JOHN A. JARVEY, District Judge.
I. Background and Material Facts.................................................880
A. Manufacturing Enfamil ® Human Milk Fortifier...........................880
B. Microbiological Risks of E. sak............................................882
C. D.J.K.'s Illness and Investigation.........................................883
II. Summary of Arguments.........................................................885
III. Summary Judgment Standard...................................................886
IV. Plaintiffs Cannot Establish Medical Causation ...............................886
A. Expert Testimony..........................................................889
1. Plaintiffs'Experts Causation Evidence..................................890
a. John Farmer, III, Ph.D..............................................890
b. Kathleen Harriman, Ph.D.............................................890
c. Janine Jason, M.D...................................................891
d. Gregory Pincar......................................................891
e. Robert Behling......................................................892
2. Defendant's Experts Causation Evidence.................................892
a. Robert Baltimore, M.D...............................................892
b. Michael Doyle, Ph.D.................................................893
c. Stephen Forsythe, Ph.D..............................................893
d. Nancy Nevin-Folino, R.D.............................................894
B. Temporal Relationship.....................................................894
C. Other Possible Sources....................................................896
V. Conclusion....................................................................898
This matter comes before the Court pursuant to Defendant Mead Johnson & Company, LLC's ("Mead Johnson") April 5, 2010 Motion for Summary Judgment. [Dkt. No. 31.] Plaintiffs Patrick Korte and Michelle L. Korte, individually and as Parents of D.J.K. filed a response to Mead Johnson's motion for summary judgment with the Court on April 29, 2010. [Dkt. No. 44.] The Court granted Mead Johnson's May 5, 2010 resisted motion for extension of time to file a reply to its motion for summary judgment, which Mead Johnson
The Court held a hearing on this matter on May 24, 2010. [Dkt. No. 62.] The Court grants summary judgment in its entirety to Mead Johnson.
Premature infants often need enhancements or supplements added to breast milk. Breast milk for premature infants can be nutritionally insufficient because they require additional calories, proteins, vitamins, and minerals in order to achieve growth and development comparable to what they would have achieved in utero. Mead Johnson's Enfamil® Human Milk Fortifier ("EHMF") is one such product used to supplement breast milk. EHMF is a powdered formula that permits supplementation of breast milk without displacing breast milk volume. In other words, a doctor can maximize the amount of breast milk in a feeding because the powdered formula is mixed into the breast milk, whereas a liquid formula added to breast milk reduces the volume of breast milk fed to an infant.
The batch of EMHF at issue here, Batch No. BMO05C, was manufactured in late 2006 and early 2007. Beginning in 2002, Mead Johnson had made manufacturing and quality control testing changes to its products in order to make it difficult for bacteria to enter and propagate. But because EHMF is not a sterile product, there is an inherent risk that Enterobacter sakazakii
EHMF is made at the Zeeland Specialty Products manufacturing plant in Zeeland, Michigan ("ZSP Plant"). Mead Johnson manufactures EHMF in three phases. The first phase involves a "wet blending" process. In this "wet blending" process, Mead Johnson formulates the base mix by pasteurizing and then drying the milk-based component of the product. In the second phase, other dry ingredients of vitamins and minerals from outside suppliers are blended with the base mix in a dry process and on equipment that curtails microbial growth. These suppliers are audited by Mead Johnson to make sure they have manufactured the ingredients under hygienic conditions. The residual moisture content of the finished product is less than 3%. The blending stage for Batch No. BMO05C was finished by December 27, 2006. Lastly, Mead Johnson packages the EHMF for sale on dedicated equipment in individual tubular sachets. Each sachet weighs .71 gram and every box contains 100 sachets. The total amount of finished product for Batch No. BMO05C was 204.5 kilograms or 204,500 grams.
