- Long Island county sues opioid drug makers for misleading marketing (statnews.com)
You can add Suffolk County, N.Y., to the list of local and state governments that are filing lawsuits against the drug makers that market opioid painkillers...The Long Island county...accused several companies — Purdue Pharma, Johnson & Johnson, and Endo International, among others — of using deceptive marketing to downplay the risks of their painkillers, and of improperly encouraging physicians to prescribe the medicines in a way that caused some patients to become addicts…The allegations are...identical to lawsuits filed by the city of Chicago; Orange and Santa Clara counties in California; and the state of Mississippi. In each case, the governments have charged the drug makers with illegally widening markets for their opioid painkillers and, as a result, forcing taxpayers to pay for medicines that were often prescribed unnecessarily...The companies "sought to create a false perception of the safety and efficacy of opioids in the minds of medical professionals and members of the public that would encourage the use of opioids for longer periods of time and to treat a wider range of problems, including such common aches and pains as lower back pain, arthritis, and headaches…
- Illinois attorney general sues Insys over fentanyl drug marketing (reuters.com)
Illinois' attorney general...sued Insys Therapeutics Inc, accusing it of deceptively marketing and selling an addictive fentanyl-based medication, intended to treat cancer pain, to doctors for off-label uses...The lawsuit...comes as Insys faces a number of state and investigations involving its drug Subsys (fentanyl sublingual) as U.S. authorities seek to combat a national opioid abuse epidemic...This drug company's desire for increased profits led it to disregard patients' health and push addictive opioids for non-FDA approved purposes…the lawsuit seeks to bar Insys from selling its products in Illinois and impose financial penalties on the company...
- Business groups sue U.S. gov over tax rules that spoiled ‘Pfizergan’ (fiercepharma.com)
Pfizer and Allergan weren’t the only ones that were unhappy with the U.S. Treasury’s April move to block their $160 billion proposed megamerger. The U.S. Chamber of Commerce and one Texas business group were, too--and now they’re doing something about it...The pair sued the federal government...claiming that the Treasury Department’s move to tighten the reins on inversion deals violated the law...According to the allegations, the government tweaked the Internal Revenue Code itself after Congress refused to get on board with President Barack Obama’s inversion-limiting legislative changes--and the way Thomas Donohue, the chamber’s president and CEO, sees it, "this is not the way government is supposed to work."..."Instead of breaking the rules to punish companies engaged in lawful transactions, Washington should just do its job and comprehensively reform the tax code...The inversion crackdown that scuttled the Pfizergan transaction wasn’t the first of its kind. The April actions represented the third time the U.S. Treasury took matters into its own hands, with the first set--in October of 2014--toppling a proposed AbbVie-Shire merger....
- Pfizer agrees to settle shareholder class action on Celebrex and Bextra (fiercepharma.com)
Pfizer’s Bextra (valdecoxib) has not been on the market in more than a decade, but the litigation tied to it and pain drug Celebrex (celecoxib) continues to play out. The New York drugmaker has now put to rest a long-running class action by Pfizer shareholders who said a controversy over the drugs’ safety whacked the stock price and cost them a lot of money...Pfizer last week reached an agreement-in-principle to resolve the securities class action case for all defendants...the resolution is pending court approval and the terms are confidential until a formal agreement has been approved...The pain drugs made Pfizer a lot of money, at one time being among the company’s best-selling meds. But the controversy over their risks has also cost it tremendously. In 2009, Pfizer agreed to hand over $2.3 billion to settle a Department of Justice probe into its marketing of Bextra...And last year, the drugmaker settled another related investor suit for $400 million.
- Purdue Pharma rejects request from New Hampshire attorney general for information on suspected diversion of OxyContin (latimes.com)
The top law enforcement official in New Hampshire...accused the manufacturer of OxyContin...of stonewalling demands for information the company collects about suspected criminal trafficking of its painkiller..."They are just refusing to turn over documents," state Atty. Gen. Joseph Foster said of drugmaker Purdue Pharma..."On one hand, they tell us they have nothing to hide and they are doing everything appropriately, but then why are they fighting so hard not to turn over this information?"…In refusing to comply with the...subpoena, Purdue cited longstanding objections to the state’s use of a private law firm in an ongoing investigation of the company and other opioid makers…company lawyers have said Purdue is willing to provide records to the attorney general and his lawyers, but on the condition they not share them with the private attorneys, who they have suggested have a financial incentive to wrest multimillion-dollar judgments from the company in civil suits.
