September 26th is National Prescription Drug Take-Back Day. Be Careful With Your Excess Prescription Medications.

Today, September 26th, is National Prescription Drug Take-Back Day. 

It’s a day where you can safely, conveniently, and responsibly dispose of expired and unwanted prescription drugs at collection sites in your community. 

This way no one else takes your medications in a way not intended. It used to be that we had to lock up our liquor cabinets, but now we need to lock up our medicine chests and make sure that no one has access to controlled substances. Young people especially may view these prescription drugs as "safe" and not be aware of the danger when they take them in excess of as prescribed or when they are mixed with other drugs or alcohol.

Whether it is that someone might use them for unintended purposes (such as recreational partying or getting high) or may use them to harm themselves or end their life, we have to be careful. Here’s why this matters: More Americans are dying from drug overdoses by improperly using prescribed medications. 

Here's a link on where you can take the drugs. Enter your zip code. Flushing down the toilet affects our drinking water and it is preferable to have them destroyed.  Throwing them away is not ideal either. This is the safest way to make sure the drugs are destroyed in the proper manner.  Physicians and Pharmacists can encourage their patients to do so as well.

http://www.deadiversion.usdoj.gov/drug_disposal/…/index.html

Posted by Green and Associates, Attorneys at Law.

September 11 - Let Us Never Forget

I am lucky to be a woman lawyer in the United States. But for the flip of a coin, I could have been born somewhere that does not have our democratic system and commitment to equality and justice for all. While I seek to make things better in our country for the justice system and our community (as well as my clients) I never forgot how lucky I am to live in the United States.

I remember the attacks of 9/11 both in 2001 on our country and in 2012 on our embassy in Benghazi. As we remember the evils of September 11th, let us turn our hearts and minds towards the good. Let's mourn all those who perished, were injured and lost loved ones. Let's embrace our nation, and let time never lessen the impact of this day. May we never forget. Protect those who go in harm’s way to save others, and those who suffer and die to safeguard our nation. Give wisdom to our leaders, that they may make choices that prevent another day such as this. Let us banish from the world the darkness that allows such hate to remain.

Lawsuit By Orange County Against Pharma Companies for Fraudulently Marketing Addictive Painkillers Dismissed On Grounds FDA Had Exclusive Jurisdiction

On August 27, 2015, a California state court dismissed a groundbreaking lawuit filed last year by Orange and Santa Clara counties accusing the companies of fraudulently marketing addictive painkillers to undermine the effect of warning labels required by the U.S. Food and Drug Administration. The counties say that the efforts boosted sales of the dangerous drugs at the expense of public health. See Los Angeles Times article on this ruling.

In Thursday's hearing before Orange County Superior Court Judge Robert J. Moss, the companies asked that the case be dismissed on the grounds that the FDA had exclusive jurisdiction over the matter. The court ruled that the FDA had exclusive jurisdiction.

The 105-page lawsuit, filed in Orange County by District Attorney Tony Rackauckas, alleges five pharmaceutical companies spent millions of dollars to convince the public that drugs meant only for short-term use by cancer patients should be taken for chronic pain.  The marketing campaign changed prescription opioids from a niche drug to an $8 billion industry by 2010 and contributed to more than 16,000 overdose deaths that same year, putting profits above health, the suit states.

The rise in highly addictive painkillers also created an atmosphere where doctors made life-and-death decisions based not on science but on hype and marketing by the company to doctors directly, the suit states. Orange County was hit particularly hard by this epidemic. 

Rackauckas stated in prior interviews that the pharmaceutical companies are like the tobacco industry. “What we’re after is to make these companies stop the practice of false advertising and false claims that these drugs are benign,” he said. “The effort is to require them to be truthful.” The Orange County DA also apparently wanted to capitalize on the fact that Purdue and its executives plead guilty in 2007 to illegally marketing OxyContin.

The lawsuit was filed after an extensive series of Orange County Register columns over 3 years blaming much of the epidemic on drug companies. The lawsuit named Purdue Pharma (maker of OxyContin), Teva Pharmaceutical Industries, Janssen Pharmaceuticals – a subsidiary of Johnson & Johnson, Endo Health Solutions, and Actavis, as well as affiliated companies.

One reason why the lawsuit was filed is that Purdue, which makes the best-selling painkiller OxyContin, has never gone to trial on a case of OxyContin abuse. It has won dismissals in more than 400 personal-injury lawsuits related to the drug. And while it has settled some product-liability cases related to OxyContin under secret terms, Purdue has defeated more than 10 efforts to wage class-actions against it. 

All the companies were accused of false advertising, unfair competition and creating a public nuisance. With the state court dismissal, Orange County and Santa Clara will have to determine whether an appeal will be filed.  The marketing was not geared to patients but to family practice doctors who treat non-cancer patients. 

One of the issues is that FDA only has limited jurisdiction over the marketing of prescription medications directly to physicians. That is left to the Federal Trade Commission. When Purdue Pharma introduced OxyContin in 1996, it was aggressively marketed and highly promoted. Sales grew from $48 million in 1996 to almost $1.1 billion in 2000. Ultimately, the high availability of OxyContin correlated with increased abuse, diversion, and addiction, and by 2008 OxyContin had become a leading drug of abuse in the United States. 