Mead Johnson tests the product during each phase for E. sak and Batch No. BMO05C passed all three phases of product testing. If any batch tests positive for E. sak, then the entire batch is rejected. In January 2007, Mead Johnson tested 999 grams of Batch No. BMO05C between the base mix, its prepackaged blend, and all the ingredients, and all tests were negative
Daniel March, Director of Food Safety at Mead Johnson, states that the testing protocols "give a high measure of assurance that even if E. sak were to enter the [E]HMF, it would be in very low concentrations, and, to a near statistical certainty, would not exceed one CFU per any one feeding." If a sample tests positive for E. sak, then the results would be "reported as the number of [CFU] per weight of product." Of course, there is no way to confirm whether amounts not tested did not have E. sak present in excess of one CFU per feeding. But product contamination by a bacteria like E. sak is a "non-uniform event" and "testing protocols do not exist to confirm the complete absence" of E. sak in a finished product. Further, Plaintiffs assert that it is possible for E. sak to exist as a biofilm and biofilms, by definition, "can contain many individual cells."
A pathogen like E. sak can also contaminate and become established in powdered formula manufacturing plants, with such harbourage sites serving as a source of future contamination. E. sak may remain in low levels in an otherwise highly hygienic environment if there is an inadequate separation of wet and dry areas and/or by poor control over the movement of employees, equipment and goods." There is no evidence that Mead Johnson had any harbourage sites in the production area of EHMF. Before January 2007, Mead Johnson had some positive tests for the presence of E. sak in certain finished powdered products.
In summary, all samples of Batch No. BMO05C that Mead Johnson tested were negative for E. sak and all related documents to Batch No. BMO05C indicate the batch was in compliance with the manufacturing specifications.
Because powdered infant formulas are not sterile, there is the risk of E. sak contamination. Any infection in an infant can have significant consequences. Premature infants have immature or not fully developed gastrointestinal, immune, and blood-brain barriers. As a result, neonates are extremely susceptible to rapid and destructive invasion and growth by infections, including E. sak. Premature infants do have some defensive physiological and immune mechanisms that can prevent or slow bacterial growth.
In 2002, the FDA informed health care professionals of certain precautions they should take when using powdered infant formulas:
Additionally, the Food and Agricultural Organization and the World Health Organization ("FAO/WHO") convened panels of experts in 2004, 2006, and 2008 to "evaluate and develop strategies to reduce risks of infection due to E. sak and other bacteria." In its studies, the FAO/WHO determined that E. sak in formula has caused illness and that epidemiological evidence associates powdered infant formula with E. sak. But the FAO/WHO literature does not conclude that every E. sak case can be causally linked to powdered infant formula, or more specifically, EHMF.
The Codex Alimentarius Commission, associated with the WHO, issued guidelines in 2008 for the "manufacture, testing, and use of powdered formulas in a manner to reduce the risks of E. sak infection." The American Dietetic Association also updated its recommendations for infant feedings of powdered formula to reduce E. sak risks. Mead Johnson's manufacturing process and testing protocols for EHMF conformed to the recommendations of the FAO/WHO and the Codex Alimentarius Commission.
Beginning in 2005, Mead Johnson labeled EHMF with the following statement:
This label appeared on Batch No. BMO05C. Mead Johnson also provided Mercy Medical Center ("MMC") from 2002 to 2007, with educational products related to EHMF and the microbiological inherent risk. MMC adopted the following protocol related to powdered infant formula in 2004:
The precise incubation period for an E. sak infection is unknown. Scientists cannot definitively establish the period of time between the pathogen exposure and the
D.J.K. and his twin were born by cesarian section on April 23, 2007. From birth, the infants both suffered from multiple episodes of apnea, a secession of breathing, and bradycardia, a slowing of the heart rate as a result of the apnea. Apnea and bradycardia episodes are typical for premature infants. MMC medical personnel treated D.J.K.'s apnea and bradycardia episodes with medicine and oxygen delivered through a nasal tube. He was fed both by intravenous—or "parenteral" nutrition—delivered through a catheter and breast milk and/or liquid premature baby formula through a naso-gastric tube.
On May 5, 2007, at a gestational age of thirty weeks or twelve days after birth, D.J.K.'s physician and neonatologist, Dr. Terri Whalig, decided that D.J.K. needed to receive more calories to encourage better growth. Nursing staff understood her direction to increase calories to mean that D.J.K. should receive EHMF. At approximately 9:30 am, Dr. Whalig noted on D.J.K.'s chart that she was increasing his flow of oxygen to be doubled from 1 to 2 liters/minute because of his increased episodes of apnea and bradycardia. The increased oxygen flow had previously ameliorated his apnea and bradycardia spells. After the increase in oxygen flow, D.J.K. still suffered from additional spells of apnea at 1:23 pm, 4:45 pm, 6:20 pm, and 7:20 pm.
