Washington Injury Attorney Blog

The Pacific Northwest has experienced a severe storm this past week and The Seattle Times reports that 191,000 Puget Sound Energy power customers are without power.

During times of power outages, there are always several incidences of people suffering carbon monoxide poisoning or death.

In Kent, Washington, in two separate incidences, two families were hospitalized after becoming ill from carbon monoxide poisoning. In both cases, the families were using charcoal barbecues for heat according to KOMO News.

Carbon monoxide is a toxic gas that is colorless and odorless and when people are exposed to it without sufficient proper ventilation they are unable to absorb oxygen and they become ill with symptoms what include confusion, headaches, chest pains, confusion, shortness of breath, vomiting, drowsiness and flu-like symptoms. With higher exposure levels victims can experience central nervous system damage, heart problems and even death.

Carbon monoxide poisoning is the number one cause of accidental poisoning deaths every year. According to the Centers for Disease Control, 500 people die and more than 15,000 are treated in hospital ER rooms every year due to carbon monoxide poisoning.

Carbon monoxide poisoning cases arise during power outages when people try to warm their homes with alternate methods including portable stoves, barbecues and generators.

Of course it doesn't have to be the middle of a power outage for carbon monoxide poisoning occur. Faulty appliances, unventilated heaters, clogged chimneys and cars left running in a garage can all lead to carbon monoxide poisoning.

Continue reading "Carbon monoxide poisoning a danger during power outages" »

The American College of Obstetricians and Gynecologists (The College) and the American Urogynecoloc Society (AUGS)recommends that synthetic mesh placed vaginally to treat pelvic organ prolapse (POP) should only be performed on women that surgeons deem "high risk" whose benefit from the surgery outweighs the risks. This is only one of the recommendations of The College and AUGS involving this surgical procedure in wake of many women coming forward with continuing pain after the corrective surgery and other complications.

The joint committee of The College and AUGS is also calling for a development of a national registry to track the outcomes of patients who have been or will be treated with surgical mesh.

More than 350,000 women have surgery for POP every year in the United States. POP is a condition in which the muscles in the pelvis become torn or stretched and organs in the pelvis can bulge into the vagina. A leading cause of POP is childbirth but other factors such as obesity, constipation, coughing, aging and physical activity can contribute to the condition.

Surgical mesh was first introduced to repair POP in 2001 and it was cleared through the FDA 501(k) premarket notification system which is the "fast track" for a product to get FDA approval. The approval was based on the vaginal mesh being "substantially equivalent" to the surgical mesh used in hernia repair. Products introduced to the market using the 501(k) approval do not have to go through clinical trials and provide data which supports the safety of the medical devices.

Another recommendation by The College and AUGS is that surgeons be trained specifically in the procedure to place the device. Many suspect that one factor in the device failure unskilled surgeons performing the operation.

This information is provided by Washington Injury Attorney blog, a service of The Farber Law Group. We are a personal injury law firm and we represent people who have been seriously injured due to dangerous or defective products.

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Patients in Washington state and throughout the Northwest are not the only ones mulling over their options after the ASR XL Acetabular and Hip Resurfacing Systems hip implant was recalled after many patients had very serious health repercussions due to the faulty design of the hip implant. Common complications include swelling, loosening of the joint, severe pain and fractures. More serious complications include metallosis which is metal poisoning.

In Australia, their senate is mulling over whether they want to mandate that doctors be forced to report problems that they observe with medical devices. This comes after the DePuy hip implant failed in about 5,000 Australian patients who received the device and these same patients have initiated a class action lawsuit.

One of the Australian senators said that he believes that the Therapeutic Goods Administration (TGA), a consumer watchdog agency which is similar to the Federal Drug Administration here in the U.S., "failed consumers".

One Australian news agency went so far as to call the massive DePuy failure a "scandal".

The community affairs committee of their Senate is recommending a couple of major reforms in the Australian healthcare system including:

• Mandatory reporting -- Requires all health practitioners report adverse results from medical devices to the Therapeutic Goods Administration (TGA).
  
• Transparency -- Eliminates financial incentives paid to doctors by medical device manufacturers and pharmaceutical companies to use their products.

Looking at Australia from the U.S., it seems like their TGA did a better job than the FDA did here in the U.S. as the DePuy hip devices were pulled from their market while they were still being implanted here in the U.S.

Source: "Doctors could be forced to report faults", news.com.au, 11/22/11

This information is provided by Washington Injury Attorney blog, a service of The Farber Law Group. We are a personal injury law firm representing patients with failed DePuy hip implants in the greater Seattle area and throughout the Pacific Northwest.

