Infuse (implant)

Main article: The rejected and dangerous products of Medtronic

Infuse is the bone implant developed by Medtronic company. It represents the collagenic sponge impregnated with a human recombinant bone morphogenetic protein. Application of Infuse at defects of bone tissues stimulates formation of own bone that allows to avoid the injuring transactions of change of a bone tissue from other parts of the body of the patient.

2018: Medtronic will pay $43 million for concealment of defects of Infuse

At the end of July, 2018 Medtronic agreed to pay investors $43 million to permit one of the last remained legal procedures connected with bone material for Infuse implantation. This implant contains recombinant protein of the person which stimulates bone growth, allowing to avoid other injuring transactions. However its application can be also followed by the undesirable growth and hypostasis of a bone tissue.

Institutional investors which filed a lawsuit against Medtronic, claimed that the company secretly did payments to surgeons to hide harmful effects of the product Infuse. Besides, they accused the company that it asked specialists to exaggerate shortcomings of alternative methods of treatment. Medtronic denies all charges connected with this case including that shareholders suffered from crash of the share price which was artificially overestimated using false advertizing and concealment of data on security of Infuse.

Medtronic paid $43 million for bribery of surgeons for the purpose of concealment of defects in a bone implant

According to court documents, claimants filed a complaint in November, 2013 and consider that the stated agreement is the best solution of this long-term dispute. The retired judge Line of Philips (Layn Philips) acted as the intermediary between warring parties. Cash payment in the amount of $43 million, however this amount is provided in the agreement on settlement of the claim, according to documents, "is subject to discussion and should be approved by court".

This agreement is only a compromise which allow to avoid costs and failures when conducting trials, - the representative of Medtronic Eric Epperson said. - The solution of this legal procedure will allow the company to continue to allocate funds for activities for promotion of means of therapy and care of patients.[1]

2017: A fine of $12 million for false advertizing

On December 13, 2017 the Attorney-General of the State of Massachusetts Maura Healey reported that the producer of the medical equipment Medtronic agreed to pay $12 million for holding obviously false marketing campaign for promotion of a bone implant of Infuse which is used for gain of growth of bones.

Maura Healy reported that court's decision will depend on results of investigation which groups of specialists from the USA and four more countries are going to conduct. They will analyze in detail a campaign for Infuse promotion.

Bone implant of Infuse

According to the judicial protocol, Medtronic aimed to increase sales of goods, using counterfeit scientific articles with the false evidence concerning its security and advantages. Judging by the made claim, Medtronic paid millions of dollars to consulting physicians to publish researches in which ghost effects of an implant were underestimated and adverse results were not submitted for discussion.

Nevertheless, Medtronic states that the company did not break the law. Infuse on the basis of artificial hormone of growth of bones was developed as an alternative to bone transplants. The Food and Drug Administration (FDA) approved an implant for use at some backbone operations in 2002. However Infuse application not according to indications of FDA (without carrying out researches of efficiency and safety of a product) ensures 85% of sales. In 2008 opposed as FDA such use of the device, noting its life-threatening ghost effects.

In October, 2012 the U.S. Senate Committee on Finance established that Medtronic actively participated in editing the published researches and paid them to authors about $120 million Besides, Medtronic advanced information on clinical trials of Infuse, distributing medical magazines and publishing data retrieveds on the government website.^[2]

2016

Concealment of ghost effects

At the end of December, 2016 the American Federal Court of Appeal recovered the statement of claim in which Medtronic is accused of deception of shareholders by concealment of negative ghost effects from a bone implant within 10 years. The Reuters news agency reported about it.

The eighth circuit court of appeal of the city of Saint Paul (the State of Minnesota, the USA) decided that the lower court made a mistake, having established that the shareholders who submitted a claim to Medtronic made it too late – only more than two years later after studying of information on expected intentions of the company to deceive investors. The list of claimants included West Virginia Pipe Trades Health & Welfare Fund, the German Union Asset Management Holding and the pension fund of the State of Hawaii.

