Thursday, November 24, 2016

Happy Thanksgiving from the Law Office of O'Toole & Sbarbaro, P.C.



Contact Neil O'Toole and John Sbarbaro
Phone: 303-595-4777
Located in the Denver Metro area.
226 West 12th Avenue Denver, Colorado 80204

Disclaimer 


Any content of this blog is intended for informational purposes only.It is not intended to solicit business, provide legal advice from The Law Office of O'Toole & Sbarbaro, P.C. and does not serve as a medium for an attorney-client relationship. Therefore, The Law Office of O'Toole & Sbarbaro, P.C. is not responsible for the information on this blog which may not apply to every reader. Always seek professional counsel if you have any legal matters. Contents within the blog of The Law Office of O'Toole & Sbarbaro, P.C., logos and other related media are protected by the copyright laws of the United States and other jurisdictions.


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Sunday, November 13, 2016

Falt tire workers' comp

Diaz v. National Retail Transportation, Inc., No. A-3927-14T2 (N.J. Super. Ct. App. Div. 11/09/16, unpublished)

Ruling: In an unpublished decision, the New Jersey Superior Court, Appellate Division held that a mechanic was entitled to benefits for his injury.

What it means: In New Jersey, when a worker’s intoxication is the “natural or proximate cause” of an injury, benefits will not be provided. Courts have interpreted the intoxication defense to mean that the worker’s intoxication must be the sole cause of the accident.

Summary: A mechanic for National Retail Transportation was injured when he attempted to move a heavy metal lift that fell over on him. He said that the lift fell when it tilted to one side. The mechanic said that after the lift fell on him, he noticed that one of the tires on the lift was flat.

National conceded that a tire was deflated. The mechanic filed a claim for workers’ compensation benefits. National denied benefits and asserted the intoxication defense, arguing that the mechanic’s intoxication was the proximate cause of the accident.

The mechanic admitted that before going to work, he drank at least two eight-ounce glasses consisting of half whiskey and half ice water. National’s toxicologist opined that, based on the blood sample drawn from the mechanic after the accident, that he was intoxicated and impaired at the time of the accident.

The New Jersey Superior Court, Appellate Division held that the mechanic was entitled to benefits.

The court concluded that substantial credible evidence established that the flat tire may have caused the lift to fall, and therefore, intoxication was not established to be the sole cause of the accident.

The court found there was sufficient evidence that the flat tire may have also contributed to the accident. Without testimony eliminating the flat tire as a cause of the accident, the court found that National did not carry its burden to prove that the mechanic’s intoxication was the sole cause of the accident.

Original Source

Contact Neil O'Toole and John Sbarbaro
Phone: 303-595-4777
Located in the Denver Metro area.
226 West 12th Avenue Denver, Colorado 80204

Disclaimer 

Any content of this blog is intended for informational purposes only.It is not intended to solicit business, provide legal advice from The Law Office of O'Toole & Sbarbaro, P.C. and does not serve as a medium for an attorney-client relationship. Therefore, The Law Office of O'Toole & Sbarbaro, P.C. is not responsible for the information on this blog which may not apply to every reader. Always seek professional counsel if you have any legal matters. Contents within the blog of The Law Office of O'Toole & Sbarbaro, P.C., logos and other related media are protected by the copyright laws of the United States and other jurisdictions.


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Friday, November 11, 2016

Thank you Veterans, from the Law Office of O'Toole & Sbarbaro, P.C.


Contact Neil O'Toole and John Sbarbaro
Phone: 303-595-4777
Located in the Denver Metro area.
226 West 12th Avenue Denver, Colorado 80204

Disclaimer 


Any content of this blog is intended for informational purposes only.It is not intended to solicit business, provide legal advice from The Law Office of O'Toole & Sbarbaro, P.C. and does not serve as a medium for an attorney-client relationship. Therefore, The Law Office of O'Toole & Sbarbaro, P.C. is not responsible for the information on this blog which may not apply to every reader. Always seek professional counsel if you have any legal matters. Contents within the blog of The Law Office of O'Toole & Sbarbaro, P.C., logos and other related media are protected by the copyright laws of the United States and other jurisdictions.