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Continue reading "Committee recommends mandating that doctors report failed medical devices in wake of DePuy hip implant recall" »

A personal injury is any kind of accident where you are injured. If you have an accident and feel another party is at fault, you may decide to file what is called a personal injury claim in order to be compensated for damages that may occur from medical or emotional costs associated with the accident.

There are many types of personal injury claims, and while you can file a personal injury claim for just about anything, the most common types of claims are those that involve car accidents, work related injuries, slip and fall accidents, accidents in your home and holiday accidents. Others include product liability claims such as when you are injured from a defective product that you have purchased.

When you file a personal injury claim, you are asked to describe the accident, and provide a dollar amount that you think is suitable compensation. This can include medical and dental bills, money lost due to time missed from not being able to work, or even emotional damage if you can prove your accident caused you emotional or psychological stress.

While filing a personal injury claim seems like a straightforward process, it’s actually very complex and often a controversial topic, with many politicians and attorneys calling for caps on the amount that someone can receive due to a personal injury claim.

If you think you have been in an accident that is clearly the fault of some other party whether it is a business, company or another person, you have the right to file such a claim. The best thing to do first is to note all of your injuries and keep good records of every step of your process. If you have seen a medical doctor, keep good records of the diagnosis.

You will probably find navigating the system on your own challenging and frustrating, and in this case, you may need to hire a personal injury lawyer to give you advice on what to do next, how much your case is worth in damages, and any providing you with any other necessary information to make the process of filing a personal injury claim run smoothly.

If you are hurt in any type of accident, you should not just sit idly by if someone else is clearly at fault. A personal injury claim can make sure that you receive the proper compensation for your accident.

This information is provided by Washington Injury Attorney blog, a service of The Farber Law Group. We represent people who have serious personal injuries due to the negligence of another.

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In August 2010, the DePuy Orthopaedic division of Johnson & Johnson recalled the ASR XL Acetabular and Hip Resurfacing Systems due to a high failure rate compared to traditional hip implants. Patients fitted with the DePuy implants were advised to meet with their orthopedic surgeons to determine if they might require a hip "revision" or the replacement of their hip prosthesis.

The DePuy hip implants were touted by the company as the device that should be used in younger and active patients because the metal-on-metal design would have a longer life and the design would allow the patient to remain active.

Unfortunately, studies have shown that the metal-on-metal design of the hip implant caused cobalt and chromium ions, or metal artifacts, to be released into the patient's tissue which caused a number of complications.

One complication is that metal released in a patient's system can cause pseudo-tumors or granulomas. A granulomatous reaction can occur when immune cells called macrophages wall off foreign substances that the body is unable to eliminate. In the case of the metal-on-metal hip implants, the masses can form as an immune reaction to metal debris. These pseudo-tumors can also contain necrosis, or dead cells.

If a pseudo-tumor grows large, it can cause loosening of the hip joint and it can eat away at the bone.

What tests can determine the presence of a pseudo-tumor?

Doctors have several tests which they can use to determine what is causing a patient's symptoms or to see how the hip implant is doing.

Sonography/Ultrasound

Sonograms is a diagnostic tool that is non-invasive and uses sound waves to generate an image that a medical profession can uses to assess and diagnose. It can be used to look at soft tissue masses and bone surfaces. It is often used as an initial screening tool as it is inexpensive and easy to perform.

Magnetic resonance imaging (MRI)

MRI's can be costly exams but they are able to provide detailed visualizations of internal structures. They can show reactive masses such as pseudotumors because they can show contrast of the different soft tissues of the body.

CT Scans/catScan

A CT scan can also be a useful tool with its 3-D imaging to show pseudo-tumors. However, the MRI provides a greater contrast between the various soft tissue.

Blood Tests

DePuy hip implant replacement patients are also advised to have a blood test which can determine whether there is an excess of metal in the bloodstream. Some patients with the DePuy hip implant have been found to have cobalt and chromium levels at more than 100 times a normal level. Metal at high levels is known to be a cancer causing agent.

This information is provided by Washington Injury Attorney blog, a service of The Farber Law Group. We represents patients throughout western Washington and the Pacific Northwest who have had their DePuy artificial hip recalled.

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Continue reading "Diagnostic tools to detect metal-on-metal hip implant complications" »

The largest joint database in the wold which tracks more than a million patients with hip, knee and ankle joint surgeries finds that 25% of the patients with DePuy ASR hip implants had their implant fail within six years of implantation.

