Vaage Law Offices

San Diego Child Safety Alert: Could Your Child’s Bassinet Be Defective?

vaagelaw — Thu, 17 May 2012 01:01:06 +0000

As San Diego product liability attorneys, we are well aware of the dangers posed by defective products, particularly to small children. However, in many cases, safety alerts don’t reach parents in time.

This week we want to share an important safety recall involving defective bassinets.

The U.S. Consumer Product and Safety Commission has announced that approximately 46,000 Kolcraft Tender Vibes & Light Vibes bassinets are being recalled. The latches that attach the bassinet base onto the metal frame can appear to be locked in place but still remain unlocked. This allows the bassinet to become detached from the metal frame, causing the bassinet to fall and the infant to be injured.

According to the CPSC, there have been seven reports of latches that detached from the bassinet frame. One infant received a bruised cheek when the bassinet detached from the metal frame and landed sideways on the floor with the infant inside.

This recall specifically includes Kolcraft Tender Vibes bassinets with model numbers KB021-ARC, KB022-VER, KB039-CMR1 and Light Vibes bassinet with model number KB043-BNT1. A label with the model/item number of the bassinet is located on one of the legs of the metal frame. The recalled bassinets were manufactured from July 2008 through May 2010 and were sold nationwide and online from July 2008 through May 2012 for between about $50 and $100.

Consumers are advised to immediately stop using the recalled bassinets and contact the firm to receive a repair kit and instructions for securing the latches to the metal frame. In the meantime, parents are urged to find an alternate, safe sleeping environment for the child, such as a crib that meets current safety standards or play yard depending on the child’s age.

For additional information, contact Kolcraft toll-free at (888) 624-1908 between 7 a.m. and 6 p.m. ET Monday through Friday or visit the firm’s website at www.kolcraft.com

If you or someone you love has been seriously injured by a dangerous or defective product, don’t hesitate to contact a San Diego product liability attorney at the Law Offices of Robert Vaage for a free consultation.

The lawyers at the Law Offices of Robert Vaage in San Diego provide knowledgeable legal representation in the areas of product liability, personal injury/negligence, medical malpractice, elder abuse, and employment discrimination.

FDA Wants Medical Device Manufacturers to Make X-Rays Safer for Children

vaagelaw — Wed, 16 May 2012 00:57:52 +0000

The Food and Drug Administration is seeking public comment on a proposal encouraging medical device manufacturers to consider child safety in the design of new X-ray imaging devices. In the draft guidance, FDA is recommending that manufacturers design new X-ray imaging devices with protocols and instructions that address use on pediatric patients.

The FDA also proposes that manufacturers who do not adequately demonstrate that their new X-ray imaging devices are safe and effective in pediatric patients should include a label on their device that cautions against use in pediatric populations. The proposals are part of the FDA’s efforts to help reduce unnecessary radiation exposure in children.

As the FDA highlights, when used appropriately, X-ray imaging can provide valuable information to help with diagnosis, treatment planning, and surgical intervention in adults and children. However, these types of exams also expose patients to ionizing radiation, which can be of particular concern in pediatric patients.

The cancer risk per unit dose of ionizing radiation is generally higher for younger patients than adults, and younger patients have a longer lifetime for the effects of radiation exposure to manifest. Also, the use of X-ray equipment settings designed for adults can result in a larger radiation dose than necessary to produce a useful image for a smaller pediatric patient.

“The risk from a medically necessary imaging exam is quite small when compared to the benefit of accurate diagnosis or intervention. There is no reason for patients who need these exams to avoid them,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “Parents should engage in a discussion with their child’s physician about benefits and risks of X-ray, computed tomography (CT), and fluoroscopy exams.”

If you or someone you love has been seriously injured by a dangerous or defective medical device, don’t hesitate to contact a San Diego product liability attorney at the Law Offices of Robert Vaage for a free consultation.

California Eye Infections Traced to Contamination at Florida Pharmacy

vaagelaw — Tue, 15 May 2012 00:57:43 +0000

As San Diego medical malpractice attorneys, we are concerned that a total of 33 rare fungal eye infections have been traced back to contamination at a Florida pharmacy with a troubled history. Franck’s Compounding Lab in Ocala was previously linked to the deaths of 33 polo horses in 2009.

California health officials first alerted the Centers for Disease Control and Prevention after nine patients developed eye infections in March. Infections have now been reported in seven states. The patients had all undergone some type of eye procedure, including surgery or injections. Twenty-three experienced some degree of vision loss and 24 patients had to undergo another eye surgery, according to a CDC report.