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Tuesday, November 1, 2016

Lyme Disease Qualifies as Disability

    In Cook v. Gregory Press, Inc., 2016 N.J. Super. Unpub. LEXIS 1885 (App. Div. August 11, 2016), the Appellate Division reversed a trial court’s dismissal of a plaintiff’s disability discrimination case involving an employee eventually diagnosed with Lyme disease.  The case involved Matthew Cook, who worked as a printing machine operator since 2002.  In 2011, he began experiencing facial numbness, tingling in the hands, and neck pain.  He saw a neurologist who thought he might have a demyelinating disease, recommending an MRI of the brain and spine.
Before Cook went for the MRI, his home was damaged by Hurricane Irene, and he was out of work for almost a week making repairs. He was given a day off from work on September 9, 2011 to undergo the MRI, which showed myelitis.  His doctor recommended next a spinal tap to determine whether he might have MS, Lyme disease, or a virus. His boss granted him time off to get the spinal tap but suggested that Cook really had nothing wrong with him.  The boss said he thought his problem was stress from the flood.  Cook responded that this would not explain a lesion on his spine.
The spinal tap occurred on September 16, 2011, and Cook experienced complications from the spinal tap, including dizziness and headaches.  He stayed in bed all weekend but went to work on September 19, 2011.  He found that his head was pounding as the day went on and he had to leave to go home.  His doctor prescribed fioricet.  He could not work the next day due to severe headaches and nausea.  His doctor prescribed Prednisone to relieve inflammation, but that made him jittery.  His doctor next faxed a note to Cook’s supervisor saying that Cook needed to be out until released later in the week.  Cook called his boss to ask for more time off, but his boss said that Cook better get back to work by Wednesday, September 21, 2011.
Cook did not feel well enough to return to work on September 21st but he did return anyway because he felt he had to.  His head was pounding, and the loud noise from machines was aggravating his pain.  He made a production mistake which delayed a printing job and wasted paper.  His boss then proceeded to yell at him for the production mistake.  Cook told his boss to stop yelling at him and then took off his headphones and threw them in a garbage can, walking away.  His boss continued to yell at him, whereupon Cook told his boss that he would pay for the wasted paper but admonished his boss to stop yelling.  The two men stared at each other, and then Cook walked away, telling his boss that all the yelling was aggravating his headache pain.  Shortly thereafter, Cook was fired.
At some later point in time, Cook was diagnosed with Lyme disease and began intravenous therapy for 27 days.  His doctor noted that the combination of Lyme disease and the effects of the spinal tap would naturally have an effect on Cook’s ability to handle stress.  Cook sued under the New Jersey Law Against Discrimination (NJLAD) for wrongful termination and failure to make reasonable accommodation.
The trial judge threw out Cook’s case, finding that Cook was terminated for his bad attitude, not because of any disability.  The judge also found that it not the responsibility of the company to initiate the interactive process where all the plaintiff says is that he has a headache.
The Appellate Division reversed for the following reasons.  It said that the definition of disability under the NJLAD is much broader than the ADA.  Under the NJLAD the plaintiff only has to show a physical or psychological condition which prevents the normal exercise of any bodily or mental function.  One need not show a substantial limitation of a major life activity as is required under the ADA.
Under the court’s analysis, Lyme disease is a serious condition which qualifies as a disability under the NJLAD.  It said that Cook’s doctor established that his patient had physical symptoms of Lyme disease while employed by Gregory Press.  Because of his condition, Cook had to undergo medical testing that caused severe headaches and required steroid treatment, both of which affected Cook’s ability to work.  The court also found that a jury could infer that the employer was aware of this disability, that Cook requested a reasonable accommodation in the form of leave, and that he could have been reasonably accommodated.  The court said:
Plaintiff requested and was granted time off for the MRI and spinal tap.  Plaintiff told Jeffrey (supervisor) about the spinal tap, and Gregory (another supervisor) approached plaintiff prior to the procedure and, despite knowing of the lesion on plaintiff’s spine, expressed his doubt there was anything wrong with plaintiff.  Plaintiff returned to work on Monday with a severe headache, told Jeffrey about it, and Jeffrey permitted him to leave early.  The next day, defendants received Dr. Monck’s note advising plaintiff was under her care and had an exacerbation in his neurologic condition, side effects of the spinal tap, and could not return to work until later  that week ‘based on his recovery.’ Plaintiff advised Jeffrey that he was on steroids, the headaches could last a week and asked for the rest of the week off.  Jeffrey ordered plaintiff back to work without further investigation or inquiry.  Believing he had no choice, plaintiff returned to work the rest of the week, still suffering a headache and the effects of the steroids, which attributed to the production mistake.  We conclude a jury could reasonably infer from this evidence that defendants knew of plaintiff’s disability, plaintiff requested a reasonable accommodation, plaintiff could have been reasonably accommodated, and defendants failed to make a good faith effort to provide a reasonable accommodation.
In New Jersey, it is rather easy for a plaintiff to prove a disability, so employers must take requests for time off work seriously when there are medical issues involved. The case is a primer for how an employer should not make termination decisions in a situation where an employee is having serious pain and symptoms from a cause as yet unknown.  That the employer did not know plaintiff had Lyme disease at the time of firing was not a defense.  The employer knew enough to realize that Cook may have a disability.  The employer made a number of major mistakes in this case, first in pressuring the plaintiff to return to work before his doctor approved it, and second in engaging in a verbal confrontation while Cook was complaining that the yelling was aggravating the condition that he was treating for.  It is also worth noting that the employer should not have speculated on the “real” problem that plaintiff was having, in suggesting his problems were related solely to stress. Lastly, the employer should have tried to engage in the interactive process before making the precipitous decision to fire Cook.