The National Joint Registry of England and Wales found that the actual rate of hip implant failure was 29% after six years in patients with the DePuy ASR XL Acetabular and Hip resurfacing hip implants. This number can be compared with patients with traditional style hip implants which only have a 9.9% failure rate.

The registry in England and Wales provides definitive research on the outcomes of joint replacement surgery. The U.S. has no such joint registry and therefore lagged behind the UK in discontinuing the metal-on-metal hip implant surgeries.

Johnson & Johnson's DePuy subsidiary recalled the metal-on-metal hip implants in August 2010 after reports of high failure rates started being logged. The recall affected tens of thousands of patients with many having serious symptoms including severe pain, fractures and metal poisoning caused by the rubbing of the metal-on-metal components in the hip.

This information is provided by The Farber Law Group who provides legal services to patients who had the defective hip implanted.

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Continue reading "Medical registry finds that 25% of DePuy ASR hip implants failed within six years" »

The Food and Drug Administration (FDA) met with medical device manufacturers, representatives of the medical community and health advocate groups today to discuss possible regulation regarding surgical mesh used to treat a pelvic organ prolapse. Surgical mesh is a medical device that has been linked with serious medical complications in some patients.

The recommendation of those at the meeting was to re-classify surgical mesh for pelvic organ prolapse surgery as a class III medical device. A class III device designation means that that the device needs premarket approval to evaluate the device's safety. Premarket approval is a much stricter process than the premarket notification process known as 510(k).

Through the current 510(k) process, manufacturers of medical devices only need to show that their product is equivalent to a device already on the market.

The FDA has received at least 2,000 reports of complications suffered by patients who had surgical mesh implanted trans-vaginally since 2008. In recent months, there have been reportedly 500 product liability lawsuits filed against manufacturers.

Complications associated with the surgical mesh include pelvic pain, incontinence, painful intercourse and infection. Another complication is the fact that the surgical mesh erodes or wears away the tissues surrounding the implant. Some patients have required multiple surgeries.

The Farber Law Group, a product liability law firm located in the Seattle area, represents patients with serious personal injuries due to defective and dangerous medical devices. With our help, you may recover compensation for your damages.

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Pelvic Organ Prolapse (POP) is a medical condition suffered by women where a woman's pelvic organs fall from their normal position and protrude into a patient's vagina. While the condition can occur to any woman, women who have had very long labors or large babies are more prone to the condition. Women who smoke, are obese or have strain injuries are also at increased risk to experience pelvic organ prolapse.

POP was often the cause of a hysterectomy -- removal of the uterus -- in women. Surgeons also have other surgical options which include repairs to the vaginal wall through a transvaginal procedure.

Surgeons have increasingly been using surgical mesh, implanted through the vagina, to repair the prolapse. Surgeons had an option of using a non-absorbable synthetic, an absorbable synthetic or a biolgic to do the repair. However, in most cases, surgeons used a non-absorbable synthetic polyproplene.

The FDA reports that 300,000 women underwent POP repair in 2010 alone and in 75,000 of those cases, surgeons opted for the mesh repair.

Now it has come to light that some women who have had a repair with non-absorbable surgical mesh have suffered some serious and some time debilitating complications.

On July 13, the U.S. Food and Drug Administration issued a notice that with who had the transvaginal mesh repair have a five fold increase of pain and injuries. Last week Public Citizen, a consumer advocacy group petitioned the FDA to have the medical devices pulled off the market.

Up to 600 women with serious injuries have filed lawsuits against some of the leading manufacturers of the surgical mesh including Johnson & Johnson. The lawsuits claim that the manufacturers were negligent in bringing the product to market and did not do due diligence in testing what they say is a defective product. So far, none of the lawsuits have gone to trial.

The Farber Law Group is closely monitoring news feeds from the FDA and keeping abreast of the latest developments. We are a personal injury law firm and we represent people who have been seriously injured by dangerous or defective products .

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In the past couple of years, quite a few medical devices have either been recalled or come under scrutiny after reports of patients being seriously injured or killed due to a defective device. In the case of DePuy's artificial hip implant, Johnson & Johnson's surgical mesh product for pelvic organ prolapse (POP) and the Myxo ETIlogix annuloplasty ring, these devices were approved by the FDA through the 510(k) process which allows new medical devices to come to market through a nominal premarket approval process.

Now, the U.S. Institute of Medicine, a non-governmental non-profit organization which provides unbiased and authoritative advice on science, medical and health issues, is calling for a complete overhaul of the FDA process for approving new medical devices.

