Defective medical devices are responsible for billions of dollars in medical expenses in the United States annually and an untold amount of needless pain and suffering. Although the United States government has an agency (The FDA) in place to review the safety and effectiveness of medical devices before they are released for public use, there are still a lot of ways for a company to get an unsafe or ineffective product on the market. If you have been injured by a defective medical device, you may be entitled to compensation. The Merman Law Firm is experienced in handling injuries caused by a defective medical device.
How a defective medical device gets on the market
Typically a device will have to go through rigorous testing before the FDA will issue market approval. But the FDA is overworked and the product designers and manufacturers have millions of dollars on the line, so the device companies found a loop hole. Instead of going through the normal process, whereby a product is tested for months or years prior to market placement, some companies obtain approval from the FDA to market their in the United States through the 510(k) premarket notification process pursuant to 21 U.S.C. § 360(k). Under this loophole, companies assert that their product is substantially equivalent to other products already available on the market. Under this scenario, the actual product is approved for use in the United States by the Food and Drug Administration (FDA), but without the clinical testing that products typically receive. The FDA relies on the representations of the device manufacturer that the device is “substantially similar” to a device the FDA has already tested and approved. The device manufacturer asks the FDA to certify its product is safe because another device that was “substantially similar” was safe. But “substantial similarity” is in the eye of the beholder, and when it is the company that stands to make billions of dollars making that call, substantial similarity becomes very broad.
Recent defective medical device recalls
Visit our product liability blog for recent medical device recalls. If you or a loved one has been injured by any of the following products, all of which have been recalled, call the Merman Law Firm immediately:
- Abbott Glucose Test Strips
- Acclarent Inspira AIR Balloon Dilation System, size 18X40mm.
- AngioScore Inc., AngioSculpt Percutaneous Transluminal Angioplasty (PTA) Scoring Balloon CatheterOTW 0.018″ Platform (multiple sizes)
- Arrow International, Inc. Arrow NextStep Antegrade Chronic Hemodialysis Catheter
- Arrow Ultra 8 Intra-Aortic Balloon Catheters (IABS) 8 FR 30CC and 40CC Universal and Arrow Intra-Aortic Balloon (IAB) Catheter with a Fiber Optic Sensor and Measurement System: UPDATE 01/26/2011
- Arstasis One Access System
- B. Braun, Outlook 400ES Safety Infusion System, Model Number 621-400ES
- Baxa Corporation Abacus Total Parenteral Nutrition (TPN) Calculation Software
- Beckman Coulter, Inc., Synchron LX Clinical Systems Ion Selective Electrolyte (ISE) Flow Cell
- bioMérieux, Inc., VITEK® 2 Gram Negative Susceptibility Cards Containing Piperacillin/Tazobactam (TZP2) – Expanded Recall
- Boston Scientific iCross and Atlantis SR Pro 2 Coronary Imaging Catheters
- Boston Scientific Innova Self-Expanding Stent System
- Cardiac Science Powerheart, CardioVive, CardioLife; GE Responder and Responder Pro; and Nihon-Kohden Automated External Defibrillators (AEDs)
- CareFusion AVEA Ventilator
- CareFusion EnVe Ventilators
- CareFusion NicoletOne Software Used with CareFusion Cortical Stimulator Control Unit
- Churchill Medical Systems, a Vygon Company, Skin-Prep Wipes Used in Convenience Kits and Tray
- Cook Inc., Single, Double, Triple and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripheral Inserted Central Venous Catheter Trays
- CooperVision AVAIRA Toric and Sphere Soft Contact Lenses
- Davol Inc., XenMatrix Surgical Graft
- Defibtech LLC, Lifeline and ReviveR AEDs: Software Defect May Cancel Shock
- DePuy ASR Metal-on-Metal hip replacement
- DePuy LPS Diaphyseal Sleeve
- Transvaginal Mesh
- CareFusion AVEA Ventilator
- Draeger Medical Inc., Infinity Acute Care System Monitoring Solution (M540)
- Flight Medical V24-00400-29 Cable for Newport HT50 Ventilator
- Fresenius Medical Care North America, CombiSet True Flow Series Hemodialysis Blood Tubing Set with Priming Set and Transducer Protectors for Use with the Blood Volume Monitor
- Fresenius Medical Care North America, Naturalyte and Granuflo Acid Concentrate
- GE Healthcare Vital Signs Hygroscopic Condenser Humidifier Passive Humidification Device (HCH) for Vital Signs Anesthesia Breathing Circuits
- GEM Premier 4000 PAK Cartridges for Use on the GEM Premier 4000 System
- Gen-Probe Inc., AccuProbe Group B Streptococcus Culture Identification Test, AccuProbe Mycobacterium Tuberculosis Complex Culture Identification Test, and AccuProbe Mycobacterium Avium Complex Culture Identification Test
- Global Focus Marketing & Distribution, Ltd., Silencer® S2200 Centrifuge
- iCAD (formerly Xoft Inc.), Axxent® FlexiShield Mini, Model F5300
- Ikaria INOmax DS Drug Delivery System
- King International LLC., ShoulderFlex Deep-kneading Shiatsu Massager
- Lee Medical International Inc., Custom Dialysis Trays / Kits
- Maquet Cardiovascular, LLC, Heartstring II Proximal Seal System (HS-1045)
- Maquet Datascope Corp. Intra-Aortic Balloon Pumps
- Medtronic Model 8637 SynchroMed II Implantable Infusion Pump
- Medtronic SynchroMed II and SynchroMed EL Implantable Infusion Pump and Refill Kits
- Merit Medical Systems Prelude Short Sheath Catheter Introducer
- Millar Instruments Inc., Mikro-Tip Angiographic Catheter, Model SPC-454D and SPC-454F
- Mizuho OSI Modular Table Systems
- MOOG Medical Devices Group, Curlin Infusion Administration Sets
- Nemschoff Chairs, Inc., Perinatal Pediatric Hospital Bed (Bassinet)
- Nidek Medical Products, Inc., Mark 5 Nuvo, Nuvo 8 and Nuvo Lite Oxygen Concentrators
- Oridion Medical and Philips Healthcare Microstream CO2 Filterline (FilterLine H Set Infant/Neonate, VitaLine H Set Infant/Neonate)
- Penumbra Inc., Penumbra Coil 400
- Pharmaceutical Innovations, Inc, Other-Sonic Generic Ultrasound Transmission Gel
- Respironics, Inc. Trilogy 100 Ventilators
- Roche Diagnostics Operations, ACCU-CHEK Performa Strip
- Roche Diagnostics Operations, Inc., Elecsys Troponin I and Elecsys Troponin I STAT Immunoassays
- Roche Insulin Delivery Systems, ACCU-CHEK FlexLink Plus Infusion Sets
- Salter Labs 7600 Bubble Humidifier Used with Supplemental Oxygen Therapy
- SIGMA Spectrum Infusion Pump Model 35700 – Expanded Recall
- Smiths Medical Bivona Neonatal, Pediatric and Flextend Tracheostomy Tubes
- St. Jude Medical, Riata and Riata ST Silicone Endocardial Defibrillation Leads
- Terumo Coronary Ostia Cannula 10, 12, 14 Fr
- Thoratec Corporation, HeartMate II Left Ventricular Assist System (LVAS)
- Triad Group, Triad Sterile Lubricating Jelly