Original Source

Contact Neil O'Toole and John Sbarbaro
Phone: 303-595-4777
Located in the Denver Metro area.
226 West 12th Avenue Denver, Colorado 80204

Disclaimer 


Any content of this blog is intended for informational purposes only.It is not intended to solicit business, provide legal advice from The Law Office of O'Toole & Sbarbaro, P.C. and does not serve as a medium for an attorney-client relationship. Therefore, The Law Office of O'Toole & Sbarbaro, P.C. is not responsible for the information on this blog which may not apply to every reader. Always seek professional counsel if you have any legal matters. Contents within the blog of The Law Office of O'Toole & Sbarbaro, P.C., logos and other related media are protected by the copyright laws of the United States and other jurisdictions.


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Friday, October 28, 2016

Presidential Election and Medicare

With the Presidential Elections on November 8th nearing around the corner, the industry has been wondering how the election of either Hillary Clinton or Donald Trump as President of the United States would affect Medicare Secondary Payer (MSP) Act compliance. *Note that this blogwire article is not intended to be an endorsement for either political candidate, political party, platform, or affiliation.
If Donald Trump is elected: Donald Trump’s website does not directly address his position on Medicare. However, according to a Forbes.com article, “The GOP platform advocates a “premium support model” for Medicare that would “guarantee to every enrollee an income-adjusted contribution toward a plan of their choice, with catastrophic protection.” In other words, privatization. Republicans would “save Medicare by modernizing it,” the platform says.”
                Potential Impact: Currently 31% of Medicare beneficiaries are enrolled in a private Medicare Advantage Plan (MAP). That percentage is expected to increase, and if Trump is elected, we may see that number rise more rapidly. The effect on MSP would be that we would see a rise in conditional payments being made by MAPs, versus traditional Medicare.
Over the past several years, we have seen increased case law finding that Medicare Advantage plans have the same rights as Medicare to recovery, thereby allowing the Medicare Advantage Plan to assert double damages. As Medicare Advantage Plans have become even more aggressive with lawsuits for double damages than traditional Medicare has, we could expect that to continue. Primary payers would be wise to enact a proactive solution to ensure that Medicare Advantage Plan conditional payments are addressed, particularly in those Circuits where the Courts have found in favor of MAPs having these rights.
                To learn more about MAPs and recommendations to address reimbursement of these payments, please join Franco Signor for a webinar wherein we will feature a special guest to discuss these Best Practices on November 18th, at 1:30 PM. Registration for the webinar can be found here.
If Hillary Clinton is elected: According to Hillary Clinton’s website, Hillary Clinton proposes to allow people 55 and older to buy into Medicare. She is calling this “Medicare for More.” Additionally, Clinton rejects the idea of gradually converting Medicare into a privatized system.
                Potential Impact: Currently, the age to enroll into Medicare is 65. If people aged 55 and up could now buy into Medicare, there ideally will be more MSP claims to address as the Medicare population would expand to a younger age group.
Summary: While neither candidate can single-handedly make these changes and would need the support of Congress, with either candidate we are likely to see an increase in claims that would require MSP compliance. Whether we continue to see Medicare beneficiaries move to private Medicare Advantage Plans which continue to press for their rights to double damages reimbursement, or the Medicare pool expands to individuals 55 and up, MSP compliance will be more important than ever.
