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Purdue Pharma Ends OxyContin Sales Force

The pharmaceutical giant behind the painkiller OxyContin revealed it cut its entire remaining sales team in a shift away from opioids.

Purdue Pharma announced the changes Tuesday, which will effectively end any contact the company has with medical providers regarding their medications.

The company eliminated more than half of their sales force in February when they announced an official end to their promotion of opioid painkillers directly to doctors, reports the Hartford Courant.

Representatives for Purdue did not specify how many jobs were impacted, but the previous cuts left roughly 200 employees working on their sales team.

“This information today also means that Purdue has ended its sales force engagement with prescribers for all of its medicines,” Bob Josephson, spokesman for Purdue Pharma, told the Hartford Courant. “Purdue Pharma is taking significant steps to transform and diversify beyond our historic focus of pain medications. As a consequence of these plans and as the most recent change new management has made over the last year, a number of positions at the company have been eliminated.”

The company says that while it will still manufacture opioid-based medications, it is shifting primary focus to research and development into medications aimed at treating cancer and central nervous system disorders.

Dozens of lawsuits across the country allege Purdue Pharma launched a fraudulent marketing scheme to boost sales of OxyContin in the late 1990s that downplayed the risks for addiction from pain medication, contributing to the current opioid crisis.

Purdue Pharma denies allegations of complicity in the opioid epidemic and said they are committed to curbing rates of opioid abuse.

Purdue Pharma is owned by the Sackler family, listed at 19th on the annual Forbes list of wealthiest families in the country at a worth of $13 billion. The family’s fortune largely comes from OxyContin sales, which its company branded and introduced as an extended release painkiller in 1995.

Ronald Grusd M.D. to Serve 10 Years in Prison

Beverly Hills Radiologist Ronald Grusd and two of his corporations, California Imaging Network Medical Group and Willows Consulting Company, were sentenced in federal court on Monday, after a jury trial in December resulted in convictions on 39 felony fraud counts.

U.S. District Judge Cynthia A. Bashant imposed a sentenced of 10 years in custody and a fine of $250,000, and remanded Dr. Grusd into custody. His companies, California Imaging Network and Willows Consulting Company, were each required to pay a $500,000 fine, and an additional $15,600 in special assessments.

Grusd and the corporations were originally indicted by a federal grand jury in November 2015, when the U.S. Attorney’s Office and the San Diego District Attorney’s Office, working in conjunction with the Federal Bureau of Investigation and the California Department of Insurance, announced multiple arrests arising from a long-term, proactive health care fraud investigation targeting corruption and fraud in the California Workers’ Compensation system.

According to evidence presented at trial, Dr. Grusd and his companies paid kickbacks for patient referrals from multiple clinics in San Diego and Imperial counties in order to fraudulently bill insurance companies over $22 million for medical services.

Dr. Grusd negotiated with various individuals, including a primary treating physician, the payment of kickbacks for the referral of workers’ compensation patients for various medical services, including MRIs, ultrasounds, Shockwave treatments, toxicology testing and prescription pain medications.

After the patients were referred for the treatment or service, one of Dr. Grusd’s companies, California Imaging Network Medical Group, would fraudulently bill insurance companies for the procedures, concealing from both the patients and the insurers that substantial kickbacks had been paid in violation of California law.

Another of Dr. Grusd’s companies, Willows Consulting Company, funneled the kickback payments to those directing the referral of the patients from the various clinics. Records presented at trial showed that Dr. Grusd paid over $100,000 in bribes to secure the billings for hundreds of patients, with bribes paid on a per-patient or per-body-part formula.

Grusd’s practice, California Imaging Network Medical Group, operated clinics throughout California in San Diego, Los Angeles, Beverly Hills, Fresno, Rialto, Santa Ana, Studio City, Bakersfield, Calexico, East Los Angeles, Lancaster, Victorville and Visalia.

