Prescription Drug & Medical Device Defects
People rely on prescription drugs and medical devices to improve their quality of life. Although prescription drugs and medical devices must be tested before hitting the market, but many times defects do not become apparent until it is being used for treatment in the real world. When pharmaceutical and medical device companies put dangerous drugs and defective products on the market, it can lead to serious adverse health effects and sometimes death.
If you or a loved one has been injured by a prescription drug or defective medical device, contact our Houston product liability lawyers at The Krist Law Firm, P.C. today at 281-283-8500 to find out how we can help you.
Dangerous Prescription Drugs
For many Americans, prescription drugs are an essential part of life. According to the U.S. Centers for Disease Control and Prevention (CDC), nearly 49 percent of Americans have taken at least one prescription drug in the past 30 days. While prescription drug use is on the rise in the U.S., so is the number of pharmaceutical recalls, which has surged over the past few years.
According to a 2012 study, 91 of the 1,734 recalls from 2004 to 2011 were designated Class 1, meaning that there is reasonable possibility that the use of the product will lead to serious, adverse health consequences or death. The size of recalls has also increased as 34 percent of the Class 1 recalls during that time period impacted more than 100,000 units of drugs.
Defective Prescription Drugs
Drug defects can include mislabeling, testing errors, incorrect dosing or release mechanisms, or even contamination. These types of defects can lead to serious health effects including:
- Allergic reactions
- Psychological of physical dependence
- Harmful interactions with other drugs
- Severe and/or dangerous side effects that result in illness or serious injury
- Birth defects
- Increases the risk of or leads to the development of another injury/condition
Medical Devices Overview
The FDA defines a medical device as “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory” that is:
- used in the diagnosis of a disease or condition
- used in the cure, treatment, or prevention of a disease or condition
- affects the structure or function of the body
Medical devices are divided into three categories based on the risk associated with the device–Class I (low risk), Class II (moderate-risk), and Class III (high-risk). For example, Class III devices are typically life-sustaining and can result in death if they fail or malfunction.
Defective Medical Devices
When medical devices fail to perform as intended, or contain defects, it can pose serious health risks to the public. Medical devices must be tested through either the 510(k) or PMA process, both of which are considered less rigorous than the clinical trial procedures required for prescription drugs.
Based on data from the FDA, the annual number of medical device recalls has increased by 92 percent from 2003 to 2012. Recalls for medical devices occur because a medical device is defective, could pose health risks, or both. Depending on the nature of the device and defect, a manufacturer may take corrective or removal action to address the safety issue.
The most common defects include design flaws (device and software), nonconforming materials or components, and incorrect packaging/labeling. Some of the medical devices that have been linked to serious injury over the past few years include:
- Defective pelvic or transvaginal mesh implants
- Defective knee and hip replacement implants
- Defective IUDs
- Defective defibrillators
- Defective IVC blood clot filters
- Defective robotic surgical systems
New Federal Law May Lead to an Increase the Number of Defective Prescription Drugs and Medical Devices
In December of 2016, Congress passed the 21st Century Cures Act, which many experts have warned will lower the standards for approval of prescription drugs and high-risk medical devices. Given the high number of drug and medical device recalls that already exist, critics have argued that the new legislation could endanger patients by reducing safety and efficacy requirements.
Contact our Houston Defective Product Lawyers
If you have sustained injuries because of a dangerous prescription drug or defective medical device, contact the skilled Houston product liability lawyers at The Krist Law Firm, P.C. to discuss your options. We have over 27 years of experience handling a wide variety of product liability cases including injuries caused by defective pharmaceuticals and medical devices.
We can explain your options, build a strong case against the company responsible for your injuries, and fight for the maximum compensation possible. We have successfully litigated numerous product liability claims in Texas and understand how to establish manufacturing, design, or warning defects in prescription drugs and medical devices.