Medical Device Malfunction Lawyer
Medical professionals use medical devices every day to help treat or diagnose patients’ disorders. Sometimes, though, they malfunction, break, or harm the patient they are used on. If this happened to you, you understand how potentially devastating a defective medical device can be, especially if it is a life-saving or life-sustaining product. A seasoned medical devices attorney will be able to work with you on your case to get you the proper compensation you deserve. Contact our medical device malfunction attorney at Malloy Law Offices, LLC today for your free consultation regarding your case.
Why Choose Us?
- At Malloy Law Offices, LLC, we provide professional, trustworthy, legal representation. In medical device cases, we offer counsel; on a contingency fee basis and never charge legal fees unless we win.
- With 15 years of experience allows in complex injury cases, we understand the process of seeking compensation in cases of medical device failure.
- We believe that if you have suffered health consequences due to a faulty medical device, you deserve to recover the maximum possible in compensation.
- At Malloy Law Offices, LLC we place great importance on assisting our clients to reach their goals after suffering health consequences from a faulty medical device.
- We value the relationships we forge with the people we represent. We the importance of achieving justice and keeping them informed of the progress of a medical device lawsuit
Medical Devices Defined
Generally, a medical device is defined as an instrument that is used to either diagnose or treat a medical condition. They can extend to anything from surgical instruments to joint replacements, pacemakers, pacemakers and atrial defibrillators, vaginal mesh and bladder slings, hernia mesh, and IVC filters, among others, even tongue depressors. Medical devices, like drugs, are categorized one of three ways. These categories are as follows:
- Class I – this class has the least amount of control. These are not intended to be used in emergency situations where life support or utilization in preventing severe impairment may occur. Most of the devices categorized under Class I will also not be subject to the Premarket Notification, which is where the device is demonstrated to the FDA that it is safe and effective, and include items such as tongue depressors, other hand-held surgical instruments, examination gloves, and bandages.
- Class II – these include devices that require a higher amount of regulatory control than Class I. Class II devices have special controls, such as labeling requirements and meeting a certain performance standard level. Class II devices must meet a higher standard than the ones in Class I. They include devices such as motorized wheelchairs, air purifiers, surgical drapes, and even acupuncture needles.
- Class III – this is the class subject to the greatest level of control. In addition to special controls, they must also gain premarket approval, which is a scientific review to guarantee its safety and effectiveness for use with patients. These are generally the type that would be used in emergency situations, or to sustain life, such as defibrillators, pacemakers, and even diagnostic tests for diseases.
How Liability is Determined in Medical Device Cases
Generally, medical device cases are subject to strict liability. Strict liability is where the plaintiff needs to demonstrate that the product was clearly defective and that it had been put on the market regardless of its effectiveness or lack of it. This is generally more easy to prove than negligence, which is where the plaintiff claims that any party within the manufacturing process did not fulfill their legal duty to protect their customers. The plaintiff must also demonstrate that the manufacturers failed to use a reasonable standard of care during or after the manufacturing and sale process. As with other product liability cases, there is a three-year Statute of Limitations.
One of the methods a court will use to determine liability is called the Daubert Standard. The Daubert Standard is a rule of evidence regarding the admissibility of expert witness testimony for medical devices. The purpose is to help exclude unqualified testimony from being heard by the jury. It is law in federal court, and in many states in the U.S. However, in Maryland, a similar standard, called the Frye Standard is used instead. This is a test to establish the admissibility of the scientific evidence. The expert opinion based on scientific technique is only admissible as testimony when the technique referenced is generally accepted as being reliable by the portion of the scientific community the opinion pertains to.
FDA Reauthorization Act
The FDA Reauthorization Act was passed in 2017. The purpose of the act allows more time for drug and medical device manufacturers to report malfunctions to the FDA. FDA officials claim that this extension will not harm any patients, as all devices on the market for less than two years must still be reported within thirty days of a malfunction. Additionally, the FDA has the ability to determine whether this extends to Class II and Class III devices. Critics of the bill argue that this extension will prevent medical professionals and their patients from learning about potential risks, thus creating more situations where people could be harmed or even killed through device error or malfunction. This doesn’t mean nothing is being monitored, however. The FDA approves all medical devices before they enter the market. It is up to the manufacturer to report any problems that arise once the product is successfully out on the market, however.
How Much is a Medical Device Injury Case Worth?
Every case is unique in the extent of the complications suffered by a victim due to a faulty or defective medical device. Some of what must be evaluated in determining the value of your case include:
- The need for surgery to replace the device, and the physical and emotional costs on the patient.
- The development of medical complications as a result of the faulty medical device.
- Permanent injuries related to a defective medical device.
- Diseases, conditions, and illnesses related to the device.
Medical Device Injury Cases: The Statistics
Most patients feel safe when undergoing a procedure to improve a physical condition or illness. It can be a terrible shock to discover you are facing future surgeries or serious complications due to a device that has been implanted. Each year, many medical devices are recalled by the FDA or voluntarily taken off the market by the manufacturer.
