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Medtronic Inc. is a medical device company that first started out in Minnesota. But as of current date, the company has relocated to Ireland for lower tax fees.
As 2015 came, the company acquired Covidien for $42.9 billion, which raised Medtronic Inc.’s market cap to an estimated $100 billion.
The company, with its operational headquarters in Fridley, Minnesota, operates in over 140 countries, employs over 80,000 people, and has more than 53,000 patients.
Medtronic has faced a lot of controversy and lawsuits over the years, in addition to paying settlements in the millions for these lawsuits and litigations.
The company has been known for its faulty INFUSE Bone Graft system, which has caused several patients to suffer from disabling injuries as well as debilitating pain.
In 2011, Dr. Eugene Carragee along with his colleagues, published an article in The Spine Journal. It revealed that several of the Medtronic-sponsored studies failed to disclose information regarding the side effects of rhBMP-2, a genetically engineered protein component of the INFUSE Bone Graft.
Furthermore, it alleged the company of paying its hired scientists and researches $1 million to $23 million per year for royalties and consulting fees.
Because of this product, the United States Department of Justice launched a year-long investigation of the company due to allegations of kickbacks to doctors who conducted their industry-sponsored studies in order to make use of the company’s own products between 1998 and 2003.
The United States DOJ also filed a civil lawsuit against Medtronic, which the company settled for a whopping $40 million. The suit also claimed that the company had set up fake consulting and royalty agreements with doctors. In addition, it had paid for “lavish trips to desirable locations” for the physicians.
The United States Senate also launched an investigation against the company, for allegations pertaining to journal entries written by the doctors in the sponsored studies for failing to disclose the adverse side effects of the product.
In October 2012, the Senate Finance Committee’s results for their investigation for alleged kickbacks and false advertising showed that Medtronic paid over $200 million to the study authors for consulting fees.
Medtronic has also been facing lawsuits for the Sprint Fidelis Leads, for certain models which have been found to have faulty leads or wires. These wires, when fractures, can lead to life-threatening injuries or even death in patients implanted with the device.
The company had issued a Class I recall – endorsed by the FDA – and stopped international distribution of the Sprint Fidelis Leads in October 2007.
Medtronic Inc. is an Irish medical device company with headquarters in Dublin, Ireland. The company’s operational headquarters is located in Fridley, Minnesota. According to Wikipedia, “Medtronic is the world’s largest standalone medical technology development company.”
By 2015, the same time it acquired Covidien for $42.9 billion, Medtronic’s market cap was approximately $100 billion. Medtronic operates in over 140 countries, employs more than 80,000 people, and has over 53,000 patients.
The company’s beginnings started in Minnesota, but after the acquisition, Medtronic eventually relocated to Ireland for lower tax fees. In fact, the company avoids taxation on more than $14 billion overseas.
The company develops and manufactures various devices and therapies that treat over 30 chronic diseases, which include heart failure, Parkinson’s disease, urinary incontinence, Down’s syndrome, obesity, chronic pain, spinal disorders, and diabetes.
As per the Medtronic website:
“Written in 1960, our mission dictates that our first and foremost priority is to contribute to human welfare. Over a half-century later, the Mission continues to serve as an ethical framework and an inspiration goal for our employees around the world. It guide our day-to-day work and reminds us that our efforts are transforming the lives of millions of people each year.”
The Medtronic Mission is “to contribute to human welfare by application of biomedical engineering in the research, design, manufacture, and sale of instruments or appliance that alleviate pain, restore health, and extend life.”
Whereas the breakdown of each aspect is described as:
- “To direct our growth in the areas of biomedical engineering where we display maximum strength and ability; to gather people and facilities that tend to augment these areas; to continuously build on these areas through education and knowledge assimilation; to avoid participation in areas where we cannot make unique and worthy contributions.”
- “To strive without reserve for the greatest possible reliability and quality in our products; to be the unsurpassed standard of comparison and to be recognized as a company of dedication, honesty, integrity, and service.”
- “To make a fair profit on current operations to meet out obligations, sustain our growth, and reach our goals.”
- “To recognize the personal worth of employees by providing an employment framework that allows personal satisfaction in work accomplished, security, advancement opportunity, and means to share in the company’s success.”
- “To maintain good citizenship as a company.”
The company has six core technologies that they apply onto their medical devices:
- Electrical Stimulation: using electricity to encourage normal physiology or suppress abnormal physiology.
- Implantable Structural Devices: devices that use mechanical principles and techniques – such as self-expanding metals, scaffolds, pumps, and valves – and materials that are nontoxic, sterilizable, and able to function inside the body.
- Targeted Drug and Biologics Delivery: devices that deliver medication or biologic agents directly where they are needed
- Powered and Advanced Energy Instruments: surgical instruments that use power or advanced energies, such as radiofrequency or refrigerants, to remove or ablate tissue, or seal surgical incisions.
- Surgical Navigation and Imaging: Image-guided systems and instrument-tracking technologies that allow surgeons to see better inside the body, or track their surgical instruments within the body, allowing them to perform more precise and less-invasive procedures.
- Patient and Device Management: Instruments, devices and information technologies that help healthcare professionals diagnose medical conditions, monitor and better manage a patient’s medical condition, or interrogate and program devices.
There are six businesses under the roof of Medtronic, which fall into three main groups:
- Cardiac and Vascular Group (CVG) – $8.8 billion
- Restorative Therapies Group (RTG) – $6.5 billion
- Diabetes Group (DG) – $1.7 billion.
