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Tag: 2015 News

UR and IMR – Death by a Thousand Cuts

Recent panel decisions have carved out exceptions to the UR and IMR process to resolve medical disputes. The most significant exception was pronounced in the second en banc case of Dubon v. World Restoration, Inc. (2014) 79 Cal.Comp.Cases 1298. In Dubon II the Appeals Board held that any “determination of medical necessity” is to be made by the WCAB following an untimely UR, and is to be “based on substantial medical evidence consistent with Labor Code section 4604.5.”

However, the WCAB in Dubon confirmed the mechanics of what is required to show “substantial evidence” supporting a request for medical care. Quoting from Sandhagen: the WCAB in Dubon said “The Legislature amended section 3202.5 to underscore that all parties, including injured workers, must meet the evidentiary burden of proof on all issues by a preponderance of the evidence. (Stats. 2004, ch. 34, § 9.) Accordingly, notwithstanding whatever an employer does (or does not do), an injured employee must still prove that the sought treatment is medically reasonable and necessary. That means demonstrating that the treatment request is consistent with the uniform guidelines (§ 4600, subd. (b)) or, alternatively, rebutting the application of the guidelines with a preponderance of scientific medical evidence (§ 4604.5).” (Sandhagen, supra, 44 Cal.4th at p. 242 [bolding added].)

Unfortunately, the requirement for a showing that a request for treatment meets some type of a “uniform guideline” was ignored in the recent panel decision of Jared Carnes v Auto Zone.

In an Expedited Hearing, the parties stipulated that the UR was not timely. The WCJ therefore obtained jurisdiction over whether or not to award the treatment requested by Dr. Eichbaum. A Findings and Order, ruled that applicant had presented substantial evidence of need for medical treatment consisting of a sleep number bed that cost $5,325.86. The WCAB denied reconsideration in the split panel decision.

Dr. Eichbaum made a Request for Authorization setting forth that applicant was scheduled for a major lumbar surgical procedure. He has difficulty with sleeping and his bed is over fifteen years old. He has a very poor mattress. Dr. Eichbaum recommends a new mattress better suited for him and his condition to alleviate his pain and allow him to get rest. In his next letter Dr. Eichbaum said that applicant was scheduled for a lumbar decompression and fusion. In order to optimize his recovery, he’ll need an appropriate bed to sleep on after the surgery. Dr. Eichbaum states that applicant has an inadequate bed and this would definitely be a problem following his surgery.Dr. Eichbaum specifically indicates that a “Sleep Number 18” mattress would be ideal after the surgery and would maximize his ability to recover.

What was missing from the record was any reference to any “uniform guideline” by the treating physician in his reporting, or any other medical professional that that supported an order for this bed. The decision is therefore a step back from the limits specified in Dubon and Sandhagen. The digression from exiting law that requires evidence from a “uniform guideline” did not go unnoticed by Commissioner Zalewski in the dissenting opinion.

The dissent goes on to note that an employer is obligated to provide medical treatment ”that is reasonably required to cure or relieve the injured worker from the effects of his or her injury … ” (Lab. Code, § 4600, emphasis added.) Through its enactment of recent statutes, the Legislature has shown that a dispute over whether a proposed medical treatment is reasonably required is to be determined by the use of evidence-based standards and medical opinion. (See Lab. Code, § 5307.27 [which provides for the development of a medical treatment utilization schedule (MTUS) that “shall incorporate the evidence-based, peer reviewed, nationally recognized standards of care”] and § 4610.5(c)(2) [defining “medically necessary” and “medical necessity” based upon a hierarchy of standards as follows: “A) The guidelines adopted by the administrative director pursuant to Section 5307.27. (B) Peer-reviewed scientific and medical evidence regarding the effectiveness of the disputed service. (C) Nationally recognized professional standards. (D) Expert opinion. (E) Generally accepted standards of medical practice. (F) Treatments that are likely to provide a benefit to a patient for conditions for which other treatments are not clinically efficacious.”]; cf. Lab. Code, §§ 4604.5 [MTUS are presumed to be correct on the issue of extent and scope of medical treatment], 46 I 0 [UR], 4610.5 and 4610.6 [independent medical review].)”

