Score One for the FDA as Rest of World Finally Yanks Thelin

January 3rd, 2011. By Hunter West

Time to give credit where credit is due. And this time, the US Food and Drug Administration (FDA) got it right. 

Recently it was announced, in a joint statement by Health Canada and Pfizer Canada, that Thelin (sitaxsentan) was being taken off the market in Canada, as well as every country in which it had been sold, due to risk for potentially fatal liver damage. 

Never heard of Thelin? There’s a reason for that. Thelin is not available in the US. Never was. That’s because the FDA refused to approve the drug designed to treat pulmonary hypertension. In the view of the FDA, the benefits did not outweigh the risks. 

In a bid to win FDA approval for marketing Thelin in this country, Pfizer Inc. launched a series of clinical trials. However, those trials have been abandoned following the deaths of three trial participants. 

According to a report in the Globe and Mail, Canada’s national newspaper, liver damage was a known complication of Thelin. However, in announcing that it was abandoning further clinical trials, Pfizer noted that it had discovered a  “new potentially life-threatening idiosyncratic risk” of liver injury among patients that is difficult to predict or guard against. 

Thus, there will be no further clinical trials, and Thelin will be coming off the market in Australia, Europe and Canada where it had been previously approved. Given the known risks associated with Thelin, Canadians are wondering how Thelin ever won Health Canada approval in the first place. 

The FDA has been maligned, chastised, ridiculed and kicked to the curb over the appearance of lax oversight both in the approval, and ongoing supervision of drugs and medical devices. And to be sure, much of that criticism is warranted. 

However, on this occasion the FDA stuck to its guns and has been vindicated. There can be Read the rest of this entry »

Asbestos News Roundup: 12.30.10

December 30th, 2010. By LucyC

A roundup of recent asbestos-related news and information that you should be aware of. An ongoing list of asbestos hot spots from the Asbestos News Roundup archive appears on our asbestos map.

Asbestos Lawsuits

Charleston, WV:  Delbert Warren Kittle, of Fairmont, is suing 97 companies he alleges caused his lung cancer. On December 11, 2008, Kittle was diagnosed with lung cancer.

The 97 companies named as defendants are: A.W. Chesterton Company; Ajax Magnethermic Corporation; Aurora Pump Company; 3M Company; Beazer East, Inc.; Borg-Warner Corporation; Brand Insulations, Inc.; Buffalo Pumps, Inc.; BW IP, Inc.; Catalytic Construction Company; Caterpillar, Inc.; Certainteed Corporation; Chicago Pump Company; Cleaver-Brooks Company, Inc.; Columbus McKinnon Corporation; Continental Electric Company, Inc.; Copes-Vulcan, Inc.; Crane Co.; Crown Cork & Seal USA, Inc.; Dezurik, Inc.; Dow Chemical Company; Dravo Corporation; Durabla Manufacturing Company; Eaton Corporation; Elliott Company; Flowserve, Inc.; Flowserve FSD Corporation; Durametallic Corporation; Flowserve US, Inc. f/k/a Durco International, Inc.; FMC Corporation; Foster Wheeler Energy Corporation; George V. Hamilton, Inc.; Georgia Pacific Corporation; General Electric Company; General Refractories Company; Gordon Gasket & Packing Co.; Goulds Pumps; Greene Tweed & Company; Grinnell Corporation; Henry Vogt Machine Company; Hercules, Inc.; Honeywell International, Inc.; Honeywell International, Inc. f/k/a AlliedSignal, Inc.; Howden-Buffalo, Inc.; I.U. North America, Inc.; IMO Industries, Inc.; Industrial Holdings Corporation; Ingersoll-Rand Company; ITT Corporation; J.H. France Refractories Company; Kelsey-Hayes Company; Lockheed Martin Corporation; Maremont Corporation; McJunkin Corporation; McNally Industries; Met-Pro Corporation; Monsanto Company; NACCO Materials Handling Group; Nagle Pumps, Inc.; Nitro Industrial Coverings, Inc.; National Service Industries Venutres, Inc.; Oakfabco, Inc.; Ohio Valley Insulating Company, Inc.; Owens-Illinois, Inc.; Pneumo Abex Corporation; Premiere Refractories, Inc.; Rapid American Corporation; Riley Power, Inc.; Rockwell Automation, Inc.; Roper Pump Company; Rust Constructors, Inc.; Rust Engineering & Construction, Inc.; Schneider Electric USA, Inc.; State Electric Supply Company; Sterling Fluid Systems (USA), LLC; Stockham Valves & Fittings; Superior Boiler Works, Inc.; Tasco Insulations, Inc.; the Gage Company; the William Powell Company; Tyco Flow Control Company, LLC; Tyco Flow Control Company, LLC, a/k/a Lunkenheimer Valves; UB West Virginia, Inc.; Union Carbide Chemical & Plastics Company; Uniroyal, Inc.; Uniroyal Holding, Inc.; United Engineers & Constructors, Inc.; Energy & Construction, Inc.; Viacom, Inc.; Viking Pump Company; Vimasco Corporation; Warren Pumps, Inc.; Waukesha Cherry-Burrell; Washington Group International; Weil-McLain Company; West Virginia State Electric Supply; and Zurn Industries, Inc. (wvrecord.com)

