Tag Archives: big pharma

Scott, Campbell counties hop on board Big Pharma racketeering lawsuit train


Two East Tennessee counties are now on board to join a growing and fast-moving national effort to use federal racketeering laws to hold drug makers, distributors and dispensers accountable for creating and fostering the opioid epidemic in the United States, records show.

Government leaders in Campbell and Scott Counties have authorized the filing of lawsuits in U.S. District Court against the firms that make, distribute and dispense opiate prescription painkillers.

The law firm Jessee & Jessee filed the first such legal action in the federal Eastern District of Tennessee on behalf of Campbell County earlier this year. The law firms Lieff Cabraser Heimann & Bernstein and Taylor & Knight filed a similar action on behalf of Scott County late last week.

Full Read – https://www.knoxnews.com/story/news/crime/2018/03/06/scott-campbell-counties-opioid-epidemic-big-pharma-racketeering-lawsuits/399172002/

Drug companies want to dismiss Ohio’s lawsuit over opioid epidemic

CHILLICOTHE, Ohio – Companies that make prescription opioids want a Ross County Common Pleas judge to dismiss a lawsuit filed by Ohio Attorney General Mike DeWine that charged them with stoking Ohio’s opioid epidemic by fraudulently marketing their products.

Legal briefs filed by Purdue Pharma, which makes Oxycontin, say U.S. Food and Drug Administration requirements for its products preempt Ohio law, and DeWine’s lawsuit also failed to prove the company’s actions caused the harm he cites.

“The State does not identify a single physician who prescribed one of Purdue’s opioid medications to any patient when it was allegedly medically unnecessary, much less, a physician who did so because of Purdue’s allegedly misleading marketing or promotional materials,” the company’s legal filings say.

Read Full – http://www.cleveland.com/metro/index.ssf/2017/09/drug_companies_want_to_dismiss.html

FDA Wants To Stop Pharma From ‘Gaming’ Generic Drug System

The U.S. Food and Drug Administration moved on Wednesday to prevent pharmaceutical companies from “gaming” the system to block or delay entry of generic rivals.

FDA Commissioner Scott Gottlieb said in a blog post that the agency plans to hold a public meeting on July 18 to identify ways pharmaceutical companies are using FDA rules to place obstacles in the way of generic competition.

“We know that sometimes our regulatory rules might be ‘gamed’ in ways that may delay generic drug approvals beyond the time frame the law intended, in order to reduce competition,” he said in the blog post. “We are actively looking at ways our rules are being used and, in some cases, misused.”

The move comes as President Donald Trump and lawmakers in Congress search for ways to lower the cost of prescription drugs. Trump is preparing to put out an executive order on drug pricing, according to media reports, and last week U.S. Senator Ron Wyden introduced a bill to require companies to explain the reasons for significant price increases.

Full Read – http://www.nbcnews.com/health/health-news/fda-wants-stop-pharma-gaming-generic-drug-system-n775151

6 pharma executives face criminal charges for alleged fentanyl racketeering scheme

Six pharmaceutical executives who worked for Chandler, Ariz.-based Insys Therapeutics were arrested Thursday on charges that they led a nationwide conspiracy to bribe clinicians to unnecessarily prescribe fentanyl-based pain medication, according to the Department of Justice.

The government claims the executives conspired to bribe physicians and medical practitioners in several states, many of whom worked in pain clinics, to prescribe their pain medication called Subsys. This narcotic contains fentanyl, a highly addictive synthetic opioid, and is intended to treat cancer patients suffering intense episodes of breakthrough pain.

In exchange for kickbacks and bribes, practitioners allegedly wrote large numbers of prescriptions for patients, few of whom were diagnosed with cancer. The indictment also alleges the former Insys executives conspired to defraud health insurers that showed reluctance to approve payment for Subsys when it was prescribed to non-cancer patients. The defendants allegedly did so by establishing a “reimbursement unit” that obtained prior authorization directly from insurers and pharmacy benefit managers.

Here are the names of the defendants, all of whom are no longer employed by Insys Therapeutics, along with the respective charges they face:

  • Michael Babich, former president and CEO: conspiracy to commit racketeering, conspiracy to commit wire and mail fraud and conspiracy to violate the Anti-Kickback Law
  • Alec Burlakoff, former vice president of sales: Racketeer Influence and Corrupt Organizations Act conspiracy, mail fraud conspiracy and conspiracy to violate the Anti-Kickback Law
  • Richard M. Simon, former national director of sales: RICO conspiracy, mail fraud conspiracy and conspiracy to violate the Anti-Kickback Law
  • Sunrise Lee, former regional sales director: RICO conspiracy, mail fraud conspiracy and conspiracy to violate the Anti-Kickback Law
  • Joseph A. Rowan, former regional sales director: RICO conspiracy, mail fraud conspiracy and conspiracy to violate the Anti-Kickback Law
  • Michael J. Gurry, former vice president of managed markets: RICO conspiracy and wire fraud conspiracy

Criminal charges are rarely pressed in cases involving pharmaceutical companies, and several agents noted the severity of the charges in statements.

Full Read – http://www.beckershospitalreview.com/legal-regulatory-issues/6-pharma-executives-face-criminal-charges-for-alleged-fentanyl-racketeering-scheme.html