Additionally, CMS has indicated that an award for the Workers’ Compensation Review Contractor (WCRC) will take place in the second quarter of next year. With the new WCRC, we may also have thresholds for Liability Medicare Set-Aside (LMSA) review. 2017 will be an interesting year, and having a strategic partner that is ready to provide a holistic claims strategy to your MSP compliance program will be vital.
Contact Neil O'Toole and John Sbarbaro
Phone: 303-595-4777
Located in the Denver Metro area.
226 West 12th Avenue Denver, Colorado 80204

Disclaimer 


Any content of this blog is intended for informational purposes only.It is not intended to solicit business, provide legal advice from The Law Office of O'Toole & Sbarbaro, P.C. and does not serve as a medium for an attorney-client relationship. Therefore, The Law Office of O'Toole & Sbarbaro, P.C. is not responsible for the information on this blog which may not apply to every reader. Always seek professional counsel if you have any legal matters. Contents within the blog of The Law Office of O'Toole & Sbarbaro, P.C., logos and other related media are protected by the copyright laws of the United States and other jurisdictions.


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Wednesday, October 19, 2016

Rate drop of Recordable Workplace Injuries

Asst Sec of Labor Encouraged by BLS Report on Occ Injuries & Illnesses in 2015

Washington, DC – Occupational injury and illness data recently released by the Bureau of Labor Statistics showed a significant drop in the rate of recordable workplace injuries and illnesses in 2015, continuing a pattern of decline that, apart from 2012, has occurred annually for the last 13 years.
Private industry employers reported about 2.9 million nonfatal workplace injuries and illnesses in 2015, representing a decline of about 48,000 from 2014, despite an increase in total hours worked. The rate of cases recorded was 3.0 cases per 100 full-time workers – down from 3.2 in 2014. The rate is the lowest recorded since at least 2002, when OSHA recordkeeping requirements were modified.
Assistant Secretary of Labor for Occupational Safety and Health issued the following statement:
“We are encouraged to see the significant decline in worker injury and illness rates. This is the result of the relentless efforts of employers, unions, worker advocates, occupational safety and health professionals, and federal and state government agencies ensuring that worker safety and health remains a top priority every day.”
“Despite the decline, approximately 2.9 million private sector workers suffered nonfatal injuries and illnesses last year. That is still far too many. At OSHA, we will continue to do all that we can to continue driving the rate down.”
Click here to view: BLS Report on Occupational Injuries and Illnesses in 2015 (PDF)
Source: OSHA

Original Source


Contact 
Neil O'Toole and John Sbarbaro
Phone: 303-595-4777
Located in the Denver Metro area.
226 West 12th Avenue Denver, Colorado 80204

Disclaimer 

Any content of this blog is intended for informational purposes only.It is not intended to solicit business, provide legal advice from The Law Office of O'Toole & Sbarbaro, P.C. and does not serve as a medium for an attorney-client relationship. Therefore, The Law Office of O'Toole & Sbarbaro, P.C. is not responsible for the information on this blog which may not apply to every reader. Always seek professional counsel if you have any legal matters. Contents within the blog of The Law Office of O'Toole & Sbarbaro, P.C., logos and other related media are protected by the copyright laws of the United States and other jurisdictions.