Commissioner Zelewski points out that none the evidence in this case meets this standard, and thus the Finding is not supported by substantial evidence. The majority consisting of Commissioners Frank Brass and Marguerite Sweeny seemed to believe that this standard was met, without explanation except to say that “For the reasons stated by the WCJ in his Report, which is adopted and incorporated by this reference, the December 23, 2014 decision is affirmed and defendant’s petition for reconsideration is denied.”

The mandates of Sandhagen and Dubon have thus been eroded – without explanation by the majority,- and are in the process of death by a thousand small cuts.

Medical Fraud Setting Records in 2015

In 2014, the federal government recovered nearly $5.7 billion in fraud cases, up $1.9 billion from the prior fiscal year. Of that amount, $2.3 billion was tied to fraud against the federal government. Already, 2015 has seen a host of major fraud news involving dozens of individuals and amounting to millions in abuse, often related to Medicare fraud.

$100 Million: Thirty-seven people, including 24 doctors, pleaded guilty to a massive healthcare bribery scheme resulting in more than $100 million in payments from Medicare and various private insurance companies to Biodiagnostic Laboratory Services in New Jersey. On March 3, Michael J. Zarrelli, 48, of Berkeley Heights, New Jersey pleaded guilty to bribing a doctor in exchange for test referrals.

$75 Million: Community Health Systems and three of its hospitals in New Mexico in February agreed to pay a $75 million settlement to the federal government over a whistleblower suit that claimed it illegally donated money between 2000 and 2011 to New Mexico counties in return for higher Medicaid payments to cover the costs of indigent care. The activity was uncovered by whistleblower Robert Baker, a former revenue manager at Community Health Systems Professional Services Corp.

$30 Million: Operators of a Louisiana home care company, Priority Care at Home, as well as 20 other accomplices were indicted in March for their alleged role in a $30 million Medicare fraud scheme. The defendants allegedly hired “house doctors” to sign orders and plans of care for Medicare beneficiaries who had no legitimate medical necessity for home health services.

$14 Million: Jonathan Wade Dunning, a former CEO of two nonprofit health clinics in Alabama, was arrested in February on 112 counts related to alleged conspiracy, fraud and money-laundering of cash meant for the poor and homeless. The charges allege Dunning, as CEO and in other positions, participated in conspiracy and executed schemes to defraud Birmingham Health Care, Central Alabama Comprehensive Health and others of “substantial resources,” according to the indictment.

$7.9 Million: Pharmaceutical giant AstraZeneca in February agreed to pay the government $7.9 million to settle allegations that it engaged in a kickback scheme regarding its drug Nexium. The complaint said AstraZeneca paid Medco Health Solutions, a pharmacy benefit manager, in exchange for Medco maintaining Nexium’s “sole and exclusive” status on certain Medco formularies and through other marketing activities.

$6.9 Million: Orelvis Olivera, a 45-year-old owner of Acclaim Home Health Care in Miami, in February admitted to running a $6.9 million Medicare fraud in which he and his conspirators billed the government for expensive therapies that patients did not need.

$3.5 Million:The New York-based Catholic Health Care System, an operator of skilled nursing facilities, agreed in March to pay $3.5 million to settle allegations that it inflated Medicare claims for rehabilitation therapy.

$1.6 Million: Vivian Yusuf, 44, the former owner of the Houston-area Ivy Health Care Supply company in February was sentenced to 7 years federal prison and ordered to pay $1.6 million in restitution on a conviction of conspiracy to commit healthcare fraud. From June 2007 to May 2009, Yusuf and co-conspirators improperly acquired Medicare patient information to submit false claims to Medicare totaling more than $3.4 million.

$1.1 Million: A Texas man impersonating an MRI salesman working with Cerner Corp. convinced employees of a Dallas hospital to wire him more than $1 million using an elaborate network of fake correspondence and several co-conspiratorsi. Albert Davis, 54, of Richardson, Texas, was charged with wire fraud after employees of Dallas Medical Center and Prime Health Care — which acquired the hospital during the course of the scheme — transmitted two wire payments totaling $1.1 million to the conspirators’ bank account to purchase the MRI.

Is Comp Fraud Grant Funding Model a Solution for Underground Economy Fight?

The California Little Hoover Commission, is an independent state agency charged with recommending ways to improve the efficiency and effectiveness of state programs. The Commission’s recommendations are submitted to the Governor and the Legislature for their consideration and action. By statute, the Commission is a bipartisan board composed of five public members appointed by the governor, four public members appointed by the Legislature, two senators and two assemblymembers.

