October 20th, 2015|
Power morcellators are medical devices that can perform hysterectomies and other medical procedures in a less invasive manner than traditional surgical methods. However, the device lost credibility when it was discovered it can significantly increase the chances of developing cancer in some women.
Researchers found that when the morcellator is used, dormant cancerous cells can be released into the body, where they can later metastasize into tumors. Data from the U.S. Food and Drug Administration shows at least 1-in-350 women are at an increased risk of developing power morcellator cancer when the devices are used.
These discoveries have led to hundreds of lawsuits being filed against the makers of the devices, claiming victims were not warned of the risks before undergoing a power morcellator surgery. Now, these cases are being consolidated into multidistrict litigation.
According to KCUR 98.3 Radio, more than two dozen power morcellator cancer lawsuits—a majority of which are filed against device manufacturer Ethicon— have been moved to a Kansas City, Kansas, federal court to be heard. U.S. District Judge, Kathryn H. Vratil, has been assigned to preside over the case.
The legal staff at Ferrer, Poirot & Wansbrough believe in holding companies accountable for the safety of the products they make. That’s why our defective medical device lawyers are hopeful a decision in the cases will bring a sense of closure to individuals harmed by morcellators.
October 6th, 2015|
Companies that manufacture medical devices are required by law to ensure the safety and proper function of their products. However, an investigation has shown that C.R. Bard, Inc.—a medical device manufacturer—may have known about risks that its Inferior Vena Cava (IVC) filter posed to patients without taking corrective action.
An IVC filter is a small spider-like medical device inserted into the largest vein in the body to prevent blood clots from making their way to the heart and lungs. At least 27 deaths and hundreds of injuries have now been associated with the use of the IVC filter made by C.R. Bard, Inc. A number of IVC filter lawsuits have led to an investigation into how the C.R. Bard, Inc. Recovery IVC filter made it’s way onto the market in spite of serious safety concerns.
NBC News reports that the company hired a consultant to help get the Recovery IVC filter approved by the U.S. Food and Drug Administration after a failed initial attempt. The consultant explains she voiced concerns over the safety of the device and refused to sign the applications for the device to seek approval. Documents show the consultant’s signature on those documents, though.
At Ferrer, Poirot & Wansbrough, we believe in protecting the health and safety of medical patients, and our defective medical device lawyers are hopeful the discovery of C.R. Bard’s potentially negligent handling of the Recovery filter’s approval process can result in action towards creating accountability among medical device manufacturers.
August 18th, 2015|
Many manufacturers of medical devices now design products that can be integrated with wireless technology. While this can be convenient for sending and receiving data, the defective medical device lawyers at Ferrer, Poirot & Wansbrough explain this technology may also compromise the safety and security of the device.
For example, infusion pumps deliver small amounts of medication to patients over an extended period of time. The amount of drug being delivered can be altered wirelessly in certain units, which may present serious safety risks if a unit is ever hacked.
The U.S. Food and Drug Administration (FDA) recently announced that the U.S. Department of Homeland Security’s Industrial Control Systems Cyber Emergency Response Team identified cybersecurity vulnerabilities in the Symbiq Infusion System. This prompted the agency to instruct facilities using the devices to switch to alternative infusion pump systems immediately. The FDA also offered tips on how to safely make the transition to another system.
While no injuries or deaths have been reported , not all problems with defective medical products are discovered before an incident occurs.
At Ferrer, Poirot & Wansbrough, we understand the risks defective medical products pose to patients, and we are hopeful the warnings issued regarding the Symbiq Infusion System can prevent patients from serious harm.
August 11th, 2015|
Regulations set by the U.S. Food and Drug Administration (FDA) are supposed to ensure the safety of all drugs and medical devices in the United States. But the defective medical device lawyers at Ferrer, Poirot & Wansbrough point out that a proposed law may do more harm than good.
According to Health News Review, the 21st Century Cures Act was passed last month by the House of Representatives and consists of new regulations that would overhaul the FDA’s pre-market approval process for medications and medical devices. The act would allow companies to submit sources other than clinical trials as evidence of a product safety. This would allow simple case histories to replace hard data and facts as proof that a medical device functions properly.
The new rules would also require all companies marketing “breakthrough technologies” to have products approved for use even faster than current laws allow. Considering the number of recalls on defective medical products approved based on minimal safety evidence, this change could present an increased safety risk to the public.
The 21st Century Cures Act would also allow companies to be able to hire third parties to conduct safety testing on products, which may present serious conflicts of interest.
Promoting the protection of the public’s health and safety is a top priority of the legal staff at Ferrer, Poirot & Wansbourgh. That’s why we’re hopeful lawmakers will carefully consider the impact of the 21st Century Cures Act will have on the lives of Americans.
January 27th, 2015|
A new report shows that certain manufacturers may be more likely to recall drugs and defective medical devices. One such company is Hospira. The manufacturer of both medications and medical devices are said to have initiated as many as 40 recalls in the last two and a half years due to problems found in their products.
According to In-PharmaTechnologist,com, the U.S. Food and Drug Administration (FDA) points out that last year, 45 class I recalls were conducted by drug makers. Of those, almost one-third involved medications made by Hospira. Those aren’t the company’s only recalls, though.
In 2012, Hospira conducted 28 drug recalls, while an additional 11 recalls were initiated for a defective medical device manufactured by the company. Several of the company’s manufacturing facilities were given warning letters by the FDA.
The company’s most recent recall involved an injectable version of sodium chloride that was contaminated by human hair before being distributed to the public.
