Author: WorkCompAcademy

Aaron Lindh, was employed as a law enforcement officer when he sustained injury arising out of and in the course of employment to his left eye. More specifically, Lindh took three to six blows to the left side of his head while engaged in a canine training course.

Afterwards, he “suffered severe headaches lasting between several hours to one or two days.” Over a month later, while off-duty, Lindh suddenly lost most of the vision in his left eye.

Dr. David Kaye, a neuro-ophthalmologist and the QME, concluded, as had the other physicians, that Lindh’s “blood circulation to his left eye was defective.” He stated Lindh “did not have any disability prior to receiving the blows to the head.” And “[a]bsent the injury,” he thought Lindh “most likely would have retained a lot of his vision in that eye,” although he could not “guess” how much. Dr. Kaye agreed “it [was] possible that [Lindh] could have gone his entire life without losing vision.” He also agreed, however, that even had Lindh not suffered the blows to his head, he still could have lost his vision “due to this underlying condition.”

As to apportionment, it was Dr. Kaye’s “opinion that [Lindh’s] underlying vasospastic personality and vasculature placed him at high risk for damage to different parts of his body.” In discussing his initial apportionment of 90 percent (which he adjusted to 85 percent), Dr. Kaye stated, “90 percent [is] due to the underlying condition and 10 percent due to the stress of the injuries,” He subsequently repeated it was “unlikely” Lindh would have suffered a vision loss if he had not had the “underlying condition” of “vascular spasticity,” a condition that is “rare.”

The parties stipulated “the medical record, not including apportionment, rates 40 percent permanent disability, and with apportionment, rates six percent permanent disability.” The ALJ rejected Dr. Kaye’s apportionment analysis, and found Lindh had 40 percent permanent disability, and the WCAB affirmed the ALJ’s decision. The Court of Appeal reversed and ordered 85% apportionment in the published case of City of Petaluma v WCAB and Aaron Lindh.

The Court of Appeal rejected the arguments presented by the Board, and the California Applicant’s Attorneys Association acting as amicus,”that there must be medical evidence that an asymptomatic preexisting condition will, in and of itself, naturally progress to disable the claimant..” pointing out that the argument “reflects the law prior to 2004.”

The 2004 enactment of Senate Bill No. 899 overhauled the statutes governing apportionment. The Legislature intended to reverse a number of the features of the worker’s compensation law, including eliminating the bar against apportionment based on pathology and asymptomatic causes.

“Lindh’s suggestion that apportionment is required only where there is medical evidence the asymptomatic preexisting condition would invariably have become symptomatic, even without the workplace injury, reflects the state of the law prior to the 2004 amendments.”

“Under the current law, the salient question is whether the disability resulted from both nonindustrial and industrial causes, and if so, apportionment is required.“

“Whether or not an asymptomatic preexisting condition that contributed to the disability would, alone, have inevitably become manifest and resulted in disability, is immaterial.“

The post-amendment cases uniformly focus on whether there is substantial medical evidence the disability was caused, in part, by nonindustrial factors, which can include pathology and asymptomatic prior conditions for which the worker has an inherited predisposition.

A doctor and patient were charged with insurance fraud for billing over $850,000 to an insurance provider for medically unnecessary prescriptions.

Between May 2014 and September 2014, Sabina Maciel Acevedo, 48, who lives in Anaheim, is accused of completing four compound cream prescription forms for herself and three immediate family members without receiving medical examinations.

Dr. David Todd Asher, 50, who lives in Fullerton, is accused of signing all of the forms without examining any of the family members or customizing each prescription. He was a graduate of the Dartmouth Medical School in 1997.

The completed prescription forms were sent to San Dimas Pharmacy in Bakersfield to be fulfilled, and the pharmacy billed $855,210 to Acevedo’s prescription insurance, Express Scripts, which is provided through the Santa Ana Unified School District.

Acevedo is accused of receiving $19,504.57 in kickbacks for fulfilling these prescriptions through San Dimas Pharmacy.

Express Scripts and SAUSD noticed the unusual charges and contacted the Orange County District Attorney’s Office, Bureau of Investigation, who investigated this case.

Dr. Asher has been charged with Insurance fraud with sentencing enhancement allegations for over $100,000 loss and an aggravated white collar crime over $500,000. He faces 13 years and eight months in state prison.

His patient, Sabina Aceedo has been charged with insurance fraud and grand theft with a sentencing enhancement allegations of a crime resulting in over$100,000 loss.

Asher was previously prosecuted in the United States District Court, Central District of California in February 2007. He was charged with conspiracy and illegal kickbacks for patient referrals. He plead guilty to the conspiracy charge in October, 2007 and placed on probation. He stipulated to discipline with the Medical Board for that offense.

Asher now faces new disciplinary charges by the California Medical Board for his conduct while a medical director of Reflections Recovery Center in Costa Mesa. The second charge appears to be related to his signing prescriptions for compounded medications for several patients who had filled out the prescription.

Actelion Pharmaceuticals US, Inc., has agreed to pay $360 million to resolve allegations that it violated the False Claims Act by paying kickbacks to Medicare patients through a purportedly independent charitable foundation.

When a Medicare beneficiary obtains a prescription drug covered by Medicare Part B or Part D, the beneficiary may be required to make a partial payment, which may take the form of a co-payment, co-insurance, or deductible. These co-pay obligations may be substantial for expensive medications.

