NuVasive CoRoent: Off-Label Promotion and the Manufacturer-Created Society

In the NuVasive CoRoent settlement, NuVasive agreed to pay $13.5 million to resolve allegations of off-label promotion and surgeon kickbacks that caused false claims for spine surgeries. The government alleged that the company created, funded and operated a surgical society that appeared independent, then paid speaker fees, honoraria and event expenses to influence physicians’ use of its implants. A former sales representative brought the case. Taxpayers were left paying for surgeries that, according to the government, did not qualify for reimbursement. For someone who knows how a device reaches the operating room, the story runs through familiar territory: training, promotional materials, physician relationships and the bill that follows the surgery.

The Justice Department announced the civil settlement on July 30, 2015. NuVasive was a California-based medical device manufacturer.

What NuVasive Allegedly Promoted

The government alleged that between 2008 and 2013, NuVasive promoted CoRoent for surgical uses that the FDA had not approved or cleared, including treatment of severe scoliosis and severe spondylolisthesis. It alleged that this promotion caused physicians and hospitals to submit claims to federal health care programs for spine surgeries that were ineligible for reimbursement.

The whistleblower’s complaint described the gap in more detail. In its account of the fusion labeling, CoRoent L and XL implants were intended for one or two contiguous levels of the lumbar spine, for degenerative disc disease with up to Grade 1 spondylolisthesis, with supplemental fixation and the patient’s own bone graft. The complaint alleged that the sales message extended beyond those limits.

According to the complaint, a brochure recommended implants for degenerative spondylolisthesis without stating the severity limit. Other promotional materials recommended them for scoliosis, and a brochure promoted CoRoent XL for thoracic disc herniation. The complaint also described before-and-after X-rays showing implants at three contiguous levels, and alleged that the sales force received training to promote use across additional spinal levels.

The complaint also alleged a direct sales incentive for extending the promoted use across additional levels: more implant use meant more revenue for NuVasive. That makes the number of spinal levels part of the sales story as well as the clinical one.

SOLAS and the Appearance of Independence

The Society of Lateral Access Surgery, known as SOLAS, was the organization at the center of the government’s kickback allegations. The Justice Department alleged that NuVasive alone created, funded and operated it despite its outward appearance of independence. The alleged benefits included promotional speaker fees, honoraria and expenses for physicians attending its events, offered to induce use of CoRoent in spine fusion surgeries.

The complaint described a society offering surgeon education, research opportunities, a physician locator, an annual meeting and an online resource library. It alleged that full membership required experience performing XLIF procedures using NuVasive products. It also quoted the society’s website as acknowledging NuVasive’s funding and placing the company’s surgical training under the SOLAS umbrella.

According to the complaint, NuVasive published the society’s newsletter and ghostwrote much of it. One issue promoted a CoRoent implant’s use for scoliosis. A frequent user of the implants allegedly received compensation for having his name displayed on newsletter issues, while another society leader worked for NuVasive.

The complaint also alleged that company employees ghostwrote and edited articles and abstracts submitted to professional journals under physicians’ names. Those physicians allegedly used CoRoent heavily and received payment for lending their names to the articles.

A surgeon reading a professional society’s newsletter is being addressed as a member of a clinical community. The government’s allegation put the implant seller behind that apparent independence. The same company allegedly controlled the society, promoted its product through it and paid benefits intended to influence the surgeons who chose the product.

The Picture and the Small Print

The complaint alleged that NuVasive’s marketing could show a use while disclaiming that same use in small print. Its example concerned CoRoent XL shown with Osteocel Plus, NuVasive’s bone-graft product:

The whistleblower pointed to a surgical-applications illustration showing the implant filled with Osteocel Plus. According to the complaint, the footnote distinguished the graft material allowed for interbody fusion from that allowed for partial vertebral body replacement. According to the complaint, the brochure showed surgeons the use, then told them in small print that it was not approved as shown.

The alleged contradiction sat on the same page. A person who prepared, approved or used that material could explain what the image was meant to communicate and how sales representatives presented it to surgeons.

The Training Went With the Marketing

The complaint alleged that NuVasive reinforced the promotional message through hands-on surgeon training and paid peer presentations. It described cadaver training in the Marquis Visit Program and events where a paid proctor surgeon demonstrated off-label techniques over a company-funded meal.