In imposing sentence, District Judge Bashant expressed concern that by paying incentives, Dr. Grusd applied pressure on the referring physician, and “made it highly questionable if all services were necessary,” a harm that the laws were designed to prevent.

Judge Bashant found that Dr. Grusd “clearly knew what he was doing.” Dr. Grusd, who had testified as to his extensive education, training, and expertise as a highly-decorated radiologist, claimed on the witness stand at trial that he was confused and did not know that what he was doing was illegal. Judge Bashant rejected this view, stating that Dr. Grusd was someone who decided to “find a way to defraud….then act dumb on the witness stand” when he got caught.

She imposed a sentencing penalty for Obstruction of Justice, finding that Grusd unequivocally committed perjury and lied at trial. The judge said she was concerned about the need for both general and specific deterrence: general, because health care fraud is an area where criminals are rarely caught, requiring a significant consequence in order to deter other would-be criminals.

In this case, specific deterrence was also applicable, because, in her view, there was a risk that Dr. Grusd could engage in further unlawful conduct in the future. “Dr. Grusd,” she noted, was someone who would “act smart enough to pull the wool over everyone’s eyes.”

Benzodiazepines and Opioids – a Deadly Combination

Common benzodiazepines include diazepam (Valium), alprazolam (Xanax), and clonazepam (Klonopin), among others. The drug class is a a type of prescription sedative commonly prescribed for anxiety or to help with insomnia. Benzodiazepines (sometimes called “benzos”) work to calm or sedate a person, by raising the level of the inhibitory neurotransmitter GABA in the brain.

Between 1996 and 2013, the number of adults who filled a benzodiazepine prescription increased by 67%, from 8.1 million to 13.5 million. The quantity obtained also increased from 1.1 kg to 3.6 kg lorazepam-equivalents per 100,000 adults.

Combining opioids and benzodiazepines can be unsafe because both types of drug sedate users and suppress breathing – the cause of overdose fatality – in addition to impairing cognitive functions. In 2015, 23 percent of people who died of an opioid overdose also tested positive for benzodiazepines. Unfortunately, many people are prescribed both drugs simultaneously.

In a study of over 300,000 continuously insured patients receiving opioid prescriptions between 2001 and 2013, the percentage of persons also prescribed benzodiazepines rose to 17 percent in 2013 from nine percent in 2001.The study showed that people concurrently using both drugs are at higher risk of visiting the emergency department or being admitted to a hospital for a drug-related emergency.

Previous studies have also highlighted the dangers of co-prescribing opioids and benzodiazepines. A cohort study in North Carolina found that the overdose death rate among patients receiving both types of medications was 10 times higher than among those only receiving opioids

In a study of overdose deaths in people prescribed opioids for noncancer pain in Canada, 60 percent also tested positive for benzodiazepines. A study among U.S. veterans with an opioid prescription found that receiving a benzodiazepine prescription was associated with increased risk of drug overdose death in a dose-response fashion.

In 2016, the Centers for Disease Control and Prevention (CDC) issued new guidelines for the prescribing of opioids. They recommend that clinicians avoid prescribing benzodiazepines concurrently with opioids whenever possible.

Both prescription opioids and benzodiazepines now carry FDA “black box” warnings on the label highlighting the dangers of using these drugs together.

People being prescribed any medications should inform their doctors about all of the other drugs and medications they use, and patients should consult with their doctors about the potential dangers of using various medications and substances together, including the use of alcohol.

And claim administrators should keep an eye out for physicians who have somehow failed to read the memo.

IMR Results Continue at 91% Uphold Rate

Data on California workers’ compensation independent medical review (IMR) decisions issued in the first quarter of this year shows that the medical dispute resolution process established as part of the 2012 workers’ comp reforms continues to produce consistent outcomes.

There has been little change in the number of IMR determination letters and decisions; the percentage of modified or denied treatment requests that are upheld; the types of treatment requests reviewed; and the small number of physicians who are linked to a majority of the disputed medical service requests.