Testing by the Food and Drug Administration on unopened bottles and unused syringes of the suspected products at Franck’s Compounding Lab revealed multiple bacterial and fungal species. Officials said the investigation to identify the root cause is ongoing and warned doctors and patients to stay away from “compounded products labeled as sterile from Franck’s,” according to the report.

As the Associated Press reports, Franck’s recalled dye lots and a single lot of triamcinolone in March. However, the pharmacy has not recalled or halted production of other sterile compounded products, which include chemotherapy and other injectable medications.

This case highlights a dangerous type of medication error that can occur during the compounding process. While pharmacists are no longer required to mix most drugs, some drugs, particularly liquid medications, must still be “compounded.” Pharmacy negligence can occur if the pharmacist uses an incorrect ingredient or combines the ingredients in the wrong amounts. As in this case, malpractice can also arise from pharmacies failing to take proper precautions to prevent contamination.

If you or someone you love has suffered from a medical error, don’t hesitate to contact a San Diego medical malpractice attorney at the Law Offices of Robert Vaage for a free consultation.

San Diego Product Liability Attorneys: This Week’s Product Safety Alert

vaagelaw — Sat, 12 May 2012 02:18:00 +0000

As San Diego product liability attorneys, we are well aware of the dangers posed by defective products. However, in many cases, safety alerts don’t reach consumers in time.

With this in mind, we would like to share this week’s product safety alert.

Kawasaki USA Recalls Recreational Off-Highway Vehicles Due to Injury, Death Hazard

The Consumer Product Safety Commission has announced that Kawasaki Motors Corp., U.S.A., of Irvine, Calif., will recall about 2,000 Teryx Recreational Off-Highway Vehicles. The recalled products have been incorrectly labeled as having a higher occupant capacity than is safe.

Operating the vehicle with additional occupants creates an injury or death hazard. Thankfully, no injuries have been reported.

The recalled vehicles are model year 2012 Kawasaki four-wheel recreational off-highway vehicles with side-by-side seating for two people, automobile style controls, with model types Teryx 750 FI 4×4, Teryx 750 FI 4×4 LE, Teryx 750 FI 750 4×4 LE SGE and Teryx 750 FI 4×4 Sport. The model type is printed on the hood of the vehicles. The recalled vehicles are available in the solid colors green, red, grey, silver, black and camouflage (khaki). They were sold at Kawasaki dealers nationwide from August 2011 through March 2012 for between $10,600 and $12,000.

Consumers will receive a replacement glove compartment cover stating the correct occupant capacity in the mail. They can install it themselves with included instructions or contact their Kawasaki dealer to schedule a free installation.

If you or someone you love has been seriously injured by a dangerous or defective product, don’t hesitate to contact a San Diego product liability attorney at the Law Offices of Robert Vaage for a free consultation.

San Diego Product Liability Attorney: Eight Defective Products That Should Be on Your Spring Cleaning List

vaagelaw — Fri, 11 May 2012 02:10:37 +0000

Although the weather is always nice in San Diego, spring still means spending more time outside with family and friends. Before you use spring-related products this season, it is important to check to see if they have been recalled. .

The Consumer Product Safety Commission has released the following list of defective recreational and outdoor products.

Adventure Playsets: The wood in the posts of the fort sections on the swing sets can weaken due to rotting, posing a fall hazard.

Pacific Cycle Dartmouth Swing Sets: The sling-style swing seats can crack or split prematurely, posing a fall hazard to consumers.

Slalom Glider: The Slalom Glider is a playground slide that lacks a transition platform on the top and sides on the chute. Children can fall when moving from the ladder to the slide and when descending the chute.

Uni-O Portable LP Gas Grills: The regulator on the grill can leak gas, which can ignite, posing a fire and burn hazard to consumers.

Kiddieland Toys Fairies Plastic Racing Trikes: The plastic fairy figures protrude from the top of the handle bar, posing a laceration hazard if a child falls on them.

Build-A-Bear Swimwear Set With Inflatable Inner Tube: The inner tube accessory can be pulled over a small child’s head, posing a strangulation hazard.

American Honda Grass Trimmers: The shaft can crack and cause the lower gear case and cutting attachment to detach, posing a laceration hazard to the operator and bystanders.

