Medical malpractice allegations that duPont Hospital for Children (in Wilmington, Delaware) improperly performed experimental sugery for the placement of non-FDA approved cardiac stents have resulted in 17 lawsuits to date. The Delaware hospital, along with renowned heart surgeon William Norwood, M.D., performed numerous open heart surgeries on patients to prepare them to receice the experimental cardiac shunt. The hospital apparently never received, or even requested, an exception from the FDA for “compassionate use” of the heart shunts. Numerous children sufferred devastating injuries, and some died, as a result of the alleged improper conduct of the hospital and the surgical team. Attorneys in the various lawsuits have claimed that the specific heart surgeries performed, as well as the use of the shunts, were experimental and negligently performed. Additionally, there are allegations that proper informed consent for the experimental procedures was never obtained.
In the most recent lawsuit to be filed, a child had two experimental open-heart surgeries to prepare the child’s heart to receive the stent. The family was eventually informed that the stent was not FDA-approved, but only two years after the last surgical procedure. The family claims that the hospital and surgical team was aware that the FDA never approved the stent and that the FDA had sent a warning letter to the hospital prohibiting the stent’s use in patients. However, the lawsuit alleges that for two years the hospital fraudulently concealed and misrepresented this information to the family, whose child had heart surgery to prepare for the stent’s use.
The duPont Hospital for Children has fired the heart surgeon and cardiologist involved in the experimental use of the heart stent, but the damage to patients and their families will last forever. As in these cases, claims of negligently performed procedures (medical malpractice), lack of informed consent and product liability often are intertwined in this type of complex litigation. Only knowledgeable, experienced and skilled attorneys are able to direct and litigate this type of difficult case to successfully uncover the wrong-doing of the doctors and hospitals and make a recovery for the patient and their family.