Johnson & Johnson faces multibillion opioids lawsuit that could upend big pharma

Authored by theguardian.com and submitted by queen-doppelpopolis
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Oklahoma is holding the drug giant with the family-friendly image responsible for its addiction epidemic

Day after day, the memos flashing across screens in an Oklahoma courtroom have jarred with the family-friendly public image of Johnson & Johnson, the pharmaceutical giant best known for baby powder and Band-Aid.

In one missive, a sales representative dismissed a doctor’s fears that patients might become addicted to the company’s opioid painkillers by telling him those who didn’t die probably wouldn’t get hooked. Another proposes targeting sales of the powerfully addictive drugs at those most at risk: men under 40.

As the state of Oklahoma’s multibillion-dollar lawsuit against Johnson & Johnson has unfolded over the past month, the company has struggled to explain marketing strategies its accusers say dangerously misrepresented the risk of opioid addiction to doctors, manipulated medical research, and helped drive an epidemic that has claimed 400,000 lives over the past two decades.

Johnson & Johnson profited further as demand for opioids surged by buying poppy growing companies in Australia to supply the raw narcotic for its own medicines and other American drug makers.

One expert witness at the forefront of combatting the epidemic, Dr Andrew Kolodny, told the court he had little idea about Johnson & Johnson’s role until he saw the evidence in the case.

“I think it’s fair to characterize Johnson & Johnson as a kingpin in our opioid crisis,” he said.

Oklahoma’s attorney general, Mike Hunter, is suing Johnson & Johnson for billions of dollars for its alleged part in driving addiction and overdoses in his state in the first full trial of a drug maker over the opioid epidemic.

But Hunter’s lawsuit has put the wider industry in the dock, too, by laying out how opioid manufacturers worked together to drive up sales by using their huge resources to influence medical policy and doctor prescribing. Hunter said the strategy was motivated by the industry’s “greed” as profits surged.

The case is being closely watched by a host of opioid makers, drug distributors and pharmacy chains facing more than 2,000 other lawsuits by communities across the country to see if a court is prepared to hold a pharmaceutical firm responsible for the worst drug epidemic in American history.

Hunter accuses Johnson & Johnson of joining with other companies to create a false narrative of an epidemic of untreated pain in the US to which opioids were the solution, in part by funding front organizations such as the American Pain Society. The strategy helped drive a surge in opioid prescribing as narcotic painkillers ballooned into a multibillion-dollar-a-year market.

Purdue Pharma kickstarted the epidemic with its high-strength, long-lasting opioid, OxyContin, in the mid-1990s. The court heard how Johnson & Johnson quickly realized the potential and set about competing.

Its drug division, Janssen, was founded by Paul Janssen, a Belgian who invented an artificial opioid, fentanyl, in 1960. In the early 1990s, Janssen Pharmaceuticals was selling a fentanyl patch, Duragesic, to treat severe pain in people with cancer. But with the arrival of OxyContin, the company aggressively widened the market for Duragesic by falsely claiming there was a very low risk of addiction to the drug, according to Hunter.

Hunter brought to court 35 boxes containing thousands of subpoenaed “call notes” – sales reps reports on their meetings with doctors – that he claimed showed Johnson & Johnson was more interested in increasing demand for its drug than seeing it properly prescribed.

Johnson & Johnson hired the consultants McKinsey & Company to identify opportunities to sell more. McKinsey recommended sales reps focus on doctors already prescribing large amounts of OxyContin. McKinsey also proposed a strategy to keep patients on Duragesic even if they had an “adverse event”. The broader push was to get as many patients as possible off of lower strength opioids and on to Johnson & Johnson’s more powerful drugs.

As the company ramped up its drive, sales of Duragesic surged past $1bn a year. A senior Johnson & Johnson marketing executive, Kimberly Deem-Eshleman, defended the sales strategy as reps “educating” doctors.

Johnson & Johnson, which is already facing compensation payments of several billion dollars after asbestos in its baby powder caused cancer, strongly denies that it bears responsibility for the opioid epidemic.

At the core of its defense is the claim that the company was distributing drugs approved by federal agencies such as the Food and Drug Administration, and that it sold a relatively small amount of opioids in Oklahoma that cannot be tied to any specific overdoses.

Hunter is painting his case on a much broader canvas by characterizing the company as working in coordination with its rivals to change the narrative around opioids to drive up prescribing across the country so that they all benefitted from a bigger market.

Some of the most damning testimony has come from Dr Russell Portenoy, a pain specialist and influential early cheerleader for the wide prescribing of opioids who was a paid adviser to Johnson & Johnson, Purdue and other drug makers.

Portenoy told the court that painkiller manufacturers “understated the risks of opioids, particularly the risk of abuse, addiction and overdose” to boost sales. He accused the drug makers of distorting his research and that of other specialists by selectively quoting the results, including omitting information about the dangers of narcotics.