The latest IMR results come from a California Workers’ Compensation Institute (CWCI) review of IMR decision letters issued in the first three months of this year in response to applications sent to the state Division of Workers’ Compensation after a utilization review (UR) physician modified or denied a medical service requested for an injured worker.

The Institute’s review of the first quarter IMR decisions found that IMR doctors upheld the UR determination 90.6% of the time, while in 9.4% of the cases they deemed the service medically necessary and overturned the UR decision.

That uphold rate nearly matched the 91.2% rate noted for IMRs from the two prior years, and just as in each of the five years since the IMR process began in 2013, pharmaceutical requests represented almost half of the IMR decisions in the first quarter of 2018.

As in the past, requests for opioids were the most common pharmaceutical request submitted for IMR, accounting for 31.0% of all prescription drug IMRs in the first quarter, even though in 91.1% of the IMRs involving opioids, the UR modification or denial was upheld.

Those percentages could change in the future, as most of the first quarter IMRs involved UR decisions from 2017, prior to the January 1 implementation of the workers’ compensation prescription drug formulary and regulations, which set new limits and rules for prescribing opioids to injured workers in California.

The latest results also show that compound drugs represent a dwindling share of the prescription drug IMRs, accounting for just 2.1% of the pharmaceutical IMRs in the first quarter, down from 4.2% in 2017 and 8.1% in 2015, a decline that may be linked to the 98% uphold rate for compound drug denials and modifications submitted to IMR.

As in prior results, the latest IMR data also showed that a small number of physicians continued to account for a disproportionate share of the disputed medical services submitted for IMR. CWCI found that the top 1% of requesting physicians (117 providers) accounted for 44% of the disputed service requests, while the top 10 percent (1,169 providers) accounted for 85% of the disputed service requests.

DWC Sets MTUS Update Hearing

The Division of Workers’ Compensation has issued a notice of public hearing for proposed evidence-based updates to the Medical Treatment Utilization Schedule (MTUS), which can be found at California Code of Regulations, title 8, sections 9792.22 and 9792.24.5.

The public hearing is scheduled for Wednesday, July 18 at 10 a.m. in the auditorium of the Elihu Harris Building, 1515 Clay Street, Oakland.

Members of the public may review and comment on the proposed updates no later than July 18.

The proposed evidence-based updates to the MTUS incorporate by reference the latest published guidelines from American College of Occupational and Environmental Medicine (ACOEM) for the following:

–Traumatic Brain Injury (ACOEM November 15, 2017)
–General Approaches section of the MTUS: Prevention (ACOEM May 1, 2011)
–General Approach to Initial Assessment and Documentation (ACOEM July 25,2016)
–Cornerstones of Disability Prevention and Management (ACOEM May 1, 2011)

Although proposed evidence-based updates to the MTUS regulations are exempt from Labor Code sections 5307.3 and 5307.4 and the rulemaking provisions of the Administrative Procedure Act, DWC is required under Labor Code section 5307.27 to have a 30-day public comment period, hold a public hearing, respond to all the comments received during the public comment period and publish the order adopting the updates online.

Three More Pacific Hospital Indictments

Three additional doctors have been charged in three new cases for their roles in a 15-year-long health care fraud scheme that involved more than $40 million in illegal kickbacks paid to doctors and other medical professionals in exchange for referring thousands of patients who received spinal surgeries. As a result of the kickback scheme, more than $580 million in fraudulent bills were submitted, mostly to California’s worker compensation system.

David Hobart Payne, 60, an orthopedic surgeon who lives in Irvine, is scheduled to be arraigned in United States District Court on charges of conspiracy, honest services fraud, and using an interstate facility to aid in unlawful activity. A five-count superseding indictment returned by a federal grand jury on April 25 alleges that Payne was bribed approximately $450,000 to steer more than $10 million in kickback-tainted surgeries to Pacific Hospital of Long Beach.

