 6,000 in Massachusetts state court, and about 500 in Minnesota state court, with tolling agreements covering an additional 6,000 or so potential claims.⁵

As of mid-2026, the litigation remains in discovery. Nearly two million documents have been produced and corporate depositions are underway. No bellwether trial has been completed, and no global settlement has been announced. The Parietex and ProGrip lines at the center of the cases reached the market through the FDA’s 510(k) “substantial equivalence” clearance rather than the more rigorous premarket approval process, a distinction that matters for preemption defenses.

MiniMed Insulin Pump Recalls and Injury Suits

Medtronic’s MiniMed insulin pump line has drawn two Class I FDA recalls, the agency’s most serious classification, and a scattering of individual injury lawsuits.

In February 2020, the FDA issued a Class I recall for more than 300,000 MiniMed 600 series pumps because the clear plastic retainer ring that locks the insulin reservoir in place could crack if the device was dropped, allowing the reservoir to disconnect and delivering too much or too little insulin. Before the recall, the FDA had received more than 26,000 complaints, 2,175 reported injuries, and one reported death tied to the defect. Medtronic expanded the recall in October 2021 to proactively replace all pumps with clear rings, offering an updated black-ring design, and noted that an independent medical panel had not confirmed a direct link between the defect and reported deaths.⁶

A separate Class I recall followed in 2024. In July of that year, Medtronic issued a safety alert for the MiniMed 600 and 700 series pumps, including the 630G, 670G, 770G, and 780G, after finding that physical impacts could damage internal electrical components, shorten battery life, and stop insulin delivery without adequate warning. The FDA’s Class I classification covered approximately 785,000 pump systems. Between January 2023 and September 2024, there were 170 reported cases of severe hyperglycemia and 11 cases of diabetic ketoacidosis linked to the defect, with no reported deaths.⁷

Despite the scale of these recalls, there is no MiniMed class action or MDL. Cases have moved forward individually, and several federal judges have dismissed claims on federal preemption grounds, ruling that FDA approval of the devices blocks certain state-law theories. A wrongful death case involving a MiniMed 630G filed in Nevada federal court (Roget v. Medtronic) was in discovery as of late 2023, and a Kentucky wrongful death case appeared close to an individual settlement as of October 2024. Overall, MiniMed litigation has been described as slowing, with many potential claims now barred by statutes of limitation or preemption.

Sprint Fidelis Defibrillator Lead Settlement

In October 2007, Medtronic recalled its Sprint Fidelis family of defibrillation leads after the wires were found prone to fracture, a defect that could deliver unnecessary electrical shocks or, worse, fail to deliver a lifesaving shock. More than 250,000 leads had been implanted before the recall, roughly 172,000 in the United States, and lead failure was suspected in about 13 deaths.⁸

In October 2010, Medtronic agreed to a $268 million settlement that terminated the multidistrict litigation and Minnesota state court proceedings, dismissed pending appeals in the Eighth Circuit and Minnesota Court of Appeals, and called for dismissal of other Fidelis-related cases nationwide.⁸ Doctors generally advised against surgically removing the defective leads because of the risk of vein tears or heart damage from scar tissue that forms around implanted wires.

SynchroMed II Consent Decree

Medtronic’s SynchroMed II implantable drug infusion pump, used to deliver medication into the spinal canal for chronic pain or spasticity, drew repeated FDA enforcement action. The device was linked to over-infusion and under-infusion caused by motor stalls, electrical shorts, battery defects, and alarm failures. By 2016, the FDA had received 103 reported adverse events tied to the device, including 16 deaths, most following medication overdoses or abrupt withdrawal.⁹

Between 2006 and 2013, FDA inspectors visited Medtronic’s Columbia Heights, Minnesota manufacturing facility five times and issued three warning letters citing failures in quality control, design documentation, and complaint handling. In 2015, the Department of Justice and FDA obtained a consent decree of permanent injunction against Medtronic and two executives, alleging the company had distributed “adulterated” devices not manufactured to federal standards. Medtronic was required to stop manufacturing and distributing new SynchroMed II pumps except where medically necessary and to hire a third-party expert to oversee corrections at the plant.¹⁰

Infuse Bone Graft Settlements

Infuse, a bone graft product used in spinal fusion surgery, generated litigation on multiple fronts. Plaintiffs and investors alleged that Medtronic promoted the product for unapproved uses and concealed adverse side effects seen in clinical trials.

In 2012, Medtronic settled a class action tied to Infuse for $85 million.¹¹ In May 2014, the company settled product liability claims brought by approximately 950 plaintiffs for $22 million, calling the deal a compromise rather than an admission of liability. About 750 filed cases involving roughly 1,200 plaintiffs remained pending at that point, with law firms indicating another 2,600 unfiled claims might follow. Medtronic took a special charge of $120 million to $140 million to cover the settlement and anticipated future costs.¹²

Investors who bought Medtronic stock between September 2010 and June 2011 brought a securities fraud lawsuit alleging the company misrepresented clinical trial data and concealed known Infuse risks; that case settled for $43 million.¹³ The Department of Justice separately investigated Infuse marketing practices but closed its investigation in 2012 without bringing charges.¹¹

Kickback and False Claims Act Settlements

Medtronic has paid tens of millions of dollars to resolve federal fraud allegations, most of them tied to alleged kickbacks and off-label promotion.

