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• Bush Nominee to Head CPSC Receives Payola from Manufacturers Ass'n

  Michael Phelan | May 16, 2007 2:30 PM | 0 CommentsRichmond, VA

  Michael Baroody, the senior lobbyist at the National Association of Manufacturers (NAM) nominated by President Bush to lead the Consumer Product Safety Commission (CPSC), will receive a $150,000.00 payment from NAM when he takes his new government job; a job that involves enforcing consumer laws against members of the association. Sounds like payola to me. Even Baroody characterized the...

• Senate Beefs Up the FDA

  Michael Phelan | May 11, 2007 12:13 PM | 0 CommentsRichmond, VA

  The day after Oxycontin manufacturer, Purdue Pharma, pleaded guilty to criminal charges that it fraudulently marketed Oxycontin for six years as a drug that was less prone to abuse and has fewer narcotic side effects, the U.S. Senate approved by a vote of 93-1 a landmark drug safety bill that would double the number of scientists at the FDA assigned to monitor drugs already on the market for...

• Don't Let K-Street Takeover the CPSC

  Michael Phelan | May 09, 2007 12:23 PM | 0 CommentsRichmond, VA

  President Bush's attempt to emasculate the federal agencies tasked with protecting the American people has reached a new nadir. The President nominated Michael Baroody to head the Consumer Product Safety Commission (CPSC). One would think the head to the CPSC would have a track record of promoting consumer product safety. For the past 13 years, Mr. Baroody has been an anti-consumer lobbyist,...

• FDA Requests Recall of ALL Shelhigh Medical Devices

  Michael Phelan | May 03, 2007 3:23 PM | 2 CommentsRichmond, VA

  On May 2, 2007, the FDA issued a formal written request to Shelhigh, Inc. to recall ALL of its medical devices remaining in the marketplace. I blogged in April about the April 17, 2007 raid by U.S. Marshals of Shelhigh's Union, N.J. plant. At the FDA's request, the Marshals seized all medical devices found at the plant because of concerns that the devices were not sterile. During the raid,...

• Virginia Jury Awards $9.25 Million for Asbestos Death

  Michael Phelan | May 01, 2007 9:32 AM | 0 CommentsRichmond, VA

  The widow of a former shipyard worker who died from exposure to asbestos while building Navy aircraft carriers was awarded $9.25 million by a Newport News, Virginia jury. The deceased worker was in daily contact with asbestos from 1963 to 1974. He retired in 1994 and was diagnosed with mesothelioma in 2004. Mesothelioma can remain latent in the body for 40 years.Sixty percent of the total...

• Industry Foxes Guarding the Regulatory Chicken Coops

  Michael Phelan | April 27, 2007 11:30 AM | 0 CommentsRichmond, VA

  The Bush Administration has placed so many of its industry cronies in charge of federal regulatory agencies that one has to wonder whether there is an agency out there that is being run by someone who isn't trying to undermine that agency's mission. Edwin Foulke was South Carolina's Republican Party Chairman, and an anti-union, anti-regulatory zealot who was well-know for his efforts to weaken...

• Strike Three for Shelhigh, Inc. and Contaminated Medical Devices

  Michael Phelan | April 20, 2007 1:34 PM | 0 CommentsRichmond, VA

  It turns out that the recent seizure by the FDA of a million parts and medical devices from the Union, NJ manufacturing plant of Shelhigh, Inc. was not the first regulatory action concerning sterility problems taken in recent years by the FDA against Shelhigh. Shelhigh sterility violations resulted in FDA warning letters being issued in 2000 and again in 2005. During the recent raid on the...

• Patient Advice Regarding Contaminated Medical Devices

  Michael Phelan | April 19, 2007 9:43 PM | 0 CommentsRichmond, VA

  FDA's inspections of Shelhigh, Inc., a New Jersey medical device manufacturer, revealed improper sterilization and extension of the expiration dates for the firm's medical devices. The conditions were bad enough that the FDA seized all the medical devices at the Union, N.J. plant. Although a milion products were seized, countless Shelhigh devices have been implanted into patients. These...

• Allianz Life Accused of Selling Bogus Annuities to Senior Citizens

  Michael Phelan | April 19, 2007 4:55 PM | 0 CommentsRichmond, VA

  There is a potential nationwide settlement involving Allianz Life Insurance Company of North America and the sale of deferred annuities to persons over the age of 65. The allegations asserted against Allianz are that they conspired with a network of insurance sales agents to fraudulently induce people 65 years of age or older to purchase deferred annuities by means of misleading...

• FDA Seizes a Million Non-Sterile Medical Devices

  Michael Phelan | April 19, 2007 3:05 PM | 0 CommentsRichmond, VA

  U.S. marshals and Food and Drug Administration investigators began seizing heart valves and other implantable medical devices made from cow and pig tissue by a New Jersey company because of concerns about sterility. The seizure from Shelhigh Inc. was expected to net an estimated one million parts and finished products. The FDA said it had found significant problems in the Union, N.J.,...