A compounding pharmacy linked to patients with post-surgical vision problems was found to be using grapeseed oil in some of its products, a South Korean maker of a homeopathic smoking cessation aid wasn't screening its ingredients, and a prominent California hospital had clean room lapses, according to the U.S. Food and Drug Administration. Here's this week's roundup of the agency's enforcement actions.
Republicans on the Senate Budget Committee advanced closer to enacting a $1.4 trillion tax cut bill on Tuesday with a vote in favor of merging the bill with recommendations from Sen. Lisa Murkowski, R-Alaska, to permit drilling in the Arctic National Wildlife Refuge.
Despite being about $226 million in the hole to the U.S. Department of the Treasury for money paid out for disputes over hospital construction contracts, the U.S. Department of Veterans Affairs has failed to request adequate funds from Congress to make up the shortfall, a VA watchdog said Tuesday.
U.S. Sen. Elizabeth Warren of Massachusetts sent a letter Tuesday to the nominee for secretary of the U.S. Department of Health and Human Services in advance of a confirmation hearing, raising concerns about his time at Eli Lilly & Co. and his “outspoken criticism” of the Affordable Care Act, among other things.
A Pennsylvania federal court agreed Tuesday that a defamation lawsuit brought by a Philadelphia County judge over his portrayal in a book about the infamous murder trial of abortion provider Kermit Gosnell could be heard in his home court.
The American Council on Exercise told a California federal court Monday that a Chubb subsidiary is refusing to pay the nearly $2 million the group spent defending against a trademark suit.
A California cardiology clinic and its five shareholder physicians agreed to pay $1.2 million to resolve False Claims Act allegations that they improperly performed and billed federal and state health care programs for unnecessary and risky heart stress tests, according to a statement by U.S. Attorney Phillip A. Talbert on Tuesday.
Siemens is leaning toward Frankfurt, Germany, for the initial public offering of its multibillion-dollar medical equipment business, SoftBank is leading a group of investors that will try to buy a sizable stake in Uber, and Sun Capital has received multiple offers for French packaging company Albea.
The Pennsylvania Supreme Court was urged in a brief on Monday to uphold a finding that the purely economic losses allegedly suffered by a putative class of University of Pittsburgh Medical Center workers following a massive data breach prevented them from winning damages through a negligence claim.
In an unprecedented move, the Office of Inspector General for the U.S. Department of Health and Human Services on Tuesday revoked an advisory opinion shielding a patient-assistance charity from kickback liability, calling the charity a potential “conduit” for drug industry dollars.
A Massachusetts federal judge Monday ruled that the founder of Insys Therapeutics Inc. could remove an electronic monitoring device that interfered with his jogging, saying the government hadn’t shown that the billionaire, accused of orchestrating a conspiracy to bribe doctors to prescribe his opioid painkiller, was a flight risk.
A Boston federal judge agreed on Monday to fast-track two pharmaceutical companies’ legal battle over their allegedly dueling access to a handful of doctors specializing in the treatment of ultra-rare enzyme deficiencies.
The head of the Connecticut Attorney General's Office's pioneering privacy and data security department is vacating his post to take the reins at health insurer Cigna. In an exclusive interview with Law360, Matthew Fitzsimmons talks about how the regulator's enforcement approach has changed over the past decade, the value of interstate cooperation and the active role he anticipates state officials will continue to play in this space.
Delaware's Supreme Court on Monday shot down a class attempt to resurrect an already-recycled suit against directors of home infusion and pharmacy service company BioScrip Inc., prompted by insider trading and drug kickback scandals.
A California federal judge overseeing a health care fraud and money laundering trial against two romantically linked doctors scolded the female defendant’s attorney Monday for “crossing the line” with direct examination of a witness that included such words about her mental health as “sane” and “crazy.”
An investor and onetime mentor of Martin Shkreli on Monday told jurors in the trial of the controversial former pharmaceutical executive’s ex-attorney of how he lied to FBI agents when questioned about what prosecutors say was a sham consulting agreement with Shkreli-founded Retrophin Inc.
A class of health care providers suing Geico over under-reimbursement of their services asked a Florida federal judge Wednesday for a judgment on their one narrow claim after she determined that the contract is vague and must be construed against the insurer.
