ICIJ RELATED MEDIA STATEMENTS

Medtronic Statement Dated November 30, 2018

MEDTRONIC STATEMENT ON MEDIA COVERAGE CONCERNING THE COMPANY’S BUSINESS CONDUCT

Medtronic is aware of recent media coverage, advanced principally by the International Consortium of Investigative Journalists (ICIJ) and ICIJ-affiliated journalists, that calls into question the company’s ethics and business practices. The articles point to people and events that are associated with unethical conduct and then attempt to assert the entire company is, in and of itself, unethical.

Medtronic strongly rejects this assertion. Medtronic has more than 86,000 employees worldwide and many thousands of independent distributors, partners, contractors and suppliers that engage with or represent the company in an ethical manner every day. The company has instituted a variety of global compliance and ethics programs to ensure these employees and affiliated partners operate with the utmost integrity – in full compliance with Tenet 3 of the Medtronic Mission which states that we strive to be “recognized as a company of dedication, honesty, integrity and service.”

We also fully acknowledge that certain employees or affiliated partners of Medtronic will not meet these high expectations and will engage in conduct that the company does not support or that may violate laws, regulations or codes of acceptable conduct. In those instances, Medtronic acts promptly to correct the situation by removing and/or terminating the employee or partner and engaging outside authorities as appropriate.

While these situations are regrettable, it is not uncommon or unique to Medtronic. This rare conduct is inherent to any global, multinational company of our size and scope.

We will continue to strive to meet the high ethical standards that our customers, patients and other stakeholders expect of us.

The following information relates to our external and internal compliance standards:

Ethical Collaboration with External Experts

Medtronic works closely with physicians, hospitals, and other outside experts to continuously improve our company’s ability to alleviate pain, restore health and extend life through our technologies. In this capacity, we recognize our need to closely follow rigorous programs and processes that ensure all interactions with external experts or consultants comply with internal, industry, and societal standards for ethical interaction and engagement.

These programs and processes include a global Code of Conduct, a global Business Conduct Standards Policy and associated procedures for ethically interacting with physicians and external experts as well as country-specific rules guiding ethical and socially responsible interactions across a broad and complete range of interactions with external experts, including, to name a few, donation- and grant-making; product sales agreements; support for third party academic conferences and symposia; and provision of educational items.

Decisions on when and how to engage with external experts begins with a determination by non-sales and non-marketing functions about whether the services of a physician or other outside expert are needed for the proposed work and whether the proposed expert has the expertise, qualifications, and capacity to deliver the services. We then ensure consultants receive fair compensation at appropriate rates for work conducted on our behalf, using a fair market value compensation analysis. Contracts also detail the services to be provided and set forth, among other things, that a physician or other outside expert will never be paid to endorse or otherwise recommend our products. Other protocols include ensuring all physicians or outside expert speakers be made aware of local legal requirements for product promotion.

We firmly believe transparency is critical. We initiated our own voluntary disclosure of payments to U.S. physicians on our website in 2010, four years in advance of the Physician Payments Sunshine Act requirements for the CMS Open Payments Database, and meet the requirements of other countries’ transparency laws.

Internal Ethics Standards

Fostering, developing and promoting an internal culture of ethics and integrity continues to be a fundamental focus for Medtronic.

Employees
Our global Code of Conduct commits all employees and those acting on our behalf to ethical behavior and requires employees to follow all applicable laws and regulations. We train all new employees and regularly retrain existing employees on the Code of Conduct, including annually educating employees on how to confidentially report any legal, compliance or ethical concerns. Our Global Conflicts of Interest Policy also provides employees with practical guidance on how to avoid or disclose real or potential conflicts of interest with business partners, suppliers, vendors and colleagues. Importantly, we enforce a global anti-retaliation policy that prohibits Medtronic employees or agents from taking any adverse action against an individual because that person reported a possible violation of law or policy.

We embed ethics and integrity throughout all Medtronic processes, including employee performance.

Distributors
Medtronic’s Global Anti-Corruption Policy requires compliance with all applicable anti-corruption laws and regulations, including the U.S. Foreign Corrupt Practices Act (FCPA), and anti-corruption laws of other countries where we or our partners do business. Our policies and contracts with global distributors also require compliance – ensuring laws and regulations are maintained relating to the distribution of our products. We also conduct background checks on distributors, provide them with local compliance training and insist they annually certify compliance as a condition of working with us.

These internal and external processes are just some of the many examples of Medtronic’s commitment to compliance. We recognize that dedication to these practices will not only help us achieve our business goals but also, and more importantly, is the right thing to do.

Medtronic Statement Dated November 29, 2018

MEDTRONIC STATEMENT ON MEDIA COVERAGE CONCERNING ITS INTEGRATED HEALTH SERVICES BUSINESS

Medtronic is aware of media stories globally, facilitated principally by the International Consortium of Investigative Journalists (ICIJ), regarding Medtronic’s Integrated Health Solutions (IHS) business. Many of these stories lack important context, omit key facts, or misstate facts regarding this business.

