Burks v. Abbott Labs.

• Decision Date: 08 January 2013
• Docket Number: Civil No. 08–3414 (JRT/JSM).
• Citation: 917 F.Supp.2d 902
• Court: U.S. District Court — District of Minnesota
• Parties: Rockland BURKS and Adrienne Lawrence, individually, and as parents and natural guardians of E.B., Plaintiffs, v. ABBOTT LABORATORIES and Mead Johnson & Co., Defendants.

917 F.Supp.2d 902

Rockland BURKS and Adrienne Lawrence, individually, and as parents and natural guardians of E.B., Plaintiffs,

v.

ABBOTT LABORATORIES and Mead Johnson & Co., Defendants.

Civil No. 08–3414 (JRT/JSM).

United States District Court, D. Minnesota.

Jan. 8, 2013.

Stephen C. Rathke, Kate G. Westad, and Nicholas A. Dolejsi, Lommen, Abdo, Cole, King & Stageberg, PA, Minneapolis, MN, for Plaintiffs.

June K. Ghezzi, Jones Day, Chicago, IL and William J. Tipping and Sara H. Daggett, Gaskins, Bennett, Birrell, Schupp, LLP, Minneapolis, MN, for Defendant Abbott Laboratories.

Anthony J. Anscombe, Sedgwick LLP, Chicago, IL and Frederick W. Morris, Leonard Street and Deinard, PA, Minneapolis, MN, for Defendant Mead Johnson & Company.

MEMORANDUM OPINION AND ORDER

JOHN R. TUNHEIM, District Judge.

Rockland Burks and Adrienne Lawrence (“plaintiffs”) bring this failure to warn action against Abbott Laboratories (“Abbott”) and Mead Johnson & Company (“Mead”) individually and on behalf of their minor child, E.B. Plaintiffs allege that defendants' powdered infant formula (“PIF”) was contaminated with Cronobacter sakazakii (C. sak), that E.B. became ill after being fed defendants' PIF, and that the PIF was unreasonably dangerous because defendants failed to provide an adequate warning of the risks of C. sak infection.

In July 2009, the Court held that Louisiana law would govern the present action and dismissed plaintiffs' claims that were not brought under the Louisiana Products Liability Act (“LPLA”) with prejudice. See Burks v. Abbott Labs., 639 F.Supp.2d 1006, 1014–15 (D.Minn.2009). The Court denied defendants' motion to dismiss plaintiffs' LPLA failure to warn claim and the parents' derivative loss of consortium claims, dismissed without prejudice plaintiffs' LPLA claims premised on manufacturing defect, design defect, and express warranty, and allowed plaintiffs to file an amended complaint. See id. at 1015–20. In April 2010, the Court again denied defendants' motions to dismiss plaintiffs' LPLA failure to warn claim and the parents' derivative loss of consortium claims, but dismissed plaintiffs' remaining LPLA claims with prejudice. See Burks v. Abbott Labs., Civ. No. 08–3414, 2010 WL 1576779 (D.Minn. Apr. 20, 2010). Accordingly, plaintiffs' sole surviving claim is for failure to warn under the LPLA, along with the parents' derivative loss of consortium claims.

Defendants move for summary judgment and assert, among other things, that plaintiffs' failure to warn claim fails because there is no direct evidence that defendants' PIF was contaminated and because plaintiffs' experts cannot opine that it is more likely than not that one particular defendant caused E.B.'s illness. Defendants assert that they are entitled to summary judgment on the parents' derivative loss of consortium claims because Plaintiffs filed the action after the statute of limitations expired. The Court will deny defendants' motion with respect to the failure to warn claim and grant the motion to dismiss the parents' loss of consortium claim. A reasonable jury could find that both defendants failed to use reasonable care to provide an adequate warning of a dangerous characteristic of their PIF and that it is more likely than not that the tortious conduct of one of the defendants caused E.B.'s illness. As the Court will explain below, the doctrine of alternative liability is applicable and plaintiffs' failure to warn claim survives summary judgment for that reason. Defendants also bring several motions to exclude plaintiffs' expert witnesses, which the Court will deny because it finds that the experts' opinions are reliable and relevant.

BACKGROUND

I. FACTS

E.B. was born on June 19, 2006. (Decl. of Melissa B. Hirst in Support of Abbott's Motion, Ex. 1 (Dep. of Adrienne Lawrence (“Lawrence Dep. A”) 60:19–20), May 21, 2012, Docket No. 323.) She was a healthy, full term baby. (Aff. of Stephen C. Rathke in Opposition, Ex. B (Dep. of Adrienne Lawrence (“Lawrence Dep. B”) 172:13–16), June 8, 2012, Docket No. 351–2.) On July 2, E.B. had a fever and plaintiffs took her to the emergency room where she was diagnosed with C. sak ¹meningitis. ( Id. 188–91; Aff. of Stephen C. Rathke in Opposition, Ex. A (Decl. of Janine Jason, M.D. (“Jason Decl.”) ¶ 277), Docket No. 351–2.)

