Category: Daily News

It has been one of the pharmaceutical industry’s most closely watched experiments: does ending kickback payments to doctors undermine drug sales?  GlaxoSmithKline, the British drugmaker, believes it has proved that raising the ethical bar on marketing practices doesn’t necessarily reduce competitiveness.

GSK Chief Executive Andrew Witty said better-than-expected 2016 first quarter results coincided with a period where the entire group had operated under a new policy that bans payments to doctors who speak on behalf of GSK. “It convinces us that the moves we’ve made are both good for our business and also good for improving the reputation of the industry,” Witty told reporters.

GSK, which was fined nearly $500 million in 2014 for bribing doctors in China, is the first drug company to implement such a broad clampdown on payments to prescribers and competitors are watching closely to assess the commercial fallout.

The former head of the Chinese division of GlaxoSmithKline was charged with corruption in connection with the bribery scandal in which GSK paid off doctors and government officials. In the prior six years Mark Reilly and some of his associates allegedly spent an approximate sum of $480 million on hospitals and its employees, in order to increase the sales of GSK pharmaceuticals in China. Shortly after the allegations against the pharmaceutical company were made public their sales in the Chinese market fell 61%.

GlaxoSmithKline announced it would stop paying doctors for promoting its drugs and scrap prescription targets for its marketing staff – a first for an industry battling scandals over its sales practices, and a challenge for its peers to follow suit. Britain’s biggest drugmaker also said it would stop payments to healthcare professionals for attending medical conferences as it tries to persuade critics it is addressing conflicts of interest that could put commercial interests ahead of the best outcome for patients.

The Chinese authorities were not only investigating GlaxoSmithKline; big international pharmaceutical companies like Novartis International AG, AstraZeneca PLC, Sanofi S.A., Bayer AG und Eli Lilly and Company have also been subjected to greater scrutiny.

In China, GSK’s business is still struggling, with sales down 28 percent in the first quarter, due to disposals of some products and lower prices, but Witty said he expected GSK to return to growth in China in the second half of 2016.

In the United States, the industry’s biggest market by far, many companies have run into conflicts over improper sales tactics and GSK reached a record $3-billion settlement a few years ago with the U.S. government over charges that it provided misleading information on certain drugs.

AstraZeneca said in 2011 it was scrapping payments for doctors to attend international congresses but others, until now, have not followed suit and GSK’s actions go further.

The shift is pragmatic to a certain extent, since many decisions about which drugs to use are now taken centrally by big insurers and governments, based on cost-effectiveness measurements, rather than by individual doctors.

Marissa Gonzalez-Ornelas injured both her knees in 2004 while working as a counselor for the County of Riverside.

In 2015, her treating physician submitted a request for authorization to provide her with Synvisc injections in both knees. Defendant submitted the request to UR, and a UR decision issued denying authorization. She appealed the UR denial to IMR. An IMR determination issued denying authorization. She timely appealed the IMR determination to the WCAB pursuant to Labor Code section 4610.6(h).

The WCJ denied applicant’s IMR appeal based upon the finding that “[t]here is no clear and convincing evidence that the determination was procured by fraud,” and “[there is no clear and convincing evidence that the determination was the result of a plainly erroneous finding of fact, which erroneous finding is a matter of ordinary knowledge, and not a matter subject to expert opinion.” The WCAB reversed the WCJ in the panel decision of Gonzalez-Ornelas v County of Riverside.

The !MR reviewer wrote that denial of authorization was because, “[t]here is no documentation that the patient failed conservative therapies” and “[t]here is no documentation that the patient is suffering from osteoarthritis or severe osteoarthritis that did not respond to conservative therapies.” These statements by the IMR reviewer are directly contradicted by what is set forth in Dr. Jackson’s December 30, 2014 notes which were in the IMR file.

Page four of the December 30, 2014 progress notes by Dr. Jackson states that applicant complained of pain in both knees at that time and that x-rays of the knees showed “some medial compartment arthritis and minimal patella-femoral arthritis.” On page five of the notes, Dr. Jackson provides a diagnosis that includes “primary osteoarthritis of the right knee … primary osteoarthritis of the left knee” and “unilateral post-traumatic osteoarthritis” of both knees. (Id.) Dr. Jackson further documents in his notes that applicant had left knee surgery “with no real decrease in her symptoms,” but that she did have “definite benefit” with Synvisc injections in both knees over the years, writing on page five that applicant “has undergone treatment on a very conservative basis which has been complicated by her morbid exogenous obesity which also would have precluded any significant intervention other than simple conservative measures as have been done.” (Id.) Dr. Jackson opined that applicant will eventually need bilateral total knee replacements, but that Synvisc injections will help her symptoms until surgery and that Synvisc is recommended because applicant “does not do well with cortisone.” (Id.)

