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Time for J&J to pay up in $124M Risperdal case as SCOTUS deflects final appeal

January 11, 2016 | By

Johnson & Johnson ($JNJ) fell short Monday in its final effort to escape a Risperdal marketing penalty in South Carolina. The U.S. Supreme Court declined to take up J&J’s last appeal in the case, putting the company on the hook for a $124 million penalty.

J&J had cited the Eighth Amendment in arguing against the penalty, saying it qualified as an “excessive fine.” As Reuters notes, the U.S. Chamber of Commerce had backed the drugmaker in seeking Supreme Court review.

J&J’s Janssen unit has been fighting South Carolina’s deceptive trade practices court win since 2011, when a jury ordered the drugmaker to pay $327 million for Risperdal marketing violations. The company succeeded in lowering the judgment twice, first to $136 million and then, last year, to the final $124 million.

The lawsuit centered on promotional materials Janssen used to market the antipsychotic drug. Key to the case was a letter sent to South Carolina physicians, which overstated Risperdal’s benefits compared with other drugs in its class and downplayed side effects, the jury found. The trial court judge ordered Janssen to pay about $4,000 for each of the more than 7,000 letters mailed.

The original $327 million judgment dwarfed other similar rulings in drug-marketing lawsuits, including sizable decisions and settlements in other Risperdal-related litigation, but it fell far short of a $1.2 billion verdict in Arkansas. The Arkansas Supreme Court struck down that judgment in March 2014, and the company later negotiated a settlement of $7.5 million.

The South Carolina decision survived that state’s top court in a ruling last year, in which Justice John Kittredge backed the decision at trial, but lowered the $327 million penalty to $136 million.

In affirming the judgment against the company, Kittredge echoed the trial judge’s “profit-at-all-costs” characterization of Janssen’s marketing efforts. “Janssen’s desire for market share and increased sales knew no bounds, leading to its egregious violation of South Carolina law,” Kittredge wrote in the February 2015 ruling.

Janssen had argued that it did not intentionally deceive doctors with the now-notorious “Risperdal letter” that has featured in several state-court lawsuits. The drugmaker also contended that South Carolina’s attorney general didn’t prove patients were actually harmed by the drug. It was on that point that Kittredge lowered the judgment.

The “Risperdal letter” lawsuits compose only part of the mountain of litigation J&J has fought over the antipsychotic drug. The company agreed to pay $2.2 billion in a marketing settlement with the U.S. Justice Department and a group of states.

And the litigation isn’t over yet. The company now faces more than 1,000 lawsuits over Risperdal’s ability to trigger breast development in boys. J&J lost the first court battle last February, as a Philadelphia jury ordered J&J to pay almost $2.5 million to a young man who developed breasts while using Risperdal. In November, another jury awarded $1.75 million in a similar case.

Read Full Article – http://www.fiercepharma.com/story/time-jj-pay-124m-risperdal-case-scotus-deflects-final-appeal/2016-01-11

Massachusetts Senate Panel on Legal Pot to Visit Colorado

  • By BOB SALSBERG, ASSOCIATED PRESS

BOSTON — Jan 8, 2016, 5:04 PM ET

Members of a Massachusetts Senate panel plan to visit Colorado next week to learn more about that state’s experience with the legalized use of recreational marijuana.

The Senate Special Committee on Marijuana was created last year in response to a likely 2016 ballot question that — if approved by voters — would allow pot to be used recreationally in Massachusetts.

A draft itinerary for the four-day trip starting Monday includes meetings and discussions with Colorado state regulators, legislators and law enforcement officials.

“We have recognized all along that the best way to really learn about the impact of legalizing marijuana is to spend time on the ground in the state that has the most experience with it, and that is Colorado,” said Sen. Jason Lewis, a Winchester Democrat who chairs the committee of 10 senators, eight of whom plan to be on the trip.

The visit is being paid for by Milbank Memorial Fund, a nonprofit foundation that specializes in health policy, Lewis said Friday.

Three other states — Washington, Alaska and Oregon — have legalized recreational pot.

A group called The Campaign to Regulate Marijuana Like Alcohol collected more than enough signatures last year to advance the proposed ballot question, which would allow Massachusetts residents 21 or older to possess up to 1 ounce of marijuana. It would also create a 3.75 percent state excise tax on retail marijuana sales that would be assessed on top of the state’s 6.25 percent sales tax.

Massachusetts voters approved two earlier ballot questions that decriminalized possession of small amounts of marijuana and authorized patients with certain medical conditions to use the drug.

“We don’t want to repeat the mistakes and the challenges we had in implementing the medical marijuana question,” said Lewis, referring to regulatory delays that kept the first dispensaries from opening until last year.

Regulating recreational marijuana would be even more complex, he said, with issues that include public safety, licensing, taxes and compliance with federal law.

Republican Gov. Charlie Baker and state Attorney General Maura Healey, a Democrat, are among those lined up against the proposed ballot question, with Baker saying he is “unalterably opposed” to legalizing marijuana.

Read Full Article  – http://abcnews.go.com/US/wireStory/massachusetts-senate-panel-legal-pot-visit-colorado-36170306

From Snoop Dogg to Willie Nelson, Pot Industry Tries to Build Brands

Snoop Dogg has his own line of marijuana. So does Willie Nelson.Melissa Etheridge has a marijuana-infused wine.

