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Semler Research Center says the US FDA caused the “complete annihilation” of its business after regulators rejected bioanalytical studies on the back of data integrity concerns...In April 2016, the US Food and Drug Administration issued Semler Research Center an ‘Untitled Letter’​ stating evidence it had found of data manipulation in a number of bioanalytical studies during an inspection of its facility in Bangalore, India...The Agency then sent a notice​ to drug sponsors that bioavailability/bioequivalence studies conducted by the contract research organisation would need to be repeated...Semler filed a lawsuit against the FDA, the United States Department Of Health And Human Services and the United States Of America – along with various individuals – for total damages of approximately $50m...The firm claims the FDA’s actions were in violation of the Fifth Amendment, interfered with economic advantages and intentionally inflicted financial distress on the company.

A federal judge in Oklahoma has dealt a blow to a Cherokee Nation lawsuit seeking to stop the flow of addictive opioid painkillers in its territory by issuing a preliminary injunction to prevent the case from being heard in tribal court...District Judge Terence Kern ruled the tribal court lacked jurisdiction because the lawsuit involving six wholesale drug distributors and pharmacy operators does not directly concern tribal self-government...“While noting Defendants’ (Cherokee Nation‘s) evidence of the harm opioid abuse has caused to individual tribal members and families, and costs borne by the tribe, the Court cannot plausibly find that such harm is ‘catastrophic for tribal self-government’,” Kern said...The Cherokee Nation in April 2017 became the first major Native American tribe to seek redress in tribal court from wholesale drug distributors and pharmacy operators...The tribe said the highly addictive painkillers were saturating its territory and contributing to violence, delinquency and mortality...The companies said the lawsuit attempted to civilly enforce a federal statute, the Controlled Substances Act, under the guise of the tribe’s statutory and common law...

The Dengvaxia debacle in the Philippines just keeps heating up, as more than 70 mothers with vaccinated children filed for criminal prosecution against former officials, including ex-President Benigno Aquino III, and Sanofi executives...In their legal complaint, which asks prosecutors to consider criminal charges, the families targeted Aquino, former Department of Health chief Janette Garin, M.D., and two other government officials, as well as five Sanofi executives including CEO Olivier Brandicourt and Asia-Pacific head Thomas Triomphe...Invoking the country’s Anti-Graft and Corrupt Practices Act, the families claim that the government officials are “guilty of gross inexcusable negligence” for rolling out the program without due diligence...adding that they gave “excessive accommodations” to the global drug giant. The families also questioned “whether [Aquino] acted in conspiracy with Sanofi officials” in purchasing about $70 million worth of Dengvaxia doses...after Sanofi released results from a new analysis indicating that its vaccine could cause more serious infections if given to those who haven't previously encountered dengue. The country immediately stopped its mass vaccination program, and government officials took a tough tone with the company

When former Clark County School District school psychologist Diana Goodsell was injured by an alleged drunken driver in 2015, she required a cervical spinal fusion surgery...just before the operation...she was told it would cost her $6,800 out of pocket...that was part of the agreement with the Teachers Health Trust...Now Goodsell and other current and former district employees have filied (filed) a class action lawsuit against the Teachers Health Trust, which provides health insurance for thousands of Clark County School District employees and their dependents. The lawsuit...alleges breach of contract, consumer fraud and other actions that the plaintiffs say have forced them to pay more for health care and receive less...The lawsuit names the trust, seven of its trustees and WellHealth Quality Care...as defendants. It claims that WellHealth violated its contract by refusing to pay claims, charging double the $10 co-pay for doctor visits and leaving teachers with higher yearly out-of-pocket expenses than the specified cap of approximately $6,800...The School Board said it has received numerous complaints about the trust’s health care coverage...

Shares of generic-drug makers including Mylan NV and Teva Pharmaceutical Industries Ltd. fell after the Justice Department’s antitrust division said it might sue them for damages in a price-fixing probe...If taxpayers were overcharged because drugmakers conspired to raise the price of drugs, the Justice Department will consider suing to seek damages, Makan Delrahim, the division’s chief, said...“To the extent that taxpayers have had to pay that bill, I think the taxpayers should recover,” he said. “We will get involved on the civil side and recover damages for the U.S. government.”...Mylan dropped as much as 3.1 percent after the comments and traded down 0.6 percent to $46.25 at 1:37 p.m. in New York. Teva’s U.S. depositary receipts dropped as much as 2.8 percent and were down 1.5 percent to $20.41 and Endo International Plc fell 5.6 percent to $6.92...The three drugmakers are among more than a dozen companies targeted by the Justice Department and state attorneys general in a multi-year investigation into generic drug price-fixing. So far, the probe has led to guilty pleas from two former executives of Heritage Pharmaceuticals...