Pourable Gel Fuel: The pourable gel fuel can ignite unexpectedly and splatter onto people and objects nearby when it is poured into a firepot that is still burning. This hazard can occur if the consumer does not see the flame or is not aware that the firepot is still ignited. Gel fuel that splatters and ignites can pose fire and burn risks to consumers that can be fatal.

San Diego Accident Attorneys: Are Brain Injuries More Common Than Once Thought?

vaagelaw — Thu, 10 May 2012 02:05:14 +0000

As San Diego accident attorneys, we are concerned by a new report suggesting that traumatic brain injuries may be more common than previously thought. The study, conducted by researchers at the Mayo Clinic, applied a new system for classifying injuries caused by force to the head and found that the incidence of traumatic brain injury is likely greater than has been estimated by the Centers for Disease Control and Prevention (CDC).

“Even mild traumatic brain injuries can affect sensory-motor functions, thinking and awareness, and communication,” says study author Allen Brown, M.D., director of brain rehabilitation research at Mayo Clinic. “In assessing frequency, we have likely been missing a lot of cases. This is the first population-based analysis to determine prevalence along the whole spectrum of these injuries.”

Researchers used the Mayo Traumatic Brain Injury Classification System, a new brain injury method that classifies head injuries along a more comprehensive scale. The categories label patients with “definite,” “probable” and “possible” TBIs, after taking count of the patient’s symptoms.

Here is what they found:

TBIs occur in as many as 558 per 100,000 people, compared to the 341 per 100,000 estimated by the CDC.
Researchers found that 60 percent of injuries fell outside the standard categorization used by the CDC, even though two-thirds of them were symptomatic.
Mayo researchers found the elderly and the young were found most at risk for “definite” and “possible” injury, respectively, and men were more at risk than women.

As the researchers note, the findings support current efforts by the CDC to create a new brain injury classification system that more broadly defines traumatic head injury.

“With more complete assessment of frequency, we’ll have better tools to develop prevention programs, optimize treatments, understand cost-effectiveness of care and predict outcomes for patients,” says Dr. Brown.

If you or a member of your family has suffered from a severe head injury, you may be entitled to compensation. Contact experienced San Diego personal injury attorney Robert Vaage for a free consultation.

San Diego Medical Malpractice Lawyer: Do Electronic Records Impact Medical Errors?

vaagelaw — Wed, 09 May 2012 02:02:20 +0000

As San Diego medical malpractice lawyers, we are closely monitoring whether the increasing use of electronic records is resulting in an increase or decrease in medical errors. At this point, the evidence does not seem to point conclusively in one direction, suggesting additional research is needed.

The benefits of electronic medical records are numerous. For instance, they make it easier for doctors to review, share, and update patient medical records. Similarly, electronic prescribing can reduce the likelihood of medication errors and can automatically search for drug allergies and interactions.

However, like all technology, electronic health records systems are not perfect. Studies have documented medical errors in ordering tests or medications as well as other mistakes that result from disrupting a physician’s normal workflow. But the extent of the “glitches” has not been well documented, and it is unclear how these problems may be impacting patient safety.

“In 2012, the debate can not be, should we or shouldn’t we” use electronic records, said Dr. Ashsh Jha, associate professor of health policy at Harvard School of Public Health. “The new question is how do we do it well? How do we not cause harm? . . . That’s the more compelling question and one for which we essentially have no data.”

A recent report by the Institutes of Medicine recommends requiring makers of the systems to report patient injuries or deaths related to the technology to a national database. The report also called for more research and an independent body to investigate when something goes wrong, much like the National Transportation Safety Board investigates aviation accidents. If the private sector does not take actions to ensure the systems are safe, the report said, the Food and Drug Administration should step in, the report recommended.

The Office of the National Coordinator for Health Information Technology is taking comments on proposed rules that, if approved in the final version, could establish the reporting database, said David Muntz, principal deputy in that office. Please stay tuned for further updates on this important patient safety issue.

Source: Boston.com

Will Defective Heart Devices Prompt New FDA Reporting Protocols?

vaagelaw — Tue, 08 May 2012 02:02:00 +0000

The Food and Drug Administration is facing mounting pressure over the way it currently tracks defective medical devices, after new research revealed that faulty heart-defibrillator wires manufactured by St. Jude Medical Inc. were linked to 20 deaths. In response, the FDA is reportedly looking to create a new bar-code identification system to make it easier to track faulty medical devices.

