Opioid manufacturers continue to miss an opportunity to defend themselves by not using State PDMP data in opioid trials.

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By  R Carter

In an article released today on NPR, Oklahoma District Judge Thad Balkman has clarified a previous ruling against Johnson & Johnson. He’s now ruling the drug maker must make a onetime payment of $465 million, not the $572 million he had originally ordered.

Balkman’s original fine was a point of confusion for attorneys on both sides over whether the $572 million represented the final amount or just one installment in a larger payment plan.

Balkman stated a math error was the reason for the reduction as he had set aside $107.6 million to support programs treating addiction in babies exposed to opioids in the womb when in reality he meant to set aside roughly $107,600.

The ruling answers one of two questions. Are drug makers liable for the effects of the highly addictive opioid medications they produce? And if so, how much money should they owe to help combat those effects?

The lawsuit brought by the State of Oklahoma is based on a charge of being a public nuisance, for overly aggressive and deceptive marketing practices that helped lead to thousands of overdose deaths.

State AG’s across America have watched closely in this first case to go to trial, as more than 2,500 law suits have now been filed again multiple opioid manufactures. In each of these cases, allegations are opioid manufactures caused the opioid crisis. Yet guilt continues to shift as different groups point a finger at who’s to blame.  At the federal level, the 2,500 lawsuits filed by local and other governments against drug makers, distributors and pharmacies have been folded into one massive federal case now being overseen in the Northern District of Ohio.

As the number of opioid deaths have continued to rise, public health officials have blamed doctors for over prescribing, the DEA arresting and jailing hundreds of doctors accused of prescribing outside the boundaries of legitimate medical care; as well as numerous high profile drug busts for illegal importation of controlled substances. Yet the DOJ’s internal investigation of the DEA showed internal strife, confusion and posturing between agencies which handicapped the agency’s efforts from 2003 – 2015, allowing manufactures, distributors and pharmacies to operate on an honor basis without oversight or investigation into numerous reports of diversion.

State Medical Boards have fined and suspended physicians, Pharmacy Boards have done the same with Pharmacist, and local law enforcement has jailed those dispensing controlled substances which are far in excess of legitimate need.

Under threat from medical boards and law enforcement, primary care providers as well as pain specialist by the thousands have stopped treating painful condition. Those who’ve continued have forced patients either off medication or reduced amounts which leave patients bed ridden and unemployable, decimating a segment of our population innocent of any wrong doing.

States have implemented prescription drug monitoring programs in their efforts to account for each and every pill manufactured, prescribed by doctors and dispensed by pharmacies. Trying to connect the dots to identify and prove widespread claims of over prescribing and diversion. Yet after ten years of doing so, all U.S. States except Massachusetts remain silent on how effective such efforts have been. At a cost of nearly $1 billion annually to each State, the only claims made so far have been on the efforts at reducing the number of pills dispensed. As to whether such efforts have reduced overdose deaths from opioids, States have yet to make their case in this regards.

Despite all these efforts, the number of overdose deaths from opioids continues to set new highs each year, with an estimated 70,000 deaths in 2017, primarily from illegal poly drug use involving heroin, Chinese fentanyl and cocaine.

Johnson & Johnson said it plans to appeal the judgment “because it is neither supported by the facts nor the law.” “We recognize the opioid crisis is a tremendously complex public health issue and have deep sympathy for everyone affected,” the company said. “We do not believe litigation is the answer and are continuing to work with partners to find solutions.” The case will likely head to the Oklahoma State Supreme Court.

Given the facts that States have 7-10 years of PDMP data combined with State and Federal funds earmarked for performing post mortem investigations behind overdose deaths, one would think companies like Johnson and Johnson, would petition the courts to have such data released for trial. If such results are anything like the data released by Massachusetts, which showed only 1.3% of opioid overdoses had an active prescription at the time of death, then opioid manufacturers could make a strong argument in their defense.

On the flip side of that, it doesn’t take much imagination to understand why States refuse to publish such data ahead of law suits they’re bringing against opioid manufacturers.

 

 

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