Beginning at 2 pm on May 5, D.J.K. received breast milk fortified with EHMF. At MMC, only a physician
Each feeding to D.J.K. was approximately 20 milliliters (or four teaspoons) with a caloric concentration of 24 cal/oz. A feeding consisted of 50% fortified breast milk (10 mls) and 50% premature liquid infant formula (10 mls). It takes approximately.28 gram of a .71 gram packet to reach a caloric density of 24 cal/oz for each 20 ml serving D.J.K. received. D.J.K. also received breast milk fortified with EHMF again at 5 pm and 8 pm. Overall, it is likely that D.J.K. received no more than two packets of EHMF.
As the day progressed, nurses noted that D.J.K. continued to have apnea and bradycardia spells. Nurses noted that he looked as if he were not feeling well and there were several signs of emerging sepsis
Following the confirmed presence of E. sak, MMC involved, among others, the University Hygienic Laboratory ("UHL") at the University of Iowa and the CDC for testing. The CDC did not find E. sak in any of the twenty-six packets of remaining EHMF taken from the same box used for D.J.K. There was a similar negative finding when the UHL tested 190 grams of EHMF from Batch No. BMO05C and when the FDA tested at least half of 710 grams of EHMF obtained directly from Mead Johnson.
Because it did not find E. sak in any of the EHMF samples, the Iowa Department of Public Health then conducted epidemiological tests in D.J.K.'s hospital room on May 10, 2007.
The Iowa Department of Public Health concluded that: "This is a sporadic case of undetermined origin. No definitive conclusions can be made as all additional clinical, environmental, and product samples tested by Hospital A Laboratory or UHL were negative for Enterbacter sakazakii." Lastly, the FDA did not recall Batch No. BMO05C and allowed Mead Johnson to sell the remaining EHMF from that batch.
Plaintiffs claim that the EHMF D.J.K. ingested was contaminated with E. sak, and that EHMF was the source of D.J.K.'s subsequent illness. Because the EHMF was contaminated, the Plaintiffs argue that the EHMF had a manufacturing defect or that the sale of EHMF containing E. sak is a breach of warranty. Further, Plaintiffs claim that EHMF manufactured with E. sak constitutes negligence per se or negligence. They assert Mead Johnson had a duty to manufacture the EHMF without contaminants, Mead Johnson breached that duty, there is medical causation, and D.J.K. was damaged as a result. Lastly, Plaintiffs assert a loss of consortium claim.
First, in Mead Johnson's motion for summary judgment, it asserts that Plaintiffs cannot prove medical causation, such that the EHMF D.J.K. ingested was contaminated with E. sak and led to his bacterial meningitis. Mead Johnson states that it is temporally impossible for EHMF to be the cause of D.J.K.'s illness based on the timing of his breast milk-enhanced EHMF feedings. Mead Johnson's experts opine that any E. sak possibly in EHMF would be in a "dessicated form" and there would be an inherent "lag time" needed before the bacteria could even begin proliferating. Further, Mead Johnson asserts that Plaintiffs cannot eliminate other potential sources of the infection. The epidemiological investigation did not establish that the breast milk, environmental exposure, person to person exposure, or parenteral feedings, were not alternative sources of the E. sak bacteria. For these reasons, Mead Johnson asserts that there is insufficient
Plaintiffs, however, assert that the EHMF was the most likely source for D.J.K.'s infection. Contrary to Mead Johnson's medical experts' opinions, Plaintiffs assert that it is possible that the EHMF feeding was the cause as "[n]eonates' gastrointestinal, immune, and blood-brain barrier immaturities make them extremely susceptible to rapid and destructive invasion and growth by" bacteria. Further, D.J.K. only became ill after ingestion of the EHMF. Additionally, Plaintiffs assert that EHMF was the specific cause of D.J.K.'s infection because the epidemiological investigation did not uncover any other source of infection. Plaintiffs assert that as E. sak has previously been "epidemiologically and microbiologically linked to ingestion of powdered infant formula intrinsically contaminated with" E. sak, that EHMF is the most likely infectious source.