The Commission said in the 140 page report, that California businesses are losing ground to unscrupulous competitors who break the rules to gain an unfair advantage,in a report calling on the Governor and Legislature to more effectively fight the state’s underground economy. The Commission found the underground economy is growing and thriving in part because of insufficient resources for enforcement. The Commission learned that many cheaters break the rules because getting caught is unlikely. If they are caught, few are charged in court. When found guilty, the profits from cheating often outweigh the fines and penalties. More, there is an abysmal record of collecting restitution. The state loses an estimated $8.5 billion or more annually in tax revenue, yet efforts to combat the underground economy are disjointed and under-resourced, the Commission found. It reported that the state’s bureaucratic disorganization and neglect provide significant incentives to cheat, making the rewards of participating in the underground economy outweigh the risks.

The Commission found that existing laws can be so confusing and inconsistent that even business owners who try to comply sometimes later learn they have broken rules. Recommended improvements include defining independent contractor in statute, bolstering asset seizure laws, and generally refining laws to improve clarity and to ensure rewards don’t outweigh risks.

The Commission also recommends replicating the current workers’ compensation fraud grant funding model to other high-fraud areas, enabling local district attorneys to increase their role in tackling the underground economy. Many stakeholders told the Commission that the workers’ compensation grant model, financed by premiums paid by California employers for fraud investigations and prosecutions, is an effective funding model. Nearly $59 million has been allocated for the FY 2015-16 grant cycle. A worker’s compensation manager of a Fortune 100 company and member of the Fraud Assessment Commission, which determines how much grant funding will be available for the program, told Commission staff that good oversight is what makes the grant process effective. “The Fraud Assessment Commission pushes and pushes and pushes for counties to do better. We constantly tell them that they have to do better to get the money. And it works,” he said. “If similar programs are established, you should create a similar mechanism that requires proven performance for funding.”

Counties funded by the grant dedicate prosecutors to investigating workers’ compensation fraud. “I have no problem finding prosecutors for workers’ compensation cases, because of the grant,” the EDD Chief of Investigations told the Commission.Many district attorney offices have opened workers’ compensation fraud sections, in part because of the grant. Representatives from the Orange County District Attorney’s Office said the grant program allowed them to hire fraud specialists. “These cases can take years sometimes to get up to speed. The grant funding allows someone to build an expertise in fraud.”

Prosecutors investigating workers’ compensation fraud cases frequently uncover additional unlawful activity. San Bernardino Deputy District Attorney David Simon told Commission staff: “Workers’ compensation fraud is just one spoke in a wheel of a wide variety of illegal conduct that we refer to as unfair business practices. This is what the Business and Professions Code defines as practices that unfairly advantage one business that disadvantage another business in the free market. We find that businesses without workers’ compensation are often unlicensed to do contracting, engaging in cash-pay transactions and income tax evasion, not paying overtime or engaging in theft of labor. They’re all related and a legitimate business person cannot possibly compete against the bid of these companies.”

The Report concludes “Because of the effectiveness of the workers’ compensation grant program, stakeholders suggested that it could be expanded and replicated in other high-fraud areas, including dedicated funding for complex cases.”

FDA Modifies Approval Process to Limit Superbug Infection

The U.S. Food and Drug Administration announced new actions to enhance the safety of reusable medical devices and address the possible spread of infectious agents between uses. A key change is that when manufacturers submit instructions for disinfecting the devices between uses, the Food and Drug Administration will not take the company’s word that the instructions work, but will demand proof. In the past, the agency essentially took manufacturers at their word when they claimed a procedure worked; now they will have to submit data proving so “with a high degree of assurance,” the agency said. The new recommendations are outlined in a final industry guidance aimed at helping device manufacturers develop safer reusable devices, especially those devices that pose a greater risk of infection.

The FDA issued a draft guidance discussing the reprocessing of reusable medical devices in 2011, and considered almost 500 comments before issuing the final guidance. The final guidance provides more clarity about testing protocols and what data should be submitted to the agency for a premarket submission, such as the data FDA needs to evaluate substantial equivalence for a 510(k) premarket submission. Manufacturers seeking to bring to market certain reusable devices, such as duodenoscopes, bronchoscopes and endoscopes, should submit to the FDA for review their data validating the effectiveness of their reprocessing methods and instructions.

