For the last several years, Medtronic PLC has been at the source of a medicinal scandal that has plagued thousands of patients. In 2002, the FDA approved the company’s bone graft device. Since then, it has come to surface that the product might do more harm than good. Now the company may be nearing the closure of thousands of settlements with defective product victims.
In a Nutshell
Using lab-generated proteins, Infuse is supposed to treat back pain by inducing the fusion of several vertebrae. This is supposed to cause the back pain to subside. Instead the device has caused a mass of life-altering injuries, such as sterility, infection and bone growth. According to reporting done by the Star Tribune, there were 1,000 cases of Infuse-induced injuries during a five-year period. None of those injuries were reported to the FDA.
After years of controversy and over 1 million surgeries later, the company has indicated it has plans to settle almost every one of the 6,000 lawsuits that are either ongoing or anticipated. In late June, Medtronic submitted its annual report to the Securities and Exchange Committee (SEC), in which it stated its intention to bring an end to Infuse legal disputes.
According to Medtronic’s filing with the agency, the company devoted $300 million to “certain litigation charges” for the 2017 fiscal year, which ended this past April. The report stated, “As of June 1, 2017, the Company has reached agreements to settle substantially all of these claims, resolving the [Infuse liability cases].”
It’s not just patients who have pursued compensation. Shareholders and employees have also entered the fray over the years. Several years ago, shareholders were upset at Medtronic’s (alleged) underhanded attempt to hide Infuse’s many risks, a move that may have undermined investors’ ability to make reasoned investment decisions. In 2012, Medtronic paid $85 million to settle disputes with shareholders.
And in 2006, allegations were put forward by a whistleblower claiming the company incentivized doctors to use Infuse by offering them payment. Medtronic ended up paying a settlement sum of $40 million to the DOJ. In 2014, the company settled suits with victimized patients, paying $22 million to nearly 1,000 people.
Additionally, the company is currently dealing with several inquiries from state attorneys general from around the country. In regard to those dealings, a spokesman for Medtronic said the following in an email to the Star Tribune: “We continue to cooperate in the State AG inquiries and are hopeful an acceptable resolution can be reached.”
Researchers Speak Out
Nonetheless, the company has consistently maintained its innocence with regard to the product’s adverse effects. This may appear odd to some, as Independent studies have shown the device to have obvious risks – risks that the corporation has failed to acknowledge in its own reports. Some researchers from the Spine Journal even called the company’s claims about the product “biased and corrupted,” as reported by the New York Times. Researchers went on to say, “It harms patients to have unaccountable special interests permeate medical research.”
As observed by the Spine Journal, Medtronic paid exorbitant sums of money to researchers for studies that played down the negative effects of the device. In some cases, individuals were paid $12 and $16 million.
Medtronic may feel justified in claiming its innocence because of a regulatory loophole. According to the company, it cannot be held responsible for the actions of doctors who choose to use Infuse in a way that differs from the label’s suggestion. Basically, the FDA’s jurisdiction only covers products, leaving aside the practices of doctors who choose to use the device in an “off-label” manner. This is troubling as it has been shown that 85 percent of doctors use Infuse in this way.
Once again, a profit-seeking corporation has done everything it can to avoid taking responsibility for its actions, leaving thousands of injured patients to fend for themselves as they attempt to recover after being subject to negligent (and malicious) intent. Hopefully, the $300 million will provide some comfort to those in need, but it cannot address the much deeper concern of corporate (un)accountability.