Personal Injury and Social Security Disability Blog

FDA Requires Black Box Warning for Reglan (Metoclopramide)

The AP (2/27) reports, "Federal health officials are adding their sternest warning to a heartburn drug that has been linked to muscle spasms." The agency claims that "the drug, widely known as Reglan [metoclopramide], has been shown to cause spasms and tics when used for long periods of time or at high doses." These problems "are usually irreversible, even after patients stop taking the drug," the FDA notes. As a result, "the agency is requiring drugmakers to add a black box warning, the most serious type available, to their products" and to "distribute medication safety guides to patients." Although "the drug's current labeling already mentions risks of developing the spasms, called dyskinesia...the agency's action Thursday elevates the warning to the top of the label."

According to Bloomberg News (2/27, Larkin), Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, warned that "chronic use of metoclopramide therapy should be avoided in all but rare cases where the benefit is believed to outweigh the risk." The drug works "by increasing movement of the stomach muscles, accelerating the stomach's emptying into the intestines." New research has shown that "the treatment causes more movement disorders than any other drug," officials note.

The drug "is made by several drugmakers including Baxter Healthcare Corp.," and "the products are available in a variety of formulations including tablets, syrups and injections," Dow Jones Newswires (2/27, Dooren) adds. It is "sold under brand names including Reglan Tablets, Reglan Oral Disintegrating Tablets, Metoclopramide Oral Solution and Reglan Injection."

From the American Association for Justice news release.

Toys Recalled for Lead, Choking Hazard

This announcement is from the U.S. Consumer Product Safety Commission:

Various Toys Recalled by CBB Group Due to Choking Hazard and Violation of Lead Paint Standard

WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed.

Name of product: Fishing Games, Rattles, Pull-A-Long Cars, Mini Pull Back Cars, and Cartoon Bubble Guns

Units: About 39,000

Importer/Distributor: CBB Group Inc., City of Commerce, Calif.

Hazard: The fishing games, baby rattles and pull-a-long cars contain small parts, which can detach and pose a choking hazard to children. The mini pull back cars and bubble guns have surface paints which contain excessive levels of lead, violating the federal lead paint standard.

Incidents/Injuries: None reported.

Description: The recalled toys are described in the chart below:

Product	Information
Fishing Games	Model KK-4296 UPC# 782468042968 Model PT-2006 UPC# 830002020061 Model T-8112 UPC# 704291081129 Model KK-4461 UPC# 782468044610
6-Piece Rattle Set	Model ET-1293 UPC# 800323012939
6-Piece 3” Pull Back Cars	Model KK-4382 UPC# 78246804382
3-Piece Rattle Set	Model ET-1388 UPC#800323013882
Pull-A-Long Car	Model ET-1041 UPC# 800323010416 Model KK-4218 UPC# 782468042180
Battery-Operated Cartoon Bubble Gun	Model KK-4275 UPC# 782468042753 Model KK-4276 UPC#782468042760
Battery-Operated Dolphin Bubble Gun	Model OR-2238 UPC# 868333022386

Sold at: Dollar stores and toy stores nationwide from July 2007 through December 2008 for between $1 and $5.

Manufactured in: China

Remedy: Consumers should take the recalled products away from young children immediately and return them to the place where purchased for a full refund.

Consumer Contact: For additional information, contact CBB Group, Inc. toll-free at (866) 628-6238 anytime, or visit the firm’s Web site at www.cbbgroup.com

Medtronic to Join Other Companies in Disclosing Payments to Doctors

The Wall Street Journal (2/25, B2, Burton) reports that "medical-device maker Medtronic Inc. said it will begin to make public disclosure of all payments over $5,000 it makes to doctors." The company "said it will report the information annually and that the first such disclosure will take place in March 2011 for payments beginning next January."