The WCAB panel concluded that “Denying authorization based upon a finding that there is “no documentation” when such documentation is, in fact, in the possession of the IMR reviewer is “a plainly erroneous express or implied finding of fact [as] a matter of ordinary knowledge based on the information submitted for review … and not a matter that is subject to expert opinion” as described in section 4610.6(h)(5). It is also an action taken “without or in excess of the administrative director’s powers” as described in section 4610.6(h)(I). The !MR appeal should have been granted by the WCJ on both those grounds.”

“Contrary to the view expressed by the WCJ in her Report, expert opinion is not needed in order to determine that the IMR decision in this case is defective. It is within the realm of ordinary knowledge to conclude that it was error for the IMR reviewer to state that there is “no documentation” when such documentation is part of the record, as in this case. It is also within the realm of ordinary knowledge to determine from the face of the IMR decision that the use of the injections is recommended by the ODG for people who suffer from osteoarthritis in their knees, like applicant.”

The panel ordered the Administrative Director to “provide a new IMR of the treatment forthwith in accordance with section 4610.6(i) and this decision. As part of the new IMR, the ODO should be applied based upon the documentation in the record, which as discussed above, appears to support the provision of the Synvisc injections.”

Nearly three years ago, the N.F.L. and lawyers for thousands of retired football players agreed to resolve lawsuits brought by former players who alleged that the NFL failed to inform them of and protect them from the risks of concussions in football. The District Court approved a class action settlement that covered over 20,000 retired players and released all concussion-related claims against the NFL. Objectors have appealed that decision to the United States Court of Appeals for the Third Circuit, arguing that class certification was improper and that the settlement was unfair.

The huge case had its birth in California. In July 2011, 73 former professional football players sued the NFL and Riddell, Inc. in the Superior Court of California. The NFL removed the case to federal court on the ground that the players’ claims under state law were preempted by federal labor law. More lawsuits by retired players followed and the NFL moved to consolidate the pending suits before a single judge for pretrial proceedings which was granted. The cases ultimately ended up in a federal court for the Eastern District of Pennsylvania as a multidistrict litigation.

Under the settlement, retired players or their beneficiaries are compensated for developing one of several neurocognitive and neuromuscular impairments or “Qualifying Diagnoses.” This award is subject to several offsets, that is, awards decrease: (1) as the age at which a retired player is diagnosed increases; (2) if the retired player played fewer than five eligible seasons; (3) if the player did not have a baseline assessment examination; and (4) if the player suffered a severe traumatic brain injury or stroke unrelated to NFL play.

The Monetary Award Fund is uncapped and will remain in place for 65 years. Every retired player who timely registers and qualifies during the lifespan of the settlement will receive an award. If, after receiving an initial award, a retired player receives a more serious Qualifying Diagnosis, he may receive a supplemental award.

Of the over 20,000 estimated class members (the NFL states that the number exceeds 21,000), 234 initially asked to opt out from the settlement and 205 class members joined 83 written objections submitted to the District Court. Before the fairness hearing, 26 of the 234 opt-outs sought readmission to the class. After the District Court granted final approval, another 6 opt-outs sought readmission. This leaves 202 current opt-outs, of which class counsel notes only 169 were timely filed.

This appeal principally presents two questions – whether the District Court abused its discretion (1) in certifying the class of retired NFL players and (2) in concluding that the terms of the settlement were fair, reasonable, and adequate. Objectors (95 in all) have filed 11 separate briefs totaling some 500 pages addressing these questions.

On April 18, the Court of Appeals approved the settlement in the 69 page decision. After reviewing the case and all of the arguments submitted by the objectors, the Court concluded. “It is the nature of a settlement that some will be dissatisfied with the ultimate result. Our case is no different, and we do not doubt that objectors are well-intentioned in making thoughtful arguments against certification of the class and approval of this settlement. They aim to ensure that the claims of retired players are not given up in exchange for anything less than a generous settlement agreement negotiated by very able representatives. But they risk making the perfect the enemy of the good. This settlement will provide nearly $1 billion in value to the class of retired players. It is a testament to the players, researchers, and advocates who have worked to expose the true human costs of a sport so many love. Though not perfect, it is fair. In sum, we affirm because we are satisfied that the District Court ably exercised its discretion in certifying the class and approving the settlement.”

