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 »
A roundup of recent asbestos-related news and information that you should be aware of.
Charleston, WV: Frank S. Reisberger of Shadyside, Ohio, is suing 95 companies alleging that they are responsible for his developing malignant asbestos mesothelioma. Reisberger was diagnosed with the fatal disease on August 17.
The 95 defendants include: 3M Company; A.O. Smith Corporation; A.W. Chesterton Company; Allegheny Power Systems; Armstrong International, Inc.; Armstrong Pumps, Inc.; Aurora Pump Company; Bayer Cropscience, LP; Brand Insulations, Inc.; Buffalo Pumps; Catalytic Construction Company; Ceitainteed Corporation; Chemtura Corporation; Cleaver-Brooks, Inc.; Cameron International Corporation; Copes-Vulcan; Crane Co.; Crane Valves North America & Stockham Company; Dezurik, Inc.; Dunham-Bush, Inc.; Eaton Electrical, Inc.; Elliott Company; F.B. Wright; Fairmont Supply Company; Felt Products Mfg. Co.; First Energy Corporation; Flowserve US, Inc., f/k/a Flowserve FSD Corporation; Flowserve US, Inc., f/k/a Durco International, Inc.; Flowserve US, Inc., and its Byron Jackson Pump Division; Fluor Enterprises, Inc.; Flour Corporation; FMC Corporation; Foster Wheeler Energy Corporation; General Electric Company, Inc.; General Refractories Company; Geo. V. Hamilton, Inc.; Goulds Pumps, Inc.; Graybar Electric Company; Grinnell, LLC; Hercules, Inc.; Honeywell International f/k/a Allied Signal, Inc.; Honeywell International, Inc.; I.U. North America, Inc.; IMO Industries, Inc.; Industrial Holdings Corporation; Ingersoll-Rand Company; ITT Corporation; John Crane, Inc.; McJunkin Corporation; Milwaukee Valve Company; Mobay Chemical Corporation; Mueller Steam Specialty; Nagle Pumps; National Service Industries Venture, Inc.; Nibco, Inc.; O.C. Keckley Company; Nitro Industrial Coverings, Inc.; Oakfabco, Inc.; Ohio Valley Insulating Company, Inc.; Peerless Boilers Company; Pneumo Abex Corporation; Rapid American Corporation; Reliance Electric, Inc.; Riley Power, Inc.; Rockwell Automation, Inc.; Rust Engineering & Construction, Inc.; Rust Constructors, Inc.; Rust International, Inc.; Smith Cast Iron Boilers; Spirax Sarco, Inc.; Square D Company; Standco Industries, Inc.; State Electric Supply Company; Sterling Fluid Systems (USA), LLC; Taco, Inc.; TAMKO Roofing Products; Tasco Insulations, Inc.; the William Powell Company; Townsend & Bottom, Inc.; Trane U.S., Inc.; Tyco Flow Control Company LLC; UB West Virginia, Inc.; Uniroyal, Inc.; United Engineers & Constructors, Inc.; Vellumoid, Inc.; Viacom, Inc.; Viking Pump, Inc.; Vimasco Corporation; Washington Group International; Watson McDaniel Company; Warren Pumps; Weil-McLain Company; Wilsonart International, Inc.; Yarway Corporation; and Zurn Industries, Inc. (wvirginiarecord.com)
Parkesburg, WV: A Parkersburg couple have filed an asbestos suit naming 58 defendants Read the rest of this entry »
From time to time, we here at Lawyers and Settlements focus on some of the more bizarre class action settlements making their way through the courts. Looks like Enterprise car rentals side airbags class action is destined for the “are you kidding?” category.
The back story—Enterprise Holdings Inc, is being sued in a class action by more than 100,000 people who bought certain Chevy and Buick model vehicles from the company that did not have side curtain airbags. FYI—those are the airbags that are meant to protect your head in a crash. (question—why would a manufacturer make those optional?)
The deal was that for the past three years Enterprise has ordered new vehicles, mostly Chevrolet Impalas, according to the dallasnews.com, without the airbags that would normally come standard, thereby saving about $175 per car. According to the paper, an investigation by McClatchy Newspapers in 2009, “revealed that General Motors Co. allowed Enterprise and other large fleet buyers to “delete” side airbags on the factory floor. Enterprise acknowledged taking advantage of the $175 discount on more than 60,000 Impalas over a three-year period, but not on all Impalas it ordered.”
This “some but not all” situation has caused great confusion in the used car market, not Read the rest of this entry »
Welcome to Totally Tortelicious—a review of some of the more bizarre legal stories making news—and there’s certainly no shortage of them.
She’s in Deep Doo-Doo Now. Ever been out walking and stepped in pile of dog pooh? It’s pretty annoying. And while you might harbor secret fantasies about picking it up and hucking it at the errant dog owner, what you really do is swear under your breath and walk on. Well, not so for a woman in Illinois, who clearly had had enough.
Police in Naperville, a suburb of Chicago, have said that the woman, Susan Miller, stepped in dog feces outside her apartment and retaliated by heaving it at the door of her neighbor who owns a dog. (Don’t grin too loudly). So they charged her with disorderly conduct.
The local paper, The Naperville Sun, also reported that Miller apparently uprooted a sign telling residents to pick up dog waste and placed it on the neighbor’s patio. The neighbor, no doubt afraid of what may be coming next, called the police who arrested Ms. Miller.
She was quite unapologetic, stating that if she could pick up the poop from her 80-pound dog, then her neighbors could do the same for their 20-pound pooch. Seems reasonable…
Hey, at the very least, maybe Ms. Miller could just suggest the PooTrap, shown above. We’re not proponents of it, but perhaps it’s a solution for those who don’t quite get that owning a dog comes with some, uhh, responsibilities…
New Meaning for ‘Name Brand’. This is weird. Really, really weird. A woman in California is Read the rest of this entry »
Signing up for military service—in other words, putting your life as you know it on hold for the benefit of your country—should not be met with questions, stonewalling, or delays from the US Department of Veterans Affairs (the VA) when you come back from some god-forsaken sector of the world half the man you used to be.
The VA should kiss the ground you walk on—that is, if you can even walk at all.
Tim Wymore can barely walk. He can do so only with a cane. He can barely stand. Of course, he can’t work. Worse, it seems he can’t look after himself, either. His wife has had to put her career on hold, and suffer the loss of her income (a loss felt by the entire family of five) in order to care for her husband.
Yes, Wymore gets VA disability benefits. But he doesn’t get the full measure of his due. That’s because, incredibly, the VA does not consider his disability permanent. In fact, the VA, according to an article at stltoday.com, thinks Wymore’s condition “may improve”. The obvious question is that if his condition “may” improve, then isn’t it reasonable to think it also “may not”?
So even though the man cannot work, can barely stand, can only walk with a cane and is 44 years old, the VA is withholding benefits that would ensure his family would be looked after once Wymore is gone.
For the Wymores, that sad day is not an ‘if’, but a ‘when.’ And they worry that the ‘when’ is Read the rest of this entry »