FDA’s final guidance document, titled “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling” includes recommendations medical device manufacturers should follow pre-market and post-market for the safe and effective use of reprocessed devices. A device manufacturer’s reprocessing instructions are critical to protect patients against the spread of infections. As part of its regulatory review for reusable medical devices, the FDA reviews the manufacturer’s reprocessing instructions to determine whether they are appropriate and able to be understood and followed by end users. The guidance lists six criteria that should be addressed in the instructions for use with every reusable device to ensure users understand and correctly follow the reprocessing instructions.

Separately, the FDA also announced in the Federal Register that the agency’s Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee will hold a public meeting on May 14 and 15, 2015 to discuss recent reports and epidemiologic investigations of transmission of infections associated with the use of duodenoscopes in endoscopic retrograde cholangiopancreatography (ERCP) procedures in hospitals in the United States.

The FDA action followed reports last month that hundreds of patients may have been exposed to pathogens, including antibiotic-resistant “superbugs,” after flexible tubes called duodenoscopes were not properly disinfected between patients. Two patients at the University of California-Los Angeles died. The new recommendations apply, however, not only to duodenoscopes but to most medical devices intended for repeated use, including bronchoscopes and endoscopes.

To deal with the thousands of devices already in use, whose disinfection protocols were not subjected to rigorous validation, the U.S. Centers for Disease Control and Prevention released instructions for reducing the risk of transmitting infections. The protocol calls for swabbing the device after it has supposedly been disinfected and seeing if any microbes grow into detectable colonies, much as doctors take throat swabs to determine if a patient has a strep infection, before the device is used again. The duodenoscopes at the center of the recent superbug outbreaks are made by Olympus Corp, Fujifilm Holdings Corp, and Pentax.

As far back as 2009, the FDA believed that transmission of infection by duodenoscopes occurred when hospitals did not properly follow manufacturers’ instructions for “reprocessing,” or disinfecting, the devices between use. Only recently, the agency said, did it conclude that such transmission can occur even when the instructions are followed to the letter, an indication of how difficult it is to clean the complex equipment.

The FDA does not, however, “have the authority to require manufacturers to change their (device’s) design” even if it prevents disinfection, Dr. William Maisel, FDA’s deputy center director for science, told reporters.

CWCI – WCIRB Joint Study Confirms SB863 ASC Cost Savings

In recent years, the increasing cost of treatment at ambulatory surgery centers has been one factor in the escalation of California workers’ compensation medical costs. In 2012, state lawmakers sought to address these escalating costs by including provisions in SB 863 that, among other things, reduced the maximum facility fees for services performed in ASCs to 80 percent of the fee paid by Medicare for the use of hospital outpatient surgery departments. The WCIRB initially projected that this change in the fee schedule would reduce ASC payments by 25 percent. This new WCIRB CIRB joint study is a follow-up to the authors’ initial February 2014 study that measured the extent to which the change in ASC reimbursements achieved its intended goal of reducing these costs. It includes an entire year of additional data, encompassing episodes from January 2012 through June 2014.

Prior to 2004, California workers’ compensation outpatient surgery facility fees were not subject to a fee schedule, and payments varied widely as payers negotiated or paid usual and customary fees. In the absence of a fee schedule, California workers’ compensation paid significantly more than federal health care programs such as Medicare for comparable services, as was noted in a 2002 study by Kominsky and Gardner.

In 2003, California lawmakers amended Labor Code §5307.1(c)(1) in SB 228 to require the Division of Workers’ Compensation (DWC) to promulgate a fee schedule that utilizes the Medicare payment rules for the use of outpatient surgery rooms and emergency rooms. Under Medicare, each Current Procedural Terminology (CPT) code for a specific outpatient surgical procedure is classified into an Ambulatory Procedure Classification (APC). The final fee is calculated using a formula rather than a prescribed dollar amount. Under the fee schedule, which took effect for services on or after June 15, 2004, maximum facility fees could not exceed 120 percent of the Medicare fee. The adoption of the outpatient facility fee schedule had an immediate effect on costs. CWCI research from 2005 compared pre and post SB 228 payments for 239 distinct outpatient procedures performed in ASCs and found that after adjusting for medical inflation and changes in the mix of medical procedures, average outpatient surgery facility fee payments fell 38.9 percent following the adoption of the Outpatient Surgery Facility Fee Schedule in 2004.

