Monday, November 29, 2010

Patient Safety at Hospitals Still Lacking

Study finds hospital safety still lacking.
In a front-page study, the New York Times (11/25, A1 Grady) reported efforts "to make hospitals safer for patients are falling short, researchers report in the first large study in a decade to analyze harm from medical care and to track it over time." The study, "conducted from 2002 to 2007 in 10 North Carolina hospitals, found that harm to patients was common and that the number of incidents did not decrease over time. The most common problems were complications from procedures or drugs and hospital-acquired infections." The study, which is "being published on Thursday in The New England Journal of Medicine," is "one of the most rigorous efforts to collect data about patient safety since a landmark report in 1999 found that medical mistakes caused as many as 98,000 deaths and more than one million injuries a year in the United States."
Bloomberg News (11/29, Olmos) reports the study found "almost one in five hospital patients was injured by their care," and researchers "found little improvement from industry and government efforts to improve safety." The "six-year study of 2,341 hospital admissions in North Carolina found that 18 percent of patients suffered at least one safety-related incident, ranging from minor injuries with little harm to life-threatening mistakes and fourteen deaths." The North Carolina hospitals "were chosen because the state is considered a leader in efforts to improve patient safety."
The Boston Globe (11/29, Cooney) reports Dr. Christopher Landrigan, "a patient safety researcher at both Children's Hospital Boston and Brigham and Women's Hospital, led a team that studied a sample of more than 2,300 patient admissions to 10 hospitals in North Carolina between 2002 and 2007." They "picked the state because of its active role in safety training programs. To see if those efforts were paying off, they used a tool designed by the Cambridge-based Institute for Healthcare Improvement to detect cases in which care went wrong." Overall, "there were 588 instances of harm suffered by nearly 1 in 5 patients admitted to all 10 hospitals." Modern Healthcare (11/29) reports "the rate of harm -- 25 instances per 100 hospital admissions -- did not change significantly during the study's five-year span from 2002 to 2007, they said. And of the instances of patient harm they detected, 50 were life-threatening and 14 patient deaths were attributable to medical errors."

Tuesday, November 23, 2010

Volvo recalls 2010 XC60

Volvo recalls models over airbag errors, fire-prone navigation units. writer Colin Bird reported in the Chicago Tribune (11/22) that "Volvo is recalling the 2010 XC60 over airbag concerns." According to Bird, "58 XC60s are being recalled for side curtain airbags that may have been misassembled. The error may cause the airbags not to deploy correctly or possibly not at all, which could increase the risk of injury in a crash." The automaker also issued a separate recall for several models containing faulty Garmin 760 GPS units, "which can potentially overheat, possibly causing a fire in the car."

Friday, November 19, 2010

Depuy Orthopedics ASR Hip Implant Recall

In 2005, DePuy, a division of Johnson & Johnson, introduced the ASR and ASR XL hip replacement systems in the US after winning “510(k) clearance” from the Food and Drug Administration (FDA). This type of clearance meant that the product was approved without having to pass clinical trials to ensure it was safe. In 2008, The British equivalent to the FDA recognized “evidence of genetic damage in patients with certain metal hip implants,” such as the ASR system. Also in 2008, the FDA received higher than expected complaints from patients who received ASR hips. In 2009, DePuy voluntarily withdrew the ASR system from the Australian market due to higher than expected failure rates. In early 2010, DePuy notified physicians that the ASR system would be phased out by the end of the year. It was not until August 24, 2010, that DePuy recalled the ASR hip replacement system in the US and worldwide.
DePuy Orthopedics, Inc., and Johnson & Johnson are working hard to control the problems created by the DePuy ASR hip prosthesis. Part of this effort includes using physicians to ask patients to sign waivers and authorizations allowing DePuy access to patient records. DePuy is using Broadspire to manage this process. While DePuy promises to cover certain medical expenses associated with revision surgery, there remain a number of important concerns patients should have regarding this process. First, when a patient signs the waivers and authorizations, the manufacturer is given access to private medical information. Second, once the manufacturer gets copies of private medical records and the parts of the prosthesis removed during revision surgery, the manufacturer may not preserve that information properly. Third, while the manufacturer has promised to pay certain costs, the manufacturer is not volunteering to compensate for harm suffered as a result of the defective prosthesis. To be fully compensated for all of the injuries caused by the defective prosthesis, a patient may need to sue the manufacturer.