OxyContin Maker Continues To Fight With Government And FDA Regarding Its Formulation In Light Of Prior Plea Agreement

Purdue Pharmacy continues to battle the government over its controversial prescription drug OxyContin. Now Purdue wants Medicare, Medi-Cal or Medicaid and other government programs to approve payment even after longstanding lawsuits and concerns about Purdue's actions in the past. Purdue cancelled a meeting with the FDA this past July to go over whether this formulation will deter abuse.

The history here is lengthy. In 2007, in United States of America v. The Purdue Frederick Company, Inc., Purdue and its top executives pleaded guilty to charges that it misled doctors and patients about the addictive properties of OxyContin and misbranded the product as "abuse resistant." Prosecutors found a "corporate culture that allowed this product to be misbranded with the intent to defraud and mislead." Purdue Pharma paid $600 million in fines, among the largest settlements in U.S. history for a pharmaceutical company. 

Three former and current executives of Purdue Pharma, LP, the maker of OxyContin, pled guilty to misdemeanor charges of drug misbranding on May 10, acknowledging that they deceived consumers about the risks associated with the drug. Michael Friedman, the company's president, Howard Udell, Purdue's principal lawyer, and Paul Goldenheim, the company's former chief medical officer, will pay $634.5 million in fines for alleging that OxyContin had a lower incidence of abuse and addiction than the drug's competitors, according to United States Attorney John Brownlee. 

"With its OxyContin, Purdue unleashed a highly abusable, addictive, and potentially dangerous drug on an unsuspecting and unknowing public. For these misrepresentations and crimes, Purdue and its executives have been brought to justice," Brownlee said. 

The plea deal is yet another juncture in the drug's legal history. Two days prior to the agreement, Purdue Pharma, LP, said it would pay $19.5 million to resolve allegations that it persuaded physicians to overprescribe OxyContin in 26 states across the United States, as well as the District of Columbia.

The addictive side effects of OxyContin were discovered by the company in 1995 when physicians in focus groups voiced their concerns over the likelihood of drug dependence. However, even after that information was obtained, the company knowingly provided sales representatives with inaccurate data about the drug's addictive nature in comparison with other painkillers, specifically regarding the high potential the drug has for abuse.  

Ken Jost from the Justice Department's Office of Consumer Litigation said the case would serve as a deterrent to ward off other pharmaceutical companies who may be tempted to provide false information about their drugs in order to increase their profits. And, more importantly, the case will show that if other companies have misled the public, they too will be prosecuted. 

OxyContin's maker acknowledged and assumed responsibility for the wrongdoings of its employees. Purdue Pharma explained in a news release, "During the past six years, we have implemented changes to our internal training, compliance, and monitoring systems that seek to ensure that similar events do not occur again." 

According to the FDA, OxyContin, whose active ingredient is oxycodone, is "a narcotic drug approved for the treatment of moderate to severe pain." When properly used, the drug is intended to be consumed whole and subsequently digested over an eight- to 12-hour time span. However, when used improperly, the drug is known to cause a high that is similar to that of heroin. Illegal use of the drug entails individuals crushing OxyContin pills and then swallowing, snorting, or injecting the drug. 

According to a United States Drug Enforcement Administration report, oxycodone-related deaths increased by 500%, which directly corresponded to a significant increase in prescriptions of the drug. The three Purdue Pharma executives, Friedman, Udell, and Goldenheim, are personally responsible for $34.5 million of the $634.5 million fine, which will be divided among several federal and state law enforcement agencies, as well as the federal government, among other organizations. Additionally, $5 million will be used by Purdue Pharma to ensure conformity with the deal. 

The Pain Medication Conundrum - How Are To Physicians Deal With Subjective Pain Patients?

Stuart Isett for The New York Times

The New York Times has a well done opinion-editorial article entitled "The Pain Medication Conundrum" by Dr. Danielle Ofri about the challenges faced by physicians who are asked to prescribe pain medication. Here are some excerpts from the article:  
"Here it was again: the dreaded pain conundrum. A patient requests a strong pain medication and the doctor has to figure out whether the request is legitimate. This is an aggravating situation on many levels. On the individual level, there are the immediate issues of trust — do I trust Mr. W.’s story, and, conversely, how will my decision affect Mr. W.’s trust in me?"

"Then there is the larger issue of how we doctors treat pain in general. A 2011 report from the Institute of Medicine highlighted how poorly the medical field handles pain. Undertreating pain, we are admonished, violates the basic ethical principles of medicine. On the other hand, we are lambasted for overprescribing pain medications, enabling addicts and creating an epidemic of overdose deaths."

"What are doctors to do? Pain is a subjective symptom. There is no instrument to indicate its severity. All that a doctor has is the patient’s word."