As San Diego product liability attorneys, we agree that the FDA needs to take further action to protect patients from defective medical devices. Under the current system, the FDA relies heavily on a safety program in which about 300 hospitals voluntarily report when devices malfunction. This system is clearly not working.

Robert G. Hauser, a prominent cardiologist at the Minneapolis Heart Institute, said, the story of the St. Jude wires “is another example of our flawed regulatory system.”

Others in the medical community agree. “We don’t know the numerator of device failures at all,” said Edward J. Schloss, medical director of cardiac electrophysiology at Christ Hospital in Cincinnati. “There are times a lead fails, and no one knows it failed.”

The new system would allow the FDA to monitor data from hospitals and insurance companies to detect when devices are failing. “The ability of the unique device identifier number to strengthen our post-market surveillance is enormous,” says Peper Long, associate director for external relations at the FDA’s medical-device center.

The FDA is expected to release additional information about the new tracking system in the coming months. We will, of course, keep you updated.

Source: FDA

Could Interpreters Help Prevent San Diego Medical Errors?

vaagelaw — Fri, 04 May 2012 16:28:26 +0000

Equipping emergency rooms with professional interpreters may help prevent San Diego medical errors, according to new research. The study, conducted at two pediatric ERs and published in the Annals of Emergency Medicine, found that mistakes with the potential to result in “clinical consequences,” such as administering the wrong medication dose, were about twice as likely if there were no interpreters or if the translator was an amateur.

“The findings document that interpreter errors of potential clinical consequence are significantly more likely to occur when there is an ‘ad hoc’ or no interpreter, compared with a professional interpreter,” said lead researcher Glenn Flores, of the University of Texas Southwestern Medical Center in Dallas.

U.S. hospitals that receive federal funds are required to offer some type of translation assistance for those patients. Those services can include a professional interpreter who works for the hospital or telephone or video-based translation services. This study, based on 57 families seen in either of two Massachusetts pediatric emergency rooms, was the first to show how valuable professional translators can be, particularly in the ER.

Below are several additional findings:

When trained interpreters were available, 12 percent of translation slips could have potential health risks to a child.
When the interpreter was somebody such as a family member or a bilingual member of the hospital staff, 20 to 22 percent of their translation errors were potentially risky.
Errors were least common when the interpreters had 100 hours of training or more. In these cases, only two percent of their translation slips had the potential for doing the child harm.

“These findings suggest that requiring at least 100 hours of training for interpreters might have a major impact on reducing interpreter errors and their consequences in health care, while improving quality and patient safety,” the researchers wrote.

Source: Reuters

San Diego Product Liability Attorney: Important Drug Recall Alert

vaagelaw — Fri, 04 May 2012 02:23:57 +0000

As San Diego product liability attorneys, we are well aware of the dangers posed by defective products. However, in many cases, drug recalls and safety alerts don’t reach the patients that need them the most.

With this in mind, we would like to share the following drug recall alert.

Hospira, Inc. has announced that it is initiating a voluntary user level recall of one lot of Morphine Sulfate Injection USP, 4 mg/mL (C-II), 1 mL fill in 2.5 mL Carpuject, NDC 0409-1258-30, due to a customer report of two Carpujects syringes containing more than the 1 mL labeled fill volume.

Opioid pain medications such as morphine have life-threatening consequences if overdosed. Those consequences can include respiratory depression (slowed breathing or suspension of breathing), and low blood pressure.

The affected product is a prefilled glass cartridge for use with the Carpuject™ Syringe system. The affected lot number is 10830LL. The expiration date is April 1, 2013. Morphine Sulfate Carpujects 4 mg/mL are packaged in Slim-Pak® tamper detection packages with each box containing 10 Carpujects (NDC 0409-1258-30).

The affected lot was distributed in January 2012. It was initially distributed to wholesalers and a limited number of hospitals in Arizona, Colorado, Hawaii, Illinois, Indiana, Michigan, Minnesota, Ohio, Texas and Virginia.

Hospira has not received any reports of adverse events related to this issue for this lot. This is believed to be an isolated event, and Hospira has initiated an investigation to determine the root cause and preventive actions.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

Anyone with an existing inventory of affected product should stop use and distribution and quarantine the product immediately and call Stericycle at 1-888-912-7088 to arrange for the return of the product.

Source: FDA

If you or someone you love has been seriously injured by a dangerous or defective drug, don’t hesitate to contact a San Diego product liability attorney at the Law Offices of Robert Vaage for a free consultation.