In October 2020, Medtronic agreed to pay $9.2 million to settle allegations that it paid kickbacks to South Dakota neurosurgeon Wilson Asfora to induce him to use SynchroMed II pumps. The DOJ said Medtronic held more than 130 social events at a Brazilian steakhouse owned by Asfora and his wife between 2010 and 2019, spending over $87,000, and that employees documented the gatherings as educational meetings even though they were social dinners featuring meals and alcohol in public areas of the restaurant.¹⁴ Of the total, $8.1 million resolved the kickback allegations and $1.1 million resolved charges that Medtronic underreported payments to Asfora under the federal Open Payments Program.¹⁵ Medtronic fired the sales representative principally responsible and his manager and disciplined twelve other employees. The settlement was not an admission of liability.¹⁶ Asfora later settled his own False Claims Act case with the DOJ for $4.4 million in May 2021 and was excluded from federal healthcare programs for six years.¹⁷

In December 2018, Medtronic paid approximately $51 million to resolve three federal cases involving conduct at subsidiaries it had acquired. Medtronic subsidiary ev3 pleaded guilty in Massachusetts federal court to a misdemeanor for distributing the Onyx Liquid Embolic System for unapproved uses outside the brain between 2005 and 2009, paying an $11.9 million fine and $6 million in forfeitures, while Medtronic paid an additional $20 million and agreed to new compliance terms for Onyx marketing. Covidien paid $13 million to resolve civil False Claims Act allegations that it used a patient registry to funnel kickbacks to hospitals to incentivize use of its Solitaire mechanical thrombectomy device for stroke patients.¹⁸ Medtronic noted that the underlying conduct at both ev3 and Covidien occurred before its acquisitions and did not admit wrongdoing.

Why Medtronic v. Lohr Still Shapes These Cases

Many of the product liability suits Medtronic faces today are governed by a 1996 Supreme Court decision bearing the company’s own name. In Medtronic, Inc. v. Lohr, Lora Lohr sued after her pacemaker failed, asserting negligence and strict liability under state law. Medtronic argued that the Medical Device Amendments of 1976 preempted her claims entirely.¹⁹

The Court ruled against Medtronic. It held that the FDA’s 510(k) “substantial equivalence” clearance process does not impose the kind of device-specific federal safety requirements needed to block state tort suits, reasoning that 510(k) review focuses on whether a device resembles an existing product rather than on whether it is safe. Reading the statute to grant manufacturers blanket protection would give the industry “complete immunity from design defect liability.”²⁰ Because most devices reach the market through 510(k) clearance, Lohr preserved patients’ ability to bring state-law claims, and it explains why cases like the Covidien hernia mesh MDL, involving 510(k)-cleared products, can proceed even when devices with fuller premarket approval are largely shielded. Courts continue to draw the preemption line case by case, which is why some MiniMed suits have been dismissed on preemption grounds while others move forward.

1
MobiHealthNews. Medtronic Ordered to Pay Almost $382M in Applied Medical Antitrust Ruling
2
Source on Healthcare. Verdict in Medtronic Highlights Problems in Misusing Monopoly Power
3
Federal Trade Commission. FTC Files Amicus Brief to Clarify Antitrust Standards Involving Exclusive-Dealing and Bundling Arrangements
4
Law360. Medtronic Can’t Ax $382M Trial Loss, Applied Medical Says
5
U.S. Judicial Panel on Multidistrict Litigation. In Re: Covidien Hernia Mesh Products Liability Litigation (No. II), MDL No. 3029
6
FDA. Update to Recall of MiniMed 600 Series Insulin Pumps With Clear Retainer Rings
7
FDA. Insulin Pump Recall – Medtronic Notifies Users of MiniMed 600 and 700 Series Pumps Risk of Shorter Expected Battery Life
8
DI Cardiology. Medtronic Settles Lawsuits on Defibrillation Leads
9
MD+DI Online. More Patient Deaths Linked to Medtronic Infusion Pump
10
Searcy Law. Permanent Injunction Against Medtronic
11
MPR News. Medtronic Infuse
12
Medtronic. Medtronic Agrees to Settle Certain INFUSE Bone Graft Product Liability Cases
13
Motley Rice. Medtronic
14
HHS Office of Inspector General. Medtronic to Pay Over $9.2 Million to Settle Allegations of Improper Payments to South Dakota Neurosurgeon
15
DOJ. Medtronic Settlement Agreement
16
MedTech Dive. Medtronic DOJ Settlement SynchroMed
17
DOJ USAO-SD. Neurosurgeon and Two Affiliated Companies Agree to Pay $4.4 Million to Settle Healthcare Fraud
18
Health Leaders Media. Medtronic Subsidiaries Pay $31M to Settle Criminal, Civil Complaints
19
Justia. Medtronic, Inc. v. Lohr, 518 U.S. 470
20
Cornell Law Institute. Medtronic, Inc. v. Lohr