Tag: 2017 News

Employees of Monsanto Co ghostwrote scientific reports that U.S. regulators relied on to determine that a chemical in its Roundup weed killer does not cause cancer, farmers and others suing the company claimed in court filings.

The documents, which were made public on Tuesday, are part of a mass litigation in federal court in San Francisco claiming Monsanto failed to warn that exposure to Roundup could cause non-Hodgkin’s lymphoma, a type of cancer. Roundup is used by farmers, homeowners and others around the globe and brought Monsanto $4.8 billion in revenue in its fiscal 2015.

In the event California farm workers file cancer related industrial injury claims based on exposure to Monsanto farming products, this federal litigation may give rise to subrogation opportunities. Or, successful recoveries in this case by farm workers may later become the basis for benefit credit petitions in individual WCAB cases they may later file.

The company has denied that the product causes cancer. Plaintiffs claim that Monsanto’s toxicology manager ghostwrote parts of a scientific report in 2013 that was published under the names of several academic scientists, and his boss ghostwrote parts of another in 2000.

Both reports were used by the EPA to determine that glyphosate, a chemical in Roundup, was safe, they said.

They cited an email from a Monsanto executive proposing to ghostwrite parts of the 2013 report, saying, “we would be keeping the cost down by us doing the writing” while researchers “would just edit & sign their names so to speak.”

In an email to Reuters, a Monsanto spokeswoman denied that Monsanto scientists ghostwrote the 2000 report but did not directly address the 2013 report. She said the ghostwriting allegations were based on “cherry-picking” one email out of 10 million pages of documents.

Another filing focused on Jess Rowland, a former deputy director at the Environmental Protection Agency who chaired a committee on cancer risk and who plaintiffs say worked with Monsanto to suppress studies of glyphosate.

The filing includes an email from a Monsanto employee recounting how Rowland told him he “should get a medal” if he could “kill” a study of glyphosate at the Department of Health and Human Services, a separate federal agency.

Rowland, who is retired, is not a defendant in the litigation. He could not immediately be located for comment. The EPA had no immediate comment.

The federal mass litigation includes about 60 lawsuits, according to Aimee Wagstaff, an attorney for the plaintiffs. Several hundred more lawsuits are pending in state courts, she said.

Monsanto is also fending off claims over its past manufacturing of polychlorinated biphenyls (PCBs), which the WHO classifies as known carcinogens. At least 700 lawsuits against Monsanto or Monsanto-related entities are pending, brought by law firms on behalf of people who claim their non-Hodgkin lymphoma was caused by exposure to PCBs that the company had manufactured until the late 1970s.

The case is In re Roundup Products Liability Litigation, U.S. District Court, Northern District of California, No. 16-md-02741.

Theodore Davis filed two applications for adjudication of his workers’ compensation claim alleging he contracted prostate cancer due to both specific industrial exposure and as a cumulative trauma injury through March 31, 2014, while performing his duties as a firefighter for the City of Modesto.

The parties selected Thomas Allems, M.D., as the panel Qualified Medical Examiner (QME) during the discovery process. Dr. Allems produced two medical-legal reports concluding Davis’s cancer was not related to his employment.

At his own expense, Davis hired Gerald Besses, M.D., to review Dr. Allems’s reports and to evaluate him regarding the causation of his prostate cancer. Davis forwarded Dr. Besses’ reporting to Dr. Allems with a request to prepare a supplemental report addressing Dr. Besses’ evaluation, but Modesto objected and filed a declaration of readiness to proceed to a hearing, claiming the request was an attempt to violate the workers’ compensation discovery process.

The WCJ concluded Dr. Besses’ report was not admissible because it was not obtained pursuant to section 4060 (Batten v. Workers’ Comp. Appeals Bd. (2015) 241 Cal.App.4th 1009 (Batten)), but that the report may nevertheless be reviewed and commented on by Dr. Allems as the QME pursuant to Labor Code 4605.

LC 4605 provides that “Nothing contained in this chapter shall limit the right of the employee to provide, at his or her own expense, a consulting physician or any attending physicians whom he or she desires. Any report prepared by consulting or attending physicians pursuant to this section shall not be the sole basis of an award of compensation. A qualified medical evaluator or authorized treating physician shall address any report procured pursuant to this section and shall indicate whether he or she agrees or disagrees with the findings or opinions stated in the report, and shall identify the bases for this opinion.”