Thursday, November 18, 2010

Automotive News Email Blast for Subscribers, November 18 2010

Automotive News Email Blast for Subscribers, November 18 2010

Window Shades and Blinds Recalled amid Safety Review

WASHINGTON — The death of a toddler who strangled in a window shade cord spurred a huge recall Wednesday, even as the industry crafts a better standard to make window coverings in American homes safer for children.
The Consumer Product Safety Commission says Hanover Direct, of Weehawken, N.J., has agreed to recall about 495,000 roman shades and some 28,500 blinds. Hanover is the parent company for Domestications, The Company Store, and Company Kids.
CPSC says the 22-month-old boy in Cedar Falls, Iowa, became trapped in the pull cord of a roman shade in May. He was found hanging by his neck and was rescued by his father, but died later at a hospital.
The commission estimates that one child dies every month after strangling on the cords of blinds or roman shades.
Consumer safety groups have complained that the government and industry have been slow over the last two decades to cut child deaths from blinds. More recently, however, CPSC has stepped up its efforts to get safer window coverings on the market.
At a meeting of industry officials and consumer advocates at CPSC headquarters in Bethesda, Md., this week, the head of the commission urged manufacturers to move swiftly to approve new safety rules.
"Chart a new course today," said Chairman Inez Tenenbaum, "a course that promises to eliminate, not just mitigate, the risk of harm to children."
While there have been millions of blinds and shades recalled in the past several years, safety advocates say fatality rates haven't improved much and the process for moving safer designs to the market has been sluggish.
The problem is the cord on the blinds and shades that rolls them up and down. Young children can get tangled and trapped in the cords, leading to injuries and deaths. Since 1990, CPSC estimates that nearly 250 infants and young children have died from accidentally strangling on window cords.
Ralph Vasami, executive director of the Window Covering Manufacturers Association, says blinds and shades can be used by most people with no problem at all. "But there is a hidden risk to children," he said in an interview.
Vasami says manufacturers are pressing ahead to revise the current voluntary safety rules on the books, standards developed by industry. He expects to have new rules ready for a vote by next October.
Current standards for roman shades, Vasami says, call for them to be cordless; have cords that are inaccessible to children; or if the cord is in reach of a child, then it cannot be able to form a hazardous loop that could trap a child's head. That standard would likely serve as a model and be expanded to cover blinds in the new writing of standards underway.
Wednesday's recall involving Hanover is an expansion of a previous recall from October 2009 of about 90,000 roman shades. Thousands more roman shades as well as roller and roll-up blinds are now being called back. The products were sold through the company nationwide from January 1996 through October 2009.
Consumers can contact the firm at 800-453-1106 or and for more information.

GM recalls Buick Lucerne and Cadillac DTS after fire reports

GM recalls 13,780 vehicles after fire reports; Chrysler recalls 16,000 Jeep Libertys
DETROIT -- General Motors Co. is recalling 13,780 Buick Lucerne and Cadillac DTS cars in the United States because of a flaw that can cause power-steering fluid to leak and ignite a fire in the engine.
Chrysler, meanwhile, said it plans to recall 16,000 Jeep Liberty SUVs to fix faulty windshield wiper systems, according to The Associated Press.
The company is targeting model year 2010 and 2011 Lucerne and DTS vehicles following reports of two fires related to electrical arcing triggered by leaking fluid coming into contact with the starter or alternator cable, according to a letter on the National Highway Traffic Safety Administration's Web site today.
No injuries were reported in the fires, Alan Adler, a spokesman for Detroit-based GM, said in an interview.
The automaker concluded the starter and alternator cables were incorrectly installed so they touch a power-steering line, it said in the letter to NHTSA, the U.S. auto-safety regulator.
GM will repair the cars, which are under warranty, free of charge to owners. The recall totals 14,245 cars worldwide, GM said in a statement on its Web site.
The company this year has recalled 1.53 million cars and trucks for a windshield-wiper flaw that may cause fires, and 303,100 Impala cars in the U.S. because seat belts in the front seat may not be properly anchored and may fail to restrain passengers in a crash.
Wiper problems
In the Chrysler recall, the automaker said the wiper problem involves certain 2008 Jeep Liberty SUVs, the AP said. Chrysler said water could get into the windshield wiper motor of the Jeeps and stop the wipers.
Chrysler said no crashes or injuries have been tied to the recalls, the AP reported.
Jeep dealers will replace the windshield wiper motor free of charge, according to the report, and the recall is expected to begin this month.

Ford Winstar Minivans Need to be Fixed

NHTSA: only fraction of recalled minivans repaired.
The AP (11/17) reported, "The government is urging owners of recalled Ford Motor Co. minivans to get their vehicles fixed." According to the National Highway Traffic Safety Administration, "only about 75,000 of the minivans had been fixed by the recall, leaving a large number of vehicles still to be repaired." Concerns "that the rear axles could corrode and potentially break" prompted the August recall of nearly 575,000Ford Windstar models.

Tuesday, November 16, 2010

Study Shows one in Seven Medicare Patients Harmed by Medical Error

Study: one in seven hospitalized Medicare patients harmed.
The New York Times (11/16, B3, Wilson) reports, "One of every seven Medicare beneficiaries who is hospitalized is harmed as a result of problems with the medical care there, according to a new study from the Office of Inspector General for" HHS, which also "said unexpected adverse events added at least $4.4 billion a year to government health costs and contributed to the deaths of about 180,000 patients a year." In response to the findings, "Dr. Carolyn M. Clancy, director of the federal Agency for Healthcare Research and Quality, said the adverse events were affecting hospital patients at an 'alarming rate' and promised to work to improve it." And, "Dr. Donald M. Berwick, administrator of the Centers for Medicare and Medicaid Services, said it would aggressively pursue recommendations to broaden the definition of adverse events, monitor and prevent them."
USA Today (11/16, Rubin) reports, "The study is the first of its kind aimed at understanding 'adverse events' in hospitals -- essentially, any medical care that causes harm to a patient, according to the Department of Health and Human Services' Office of Inspector General." Notably, "patients in the study, a nationally representative sample that focused on 780 Medicare patients discharged from hospitals in October 2008, suffered such problems as bed sores, infections and excessive bleeding from blood-thinning drugs, the report found."