Jeffrey David Gross, 52, an orthopedic surgeon who resides in Dana Point and Las Vegas, Nevada, appeared in federal court and pleaded not guilty to charges contained in a 14-count indictment returned earlier this year by a federal grand jury. Gross, who faces charges of conspiracy, honest services mail fraud and honest services wire fraud, was ordered to stand trial on August 7. The indictment alleges that Gross made at least $622,000 in exchange for performing and/or referring more than $19 million in kickback-tainted surgeries to Pacific Hospital.

In the third indictment being announced today, Lokesh Tantuwaya, 51, who maintains residences in Rancho Santa Fe and Rock Springs, Wyoming, was charged in February by a federal grand jury. The 13-count indictment charges Tantuwaya with conspiracy, honest services fraud, and using an interstate facility to aid in unlawful activity. Tantuwaya, who pleaded not guilty in April, has been ordered to stand trial on November 6. The indictment alleges that Tantuwaya received approximately $3.2 million in kickbacks for referring and/or performing $38 million in surgeries to Pacific Hospital.

The kickback scheme centered on Pacific Hospital of Long Beach, which specialized in surgeries, especially spinal and orthopedic procedures.

The owner of Pacific Hospital, Michael D. Drobot, conspired with doctors, chiropractors and marketers to pay kickbacks in return for the referral of thousands of patients to Pacific Hospital for spinal surgeries and other medical services paid for primarily through the California workers’ compensation system. During its final five years, the scheme resulted in the submission of over $500 million in fraudulent medical bills. To date, nine defendants have been convicted for participating in the kickback scheme.

If they were to be convicted of the charges in the indictments announced today, Payne, Gross and Tantuwaya would face potential sentences of decades in federal prison.

CalChamber Releases 2018 Job Killer List

Each year the California Chamber of Commerce releases a list of job killer bills to identify legislation that it says will decimate economic and job growth in California. The CalChamber tracks the bills throughout the rest of the legislative session and works to educate legislators about the serious consequences these bills will have on the state.

The 2018 annual list of job killer bills, calls attention to the negative impact that 28 proposed measures would have on California’s job climate and economic recovery should they become law. Of the 28 on the list, some have been removed as a result of the amendments removing targeted problems. Others have failed to meet legislative deadlines for the year. Of those remaining the following are likely the most crucial to follow.

AB 2351 (Eggman; D-Stockton) Targeted Tax on High Earners – Unfairly increases the personal income tax rate from 13.3% – which is already, by far, the highest income tax rate in the country – to 14.3% for one category of taxpayers (including some proprietors), who already pay half of California’s income taxes, forcing them to mitigate these costs through means that include reducing workforce, in order to provide more funding for higher education.

AB 3080 (Gonzalez Fletcher; D-San Diego) Ban on Settlement Agreements and Arbitration Agreements – Significantly expands employment litigation and increases costs for employers and employees by banning settlement agreements for labor and employment claims as well as arbitration agreements made as a condition of employment, which is likely preempted under the Federal Arbitration Act and will only delay the resolution of claims. Banning such agreements benefits the trial attorneys, not the employer or employee.

ACA 22 (McCarty; D-Sacramento) Middle Class Fiscal Relief Act – Unnecessarily increases California’s 8.84% corporate tax rate, already one of the highest in the nation, to 18.84%, which will encourage companies to leave the state and discourage companies from expanding or relocating here.

SB 993 (Hertzberg; D- Van Nuys) Tax on Services – Imposes a 3% tax on services purchased by businesses in California, with some exceptions, adding another layer of taxes onto California companies, raising costs, and putting them at a competitive disadvantage.

SB 1398 (Skinner; D-Berkeley) Increased Tax Rate – Threatens to significantly increase the corporate tax rate on publicly held corporations and financial institutions up to 15% according to the wages paid to employees in the United States, and threatens to increase that rate by 50% thereafter, if the corporation or institution reduces its workforce in the United States and simultaneously increases its contractors.