A. E.B.'s Feedings

During the first week of E.B.'s life, she ate milk-based, ready-to-feed liquid formula at the hospital and at home. (Jason Decl. ¶ 250; Lawrence Dep. B 142–43.) On or about June 27, E.B. showed signs of an upset stomach and Lawrence decided, upon the advice of a physician, to feed E.B. soy-based formula instead of milk-based formula. (Lawrence Dep. B 157–58:16–4.) The only soy-based formula Lawrence had was a sample of Abbott's Similac PIF that she had received in an unsolicited mailing two or three weeks before E.B. was born. (Lawrence Dep. B 155:6–8.) Lawrence fed E.B. a packet of Abbott's PIF on the morning of June 28. ( Id. 158:6–11.) That same day, Lawrence purchased two cans of Mead's Enfamil ProSobee Lipil PIF. ( Id. 159:14–22.) Between the afternoon of June 27 or 28 and the evening of June 30, Lawrence fed E.B. Mead's PIF three times. ( Id. 169:17–24.) Each time Lawrence fed E.B. PIF, she mixed it with Music Mountain bottled water, which was delivered to her home on a weekly basis. ( Id. 158–65.) Lawrence testified at length regarding the cleanliness of her home, the care she took in sanitizing E.B.'s bottles and storing E.B.'s food, and the care she took to ensure that her hands and the surrounding surfaces were sanitary when she fed E.B. ( See, e.g., id. 108–25.)

B. The PIF Warning Labels

Mead and Abbott's PIF featured nearly identical instructions and warnings. Mead's label included “Instructions for Preparation & Use,” which began as follows:

Your baby's health depends on carefully following the instructions below. Proper hygiene, preparation, dilution, use and storage are important when preparing infant formula. [PIFs] are not sterile and should not be fed to premature infants or infants who might have immune problems unless directed and supervised by your baby's doctor. Ask your baby's doctor which formula is appropriate for your baby.

(Decl. of David J. Grycz in Support, Ex. 12, May 18, 2012, Docket No. 312.) Following the instructions, Mead's label stated that “[f]ailure to follow these instructions could result in severe harm.” Id. The only use of the word “warning” on the label was a warning that using a microwave to warm the formula could cause serious burns. Id.

C. C. sak, PIF, and Neonates

As the labels indicate, PIF is not sterile. According to Mead, this is because it cannot undergo a terminal heat process without destroying the powder. (Mead's Memo in Support at 4–5, May 18, 2012, Docket No. 311.) C. sak is an enteric bacterium that is frequently isolated in PIF, but it has also been isolated in other environments. (Jason Decl. ¶¶ 19, 63, 77.) Although C. sak infections are rare,² C. sak outbreaks have historically been linked to PIF. ( Id. ¶¶ 85–95.) For these reasons, the World Health Organization (“WHO”) has convened expert panels on three occasionsover the past decade to assess the risks of PIF and identify ways to make PIF safer. ( Id. ¶ 54.)

The PIF labels suggest that PIF may not be safe for infants who are particularly susceptible to infection, such as premature infants and infants with immune problems. But the labels do not explicitly refer to healthy, full term infants. Healthy, full term infants that are less than four weeks old—neonates—do not have fully developed enteric (gut) immunity. ( Id. ¶ 32.) The root of plaintiffs' failure to warn claim is that healthy, full term neonates are particularly susceptible to C. sak infection (like premature infants and infants with immune problems) and the label should have included a warning about this category of infants as well. ( Id. ¶ 55.)

D. Investigations Following E.B.'s Diagnosis

Following E.B.'s diagnosis, the Food and Drug Administration (“FDA”) and Center for Disease Control (“CDC”) commenced an investigation. (Decl. of David J. Grycz in Support, Ex. 4 (Dep. of Adrienne Lawrence (“Lawrence Dep. C”) 203–07) May 18, 2012, Docket No. 312.) The FDA obtained the remaining Mead PIF from Lawrence; an unopened can from the same batch, which it purchased at the same store that Lawrence purchased the PIF; and thirty cans from the same batch, which it collected from a distributor's warehouse. (Decl. of David J. Grycz in Support, Ex. 13, May 18, 2012, Docket No. 312.) Testing by the FDA and CDC did not identify C. sak in the samples.³ The FDA did not conduct any testing of the Burks' home because E.B.'s grandmother had sanitized the home after E.B.'s diagnosis. ( Id.) The FDA also did not analyze the Music Mountain water dispenser because the investigator believed the jug used for E.B.'s feedings was no longer available. ( Id.) Plaintiffs' experts contend that the negative tests do not establish that the PIF did not contain C. sak and advance various theories to support their opinions. ( See, e.g., Jason Decl. ¶¶ 155–57, 311–14; Aff. of Stephen C. Rathke in Opposition, Ex. C (Decl. of John (Jim) Farmer (“Farmer Decl.”), ¶¶ 125–28), June 8, 2012, Docket No. 351–2.)

ANALYSIS

I. MOTIONS FOR SUMMARY JUDGMENT

A. Standard of Review

Summary judgment is appropriate where there are no genuine issues of material fact and the moving party can demonstrate that it is entitled to judgment as a matter of law. Fed.R.Civ.P. 56(a). A fact is material if it might affect the outcome of the suit, and a dispute is genuine if the evidence is such that it could lead a reasonable jury to return a verdict for either party. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). A court considering a motion for summary judgment must view the facts in the light most favorable to the non-moving party and give that party the benefit of all reasonable inferences that can be drawn from...