The DePuy Synthes Craniomaxillofacial Distraction System (external mandibular fixator) consists of multiple internal distractors that stabilize or lengthen lower jaw bones and along the side of the lower jaw bone plate. Surgeons implant the device in adults, children, and infants to correct post-traumatic and congenital birth jaw bone defects. When installed properly, the distractors can gradually expand the length of the bone. DePuy Synthes is a subsidiary of the healthcare and pharmaceutical giant Johnson & Johnson.
FDA Alert Concerning Defective Design of DePuy Synthes Craniomaxillofacial Distraction System
In August 2014, the Food and Drug Administration (FDA) issued a Safety Communication warning doctors and patients of the defect design of the DePuy Synthes Craniomaxillofacial Distraction System. The highest designation Class I product recall announcement stated that infants undergoing the procedure may experience a sudden unexpected obstruction of the trachea that could result in respiratory failure and/or wrongful death. However, adults and children who can maintain an open airway have a decrease potential risk of suffering a severe injury with the device, compared to children who are 12 months old and younger.
The FDA’s August 8, 2014, decision to recall the device was released just before DePuy Synthes sent consumers an Urgent Notice on April 16, 2014. The notice identified the fundamental problem with the design of the product and its potential for causing serious harm by reversing direction unexpectedly and losing distraction distance after the device has been surgically implanted.
Every lot of the DePuy Synthes device manufactured between April 20, 2009, and April 15, 2011, was recalled by the company under the direction of the FDA. Many of these devices were still available for purchase from the manufacturer until April 14, 2014, which was two days before the company sent their Urgent Notice to patients, hospitals, medical centers, and doctors. A Class I recall designation is the most serious form of medical device product recalls due to their potential for causing severe adverse health consequences, lifelong harm or death.
So far, there have been at least 15 cases of serious injuries related to using the external mandibular fixator system reported to the Food and Drug Administration requiring surgical intervention or replacement of the device. This is not the first time that Johnson & Johnson has faced a Class I recall issued by federal regulators. Since 2012, the pharmaceutical and healthcare giant has had twelve products recalled from the medical marketplace. Hospitals and medical offices received the DePuy Synthes Urgent Notice in April 2014 instructing them to check their device inventory and remove every recall-affected distractor from their current stock, especially the “AB” and “BC” distractor bodies.
The recall attorneys at the Drug Law Centered are currently reviewing cases and filing Defective CMF Distractor System lawsuits on behalf of clients who have suffered injuries caused by the bad medical device. Currently, the law firm is accepting claims to obtain financial compensation for injured victims and family members of loved ones who received a defective unit.
Potential Complications Related to Craniomaxillofacial Distraction System
The Food and Drug Administration recalled the Craniomaxillofacial Distraction System due to potential complications that could include:
- Unexpected tracheal obstruction in adults, children, and infants. The obstruction can cause respiratory failure and death, especially in children 12 months old or younger.
- Failure of the medical device in children and adults who can still maintain an open airway that does not lead to a tracheal obstruction.
- Medical device failure that leads to surgical intervention or a failed device replacement.
What to Do?
Doctors must closely monitor the condition of their patients who have received implanted distractors and take appropriate action if imaging or clinical evaluation confirms that there is a problem. Both the FDA and DePuy Synthes have asked doctors to schedule appointments to evaluate their patients who might not be aware of any abnormality with their implanted Craniomaxillofacial Distraction System (CMF).
When formulating a Plan of Care, the physician should consider their patient’s age, their caregiving environment and their capacity to protect their airway from obstruction while the implant remains in place. Doctors are also being warned by the FDA that the nutritional status of their patients after the operation or their failure to obtain supported treatment could place their health and well-being in jeopardy.
Obtain Legal Representation Related to Injuries Due to DePuy Synthes CMF Distraction System
If you, or your loved one, sustained a severe injury caused by the DePuy Synthes CMF Distraction System, let us protect your legal rights to obtain financial recompense or your damages. The experienced CMF Distraction System attorneys at the Drug Law Center can handle every aspect of your Craniomaxillofacial Distraction System Lawsuit to ensure you receive adequate compensation to cover your medical bills, lost time away from work, funeral expenses, pain, suffering, and mental anguish.
Our legal team is skilled at handling cases involving defective medical devices. We build our compensation claims and lawsuits on the manufacturer’s failure to protect consumers of specific complications with their faulty units. Our lawyers working on your behalf may take legal action against Johnson & Johnson and DePuy Synthes for their failure to adequately warn patients and doctors of the potential serious risk of respiratory failure, tracheal obstruction, and wrongful death.
Our law firm will provide you our legal services under a contingency fee arrangement, meaning you pay no out-of-pocket expenses to hire our team. We provide a “No Win – No Pay” Guarantee and will receive no lawyer fees or financial reimbursement of our expenses unless we successfully negotiate an acceptable out of court settlement or win financial recovery at the conclusion of a jury trial.
Contact our law offices today to schedule a free consultation with our reputable medical device injury attorneys. Let us begin your case by investigating your claim to provide you numerous legal options on how best to proceed to obtain an adequate financial recovery that covers your losses. We can build a solid case for recompense to prove how the healthcare medical device giant Johnson & Johnson and their subsidiary DePuy Synthes are legally responsible for your damages and injuries.
If you have lost a loved one because of an injury caused by the CMF Distraction System, our lawyers can file and resolve a wrongful death lawsuit on your family’s behalf.