The Department of Industrial Relations has issued a report that shows the number of Californians who died on the job decreased in 2014. A review of the past ten years indicates that workplace fatalities remain below the average rate of fatalities prior to 2008, when the last recession began.

Data comes from the Census of Fatal Occupational Injuries (CFOI) which is conducted annually in conjunction with the U.S. Bureau of Labor Statistics (BLS). There were 344 fatal injuries on the job in California in 2014, compared to 396 in 2013 and 375 in 2012. Key findings from the latest census in California include:

1) Over one third (35%) of all California workplace deaths identified in 2014 occurred in transportation incidents.
2) One in five (22%) of all California workplace deaths identified in 2014 were attributed to violent acts.
3) One in five (21%) of all California workplace deaths identified in 2014 were attributed to trips, slips and falls.
4) Fatal workplace injuries among Latino workers in 2014 decreased to 130 (38% of all worker deaths) from 194 (49%) in 2013, and 137 (37%) in 2012.

The high rate of workplace fatalities for Latinos continues to be an area the department is tracking closely. DIR over the past six years has increased workplace safety outreach and education to Spanish-speaking workers, with a focus on high-hazard work.

A table reflecting final data for 2014 for California is posted online. Detailed tables will be posted as soon as available from Bureau of Labor Statistics (BLS).

The Census is conducted annually by DIR in conjunction with the U.S. Bureau of Labor Statistics. CFOI produces comprehensive, accurate and timely counts of fatal work This Federal-State cooperative program was implemented in all 50 states and the District of Columbia in 1992.

DIR protects and improves the health, safety and economic well-being of over 18 million wage earners, and helps their employers comply with state labor laws. Its Division of Occupational Safety and Health, commonly known as Cal/OSHA, helps protect workers from health and safety hazards on the job in almost every workplace in California. Cal/OSHA does not have authority when injuries occur on public roadways.

Cal/OSHA’s Consultation Services Branch provides free and voluntary assistance to employers and employee organizations to improve their health and safety programs. Employers should call (800) 963-9424 for assistance from Cal/OSHA Consultation Services.

Employees with work-related questions or complaints may contact DIR’s Call Center in English or Spanish at 844-LABOR-DIR (844-522-6734). The California Workers’ Information line at 866-924-9757 provides recorded information in English and Spanish on a variety of work-related topics. Complaints can also be filed confidentially with Cal/OSHA district offices.

The Division of Workers’ Compensation has posted on its website fact sheets and claim forms for injured workers in Chinese, Korean, Tagalog and Vietnamese. The documents were previously only available in English and Spanish.

The fact sheets include questions and answers regarding temporary and permanent disability, qualified medical evaluators and agreed medical evaluators, utilization review, and the Uninsured Employers Benefits Trust Fund. The DWC 1 claim form, which workers file with employers, has also been translated.

The translations were produced pursuant to AB 438, which requires DWC to make available workers’ compensation information in the four specified languages.

The California Dymally-Alatorre Bilingual Services Act, which was enacted in 1973, requires that all state agencies translate materials into any language spoken by 5 percent or more of those served and hire bilingual staff. Previously, the Labor Code mandated that some of the worker’s compensation forms be prepared in English and Spanish, and was silent as to any other language. The obligation of the DWC was clarified by AB 438 which provides that both the DWC and the DIR shall be subject to the Dymally-Alatorre Bilingual Services Act, for purposes of the forms and notices that are required to be provided to injured workers. The new law required the Department of Industrial Relations and the Division of Workers’ Compensation to make specified forms, notices, and fact sheets available in Chinese, Tagalog, Korean, and Vietnamese. The bill also required the Administrative Director to make recommendations regarding any other documents that should be translated into languages other than English, as specified, and require the department and the division to submit the recommendations and any translated documents to the Legislature.

DWC began translating materials before the AB 438 January 2018 deadline required by the bill, and additional materials are in progress. Among them are the application for the Return-to-Work Supplement Program, the Supplemental Job Displacement Non-Transferable Voucher and a glossary of terms relevant to workers’ compensation.

The translated forms and guides can be found on DWC’s website.