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A longtime Elko obstetrician whose medical privileges have been revoked has filed a lawsuit against Northeastern Nevada Regional Hospital...Dr. George A. Winch Jr. and the Elko Women’s Health Center filed the complaint...The complaint alleges that “NNRH began a campaign to suspend and revoke Dr. Winch’s privileges from NNRH based upon pre-textual, wrongful and false grounds.”...Furthermore, it says the “defendants’ bad faith breaches of the implied covenant were done maliciously, fraudulently, and oppressively, with the wrongful intention of injuring plaintiffs, and acted with an improper and evil motive amounting to malice, and in conscious disregard of the plaintiff’s rights.”

Compounding pharmacy Downing Labs LLC (formerly known as NuVision Pharmacy), its co-owners, and its pharmacist-in-charge have been issued a consent decree of permanent injunction...The Texas-based company is allegedly in violation of current good manufacturing practice requirements under the Federal Food, Drug, and Cosmetic Act...Downing Labs is accused of manufacturing and distributing adulterated drugs that were made in insanitary conditions, meaning they were bad enough to endanger public health...“Despite multiple warnings to the company, Downing Labs continued to manufacture injectable drugs under insanitary conditions, putting the health and safety of patients at risk,”...“The FDA pursued appropriate and aggressive action to protect the public health.”...Downing Labs said it has worked "collaboratively and cooperatively” with the FDA to reach an agreement that will enable it to resume the production of compounded sterile medication...also noted that, as part of the consent decree, it voluntarily agreed to participate in a regular program of testing, audit, and inspection “to ensure it is achieving and exceeding its quality goals.”

After nearly three years of sparring with a recalcitrant compounder, the Food and Drug Administration has filed a lawsuit asking a federal court to prevent Downing Labs from continuing operations. And the compounder agreed to a consent decree, which requires the company to take various steps before operations can resume...In the lawsuit, the agency cited numerous violations of so-called good manufacturing practices and several issued warnings to the company...about its failure to comply with regulations. Most recently, the Dallas-based compounder, which in 2014 refused to an FDA request to recall some products, failed yet another FDA inspection...the FDA inspectors found unsanitary conditions, according to the lawsuit...tests...found traces of...bacteria which, “if introduced into the body, can cause septic shock, pneumonia, and urinary tract infections,” the lawsuit stated...the Drug Quality and Security Act was passed to, in part, bolster compounding oversight. In fact, the FDA cited the defiant posture taken by Downing as an example of why a new law was needed to allow the agency to bolster its oversight and pursue legal options when compounders refused to upgrade operations.

A fight over a Reno hospital providing life-support for a 20-year-old woman goes back before a judge on Tuesday for more arguments about the legal standard for brain death and tests to prove it...A decision isn’t immediately expected. Washoe County Family Court Judge Frances Doherty is due to hold at least one more hearing Jan. 22 before ruling...The Nevada Supreme Court sent the case back to Doherty last month, saying she too quickly rejected Aden Hailu family’s bid to have Saint Mary’s Regional Medical Center keep her on life-support...Hailu had been hospitalized April 1 after complaining of abdominal pain. Doctors said she suffered severe low blood pressure and a lack of oxygen to the brain during the surgery...Gebreyes (Fanuel Gebreyes, father) has declined interview requests. O’Mara (David O’Mara, attorney, representing the father) said Gebreyes knows Hailu’s condition isn’t good, but believes she can recover.

What’s in a name?...Plenty, especially if you happen to run a company called Merck. In fact, there are two drug makers with that moniker. One is based in the United States and the other is headquartered in Germany, but is formally known as Merck KGgA (Merck Kommanditgesellschaft auf Aktien). And not surprisingly, they are warring over use of the name — again...To be specific, the company in Germany has the rights to use the Merck name everywhere in the world, except in the US and Canada. However, the English High Court has just ruled that the other Merck — the drug maker that is based in the US — breached a 46-year-old agreement and infringed on a trademark by using the name ‘Merck’ alone in the United Kingdom...In the lawsuit filed today, the US Merck argues that its German rival is deliberately pursuing a confusing corporate branding campaign as part of a revamped US business to bolster its presence in oncology...why do both drug makers have the same name?...The original Merck was established as a drug manufacturer in Germany in the 1800’s, but a Merck descendant later immigrated to the US and created a unit known as Merck & Co., which is based in New Jersey. But the company was confiscated by the US government during World War I and later established as a separate drug maker...Perhaps all of this would make more sense if the companies were renamed ‘Murk.’