A motion for summary judgment may be granted only if, after examining all of the evidence in the light most favorable to the nonmoving party, the court finds that no genuine issues of material fact exist and that the moving party is entitled to judgment as a matter of law. HDC Med., Inc. v. Minntech Corp., 474 F.3d 543, 546 (8th Cir.2007) (citation omitted); see also Kountze ex rel. Hitchcock Found v. Gaines, 536 F.3d 813, 817 (8th Cir.2008) ("[S]ummary judgment is appropriate where the pleadings, discovery materials, and any affidavits show that there is no genuine issue as to any material fact and that the movant is entitled to summary judgment as a matter of law.").
Once the movant has properly supported its motion, the nonmovant "may not rest upon the mere allegations or denials of [its] pleading, but ... must set forth specific facts showing that there is a genuine issue for trial." FED.R.CIV.P. 56(e). "[A]n issue of material fact is genuine if the evidence is sufficient to allow a reasonable jury verdict for the nonmoving party." Great Plains Real Estate Dev., L.L.C. v. Union Cent. Life Ins. et al., 536 F.3d 939, 944 (8th Cir.2008) (citation omitted). "A genuine issue of fact is material if it `might affect the outcome of the suit under the governing law.'" Saffels v. Rice, 40 F.3d 1546, 1550 (8th Cir.1994) (citation omitted). The nonmoving party is entitled to all reasonable inferences that can be drawn from the evidence without resort to speculation. Sprenger v. Fed. Home Loan Bank of Des Moines, 253 F.3d 1106, 1110 (8th Cir.2001). "[A]lthough [the non-moving party] does not have to provide direct proof that genuine issues of fact exist for trial, the facts and circumstances that she [or he] relies `upon must attain the dignity of substantial evidence and not be such as merely to create a suspicion.'" Taylor v. White, 321 F.3d 710, 715 (8th Cir.2003) (citation omitted). The mere existence of a scintilla of evidence in support of the plaintiff's position will be insufficient; there must be evidence on which the jury could reasonably find for the plaintiff. Sprenger, 253 F.3d at 1110.
Mead Johnson asserts that Plaintiffs' claims must fail because Plaintiffs cannot prove that the EHMF D.J.K. ingested caused his illness. The parties disagree as to whether it was temporally possible for E. sak bacteria to generate an infection from a desiccated state and whether Plaintiffs have eliminated other potential sources of infection. Plaintiffs assert that they have established general causation because E. sak has been found in other powdered formulas and can be found in EHMF. Plaintiffs also assert that they can
Under Iowa law, the burden of proving proximate cause is on the plaintiff. Banks v. Harley-Davidson, Inc., 73 F.3d 213, 215 (8th Cir.1996). "In products liability, the plaintiff must prove his or her injuries were proximately caused by an item manufactured or supplied by the defendant." Spaur v. Owens-Corning Fiberglas Corp., 510 N.W.2d 854, 858 (Iowa 1994); Lovick v. Wil-Rich, 588 N.W.2d 688, 700 (Iowa 1999) (must be a causal relationship between the product and resulting injury). The plaintiff also must show that the manufacturing defect was a "substantial factor" and that the injury would not have occurred "but for" that defect. Id. (citing Jones v. City of Des Moines, 355 N.W.2d 49, 50 (Iowa 1984) (defining proximate cause as the substantial factor and but for cause)).
When plaintiffs put forth circumstantial evidence to prove proximate cause, "that evidence `must be sufficient to make plaintiffs' theory asserted reasonably probable, not merely possible, and more probable than any other theory based on such evidence.'" Banks, 73 F.3d at 215 (quoting Oak Leaf Country Club, Inc. v. Wilson, 257 N.W.2d 739, 746 (Iowa 1977)). Plaintiffs must use the testimony of medical experts to prove medical causation. In re Baycol Litig., 596 F.3d 884, 889 (8th Cir. 2010). The trier of fact usually determines whether circumstantial evidence establishes proximate cause. Oak Leaf Country Club, Inc., 257 N.W.2d at 746. Proximate cause "will be decided as a matter of law only in extraordinary cases", Boham v. City of Sioux City, 567 N.W.2d 431, 435 (Iowa 1997), or when "reasonable minds can come to no other conclusion." Peters v. Howser, 419 N.W.2d 392, 394 (Iowa 1988).
