Medical Device Malfunctions

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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 us at Malloy Law Offices today for your free consultation regarding your case.

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.

Daubert Standard

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.

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 anticoagulants, 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. 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 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.

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