Bone implant of Infuse

Though the bone implant of Infuse is approved by Management on products and drugs of the USA (Food and Drug Administration, FDA) in 2002, 85% of sales of this product were the share of the version which is not approved on medical indications. In 2008 FDA warned that you should not use the device out of the registered indications.

In 2012 the U.S. Senate Committee on Finance stated that it of Medtronic interfered with formation of results of the independent clinical trials estimating risks of use of Infuse. This bone implant was applied more than in 1 million transactions worldwide.

Actions of Medtronic led to overestimate of share value of the company, and investors lost hundreds of millions dollars when the truth came to light, Reuters notes.

At the end of December, 2016 the circuit judge Raymond Gruender reported that before emergence of the exposing publication in the The Spine Journal edition shareholders had no bases to believe about emergence of problems as a result of intentions of Medtronic to deceive them.

No company has the right to charge to individuals to do any action, to pay them for it, and then to say that any causal relationship is too far when case is finished. Expected manipulations of Medtronic directly affected results of clinical trials to which the market referred, – Gryunder said.[3]

Two patients adjuded $8.45 million for inadequate use of an implant

In August, 2016 it became known that two patients affected by inadequate use of a bone implant of Infuse seized from the University of California, Los Angeles (University of California, Los Angeles, UCLA) in total $8.45 million.

Ralph Weiss and Jerome Lew filed a lawsuit against the surgeon Jeffrey Wang working in UCLA, accusing him of use of the Infuse device with violation of the instructions for application approved by Management on products and drugs of the USA (Food and Drug Administration, FDA). Claimants claim that Jeffrey Wang deceived them, having decided to use without notifications a bone implant of Medtronic not on the approved indications.

Two patients adjuded $8.5 million for inadequate use of a bone implant of Medtronic

Besides, according to accusing the parties, the surgeon, abusing the official position, within several years received from Medtronic money in the form of royalties, grants and transfers for the consulting services connected with Infuse use. Only in 2008-2009 the amount of assignments was about $300 thousand.

The fact that Infuse is involved in some medical institutions bypassing the approved indications became known almost right after the output of this device to the market in 2002. Direct participation of Medtronic in such promotion of a product led to conducting investigations by the authorities and legal claims. Within one of trials the research which showed that the devices used to stimulation of growth of natural bone structures in 85% cases are used bypassing the indications registered by FDA was conducted.

So was also with Ralf Weis and Jerome Lew: the wrong implementation of Infuse led to the undesirable growth of bones of a backbone that caused complications and demanded additional transactions. UCLA agreed to settle the conflict with patients and to pay $4.25 million to 61-year-old Weis and $4.2 million to 52-year-old Lew.^[4]

Ghost effects

In April, 2016 the The Minneapolis Star Tribune edition published the exposing article about Infuse. Journalists found out that Medtronic stopped carrying out the researches connected with Infuse, having detected serious problems when using a bone implant in patients. The company preferred to hold back negative effects.

In 2008 Medtronic began the retrospective analysis of medical records of the patients who took part in Infuse testing. More than 3600 people who free of charge received this bone implant were involved in a large-scale experiment. During the experiment examinees had more than 1000 complications, part of them had a direct bearing on Infuse. Even the fatal cases caused by heart troubles and cancer tumors are recorded. However whether these lethal outcomes were connected with an implant of Medtronic, is not specified.

Medtronic hid many years problems with a bone implant

Authors of publications showed that in researches the efficiency of medicine was exaggerated and serious ghost effects of its application, including the increased frequency of complaints to pains in extremities, radiculitis and also the retrograde ejaculation recorded at some patients were not mentioned (emission of a seed in a bladder at sexual intercourse).

Staff of Medtronic decided to leave results of a research in archives of the company and not to send them to Management on control of product quality of a power supply and medicines of the USA (FDA). At the same time the project was stopped, the research was stopped.

Medtronic provided to FDA data on ghost effects of Infuse only in 2013 when information on complications at the patients using this bone implant began to emerge. To Medtronic more than 6 thousand actions for damages were submitted in total. The Humana insurance company also filed a lawsuit against Medtronic.^[5]

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