Premature babies or babies with low birth weight often require additional nutrition to address their low weight and boost development. Many hospitals, doctors, and nurses recommend that preterm infants are put on formula, especially if the infant won't breastfeed. Formulas are a perfectly normal recommendation that many parents expect to be safe. Unfortunately, this is not always the case. Recent studies and research indicate that specific cow milk-based formulas are linked to a deadly condition known as necrotizing enterocolitis (NEC). This condition causes inflammation and destruction of the intestines. NEC could lead to blood poisoning, infection, and death.

If your preterm baby is diagnosed with NEC after being given Enfamil or Similac, you can bring a product liability lawsuit against the formula manufacturer and seek compensation for your loss. In addition, you can pursue a case against the manufacturer for failing to warn parents and physicians about the NEC risks in premature babies.

Whether Similac Causes NEC

Many scientific studies reveal that bovine-based baby formulas like Similac and Enfamil can cause preterm babies’ bowel disease (NEC). The condition mainly develops in preemies between two and six weeks. One study conducted decades ago revealed that preterm infants fed on formula were six to ten times more likely to develop NEC than infants who consumed breast milk. Formula-fed preterm babies are also three times more likely to develop NEC than babies fed on formula and breast milk.

Back in 2011, a group of hospitals concluded that infants fed on cow-milk formula were at a higher risk of developing NEC than babies fed on donor breast milk. In 2011, the then US Surgeon General outlined that premature babies fed on formula milk were more likely to develop NEC. In 2012, the American Academy of Pediatrics medical representatives proclaimed premature babies should not be fed on cow-milk formula due to the associated high risk of NEC. Instead, preterm babies should only be fed human milk.

The American health care company Abbott manufactures Similac. The company has its headquarters in Abbott Park, Illinois. It has a principal place of business in Lake County, Illinois. Initially, Ross Laboratories manufactured Similac. The company merged with Abbot in 1964. Abbott Nutritional also manufactures Ensure, Pedialyte, and Glucerna. Abbot is incorporated in Delaware. In 2019, Abbott sales of Similac amounted to more than one billion dollars.

Understanding Necrotizing Enterocolitis

Commonly abbreviated as NEC, necrotizing enterocolitis is a bacterial gastrointestinal infection in preterm babies. NEC causes inflammation of the intestines, causing tissue death. Usually, NEC is treated with antibiotics. Abdominal repair is necessary for some instances. NEC could result in many health issues and complications, the most common being intestinal strictures, sepsis, development problems, perforation of intestinal problems, cerebral palsy, and death.

The following are the common symptoms of NEC in preterm babies:

  • Constipation
  • Dark stools or diarrhea with blood
  • Trouble eating and gaining weight
  • Vomit that is green or yellow
  • Apnea
  • Lethargy
  • Distended abdomen
  • Shock in advanced cases of NEC
  • Lowered blood pressure and heart rate

NEC is a progressive condition. Therefore, prompt identification of the symptoms is essential so that the infant can commence treatment. With an immediate diagnosis and treatment, most infants with NEC recover well and proceed to have a normal life expectancy without complications.

The most common method of diagnosing NEC is observing symptoms by a pediatrician. Other diagnostic tools that can be used in addition to clinical symptoms include abdominal imaging, blood testing, cultures, and blood gas levels.

NEC treatment involves discontinuing all forms of oral feeding and administering strong antibiotics to the infant. The baby receives nutrients intravenously until the infection is eliminated and the baby's intestines heal fully. Depending on the extent of the illness, nasogastric drainage alongside circulatory support may be necessary. In severe cases of NEC, tissues in the intestines might be left dead and decayed. If this is the case, the infant must undergo surgery to allow doctors to remove the dead intestinal tissues.

In the United States, around 480,000 premature babies are born every year. Every year, approximately 9,000 infants develop NEC. About 90% of these NEC cases occur in premature babies. There are four common types of NEC:

  • Atypical NEC
  • Classic NEC
  • Transfusion-associated NEC
  • Term infant NEC

Classic NEC is the most common complication associated with cow milk formula.

Recall Of Baby Formulas That Cause NEC

Similac infant formula remains on the market despite its high risk of causing NEC in premature babies. The formula manufacturer, Abbott, has not recalled NEC, and neither has the FDA (Food and Drug Administration). Some of the popular Similac products in the market are:

  • Similac Special Care
  • Similac Pro-Advance
  • Similac NeoSure
  • Similac Pro-Sensitive
  • Similac Human Milk Fortifier

In instances where the preterm baby does not develop NEC, Similac effectively provides preemies with calories, especially if the preemie has trouble breastfeeding. Prolacta is a better alternative to Similac. Prolacta is a human milk-based fortifier that has been in use since 2006. Prolacta has a ready-to-feed infant formula that has been available in the market since 2014.

Infants can also be fed donor milk from the European Milk Bank Association or the Human Milk Banking Association of North America.

Lawsuits Against Similac Maker Abbott Laboratories, Inc

Many parents who have preterm babies who suffered from NEC never think of filing a lawsuit against the formula manufacturer; most don't understand the connection between these formulas and NEC. For many years, malpractice attorneys filed medical malpractice cases against doctors and nurses, alleging that the doctors should have reduced or avoided feeding infants with cow-based milk products because these products are known to cause NEC.

In many of these medical malpractice lawsuits, the doctors responded that they did not know any medical literature connecting Enfamil or Similac with NEC. In the end, the plaintiffs' attorneys connected the dots and realized that both doctors and parents were not informed about the NEC risks posed by the formulas. Even now, you will still receive mixed responses when you ask pediatricians whether baby formulas can cause NEC despite the numerous NEC lawsuits.