A medical device can be a simple tool like a thermometer, bandage or complex such as pace-makers, artificial hips or MRI machines. The FDA is responsible for ensuring that a medical devices have a "reasonable assurance of safety and effectiveness" before it can come onto market. Devices that may pose some risk to patients must be cleared through the Section 510(K) process.

The 510(k) process is a "fast track" through FDA approval and allows manufacturers to claim that a new device is substantially equivalent to other devices and therefore do not require expensive medical scrutiny and clinical trials. In the case of the DePuy hip implant that was recalled, the design was of significant departure from previous hip implant designs but was still given market clearance.

The Archives of Internal Medicine published a study that found that medical devices that resulted in serious patient injury or death were more likely to have been approved by the FDA through the 510(k) process.

On July 29, 2011, the U.S. Institute of Medicine published the results of a study of the FDA approval process which found that the 510(k) process is flawed and rather than trying to fix it, the FDA should develop "an integrated premarket and post market regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life cycle." (Read the Press Release, "FDA Should Invest in Developing a New Regulatory Framework To Replace Flawed 510(k) Medical Device Clearance Process")

Pressure is on the FDA to change the approval of medical devices but also to put in place a system in which problems with the devices are tracked and patient symptoms noted.

Hopefully, the FDA will move forward with insuring patient safety from defective medical devices.

This information is provided by Washington Injury Attorney blog, a service of The Farber Law Group. We represent people who have been seriously injured by defective medical devices and through medical malpractice.

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A U.S. Food and Drug Administration (FDA) advisory panel is meeting next week to discuss problems associated with vaginal repair of pelvic organ prolapse (POP) in women using non-absorbable surgical mesh.

The panel is meeting after Public Citizen, a consumer advocacy group, petitioned the FDA to ban surgical mesh for transvaginal repair of POP.

Tens of thousands of women have suffered serious side effects when their surgeon used a transvaginal technique to implant the mesh. Patients report complications including vaginal tissue erosion, neuromuscular disorders, severe pain, infection, painful sexual intercourse, bleeding and organ perforation. In some cases, women have had to be hospitalized to treat the complications or to have the mesh surgically removed. Surgery to remove the mesh is often complicated because the mesh becomes embedded into the vaginal tissue. Some women have required two or more surgeries.

Public Citizen says that the transvaginal repairs using surgical mesh should be banned because this technique offers no benefits in comparison to other surgical options and because there is a high rate of serious complications, some of which are permanent and life-altering.

Currently, there are several manufacturers that market surgical mesh products for transvaginal repair of POP. These include:

• Gynecare Prolift Total, Anterior, and Posterior Pelvic Floor Repair Systems
  (Ethicon, Inc., Somerville, NJ)
  
• Gynecare Prolift +M Total, Anterior, and Posterior Pelvic Floor Repair Systems
  (Ethicon, Inc.)
  
• Gynemesh Prolene Soft Nonabsorbable Synthetic (Ethicon, Inc.)
  
• AMS Elevate Anterior and Apical Prolapse Repair System (American Medical
  Systems, Inc., Minnetonka, MN)
  
• Pinnacle Pelvic Floor Repair Kits (Boston Scientific Corp., Marlborough, MA)
  
• Avaulto Support System (C.R. Bard, Inc., Covington, GA)
  
• Polyform Synthetic Mesh (Proxy Biomedical, Ltd., Galway, Ireland)

The FDA 501(k) premarket notification system, a "fast track" in bringing a medical device to market, is again criticized with this mesh debacle. Like other medical devices, including the DePuy hip implant that has been recalled, surgical mesh systems were allowed by the FDA to come onto the market without clinical data which proved that the devices were safe and effective. All the while, the manufacturers and marketers promoted the devices while tens of thousands of women were harmed.

In recent months, more than 100 women have filed suit against the mesh system manufacturers seeking compensatory and punitive damages. The lawsuits claim that the companies were negligent in the defective product design.

This information is provided by Washington Injury Attorney blog, a service of The Farber Law Group. We are personal injury law firm that represent product liability and medical malpractice cases. With our help, you may receive compensation for your damages.

Source:Petition to Ban Surgical Mesh for Transvaginal Repair of Pelvic Organ Prolapse, Public Citizen, August 25, 2011

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Continue reading "FDA advisory panel to look at safety of surgical mesh for pelvic organ prolapse (POP)" »

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Posted In: Dangerous Products , Medical Malpractice , Product Liability , Serious Personal Injuries