A plaintiff must prove general causation, such that a product causes a "particular injury or condition in the general population". Junk v. Terminix, 2008 WL 5142193, at *3 (S.D.Iowa Nov. 3, 2008) (citing Knight v. Kirby Inland Marine, Inc., 482 F.3d 347, 351 (5th Cir.2007)); see also Meister v. Med. Eng'g Corp., 267 F.3d 1123, 1132 (D.C.Cir.2001) (affirming judgment as a matter of law where plaintiffs' experts were unable to show that breast implants caused schleroderma and epidemiological evidence failed to show a causal relationship). Likewise, a plaintiff must show specific causation, in that the product actually caused the injury. Colon v. Abbott Labs., 397 F.Supp.2d 405, 416-17 (E.D.N.Y.2005) (in a summary judgment motion, holding that expert's opinion as to specific causation was too "speculative" to prove that Similac formula caused Type 1 juvenile diabetes). "Mere use of the product and subsequent injury ... are not a sufficient basis from which to infer causation." Id. (quoting Gilks v. Olay Co., 30 F.Supp.2d 438, 443 (S.D.N.Y.1998)). Thus, in a products liability suit, a plaintiff must show that both general and specific causation is present. See, e.g., Barrett v. Rhodia, Inc., 606 F.3d 975, 983-85 (8th Cir. 2010) (applying Nebraska law, court concluded that experts' opinions stating that symptoms were "consistent with" exposure to hydrogen sulfide gas was insufficient to establish causation; while experts could establish general causation, experts could not establish specific causation); Hendrix ex rel. G.P. v. Evenflo Co., Inc., 609 F.3d 1183, 1197 (11th Cir.2010) (quoting Black v. Food Lion, Inc., 171 F.3d 308, 314 (5th Cir.1999) (explaining that "[t]he underlying
In Wheat v. Pfizer, Inc., the Fifth Circuit Court of Appeals affirmed judgment as a matter of law in favor of Pfizer, Inc. because the plaintiff failed to show specific causation. Wheat v. Pfizer, Inc., 31 F.3d 340, 341 (5th Cir.1994). In Wheat, a physician prescribed Feldene to Margaret Gordon, a drug manufactured by Pfizer, for her chronic neck pain in July 1989. Id. Approximately five weeks later her physician also prescribed Parafon Forte DSC for pain management. Id. The pharmacy used the generic drug Chlorzoxazone to fill Mrs. Gordon's prescription. Id. During Thanksgiving week of 1989, Mrs. Gordon became "violently ill" and her physician ordered her to cease taking Feldene on November 28, 1989. Id. at 342. Lab tests showed "serious liver dysfunction, and her condition was diagnosed as hepatitis." Id. Mrs. Gordon tested negative for the viral hepatitis strains A and B, without any test at the time capable of testing for hepatitis C. Id. Mrs. Gordon later lapsed into a coma and died December 13. Id. Plaintiffs then sued, claiming that the Feldene and Parafon caused her hepatitis. Id. The court affirmed the district court's holding
Likewise, in Sorensen v. Shaklee Corp., 31 F.3d 638 (8th Cir.1994), the Eighth Circuit affirmed a district court's grant of summary judgment in favor of the manufacturer. The court found that the plaintiffs failed to prove both general and specific causation because the plaintiffs failed to prove that consumption of ethylene oxide (EtO) residue causes mental retardation or that their consumption of chemically treated alfalfa tablets caused mental retardation in their children. Sorensen, 31 F.3d at 651.
Id. at 649.
Mead Johnson asserts that Plaintiffs cannot prove medical causation. While the Court views the facts in the light most favorable to Plaintiffs, the Plaintiffs still must show that there is a genuine issue of material fact as to whether EHMF can be causally related to D.J.K.'s infection. For general causation, the issue is whether EHMF can contain E. sak; Mead Johnson concedes that it can. Thus, the Court primarily focuses on whether the EHMF ingested by D.J.K. was actually contaminated with E. sak. This is the narrower issue of specific causation. The record must demonstrate to the Court that there is no genuine issue of material fact that EHMF caused the injury to D.J.K.