The 2018 list also tracks 2017 Carry-Over Bills that were started in 2017, and continue to be considered in the 2018 legislative session. More details and updates on all of the 2018 legislation can be tracked on the 2018 Job Killer Bills webpages.

Properly Worded C&R Also Releases FEHA Claims

Artemio Elguea was a pizza delivery driver for Pizza Hut.. His general manager was Alex Rodriguez.

Elguea alleged that Rodriguez discriminated against him on the basis of his age – reducing his hours, stealing his tips, and allowing other employees (who were related to Rodriguez) to throw food at him. Elguea’s doctor placed him on medical leave for stress, and he never returned to Pizza Hut.

Elguea brought suit against PIzza Hut alleging age discrimination, related causes of action under the Fair Employment and Housing Act (FEHA) and other torts.

While this action was pending, Elguea was also pursuing multiple workers’ compensation claims. The four workers’ compensation cases were resolved by two simultaneous settlements, each for slightly less than $25,000 (to avoid MSA approval requirements). Each Compromise & Release was signed by Elguea, and one of his workers’ compensation attorneys, Diana Sparagna.

Each C&R had an addendum which specifically stated the following: “This Compromise & Release also includes resolution of all claims arising under any state or federal law regulation, including the California Fair Employment and Housing Act, federal and state wage and hour laws, federal and state False Claims Acts, Title VII of the Civil Rights Act, the Americans With Disabilities Act, the Family Medical Leave Act, the California Family Rights Act, the California Labor Code,…….(etc)”

Pizza Hut then moved for judgment on the pleadings in the civil case, based on the releases and, specifically, the broad language in the addenda to the C&R. The court granted judgment on the pleadings without leave to amend. The Court of Appeal affirmed in the unpublished case of Elguea v. Southern Cal. Pizza Co., LLC. Elquea also attempted to set aside the C&R at the WCAB, but his Petition in this regard was denied.

Elguea argued, among other things, that he does not understand English and was never informed in the workers’ compensation action that he was releasing his civil claims. Elguea asserted that he was represented by counsel in the FEHA action at the time of the workers’ compensation settlement, and nobody informed his FEHA counsel that the FEHA complaint was being addressed by the workers’ compensation settlement.

The Court of Appeal ruled that If the parties to the workers’ compensation proceeding include in their release an addendum which reflects an intention to reach beyond workers’ compensation, that addendum may be given effect and may encompass FEHA claims. (Jefferson v. Department of Youth Authority (2002) 28 Cal.4th 299, 301) “Given this controlling authority, we easily resolve the issues raised by Elguea on appeal.”

“Indeed, this case is stronger than Jefferson, in that the addendum to the workers’ compensation releases Elguea signed here expressly encompasses FEHA claims. In short, the trial court correctly concluded that a release which specifically includes FEHA claims does, in fact, release FEHA claims.”

States Now Sue Walgreens for Opioid Crisis

The Kentucky Attorney General filed suit against Walgreens on for its dual role as distributor and pharmacy in allegedly failing to legally monitor its own operations that shipped and dispensed large quantities of opioids through its more than 70 locations statewide.

The lawsuit, filed in Boone Circuit Court, alleges unfair, misleading and deceptive business practices by Walgreens for excessively distributing and dispensing opioids in Kentucky and for failing to legally report to state and federal authorities the suspiciously large orders it received for prescription opioids.

The Attorney General said he filed his sixth lawsuit in Boone County because of the large number of Kentuckians who have died from overdoses in Northern Kentucky.

The lawsuit alleges that Walgreens, whose 2018 second quarter sales topped $33 billion, failed to use its unique position as a pharmacy and distributor to prevent the flood of opioids into Kentucky.

As a distributor, the company has real-time data regarding exact amounts of pills, pill types and customer orders for its store and is legally required to report suspicious orders to the DEA. The company has distribution centers close to Kentucky’s borders in Illinois and Ohio.

As a pharmacy, it is legally required to monitor and flag suspicious customer prescriptions, such as individuals traveling long distances to fill prescriptions or doctors prescribing outside the scope of their usual practice.

