Tag Archives: drug companies

Blog, Business Law, Drug Companies, Legal News, Personal Injury, Supreme Court

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

Blog, Criminal, Drug Companies, Legal News

Indictment says Berea pharmacist distributed drugs ‘outside scope of professional practice’

38-count indictment was unsealed on Friday

Five other co-defendants named in indictment

Alleged distribution of drugs began in 2010

BY GREG KOCHER

gkocher1@herald-leader.com

A Berea pharmacist conspired with others to distribute drugs “outside the scope of professional practice” and “not for legitimate medical purposes,” according to a federal indictment unsealed Friday.

Lonnie W. Hubbard, who operated Rx Discount of Berea, was named in the 38-count indictment returned on Dec. 3, according to court records.

The indictment says Hubbard, 40, was also “aided and abetted by others” in the distribution of pseudoephedrine, which may be used in the manufacture of methamphetamine.

Hubbard also distributed and dispensed, outside the scope of professional practice and not for a legitimate medical purpose, oxycodone and a quantity of pills containing suboxone, the indictment says.

The drug distribution began in 2010 and continued into this month, the indictment says. Rx Discount of Berea was organized in 2009, according to online records with the Kentucky Secretary of State’s office.

The indictment says Hubbard and Meggan Ashley Hubbard, 30, used money from drugs to buy a 1971 Corvette for $22,909, a boat for $31,800, a GMC Sierra Denali for $25,000, and a down payment on property in Pulaski County for $40,000. They also allegedly used money from drugs to write a cashier’s check for $315,000 to buy a five-bedroom, four-bath house overlooking Lake Cumberland.

Others named in the indictment are Joseph A. McKinney, Charles McKinney and Darryl Jones.

The McKinneys, aided and abetted by Jones and Lonnie Hubbard, distributed oxycodone, the indictment says.

An unredacted indictment shows that another co-defendant, Jody Earl Gabbard, was aided and abetted by Lonnie Hubbard in distributing oxycodone in Garrard County.

Portions of the indictment remain redacted, indicating that possibly other defendants will be made public at a later date.

Lonnie Hubbard and Gabbard’s initial appearances and arraignments are scheduled Monday before U.S. Judge Magistrate Robert Wier in Lexington.

Greg Kocher: 859-231-3305, @HLpublicsafety

Blog, Drug Companies, Legal News

GNC Sued for Selling Drug-Laced Supplements Seating Chair

By Hilda Schwartz

Oct 26, 2015 Seating Chair – Independent NEWS Agency – SeatingChair.com

The lawsuit, filed in Multnomah County Circuit Court, accuses GNC of violating Oregon’s Unlawful Trade Practices Act because it misrepresented products sold in Oregon as “lawful dietary supplements, when in fact these products were adulterated and unlawful”.

The dietary supplements allegedly contain the illegal ingredient picamilon and BMPEA. It alleges GNC knowingly sold products containing an amphetamine-like substance that isn’t approved for diet pills in the USA – and left it off the label. Products containing BMPEA or picamilon were produced by third parties and accounted for less than 1 percent of total sales, GNC said.

The Food and Drug Administration sent warning letters to five companies in April telling them that eight of their products listed BMPEA and telling them to stop selling them. In a brief statement, GNC responded to the lawsuit, saying that the allegations are “without merit” and that they will “vigorously defend against these allegations”.

This is just the latest in a fight that has been going on for years between state and federal officials and supplements retailers like GNC.

Full Article –  http://seatingchair.com/2015/10/26/gnc-sued-for-selling-drug-laced-supplements-13459.html

Blog, Drug Companies, Legal News, Personal Injury

Johnson & Johnson, Ethicon Morcellator Lawsuits Centralized

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Lawsuits involving one of the biggest pharmaceutical companies and one of the most controversial medical devices in the U.S. now are centralized to a single court.

Johnson & Johnson is accused of hiding knowledge that its power morcellator could cause an accidental spread of uterine cancer during hysterectomies and surgeries to remove fibroids.

The Judicial Panel on Multidistrict Litigation transferred at least 28 morcellator lawsuits to the U.S. District Court for the District of Kansas, a multidistrict litigation (MDL) court.

“This decision by the panel is an extremely important one because it ensures that these cases will move at the fastest possible pace,” said Paul Pennock, a lead attorney at Weitz & Luxenberg who led the arguments for consolidation.

Courts consolidate lawsuits to MDLs when a large number of plaintiffs file lawsuits involving the same facts against the same defendant. The process allows the courts to operate more efficiently and decreases the costs for all parties involved.

“We believe this will allow our clients to obtain justice much more swiftly and reliably than might otherwise be the case if each client were compelled to battle the defendants in isolated courtrooms scattered across the country,” Pennock said.

The lawsuits accuse Ethicon, a subsidiary of J&J, of designing a defective product and failing to warn patients of risks.

Morcellator Controversy Growing

The surgical tool that uses small blades to break tissue into small fragments remains one of the most controversial devices in the U.S.

One congressman, U.S. Rep. Mike Fitzpatrick, fought for amendments to regulate medical devices to be added to the 21st Century Cures Act that was passed by the U.S. House of Representatives in July. The amendments stemmed from news that some women were rapidly developing cancer after surgeries involving the device.

Months later, members of Congress led by Fitzpatrick petitioned the U.S. Government Accountability Office to investigate the devices and the U.S. Food and Drug Administration process that cleared them. The GAO agreed to investigate morcellators and the FDA in September.

The recent news adds to an existing history of controversy involving power morcellators that began more than a year ago, and Johnson & Johnson’s name keeps coming up.

J&J, Ethicon May Have Known of Risks

Morcellators were once thought to have an extremely rare risk of unintentionally spreading uterine cancer, but the FDA warned the actual risk was one in 350 in April 2014. The warning came almost two decades after the device entered the market.

Read Full Article Here – http://www.drugwatch.com/2015/10/20/ethicon-morcellator-mdl-kansas/