- Allergan and New York settle suit over Alzheimer’s drug switching (statnews.com)Actavis Confirms Appeals Court Ruling Requiring Continued Distribution of NAMENDA IR (finance.yahoo.com)
Allergan and New York State have settled a heated antitrust lawsuit that accused the drug maker of switching patients from an older dementia pill to a newer and more expensive version in order to avoid generic competition…Allergan agreed to pay $172,000 in litigation expenses and withdraw an appeal filed last month with the US Supreme Court…The arrangement ends a bitterly fought battle over a pharmaceutical industry practice known as forced switching or product hopping. This involves pushing consumers from one product to another. The case was closely watched because it held the potential to decide the extent to which a drug maker can force a product switch without running afoul of antitrust laws…The lawsuit triggered a debate over the sometimes controversial practice of reformulating a medicine and then obtaining a patent to extend its product life cycle. But the move by Allergan highlighted competing arguments over whether the strategy is really a ruse to create an unfair monopoly or is a legitimate use of intellectual property to protect a profitable product.
- Sanofi whistleblower lawsuit kicks into higher gear (cnbc.com)
A whistleblowing former paralegal at drug giant Sanofi is now claiming she was aware of "many instances" where Sanofi lawyers destroyed documents to avoid turning them over to opponents in prior legal cases…Ex-Sanofi paralegal Diane Ponte's new allegation comes in an affidavit she filed in her pending lawsuit against the company...claims she learned of an alleged scheme at Sanofi to pay more than $30 million in kickbacks to promote the company's diabetes drugs. The suit came a year after the France-based drug company already agreed to pay more than $100 million to the U.S. federal government to settle other claims related to alleged kickbacks to doctors, and seven months after Sanofi agreed to pay a nearly $40 million fine in Germany in connection with two employees who were convicted there of paying bribes to boost drug sales.
- Merck may appeal to Supreme Court after again losing fight to protect Cubicin patents (fiercepharma.com)
Appeals court invalidates 4 of 5 patents, exposing it to generic compeition come June...Merck & Co.is running low on options after a federal appeals court…again declined to back four patents that would have held at bay for 5 more years generics of the antibiotic Cubicin, the drug that was key to its $9.5 billion buyout of Cubist. Next up may be an appeal to the U.S. Supreme Court…In a three-sentence statement...a federal appeals court upheld a fifth patent, but that one expires next June anyway, potentially leaving only months before copies from Hospira and others could launch. The court invalidated four other patents that expire in 2019 and 2020. The company says it is "considering its next steps, which may include seeking further review" at the federal circuit level or the Supreme Court...
- Court case puts patient privacy in peril (ama-assn.org)
What happens to physician-patient confidentiality when any government agency can obtain a patient’s prescription records without a warrant? A case before a state supreme court threatens to keep these indiscriminant lines of investigation wide open…Lewis v. Superior Court of Los Angeles County, a case before the Supreme Court of the State of California, calls into question whether or not the California Medical Board infringed upon patients’ constitutional right to privacy when it obtained prescription data without a showing of good cause. The board did so through the California Department of Justice database, which allows broad and indiscriminate disclosures to state, local and federal agencies—including law enforcement—and fails to adequately protect patient privacy.
- Las Vegas woman in middle of brain death battle (reviewjournal.com)Supreme Court orders Vegas woman to be kept on life support (reviewjournal.com)
The battle over maintaining life support for a 20-year-old Las Vegas woman continues this week in Reno. It focuses on the question of when is a person considered dead…The unknown is whether doctors for Saint Mary's Regional Medical Center in Reno will continue to try to pull the plug on Aden Hailu, who sought treatment for abdominal pain in April and suffered catastrophic lack of oxygen and brain damage during an exploratory surgery…An attorney for Hailu's family said the next step must be to develop a plan of care…"There is hope that she will regain consciousness," said David O'Mara, the…attorney representing, Hailu's father…The state Supreme Court ruled last week that the standards used by the hospital to make a determination of brain death might not satisfy state law. Hailu was declared brain dead at the hospital May 28 after doctors concluded that she was unresponsive, lacked brain activity as determined by reflexes and eye movement, and could not breathe on her own.
