Medical devices save thousands of lives each year; many, many more lives are improved through the use of equipment which eases pain, enhances mobility or improves surgical outcomes. The fact is, however, each year, hundreds of medical devices are found to actually cause health problems and even lead to death because they are not properly tested, manufactured, labeled or packaged.
The authority for regulating medical devices in the United States is given to the Federal Drug Administration (FDA). When they are alerted to a problem arising from the use of a medical device, the FDA can recall the product and either require corrective action or mandate its removal from the marketplace. In 2012, the FDA recalled 1,190 medical devices and radiation-emitting products.
Recalls are classified by risk, with Class I recalls indicating there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death; there were 57 such recalls in 2012. A Class II recall is made when use of or exposure to the product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote, as in 1,043 of the 2012 recalls. A Class III recall is the least serious, made when adverse health consequences are not likely; there were 90 Class III recalls in 2012.
MEDICAL DEVICES FOUND TO BE DANGEROUS
Most of the hundreds of recalls each year go unnoticed by the public. But from time to time a medical device recall hits the news because of the numbers of consumers affected and the serious risks they face. Additionally, manufacturers have on occasion voluntarily withdrawn their products from the market after being sued for the damage they have caused. Here are some of the dangerous or defective medical devices which have been the focus of negative attention in recent years:
Metal-on-metal hip implants
- DePuy ASR TM XL Acetabular System
- Smith & Nephew R3 Metal Liners of the R3 Acetabular System,
- Zimmer Durom Acetabular Component
- Stryker Rejuvenate and ABG II hip systems
- Biomet M2a
- Wright Medical Technology Conserve Plus
- Sulzer Inter Op Shell
Metal-on-metal hip implants often have to be replaced or removed within 5 years of surgery. Additionally, they can release metal particles into the body (metallosis), causing damage to the heart, kidneys, nervous system and thyroid. They are associated with severe inflammation, pseudotumors and a high rate of infection.
- Zimmer NexGen LPS, CR and MIS
- Zimmer Natural Knee System
- Stryker Scorpio CR and PS components
- Stryker Duracon Total Knee
- Stryker Unicompartmental Knee System
- Smith & Nephew Oxinium Genesis II and Profix II
- Smith & Nephew Journey Uni Tibial Baseplate
- Biomet Vanguard CR
- DePuy LCS
- DePuy PFC Sigma
These knee replacement products have been found to prematurely fail or loosen and lead to injuries, pain, infection, inflammation, and bone or muscle damage. Many patients have been forced to endure painful revision surgery.
- Medtronic SynchroMed II
- I-Flow ON-Q Pump
- Stryker PainPump Two Site Infusion Kit
- Sorenson Medical pumps
When oral pain medications are not sufficient to control a patient’s pain, the doctor may implant a pump to send medication directly to the area of trauma rather than prescribing a form that must be orally ingested and then digested. A number of patients have died because the pain medication was injected directly into their tissue instead of into the pump; other deaths were caused by electrical shorts. When pain pumps are used to inject medication into joint spaces (such as after shoulder surgery), they may cause a breakdown of cartilage, severe pain and stiffness.
Surgical Mesh Products
- Boston Scientific ProtoGen transvaginal mesh
- Mentor Corp. ObTape Vaginal Sling
- Johnson & Johnson Gynecare Prolift, TVT Secur and Prosima pelvic mesh
- C.R. Bard Avaulta Plus pelvic mesh
- C.R. Bard Composix Kugel hernia patch
- Ethicon Proceed hernia mesh
- LifeCell AlloDerm hernia mesh
Often used in surgeries to repair hernias, pelvic organ prolapse and stress urinary incontinence, these mesh products can cause serious consequences, such as pain, infection, damage to nearby organs and additional surgeries.
- Medtronic Kappa
- Medtronic Sigma
- Guidant Insignia
- Intermedics Nexus
Pacemakers can be implanted in heart patients to monitor and adjust the function of the heart, but some of these medical devices have been recalled due to separation of the wires connecting the electronic circuit to other components, such as the battery. Pacemakers can also malfunction due to loose or broken wires between the pacemaker and the heart and because of electronic circuit failure.
LEGAL REMEDIES FOR THOSE HARMED BY DEFECTIVE MEDICAL DEVICES
The American court system provides an avenue for those injured by defective medical devices to seek justice. Victims of faulty medical devices may seek compensation for their injuries, pain and suffering, medical expenses, rehabilitation, loss of income and reduced quality of life.
Manufacturers of medical devices that have caused injury may be held accountable for negligence which leads to one of the following:
- Design defects, aspects inherent in the product’s design which could have been foreseen to be unsafe;
- Marketing defects, such as a failure to give adequate instructions for use or failing to warn of risks;
- Manufacturing defects, in which an error occurs during the fabrication of the product.
POTENTIAL DEFENDANTS IN MEDICAL DEVICE LAWSUITS
When an experienced product injury lawyer like those at McNeely Stephenson evaluates a potential claim, he looks at every aspect of the product’s chain of development to make sure all appropriate defendants are named in the lawsuit, thereby maximizing the potential recovery for the injured plaintiff. Possible defendants in defective medical device claims are laboratories which performed pre-market testing; companies which manufactured the device or its individual components; doctors and hospitals which failed to provide adequate warnings or instructions; sales representatives; and retailers.
DEFECTIVE MEDICAL DEVICE SETTLEMENTS AND AWARDS
When a number of lawsuits have been filed by patients who have been similarly injured by the same product, the court may consolidate them into a class action so that all claims are litigated at once, for economy and the sake of justice. In some instances, where the claims have been filed all across the country, they may be assigned to a special Multidistrict Litigation (MDL) panel.
Often, manufacturers who face a large number of lawsuits will offer a settlement to those injured by their products: On November 19, 2013, Johnson & Johnson announced its agreement to pay at least $2.5 billion to resolve thousands of defective DePuy ASR hip implant lawsuits. Stryker has settled with many of the more than 1,000 plaintiffs injured by their hip implants and is expected to offer a global settlement. C.R. Bard agreed to settle Kugel hernia mesh lawsuits for an estimated $184 million. Cases which go to the jury may result in substantial damage awards to injured plaintiffs: Boston Scientific Corp. manufactured a transvaginal sling, injuring a patient who was awarded $73.4 million.