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Friday, September 16, 2016

Amendment 69 and Workers' Compensation

Passage of Amendment 69 Could be Bad News for Colorado Workers’ Compensation
by Kaplan Morrell
Colorado has long been a sort of “proving ground” for new and tentative legislation. Some reasons for this is our status as a swing state and the ease of getting initiatives on our voting ballots in the first place. National groups frequently test proposals in our state, and often the proposed legislation is quite extraordinary. Take legalized recreational marijuana in 2012, for instance. This election year will be no different, and there will be several controversial initiatives on the ballot for voters to decide upon, such as “right to die” and raising the minimum wage to $12. One such ballot initiatives that is of particular interest for Colorado’s workers’ compensation system is universal health care.

Amendment 69 – ColoradoCare Ballot Initiative

This proposed amendment is an attempt to introduce a single payer system, also called universal health care, to Colorado. The proposed program, named ColoradoCare, would replace the Affordable Care Act. Estimates place the yearly price tag for ColoradoCare at around $25 billion dollars. A business and worker tax, along with an increased state tax rate, is meant to pay for the program. This tax option does away with deductibles and medical insurance premiums. However, this tax increase would practically double the current state budget, and saddles Coloradans with the highest income tax rate in the nation.

Accountability is questionable. This program is to be run by a board of 21 members who will be elected by plan members. Furthermore, there are no real specifics about what the new plan will cover, just what programs it will replace. The board will retain sole authority on coverage decisions. Hospital and doctor reimbursement levels are uncertain, calling into question continued quality care under the new system.

Potential Impact on our Workers’ Compensation (WC) Program

ColoradoCare will collect funding and administer the Colorado Workers’ Compensation program, as well as all other state and federal programs, with the exception of Medicare. This has the very real potential of destabilizing a well-functioning system. Our Workers’ Compensation program in Colorado is widely viewed as one of the best in the nation, as it efficiently balances affordable premiums for employers and the provision of fair benefits for injured employees. Denver Workers’ Compensation attorneys are a big part of this system.

– Overhaul of how the Colorado Workers’ Compensation program works

Currently, the system both replaces lost wages and provides medical care for injured workers. The proposed single-payer system will remove the healthcare portion of this system from the program and move it under ColoradoCare. It’s not known how the new set-up will work with only wage replacement under WC, but confusion and disarray are far too likely. There is also the question of cost. Employers currently pay for Workers’ Compensation insurance to cover all of the benefits for injured employees. They will now pay a higher tax rate for ColoradoCare and still be on the hook for the indemnity portion of Workers’ Compensation. It’s a quagmire.

– Unsettles a working system

Workers’ Compensation in Colorado does more than pay out benefits. It promotes worker-safety programs and encourages employers to prevent workplace injuries. Providers and established Workers’ Compensation health professionals are experienced in managing worker injuries. They collaborate with employers and workers to help them get to maximum medical improvement and get back to their jobs safely, whenever possible.

– Eliminates subrogation

Workers Compensation is a no-fault system. But sometimes, there is fault, due to a non-employer third-party. In these cases, Workers’ Compensation insurers can pursue monetary recovery from the negligent party through subrogation. With the passage of Amendment 69, first rights to subrogation cedes to ColoradoCares. This loss of funds impacts the insurers and injured workers ability to recover for injuries.

– More Unknowns

At this time, it is not even known whether ColoradoCare will cover the incidental expenses that Workers’ Compensation in Colorado addresses, such as transportation to medical appointments. And there is no guarantee that injured workers will continue to be able to see qualified professionals in occupational medicine and other specialties that are required to give injured employees the best possible specialized care in a timely manner. Overall, there are simply too many variables and unknowns to enthusiastically support Amendment 69 for implementation of ColoradoCare in our state this November. For individuals who are injured at work, the best thing they can do is seek a qualified attorney. Our top rated Denver workers’ compensation attorneys can help injured workers file their claim, get the medical care they need, and help them seek lost wages to help cover living expenses and medical bills.

