Category:

Allergan Inc was sued...by four large U.S. retailers that accused the drugmaker of antitrust violations for trying to stop rivals from selling generic versions of Restasis, its medication to treat dry-eye disease...Walgreen Co, Kroger Co, Albertsons Cos and HEB Grocery Co accused Allergan of illegally preserving its monopoly by obtaining illegal patents, suing rivals that challenged those patents and transferring the patents to a sovereign Native American tribe, New York’s Saint Regis Mohawk Tribe, to escape scrutiny by U.S. courts...The retailers said generic Restasis would have been on the U.S. market by May 2014 but for Allergan’s activities, and that the...company should pay triple and other damages for its anticompetitive conduct...The company holds patents covering various elements of Restasis that expire in 2024...

The Nevada Supreme Court heard oral arguments...in the case of a death row inmate who wants the state to put him to death with a lethal injection method never before used in Nevada or elsewhere...Scott Raymond Dozier, 47, is a death row inmate convicted in Clark County of the 2002 killing and dismemberment of Jeremiah Miller...also...has repeatedly expressed his desire to give up his appeals and be put to death...Dozier’s lawyers are particularly concerned that the execution protocol calls for a paralytic (cisatracurium) in addition to two other drugs (fentanyl and diazepam) meant to kill the defendant...the paralytic doesn’t serve a medical purpose but is only included to mask signs of distress, potentially hiding any indicators of a painful or botched killing...The issue the court must decide is whether the state’s use of the paralytic in the execution violates Dozier’s right, under the Nevada and U.S. constitutions, to avoid any cruel and unusual punishment...

A federal appeals court...declared unconstitutional a 2017 Maryland law that lets the state attorney general sue generic drugmakers who sharply raise prices on medications...The 4th U.S. Circuit Court of Appeals sided with the main trade group for generic pharmaceutical companies in holding that the law violated the U.S. Constitution by regulating the price of transactions that occur outside of Maryland...the law violated the Constitution’s bar against states interfering with interstate commerce, by targeting wholesale rather than retail pricing in transactions that occur largely outside of Maryland...

A foreign pharmaceutical company has become entangled in bribery allegations in China, in spite of efforts in fighting rampant commercial corruption in the medical sector...An employee at Swiss multinational pharmaceutical company Novartis International AG's affiliate in China (Beijing Novartis Pharma Co., Ltd) accused the drugmaker of money laundering via funding fake academic activities…To promote the company's new drugs such as benazepril and DIOVAN tablets, the company held fake academic activities and paid clinical doctors kickbacks…Novartis...agreed to pay $25 million in 2016 to settle charges that it violated the US Foreign Corrupt Practices Act when its China-based subsidiaries engaged in pay-to-prescribe schemes to increase sales...Novartis said...that the company has launched an investigation into the claim, and promised to take serious measures against any practices that violate rules and regulations...

The U.S. Department of Justice has joined whistleblower litigation accusing Insys Therapeutics Inc of trying to generate more profit by paying kickbacks to doctors to prescribe powerful opioid medications...The government’s involvement...adds firepower to the civil litigation as Insys tries to resolve a federal probe into its marketing of Subsys, a spray form of fentanyl...Six U.S. states - California, Colorado, Indiana, New York, North Carolina and Virginia - also joined whistleblower litigation against Insys, according to the filing in U.S. District Court in Los Angeles...The litigation comes amid a wave of related criminal cases against medical practitioners, and former executives and sales representatives employed by Insys, including its billionaire founder John Kapoor.

...Drug Enforcement Administration said...it had suspended a Louisiana pharmaceutical distributor from selling controlled substances for allegedly selling unusually large quantities of opioids to pharmacies without reporting the sales...Morris & Dickson Co...investigation showed “it failed to properly identify large suspicious orders for controlled substances sold to independent pharmacies with questionable need for the drugs.”...Morris & Dickson filed in federal court...an injunction against the suspension, and U.S. District Judge Elizabeth Foote in Shreveport has scheduled a hearing...on its request for a temporary restraining order...The probe, which focused on purchases of Oxycodone and Hydrocodone, showed that in some cases, pharmacies were allowed to buy as much as six times the quantity of narcotics they would normally order...

An online pharmacy that bills itself as Canada's largest was fined $34 million...for importing counterfeit cancer drugs and other unapproved pharmaceuticals into the United States...U.S. prosecutors say Canada Drugs' business model is based entirely on illegally importing unapproved and misbranded drugs not just from Canada, but from all over the world. The company has made at least $78 million through illegal imports, including two that were counterfeit versions of the cancer drugs Avastin and Altuzan that had no active ingredient, prosecutors said...judge...approved federal prosecutors' recommended sentences that include $29 million forfeited, $5 million in fines and five years' probation for Canada Drugs...also sentenced Thorkelson (founder, Kris Thorkelson) to six months' house arrest, five years' probation and a $250,000 fine...

A federal judge blocked the U.S. Drug Enforcement Administration from suspending a Louisiana drug distributor from selling controlled substances over allegations it failed to identify suspicious orders of opioids that were diverted for illicit uses...U.S. District Judge Elizabeth Foote in Shreveport, Louisiana, on Tuesday entered a temporary restraining order blocking the DEA from enforcing an order issued last week that immediately suspended Morris & Dickson Co’s registration...The DEA’s order marked the first time during President Donald Trump’s administration that it had moved to immediately block narcotic sales by a distributor as the agency attempts to combat a national opioid abuse epidemic...The DEA on Friday announced it was suspending the registration of privately-held Morris & Dickson, saying the distributor failed to properly identify large, suspicious orders of drugs sold to independent pharmacies.

Branded drugmakers have said "no fair" to the U.S. Patent and Trademark Office's inter partes review system almost since its inception seven years ago. One reason? "It's unconstitutional," the companies contend...The Supreme Court...disagreed...In a 7-2 vote, the U.S. High Court held that the system is constitutional. It doesn't violate Article III of the Constitution, which gives the judicial branch alone the power to decide legal arguments. Nor does it violate the Seventh Amendment, the right to a trial by jury...It's a limited ruling specific to the issues in this particular case, Oil States Energy Services v. Greene’s Energy Group...Justices John Roberts and Neil Gorsuch dissented, saying only an independent judge—not a political appointee at the PTO—should be able to revoke patents, which they equated with personal property such as a home or a farm...PhRMA...said the "narrowly tailored decision" found only that IPRs are constitutional, not "efficient or fair." The arguments and a...ruling in another case—SAS Institute v. Iancu—mean it's "clear there are problems with the IPR process that need to be addressed,"...

A federal judge...ordered "pharma bro" scammer Martin Shkreli to immediately pay a defrauded hedge fund investor about $388,000 in restitution, roughly half of what the investor asked for… The order comes a month after Judge Kiyo Matsumoto sentenced Shkreli to seven years in prison for defrauding that investor, Richard Kocher, and a number other people, as well as for conspiring to manipulate stock shares...In addition to his prison sentence, Matsumoto also imposed a fine of $75,000 on the 35-year-old Shkreli and ordered him to forfeit almost $7.4 million in assets to the federal government...