“Those messages about risk were neglected and de-emphasised,” he said in recorded video testimony shown in court. “I think the purpose of doing that was to improve the sales of their products. ”

Portenoy was among a group of doctors hired by Johnson & Johnson and Purdue as speakers to promote opioids to other physicians. He said the talks “generally favored the drugs created by the drug companies” even though they were ostensibly offering independent advice.

The court was shown Janssen’s 2012 business plan which said that “speaker programs often trigger first use” of Duragesic.

The Oklahoma case is closely watched by other drug firms being sued by towns, cities and counties in nearly 2,000 lawsuits combined in a single action in federal court in Ohio, known as the Multi District Litigation (MDL).

Last week, lawyers for the plaintiffs in the MDL proposed that any compensation settlement cover every municipality and county in the US in order to deal with all potential lawsuits at once. The lawyers believe this will be an incentive for the drug firms to settle because an agreement will shield them from further claims, although it would not deal with actions by state attorney generals such as the one underway in Oklahoma.

Paul Farrell, one of the lead lawyers on the MDL, said he was hesitant to put too much weight on any one trial. But he said that if Johnson & Johnson lose the Oklahoma case it would be a blow to the other drug companies pursuing similar lines of defence.

“If the judge decides to rule that Johnson & Johnson is not liable in Oklahoma because of the facts in Oklahoma, then I think they’re going to have to replicate that result in 49 other states and in at least 1,900 other governmental entity cases. If, on the other hand, the judge does find liability against Johnson & Johnson, despite the fact that they claim their market share was so small, you would think that that would have reverberations across the industry,” he said.

semideclared on June 23rd, 2019 at 12:43 UTC »

This issue is much deeper than a few drug companies over selling the benefits

In 1999 at a was a small dinner, sitting at the table Governor Jeb Bush with Lt. Gov. Toni Jennings, state Sen. Locke Burt and James McDonough, who would become the state’s hard-nosed drug czar. The dinner was to discuss a solution to big issue about to get much bigger

the explosion of prescription painkillers.

By the time the meal ended, all had agreed on the need for establishing a prescription drug monitoring program that would collect information and track prescriptions written for controlled substances, such as oxycodone.

Absent a prescription drug monitoring database, there was no way to know whether someone was “doctor shopping,” going from doctor to doctor, getting more and more prescriptions to feed their habit.

In November, Florida Attorney General Bob Butterworth appeared poised to take on Purdue Pharma. Instead, Butterworth and Purdue struck a settlement. As part of a $2 million deal, Purdue would pay to establish a prescription monitoring database, the same silver bullet sought by Bush. After Florida’s computerized system was up and running, the same system would be free to any other state. The entire country, not just Florida, would benefit.

It could have been a groundbreaking deal.

A rising state lawmaker in 2002, now-U.S. Sen. Marco Rubio had the clout to make or break the legislation. He had been one of two state House majority whips and was on the fast track to becoming House speaker.

Rubio didn’t kill the 2002 bill out of opposition to prescription monitoring.

It was politics.

Even after doctors are charged with illegally prescribing medicine or are linked to overdoses, the Florida State Department of Health doesn't automatically suspend or revoke their licenses.

"We failed to enact proper controls and procedures that would keep this from getting out of hand," said Bruce Grant, the state's former drug czar.

Florida Attorney General Pam Bondi said. "Florida is the epicenter of the pill-mill crisis because of our lack of tough regulations and laws."

Twin Brothers Chris and Jeffrey George make $43 million from 2007-2009 from the illicit sale of oxycodone and other drugs out of their South Florida pain clinics. When patients start dying, their pill mills get unwanted attention from the Feds.

$4.5 million in cash was hidden by the twins’ mother in her attic.

Late in 2007, Chris George, a 27-year-old former convict with no medical training, opened his first pain pill clinic in South Florida. With no laws to stop him, George and his twin brother, Jeff, were about to become kingpins, running pills up and down I-75 — quickly dubbed “Oxy Alley.”

Their top clinic, American Pain alone prescribed almost 20 million pills over two years.

Inked muscle-heads ran the clinic's security. Former strippers operated the pharmacy, counting out pills and stashing cash in garbage bags. Under their lab coats, the doctors carried guns--and it was all legal... sort of.

The clinic’s top performer was a young doctor named Cynthia Cadet. During her 16-month tenure, Cadet became the No. 1 writer of scrips for oxycodone pills in the country — some days seeing more than 70 patients.

Cadet stood trial for distributing narcotics for non-medical reasons and a resultant seven deaths. In fact, Cadet alone had served 51 patients whose deaths could be linked to prescription pills.

Cadet was found not guilty. Her defense: How could she possibly know if patients were lying about their pain levels?

Jury acquit 2nd former pain clinic doctor of murder, convicts him of minor drug charge. The panel of eight women and four men deliberated about five hours before deciding to acquit Klein of murder in the Feb. 28, 2009 overdose death of Joseph Bartolucci, 24, of West Palm Beach. The jury also found Klein not guilty on nine other charges, including trafficking in the painkillers oxycodone and hydromorphone.

"The state did not prove it to me," Fuller said of the serious charges.