The NY Times reports that in the past decade, more than 80,000 deaths occurred that are directly linked to faulty medical devices. Many patient advocates are pressuring the FDA to demand more extensive testing prior to allowing medical devices on the market. While this is clearly important, for a person who has already suffered serious health consequences, it is too late. That’s when the Malloy Law Offices, LLC team of trial lawyers can step in and help you seek justice and full compensation.
Medical Device Recalls and You
If you have had a medical device implanted, you may not experience problems. Unfortunately, in many cases, the patient has suffered very serious consequences, and has needed to undergo multiple surgeries to try to resolve the damage. Any surgical procedure has inherent risks. The need for another surgery to attempt to repair the damage from a defective medical device may lead to very serious consequences, including loss of life.
According to reports, more than 232,475 hidden reports related to faulty medical devices were filed last year – a staggering number, that continues to increase with each passing each year. Patients may be suffering health consequences but may even be told that the health consequences are unrelated to the medical device – which may be false. Recently, vaginal medical mesh, used to improve weakened pelvic issues, has led to tens of thousands of injured women filing claims to recover compensation for the complications they suffered. If you are one of the many women who has suffered serious complications from medical mesh, we urge you to call Malloy Law Offices, LLC at once.
Most Common Medical Device Cases
While almost any medical device can potentially fail or malfunction, some of the most well-known medical device failures are listed below:
- Physiomesh: many hernias are repaired using surgical mesh to help reinforce and strengthen the abdominal wall. One type, in particular, called Physiomesh, has come to attention. Manufactured by Ethicon, Physiomesh was designed to be used as a hernia mesh during surgical repairs. Instead of being subjected to the usual amount of testing, Physiomesh was rushed to the market before it gained standard FDA approval. Serious side effects arose, sometimes even resulting in death. Due to surgical methods being used, Physiomesh would wrinkle, shrink, or change shape after being attached to the herniated tissue. In some cases, this would cause it to grow into the intestinal wall, obstruct the bowels, cause infection, or cause other complications, which would then necessitate revision surgeries.
- Vaginal Mesh: another type of surgical mesh, vaginal mesh is used on women who suffer from Pelvic Organ Prolapse (POP) or Stress Urinary Incontinence (SUI) to provide support to the pelvic region and prevent incontinence. Some complications that can arise from having vaginal mesh put in place include perforation of the bowel, bladder, or intestines, vaginal epithelium erosion, and infection. Revisional surgery is often required in these situations, which increases the patient’s pain and suffering, as well as the length of their recovery time.
- IVC Filter: also known as an Inferior Vena Cava Filter, these are usually prescribed to patients with pulmonary embolisms who are also unable to take anti-coagulants, or blood thinners. The IVC filter is a small metal device that sits inside the blood vessel and prevents blood clots from traveling up into the lungs. However, especially if retrievable IVC filters have been left in longer than five years, they can shear off and dangerous metal fragments can travel through a person’s blood vessels to the heart or lodge in other tissue. Multiple complications occur from this, the most severe being sudden death if the fragment gets lodged in an active area of the heart. One IVC filter manufacturing company, in particular, C.R. Bard, had additional deaths attributed to their newer, purportedly safer models, as well as having reports of device failure only four months post-market entry, yet they did not recall them until five years after.
- Metal-on-Metal Hip Implant: three manufacturers, in particular, have been involved in lawsuits over the last several years; DePuy, a subsidiary of Johnson and Johnson, Biomet, now Zimmer Biomet, and Stryker. Each of these companies developed a type of hip implant that is called “metal-on-metal”, or a metal ball joint with a metal socket. It was revealed that DePuy’s ASR XL Acetabular System and Pinnacle Hip implants had a much higher failure rate of 1 in 8, or thirteen percent, and were in need of revision surgery.
Complications From Faulty Hip Implants
Some side effects patients encountered included loosening of the implant, metallosis, or metal poisoning due to metal particles entering the blood system, infection, and implant failure. Biomet had a similar situation to DePuy in that their metal-on-metal hip replacements were loosening and metal particles were rubbing off the implant and entering the bloodstream, causing metallosis.
Since Biomet was designed for active individuals, the heads on the hip replacements were larger than normal to allow for a greater range of motion. This increased the surface area, which increased the amount of fretting and thus metal particles contaminating the replacement site. Stryker, on the other hand, was not a ball and joint implant. Instead, they had a range of different-sized necks and stems, which was for greater stability and customization to patient age and body type. The implant would fret and release metal particles into the patient’s body as the metal neck rubbed against the stem.
How a Medical Device Attorney Can Help
Mass torts, or class-action suits, are incredibly complex. Any one person attempting to lay out their case would be hopelessly overwhelmed with the intricacies of Personal Injury law, especially when it comes to malfunctioning medical devices that are supposed to be saving lives, not harming them. Retaining the services of a highly skilled medical device lawyer will greatly help in taking the strain of litigation off your shoulders. They will handle every aspect of your case, this way you can focus on your recovery. Contact our attorneys today for your free consultation about your medical device product liability case.