- J&J slapped with $1.75M verdict in Risperdal breast growth case (fiercepharma.com)Trial Evidence Indicates J&J Hid Risperdal Study Results From FDA (drugwatch.com)
Johnson & Johnson (Janssen Pharmaceuticals) lost another courtroom battle over claims that the company failed to warn doctors and patients that its antipsychotic drug Risperdal (risperidone) could cause breast growth in boys, a blow for the company as it continues to deal with related cases…state court jury in Philadelphia ordered J&J to pony up $1.75 million, including damages for disfigurement and mental anguish, to a young man who developed gynecomastia…while taking the drug as a teen…The company and its Janssen unit still face about 1,500 cases…
- CMS warns state Medicaid programs on hepatitis c drug restrictions (pharmalot.com)
…the Obama administration wrote state Medicaid programs that they may be violating federal law by restricting access to hepatitis C medicines. At the same time, the Centers for Medicare and Medicaid Services wrote four drug makers asking for information about pricing arrangements with insurers and pharmacy benefits managers… A new crop of hepatitis C treatments have factored heavily in the conversation, thanks to very high cure rates but also high price tags… Ever since the new hepatitis C medications arrived nearly two years ago, public and private payers have called them budget-busters...some state Medicaid programs began restricting access based on a number of factors…CMS officials warned the state Medicaid programs against “imposing conditions for coverage that may unreasonably restrict access” to hepatitis C drugs. Placing restrictions may be “contrary to the statutory requirements” of a federal law that requires state Medicaid programs to pay for all medically necessary treatments…
- Testosterone Suits Soar Past 2,500 As Legal Milestone Looms For AbbVie (forbes.com)
…lawyers for AndroGel maker AbbVie will present their selection of 16 plaintiffs they’d like to represent the growing class of men who are suing the company over allegations that its product, a topical form of testosterone, caused blood clots, heart attacks and other adverse events. Lawyers representing the men will do the same in a process that will culminate in the selection of 12 “bellwether” cases to be tried starting late next year…men suing over testosterone has soared…to 2,744…Claims have been filed against seven makers of testosterone products…The court chose AbbVie as the subject of the first trials, with the first six bellwethers to involve men alleging “thromboembolic” injuries…and the second six alleging heart attacks or strokes...
- Pharmacist at center of Valeant scandal accuses drugmaker of ‘massive fraud’ (latimes.com)
..pharmacist Russell Reitz…agreed to sell his pharmacy (R&O Pharmacy), in a quiet suburban office park, to the group (East Coast investors) for $350,000…he continued as manager, Reitz began finding his store's name and his national pharmacy license number on an avalanche of prescriptions nationwide…a torrent of insurers' money started flowing to his small shop…on pace to equal $230 million a year…Reitz now finds himself at the center of the national scandal enveloping Valeant…In the last two months, Reitz has filed papers in two Los Angeles courthouses laying out details of what he and his lawyer call "a massive fraud."…Until Reitz's court filings…few people knew about Valeant's close ties to Philidor...Reitz detailed how he had discovered that Philidor was using his national pharmacy identification number on prescriptions being filled at other pharmacies — and even on some that were filled and billed before he signed the agreement to sell R&O…Reitz said he believes that Philidor had targeted his pharmacy because it needed access to his licenses, which he has in California and 33 other states, as well as to the contracts he had negotiated with insurers.
- Supreme Court asked to review Namenda product switching case (pharmalot.com)
Supreme Court is weighing a request from Allergan to rule on whether drug companies can pull a medication from the market as generic competition looms in order to force patients to switch to new versions of the drug…The move, which may hinge on antitrust laws, will be closely watched by the pharmaceutical industry…Allergan’s request follows a heated battle between the drug maker and New York Attorney General...over a tactic known variously as product-hopping or forced switching, which involves pushing consumers from one product to another (Namenda IR to Namenda XR). A federal appeals court earlier this year ruled that a switch Allergan had planned would harm consumers.