Medtronic is committed to improving healthcare for patients across the globe. The company’s IHS business aims to enhance efficiency and effectiveness of patient care settings, such as cardiac catheterization labs and operating rooms, while also optimizing healthcare delivery from the time a patient is referred for treatment to the time he or she has fully recovered. To accomplish this, we leverage data to highlight variations in clinical decision-making, and we manage processes to enable more standardized and effective decision-making amongst healthcare providers – all as permitted by applicable law. This helps the healthcare provider to align the appropriate care for patients and can improve patient outcomes in relation to costs.

The following information was provided to ICIJ and their affiliated journalists but were either omitted or mischaracterized. Despite claims in media stories and those made by anonymous sources within those stories, the following is true about the Medtronic IHS business:

1. Medtronic does not control clinical protocols or purchasing decisions.
   
   • Our Integrated Health Solutions business focuses on improving healthcare delivery for patients. Throughout our engagement and beyond, healthcare providers and their health systems retain full autonomy to decide which procedures are indicated for which patients, and which medical devices they will use from which companies. We do not control or direct healthcare professionals’ decision-making when it comes to patient care, the indications for procedures, the use of technology in patient care, or the selection of specific medical devices, nor do we stifle competition or limit options for patients. IHS operates with the Medtronic IHS managed service organization (MSO), which is a separate business enterprise that houses the Medtronic services and solutions business and is unrelated to the manufacture and sale of medical therapies and products. IHS has firewalls that are designed to prevent the inappropriate flow of information to Medtronic’s medical device businesses, such as protected patient data and sensitive clinical operations data (e.g., pricing information), and help maintain independence from the device company — so the healthcare provider retains full control over clinical decision-making.
2. Medtronic does not donate staff or offer staff free of charge.
   
   • Staff employed by Medtronic to perform non-clinical operations within the customer’s health system are compensated for by the customer as a service offered in the contract.
3. Medtronic may finance or underwrite the purchase of certain medical equipment used in the hospital setting and when we do, that equipment is fully reimbursed and paid for by customers.
   
   • As part of Medtronic’s overall service contracts with health care providers, HCP’s may contract for hospital equipment. This equipment is included in the overall price of the contract and is paid for over the length of the contract. This may be done through financing or lease arrangements, which are common arrangements and contracting models for purchasing capital equipment in health care and other industries. The equipment is not free or given away in exchange for market share.
4. Diabeter is not a medical device.
   
   • “Diabeter” is not a device. Diabeter refers to Medtronic’s diabetes management clinics, which are an example of our commitment to improving healthcare delivery. These diabetes management clinics provide comprehensive, cutting-edge care — supported by dedicated healthcare professional and specialists — for more than 1,500 children and adults who are living with type 1 diabetes. The Diabeter clinics, located in the Netherlands and operated by a subsidiary of Medtronic, offer patients an independent specialized center where diabetes is the only focus of attention. Patients have a choice of medical therapies and a host of professional support services from endocrinologists, nutritionists, and psychologists. Physicians at these clinics use their medical judgment in selecting appropriate treatment for their patients. Medtronic is not involved in the physicians’ medical decision-making process, nor are any incentives provided for using Medtronic products. While the Diabeter Clinics are in their early stages, the results are promising, with improved clinical outcomes (better blood glucose control) and reduced costs.

More information on Medtronic’s IHS business is available here and here.

Medtronic Statement Dated November 28, 2018

MEDTRONIC STATEMENT REGARDING NEWS COVERAGE PERTAINING TO MEDTRONIC MEDICAL DEVICE ADVERSE EVENTS

Medtronic is aware of several misleading claims in the media, principally advanced by reporting from the International Consortium of Investigative Journalists (ICIJ), about adverse events and deaths allegedly linked to our products. Based on our experience over decades witnessing how patients react to news reports of this nature, we are concerned that these claims, most of which are provided without context or substantiation, will create unfounded fear among patients and cause them to make choices that may harm their health, including avoiding seeking well-supported, standard-of-care treatments that can improve or save their lives.

Medtronic fully acknowledges and understands that, on rare occasions, not all medical devices work as intended. We also appreciate and sincerely empathize with patients who experience these complications or the unintended impacts of medical devices. We strive every day to eliminate these issues where they exist and to ensure that patients and physicians have the most up-to-date information regarding our products so that their decision-making process is based on an accurate understanding of the therapies’ benefits and risks.

We welcome fair and rigorous dialogue with stakeholders on how we and others can improve our industry to advance patient care and safety. We will not, however, allow misrepresentation and a lack of rigor and responsibility by certain journalists to cloud the demonstrated performance of our products and therapies and, as a result, negatively impact the millions of patients who have benefited from these products.

Accordingly, Medtronic provides the following statement:

ICIJ’s analysis and use of adverse event numbers in their reporting are based on unsupported methods, omit important context, and should not be accepted as credible.