Here, Plaintiffs' evidence has failed to generate a genuine issue of material fact. The record does not demonstrate to the Court that there is not a causal relationship between the alleged defective EHMF and the E. sak infection D.J.K. sustained. McCleary v. Wirtz, 222 N.W.2d 409, 414 (Iowa 1974). The Court finds there is not medical causation on the basis of the following.
The parties have secured and deposed multiple experts. In determining the issue of causation, Iowa has long recognized the necessity of "opinion testimony if it is of a nature which will aid the jury and is based on special training, experience, or knowledge [as] to the issue in question." Yates v. Iowa West Racing Ass'n, 721 N.W.2d 762, 774 (Iowa 2006) (citing Iowa Power & Light Co. v. Stortenbecker, 334 N.W.2d 326, 330 (Iowa Ct.App.1983)). If not within the realm of laypersons, "[b]efore [medical] testimony can be considered competent, there must be sufficient data upon which the expert judgment can be made," without the facts being "mere conjecture or speculation." Id. (citing Stortenbecker, 334 N.W.2d at 330-31). In this case, the Defendant's evidence on the issue of causation consists of four expert opinions. The
In Dr. John Farmer's
It is the opinion of Dr. Kathleen Harriman
In Dr. Janine Jason's
In the opinion of Mr. Gregory Pincar
In Mr. Robert Behling's
At his deposition in this case, Dr. Robert Baltimore
Dr. Michael Doyle
It is Dr. Stephen Forsythe's
In Nancy Nevin-Folino's
The parties dispute whether the temporal relationship between the feedings of EHMF to D.J.K. indicates the EHMF contained the disease-causing E. sak bacteria. "Under some circumstances, a strong temporal connection is powerful evidence of causation." Bonner v. ISP Techs., Inc. 259 F.3d 924, 931 (8th Cir.2001); Federal Judicial Center, Reference Guide on Toxicology 422 (2000) (hereinafter "Toxicology"). For example, the court in Bonner found strong evidence of causation "`if a person were doused with chemical X and immediately thereafter developed symptom Y'". Bonner, 259 F.3d at 931 (quoting Heller v. Shaw Indus., Inc., 167 F.3d 146, 154 (3d Cir.1999)). Temporal proximity from the ingestion of a substance to a resulting illness can depend on the biology of the body, such as the absorption rate of the substance, among other factors.
But courts have long held that a differential diagnosis based only on the assumption of causation due to a temporal relationship is "entitled to little weight in determining causation." Moore v. Ashland Chem., Inc., 151 F.3d 269, 278 (5th Cir.1998); Bland v. Verizon Wireless (VAW) L.L.C., 2007 WL 5681791, at *10 (S.D.Iowa Aug. 9, 2007), aff'd, 538 F.3d 893 (8th Cir.2008) (holding that doctor's hypothesis as to "temporal relationship between
Here, the issue is whether the feedings of EHMF are sufficiently temporally related to D.J.K.'s subsequent infection to create a genuine issue of material fact on the issue of causation. It is an uncontroverted fact that D.J.K. first consumed EHMF at his 2 pm feeding, followed by additional feedings at 5 pm and 8 pm. Lab results at 10:45 pm indicated severe sepsis and cerebrospinal fluid taken at 11:30 pm revealed a meningitis infection. Plaintiffs' expert, Dr. Jason, opines there was a "precipitous change" in D.J.K.'s condition by 9:30 pm. Thus, the time frame between D.J.K.'s first consumption of EHMF at 2 pm to the time of his "precipitous change" occurs over 7.5 hours.
It is Dr. Baltimore's opinion that it was impossible for EHMF to cause D.J.K.'s infection because the time window is too narrow. E. sak would need to traverse the intestinal system, pass through the bowel walls, enter the bloodstream, multiply in the blood, cross the blood-brain barrier, and multiply in the cerebrospinal fluid to cause the meningitis detected at 11:45 pm. Dr. Forsythe concurs in Dr. Baltimore's findings that the time from exposure to the bacterial meningitis infection is "not microbiologically possible." Dr. Jason, however, testifies that a bacteria like E. sak could result in a devastatingly quick infection because infants' stomachs cannot control or prevent, to the degree capable in adults, bacteria in the stomach from crossing into the bloodstream. Likewise, infants have a "leaky" blood-brain barrier and it is easier for bacteria to enter the brain. In her opinion, it can take only a "matter of hours" for a severe infection to arise. Dr. Harriman agrees that such short incubation periods are possible.