A hospital chain whose patients’ medical information leaked online in two separate data breaches has agreed to upgrade its security measures and pay $2 million to settle claims it failed to implement basic safeguards, the California attorney general’s office has announced.
A Florida federal judge sentenced Former WellCare Health Plans Inc. general counsel Thaddeus M.S. Bereday to six months in prison and fined him $50,000 after he previously pled guilty to participating in a Medicaid fraud scheme, the U.S. Department of Justice announced.
A Colorado-based assisted living company has agreed to pay $335,000 to settle allegations by the U.S. Equal Employment Opportunity Commission that it fired care providers because they were of African origin.
Federal courts across the country are handing down important rulings interpreting the U.S. Supreme Court’s landmark decision on False Claims Act liability in Universal Health Services v. Escobar. As the rulings keep pouring in, stay up to speed on Law360’s latest coverage and analysis of Escobar’s impact.
The initial hurdle in every case involving bar order litigation is whether the bankruptcy court has jurisdiction to enter the proposed bar order. The Eleventh Circuit’s recent opinion in Fundamental Long Term Care offers the clearest statement to date of the law upholding the power of bankruptcy courts to issue bar orders, say attorneys with Berger Singerman LLP.
In a False Claims Act case last month, the Ninth Circuit rejected a company’s attempt to push its former employee into arbitration under a very broadly worded agreement that she had signed at hiring. The My Left Foot ruling offers some pointers for employees wishing to avoid the tilted field of forced arbitration, say Scott Oswald and Andrew Witko of The Employment Law Group PC.
Today's law firm chief financial officer should be involved in many areas beyond traditional financial management, including operations, risk management and information technology. He or she can support strategic planning throughout the process, from development of the plan to its implementation, measurement and eventual evolution, say Tyler Quinn and Marc Feigelson of Kaufman Rossin PA.
Many employers are seeing an increase in requests for religious accommodations. Several recent court decisions and statistics from the U.S. Equal Employment Opportunity Commission provide insight into the rise in claims related to these requests, and the importance of employers understanding their obligations to accommodate, say Barbara Hoey and Alyssa Smilowitz of Kelley Drye & Warren LLP.
On Sunday, the results of a six-month joint investigation by "60 Minutes" and The Washington Post concluded that "the drug industry, with the help of Congress, turned the opioid epidemic into a full blown crisis." In the coming months, insurers and pharmacy benefit managers are expected to undertake new and innovative efforts to control and disincentivize the use and prescription of opioids, says Adam Fleischer of BatesCarey LLP.
Financial Crisis Anniversary
After nearly a decade of recession-accelerated change in the legal industry, “merit-based” compensation has largely come to mean measuring attorney success using some combination of origination and working attorney hours metrics. However, there are signs that the real impact of the recession is still around the corner, and that building a book isn’t enough, says Peter Zeughauser of Zeughauser Group.
Given the uptick in global awareness and enforcement of anti-bribery and corruption laws, most U.S.-based health care companies are attuned to the risks associated with legal infractions caused by their operations and conduct abroad. However, such ex-U.S. activities may also impact health care companies’ ability to conduct business within the U.S., say attorneys with Ropes & Gray LLP.
The Florida Supreme Court's recent decision in White v. Mederi Caretenders Visiting Services of Southeast Florida and Americare Home Therapy v. Hiles recognizes that referral sources are the lifeblood of the home health care business and worthy of protection. The ruling should be viewed as a strong statement by the court that restrictive covenants will be enforced to prevent unfair competition, says Leonard Samuels of Berger Singerman LLP.
Life sciences and health care companies nationwide are being sued by shareholders far more frequently this year, but the good news for such companies in Massachusetts is that after several years of issuing no significant decisions in securities class actions, the First Circuit has now issued several favorable dismissals, say Caroline Bullerjahn and Deborah Birnbach of Goodwin Procter LLP.
With respect to Health Insurance Portability and Accountability Act compliance, in the past five months, the U.S. Department of Health and Human Services has announced only one compliance agreement, and has been quiet save responses to the WannaCry attack and Hurricanes Harvey, Irma and Maria. So now, eight months into the Trump administration, we are left to wonder if this is the new HHS, says David Saunders of Jenner & Block LLP.