Congress included co-pay requirements in these programs, in part, to encourage market forces to serve as a check on health care costs, including the prices that pharmaceutical manufacturers can demand for their drugs.

The Anti-Kickback Statute prohibits pharmaceutical companies from offering or paying, directly or indirectly, any remuneration – which includes money or any other thing of value – to induce Medicare patients to purchase the companies’ drugs.

Prosecutors alleged that Actelion used a foundation as a conduit to pay the co-pay obligations of thousands of Medicare patients taking Actelion’s PAH drugs. By doing so, the government alleged, Actelion was able to induce patients to purchase its drugs when the prices Actelion had set for those drugs otherwise could have posed a barrier to purchases.

The government alleges that Actelion routinely obtained data from the foundation detailing how many patients on each Actelion drug the foundation had assisted, how much the foundation had spent on those patients, and how much the foundation expected to spend on those patients in the future.

Actelion used this information to budget for future payments to the foundation on a drug-specific basis and to confirm that its contribution amounts to the foundation were sufficient to cover the copays of patients taking Actelion’s drugs, but not of patients taking other manufacturers’ PAH drugs.

Actelion engaged in this practice even though the foundation warned the company against receiving data concerning the foundation’s expenditures on copays for Actelion’s drugs.

Meanwhile, the government also alleged that Actelion had a policy of not permitting Medicare patients to participate in its free drug program, which was open to other financially needy patients, even if those Medicare patients could not afford their copays for Actelion’s drugs. Instead, to generate revenue from Medicare and induce purchases of its drugs, the government alleged that Actelion referred such Medicare patients to the foundation, which allowed the patients’ copays to be paid and resulted in claims to Medicare for the remaining cost.  

On June 16, 2017, after the alleged conduct, Johnson & Johnson acquired Actelion. Johnson & Johnson was not involved, directly or indirectly, in the alleged conduct and the allegations above do not relate in any way to Johnson & Johnson.

Minnesota-based medical device manufacturer ev3 Inc. has agreed to plead guilty to charges related to its neurovascular medical device, Onyx Liquid Embolic System, and pay $17.9 million. Covidien LP, whose parent acquired ev3, separately paid $13 million to resolve False Claims Act allegations resulting from its alleged payment of kickbacks in connection with another medical device, the Solitaire mechanical thrombectomy device.

ev3 will plead guilty to a misdemeanor charge in connection with the company’s distribution of adulterated Onyx, in violation of the Food, Drug and Cosmetic Act. As part of the criminal resolution, ev3 will pay a criminal fine of $11.9 million and will forfeit $6 million.

According to the plea agreement, Onyx was approved by the U.S. Food and Drug Administration (FDA) as a liquid embolization device that is surgically injected into blood vessels to block blood flow to arteriovenous malformations in the brain. The FDA has approved Onyx only for use inside the brain.

Despite the FDA’s limited approval of Onyx, from 2005 to 2009, ev3 sales representatives encouraged surgeons to use Onyx in large quantities for unproven and potentially dangerous surgical uses outside the brain. The company’s sales force continued to tout unapproved and potentially dangerous uses of Onyx even after FDA officials told ev3 executives that they had specific safety concerns regarding uses of Onyx outside the brain at a 2008 meeting. FDA officials told ev3 executives that a study would be required to gain approval for uses of Onyx outside the brain and to ensure that the benefits of the device outweighed the risks.

According to the criminal information, ev3’s management also set-up a system of sales quotas and bonuses that incentivized sales representatives to sell Onyx for unapproved uses and trained the sales force how to instruct physicians on unapproved uses of the device.

Covidien acquired ev3 in 2010, subsequent to the course of criminal conduct covered by the plea agreement. Covidien was acquired by Medtronic in 2015. Although Medtronic played no role in the criminal conduct, the company has agreed as part of the ev3 criminal resolution to implement new compensation structures to ensure the sales force responsible for marketing Onyx is not incentivized to sell the device for unapproved uses. Medtronic has also agreed to conduct compliance monitoring related to the Onyx sales and marketing components.

Covidien separately has agreed to pay $13 million to resolve its civil liability for allegedly paying kickbacks to induce the use of its Solitaire mechanical thrombectomy device. The Solitaire device is intended to restore blood flow and retrieve a blood clot in certain stroke patients.

The United States alleged that Covidien caused false claims to be submitted to Medicare and Medicaid by paying kickbacks to hospitals and institutions to induce them to use Covidien’s Solitaire device. Specifically, the United States alleged that after receiving FDA clearance for the Solitaire device, Covidien launched a registry to pay hospitals and institutions to collect data about user experiences with the device.

For about two years beginning in August 2014, Covidien paid a fee to hospitals and institutions that participated in a registry each time they used a new Solitaire device and reported certain clinical data about their practices for treating stroke patients to Covidien. Covidien solicited certain hospitals and institutions for the registry in order to convert their business from the competitor’s product and/or persuade them to continue using Covidien products, and knowingly and willfully used the registry as a means of increasing device sales.

The civil lawsuit was filed by Jeffrey Faatz, who worked for Covidien from 2012 to 2014, under the qui tam, or whistleblower, provisions of the False Claims Act. The Act allows private parties to sue on behalf of the government for false claims and to share in any recovery. As part of today’s resolution, Mr. Faatz will receive $2,015,000. The case is captioned United States ex rel. Doe v. Covidien PLC et al., Civil Action No. 8:15-cv-01796 AG (JCGx) (C.D. Cal.).