But the juror said the evidence was there to support a conviction of a charge called sale of alprazolam

In the end The state did convict the man behind the show of 2 crimes

Circuit Judge Joseph Marx said he had no qualms about punishing Jeff George, 35, with the maximum possible 20-year prison term in a plea deal concerning second-degree murder and drug trafficking charges.

Chris George got 14 years

In the first six months of 2010, Ohio doctors and health care practitioners bought the second-largest number of oxycodone doses in the country: Just under 1 million.

Florida’s bought 40.8 million.

Of the country’s top 50 oxycodone-dispensing clinics,

49 were in Florida

People on both sides of the counter knew what was going on: In a letter to the chief executive of Walgreens, Oviedo’s police chief warned that people were walking out of the town’s two Walgreens stores and selling their drugs on the spot

On average in 2011, a U.S. pharmacy bought 73,000 doses of oxycodone in a year.

By contrast, a single Walgreens pharmacy in the Central Florida town of Oviedo bought 169,700 doses of oxycodone in 30 days.

a Florida Walgreens drug distribution center

sold 2.2 million tablets to a single Walgreens’ pharmacy in tiny Hudson

In 40 days 327,100 doses of the drug were shipped to a Port Richey Walgreens pharmacy,

prompting a distribution manager to ask: “How can they even house this many bottles?”

Cardinal Health, one of the nation’s biggest distributors, sold two CVS pharmacies in Sanford, FL a combined 3 million doses of oxycodone

Masters Pharmaceuticals Inc. was a middling-sized drug distributor selling oxycodone to Florida pharmacies.

Oxycodone made up more than 60 percent of its drug sales in 2009 and 2010, according to federal records. Of its top 55 oxycodone customers, 44 were in Florida.

Company CEO Dennis Smith worried that the Florida-bound oxycodone was getting in the wrong hands. A trip to Broward did nothing to ease his mind. “It was,” he later testified, “the Wild West of oxycodone prescribing.”

Smith stopped selling to pain clinics.

But the company continued to shovel millions of oxycodone pills to Florida pharmacies.

Tru-Valu Drugs It had been in business for 43 years. The owner and head pharmacist had been there for 32. It had shaded parking and a downtown location, a stone’s throw from the City Hall Annex.

Of the 300,000 doses of all drugs the small pharmacy dispensed in December 2008, 192,000 were for oxycodone. The huge oxycodone volume was no accident. The owner and head pharmacist, told a Masters inspector that the pharmacy “has pushed for this (narcotic) business with many of the area pain doctors.”

There was a culture of customers that knew what to do to get what they wanted

Teenage high-school wrestling buddies in New Port Richey ran oxycodone into Tennessee; they were paid with cash hidden in teddy bears.

A Hillsborough County man mailed 17,000 pills to Glen Fork, W.Va., a month’s supply for every man woman and child in the tiny town.

A Boston Chinatown crime boss trafficked pills from Sunrise into Massachusetts, New York, Rhode Island and South Carolina.

At Palm Beach International Airport, two federal security agents accepted $500 a pop each time they waved through thousands of pills bound for Connecticut and New York.

A Palm Bay man’s Puerto Rican family bought local pills destined for the working class town of Holyoke, Mass.

In Rhode Island, police pulled over a Lauderhill man caught speeding through Providence. They found 903 oxycodone tablets and 56 morphine pills in the car.

Senior citizen and Tulane business graduate Joel Shumrak funneled more than 1 million pills into eastern Kentucky from his South Florida and Georgia clinics, much of it headed for street sales — an estimated 20 percent of the illicit oxycodone in the entire state.

Van loads of pill-seekers organized by “VIP buyers” traveled from Columbus, Ohio, to three Jacksonville clinics, where armed guards handled crowd control and doctors generated prescriptions totaling 3.2 million pills in six months

Kenneth Hammond didn’t make it back to his Knoxville, Tenn., home. He had a seizure after picking up prescriptions for 540 pills and died in an Ocala gas station parking lot.

Matthew Koutouzis drove from Toms River, N.J., to see Averill in her Broward County pain clinic. The 26-year-old collected prescriptions for 390 pills and overdosed two days later.

Brian Moore traveled 13 hours from his Laurel County, Ky., home to see Averill. He left with prescriptions for 600 pills and also overdosed within 48 hours

Keith Konkol didn’t make it back to Tennessee, either. His body was dumped on the side of a remote South Carolina road after he overdosed in the back seat of a car the same day of his clinic visit. He had collected eight prescriptions totaling 720 doses of oxycodone, methadone, Soma and Xanax.

Edit. Thanks for the gold.

SaborW on June 23rd, 2019 at 12:28 UTC »

How about a lawsuit for their 'No tears' claim on their shampoos, too? I'm beginning to think this company is evil

Ruraraid on June 23rd, 2019 at 11:17 UTC »

I never even heard about J&J being involved with the opiod crisis. Last thing I heard about them was the Aesbestos in baby powder lawsuit.

Sucks to keep seeing how deep this Opiod Crisis rabbit hole goes. Strange thing is how I rarely see it being covered on the news which if I'm being honest is really creepy.