Device maker, Medtronic Inc., is laying off about 4 percent of its spinal business workforce worldwide.
The layoffs amount to about 230 of it spinal division’s 5,600 employees, said Twin Cities Business, according to Mass Device.com. As layoffs are being planned, Cindy Resman, Medtronic spokeswoman, said that Medtronic is still hiring in its spinal business and has some 450 job openings posted online.
The layoffs, said Resman, are part of a broader Medtronic effort to reduce costs by 5 percent, which includes, she told MassDevice.com, “targeted employee reductions in certain business functions and locations.” Resman noted that, “Like most companies, we will continue to evaluate our markets and organization structure to look at areas where efficiency can be improved throughout our business… This may require us to shift resources from low growth to high growth areas to optimize performance and are a normal course of business for any organization.”
About one year ago, Medtronic discussed cutting spinal device staff after reported slowed growth in both spinal and cardiac rhythm management units, said MassDevice.com. Last year, Medtronic warned that cuts were likely. Various controversies surrounding the Medtronic InFuse® Bone Graft product helped prompt last year’s restructuring that sparked layoffs at the company.
Medtronic InFuse® is a synthetic form of recombinant human Bone Morphogenetic Protein (rhBMP-2) that is approved for use in a certain type of spinal surgery. Over the last several years, the safety of InFuse®. has been called into question, as has Medtronic’s marketing of the product.
Among other things, a critical analysis previously published by the Spine Journal charged that 13 Medtronic sponsored Infuse clinical trials failed to report serious complications, including uncontrolled bone growth, male sterility, retrograde ejaculation, and cancer.
While it dodged federal charges related to InFuse® marketing, Medtronic continues to face personal injury lawsuits filed by patients who claim the company illegally marketed Infuse for off-label uses. In fact, Medtronic was named in whistleblower lawsuit that accused the drug maker of installing a “crony” at the Journal of Spinal Disorders and Techniques to promote positive data on InFuse®. Ultimately, Medtronic agreed to pay $85 million to resolve a federal lawsuit brought by shareholders that alleged the company’s officers and executives made false and misleading public statements about InFuse®, which then artificially inflated the company’s stock price, according to a prior MassDevice.com report.
At a recent North American Spine Society (NASS) annual meeting links between cancer and products such as Medtronic’s InFuse® were discussed. At the annual meeting, renowned expert, Eugene J. Carragee, MD, and colleagues, discussed the increased cancer risk associated with use of BMP-2 in fusion surgeries, said the Back Pain Relief Center citing the Society’s Back Letter. Although Medtronic maintains there is no link to cancer with the product, reporting in 2010 at FDA hearings that no statistically significant associations exist between cancer and the use of BMP-2 in the clinical trials submitted to the agency, Carragee disagrees, said the Back Pain Relief Center.
Carragee and colleagues presented new analysis revealing that patients who received BMP-2 in the trials performed under so-called “FDA auspices,” or pooled study data, were at least two times likelier to develop cancer when compared to control subjects. Also, patients treated with a higher dose in the AMPLIFY trial experienced a three-fold likelihood of developing cancer in the three-year follow-up when compared to control subjects, said the Back Pain Relief Center. AMPLIFY is a randomized trial evaluating BMP-2 in posterolateral fusion surgeries.
What is causing the cancer remains unclear, said Carragee, “It is unlikely that these cancers stem from a direct carcinogenic effect where BMP-2 is the root cause of the cancer…. The lead time is too short,” he explained, adding. “I think the most likely hypothesis is that there is a cancer-promotion effect related to the use of BMP-2.”