Asbestos Hot Spots

Merrimac, MA: The Donaghue School will likely be kept closed beyond the end of winter vacation due to the presence of asbestos in the floor tiles. The asbestos-containing floor tiles were found during mold remediation at the 400-student facility.

According to an e-mail from Superintendent of Schools Paul Livingston, “we encountered a problem with some of the old asbestos tile, previously encapsulated under the rugs, drying out and curling on the edges.” Areas affected include the fifth- and sixth-grade hallway and several places in the third- and fourth-grade wing.

Board of Health Chairwoman Eileen Hurley explained the situation: “Plans have been laid out and approved by the DEP, licensed personnel have been retained, a large crew of workers will work two shifts per day, asbestos tiles will be removed and properly discarded, everything will be thoroughly cleaned, air clearance will be done through TEM (Transmission Electron Microscopy) as mandated by the state, and maintenance people will move furniture into the rooms after we receive clearance.”

Hurley added that it was very likely the school would remain closed past its planned opening date of Monday, though whether the Board of Health will allow the school to open next week has not been discussed or determined yet. (Newburyportnews.com)

Turkey Bans Asbestos as of Friday, December 31, 2010.

Ankara, Turkey: Turkey’s Environment Management Directorate General released a statement this announcing a regulation banning use of asbestos, effective as of Friday.

The country had partially banned asbestos some time ago. This complete ban brings the country into full compliance with European Union (EU) regulations.

The regulation bans the use of asbestos in production of any goods and supply of all products containing asbestos. “The ban on use of asbestos will both eliminate diseases stemming from the substance and end emission of asbestos to the environment,” the statement said. (The Anatolia News Agency)

5 of the Highest Settlement Awards for 2010

December 29th, 2010. By Kristine B

Once again we find ourselves at the end of a year—and it’s been a pretty big year for lawsuits. So, in celebration of the year that was, we’ve compiled some of the biggest settlements—in terms of amount of the award or settlement—of 2010. My deepest thanks to the incredibly talented, wonderful, smart, beautiful, fantastic duo of Lucy C. and Abi K. for helping me compile this list…

Personal Injury Lawsuits 

When it came to personal injury, wrongful death and negligence lawsuits, there were some pretty large awards and settlements given out in 2010. 

One settlement of $176 million was approved in a lawsuit filed after a 2003 nightclub fire in Rhode Island killed 100 people. The settlement money will go to survivors of the fire who suffered serious injury and to the children who lost parents in the fire. 

