Closing arguments are expected Friday in Inman v. Mead Johnson & Company, the first federal NEC bellwether to reach a jury.
Alexis Inman alleges Mead Johnson failed to adequately warn physicians about the increased risk of necrotizing enterocolitis associated with cow’s-milk-based formula fed to premature infants. For plaintiff lawyers following MDL 3026, Inman represents an important moment.
Earlier federal bellwethers involving Abbott’s Similac products ended before juries were asked to decide liability. Inman survived summary judgment and expert challenges, putting Mead Johnson’s conduct, warnings and scientific evidence before a federal jury. Timing adds to the significance.
While jurors in Inman were hearing evidence, Abbott announced a $670 million agreement resolving the Gill judgment and NEC claims involving approximately 2,000 additional infants. Abbott admitted no liability, and that agreement does not resolve claims against Mead Johnson. Still, it changes the broader landscape as Mead Johnson prepares to place its own NEC case in the hands of a jury.
What the Jury Is Being Asked to Decide
Daniel Windley was born at 29 weeks gestation, weighing approximately 670 grams. His medical history was complicated from birth, a fact Mead Johnson has relied on heavily in its defense. Daniel received human milk during portions of his NICU stay before his care team began feeding him Enfamil Premature Formula.
By June 2020, Daniel was receiving a combination of donor milk and Enfamil. His feeds were later changed to Enfamil Premature. His condition deteriorated; he developed NEC, underwent surgery and ultimately died from complications associated with the disease.
Plaintiff counsel has focused the case on three questions: what Mead Johnson knew, what it told the medical community and whether stronger warnings would have changed Daniel’s feeding decisions. That theme has been present since opening statements. Plaintiff counsel argued Mead Johnson knew of an increased NEC risk but failed to provide physicians with a clear warning. Mead Johnson denies its formula caused Daniel’s NEC and points instead to his extreme prematurity, low birth weight and significant medical complications.
Why Inman Reached a Jury
One of the most important features of Inman is the evidence surrounding Daniel’s actual feeding decisions. Plaintiff counsel has argued that feeding choices in the NICU involved more than a simple decision between formula and human milk. Doctors considered the amount and type of formula, fortification, supplementation and the availability of mother’s milk and donor milk. That matters because warning cases often turn on whether different information would actually have changed a physician’s decision.
Here, plaintiff counsel was able to develop enough evidence on that question to put warning causation before the jury.
Mead Johnson and the NICU
Plaintiff counsel also presented evidence concerning Mead Johnson’s involvement in the NICU marketplace. Evidence in the case includes allegations that Mead Johnson pursued an “own the NICU” strategy as hospitals increasingly turned toward donor human milk.
Jurors heard about Mead Johnson’s relationships with medical professionals and key opinion leaders, along with company contact with the nutritionist involved in developing the feeding roadmap used at Daniel’s hospital. Mead Johnson disputes the plaintiff’s characterization of those relationships and maintains that Daniel’s treating physicians made independent medical decisions. For closing arguments, that evidence gives plaintiff counsel a broader point to make.
Was Mead Johnson simply supplying a product selected independently by neonatologists, or was the company helping shape the environment in which those feeding decisions were being made while failing to clearly communicate the NEC risk alleged by the family?
Internal Science Becomes Part of the Story
Evidence concerning Mead Johnson’s own research may also play an important role in closing. Pretrial proceedings identified internal research and discussions concerning whether changing the carbohydrate composition of Enfamil Premature could reduce NEC risk.
Mead Johnson researchers evaluated formulations using lactose as the principal carbohydrate rather than corn-syrup solids and maltodextrin. Internal research included animal studies looking at NEC outcomes and discussions regarding possible reformulation. That work did not result in a new commercial formulation.
Plaintiff counsel can use that evidence to ask a straightforward question: if Mead Johnson was internally studying ways to make premature-infant formula more protective against NEC, what did company scientists understand about the risk?
Mead Johnson has an equally important response. Animal studies do not establish that Enfamil causes NEC in human infants, and internal product research is not the same as proof of causation. Expect that issue to receive attention Friday.
Mead Johnson’s Defense: Daniel Was Exceptionally Vulnerable
Mead Johnson has substantial medical facts to work with. Daniel was extremely premature, weighed less than 1.5 pounds and suffered severe fetal growth restriction and anemia. His medical course included numerous blood transfusions and significant complications associated with extreme prematurity.
Mead Johnson’s position is that those facts cannot be separated from the NEC diagnosis. Extreme prematurity itself is one of the strongest known risk factors for NEC. Defense counsel has also argued that Daniel’s physicians understood the benefits of human milk, understood his nutritional needs and made individualized decisions concerning his feeds. That sets up what may be the central question for the jury.