By 2012, however, several years of escalating workers’ compensation medical costs and a growing desire to increase injured workers’ permanent disability benefits led state lawmakers to revisit the issue of ASC fees as one cost-saving component of a legislative reform deal (SB 863) hammered out by representatives of labor, employers and the Brown Administration.The final version of that bill called for the DWC to modify the Outpatient Facility Fee Schedule so that maximum facility fees for services performed in ASCs were reduced from 120 percent to 80 percent of the Medicare fee for those services, though hospital-based outpatient facility maximum fees were kept at 120 percent of the Medicare rate.

As found in the prior study, this update on the effects of SB 863 finds that the reduction in payments has been slightly better than the initial predictions, with a 27 percent decrease in payments per episode and a 29 percent decrease in the payments per procedure from the pre-reform to the post- reform period. There was no evidence of significant changes in service mix or intensity or shifts away from the ASC to the hospital setting. The study concludes by saying “These results are similar to the 2014 findings using the identical measures and show that thus far, the change in the ASC Fee Schedule has achieved its intended objective of reducing one aspect of workers’ compensation medical costs.

Orange County Pair Convicted of $71 Million Surgical Center Fraud

A federal jury has convicted two Southern California residents in connection with a scheme to defraud union and private health insurance programs by submitting bills for more than $71 million and receiving over $50 million in payments for medically unnecessary procedures performed on insurance beneficiaries who received free or discounted cosmetic surgeries. A large number of the fraudulent claims were submitted to the International Longshore and Warehouse Union and Operating Engineers Union health insurance plans. Other victim insurers included Aetna and Anthem.

The two defendants found guilty are Theresa Fisher, 45, of Tustin, who was found guilty of five counts of mail fraud; and Lindsay Hardgraves, 30, of San Pedro, who was found guilty of two counts of mail fraud.

The evidence presented during a six-day trial showed that members of the scheme lured insured “patients” to a surgery center in Orange with promises that they could use their union or PPO health insurance plans to pay for cosmetic surgeries, which are generally not covered by insurance. The surgery center was known at various times as Princess Cosmetic Surgery, Vista Surgical Center, and Empire Surgical Center.

Marketers such as Hardgraves referred “patients” to the surgery center, where they were told they could receive free or discounted cosmetic surgeries if they underwent multiple, medically unnecessary procedures that would be billed to their union or PPO health care benefit program. Fisher was a consultant at the surgery center who scheduled procedures after telling the “patients” about the free cosmetic procedures they could receive and coaching them to fabricate or exaggerate symptoms so that their medical procedures would be covered by their insurance.

The unnecessary procedures typically performed on the “patients” were endoscopies (usually sophagogastroduodenoscopies, or EGDs), colonoscopies and cystoscopies. Once the health care benefit program paid the claims, the patients were given free or discounted cosmetic surgeries, including tummy tucks, breast augmentations and liposuction. In some cases, the surgery center simply billed cosmetic procedures (such as tummy tucks) as if they were medically necessary procedures (such as hernia surgeries).

Fisher and Hardgraves are scheduled to be sentenced on May 29. A third defendant in this case – Vi Nguyen, 31, of Placentia, another consultant at the surgery center – pleaded guilty in January to four counts of mail fraud and faces sentencing before Judge Staton on July 10. At sentencing, each defendant faces a statutory maximum sentence of 20 years in federal prison for each count of mail fraud.

Orange County Insurance Agent Sentenced to Seven Years

Jacob Richard Bonzer, 28, formerly of Lake Forest, Calif. was arrested last August in Chicago by a U.S. Marshals Task Force on 96 felony counts including grand theft, forgery and denial of benefits. He pleaded guilty and was sentenced to seven years in prison last Friday for selling fraudulent insurance polices in Orange County to fund a lavish lifestyle.

Between 2009 to 2013, Bonzer, collected more than $900,000 in commissions and premium payments for the fake polices, and created fake insurance companies to defraud customers, a statement from the Orange County District Attorney said.