Meanwhile, in one of the largest jury awards ever in the US, a jury in El Paso awarded $132 million to victims of a bus crash in which two people were killed and several others were injured. The vehicle reportedly crashed when the driver began speeding and eating at the same time. The bus rolled down an embankment. 

Defective Products 

Speaking of automobiles, a settlement was reached earlier this year between Volkswagen of America, Inc. and vehicle owners who said their cars leaked during rainstorms. The defective product lawsuit alleged certain Volkswagen and Audi models contained design defects that allowed water to enter the passenger component and, in some cases, damaged electronic components of the vehicle. As part of the settlement, Audi was required to pay $10,000 to each of the class representatives, $9.2 million in fees and $675,000 in costs for the class-counsel firms. 

And in another defective product lawsuit, Medtronic agreed to pay $268 million to settle lawsuits regarding the company’s Sprint Fidelis Leads. The leads were alleged to have been defectively designed, allowing the wires to crack and causing unnecessary shocks to patients’ hearts. 

And, in a defective drugs lawsuit, the maker of Seroquel agreed to pay 17,500 patients a total of $198 million to settle allegations that the medication caused illnesses such as diabetes. 

Happy Meal Lawsuit: Where Do I Sign Up?

December 29th, 2010. By janem

Hey Kids, contrary to what those clever folks at McDonald’s (the experts in deceptive marketing) have led you to believe, Happy Meals are not Happy Toys.

The Center for Science in the Public Interest (CSPI) has filed a class action lawsuit on behalf of a Sacramento Mom against McDonald’s, claiming the fast food giant engages in “the unfair, unlawful, deceptive and fraudulent practice of promoting and advertising McDonald’s Happy Meal products to very young California children, using the inducement of various toys.”

Of course Monet Parham (Mom and Plaintiff) knows that she can simply say “No” when her two kids demand a Happy Meal, and likely anticipated a backlash from media and parents suggesting she do just that. But like a gazillion working parents, she is sick and tired of having to say no over and over again. If not for McDonald’s “Neuromarketing” (yep, that’s what they call it, getting into your kid’s head) she probably wouldn’t mind them having a Happy Meal now and then.

But McDonald’s aggressive marketing tactics have got to be reigned in. Any corporation that has so much impact on a child’s health must also have a moral responsibility to ensure they are serving healthy food and not paving the way for toddlers to become obese before they turn into teenagers.

A lot of thought—which spells mega-profit—is behind the marketing of Happy Meal toys. According to the CSPI lawsuit, QSR (quick service restaurant) magazine quoted Roy Bergold, Read the rest of this entry »

iPhone as Deadly Weapon? Mmmaybe Not

December 29th, 2010. By LucyC

Don’t Drive Up, Drive Right Thru the ATM! Here’s an alternate approach to breaking the bank. A man in Jacksonville, FL, decided to hit the ATM before Christmas…using his bulldozer. That would have attracted attention, no doubt. And of course he got caught—but not without putting up a fight. 

Thirty-one year old Robert Anderson used his frontloader to rip open a VyStar ATM near Marietta, and he was successful in getting some cash. However, during his getaway he allegedly tried to run over a police officer. A move not recommended, for a number of reasons. The police claim that Anderson didn’t stop when they tried to pull him over. Instead, he put the bulldozer in reverse and drove toward one of the officers. Problem solving is obviously not this guy’s strong suit. 

In any event, he was caught, and is now being held in jail. He is being held on grand theft charges having made off with an unspecified amount—something between $20,000 and $100,000. His wife misses him very much and wishes he was home for Christmas—so their children can spend Christmas with him. Well, they can always visit him. 

Armed with a Deadly iPhone? Does your iPhone have the restaurant robbery app? This guy’s does. Twenty-year old Jerome Taylor, from New London, CT, tried to rob a Northern Indian restaurant the Wednesday before Christmas, but rethought that plan on the fly, when the Read the rest of this entry »