Medtronic Products Benefit Millions of Patients Each Year
Medtronic’s Mission is to alleviate pain, restore health, and extend life. Every second, two patients around the world undergo treatment from one or more of our therapies, and this year alone that includes more than 70 million people. We strive to make those clinical experiences beneficial at the highest level, with the lowest possible risk of harm based on our rigorous clinical research and compliance with key regulatory bodies and academic leaders. We are proud of our people, products and services, as well as our track record of quality.

Misuse of Adverse Event Reporting by ICIJ
Medtronic takes adverse event reporting very seriously and investigates them thoroughly. It is also critical to understand that these reports have significant and well-recognized limitations. It is because of these limitations that the FDA recognizes that these voluntarily reported, non-adjudicated adverse event reports “cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices” and that “the number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices.”¹

Notwithstanding this clear admonition from the FDA, the ICIJ has chosen to make adverse event numbers a hallmark of their stories by citing any reported adverse event as a consequence of the medical device, without consideration of the role of the underlying medical condition or adjacent surgical therapy. Thus, without a shred of evidence regarding the potential contribution of a given device to a reported adverse event, they have generated a false narrative that medical devices are killing or harming people at an alarming rate – misusing data that even the FDA and other medical professionals clearly warn should not be used in this manner. Such behavior in an academic, scientific setting would be labelled as academic misconduct. Moreover, this misuse of data by ICIJ is a disservice to the patients Medtronic serves around the world.

Contextual Factors Around Adverse Events
Any reports on the numbers of adverse events must be put in the context of the total number of devices available to patients. In many of these media reports, Medtronic has been identified as the company with the highest number of adverse events. Medtronic is the leading medical device manufacturer in the world with the greatest number and breadth of products of any company - used by more than 70 million patients this year alone. Recent media reports have chosen to omit this important context, but it is necessary because the FDA itself has recognized that “the largest device makers likely would have the most adverse events because they make the most devices.”

Adverse event reports have other significant limitations. The fact that an adverse event is reported regarding a certain device does not mean that the device malfunctioned or that the event is attributable to the device. In particular, Medtronic closely reviews all adverse events involving death, often with direct involvement of our internal team of medical professionals and at times in consultation with independent physician panels.

Because Medtronic believes that it is important for regulators to have this information, it is our policy to report death events to FDA and other regulators even if causation is not established. As a result, any Medical Device Reports (MDR’s) will link our products to deaths even when the product may have had no part in causing the patient’s death. Reported deaths include, among other causes, patients in car accidents, patients receiving end of life care for cancer, and patients receiving treatment for other medical conditions. For example, in one case, it was reported that a patient with an insulin pump died due to cancer. According to the report by Medtronic, the insulin pump had been disconnected for days prior to the patient death.

Other limitations of adverse event reports include the fact that such reports may be voluntarily filed by individuals with no medical training (e.g., patients, family members, or lawyers) and may contain limited or incomplete information. The reports can be duplicative and occasionally affected by external factors such as media reports or litigation.

In evaluating and monitoring the safety of our products, Medtronic carefully considers the totality of available scientific evidence, with particular emphasis on data from controlled clinical trials and studies conducted under real world-conditions. Such studies provide the most reliable evidence regarding the safety and efficacy of our medical devices and therapies and allow for direct comparison to other products and therapies. ICIJ indicated to Medtronic on November 27, 2018 that this type of data was specifically excluded from their analysis.

For all these reasons, it is not valid to draw conclusions about device safety across thousands of individual medical products based solely on the number of reported events. ICIJ’s analysis and use of adverse event numbers in their reporting are based on unsupported methods, omit important context, and should not be accepted as credible.

We are proud of our safety record and stand behind the safety and efficacy of all our therapies.

Medtronic Statement Dated November 25, 2018

Over the past several weeks, Medtronic became aware of the International Consortium of Investigative Journalists (ICIJ) and their affiliates focus on the global medical device industry. Our first priority is patient safety. As we continue to assess ICIJ’s point of view and the news that is being generated around the world, we are most concerned that inaccurate, misleading media stories will fail to adequately represent the value that patients receive from medical device therapies and may cause unnecessary alarm and confusion among patients and healthcare providers, potentially leading to choices that may harm health.

Medtronic is proud of its long history and tradition of providing high quality, innovative healthcare products and services. We strive to adhere to the highest medical, scientific, regulatory, legal and ethical standards. We will actively ensure that the facts regarding Medtronic and our industry are accurately represented, and that the value of our therapies and their true benefits are known.

Medtronic always strives to put patients’ needs first to alleviate their pain, restore their health or extend their life and has led the medical device industry for years, based on our commitment and, in large part, our ability to listen and respond to stakeholders and their needs. In this spirit, we will surely listen, respond to and engage with our stakeholders during this time of industry scrutiny, and use this critique of industry practices as an opportune time to reinforce our Mission and our steadfast commitments to honesty, integrity and service among our employees and health communities.