Before being sentenced, Bonzer pleaded guilty to 49 counts of grand theft, one felony count of forging a California Department of Insurance Examination report, transacting insurance business without a certificate of authority, 45 felony counts of insurance fraud, with sentencing enhancements for aggravated white-collar crime totaling more than $500,000 and taking more than $200,000. He was ordered to pay $918,300 to his victims. Bonzer used the money to pay for fine dining, travel, wine club memberships and to rent luxury high-rise apartments.

Between 2009 to 2010, Bonzer worked at a Farmers Insurance Group office in Brea, before being fired after failing the company’s career program. The Department of Insurance received a complaint alleging Bonzer submitted 128 fraudulent homeowners insurance applications containing bogus information using nonexistent policyholders for real properties, causing valid policies to be issued for phantom homeowners in escrow. Bonzer allegedly received $46,000 in advanced commissions from the insurance company that expected to collect premiums when the properties closed escrow. Since the applicants were bogus, the insurer never received premium payments and Bonzer was eventually fired.

In 2011, he continued his criminal activities and created a fake company and, with another insurance agent to whom he lied, created 800 more homeowner polices that listed fake names. The fake company was called GW Mutual Risk Retention Group, LLC, which was registered in Florida. GW Mutual is not licensed to write insurance in California though Bonzer sold workers’ comp and commercial insurance policies through his agency, Bonzer Insurance Brokerage, located in Orange County.

Bonzer collected roughly $280,000 in premium from 58 California businesses that believed they were purchasing valid coverage.The other agent paid back his half of the $573,242 in commissions. When questioned by a customer about his ability to sell insurance in California, Bonzer provided him with a fake document from the state department of insurance.

Bonzer orchestrated these elaborate scams by using multiple post office boxes, virtual assistants, business entities, office spaces, email accounts, website domains and bank accounts.

National Prescription Drug Spending Increased 13%

The nation’s largest pharmacy benefits manager says prescription drugs spending rose 13 percent last year, the largest annual increase since 2003. Express Scripts says the gains were fueled by pricey specialty drugs that accounted for about 31 cents of every dollar spent on prescriptions even though they represented only 1 percent of all U.S. prescriptions filled.

New hepatitis C therapies with high price tags and the exploitation of loopholes for compounded medications drove a 13.1% increase in U.S. drug spending in 2014 – a rate not seen in more than a decade. The report says that these findings “demonstrate the need for plans to take decisive action and more closely manage the pharmacy benefit to ensure all patients are able to achieve the best possible health outcomes at a price our country can afford.”

Inflammatory conditions, multiple sclerosis and cancer remained the top three specialty therapy classes for the fifth consecutive year, collectively contributing to 55.9% of the spend for all specialty medications billed through the pharmacy benefit in 2014.

Spending on traditional medications continues to rise as a result of compounded drugs, which emerged in the top 10 traditional therapy classes for the first time and accounted for 35% of the increase in spending. However, Express Scripts expects spend on compounded medications to decline sharply in 2015 due to widespread adoption of our compound utilization management solution. Express Scripts’ compound management solution, implemented in mid-2014, will save its clients more than $1.9 billion in 2015 that would have otherwise been wasted on compounded medications that do not provide a proven clinical benefit.

Drugmaker consolidation and drug shortages also led to increases in traditional drug trend, which rose to 6.4% in 2014. Half of the top 10 therapy classes experienced negative trend in 2014 due to generics. While it expects that trend to persist for the next two years, some categories will face challenges from continued drugmaker consolidation, which can lead to price increases from drug shortages and decreased competition.

UCLA Super Bug Victim Sues Medical Device Maker

Antonia Torres Cerda, 48, died at UCLA Ronald Reagan Medical Center after she allegedly was infected with a “superbug” bacteria transmitted into her body by medical equipment. The Fresno Bee reports that the family is now suing the equipment maker for wrongful death, negligence and fraud. Cerda’s family is asking for punitive and exemplary damages of an unspecified amount. The University of California at Los Angeles is not named in the lawsuit.

Cerda had been given a procedure for ERCP, or endoscopic retrograde cholangiopancreatography, before the transplant and a second procedure afterward, said Peter L. Kaufman, a Los Angeles lawyer who is representing Cerda’s husband, Armando Cerda, her four children and her mother. The procedures were done using a duodenoscope manufactured by Olympus Medical System Corp. of Japan and marketed and sold by Olympus Corp. of the Americas and Olympus Medical System Corp. The scopes are flexible tubes inserted down the throat into the small intestines. About 500,000 people in the U.S. undergo procedures with the scopes every year, according to the federal Food and Drug Administration.