"The move comes months after two US senators asked the company to disclose more about its consulting arrangements with physicians and cited prior allegations that the company paid surgeons to boost spinal implant sales," the AP (2/25) notes. "Eli Lilly & Co. and Pfizer Inc. have already volunteered to publish such information, and Medtronic said its decision was also voluntary."
       

Minnesota's Star Tribune (2/25, Moore) adds that "Medtronic and other med-tech companies have long maintained that their relationship with doctors differs greatly from those employed by the drug industry," as physicians often "need training on new devices, or their input is needed to improve products." Critics, however, "have charged that such payments...can influence doctors' practice decisions and are designed to win brand loyalty."

From the American Association for Justice news release.

Dead Peasant Insurance Policies Draw Litigation

In a blog on the Wall Street Journal website (2/24) Ashby Jones wrote that "dead peasant" insurance policies are "spawning a good deal of litigation." Jones said, "The point of 'dead peasant' policies seems to be this: Companies contribute money to the policies, which then can be used to pay for a variety of company expenses. In addition, when employees, retirees and former employees die, the company receives tax-free death benefits." He added, "in the Texas case, the widow of a disabled former employee of Houston-based Amegy Bank NA is suing to recover $1.6 million in life-insurance death benefits the bank received after her husband died last year."

From the American Association for Justice news release.

Smith & Wesson Recalls Guns That Could Misfire

A recall of Walther PPK pistols by the manufacturer Smith & Wesson has been reported by the Dallas Morning News. There is an apparent danger that the guns might fire without the trigger being pulled. This might not be a big deal elsewhere, but in Texas, where about half the population seems to be packing heat, this could be a serious problem. Here are excerpts from the article:

The gun maker said it was recalling all Walther PPK and PPK/S pistols that it manufactured from March 21, 2002, until Feb. 3. Customers with the affected pistols can send them back to the company and have them returned with the new part at no cost, the company said.

The filing cited a problem in the affected pistol models that "may permit a round to be discharged without the trigger being pulled."

The company said it was issuing the recall "because any unintended discharge of a firearm has the potential for causing injury."

The online notice and regulatory filing did not say whether any injuries had resulted, and it did not specify how many guns were being recalled.

Customers with the affected pistols can send them back to the company and have them returned with the new part at no cost, the company said.

For more information, including serial numbers, see www.smith-wesson.com or call 1-800-331-0852.

Study Suggests Sprint Fidelis Leads May Be Failing at Higher Rate Than Previously Known

The Wall Street Journal (2/24, Burton) reports that Medtronic Inc.'s Sprint Fidelis defibrillator leads, "pulled from the market in 2007, represent an 'increasing hazard' for more than 200,000 heart patients world-wide," according to "Minneapolis Heart Institute cardiologist Robert G. Hauser, who first spotted the fractures in the Sprint Fidelis leads in early 2007, and David L. Hayes, chairman of cardiology at the Mayo Clinic in Rochester, Minn." The cardiologists say that the "potential danger from fractures and other failures increases as the implanted wires...age." The Journal adds, "It is estimated that about 150,000 Sprint Fidelis leads remain implanted in U.S. patients."

The New York Times (2/24, B9, Meier) reports that in a study published online in the journal HeartRhythm, "Dr. Hauser and Dr. Hayes reviewed the performance of all defibrillator leads implanted at their institutions from 2004 to 2008. Of about 3,000 leads implanted during that period, the Sprint Fidelis accounted for 848 leads, or about 28 percent of the total." According to the investigators, "during the period, the annual failure rate of the Sprint Fidelis was 3.75 percent compared with 0.6 percent for other leads." The researchers also found "that the failure rate was increasing." The physicians wrote, "The hazard of the Sprint Fidelis lead is increasing, while the failure rate of other defibrillator leads are low and stable." The Times adds that "Medtronic and heart experts said leads that are functioning should not be removed as a precaution, because of the risks involved in the removal procedure."

From the American Association for Justice news release.