Monday, November 8, 2010


Jaime D. Jackson recently settled a case against Keeway Motor America, Inc. involving their importation and sale in the United States of what Plaintiff alleged was a defective 250 cc Keeway Dorado motorcycle that had been manufactured by a Chinese manufacturer in China.

Plaintiff was driving her recently purchased Keeway Dorado motorcycle when the front end of the motorcycle began to wobble resulting in her exiting the roadway and crashing. After extensive investigation, it was learned that the upper and lower steering races in the steering assembly were missing some ball bearings in the steering races. This was an assembly defect that occurred at the manufacturing facility in China. The proper number of ball bearings in the steering races is critical to the safety and steering of the motorcycle.

Unfortunately, numerous plaintiffs, as was the case here, are unable to obtain proper jurisdiction over Chinese manufacturers in the United States, because China is not a party to the Hague Convention. However, in this litigation, we came up with creative theories of liability against the importer of the defective motorcycle including citing to regulations promulgated by the National Highway Traffic Safety Administration (NHTSA) that view the importer of motor vehicles (which include motorcycles) as the manufacturer of the product with an obligation to make sure that the product is free from defects and safe for its intended use before being sold in the United States.

It is unfair that injured Americans sometimes may not be able to sue a manufacturer of unsafe products because of arcane laws, however, with these new theories of liability and creative litigation strategies developed by Jaime Jackson other responsible entities such as importers and dealers can be held accountable for selling unsafe products and victims of these unsafe products can obtain justice and be properly compensated for the harm caused by these unsafe products.

Depuy Orthopedics ASR Hip Implant Recall

Depuy Orthopedics recently recalled 93,000 ASR hip implants. Finally, after they, stopped selling this hip implant in other countries outside the United States.

Tuesday, November 2, 2010

Seatbelt Load Limiters: A Dangerous Safety Defect

A load limiting device or torsion bar (hereinafter simply referred to as “load limiter”) were introduced originally by some manufacturers in the early eighties in conjunction with vehicles equipped with airbags. The theory or justification behind such devices are that they are intended to reduce belt induced injuries such as rib fractures by allowing forward movement of occupant’s torso when belt loads exceed some threshold. The release of the webbing allows an occupant to move forward until the occupant’s forward motion is finally arrested by the deployment of the frontal airbag. In theory, this design concept may work; if an occupant were to be involved in a 35 mph NCAP full frontal barrier crash test where the torsion bar releases webbing and the airbag deploys arresting the forward movement of the occupant. In virtually all other crash scenarios, i.e. rollover, offset frontals, frontal impacts where the airbag fails to deploy or any impact where airbags do not deploy, this design is extremely dangerous because it introduces slack into the seatbelt system; thereby failing to restrain the occupant and may permit the occupant to be ejected, or slam into the interior of the vehicle despite the fact that the occupant did exactly what they were supposed to in properly wearing their seatbelt.
In any crash scenario where an occupant was belted, but sustained significant injury, one place to look is whether or not the seatbelt retractor was equipped with a load limiting-type device. As mentioned, common scenarios include rollovers and offset frontal collisions where an occupant may miss the airbag because of the PDOF, or the airbag fails to deploy; since load limiters are designed to work in conjunction with an airbag.
[1] One of the original attempts at purported load limiting was sewing the seatbelt over itself or sewing a fold into the seatbelt webbing, more appropriately called rip stitching. The rip stitching would then pull apart when loaded introducing slack into the seatbelt system. Rip stitching, because it was such a dumb idea, for the most part went away and was replaced by a device referred to as a torsion bar built into the seatbelt retractor. The torsion bar is a metal rod that will twist when sufficient force is applied. The torsion bar will twist under load allowing seatbelt webbing to be released from the retractor thereby introducing slack into the system. The subject of this paper and presentation focuses on the deadly, deceitful and dangerous defect-torsion bars.

Monday, November 1, 2010

Toyota secretly bought cars to hide problems from public

Toyota secretly bought problem cars, lawsuit says
Toyota Motor Corp. secretly bought back from U.S. consumers vehicles it found with speed-control defects as part of a strategy to hide unintended-acceleration problems from safety regulators and the public, a revised lawsuit claims. The repurchase transactions included strict confidentiality agreements barring consumers from disclosing the problem to anyone and from suing the automaker, according to the amended class-action complaint.
This story should not require registration.