The alleged selection of physicians for training made the sales objective unusually plain:

The same paragraph alleged that, at a sales representative’s request, NuVasive would pay for flights, meals, a rental car and entertainment including golf. In that account, experience with the products and an interest in buying more opened the door to company-paid travel. The physician’s future product use was part of the invitation.

How Does Reimbursement Work for Medical Devices?

Medicare generally pays the hospital for the procedure with the implant cost included in that payment. The surgeon’s product choice, the hospital’s purchase and the government’s payment therefore occur at different points in the same transaction.

For this case, the Justice Department specifically alleged that the promoted uses led to physician and hospital claims for surgeries that did not qualify for federal reimbursement.

The complaint added an account of how a procedure could become the next sales pitch. It alleged that marketing personnel circulated surgical examples to the national sales force as cases of the week, including procedures using CoRoent across multiple levels or for scoliosis. The whistleblower alleged that some of those operations involved Medicare beneficiaries and generated federal payments. According to the complaint, the company then used those examples to encourage further use and billing.

The alleged loop ran from promotion to surgery to another promotional example.

What Evidence Is Needed to Prove Fraud?

In this case, the whistleblower’s complaint connected what NuVasive promoted or paid for to surgeons’ device use and the resulting government claims. The complaint identified specific brochures, sales training, society publications, travel benefits and surgical examples that could be compared with one another.

The former sales representative described his work as managing hospital accounts, selling spinal devices and instructing surgeons in their use. That role placed him close to the message the company gave its sales force and the message physicians received. His account of the business supplied detail that the settlement announcement could only summarize.

The 2020 paper A Forensic Accountant’s Guide to the Most Potent Federal Laws Used Against Healthcare Fraud, published in the Journal of Forensic and Investigative Accounting, explains that detecting complex financial fraud often depends on information from insiders.

The paper also places the payment request at the center of a False Claims Act case. Applied here, that means connecting the commercial conduct to the procedure and reimbursement, including who received the promotion, who selected the implant and what the provider billed.

We examine those connections with the insider. A marketing employee may understand the choice of illustration and disclaimer. A sales representative may know how physicians were selected for training or speaking opportunities. A compliance or billing employee may see the payment or claim that completes the account. The strength is in how those pieces fit the same course of conduct.

The Same Sales Incentive in Other Device Cases

Other device cases show how payments and apparent independence can be tied to product use. In the civil case against SpineFrontier, the government’s complaint alleged that a purportedly separate consulting company served only SpineFrontier after it began processing surgeon payments. The alleged intermediary made a manufacturer-funded relationship look like outside consulting.

In Life Spine’s case, whistleblowers alleged that consulting agreements depended on surgeons using the company’s products and meeting sales-volume expectations. Management allegedly sought weekly surgery schedules to track use. The civil settlement included admissions concerning reports comparing surgeon payments with product usage and a return-on-investment calculation. Those records put a commercial measure behind the consulting relationship.

A separate whistleblower complaint against Medtronic alleged that paid dinner speakers received prepared slides and sometimes spoke briefly or not at all. It also alleged that invitations depended on maintaining implant volume.

The complaint against Paradigm Spine alleged that the company withheld adverse coverage and coding guidance from promotional and training materials, while internal tracking showed use beyond a single spinal level.

The Settlement Allocation and Whistleblower Reward

The NuVasive resolution allocated $12,583,414 to the federal share and $916,586 to state Medicaid programs. The Justice Department announced that the former sales representative would receive approximately $2.2 million as his whistleblower reward.

A whistleblower case under the False Claims Act can pay 15% to 30% of what the government recovers.

This case began with someone who knew the sales operation from inside the company. His complaint connected product presentations, physician benefits and surgical use to the claims that followed. That is the account our whistleblower experts work to develop with people who recognize the same connections in their own business.

You Know How the Device Was Sold

If you know who shaped the sales message, approved the surgeon payments or handled the resulting claims, speak to one of our whistleblower experts about how the device was sold. We build your strongest medical device whistleblower case with you, bring in whistleblower lawyers experienced in device promotion and healthcare billing, and stay beside you through the pursuit of a recovery.