New Rule Impedes Cases Against Nursing Homes

In the Washington Post (2/24, D2) Regulators column, Cindy Skrzycki writes, "The Bush administration shut off a source of information last fall about abuse and neglect in long-term care facilities that people suing nursing homes consider crucial to their cases." Under the rule, "state inspectors and Medicare and Medicaid contractors" were designated as "federal employees, a group usually shielded from providing evidence for either side in private litigation." The regulation "generally prohibits state health departments and contractors from participating in private lawsuits involving facilities that are in the federal assistance program without approval by the head of the Department of Health and Human Services." As a result, litigants must "go to greater lengths, including seeking court orders, to get inspection reports," and such requests "now are stalled between state and federal offices." According to the Bush administration, "the rule was...necessary to accommodate the hiring of new contractors to make Medicare payments to providers, perform audit and fraud reviews."

From the American Association for Justice news release.

Poll Finds People Doubt Impartiality Of Elected Judges Towards Their Donors

In the category of breaking news such as "the earth is still round" comes this poll revealing that people think campaign contributions affect the impartiality of judges:

The Charleston (WV) Gazette (2/23, Nyden) reports that a Harris Interactive poll funded by Justice at Stake Campaign, a nonprofit coalition that includes the American Association for Justice, between February 12 and 15 of 1,006 adults, 18 years or older found that "an overwhelming majority of people...doubted that elected judges can be impartial in cases that involve major campaign donors." According to Harris, "seven of every 10 people polled believe judges are likely to be biased in cases involving major campaign supporters," and "nearly 85 percent believe those judges should step down from hearing those cases." Furthermore, "81 percent believe judges should not decide whether they can be fair and impartial." Meanwhile, "a separate USA Today poll recently found that about 90 percent of respondents believed judges should not hear cases involving campaign contributors."

From the American Association for Justice news release.

FDA Warns Of Deaths Due To Raptiva

The CBS Evening News (2/20, story 8, 0:25, Couric) reported, "Tonight, the FDA reports three patients taking the psoriasis drug Raptiva have died of a rare brain infection. The FDA added its most serious warning to Raptiva four months ago, and regulators in Europe now say the drug's benefits no longer outweigh the risk. Raptiva's maker, Genentech, says it's working with the FDA to protect patient safety."

Bunning Suggests Ginsberg Will Likely Succumb To Cancer Within Nine Months

Ouch, this is a cold-hearted thing to say:

The Louisville Courier-Journal (2/22, Gerth) reported that Kentucky Sen. Jim Bunning (R) "predicted over the weekend that U.S. Supreme Court Justice Ruth Bader Ginsburg would likely be dead from pancreatic cancer within nine months." In a speech "Saturday at the Hardin County Republican Party's Lincoln Day Dinner" in Elizabethtown, Kentucky, "Bunning said he supports conservative judges 'and that's going to be in place very shortly because Ruth Bader Ginsburg ... has cancer.' 'Bad cancer. The kind that you don't get better from,'" Bunning said, adding, "Even though she was operated on, usually, nine months is the longest that anybody would live after (being diagnosed) with pancreatic cancer." The Courier-Journal noted, "Ginsburg, who is 75, was diagnosed with pancreatic cancer earlier this month and surgeons removed a small tumor that had not spread. Doctors termed it a 'Stage 1' cancer, meaning they found it in the early stages when it is most curable."

In a story headlined "Sen. Bunning counting Justice Ginsburg's days," The Hill (2/23, Wilson) follows up on the "report in the Louisville Courier-Journal," noting, "Though mortality rates for pancreatic cancer are high, Ginsburg's was caught unusually early, giving her a better chance for long-term survival. Ginsburg is one of the most liberal members of the Supreme Court, a reliable ally of Justices John Paul Stevens, David Souter and Stephen Breyer among the Court's left-leaning bloc. ... Ginsburg is seen as one of the most likely members of the Court to step down during President Obama's first term, along with the 88-year-old Stevens."

From the American Association for Justice news release.