05 Tuesday Jan 2016
Posted in Government, Litigation, Product Liability
≈ Comments Off on FDA Finally Issues Stronger Requirements for Transvaginal Mesh.
The FDA Is Doing Too Little, Too Late About Transvaginal Mesh, by Max Kennerly, Esq., Litigation and Law Blog
I’ve written about transvaginal mesh so many times I feel like a broken record. But it’s still an issue affecting tens of thousands of families and will continue to be an issue as long as that infernal implant keeps being sold and the manufacturers keep refusing to do right by the families that have already been hurt by them. . . .
01 Thursday Oct 2015
Posted in Drug Promotion, Government, Health Law, Health Reform, Intellectual Property, Patent Law, U.S. Department of Health and Human Services
≈ Comments Off on Could Lawyers Fix The Rising Cost of Medicine?
Tags
Cancer, FDA, Litigation & Trial, Max Kennerly, Medicaid, Medicare, Pfizer, Prescription Drugs, RICO, Schering–Plough
Send In The Lawyers: A Partial Fix For America’s Dystopian Prescription Drug Market, by Max Kennerly, Esq., Litigation & Trial Blog
It’s hard to read any news about prescription drugs these days without wondering if you’ve somehow fallen into a Philip K. Dick novel. Just look at some of these titles over the past week:
- ‘2 new studies show the FDA is rushing more drugs to market based on shoddy evidence’
- ‘The True Cost of an Expensive Medication’
- ‘U.S. drug company sues Canada for trying to lower cost of $700K-a-year drug’
- ‘Outrage could lead to lowering price of high-cost drugs’
All of these stories are about different drugs, but the common theme among all of the stories is, of course, money. The Mayo Clinical Proceedings recently found ‘In the United States, the average price of cancer drugs for about a year of therapy increased from $5000 to $10,000 before 2000 to more than $100,000 by 2012, while the average household income has decreased by about 8% in the past decade. Further, although 85% of cancer basic research is funded through taxpayers’ money, Americans with cancer pay 50% to 100% more for the same patented drug than patients in other countries.’ . . .
27 Monday Jan 2014
Posted in Freedom of Information Act, Government, Health Law, U.S. Department of Food and Drug Administration
≈ Comments Off on FDA Documents Reveal Its Inadequate Response to High Risk Antibiotics in Livestock.
Tags
Andrew Martin, Antibiotic Resistance, Antibiotics, Bloomberg Businessweek, Farm Animals, FDA, Freedom of Information Act, Livestock, Natural Resources Defense Council, U.S. Food and Drug Administration
The FDA Allows Sale of ‘High Risk’ Antibiotics for Livestock, Report Says, by Andrew Martin, Bloomberg Businessweek
There are hyperlinks throughout the article to additional blog posts that shed more light on the world-wide scope of this situation. -CCE
A U.S. Food and Drug Administration review of 30 antibiotics used in livestock found that more than half posed a significant risk of exposing humans to antibiotic-resistant bacteria.
Despite the review, which occurred from 2001 to 2010, the federal agency allowed the drugs—used as additives in animal feed and water—to remain on the market, according to a report released on Monday by the Natural Resources Defense Council, an environmental group that based its findings on internal documents obtained under the Freedom of Information Act.
11 Saturday Jan 2014
Posted in Employment Law, Health Law, Whistleblower
≈ Comments Off on Drug Regulation Expert Awarded Almost $4 Million As Whistleblower Under False Claims Act.
Tags
CareFusion, Carrie Brous, ChloraPrep, Cynthia Kirk, False Claims Act, FDA, Greg Hack, Leawood, The Kansas City Star, Whistleblower
Leawood Expert On Drug Regulation Wins $4 Million Whistleblower Award, by Greg Hack, The Kansas City Star
CareFusion will pay $40.1 million in final settlement with the Department of Justice under the False Claims Act whistleblower law. Cynthia Kirk, an expert on drug regulation, will receive almost $4 million in reward as the whistleblower. -CCE
The Researching Paralegal 
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