A controversy emerged this week over an alleged agreement between the US Food and Drug Administration (FDA) and Johnson & Johnson subsidiary McNeil HealthCare over a ‘soft’ recall of Children’s Motrin and other products that were thought to be defective due to lax GMP (Good Manufacturing Practice) at one of McNeil’s facilities.
The allegation, if true, suggests that one arm of the FDA doesn’t know what the other is doing. It also appears to suggest—again—that so long as the FDA does not have the mandate to force a drug company to conduct a recall, or do anything it doesn’t want to, for that matter, the federal drug regulator is like a tiger without teeth.
As for the drug companies, it appears as if they subscribe to the credo, “don’t ask permission, beg forgiveness.”
According to documents and testimony at a congressional hearing this week, the FDA had decided that Motrin product, which had been identified as defective due to GMP problems at the facility where it was manufactured, should be subject to a Class 2 recall.
There are various levels of recall identified by the FDA, with a Class 1 as the most serious. The latter is urged if there is a problem that could lead to serious health effects or even death. Class 2 is suggested if the problem could cause temporary, or medically reversible adverse health consequences.
Further, a Class 3 is issued if a product defect is not likely to cause serous health consequences at all.
Then there’s the ‘market withdrawal,’ which according to CNN Money on Tuesday is not a recall Read the rest of this entry »
Top Class ActionsRecall on a Rolling Basis. This week’s pharmaceutical lawsuit is against Johnson &Johnson (J&J) alleging fraud and racketeering and demanding compensation for recalled children’s allergy and cold medicines—you remember—the recall that kept going and going—first on April 30th concerning over 40 different types of kiddies cold meds, and then again in June—’oops—we maybe should have recalled these also…’ and once more for good measure in July.
But it’s not the recall that’s the problem apparently, it’s the fact that J&J’s McNeil Consumer Healthcare and McNeil-PPC had offered consumers coupons for refunds of the recalled products, which consumers have rejected, according to the suit.
According to a report on Bloomberg’s Businessweek, the complaint states the coupons are worthless because McNeil has stopped making the medicines and “wrongly assumes that all consumers will want to purchase the company’s children’s products at some uncertain future date.”
So, the suits seek to proceed on behalf of plaintiffs’ groups for residents of Illinois, Texas and Florida, as well as consumers in the U.S. and Canada, who have bought the drugs since December 2008.
Sweating the Glass Ceiling? 24-hour Fitness also got hit with a class action this week brought by its employees over allegations of discrimination on the basis of race, color, national origin and gender.
Apparently this very large chain of fitness facilities—as in 400 fitness centers, Read the rest of this entry »
Top Class ActionsIs GM cutting corners? Maybe. Certainly Jimmy Hendon believes they are, so he filed a class action lawsuit against the automotive manufacturer, over alleged unfair business practices associated with its extended warranty plans.
Mr. Hendon is claiming that GM improperly calculated his prorated cancellation refund associated with his GM Major Guard Vehicle Service Contract. Hendon purchased the extended warranty in 2006 as additional 12 month/44,000 mile coverage to the GM standard 36 month/36,000 mile factory warranty which came with the new 2006 Chevy Avalanche he had just bought. Hendon canceled the extended warranty in 2009, with 18,483 miles remaining on the contract.
Specifically, the complaint alleges that GM calculated Hendon’s refund by taking the remaining miles divided by the 80,000 total miles under warranty, resulting in a $295 refund. Hendon claims GM should have calculated his refund by dividing his remaining miles by the 44,000 mile extension, resulting in a $580 refund.
The suit claims that GM should be prorating the canceled refund by dividing the remaining miles or days by the number of miles or days that the service contract extended the factory warranty.
While you may think that $200 or $300 may not sound like much for GM—why would they bother?—if you multiply that sum over the potentially thousands of folk in similar situations to Jimmy—well heck, you might just have enough for a bailout payment…
The Gulf of Mexico Tragedy in the Making… Hopefully BP won’t get away with this environmental Read the rest of this entry »


