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Label of Estring menopause treatment updated to include estrogen-class standards

Estring black box warning

The black box warning and other warnings and precautions on the hormonal postmenopausal symptom reliever Estring have been updated to reflect current recommended estrogen-class labeling standards which include risk of uterine cancer, breast cancer, heart attack, stroke, blood clots and dementia. Estring is a vaginal ring made by Pfizer that contains estradiol, a synthetic estrogen. It is inserted into the vagina and should be removed after 90 days of continuous use. Estring is used after menopause to treat moderate to severe vaginal itching, burning and dryness, painful intercourse, urinary urgency and painful urination due to urogenital atrophy. Hormone replacement therapy, ... Read More

U.S. chooses to intervene in whistleblower case against Sikorsky Aircraft and subisdiaries

whistleblower

The federal government said that it has chosen to intervene in a whistleblower lawsuit against Sikorsky Aircraft Corporation and two of its subsidiaries alleging the companies, under contract to the Defense Department, used illegal subcontracts to overcharge the U.S. Navy for aircraft parts and maintenance. Whistleblower Mary Patzer, a former financial analyst for Milwaukee-based Derco Aerospace Inc., one of the Sikorsky companies, filed the lawsuit in 2011 under the qui tam or “whistleblower” provisions of the False Claims Act. The Act allows private individuals to sue on behalf of the federal government when they have good, original evidence of fraud ... Read More

Verdict in whistleblower guardrail case could be breakthrough for False Claims Act suit

guard-rail - KCPQ-TV image

Just because the U.S. government fails to intervene in a False Claims Act case doesn’t mean the lawsuit can’t prevail in court, a fact demonstrated by the $175-million verdict a Texas federal jury handed down this week in a whistleblower case against the nation’s leading guardrail manufacturer. According to the Wall Street Journal, the verdict in whistleblower Josh Harman’s case against Trinity Industries Inc. should serve as a “False Claims Act wake-up call” to companies that contract with or in other ways do business with federal agencies and programs, signaling that even false claims lawsuits without the government’s backing can ... Read More

New black box warning added to blood thinner Eliquis

blood cells

The blood thinner Eliquis (apixaban) has a new black box warning that prematurely discontinuing therapy for reasons other than pathological bleeding or completion of a course of therapy increases the risk of blood clots. If therapy is prematurely discontinued, it is advised that patients be given another anticoagulant to prevent this risk. Eliquis is used to reduce the risk of strokes or blood clots in patients with a common heart rhythm abnormality known as atrial fibrillation, not caused by a heart valve problem. It is also approved to prevent and treat blood clots in the veins of the legs, known ... Read More

U.S. settles whistleblower allegations with diagnostic centers for $2.6 million

whistleblower

Two groups of Houston-based medical diagnostic centers have agreed to pay the U.S. more than $2.6 million to resolve a group of whistleblower allegations that they entered into improper financial agreements with physicians in schemes to boost Medicare referrals. According to the U.S. Justice Department, One Step Diagnostic has agreed to pay $1.2 million to settle allegations it violated the Stark Statute and the False Claims Act by entering into bogus consulting and medical director agreements with physicians who referred patients to One Step Diagnostic Centers. The other group of centers consists of Complete Imaging Solutions doing business as Houston ... Read More

More U.S. farmers sue Syngenta for tainting corn supply with genetically engineered strains

corn supply contamination negatively affects US farmers export

Farmers in Alabama and 10 other states have filed lawsuits against Swiss agribusiness giant Syngenta AG alleging the company contaminated the U.S. corn supply with a genetically engineered strain of corn that China refuses to import. The lawsuits claim that Syngenta’s contamination of the corn supply, much of which is bound for export, caused China to reject nearly 1.5 million tons of U.S. corn shipments, resulting in an 11-cent-per-bushel drop in prices and depressing the overall corn market. This in turn, plaintiffs allege, has hurt corn farmers across the country. The complaints stem from Syngenta’s genetically modified Agrisure Viptera corn, which ... Read More

Kentucky cardiologists settle health care fraud charges brought by whistleblowers

whistleblower

Two Kentucky cardiologists have agreed to pay $380,000 to settle allegations made by whistleblowers that they violated the U.S. False Claims Act, federal Anti-Kickback Statute, and the Stark Law by making “sham agreements” with a London, Ky., hospital that resulted in referrals for cardiology procedures and other health care services. According to the U.S. Justice Department, Dr. Satyabrata Chatterjee and Dr. Ashwini Anand jointly own Cumberland Clinic, a physician group that provides cardiology services. The government alleged that St. Joseph Hospital of London, Kentucky had agreements with the doctors under which the hospital paid the physicians to provide fictitious management ... Read More

Makers of generic Reglan hoping federal law preempts lower court’s ruling

Reglan

Drug companies Pliva Inc., Actavis Elizabeth LLC, and Teva Pharmaceuticals USA Inc., hope the New Jersey Appellate Division will find that federal law overrides a lower court’s ruling that consumers can sue makers of generic versions of the heartburn drug Reglan (metoclopramide) who they claim failed to update their labels to include new warnings on the brand name drug’s label. Reglan, known generically as metoclopramide, is used to treat gastric esophageal reflux disease (GERD). It is also used to treat nausea and vomiting, and heartburn caused by a stomach problem known as gastroparesis in diabetic patients. The issue stems from a ... Read More

NHTSA updates air bag defect warning to include another three million vehicles

Takata airbag - image source alexauto321, wikicommons

Shortly following the U.S. government’s plea to nearly five million car owners to learn more about a life-threatening air bag defect, the National Highway Traffic Safety Administration (NHTSA) has updated its warning to include three million more car owners believed to be driving under dangerous circumstances. According to the safety alert, the NHTSA is making the public aware of inflator mechanisms within the affected vehicles’ airbag systems that may rupture upon impact, triggering an arsenal of metal fragments to violently fly out as the bags are being deployed. Takata Corp., one of the world’s largest automotive suppliers in the world, manufacturing air ... Read More

Naproxen recall issued due to packaging mix-up

Assured brand naproxen sodium tablets recalled

Thousands of boxes of the over-the-counter painkiller Naproxen Sodium are being recalled because some cartons actually contain bottles of ibuprofen, a different pain reliever. The naproxen recall, initiated by Contract Packaging Resources, involves 11,640 boxes of Assured brand Naproxen Sodium Tablets 220mg, 15 count with the Lot #FH4102A and SKU #122368/UPC #639277223685. The boxes contain bottles of ibuprofen softgels in 200mg. The mix-up could cause problems for consumers who intentionally avoid using ibuprofen due to allergies or other medical conditions. Allergic reactions can range from mild irritation or hives to serious reactions such as anaphylaxes that may be life-threatening. Contract ... Read More