Prescription drug distributor McKesson Corporation is the target of a complaint alleging it fueled West Virginia's prescription drug addiction problem by "failing to identify, detect, report and help stop the flood of suspicious drug orders into the state," Attorney General Patrick Morrisey said…the...complaint…alleges McKesson flooded West Virginia with highly addictive prescription medications, delivering roughly 99.5 million doses of hydrocodone and oxycodone…McKesson…"made no efforts to determine whether the volume of prescription pain killers it was shipping ...was excessive and whether any of the orders it filled qualified as suspicious orders, which should have been refused."…Sales agents and managers received commissions and bonuses based on sales numbers, and made "little to no effort to visit pharmacies" to ensure shipments weren't being diverted to illegal use…"In the near future, the office will seek to join this case with the ongoing matter in Boone County involving 12 other drug wholesaler defendants," he said in a prepared statement…in order to coordinate the Amerisource and McKesson cases and to ensure adequate resources are available to prosecute the McKesson case, the state has awarded an outside counsel appointment...Morrisey also announced Jan. 8 he will be handing off the management of both the Amerisource and McKesson cases to...Anthony Martin and...Vaughn Sizemore and will voluntarily step aside, going further than the rules require. Morrisey has had ties to Cardinal Health, one of the nation's largest drug distributors.

In the latest skirmish over prescription drug pricing, consumer activists filed a lawsuit against Ohio officials for ordering a review of signatures collected for a ballot measure designed to lower the cost of medicines...The proposed measure, known as the Ohio Drug Price Relief Act, would require the state to pay no more for medicines than the Department of Veterans Affairs. Currently, the VA gets a 24 percent discount off average manufacturer prices. A similar measure recently qualified for the ballot in California, despite opposition from the pharmaceutical industry...The lawsuit was filed two days after Ohio Secretary of State John Husted demanded election officials conduct another review of more than 171,000 signatures. He took that step after attorneys for the Pharmaceutical Research & Manufacturers of America, the industry trade group, wrote a letter to Husted to question the validity of many of the signatures that had been submitted...Drug makers are not taking any chances. In California, for instance, a spokeswoman for the industry campaign to defeat the ballot initiative recently called the proposal “misleading and flawed.”...She also argued the measure will increase the prices of prescription drugs sold to veterans and many California consumers, and reduce choices of medicines available. At the same time, she maintained the measure will cost taxpayers “millions more in state bureaucracy and lawsuits because it will be virtually impossible to implement.”

Merck...said it would pay $830 million to settle a federal class action lawsuit involving allegations the company failed to adequately inform investors about heart risks from its now-recalled Vioxx (rofecoxib) pain medication....The drug...became a blockbuster product...But the company in 2004 recalled Vioxx from the market after a colon-polyp prevention study showed it more than doubled the risk of heart attacks or stroke after 18 months of use...After thousands of former users of Vioxx sued Merck, claiming they had been harmed by the drug, Merck in 2008 settled most remaining product-liability lawsuits for $4.85 billion...other litigation continued, including a multi-district class action lawsuit...Merck kept investors in the dark about negative data from earlier company-sponsored trials of the medicine...The company's cash payment for the settlement and fees will be about $680 million...company said it still faces other individual securities lawsuits related to Vioxx.

Docket Alarm’s new suite of tools has components that help give Orange Book litigators a competitive edge…the first legal research platform to provide Orange Book litigators a suite of tools for their practice. The features include the ability to track changes to the Orange Book and related litigation, search correspondence between drug companies and the FDA, and analytics on Orange Book cases in the Patent Trial and Appeal Board…The "Orange Book,"…is the authoritative resource on FDA approved drugs for patent litigators. When a drug company wins FDA approval for a new drug, they submit an Orange Book listing detailing applicable patents covering the new drug and the drug’s labeling. Generic drug manufacturers engage in patent litigation with the branded company over whether the patents listed in the Orange Book are valid and properly cover the corresponding drug.

Dr. Reddy’s Laboratories is feeling blue over a purple pill...The generic drug maker last week agreed to change the color of its new version of the Nexium heartburn medicine from purple to blue in order to settle a lawsuit that was filed by AstraZeneca....For more than two decades, AstraZeneca has capitalized on a marketing campaign that labeled its two widely prescribed heartburn drugs — first, Prilosec and then Nexium — as “the Purple Pill.” But after Dr. Reddy’s last September began selling a lower-cost generic version, which resembled the brand-name drug, AstraZeneca claimed the Indian drug maker was ripping off its trademark look...