FDA can be sued in Prescription Opioid Epidemic — and should be!


The FDA’s approval of dangerous prescription opioids over the years can best be described as “fire, aim, ready” as the epidemic continues to rage out of control.

Marianne Skolek-Perez Global News Centre

(MYRTLE BEACH)  Attached is a Memorandum of Law in Support of Plaintiff (Pharmaceutical Manufacturing Research Services Inc’s (PMRS) Motion for Summary Judgment filed against the United States Food and Drug administration (FDA) and the United States Department of Health and Human Services (HHS).  I encourage every Attorney General and law firm in the country suing Purdue Pharma, maker of OxyContin to read this filing carefully and apply it to current and future lawsuits.

It has long been thought that the FDA and HHS were “untouchable” in the prescription opioid epidemic destroying lives in the tens of thousands.  I have long written and spoken that this epidemic’s roots were at “the top”.  PMRS has dispelled the myth that these federal agencies in place to protect the American people could use the approval process of dangerous opioids with the mentality of “fire, aim, ready.”

Here are some highlights of the attached filing against the FDA and HHS in italics:

In the past two years, it has come to light that FDA has been approving opioid drug products for treatment of chronic pain despite a lack of substantial evidence, as is required by 21 U.S.C. 355(b) to support the efficacy of those products in a chronic use setting.

In the past years, it has come to light that FDA’s current methodology for approval of so-called abuse deterrent labeling for opioids does not satisfy the requisite statutory standards, is scientifically flawed, and results in false and misleading labeling.  Such labeling gives a false sense of security as to any meaningful solution to the raging opioid epidemic.

Rather than addressing improper approval processes for opioids with labeling for treatment of chronic pain, FDA pursued abuse deterrent formulation and labeling, an approach that has done nothing but fuel the opioid crisis.

FDA defines chronic pain as “either pain persisting for longer than 1 month beyond resolution of the underlying insult, or pain persisting beyond 3 months (i.e., 12 weeks).”  See FDA00448-482.  After conducting a comprehensive review of the scientific evidence supporting the purported effectiveness of long-term opioid therapy for chronic pain in 2016, the Centers for Disease Control and Prevention (“CDC”) found that:

Most placebo-controlled, randomized trials of opioids have lasted 6 weeks or less, and we are aware of no study that has compared opioid therapy with other treatments in terms of long-term (more than 1 year) outcomes related to pain, function, or quality of life.  The few randomized trials to evaluate opioid efficacy for longer than 6 weeks had consistently poor results.

CDC reported that “the clinical evidence review found insufficient evidence to determine long-term benefits of opioid therapy for chronic pain and found an increased risk for serious harms related to long-term opioid therapy that appears to be dose-dependent.”  FDA00558.  As such, the CDC concluded that, “the science of opioids for chronic pain is clear: for the vast majority of patients, the known, serious, and too-often fatal risks far outweigh the unproven and transient benefits.”  (Exhibit F at 3 in filing attached).

Indeed, as FDA previously conceded, FDA “is not aware of adequate and well-controlled studies of opioid use longer than 12 weeks.”  (Exhibit G, at 10 in filing attached).

Indeed, at the time of PERCODAN’s approval in 1950, medical teaching advised that prescription opioids “should be avoided when treating chronic pain.”  Exhibit N, at 417 in the attached filing.  The medical community concern about the long-term use of opioids to treat chronic pain was based on two facts.  (1)  “fear that chronic use would be associated with an unacceptably high risk of addiction” and (2)  “a belief that neuropathic pain (which accounts for much chronic intractable pain) is not responsive to opioids.”  Id.

Despite the continued lack of scientific evidence to support the use of opioid products for treatment of chronic pain, on July 18, 2001, FDA changed the labeling for OxyContin and other opioids.

Specifically, FDA supported labeling updates that changed the indication of OxyContin for treatment of acute pain to chronic pain.  In support of their determination, FDA merely stated that the basis for this change was “to reinforce the appropriate patient population for whom this product is intended.”

More recently, in March 2016, the CDC conducted a comprehensive review of the scientific evidence supporting the effectiveness of long-term opioid therapy for chronic pain, and concluded that “the few randomized trials to evaluate opioid efficacy for longer than 6-weeks had consistently poor results.”

Private law firms may not want to “take on the FDA and HHS” citing not having the resources to hold these agencies accountable in the prescription opioid epidemic.  It is a different scenario with every Attorney General in the country who has an obligation to go to the root of the prescription opioid epidemic — the top and stop the loss of human life in the tens of thousands.

It’s time for “ready, aim, fire” to sweep the FDA and HHS clean and save lives — not enable the pharmaceutical industry to earns billions of dollars while we continue to lose a future generation compliments of agencies in place to protect the American people.


Marianne Skolek Perez, Consultant
Prescription Opioid Epidemic

skolek-new-photo-700Global News Centre’s Marianne Skolek, is an Investigative Reporter who focuses on the Prescription Opioid/Heroin Epidemic in the U.S. and Canada. In particular, Marianne has covered the criminal marketing of OxyContin going back to 1999 and continuing to the present.

In 2002, Marianne lost her daughter, Jill to prescribed OxyContin which her physician referred to as “mobility in a bottle.” It was, in fact, death in a bottle. After doing extensive research on the maker of OxyContin, Purdue Pharma, Marianne began working with the Department of Justice in Virginia in their criminal investigation into Purdue Pharma and in July 2007 was asked by the U.S. Attorney John Brownlee prosecuting the case to testify against the three CEO’s of Purdue Pharma, Michael Friedman, Paul Goldenheim, MD and Howard Udell, Chief Counsel. The CEO’s pleaded guilty to misleading the medical profession about the dangers of OxyContin. Marianne also testified against Purdue Pharma at a Judiciary Hearing of the U.S. Senate in July 2007.

In addition, a dangerous and highly addictive opioid named Zohydro has been approved by the FDA against their Advisory Committee’s advice and Marianne continues to alert Attorneys General, Senators and Congressmen as to the FDA’s irresponsibility in the out of control prescription opioid/heroin epidemic killing and addicting in the tens of thousands each year. Zohydro has been referred to as “heroin in a capsule” and its lowest dosage (10mg) contains twice as much hydrocodone as found in a Vicodin pill. The highest single dose of Zohydro contains as much hydrocodone as 5 to 10 tablets of Vicodin or Lortab. Zohydro mixed with alcohol can be fatal and has no abuse deterrent built in which will make it easy to crush and deliver a fatal dose of the opioid.

Currently Marianne has been instrumental in calling for the termination of Margaret Hamburg, MD, Commissioner of the FDA as well as Bob A. Rappaport, MD and Douglas Throckmorton, MD for their lack of commitment to safeguarding the American public against the prescription opioid/heroin epidemic. Marianne’s research, writing and contact with government agencies and attorneys has also exposed the heavily funded pain foundations set up by the pharmaceutical industry and their paid physician spokespersons who convinced the medical boards in 50 states and Canada that dangerous opioids such as OxyContin were less likely to be addictive. These physicians — in particular Scott Fishman, MD, J. David Haddox, DDS, MD, Perry Fine, MD, Lynn R. Webster, MD, Russell Portenoy, MD also downplayed the risks of addictive opioids in books as authors. These books are still available for sale and promoted to the medical profession.

Here are links to Marianne’s involvement in exposing the national conspiracy of the prescription opioid/heroin epidemic, the FDA, the pharmaceutical industry, their pain foundations and paid physician spokespersons.




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