Parents are bringing lawsuits against Abbott Laboratories, Inc for intentionally failing to warn consumers about the risk of NEC. Every week, there are new lawsuits against Similac manufacturers for causing infants to develop NEC. The typical causes of action include:

  • Strict product liability for defective product (design defect)
  • Negligence
  • Strict liability for failing to warn consumers — Similac product information and labels still do not disclose the NEC risks associated with the formula. Instead, the label and product information only outlines that preterm babies are prone to gastrointestinal problems.
  • Negligent misrepresentation
  • Intentional misrepresentation
  • Wrongful death lawsuits in cases where the infant passes away
  • Breach of warranty

All the product liability lawsuits filed against Abbott will likely consolidate into a multi-district litigation, commonly abbreviated as MDL. Multidistrict litigation is a way of expediting the pretrial and settlement process. Multidistrict litigation is almost similar to a class action except that in an MDL, every case remains separate. Multidistrict litigation is also likely to form against the Enfamil manufacturer Mead Johnson & Company to consolidate the various lawsuits against the manufacturer.

Many state and federal court medical malpractice cases also emerge against hospitals whose neonatal intensive care unit (NICU) feeds their babies Similac.

Enfamil Baby Formula Lawsuits

Attorneys are evaluating lawsuits against Mead Johnson Nutrition, the manufacturer of Enfamil, for failing to warn parents and physicians about the risks of Enfamil in babies. You could have a viable Enfamil lawsuit if your preterm baby were fed on any of these products and developed NEC:

  • Enfamil 24 Cal Infant formula
  • Enfamil NeoPro EnfaCare Infant Formula
  • Enfamil Human Milk Fortifier
  • Enfamil Premature Infant Formula 24 Cal with Iron, among others

Eligibility For Filing An NEC Lawsuit

The parents or families of infants who suffered necrotizing enterocolitis may file an NEC lawsuit provided they prove that:

  • Their infant used Enfamil or Similac formula
  • The infant was born prematurely
  • The infant was diagnosed with NEC

Most of the NEC cases revolve around severe instances whereby the infant had to undergo surgery to reverse the effects of NEC or where the child succumbed to NEC.  So far, an MDL or class action has not yet been formed for the NEC baby formula lawsuits. However, as claims continue to build up, this litigation is underway. Infant formula attorneys will likely request an MDL class action to consolidate all necrotizing enterocolitis lawsuits under one court or judge.

NEC baby formula lawsuits are filed against the manufacturers or the doctors and nurses. It is possible that some of these lawsuits will not be handled within the expected NEC class actions but will proceed as individual cases.

Similac And Enfamil Recalls

Despite the many NEC lawsuits revolving around the adverse impacts of Similac and Enfamil, there have not been Similac or Enfamil recalls. The infant formula attorneys do not advocate for a recall. Instead, they point out that these formulas can remain in the market but should warn doctors and parents regarding the adverse effects of the formulas, including the heightened risk of NEC.

The Settlement Amount Available In An NEC Infant Formula Lawsuit

The NEC infant formulas are just getting started. Thus, it is difficult to predict the expected settlement amounts from the lawsuits. The NEC lawsuits against Similac baby formula maker Abbott and Mead Johnson Nutrition (Enfamil formula maker) seek compensatory damages for out-of-pocket expenses, medical costs, and pain and suffering. NEC can make infants sustain lifelong injuries or even die. Therefore, attorneys seek to get as much money as possible to compensate the plaintiffs.

NEC lawsuits and settlements were brought against doctors and health facilities in the past. Medical facilities and doctors are sympathetic defendants who commit medical malpractice while trying to help your child. It is rare for juries to be extremely harsh to such defendants. The doctor may have made an honest mistake in most cases but with grave consequences. There is little to no chance that the court will award punitive damages in lawsuits against doctors and hospitals.

Currently, the shift of NEC lawsuits is focusing, and parents are suing the makers of Similac and Enfamil. Higher settlement amounts are expected, especially where the plaintiffs and their attorneys prove that the makers of Similac and Enfamil did not warn doctors and parents because they knew that this warning would reduce their profits. If the jurors agree that the manufacturers of Similac and Enfamil put profits above the health and wellbeing of premature babies, there will be incredible compensations and even punitive damages awards.

That baby formula manufacturers will likely include NEC warnings and give plaintiffs reasonable settlements before these cases get before a jury. Cases with the highest trial value or value settlement amounts will be those where the child requires ongoing care. The economic cost of providing lifelong care to these children could amount to millions of dollars. Other high settlements will involve a wrongful infant death due to NEC. It would be awful for a parent to lose an infant because no one ever told them that baby formula could cause the child harm. Finally, the NEC compensation payouts may still be high in cases where the child experienced a great deal of pain and suffering but ultimately recovered. Therefore, attorneys fight to get the highest compensation possible.

How Long It Takes To Settle An NEC Lawsuit

The NEC formula litigations are just beginning, so you can only rely on predictions regarding how long it will take to receive the settlement payout. Attorneys predict that Mead Johnson and Abbott will be greatly concerned about the Similac and Enfamil lawsuits. They will be worried about both the reputation damage and the verdicts that will drive the settlement payout. The manufacturers will likely settle the cases out of court and warn about NEC risks associated with the baby formulas.

Find an NEC Lawsuit Attorney Near Me

If your preterm infant suffered NEC after being fed Similac or Enfamil in the United States, we invite you to contact Consumer Alert Now for legal advice and to discuss the best way to seek compensation. Our attorneys will review your case and advise you on the way forward. Call us at 800-511-0747 and speak to one of our attorneys.