- Drug giants pay $54M to settle charges they charged too much for drugs (bizjournals.com)
AstraZeneca and Cephalon — have agreed to pay a total of $54 million to federal and state governments to settle allegations that they shortchanged Medicaid programs on rebates for drugs… The allegations involve rebates owed to Medicare which are negotiated with pharmaceutical companies, which are often touted as a main reason that the cost of any drug is actually less than the published price…in a lawsuit against the two drug companies claiming that they violated so-called “false claims acts” by manipulating how they reported the prices of drugs in order to decrease rebates owed to state Medicaid programs… lawsuit claimed that AstraZeneca and Cephalon falsely treated certain fees paid to wholesalers as “discounts,” improperly lowering the average prices reported and they amount they paid…
- Warner Chilcott Agrees to Plead Guilty to Felony Health Care Fraud Scheme and Pay $125 Million to Resolve Criminal Liability and False Claims Act Allegations (justice.gov)
Warner Chilcott U.S. Sales LLC, a subsidiary of pharmaceutical manufacturer Warner Chilcott PLC, has agreed to plead guilty to a felony charge of health care fraud, the Justice Department announced...The plea agreement is part of a global settlement with the United States in which Warner Chilcott has agreed to pay $125 million to resolve its criminal and civil liability arising from the company’s illegal marketing of the drugs Actonel, Asacol, Atelvia, Doryx, Enablex, Estrace and Loestrin…company committed a felony violation by paying kickbacks to physicians throughout the United States to induce them to prescribe its drugs, manipulating prior authorizations to induce insurance companies to pay for prescriptions of Atelvia that the insurers may not have otherwise paid for and making unsubstantiated marketing claims for the drug Actonel…As part of today’s resolution, the whistleblowers will receive approximately $22.9 million from the federal share of the civil recovery.
- Supreme Court asked to review Namenda product switching case (pharmalot.com)
…Supreme Court is weighing a request from Allergan to rule on whether drug companies can pull a medication from the market as generic competition looms in order to force patients to switch to new versions of the drug…The move, which may hinge on antitrust laws, will be closely watched by the pharmaceutical industry…. Allergan signaled plans to end sales of its twice-a-day Namenda IR tablet for Alzheimer’s disease. The drug maker wanted to pull its drug from the market several months before the patent on the medication was set to expire— and before it faced any competition from generics…plan was to push its newer, once-daily Namenda XR, which has patent protection until 2025.
- State of Nevada makes $3.8 million available to School of Medicine for research projects to improve women’s health (medicine.nevada.edu)
Through a settlement brokered by the State of Nevada Attorney General's Office, approximately $3.8 million is available to the University of Nevada School of Medicine for research projects aimed at improving women's health in Nevada…The State of Nevada obtained the settlement with pharmaceutical companies Wyeth, Pfizer and Pharmacia & Upjohn relating to claims regarding postmenopausal hormone therapy products…The funds will be distributed by the Attorney General's Office over a five-year period ending in 2019, with half the available research funds going to School of Medicine faculty in Reno and Las Vegas and the other half going to University Medical Center of Southern Nevada.
- 6 Southern Nevada hospitals included in paying $250M settlement (reviewjournal.com)
Six Southern Nevada hospitals are among hundreds of U.S. facilities (457 hospitals in 43 states) that will pay a total of more than $250 million stemming from allegations that they implanted cardiac devices in Medicare patients in violation of coverage requirements, the U.S. Justice Department said…Medicare guidelines provide that doctors should not implant ICDs (implantable cardioverter defibrillator) in patients who have recently suffered a heart attack or had other procedures, such as heart bypass surgery. Each of the hospitals…had implanted ICDs during 40 day waiting periods that Medicaid requires for heart attack patients and 90 day waiting periods for bypass patients…Las Vegas-area hospitals involved include Centennial Hills, Desert Springs, Summerlin, Valley, Sunrise, and North Vista...