"For patients with chronic pain, especially those with syndromes that don’t fit into neat clinical boxes, being judged by doctors to see if they “merit” medication is humiliating and dispiriting. It’s equally dispiriting for doctors. This type of judgment, with its moral overtones and suspicions, is at odds with the doctor-patient relationship we work to develop."

This is going to be an issue for some years as prescription drug addiction has grown into a national health crisis. Patients with chronic pain who take these medications are not classically "addicts" even though they are reliant on these medications because they are seeking it for pain relief. Then there are addicts. How do physicians tell the difference? Years ago the medical community urged physicians to treat pain. Pain was undertreated. Now physicians are running scared. Physicians need to have new protocols and learn from those who have been too trusting of patients.

Executives and Professionals Are Held to a Higher Standard. What You Can Learn From Female Toyota Executive Who Resigned After Arrest for Mailing Prescription Drugs to Herself in Japan. Don't Let It Happen to You.

Executives and professionals are held to standards that are above and beyond those of the average person. For example, the company you work for or your licensing board may hold you to a standard that is higher than the standard for filing criminal charges in the United States. 

In addition, executives and professionals who travel or work abroad should be careful not to violate the laws in other countries since it could affect their careers and their liberty.  Other countries’ criminal justice systems are much different than ours and a person can spend weeks in jail before being brought to court.  

Toyota’s first-ever female executive officer, 55-year-old Julie Hamp, learned about the double jeopardy that exists when she mailed herself prescription painkillers to Japan where she was working.  She was arrested but not charged and ultimately resigned from her executive position at Toyota. She also learned about the Japanese legal system since she was in custody for over two weeks. In Japan, suspects can be detained for up to 23 days without a formal charge or the possibility of bail.

What happened here?  Ms. Hamp was arrested on June 18 on suspicion of importing an illegal pain medicine into Japan. Still transitioning from California to Japan after starting the move in early June, police claimed that Ms. Hamp illegally mailed herself over 50 tablets of Oxycodone to the Tokyo hotel she was staying at. Oxycodone is a legal prescription painkiller in the U.S. and Japan, but importing it into Japan without advance government permission is illegal and it is illegal to ship it by mail in Japan. The police conceded that Ms. Hamp was using the painkiller for health reasons (knee pain) and was not abusing it.

Japanese prosecutors said Ms. Hamp conspired with her father to import narcotics by hiding 57 tablets of Oxycodone in a package and sending it to Japan from the U.S. in June. The police claimed that the Oxycodone was not declared on the custom labels of the package and only stated that jewelry was inside. They also said that Ms. Hamp was aware that Oxycodone was tightly controlled under Japanese law.

On June 23^rd, media outlets reported that the Japanese police raided the Toyota headquarters, which only raised further questions about the situation. A week later, despite support from Toyota's president that Ms. Hamp had not intentionally broken the law, Ms. Hamp stepped down from her new position. Due to being in police custody for 19 days and unable to contact the company directly, Ms. Hamp used her lawyer to tender her resignation.

Per capita, Japanese use of Oxycodone is 1/60 of American use, according to the Japanese Ministry of Health, Labor and Welfare. Japanese physicians save the pain killer for extreme cases like pain from advanced cancer, meaning it can be seen as an extreme narcotic overseas.

Ultimately, Japanese prosecutors announced  that Ms. Hamp would be released and they would not be charged. Police said Hamp's intent was not malicious and reports have claimed that her father was the one who sent her the pills. If they had decided to indict her, Japanese prosecutors claim they have close to a 99 percent conviction rate in drug cases.

Toyota said it would still accept Ms. Hamp's resignation due to the concerns the situation caused their stakeholders. Overall, improperly transporting prescription drugs into another country cost Ms. Hamp a high-level position at an international company, proving the importance of understanding United States laws as well as other countries' laws before visiting them or working there. We have had clients who had prescriptions in foreign countries for controlled substances and had issues in bringing them into the United States - so it works both ways. 

When Green and Associates' law firm represents someone in an investigation, the attorney and paraprofessional staff have to consider the big picture: their career, their family, any licensing (medical license, etc.), and reputation. In the United States, there are many regulations that criminalize behavior. Many of our cases involve individuals or companies allegedly breaking rules or regulations that were not fully understood or known.

The collateral consequences of even an arrest can damage a career. For example, if a physician, lawyer, accountant, CPA, real estate agent, nurse, or other licensed professional were arrested but not charged – the governing board or bureau can start an investigation and file charges since there is a different burden of proof. “Unprofessional conduct” and “moral turptiduge” are terms that are broadly defined  and do not have to be limited to conduct that occurred on the job.

Protect your career and license that you worked hard to establish. Be careful and seek legal advice when needed to protect yourself. Reliance on the compliance advice of counsel is a defense and protection when the laws and regulations are not clear. We would rather do preventive work first and prevent potential problems. It is also far less expensive to do preventative work. Ms. Hamp learned a hard lesson and we can all learn from her unfortunate experience.

If you have any questions about your specific situation, feel free to contact attorney Tracy Green us at 213-233-2260 or email us at tgreen@greenassoc.com.

Posted by Judson O. Tomaiko, Legal Assistant (Twitter: @JTomaiko)

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