A risk of bacteria contamination has forced the Food and Drug Administration to warn off healthcare providers from using gel used during ultrasound procedures.
Certain lots of the product, known as Other-Sonic Generic Ultrasound Transmission Gel, were recently discovered to have been contaminated with Pseduomonas aeruginosa and Klebsiella oxytoca. These two strains of bacteria pose an imminent health threat to persons exposed. The former, which is typically found in water or soil, can cause a condition known as inflammatory dermatitis. And the latter, which is actually fairly common in humans’ digestive tract, can cause bloodstream infections or pneumonia if it comes into contact with the lungs.
Three lot numbers of the gel, which was produced by Pharmaceutical Innovations, were affected: 0601111, 090111, and 120111. The product was available in either 5 liter containers or 250 milliliter bottles. The gel is non-sterile and is used as a means to improve the signal of the ultrasound.
The FDA is also asking all healthcare professionals and facility personnel who have noted an adverse affect from using this product to report what happened to the agency. They are particularly interested in learning the lot number, the container size, the date and type of procedure, and the nature of the adverse event.
As a San Bernardino personal injury lawyer, I’m sorry to see a seemingly benign item pose a threat to safety. Patients rely on the equipment being used during their procedures to keep them safe, and it’s my hope as a personal injury attorney in Bakersfield that no one gets hurt by this flawed product.
The Food and Drug Administration might soon be imposing stiffer rules on a certain medical device.
It was announced today that the FDA would meet on June 27 and 28 to consider whether or not they should require metal on metal hip implants to face additional testing if such devices aim to gain approval by the organization. This comes on the heels of numerous complaints regarding the devices.
Many people have endured the failure of such devices over the past few years, leaving the implants with a reputation of having a higher than acceptable rate of failure. Devices made from other materials have not broken at the same rate.In fact, the National Joint Registry of England and Wales initiated a study which showed that 6% of recipients of a metal on metal implant device needed corrective surgery, compared with the more commonly accepted 2% that is normal with ceramics or plastics.
Last May, the FDA ruled that manufacturers needed to provide more data on these devices to demonstrate their safety. Studies have also shown that metal devices can increase the level of metal ions in the blood, which could pose a danger. The FDA wants more information about this scenario as well.
As a San Francisco personal injury lawyer, it grieves me to see an entire product line possibly do harm to the very people it was meant to help. I hope the FDA makes the right decision in their June meeting, but whatever their choice, the impact will most certainly affect many people, including a Long Beach personal injury lawyer like me.
According to recent news reports, Johnson & Johnson is hiring an outside firm to handle the recall of its DePuy ASR metal-on-metal hip implant.
This is an unusual move, as companies typically handle these matters with their in-house counsel and rely on the patient’s doctor to determine if a replacement is necessary. However, this decision means that the doctors chosen by the company Johnson & Johnson hired will determine if a replacement is necessary. That company is Broadspire Services Inc. While a doctor provided by the firm can’t override a personal physician, it does mean that funds can be withheld from paying for a revision surgery if the firm’s doctor does not believe a replacement is required.
Patients and lawyers are claiming that this move will limit Johnson & Johnson’s financial responsibility as well as patients’ access to replacement hips. DePuy officials maintain that the outside hire is simply to ensure that funds are distributed to those who require replacements directly related to the recall, and not for another reason such as a fall.
As a DePuy hip recall lawyer, I find this choice atypical. I believe this company needs to be held responsible for their actions and would like to provide legal services to anyone who has experienced pain and suffering as a result of this hip replacement. It is my hope that everyone who has been affected by this recall has access to medical treatment and revision surgery. If you have received a hip replacement, regardless of whether or not you’ve experienced pain, I urge you to contact a hip replacement recall lawyer. Statistics have shown that a majority of the DePuy hip replacements will fail, and the law limits the amount of time in which a claim can be filed. Action is necessary now to protect your rights in the future.
The lawsuits against ASR hip replacement manufacturers Johnson & Johnson and DePuy Orthopaedics are continually being filed, according to recent news sources.
Over 350 cases were filed in a Ohio Federal court in August alone. All of the cases about the metal-on-metal implants are tied to one case undergoing pre-trial proceedings in North Ohio. In order to eliminate delays and to promote judicial efficiency, Judge David Katz allowed the patients to consolidate their cases in a multi-district litigation. Texas has also adopted a similar policy toward case consolidation in order to avoid district transfers.
Since the direct filing option was made available in January, more than 1,700 cases have been filed, with 700 in the last two months alone. If you or someone you care about received a DePuy hip replacement, it is strongly recommended that you contact a DePuy ASR recall lawyer. You can contact a DePuy hip recall lawyer at our law firm to talk about protecting your rights. Even if you have not yet experienced symptoms of failure, it’s important to talk to an attorney about your hip replacement as statistics show that the majority of these hip replacements will fail. Remember, the law limits the amount of time you have to file a claim, so act immediately.