- Judge: Centennial Hills Hospital hid evidence in civil case (reviewjournal.com)
A judge has imposed severe sanctions on Centennial Hills Hospital Medical Center for intentionally concealing evidence in a civil case filed by a patient who was sexually assaulted at the Las Vegas hospital in 2008…"Centennial failed to disclose relevant evidence that it knew it had a duty to disclose, caused extensive time to pass, and caused memories to fade," District Judge Richard Scotti wrote in a 39-page order…strikes Centennial's answer in the case — a move that establishes liability against the hospital. When the case goes to trial Jan. 4, Centennial will be allowed to defend itself only on the question of damages…"A party who engages in misconduct must suffer reasonable consequences," the judge wrote. "No party should be allowed to conceal evidence, and then suffer merely a monetary sanction, while being allowed to reap the tactical benefit of the loss of that evidence."…The plaintiff, who filed the case in 2009 as Jane Doe, was one of five female patients who were victimized by certified nursing assistant Steven Farmer.
- Irmat, a Mail-Order Pharmacy, Sues OptumRx in Latest Drug-Price Skirmish (nytimes.com)
Irmat Pharmacy…looks like the neighborhood drugstore it has been since the 1970s…But two years ago it added a new business as a nationwide mail-order dispenser of expensive drugs for acne and other skin conditions…business has prospered…a large pharmacy benefit manager plans to stop doing business with it at the end of this month. Irmat is suing that company, OptumRx…It appears to be the latest skirmish in a budding war between pharmacy benefit managers, which seek to rein in spending on drugs, and mail-order pharmacies, which have been increasingly enlisted by drug manufacturers to help protect their products from being swapped for cheaper generic alternatives…a spokesman for Optum, said Irmat was being removed from Optum’s network because it violated its contract…Irmat receives most of its revenue from dispensing dermatology drugs made by two companies, Galderma and Aqua Pharmaceuticals…mail-order pharmacies say the real reason they are being targeted is that the pharmacy benefit managers own their own mail-order businesses and are trying to stifle competition…
- Dr Reddy’s sues AstraZeneca over purple colour of Nexium generic (economictimes.indiatimes.com)Despite Legal Troubles, Is Dr. Reddy's a Buy? (thestreet.com)
Hyderabad-based drug maker Dr Reddy's has filed a lawsuit in a US court against Anglo-Swedish drug giant AstraZeneca alleging material breach of a settlement agreement that had released the company from any liability in connection with generic versions of Nexium (esomeprazole)…Last week, AstraZeneca as part of a lawsuit against Dr Reddy's moved in a Delaware Court obtained a temporary restraining order preventing the Indian firm from selling copies of Nexium on grounds of trademark infringement for using the colour purple, which was similar to the original brand.
- Drug makers beat diabetes lawsuits with an unusual ruling (pharmalot.com)
Several drug makers were handed an unexpected victory this week when a federal judge ruled they weren’t required to update product labels to warn about risks of pancreatic cancer with their diabetes medicines…District Court Judge…explained the labeling changes were not required because the Food and Drug Administration would not have approved those changes. As a result, approximately 750 cases are being tossed…“Right now, it’s a ruling by one district judge in California. So at this point, it doesn’t have huge implications. But there is, potentially, a lot at stake here for the plaintiffs and similar cases,” he tells us. “If the companies were to prevail, it could become an important precedent for companies in similar cases, because it could clarify what a manufacturer has to show to avoid liability.”
- More than 100 women sue over mispackaged birth control after becoming pregnant (mcall.com)
More than 100 women who became pregnant after allegedly taking mispackaged birthcontrol pills filed suit in Philadelphia last week against Qualitest Inc., a subsidiary of the Irish drug-maker Endo Pharmaceuticals Inc…The case seeks millions in damages, including in some cases the costs of delivering, raising, and educating the children borne of the unplanned pregnancies…The discovery of the mispackaged contraceptives prompted the FDA in 2011 to issue a recall notice for 3.2 million blister packs, according to court filings…. The FDA recall was triggered when a Kansas City woman returned a package to her pharmacist after noticing the blister pack had been rotated 180 degrees, reversing the weekly tablet orientation, according to the suit filed in Philadelphia Court of Common Pleas.