Modesto petitioned the WCAB for reconsideration. In a July 15, 2016, opinion, the WCAB treated the petition as one for removal, granted removal, dismissed reconsideration, and rescinded the WCJ’s decision concluding that Dr. Besses’ report was  not reviewable by the QME

Davis filed a petition for writ of review. In addition to an answer from Modesto, the WCAB filed a letter brief stating it had reviewed the petition and determined it failed to address Labor Code section 4605 in its October 3, 2016, decision. Accordingly, the WCAB asked the court to grant the petition for review, annul the WCAB’s decision, and remand to the WCAB for further proceedings.

The Court of Appeal granted a writ of review in the unpublished decision of Davis v WCAB, and the City of Modesto. The WCAB’s October 3, 2016, Opinion and Orders Denying Petition for Reconsideration and Dismissing Petition for Removal was annulled. The matter was remanded to the WCAB to conduct any further proceedings it deems appropriate.

“Given the WCAB’s admission it did not consider section 4605, which is also apparent from the face of its October 3, 2016, opinion, we conclude the WCAB’s decision fails to ‘state the evidence relied upon and specify in detail the reasons for the decision’ as required under section 5908.5. ‘The purpose of this section requiring the appeals board to specify in detail the reasons for its decision is to assist the reviewing court to ascertain principles relied upon by the lower tribunal to help avoid careless or arbitrary action and to make the right of appeal more meaningful.’ (Burbank Studios v. Workers’ Comp. Appeals Bd. (1982) 134 Cal.App.3d 929, 936.) The WCAB’s failure to set forth its reasoning in adequate detail constitutes a sufficient basis to annul the decision and remand for a statement of reasons.”

Physical therapy is as effective as surgery in treating carpal tunnel syndrome, according to a new study published in the Journal of Orthopaedic & Sports Physical Therapy® (JOSPT®).

Researchers in Spain and the United States report that one year following treatment, patients with carpal tunnel syndrome who received physical therapy achieved results comparable to outcomes for patients who had surgery for this condition. Further, physical therapy patients saw faster improvements at the one-month mark than did patients treated surgically.

Carpal tunnel syndrome causes pain, numbness, and weakness in the wrist and hand. Nearly half of all work-related injuries are linked to this syndrome, which can result from repetitive movements. Although surgery may be considered when the symptoms are severe, more than a third of patients do not return to work within eight weeks after an operation for carpal tunnel syndrome.

The study demonstrates that physical therapy – and particularly a combination of manual therapy of the neck and median nerve and stretching exercises – may be preferable to surgery, certainly as a starting point for treatment.

“Conservative treatment may be an intervention option for patients with carpal tunnel syndrome as a first line of management prior to or instead of surgery,” says lead author César Fernández de las Peñas, PT, PhD, DMSc, with the Department of Physical Therapy, Occupational Therapy, Rehabilitation, and Physical Medicine at Universidad Rey Juan Carlos, Alcorcón, Spain.

Dr. de las Peñas and his fellow researchers studied the cases of 100 women with carpal tunnel syndrome. By random allocation, 50 women were treated with physical therapy and 50 with surgery. Patients assigned to the physical therapy group were treated with manual therapy techniques that focused on the neck and median nerve for 30 minutes, once a week, with stretching exercises at home.

After one month, the patients in the physical therapy group had better hand function during daily activities and better grip strength (also known as pinch strength between the thumb and index finger) than the patients who had surgery. At three, six, and 12 months following treatment, patients in the surgery group were no better than those in the physical therapy group. Both groups showed similar improvements in function and grip strength. Pain also decreased similarly for patients in both groups. The researchers conclude that physical therapy and surgery for carpal tunnel syndrome yield similar benefits one year after treatment. No improvements in cervical range of motion were observed in either patient group.

The researchers caution that because the study only included women from a single hospital, additional research needs to be done to generalize their findings. Further, there are no available data on the most effective dosage for the manual therapy protocol applied.

The study was funded by a research project grant (FIS PI14/ 00364) from the Health Institute Carlos III (PN I+D+I 2014-2017; Spanish Government).

A 220 page report by the California Senate Committee on Business, Professions and Economic Development says than 635 physicians are currently on administrative probation.

Doctors were disciplined for allegations such as sexual misconduct with patients, performing surgery under the influence of controlled substances and health care fraud.

Although physicians must report their probation to their employer and insurance company, they are not obligated to inform patients.  And lawmakers are considering a change to that by requiring physicians to inform each patient that they are on probation.

