Medtronic, Inc. is a medical device manufacturer that makes many devices intended to help patients manage chronic conditions. However, the company has been involved in numerous product recalls and legal complaints. Patients who have been harmed by Medtronic products may be eligible for compensation.
What does Medtronic do?
Medtronic (NYSE: MDT) is a medical device company founded in 1949. It manufactures devices and uses medical technology intended to help patients manage their health. The company focuses on devices in four categories of medicine: cardiovascular, diabetes, neuroscience and medical-surgical.
According to the medical device maker, more than 76 million patients have used Medtronic products, making it the largest medical device company in the world.
Who owns Medtronic?
Medtronic is a stand-alone American company. In 2015, it acquired Covidien, an Irish health care products company, for $42.9 billion. After that, Medtronic’s legal headquarters relocated to Ireland, while its main operations remain in America.
Medtronic’s products have been involved in numerous recalls. According to the U.S. Food and Drug Administration (FDA) recall database, the company has been named in hundreds of individual recalls.
FDA recalls are assigned a class number, which indicates the severity of the threat to the consumer. Class I recalls are the most serious level of FDA recall. According to the FDA’s recall database, Medtronic’s recalls break down as follows:
- Class I recalls: Medtronic is named in 491 Class I recalls. Class I recalls are issued when the FDA sees “reasonable probability” that the product issue will cause serious injury or death.
- Class II recalls: Medtronic is named in hundreds of Class II recalls. This type of recall is issued when the product may cause temporary or reversible health issues.
- Class III recalls: Medtronic is named in 49 Class III recalls. This class is assigned when the product isn’t likely to cause health issues but is still notable for consumers.
Many people have used or currently use a product involved in a Medtronic recall. Patients using these products should consult their doctor to determine next steps.
Medtronic has faced a variety of lawsuits. Its most notable recent involvements include a 2018 securities fraud settlement and several ongoing product harm lawsuits.
In many cases, recalls lead to lawsuits. Patients harmed by medical products may be able to file lawsuits to hold companies accountable. Lawsuits can be filed in either State or Federal court.
When many consumers are harmed by the same product in the same way, lawsuits may become class action lawsuits or be organized into multidistrict litigation. They are defined as follows:
- Class action lawsuits cover a group of people with similar experiences and injuries, called class members, whose interests are protected by a few named plaintiffs. If class action lawsuits are resolved in favor of the plaintiffs, class members can submit a claim to get their share of the award.
- Multidistrict Litigation (MDL) covers multiple individual lawsuits brought by people from different states against the same defendants that are transferred to a single court. MDLs are used to streamline discovery and pretrial work. The plaintiffs maintain their individual lawsuits and cases that go to trial are heard individually.
Below are a few notable examples of lawsuits involving Medtronic. However, this is not an exhaustive list. If you believe you were harmed by a Medtronic product, our law firm is here to help. People who experience life-threatening health issues due to a faulty product may be able to receive compensation.
Complete this webform or call 1.800.768.4026 to contact attorney, Esther Berezofsky, for more information or to discuss a potential claim.
Past Medtronic lawsuits
- In 2018, Motley Rice reached a $43 million settlement on behalf of Medtronic investors. The claims arose from Defendants’ alleged engagement in a scheme and course of conduct designed to defraud the investing public regarding Medtronic’s clinical trial design and reporting of clinical data and risks associated with the use of INFUSE Bone Graft (“INFUSE”), a product containing recombinant human bone morphogenetic protein used for spinal surgeries. Plaintiffs alleged that in order to induce physician acceptance and generate consistent sales growth of INFUSE, the Company forged relationships, including financial relationships, with physician authors who published research articles in respected medical journals and knowingly concealed in those original articles, or omitted altogether, known facts regarding INFUSE’s adverse side effects observed in clinical trials. This settlement was for investors who purchased stock between September 8, 2010, and June 28, 2011, and experienced losses.