Antonia Cerda needed the transplant because she had nonalcoholic liver cirrhosis, said her oldest daughter Cynthia, 18, a freshman at the University of California at Santa Cruz. She said her mother, who was a field worker, became ill seven or eight years ago and was on the transplant list for about five or six years. Following the transplant, her mother had started to recover but then grew ill from the infection and died. The doctors said there were no antibiotic medications that would have killed the bacteria and saved her mother.

Cerda’s is one of two patient deaths that have been connected to an antibiotic-resistant bacterial outbreak at UCLA. The outbreak is believed to have spread through the use of endoscopes. Five others were infected with the bacteria after having procedures to diagnose and treat pancreatic and bile duct problems between October and January, and UCLA notified 179 people that they may have been exposed. UCLA spokeswoman Dale Tate said seven different scopes were used at the hospital during that time but five had no sign of bacteria. “There were only two that were impacted,” she said. Both were made by Olympus.

The lawsuit alleges that Olympus failed to develop and validate an effective way to clean a redesigned Q180V Scope. Kaufman said a device manufacturer that makes and markets a reusable medical instrument has “an obligation to figure out how to clean it, and they have to prove that their cleaning method works.” Otherwise, he said, they would have to sell it as a “single-use device.” According to the lawsuit, Olympus knew the complex design of its duodenoscope “renders some part of the device extremely difficult to access” and as a result, difficult to clean. An elevator mechanism within the scope contains microscopic crevices that can’t be reached with a brush, and material can remain inside, the suit said. Olympus should have known that these “residual fluids contain microbial contamination, multiple patients would be exposed to serious risk of harm, including lethal infection,” the suit alleges.

Olympus redesigned the TJF-Q180V duodenoscope in 2014, the suit alleges, but failed to update cleaning protocols. But before the redesign, the company allegedly knew the devices were difficult to clean. In 2013, Olympus was allegedly informed of infections to patients in the state of Washington, and “at least four patients who were infected as a result of exposure to contaminated duodenoscopes died.” The suit said Olympus continued to aggressively market the devices “with conscious disregard of the extreme risks to the public of serious infection, pain, suffering and death.”

The lawsuit also includes an allegation of fraud and names three Olympus sales and marketing representatives from Southern California. The lawsuit said the three made false representations to UCLA doctors and staff between July 2014 and January 2015 about the device’s safety and risks associated with its reuse. In seeking punitive damages, the lawsuit said the family believes that Olympus “acted with ‘malice’ “.

Olympus officials did not return telephone calls or email requests from the Fresno Bee for comment.

California “Biofrequency” Device Makers Face Federal Charges

Federal law enforcement agents in Medford Oregon arrested a California couple charged with marketing unapproved medical devices that were claimed to treat ailments ranging from ulcers to AIDS.

Special agents from the Medford office of Immigration and Customs Enforcement arrested David Perez and Sandra Perez at an apartment in the 2300 block of Bromley Street in Medford on warrants issued by the U.S. District Court for the Southern District of California. An indictment claims the couple and co-defendant Beth Campbell have sold almost $700,000 worth of “biofrequency” devices under the brand name Energy Wave. Both husband and wife are charged with conspiracy, sale of adulterated devices, the sale of misbranded devices, acting to cause the shipment of adulterated or misbranded devices and making false statements.

The devices, which prosecutors say were manufactured by an un-indicted co-conspirator in his Southern California home, consist of a small computer-controlled generator connected to metal cylinders intended to be held by the user. “Users were provided with an operating manual and a listing of ‘Auto Codes’ that set forth hundreds of digital settings for the device directed to specific conditions such as abdominal pain, AIDS, diabetes, stroke, ulcer and worms,” the indictment says.

The devices apparently were not approved by the Food and Drug Administration, and prosecutors say the Perezes took extra care to hide their activities from the agency, registering their website in the Philippines and uploading the devices’ instructions to the Internet instead of including them in the box. According to the indictment, David Perez had previously been a partner in California-based CGNI Inc., the owners of which were convicted in 2011 of selling a product called the “Detox Box,” which prosecutors say was almost identical to the Energy Wave.

The Perezes were released from custody in Medford after posting $25,000 bonds, court records show.