The Kentucky Attorney General said Walgreens knew or should have known of Kentucky’s exceedingly high rate of suspicious opioid shipments and prescriptions and the significant correlating risk of abuse, misuse and diversion of prescription opioids.

This new lawsuit is the sixth opioid related lawsuit the Kentucky Attorney General has filed.

MSP Class Action Firm Sanctioned in State Farm Case

Miami lawyers expected a state court victory in 2017 to pave the way for billions of dollars from liability and workers’ compensation insurance carriers across the nation to flow back to Medicare and its beneficiaries.

The attorneys, John Ruiz and Frank Quesada of the firm MSP Recovery, are going after major liability insurers for allegedly shirking their duty to reimburse Medicare benefit providers for conditional payments. Under the Medicare Secondary Payer law known by the acronym MCP, the government can recover double damages from a primary payer that fails to pay Medicare back for medical expenses covered by a liability policy

The home page of the firm boasts of the slogan aimed to attracted its clients who are Medicare Advantage insurance companies, challenging them to “DISCOVER YOUR LOSSES – RECOVER WHAT’S YOURS.”

No attorney had ever secured class certification under the Medicare Secondary Payer law. A nuanced interplay between federal and state laws made it difficult to establish common issues of law and fact. But MSP Recovery overcame those obstacles in Miami-Dade Circuit Court in 2017, where Judge Samantha Ruiz Cohen certified a class in a lawsuit against the auto insurer Ocean Harbor Casualty Insurance, a primary payer for thousands of Medicare Part C beneficiaries.

The judge also noted MSP Recovery has developed a sophisticated system to identify claims by collecting and matching data including Centers for Medicare & Medicaid Services reports, automobile crash reports, ambulance records, insurance declaration sheets and no-fault personal injury protection payout sheets.

That system has allowed the 30-attorney firm with roughly three dozen partner firms across the country to divide claims into categories and file lawsuits across the country on behalf of more than 100 health plans. Their firms boasts of more than 100 class actions pending in state and federal courts across the nation. Targeted defendants include companies such as Allstate Property & Casualty, Liberty Mutual, State Farm Mutual Automobile, Geico and others.

But the firm has suffered some setbacks. Just recently, MSP Recovery LLC and several of its attorneys have been sanctioned by a Federal District Court.The decision is entitled Recovery v. State Farm Mut. Auto. Ins. Co. 2018 U.S. Dist. LEXIS 95789, U.S. District Court for the Central Dist. Of Ill. (June 7, 2018).

This class action involved the usual allegations by MSP Recovery LLC, essentially that MSP Recovery has assignments from various MAPs that have made Medicare conditional payments wherein State Farm should have been the primary payer and/or reimbursed the MAPs that made those conditional payments.

MSP Recovery failed to allege any facts supporting their claims. More particularly, MSP Recovery LLC failed to identify any MAPs that allegedly paid medical expenses on behalf of Medicare beneficiaries. MSP Recovery then filed its first Amended Complaint, and then attempted a Second Amended Complaint to correct the deficiency. The court found MSP Recovery’s contradictory statements to be “palpably absurd and clearly wrong under the law.”

The court issued Rule 11 sanctions in the amount of $5,000 against three of MSP Recovery LLC’s attorneys, as well as an additional $5,000 against MSP Recovery LLC itself, for a total of $20,000.

The Court explained that “Plaintiffs characterize their inaccurate allegations as “correctable flaw[s].” (Doc. 88 at 4). They argue that “it is in the nature of the course of litigation to discover additional facts that change the accuracy of the pleadings”. Id. The Court would be more amenable to this argument if Plaintiffs discovered these inaccuracies early on in litigation, or at least owned up to the misstatements once the Court questioned the Second Amended Complaint’s accuracy in April. The parties have been litigating the issue of standing for over a year, and this is Plaintiffs’ third attempt at filing an adequate complaint.”