Was Daniel’s NEC an unfortunate consequence of profound prematurity and an extraordinarily complicated medical course? Or did Enfamil Premature contribute to the development of NEC in a way Daniel’s doctors would have approached differently had Mead Johnson provided a stronger warning?
Plaintiff Trial Team
José Rojas enters closing arguments Friday after helping build this litigation from its earliest stages.
Rojas, a founding partner of Levin, Rojas, Camassar & Reck, has been involved in the NEC litigation since before the cases were consolidated into MDL 3026. He and his partners spent more than a year litigating early NEC cases before the litigation developed into the national mass tort now pending before Judge Pallmeyer.
Judge Pallmeyer appointed Rojas Co-Lead Counsel in MDL 3026 in May 2022. His role in Inman puts him in a position few lawyers get in a mass tort: taking a liability theory developed over years of discovery, expert work and motion practice and presenting it to the first federal jury asked to decide an NEC claim on the merits.
Rojas brings a trial background that predates his work in mass torts. He began his career in the Army Judge Advocate General’s Corps, later served as a Special Assistant United States Attorney and tried criminal cases as a federal prosecutor. After spending several years representing corporate and government defendants in complex civil litigation, he moved to the plaintiff side and built a practice centered on personal injury, medical malpractice and product liability cases.
Friday’s closing will give Rojas the opportunity to bring the case back to the point he has emphasized throughout Inman: what did Mead Johnson know about NEC, what information did it provide to physicians caring for premature infants, and what information was missing when those doctors made feeding decisions? Rojas is joined at trial by an experienced plaintiff team.
- Diandra “Fu” Debrosse of DiCello Levitt serves alongside Rojas as Co-Lead Counsel in the NEC litigation and has held leadership positions in several major national mass torts. Her practice has included pharmaceutical, medical product, environmental and large-scale product liability litigation. Her presence in Inman gives the trial team another lawyer who has spent years working inside the NEC litigation and its scientific record.
- Je Yon Jung, a partner at May Jung, brings more than 25 years of litigation experience to the team. Jung began her legal career with the U.S. Department of Justice Civil Rights Division and later built a practice involving civil rights, personal injury and mass tort litigation. She has also served in plaintiff leadership in other federal multidistrict litigation, bringing another layer of coordinated-litigation experience to the courtroom.
- Pearl Robertson of Irpino, Avin & Hawkins has worked inside MDL 3026 as a member of the Plaintiffs’ Steering Committee and has played a significant role in discovery and privilege issues. Robertson’s practice is heavily focused on the corporate discovery problems that often drive complex litigation, including document production, privilege disputes and electronic discovery. She has held similar responsibilities in other large MDLs.
- Steven Reck, Rojas’ law partner at Levin, Rojas, Camassar & Reck, filed the first case that ultimately helped launch the nationwide NEC litigation. What began as individual families questioning why they had never been warned about NEC risk developed into MDL 3026 and, years later, the Inman bellwether now heading to a federal jury.
For the lawyers who have been working on these cases since the beginning, Friday represents considerably more than another closing argument. It is the first opportunity to ask a federal jury to decide the case they have spent years building.
A Federal Jury Finally Gets the Question
Years of NEC litigation have centered on experts, causation, alternative designs, warnings, Daubert challenges and preemption arguments. Inman made it through those fights. Now those issues have moved out of briefing and into the jury room.
Rojas is expected to ask jurors Friday to focus on what Mead Johnson knew, what it communicated to physicians and what it failed to communicate. That is the liability question plaintiff lawyers across the country will be watching.
Why Plaintiff Lawyers Are Watching
No single bellwether establishes the value of an entire docket. NEC cases remain highly fact-specific. Gestational age, birth weight, feeding records, availability of human milk, timing of formula exposure, medical causation and physician testimony can all change the complexion of an individual case. Still, Inman is an important test.
For years, federal NEC litigation has largely been defined by motions practice, expert challenges and appellate rulings. Now a federal jury is being asked to decide the merits of a Mead Johnson NEC case. Abbott’s recently announced $670 million resolution involving the Gill judgment and roughly 2,000 additional NEC claims adds another piece to the picture.
That agreement does not bind Mead Johnson and should not be treated as a valuation model for every NEC claim. But it confirms something plaintiff lawyers already understand: NEC litigation has moved beyond theoretical exposure. Real cases have gone to verdict. Real settlement dollars are now moving. Mead Johnson’s first federal jury test comes next.
Closing arguments are expected Friday, August 28. Jury deliberations are expected to follow.