DOJ is investigating drug-makers’ financial support of patient-assistance charities...A U.S. charity offering assistance to patients for their out-of-pocket drug costs has sued the federal government over restrictions on its ability to communicate with drug-makers who donate to it...The charity, Patient Services, Inc., filed the lawsuit in federal court in Richmond, Virginia. It comes amid a Justice Department investigation into drug-makers’ financial support of patient-assistance charities...Drug-makers are prohibited from subsidizing copayments for patients enrolled in Medicare, but they may donate to nonprofits providing copay assistance as long as the charities are independent. Amid increased attention to rising drug prices, concern has arisen that drug-makers’ donations to such charities may be contributing to price inflation.

Kmart Corp. has agreed to pay $32.3 million to settle a whistleblower lawsuit alleging its pharmacies overcharged federal health care programs and some private insurers for generic prescription drugs..."Pharmacies that are not fully transparent about drug pricing can cause federal health programs to overpay for prescription drugs," Chad Readler, the acting assistant attorney general of the department's Civil Division, said..."This settlement should put pharmacies on notice that there will be consequences if they attempt to improperly increase payments from taxpayer-funded health programs by masking the true prices that they charge the general public for the same drugs."...The complaint was filed on behalf of former Kmart pharmacist James Garbe. According to the suit, in one case, Kmart had sold a 30-day supply of a generic version of a prescription drug for $5 to customers of its discount program, but then filed for reimbursement from the government for $152 for that same drug for its Medicare customers...Garbe will receive a whistleblower award of $9.3 million, which amounts to 29 percent of the federal government's recovery...

A U.S. administrative court...invalidated a Johnson & Johnson patent on its blockbuster prostate cancer drug Zytiga, bringing rivals closer to selling generic versions...The Patent Trial and Appeal Board said a Johnson & Johnson patent describing a method of administering Zytiga should not have been granted because the process it described was obvious...The ruling was a victory for U.S. generic drug company Argentum Pharmaceuticals LLC, which had asked the board to invalidate the patent in hopes of bringing its own version to market...The patent is due to expire in 2027. Argentum and other generic drug makers have been blocked from launching their own versions of the cancer drug until its expiration date...Zytiga generated nearly $2.3 billion in sales for Johnson & Johnson in 2016.

A federal judge...dismissed a lawsuit seeking to block CMS from implementing a $1.6 billion cut to hospital reimbursements under Medicare's 340B drug discount program—although hospital groups suggested they may take further legal action to try to reverse the cuts...The lawsuit's dismissal meant CMS could implement the cuts as scheduled on Jan. 1...hospital groups argued the cuts could jeopardize services at safety-net hospitals...HHS in a motion to dismiss the lawsuit claimed that hospitals had "reaped substantial profits" from subsidies under the 340B program's previous system...U.S. District Judge Rudolph Contreras in his ruling said the hospital groups lacked standing...hospitals filed the suit prematurely since the rule did not take effect until Jan. 1, adding that the groups will have to reference specific reimbursement claims to move forward with a lawsuit.

A Las Vegas investigator with the state Board of Medical Examiners was sexually harassed by her boss and retaliated against by co-workers after complaining to her superiors...The lawsuit...by investigator Lara Ward, alleges that the sexual harassment was part of a pattern of unprofessional conduct by officials in the state office that investigates complaints against licensed medical practitioners...While the sexual harassment claims form the core of the lawsuit, Ward also levels numerous allegations of unprofessional conduct by various members of the board. Among them, the complaint alleges that:

■ Andreas held personal vendettas against certain physicians, whom he targeted by keeping cases open after doctors were cleared of accusations.

■ Board officials closed several investigations of malpractice concerning high-profile physicians.

■ Doctors sued by a major insurance company for fraud had malpractice cases administratively closed. Those cases accused doctors of misuse of spinal cord and cervical injections and opioids.

■ Opioid overprescription investigations were delayed, including those resulting in death. The delays were part of an overall pattern of mishandling of overdose cases that included closure after lab reports were misread.

■ Female co-workers in the Las Vegas office favored by Andreas were promoted to investigative positions even though they lacked required bachelor’s degrees.

■ Ward, who has a bachelor’s in criminal justice from the University of Colorado, was denied a promotion to senior investigator and received poor marks from Chief of Investigations Pamela Castagnola on an employee review because she inquired about the position.