Synthes, Inc., a Pennsylvania company owned by Johnson & Johnson (J&J), issued a recall of certain lots of the DePuy Synthes Craniomaxillofacial (CMF) Distraction System, also called an External Mandibular Fixator. The system consists of distractors (devices used to lengthen bones in the jaw) and a bone plate. The FDA knows of 15 people injured by the recalled products. Babies are most at risk for serious injury and wrongful death.

Can a Baby’s Parents Sue Synthes and J&J?

Babies can’t sue, but their parents can. To get compensation for the baby, the parents can sue the manufacturer of a dangerous or defective product that injured their child. When money is won in a settlement or verdict, the money is put in a trust for the baby that the parents can use for the child’s care.

Can Parents Sue for a Baby’s Wrongful Death?

If a baby’s death is caused by a dangerous or defective product, the parents, siblings and other relatives have wrongful death claims against the manufacturer (and possibly others). When money is recovered in a settlement or verdict, the court must approve a distribution plan. In these cases, most of the money generally goes to the parents.

Why Was the Recall Issued?

The AB and BC Distractor Bodies used in this DePuy product can reverse after implant surgery. Reversing occurs when the distratxor scrow is turned in the opposite direction to cause the assembly to lose distraction distance. If that happens, the device can cause an obstruction in the trachea, causing the baby to choke. This can lead to respiratory arrest and death. Choking can also cause cerebral anoxia (brain damage caused by lack of oxygen) or other brain damage.

Although the recalled products were implanted in babies, children and adults, babies were at highest risk if the device failed. This is because their little tracheas are so small and easily blocked.

Babies, older children and adults who are injured by the DePuy Synthes Craniomaxillofacial Distraction System will most likely need to undergo prolonged distraction therapy, and some will need “revision surgery” to replace the failed device.  Every person injured by this recalled product have the legal right to sue for compensation.

Product Description: DePuy Synthes Craniomaxillofacial (CMF) Distraction System Recall

Product Classification: External Mandibular Fixator And/Or DistractorProduct Code MQN

Product: DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies)

Code Information: Part nos. 04.315.003, 04.315.004, 04.315.005, 04.315.006 04.315.023 04.315.024 04.315.025 04.315.026 04.315.027 04.315.028 04.315.053 04.315.054 04.315.055 04.315.056 04.315.063 04.315.064 04.315.065 04.315.066 04.315.067 04.315.068, with lot nos.: 6245205, 7129328, IS10400 6246203, 6582199, 6794535, 6814674, 6877737, 6921359, 6981567, 7008430, 7081952, 7129329, 7460419, 7556148 6246984, 6342006, 6964974, 7129330, 7460420, 6246983, 7389334, 7422735, 7515818 6245460, 6342005, 6454138, 6495399, 6651393, 6816023, 6898959, 6921360, 7306561, 7515824 6307904, 6365443, 6410544, 6438375, 6625839, 6651392, 6984928, 7241620, 7351855, 7390470, 7408179, 7458272, 7458273, 7458274, IS10394 6450702, 6454139, 6553925, 6625840, 6883404, 6921586, 7031344, 7185897, 7389329, 7408181, 7422706, 7422707, 7422708, 7458299, 7515832, IS10385 6393118, 6393119, 6410545, 6454140, 6512859, 6625841, 6651391, 6984925, 7185895, 7408182, 7422703, 7422704, 7422705, 7515829, 7515830 6393120, 7408180, 7515833 7122918, 7389333, 7422700, 7545381, IS10388 6252759, 7129331, 7155891, 7418771, 7448753 6245463, 6438376, 6981568, 6983876,7063885, 7129332,7309797, 7418772, 7418848, 7448754 6251769, 7081953, 7310030, 7365542, 7418849, 7448752, 7448758, 7556149 6245458, 6342007, 7129333, 7556150, IS10399 6245462, 6342003, 6824546, 6824551, 6883290, 6883301, 7082907, 7266972, 7476792, 7476810, 7657623 6280719, 6342004, 6394297, 6651390, 6737168, 6767617, 6824547, 6824550, 6883304, 6883305, 6961025, 6984927, 7041138, 7056051, 7111867, 7185893, 7266967, 7351857, 7351858, 7351859, 7351861, 7422701, 7545379, 7657820, IS10395, 6651389, 6702172, 6883306, 6883307, 6942444, 6984926, 7111868, 7185892, 7306562, 7306563, 7306564, 7499078, 7515834, 7657629, IS10389 6651388, 6741835, 6824553, 6883309, 6913921, 6942445, 6961024, 7082908, 7111869, 7122924, 7185888, 7515835, 7657633 6921585, 6942446, 7185887, 7306565, 7306566, 7408183, 7476791, 7567066, 7579433, 7657635, IS10390, IS10391, 6275129, 7082905, 7185890, 7266969, 7422697, 7609200, IS10386, IS10387

Recalling Firm/Manufacturer: Synthes, Inc. 1302 Wrights Ln EWest Chester, Pennsylvania 19380-3417

Attorneys Fred Pritzker and of Counsel David Szerlag are our lead lawyers for these cases. You can contact them at 1-888-377-8900 (toll free).

Fred Pritzker