- ACLU threatens to sue Colorado over hepatitis C drug restrictions (statnews.com)
In the latest dust-up over the high cost of hepatitis C drugs, the American Civil Liberties Union is threatening to sue Colorado officials if they refuse to widen access to the medications in the state Medicaid program...The saber rattling came in response to a long-standing policy by the state Medicaid program to restrict coverage only to people with the most advanced stages of liver disease, such as cirrhosis...“Basically, Colorado has been withholding treatment from Medicaid recipients until they have measurable damage to their livers. And we believe that the restrictions violate the Medicaid statute,” Mark Silverstein, the ACLU of Colorado Legal Director...“We hope they’ll do the right thing, but we’re prepared to pursue litigation otherwise.”...Since 2013, the state has spent $26.6 million treating 326 hepatitis C patients, or about $82,000 per person, according to a spokesman for the state Department of Health Care Policy and Financing, which oversees the state Medicaid program. If the state were to cover every Medicaid patient with hepatitis C, regardless of the stage of their disease, it would cost $174 million. “It could be a budget problem,” he said.
- Cephalon, U.S. states reach $125 million settlement over generic drugs (reuters.com)
Cephalon has reached a $125 million settlement with 48 states in connection with its alleged efforts to delay generic versions of its blockbuster sleep disorder drug Provigil from entering the market, New York Attorney General Eric Schneiderman said...The settlement...comes a little more than a year after the company struck a $1.2 billion parallel settlement with the Federal Trade Commission...The FTC accused the company of protecting its monopoly on Provigil by paying generic drug makers to drop their challenges to Cephalon's patent, in what is known as a "pay-for-delay" deal...the company successfully delayed generic competition of the drug by six years through filing patent infringement lawsuits and then settling them by paying competitions to delay selling generic versions of Provigil, Schneiderman said...When pharmaceutical companies put profits ahead of people by illegally restricting competition, it harms patients...
- California court hangs out a welcome sign: Drug makers can be sued here (statnews.com)
In a closely watched decision, the California Supreme Court ruled 4-3...that hundreds of out-of-state residents had the right to sue Bristol-Myers Squibb in the state court system over side effects caused by one of its drugs...At issue was the question of jurisdiction, which can be used to determine where a lawsuit may be filed. This particular ruling clarified the extent to which the drug maker needed to have a presence in California in order to be sued by people from Texas, Ohio, and 33 other states, who claim they were harmed by the Plavix blood thinner...Although Bristol-Myers may not be headquartered in California, the court determined the company conducts enough business — sales, marketing, distribution, and R&D — for state courts to serve as a venue for lawsuits filed by out-of-state residents...the ruling applies only to this particular case, the court may have hung a welcome sign that invites still more people from around the country to file lawsuits in California against drug makers...That’s because California state courts are seen as more hospitable to people who bring lawsuits against drug makers...
- Valeant under criminal investigation over Philidor ties: WSJ (fiercepharma.com)
With Valeant’s management assuring investors that the company is well on its way to a turnaround, the drugmaker’s problems aren’t supposed to be growing larger. But now, Valeant is facing what could be its most serious investigation yet...Federal prosecutors are probing the...drugmaker’s relationship with specialty pharmacy Philidor...while that relationship has already garnered plenty of attention from investigators...this particular set of allegations...claim Valeant defrauded insurers by hiding its close Philidor ties--is new....The new probe could also be a bigger threat. Philidor managers and Valeant itself might face criminal charges...Prosecutors are looking into whether the specialty pharmacy made false statements to insurers about its link to the drugmaker. They’re trying to figure out whether insurers thought Philidor--which helped patients snag insurance coverage for pricey Valeant meds--was neutral, rather than in Valeant’s service...
- Noted price-hiker Jazz feels the heat as PTO strikes Xyrem patents (fiercepharma.com)
Jazz Pharmaceuticals has been called out repeatedly for substantial price hikes on its leading product Xyrem. But now, the company’s cash cow could be in trouble...the...drugmaker saw four patents on its most important asset upturned by the U.S. Patent and Trademark Office, through the inter partes review system pharma has come to dread. The PTO is due to rule on two more "imminently,"...and given their similarity to those already tossed, they could well suffer the same fate...The patent loss is a blow to...Jazz, whose narcolepsy star generates more than 70% of its operating profit...The med has grown to that point somewhat controversially, as Jazz hiked its list price 841% over the 5 years ending in 2013.