Medtronic SynchroMed II Implantable Drug Infusion
SynchroMed II and SynchroMed EL Medical Devices manufactured by Medtronic which are permanently inserted into a human body and deliver or pump medication to patients to treat chronic pain, primary or metastatic cancer and severe spasticity.
Medtronic has recently issued four medical device notifications about the SynchroMed Implantable Infusion System. The Food and Drug Administration has classified these notifications as Class I recalls. There were approximately 261,000 defective devices sold in the USA, Canada and Mexico.
i. Unintended delivery of drugs during the priming bolus procedure resulting in drug overdose and underdose leading to respiratory depression, coma or death.
ii. Potential for electrical shorting, internal to the SynchroMed Infusion pump, leading to a loss of or reduction in therapy, resulting in Serious Adverse health consequences including death.
iii. Catheter Occlusion: Sutureless Connector Intrathecal Catheter connection is prone to blockage where the catheter connects to an implantable pump.
iv. Pump refill Procedure Safety Update. Reflects new product labeling to help reduce the potential for a pocket fill during the refill procedure. A pocket fill is the inadvertent injection during a refill procedure of all or some of the prescribed drug into the patient’s subcutaneous tissue instead of the pump.
This Litigation Group was formed in 2013.
The Medtronic SynchroMed II Implantable Drug Infusion Litigation Group member benefits include a Group Document Library, list server, and education programs.
This litigation group utilizes the group’s purpose in creating a collaborative working team, to attract the broadest spectrum of plaintiff’s attorneys representing clients injured by Medtronic defective SynchroMed devices possible.
Medtronic is a world-wide company, with significant resources to defend against lawsuits. The cost of litigating a SynchroMed case against Medtronic would be essentially impossible for a firm handling these cases individually. Joining this network of attorneys focused on litigating cases, and a depository of pleadings and other documents to assist in drafting effecting complaints and discovery, helps level the playing field for attorneys representing clients with these devices, and reduces the individual burden of litigating these cases.
Regulations in the medical device arena create potential “pre-emption” barriers and pitfalls to attorneys choosing for the first time to represent clients harmed by Medtronic’s medical devices. This Group focuses on not only the causation and injury issues, but also the legal challenges in an area of law largely preempted to help insure that attorneys working with medical devices for the first time can do a better job representing their clients.
AAJ Annual and Winter Conventions, or as needed by group members.