The Court must still consider the time needed for a desiccated form of E. sak to regenerate and multiply. E. sak in EHMF would be in a dry and desiccated form; it is not biologically active and cannot become infectious until after a "lag time" has passed. In Dr. Forsythe's opinion, this lag time can vary from 1.6 to 4.6 hours, but Dr. Farmer opines that the lag time can be much shorter. The lag time for this specific strain of E. sak is unknown; more broadly, scientists also do not know the lag time for E. sak in general. Plaintiffs' expert, Dr. Farmer, opines that it is possible the incubation period, even with the lag time, was long enough to
Plaintiffs attempt to point to specific symptoms that indicate EHMF in fact caused a change in D.J.K.'s condition. Plaintiffs attempt to bolster the temporal proximity with other evidence of D.J.K.'s condition that day. However, D.J.K. suffered these symptoms before and after the EHMF feedings. There is evidence that increased oxygen flow from that morning (which usually alleviated episodes) did not help because D.J.K. had another spell before his first EHMF feeding. According to Nurse Stephanie Pollard's deposition, D.J.K. had five episodes of apnea on May 4th, two on May 5th before the EHMF feeding, and then three episodes after the feeding. [Pollard Dep., Def.'s Appx. 000451, 000454.] Dr. Wahlig's deposition indicates that doctors look for many factor in order to diagnose sepsis, including apnea, vital signs, and the baby's behavior. She states that the "vital signs may have shown some early changes at approximately 8 pm, but very clearly by 10 pm." [Wahling Dep., Def.'s Appx. 000434-37.] The Court finds that the evidence relating to temporal proximity does not assist the Plaintiffs in creating a genuine issue of material fact on causation. Bonner, 259 F.3d at 931. In fact, the Court finds the temporal evidence presented here is more akin to the situation noted in Willert, where Plaintiffs assert that because bacterial meningitis occurred and it came after the EHMF feedings, that the EHMF feedings caused the bacterial meningitis. Willert, 995 F.Supp. at 981-82. This is not a case where there is indication that the E. sak came from the EHMF and immediately caused illness. Bonner, 259 F.3d at 931 (quoting Heller, 167 F.3d at 154). Based on the record, there is simply an insufficient temporal relationship for EHMF to be the medical cause of D.J.K.'s illness and there is not a genuine issue of material fact created here.
However, the Court examines the other possible sources of the E. sak to see if the Plaintiffs can meet their burden. Bland, 2007 WL 5681791, at *10.
The parties dispute whether it is possible for other sources to have been the cause of the E. sak bacterial infection. "[E]pidemiology addresses whether an agent can cause a disease, not whether an agent did cause a specific plaintiff's disease." Federal Judicial Center, Reference Guide on Epidemiology 382 (2000). As a result, a plaintiff must rule out other possible causes for injury, in order to support specific causation:
Ranes v. Adams Labs., Inc., 778 N.W.2d 677, 695 (Iowa 2010) (quoting Cavallo v. Star Enter., 892 F.Supp. 756, 771 (E.D.Va. 1995), aff'd in relevant part, 100 F.3d 1150, 1159 (4th Cir.1996)) (emphasis in original).
"A differential diagnosis that fails to take serious account of other potential causes may be so lacking that it cannot provide a reliable basis for an opinion on causation." Westberry v. Gislaved Gummi A.B., 178 F.3d 257, 265 (4th Cir.1999) (citing In re Paoli R.R. Yard PCB Litig., 35 F.3d 717, 758-61 (3d Cir.1994)). For example, without experts excluding other disease-causing alternatives, it then becomes difficult for an expert to pinpoint the actual disease-causing factor and as a result, there can be "competing causes" of a disease. See, e.g., Bland, 2007 WL 5681791, at *8 (expert could only conclude there was a "possibility" alleged product caused asthma, as expert could not exclude other factors such as plaintiff's home, environment, or other possible causes) (citing Marmo v. Tyson Fresh Meats, Inc., 457 F.3d 748, 758 (8th Cir.2006)).