Original Source

Contact Neil O'Toole and John Sbarbaro
Phone: 303-595-4777
Located in the Denver Metro area.
226 West 12th Avenue Denver, Colorado 80204

Disclaimer 

Any content of this blog is intended for informational purposes only.It is not intended to solicit business, provide legal advice from The Law Office of O'Toole & Sbarbaro, P.C. and does not serve as a medium for an attorney-client relationship. Therefore, The Law Office of O'Toole & Sbarbaro, P.C. is not responsible for the information on this blog which may not apply to every reader. Always seek professional counsel if you have any legal matters. Contents within the blog of The Law Office of O'Toole & Sbarbaro, P.C., logos and other related media are protected by the copyright laws of the United States and other jurisdictions.


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Tuesday, September 6, 2016

Companies Can't Set Own Rules For Injured Workers

A national campaign to rewrite state laws and allow businesses to decide how to care for their injured workers suffered a significant setback Tuesday when the Oklahoma Supreme Court ruled that Oklahoma's version of the law is unconstitutional.

The 2013 legislation gave Oklahoma employers the ability to "opt out" of the state workers' compensation system and write their own plans, setting the terms for what injuries were covered, which doctors workers could see, how workers were compensated and how disputes were handled. The statute was backed by the oil and gas industry and retailer Hobby Lobby.

Buoyed by the success in Oklahoma, proponents took the idea nationwide as a coalition led by Wal-Mart, Lowe's and several of the largest retail, trucking and health care companies sought to pass similar laws across the country. Bills and draft proposals have been floated in Tennessee, South Carolina, Georgia, Mississippi, West Virginia, Wisconsin and Illinois.

Last year, an investigation by ProPublica and NPR found that the plans typically had lower benefits and more restrictions than workers' comp. The story was part of a series on how states have been dismantling workers' comp, which was designed a century ago to protect businesses from lawsuits while providing medical care and lost wages to workers who had been hurt on the job.

Tuesday's decision is the latest in a series of state Supreme Court rulings that have struck down several business-driven workers' comp laws featured in the ProPublica and NPR investigation.

The Florida Supreme Court struck down laws that placed strict caps on attorney fees and limited workers to two years of temporary disability pay regardless of whether they were able to return to work. Two-year caps have also been passed in California, North Dakota, Oklahoma, West Virginia and Texas.

In addition, the top Oklahoma court in April overturned a provision that drastically cut compensation for workers who suffered permanently disabling injuries. Florida, New York and Tennessee have also significantly reduced benefits for such injuries in the past 13 years, but those provisions are still in place.

The stories also prompted two groups — one of academics and one of workers' comp regulators — to schedule separate forums later this month to discuss the various changes that have occurred and ways to improve workers' comp.

Oklahoma's ruling leaves Texas as the only state that lets employers opt out of workers' comp insurance.

Bob Burke, a longtime workers' comp attorney who has filed several successful challenges to Oklahoma's new law, called opt out "the biggest attack on the American worker" since he started practicing law.

Had the Supreme Court not acted, the Oklahoma opt-out law "would have deprived injured workers out of necessary surgeries and weekly benefits," he said in an email. "Opt out also would have allowed companies to shift the cost of paying for work-related injuries to Medicare, Medicaid and Social Security."

Bill Minick, a Dallas lawyer whose company PartnerSource wrote most of the Oklahoma opt-out plans and about half of those in Texas, said in a statement that the ruling was specific to "Oklahoma's unique constitution." He vowed that his company and other supporters would continue their efforts to promote the alternative plans in other states.

"We believe it's critical to provide better care and benefits for injured workers, decrease the number of disputed claims and significantly decrease insurance premiums and claim costs for all employers," he said.