At Ferrer, Poirot & Wansborugh, we have seen the harm that caused by using unsafe drugs and defective medical devices. That’s why our defective medical device lawyers suggest checking the FDA’s website frequently to ensure your medical products have not been recalled recently.
January 20th, 2015|
Advancements in technology have helped Americans live healthy lives, but developments in medical and health devices have raised several questions about the preventing defective medical products from reaching consumers.
Most of us concede the importance of regulations placed on items like insulin pumps or dialysis machines, but what about heart monitors people wear on their wrists while working out? Should over-the-counter gadgets be required to face the same regulations? Officials from the federal government say the answer to that question is yes.
According to Engadget, the U.S. Food and Drug Administration (FDA) is calling for public opinion on a set of rules to guide the design, manufacturing, and distribution of what’s being described as “general wellness devices.” These regulations will be placed on any device that claims to make improvements to a person’s health.
The problem is, the lines are very murky between claims to improving wellness and the treatment of medical conditions. That’s why the FDA is expected to make several changes to the drafted rules before a vote on the initiative is taken.
At Ferrer, Poirot & Wansbrough, we see the results of faulty products on a daily basis. Our defective medical device lawyers are anxious to see if these new regulations are put into place.
January 21st, 2014|
January 21, 2014
Advancements in the field of technology within the medical industry, such as the use of robotics in surgery, have gained significant ground in recent years.
The Defective Medical Device Attorneys with the law firm of Ferrer, Poirot & Wansbrough point out though, new studies have shown using this new technology may be putting patients at a greater risk of harm than previously believed.
According to Bangor Daily News, researchers have found the instances of patients being injured during robotic surgery may be significantly underreported. The team found that incidents of injury and death are supposed to be reported to the U.S. Food and Drug Administration, but an examination of records showed numerous cases that were missing and others containing incomplete data.
A fine example of these problems was seen in the reporting associated with da Vinci Surgical Robot Injuries. The device has been used to perform roughly 350,000 procedures, which resulted in 3,697 reports of injuries or deaths associated with the device being reported. Experts have shown though, several documented cases were not included in these numbers.
Officials say the problem stems from a dependence on post-market studies to determine safety of a product, rather than putting devices through rigorous testing prior to public release to the market.
These issues are why those who have been harmed by a defective medical device should pursue holding manufacturers accountable and responsible for the harm their products cause.
October 1st, 2013|
October 1, 2013
Each year, a large number of recipients of medical devices intended to help improve their quality of life suffer injuries as the result of defects in the product. The Defective Medical Device Lawyers with the law firm of Ferrer, Poirot & Wansbrough explain the U.S. Food and Drug Administration (FDA) is working to reduce this number and improve patient safety by requiring all such products to carry a unique device identification code (UDI).
According to an FDA Press Release, the codes will consist of a bar code made up of a selection of numbers and letters based on several aspects of the product. One part will be a required section of code consisting of information regarding the device’s label and model type. The second section of the code will consist of information regarding:
- Batch and Lot Numbers
- Serial Numbers
- Expiration Dates
- Manufacture Dates
- Identification Codes for Organic Devices
Experts say that the new UDI system will not only improve the quality of care and safety for patients, but will also create a more efficient system for targeting problem devices, identifying dangers, and initiating recalls. Implementation of the new system will begin in one year, but could take until 2020 to fully complete.
The law firm’s team of Hip Recall Lawyers applauds the efforts being made to reduce injuries and deaths caused by defective medical devices and are hopeful the new system is a success!
May 21st, 2013|
May 21, 2013
The results of a new Yale University study on Medtronic® Infuse Bone Graft Dangers are scheduled to be released next month. Most experts believe the findings will only support prior research that has shown significant risk in use of the product.
The Infuse Bone Graft system is a synthetic liquid form of a protein that is used to accelerate bone growth. The liquid is used in spinal and neck surgeries to help fuse bones and implants together. The product is surgically implanted into a patients body by placing a sponge that is soaked in the product between the affected vertebrae.
The problem with the system is the numerous side effects patients have reported, which include:
- Airway or Neurological Structure Compression
- Development of Certain Cancers
It was brought to light several years ago that doctors and researchers essentially swept these dangers under the rug during clinical trials because Medtronic was paying them. An article from Drug Injury Watch highlighted several instances of this behavior. Now, a well-known Yale cardiologist is reviewing all of the prior research to determine whether it was flawed.
The revelation of such issues leave many patients who had the product used on the during a surgical procedure wondering what action they should take if they were harmed.
The Defective Medical Device Lawyers with Ferrer, Poirot & Wansbrough suggest any patient who suffered negative affects from the use of the Infuse Bone Graft system should discuss their legal options with an attorney.
February 24th, 2011|
February 24, 2011
Johnson & Johnson is a renowned name in pharmaceuticals and baby products, but recent recalls may have consumers questioning the company’s reputation.
According to the Wall Street Journal, Johnson & Johnson is recalling defective medical devices, including syringes of the anti-psychotic drug Invega Susstenna because some of the syringes are cracked which could lead to infections or under-dosing of the medication.
This is the latest of a string of recalls of defective medical devices from Johnson & Johnson, including syringes of Tylenol, Benadryl, Sinutab, and Sudafed products that were manufactured during a time when equipment may have been dirty.
The company maintains that the risk of developing defective medical device injuries due to the recall is low, but there has been one report of defective medical device injury in Australia.
Have you suffered defective medical device injury due to a prescribed medication or medical device? Tell the defective medical device lawyers at Ferrer, Poirot & Wansbrough Attorneys at law about your loss.