Issue 28 of the report says that while it is true that important information is available on Medical Board of California (MBC) website, a key issue for the Committees remains how easily available it is for California patients to access easily understandable information about physicians who have been the subject of disciplinary action, placed on probation and are practicing. When the MBC places physicians on probation, generally they continue to practice medicine and see patients under restricted conditions. Terms of probation may include certain practice limitations and requirements, but most commonly physicians on probation are not required to provide any information to their patients regarding discipline taken by MBC.

A determination of probation is a step in a lengthy disciplinary process, conducted in accordance with the Administrative Procedures Act, and offering due process for accused licensees. In reviewing MBC data for current physicians on probation, proven violations that result in probation include gross negligence or incompetence, substance abuse, inappropriate prescribing, sexual misconduct or conviction of a felony.

Probationary status is not secret. MBC only orders probation for a licensee once multiple steps in the life of a case have been taken. Probation is not loosely issued for suspicions or complaints or facts gained during an investigation that lead to the filing of an accusation for which clear and convincing evidence is present.

And the report says that patients may be especially deserving of greater access to information about a physician on probation given the potential for future disciplinary action. The 2008 CRB study reported that physicians who have received serious sanctions in the past are far more likely to receive additional sanctions in the future. According to the CRB report, “These findings strongly imply that disciplinary histories provide patients with important information about the likely qualities of different physicians.”

According to MBC data, there are currently 635 physicians on probation (this includes those issued a probationary license at application and those with an out of state address of record, for a total of 497 on probation with an address in California, 83 on probation with an address in another state, 38 with a probationary license with an address in California and 17 with a probationary license with an address in another state.) The Appendix to this report starting on page 70 is a listing by name, location and type of offense of those physicians and surgeons currently on probation.

It would be interesting to review the 635 names to see how many of them currently treat i worker’ compensation cases or are members of an approved MPN.

In October, 2012 MBC staff made a proposal to the MBC to require physicians to inform their patients when the physician is on probation and required to have a monitor. In its recommendation staff said, “This would insure the public has the ability to make informed decisions regarding their healthcare provider.” MBC did not approve the staff proposal.

Jerry Hill is Chair of the Committee. He says patients need to be able to make appropriate health care decisions.

“There is no one watching or overseeing the physician to make sure that those terms of probation are being followed,” Hill says. “It meets and requires, and I think, it mandates that the patient takes responsibility for their own health care in this case.”

The committee recommends amending current law to require physicians to tell their patients they’re on probation.

A legislative committee will review the report.

The operator of rehabilitation clinic in Walnut was sentenced to 63 months in prison for his role in a $3.4 million Medicare fraud scheme that involved billing for occupational therapy services that were not medically necessary and not provided.

Simon Hong, 55, of Brea, was sentenced by U.S. District Judge George H. Wu, who also ordered to pay $2,407,857 in restitution. Hong pleaded guilty on December 15 to one count of conspiracy to commit health care fraud.

“This defendant has now been convicted and sentenced to federal prison in two separate schemes that cost taxpayers millions of dollars,” said United States Attorney Decker. “This type of fraudulent conduct is a burden on the entire health care system, drives up costs for patients and compromises the delivery of services to people who legitimately need care.”

In addition to today’s sentence, Hong was sentenced in January to over 10 years in prison in a separate case. The 63-month sentence imposed by Judge Wu will run concurrently to the sentence imposed by Judge Carter.

As part of the guilty plea that led to the current sentencing, Hong admitted that he owned JH Physical Therapy Inc., an occupational therapy clinic in Walnut, but hid his ownership in the name of a straw or nominee owner in an effort to execute and conceal the fraudulent scheme. Hong admitted that as part of the scheme, he billed Medicare for occupational therapy services when no such services were provided to the Medicare beneficiaries. Instead, the Medicare beneficiaries received acupuncture and massage services, which were not reimbursable by Medicare. Hong further admitted that he directed co-conspirator therapists to falsify medical records to make it appear as if the services billed had been actually provided and funneled 87 percent of the proceeds from Medicare to himself.

Through this scheme, Hong admitted that he and his co-conspirators billed Medicare approximately $3,454,485 from October 2009 until December 2012 in false claims and received approximately $2,407,857.

Hong was charged by indictment on June 16, 2016, along with Grace Hong, 51, of Brea, and Keith Canlapan, 38, of West Covina. Canlapan pleaded guilty to one count of conspiring to commit health care fraud, and Grace Hong is scheduled for trial March 21.

HHS-OIG investigated the case. The Criminal Division’s Fraud Section Trial Attorney Niall M. O’Donnell and Former Fraud Section Trial Attorney Blanca Quintero prosecuted the case.