As the fast-growing marijuana industry emerges from the black market and starts looking like a mainstream industry, there’s a scramble to brand and trademark pot products.

The celebrity endorsements are just the latest attempt to add cachet to a line of weed. Snoop Dogg calls his eight strains of weed “Dank From the Doggfather Himself.” Nelson’s yet-to-be-released line says the pot is “born of the awed memories of musicians who visited Willie’s bus after a show.”

The pot industry’s makeshift branding efforts, from celebrity names on boxes of weed to the many weed-themed T-shirts and stickers common in towns with a legal marijuana market, show the industry taking halting steps toward the mainstream.

Problem is, those weed brands aren’t much more substantial than the labels they’re printed on. Patents and trademarks are largely regulated by the federal government, which considers marijuana an illegal drug and therefore ineligible for any sort of legal protection.

The result is a Wild West environment of marijuana entrepreneurs trying to stake claims and establish cross-state markets using a patchwork of state laws.

Consumers have no way of knowing that celebrity-branded pot is any different than what they could get in a plastic baggie from a corner drug dealer.

“You can’t go into federal court to get federal benefits if you’re a drug dealer,” said Sam Kamin, a University of Denver law professor who tracks marijuana law.

That doesn’t mean that the pot business isn’t trying.

Hundreds of marijuana-related patents have likely been requested from the U.S. Patent and Trademark Office, according to those who work in the industry. Exact numbers aren’t available because pending patent information isn’t public.

Read Full Article – http://www.billboard.com/articles/news/6828883/snoop-dogg-dank-doggfather-willie-nelson-pot-weed-marijuana-industry-legalize

 

Drug industry hired dozens of officials from the DEA as the agency tried to curb opioid abuse

By Scott Higham, Lenny Bernstein, Steven Rich and Alice Crites

Pharmaceutical companies that manufacture or distribute highly addictive pain pills have hired dozens of officials from the top levels of the Drug Enforcement Administration during the past decade, according to a Washington Post investigation.

The hires came after the DEA launched an aggressive campaign to curb a rising opioid epidemic that has resulted in thousands of overdose deaths each year. In 2005, the DEA began to crack down on companies that were distributing inordinate numbers of pills such as oxycodone to pain-management clinics and pharmacies around the country.

Since then, the pharmaceutical companies and law firms that represent them have hired at least 42 officials from the DEA — 31 of them directly from the division responsible for regulating the industry, according to work histories compiled by The Post and interviews with current and former agency officials.

The number of hires has prompted some current and former government officials to ask whether the companies raided the division to hire away DEA officials who were architects of the agency’s enforcement campaign or were most responsible for enforcing the laws the firms were accused of violating.

“The number of employees recruited from that division points to a deliberate strategy by the pharmaceutical industry to hire people who are the biggest headaches for them,” said John Carnevale, former director of planning for the White House’s Office of National Drug Control Policy, who now runs a consulting firm. “These people understand how DEA operates, the culture around diversion and DEA’s goals, and they can advise their clients how to stay within the guidelines.”

Read Full – https://www.washingtonpost.com/investigations/key-officials-switch-sides-from-dea-to-pharmaceutical-industry/2016/12/22/55d2e938-c07b-11e6-b527-949c5893595e_story.html?utm_term=.a6e6664d1a03

Robert Downey Jr. gets holiday pardon from Gov. Jerry Brown for 1990s drug offenses

Actor Robert Downey Jr., who spent time behind bars in the late 1990s on drug convictions, received a Christmas Eve pardon from Gov. Jerry Brown, effectively removing a black mark from the movie star’s checkered past.

The actor was one of 91 people to whom the governor granted clemency for past crimes, most of them minor drug offenses that no longer are felonies under California law, as well as robbery and burglary. It has become an annual Christmas Eve tradition: official proclamations for men and women who previously served time for mostly nonviolent crimes.

Downey has a long history of problems with drugs and the law, including repeated arrests in 1996.

In June 1996, he was pulled over by police in Malibu for speeding. They found him under the influence, with a gun, cocaine and heroin in the truck.

Then in July, the then-31-year-old actor turned up in the house of a neighbor, passed out in a spare bedroom. At the time, he had just completed the film “One Night Stand,” portraying a character dying from AIDS.

“It’s like I’ve got a shotgun in my mouth, my finger on the trigger and I like the taste of gun metal,” Downey told a Los Angeles judge in 1999, as he was sentenced to three years in state prison. He was released one year later, and three months after that, was arrested in a Palm Springs hotel room where cocaine also was found.

He bounced between jail and rehabilitation clinics for several years, but then remarried and, in 2008, rekindled his acting career in the role of Tony Stark and “Iron Man” in a series of Marvel films.

In total, the actor served 15 months behind bars, and in 2002, he completed his parole.

Downey obtained an order on Oct. 20 from a Los Angeles County Superior Court judge, finding that he has since “lived an honest and upright life, exhibited good moral character, and conducted himself as a law-abiding citizen.”

On Oct. 28, Brown inducted Downey into the California Hall of Fame, alongside Charlie Brown cartoonist Charles M. Schulz and country music legend Buck Owens.

The Christmas Eve pardon reads, “By completion of his sentence and good conduct in the community of his residence since his release, Robert John Downey, Jr. has paid his debt to society and earned a full and unconditional pardon.”

Read Full Article – http://www.latimes.com/politics/la-pol-sac-jerry-brown-robert-downey-jr-pardon-20151224-story.html