All medical devices must be approved by the FDA prior to use by doctors, however, most people don’t realize that there are two methods of approval, 1) pre-market approval (PMA), and 2) 510(k). With a PMA approval, the manufacturer must submit a lengthy application which details the design and test results of the product. However, with a 510(k) clearance, the manufacturer must merely show that the device has been approved by another manufacturer and is substantially similar. Surprisingly, no testing is required by the manufacturer or the FDA prior to the device being implanted in patients.
The significance is that a PMA approval provides certain protections to a manufacturer that a 510(k) clearance does not. Our firm has successfully litigated against device manufacturers with both types of approvals. These devices include spine stimulators, neuro-monitoring devices, and spinal fusion medical devices. In our investigations for clients, we have also uncovered kick-back schemes which involve doctors being paid to use certain devices. Patients are never informed of this lucrative scheme which can conflict with what is best for the patient.
Medical device litigation is complicated and dynamic with various courts around the country setting different rules and laws. Causes of action can include negligent manufacturing, design defects, failure to warn, and breach of warranty. Various statutes of limitations apply, some as short as one year. With our main office in Austin, Texas, our firm currently represents injured persons from coast to coast. If you have concerns that your medical device is not functioning or may have caused you injury, call us immediately for a free consultation.
We are currently actively investigating and litigating regarding the Medtronic RestoreSensor spine stimulator. Patients have reported issues which include a short battery life, spontaneously turning on, and injuries from the device being removed.
If you or someone you know has a Medtronic implantable medicine pump, it is important to know about a recent Complaint Filed by the U.S. Attorney’s Office in regards to manufacturing problems. This injunction filed April 27, 2015 against Medtronic and its CEO, seeks to prevent them from selling SynchroMeds that have been adulterated and to force them to improve the quality of their manufacturing methods. It describes numerous violations of the quality system regulations at Medtronic Neuro and states that many of the violations related directly to the manufacture of the SynchroMed II implantable infusion pump. The complaint references four inspections where the FDA observed and documented violations.
If your SynchroMed pump is not functioning correctly or if you had your implant removed due to problems, please call or email our office to see if you can recover damages.
The Meyerson Law Firm, P.C. (512) 330-9001
The Meyerson Law Firm has filed suit against St. Jude Medical in regards to claims of manufacturing and warranty defects with its Eon Mini stimulator. Not to be confused with St. Jude Children’s Hospital, St. Jude Medical is a for profit company that sells various medical devices throughout the world. There have been recalls and numerous complaints regarding its Eon Mini stimulator, including that it causes burning sensations while charging, it delivers painful jolts, and its battery depletes too quickly. Removing the devices can be medically risky and permanent scar tissue can build up near the spine where the leads were implanted.
Last year a one year old in Austin, Texas accessed a coin shaped “button” battery from a Vizio stereo bar remote control and ingested it. The battery lodged in his esophagus and the electric current created a caustic agent that burned his throat tissue. This serious condition put him in the hospital for what is now months of operations, treatment and observation. The Meyerson Law Firm has filed suit in San Diego Federal Court alleging a dangerous design defect in the remote.
The Meyerson Law Firm urges everyone to look through their remotes and ensure that any which use button or coin shaped batteries are secured with child safe mechanisms. If you know of anyone whose child has been injured by a similar occurrence, please have them call The Meyerson Law Firm for a free consultation.
On February 28, 2012, our client Edith went in for surgery where the doctor used the NVM5 neuromonitor manufactured by Nuvasive, Inc. In the middle of the surgery, the orthopedic doctor aborted the procedure. Nuvasive admitted in emails to the doctor that their product did not work properly during the procedure and explained what they would do to prevent problems in the future. The patient incurred damage to her lumbar plexus which affected her ability to walk. Nuvasive now blames the doctor for the injury to the patient. The case is set for trial in the U.S. District Court, Western District of Texas in October of 2014.
FDA Alert – Specialty Compounding Products
Friday, August 9th the US Food and Drug Administration (FDA) sent out an alert informing health care professionals not to use any sterile products supplied by Specialty Compounding, Cedar Park, TX. Bacterial infections had been potentially associated with contaminated calcium gluconate infusions produced by the company. FDA had received reports of 15 adverse events experienced by patients in two hospitals; the patients had developed bacterial bloodstream infections caused by Rhodococcus equi, an organism commonly found in dry soil. Cultures from an intact sample of calcium gluconate compounded by Specialty Compounding show growth of bacteria that are consistent withRhodococcus species.
As of Monday, August 11th the FDA announced nationwide voluntary recall of all products for sterile use from Specialty Compounding. The recall applies to all unexpired sterile compounded products dispensed since May 9, 2013, including all strengths and dosage forms.
According to information provided by the firm, the recalled products were distributed directly to patients nationwide, with the exception of North Carolina. Recalled products were also distributed directly to hospitals and physicians’ offices in Texas.
Please call The Meyerson Law Firm today to discuss any case. 512-330-9001
I would like to express my sincere gratitude and thanks for everything your firm and especially Mr. Daniel Orocu have done in assisting with my case. Let it be known that Daniel has gone above and beyond to resolve an issue I thought would never end and exceeded my expectations with respect to the settlement received. These efforts are recognized and greatly appreciated and I felt the need to express that I have been totally impressed by the level of dedication, commitment and professionalism in dealing with Daniel and your staff.
Again, thank you for your time and assistance in this matter. I will highly recommend your firm and seek your assistance in any future legal matters.
Blas A. de la Garza
CEO, Southwestern Logistics Services LLC
St. Jude Medical has recalled certain models of Eon and Eon Mini implantable pulse generators (IPGs). IPGs are battery powered devices that are implanted into a patient’s spinal area and provide stimulation in order to reduce chronic pain.
IPGs require the implanted internal battery to be recharged. However, these devices suffer from significant problems. In certain models, the battery fails which then prevents the device from providing pain relief. In other cases, IPGs have severely burned patients while recharging the battery. Once a problem is detected, the devices must be surgically removed from the spinal area, subjecting the patient to a host of other risks and problems such as infection, pain and scarring.
St. Jude Medical (which is sometimes confused with St. Jude’s Children’s Hospital) has announced that the battery failure problems stem from weld failures within the internal batteries of the units, sometimes allowing fluid to spill out. The battery is fully contained in the titanium shell of the unit, however, and is not at risk of leaking into the body.
If you are having problems with your St. Jude Stimulator, please contact us to discuss how our firm can help you.