The Oklahoma case involved an employee at Dillard's department store who injured her neck and shoulder while lifting shoe boxes in 2014. Dillard's, which had opted out of workers' comp and created its own benefit plan, initially paid for her medical care. But the company later denied her claims, insisting that any further damage and surgeries she might need were due to a pre-existing degenerative condition and not her injury at work.

In a 7-2 ruling, the justices found that such opt-out plans were unconstitutional because they treated one group of injured workers differently from all other injured workers in the state. In a concurring opinion, Justices Noma Gurich and Tom Colbert noted that while most Oklahoma workers have 30 days to report an injury and can request a hearing before a judge, Dillard's employees had to report injuries by the end of the workday and could only appeal in writing to a committee made up of people picked by the company.

The court sent the case back to the state's workers' comp commission to determine whether the injury was work-related and what benefits, if any, the woman should receive.

Original Source

Contact Neil O'Toole and John Sbarbaro
Phone: 303-595-4777
Located in the Denver Metro area.
226 West 12th Avenue Denver, Colorado 80204

Disclaimer 


Any content of this blog is intended for informational purposes only.It is not intended to solicit business, provide legal advice from The Law Office of O'Toole & Sbarbaro, P.C. and does not serve as a medium for an attorney-client relationship. Therefore, The Law Office of O'Toole & Sbarbaro, P.C. is not responsible for the information on this blog which may not apply to every reader. Always seek professional counsel if you have any legal matters. Contents within the blog of The Law Office of O'Toole & Sbarbaro, P.C., logos and other related media are protected by the copyright laws of the United States and other jurisdictions.


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Wednesday, August 17, 2016

More drugs.

According to the Philadelphia's "The Inquirer", Medical advisers to the FDA have recommended approval of a new abuse-deterrent formulation (ADF) opioid named Arymo ER by Egalet Corp. In fact, the vote was overwhelming; 18-1. This new painkiller is an extended-release morphine that comes in 15mg, 30mg and 60mg doses. A final decision by the FDA on that recommendation is expected by mid-October.
When compared to MS-Contin, a pharmacologist with the FDA reportedly said ...
The numerical difference or outcome in the data was less than 5 percent, raising a question about Arymo's "clinical relevance"
I applaud the concept of abuse-deterrence formulations of opioids and other dangerous drugs that can be abused. I appreciate the fact there truly are some people that need opioids for "before/during/immediately after surgery, cancer, AIDS/HIV, end-of-life care" (my broadbrush interpretation of appropriate use of opioids). I agree abuse (non-medical use) is rampant with opioids (and other dangerous drugs). I am an "all of the above" (all options on the table) kind of person when it comes to resolving our painkiller epidemic, and I do think ADF has a part to play.
But to me the bigger problem is ... legitimate prescriptions by legitimate prescribers used legitimately by patients that are clinically inappropriate. Especially for the mostly inappropriate treatment of chronic pain.
So is the introduction of a new drug just propping up bad practice? Is Big Pharma using ADF to maintain their revenues (will Arymo be a money-maker)? Will we see abuse of non-ADF drugs decline? Will we see prescriptions change from non-ADF to their ADF equivalents? Will we see generics (the majority of drugs prescribed & dispensed) also become ADF? As usual, I have more questions than answers.

Original Source

Contact Neil O'Toole and John Sbarbaro
Phone: 303-595-4777
Located in the Denver Metro area.
226 West 12th Avenue Denver, Colorado 80204

Disclaimer 

Any content of this blog is intended for informational purposes only.It is not intended to solicit business, provide legal advice from The Law Office of O'Toole & Sbarbaro, P.C. and does not serve as a medium for an attorney-client relationship. Therefore, The Law Office of O'Toole & Sbarbaro, P.C. is not responsible for the information on this blog which may not apply to every reader. Always seek professional counsel if you have any legal matters. Contents within the blog of The Law Office of O'Toole & Sbarbaro, P.C., logos and other related media are protected by the copyright laws of the United States and other jurisdictions.


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