Bone grafting is a surgical procedure done in patients who are in need of solutions for bone or joint related problems. This procedure aim to place new bones or bone substitutes by implantation around broken bones or bone defects.
There are three types of bone graft procedures:
- Autograft: a bone harvested from the patient’s healthy bone
- Allograft: a frozen, donated bone from another individual
- Synthetic bone substitutes: manmade bone substitutes which are kept in place with pins, plates, or screws.
Bone grafting is typically done to:
- Fuse joints to prevent movement
- Repair broken bones or fractures that have bone loss
- Repair injured bones that have not healed
- Regenerate bones tat have lost due to disease, infection or injury
Medtronic’s INFUSE Bone Graft is a synthetic device made up of two components: the synthetic recombinant human bone morphogenetic protein or rhBMP-2 – which comes in powdered form – mixed with sterilized water to form a solution.
The resulting solution is then applied to the sponge – manufactured from cow collagen – before it is placed inside a pair of metallic LT-CAGES. This system is a manmade bone graft, deemed to be a superior alternative to other types of bone grafts, such as an allograft and an autograft.
The United States Food and Drug Administration first approved the medical device in 2002 for patients with degenerative disc disease, including Grade I Spondylolisthesis, or a slipped disc in the spine.
During its initial approval, the medical device was only approved for use in the lower back or lumbar spine, with the anterior lumbar interbody fusion (ALIF) as the only approved surgical technique.
By 2004, the FDA further approved the bone graft system to be used in open fractures of the tibia. In 2007, the device was given approval from the FDA as a bone graft alternative in sinus augmentations.
People who have had adverse side effects related to Medtronic’s INFUSE Bone graft may experience infection, male sterility, bone and nerve injury, urinary problems, and an increased risk of cancer.
Many patients who have been implanted with the Medtronic INFUSE Bone Graft have filed lawsuits against the device maker for various injuries sustained, many of which left them with disabling and debilitating pain, which were caused by the medical device.
In spite of its values and missions stated in the company’s website, Medtronic has proven to practice otherwise as the controversies surrounding their company and one of their products came to light, which was the INFUSE Bone Graft.
In 2011, Dr. Eugene Carragee, with his colleagues, published an editorial in The Spine Journal revealing that several of the Medtronic-sponsored studies failed to disclose any information regarding the side effects of rhBMP-2.
It further alleged that researchers and scientists hired to conduct the sponsored studies received $1 million to $23 million per year in royalties and consulting fees.
While Dr. Carragee’s article sparked an increase in lawsuits, Medtronic had already been under investigation by the United States Department of Justice.
According to the civil lawsuit, the DOJ alleged the company of paying kickbacks to doctors in order for the latter to make use of the product and other spinal products in their patients between 1998 and 2003.
Furthermore, reports claimed that Medtronic had set up fake consulting and royalty agreements. It had paid for “lavish trips to desirable locations” for doctors. In 2006, Medtronic paid $40 million to settle the lawsuit.
In June 2011, the United States Senate launched an investigation into the allegations that the journal entries written by the doctors who conducted the Medtronic-sponsored studies failed to disclose the adverse and life-threatening side effects of their bone graft product.
By October 2012, the Senate Finance Committee announced the results of their year-long investigation regarding the alleged kickbacks and false advertising. It was found that Medtronic had paid the study authors more than $200 million in consulting fees.
This controversy has led the Senate into considering a legislation called the Physician Payment Sunshine Act, which forces drug and medical device companies to make all doctor payments public.
People who suffer from arrhythmia, or irregular heartbeats typically do not experience symptoms when a life-threatening hear rhythm is about to occur.
However, when symptoms do arise, they may include palpitations, feeling a pause in between heartbeats, lightheadedness, passing out, shortness of breath, or chest pains.
While most arrhythmias are not serious, they could lead to adverse complications such as stroke, cardiac arrest, heart failure, or even death.
One way for patients to manage the condition is through the use of defibrillators, which delivers doses of electrical energy to the heart. Defibrillators can be external, transvenous, or implanted.
The Medtronic Sprint Fidelis Leads (SFLs) “are specific models of cardiac electrodes or thin wires that connect to an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) directly to the heart.
ICDs and CRT-Ds are devices that protect patients when life-threatening heart rhythms occur. These devices monitor the heart rhythms of the patient and deliver doses of electrical shocks in order for the rapid heart rhythms paces to return to normal when arrhythmias are detected.
Medtronic’s Sprint Fidelis Leads were first approved by the United States Food and Drug Administration in 2004. It replaces an older model called Sprint Quattro, which has thicker leads and was approved in 2001.
It was in October 2007 when Medtronic issued an announcement regarding faulty Sprint Fidelis Leads. The wires or electrodes were found to be prone to fractures or breaks. Medtronic issued a Class 1 recall and stopped international distribution of the product in the same year.
When these leads break, one of three things may occur to the patient:
- The defibrillator could beep to alert that the patient has a problem, which requires immediate medical attention.
- A massive electrical shock could be delivered in times when it is not necessary, which could then lead to death in some patients.
- The battery could drain, causing the device to fail to deliver shocks when they are needed the most.
Several thousands of lawsuits have been filed against Medtronic for Sprint Fidelis Leads. In fact, the large amount of lawsuits has lead to a multidistrict litigation in the U.S. District Court for the District of Minnesota, called 08-MD- 1905.
It was in October 2010 when Medtronic finally came into a settlement agreement for all lawsuits and claims pending as of October 15, 2010. The company reportedly paid $268 million to settle approximately 8,100 lawsuits.
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