- In 2012, the Court approved an $85 million settlement in another securities suit involving Medtronic (and in which Motley Rice played a key role). That case alleged that Defendants violated the federal securities laws by making materially false and misleading public statements and omitting material facts concerning INFUSE. Plaintiffs specifically alleged that Defendants misleadingly touted INFUSE as an increasing source of material revenue and profit growth for Medtronic, repeatedly stated that increases in sales were driven by expanded “on-label” FDA-approved indications for the product, and falsely led investors to believe that Medtronic did not promote INFUSE for off-label uses and strictly complied with all applicable health regulations and a 2006 Corporate Integrity Agreement negotiated with the US Department of Justice. This settlement was for investors who purchased stock between November 2006 and November 2008, and experienced losses.
- In 2007, Medtronic announced an issue with its Sprint Fidelis heart defibrillators. Hundreds of patients experienced malfunctions. Motley Rice helped affected patients file lawsuits against Medtronic. The company also faced a class action lawsuit for these defibrillator defects.
Medtronic pain pumps
Pain pumps, also called drug infusion systems, help patients manage pain and symptoms. The pumps are designed to deliver programmed amounts of medication into the patient's body. Medtronic’s SynchroMed™ II intrathecal infusion pump is a programmable, implantable pump.
This product aims to eliminate the possibility of incorrect dosing, whether accidental or on purpose.
However, the SynchroMed pumps have been involved in a number of recalls and product liability cases. According to FDA databases, 64 recalls have included SynchroMed pumps and 32 of those were Class I recalls.
Medtronic pain pump settlements
Medtronic’s SynchroMed pumps have been involved in settlement agreements for product liability damages. Some settlement records are confidential. However, a few settlement details are publicly available.
In 2019, Medtronic entered into a settlement of $35 million to compensate victims of the faulty pumps.
Medtronic MiniMed insulin pumps
Medtronic also manufactures insulin pumps, which allow diabetic patients to manage their blood sugar. In November 2019, Medtronic initiated a product recall of its 600 series MiniMed insulin pumps. Subsequently, in February 2020, the FDA issued a Class I recall for the defective insulin pumps. The insulin pump recall is still open and includes MiniMed 630G and 670G pump models.
As of 2020 complaints about the MiniMed pumps included reports of more than 2,000 injuries and at least one death. These injuries may have occurred as a result of the pumps’ defective retainer ring. When damaged, the ring interferes with the attachment of the insulin cartridge and may cause incorrect dosing.
People harmed by the MiniMed 600 series insulin pumps are pursuing litigation against Medtronic. Learn more about the product defect, litigation status and how to bring a claim related to your MiniMed Insulin Pump.
Medtronic class action lawsuit: shared data
In August 2023, a data sharing complaint was filed in California as a class action lawsuit. The lawsuit alleges that apps connected to MiniMed insulin pumps and InPen insulin pens have collected and shared sensitive information.
The lawsuit is pending, so the outcome is unknown.
Our diabetes litigation experience
Our attorneys have experience representing diabetics in insulin pump cases, including representing clients in cases over other models of Medtronic insulin pumps insulin dosing.
We have investigated and litigated cases for diabetic patients who experienced complications from various diabetes medications. This includes medical drug lawsuits related to:
- Actos® and Duetact® (which have been linked to an increased risk of developing bladder cancer)
- Incretin mimetics Januvia®, Victoza®, Janumet® and Byetta® (which are linked to pancreatic cancer)
- SGLT2 Inhibitors Invokana®, Invokamet®, Farxiga®, Xigduo XR®, Jardiance®, Glyxambi® and Synjardy® (which allegedly increased the risk of kidney failure)
Our attorneys have the resources needed to thoroughly investigate and identify potentially harmful products, medical causation, compliance with FDA regulations, inadequate warnings, manufacturer wrongdoing and other issues in medical products lawsuits.
If you used any of these devices and suffered health effects as a result, we may be able to help you seek compensation for the harms you have suffered. Contact us today to learn about your legal options.
Do not stop taking a prescribed medication without first consulting with your doctor. Discontinuing a prescribed medication without your doctor’s advice can result in injury or death.
Motley Rice LLC, a South Carolina Limited Liability Company, is engaged in the New Jersey practice of law through Motley Rice New Jersey LLC. Esther Berezofsky is the attorney responsible for the New Jersey practice.