Here, to create a genuine issue of material fact on causation, Plaintiffs must be able to present evidence from which a jury can determine that they have excluded other potential sources of the E. sak infection. Dr. Forsythe and Ms. Nevin-Folino identified several areas in which the investigation following D.J.K.'s diagnosis was deficient: the breast milk, environmental sources, hospital personnel, and parenteral feedings (the tube inserted in D.J.K.). In their opinion, it is possible any one of these sources could be the cause, especially as both sides concede E. sak is "ubiquitous" in the environment. Plaintiffs' expert, Dr. Farmer, states that the following sources have been ruled out and the EHMF was most likely caused by the EHMF: hospitalization; incubation period; infectious dose; cohort of nine other infants; cohort of other infants; twin cohort; new E. sak strain; MMC and CDC initially thought EHMF cause; E. sak is a well-documented pathogen; Mead Johnson had past recalls; EHMF sample tested was very small; and epidemiological study did not include the "implicated vehicle." Dr. Harriman's opinion endorses Dr. Forsythe's opinion as to the exclusion of the sources, and further speculates that the CDC may have failed to detect E. sak in its sample of EHMF because the sample size was too small.
However, in order for Plaintiffs to succeed in their differential diagnosis, they must "rule out" potential causes. Ranes, 778 N.W.2d at 695. Here, it is unfortunate that the Plaintiffs cannot rule out all the other possible sources, but the fact remains that they cannot do so. Westberry, 178 F.3d at 265. For example, the room was cleaned on multiple occasions after May 5, there is not a record of hospital personnel visits to the room, and there was no expressed breast milk to test from the same feedings D.J.K. received on May 5. Contrary to Plaintiffs' assertion, the investigation by the Iowa Department of Health did not conclude that EHMF was the most likely cause; rather, it stated that it could not "draw definitive conclusions." The Court refers to Dr. Baltimore's report, in which he asserts that Drs. Jason and Farmer come to their conclusion on the basis of
Plaintiffs' experts cite EHMF as the cause, but cannot produce evidence that excludes other likely sources. This situation is not unlike the situation in Turner, where an expert was so focused on identifying the condition, that he failed to identify the substance causing the condition. Turner, 229 F.3d at 1208. Here, when Plaintiffs' experts identify EHMF as the source of the E. sak, they cannot, by a process of elimination, "rule out" other specific causes. Ranes, 778 N.W.2d at 695. For example, Dr. Harriman's opinion as to other environmental sources in the hospital, such as cross-contamination in the room, states that because the hospital followed its protocol for handling EHMF, then that source must be eliminated. Likewise, Dr. Harriman also endorses the finding that the absence of E. sak in the tests the CDC performed do not rule out the possibility that E. sak was in the packets D.J.K. consumed. Dr. Farmer's methodology for eliminating alternative sources follows a similar vein. He states that EHMF is the likely source because D.J.K. was hospitalized the entire time and it was only after he was fed the EHMF, that he became sick. Or that because D.J.K.'s twin remained well (a "twin cohort" study) and EHMF was the only appreciable difference in treatment, that EHMF was the cause.
Plaintiffs are not able to rule out alternative sources. There is not evidence in the record that either proves or disproves that these sources were the "implicated vehicle" for the E. sak.
The Court finds that Plaintiffs fail to offer sufficient proof that genuine issues of material fact exist as to the question of medical causation. Plaintiffs cannot demonstrate that D.J.K.'s ingestion of EHMF caused his bacterial meningitis. Accordingly, the Court finds in favor of Mead Johnson and grants Mead Johnson's motion for summary judgment in its entirety.
Upon the foregoing,
Defendant Mead Johnson's Motion for Summary Judgment is granted in its entirety. The Clerk shall enter judgment for the Defendant.
The Plaintiffs, however, disagree with the conclusion that the epidemiological investigation does not rule out these possible sources. They assert that it is not possible for the alternative sources to be the actual source of the E. sak.
Toxicology 425-26.
