Summary of a Recent
Judicial Development in
Food Safety

Magistrate Ruling and Recommendation for E. coli Litigation,
Further Delineating Personal Injury Standards

Heather N. Sutton
National AgLaw Center Research Associate

Summary of Decision

In Roney v. Wendy's Old Fashioned Hamburgers of New York, Inc., No. Civ. 2:05-CV-109-GZS, 2006 WL 696251 (D. Maine Mar. 17, 2006), the Federal District Court for the District of Maine received the determination of Magistrate Judge Kravchuk to deny a Motion to Bar Expert Testimony, deny a Motion to Strike, and to recommend that the court deny a Motion for Summary Judgment thereby allowing the plaintiff to proceed with a personal injury cause of action.

Background

Saco, Maine houses a local Wendy's restaurant where Diane Roney consumed two bites of a bacon cheeseburger that expressed approximately two tablespoons of blood akin to that of a new "wound" once the burger was cut in two for easier eating. Roney, 2006 WL 696251 at *1-2. On March 1, 2001, a total of four bacon cheeseburgers were served by Wendy's to the plaintiff's family; Roney's was the last to arrive, only to be discarded when she lost her appetite because it was unprepared. Id. at *2. The following day, abdominal cramps accompanied by back pain, diarrhea, and frequent urination plagued Roney and worsened through the night until she called an ambulance because the pain was unbearable and her urine was brown. Id. Roney did not determine whether blood appeared in the diarrhea, an omission that partially provided the basis for the motions before the Magistrate. Id. at *2, *6. Once at the hospital, her excretions stopped, Roney believed, because "she was 'out of liquid….'" Id. at *3. From that point, Roney was treated with a plasmapheresis and other medical care; eight days from her admission, on March 11, 2001, a stool culture indicated no E. coli contamination, although that test result was disputed by Dr. Owen Pickus because it was taken so long after Roney's initial symptoms appeared. Id.

Dr. Pickus, board certified in internal medicine, oncology and hematology, examined and treated Roney subsequent to her hospital admission. Id. at *3. Pickus determined that Roney endured severe thrombocytopenia and an acute renal failure due to her consumption of the undercooked Wendy's bacon cheeseburger because the meat contained live E. coli strain O157:H7. Id. Roney filed a personal injury action against Wendy's. Id. at *1.

Arguments

Wendy's offered two Motions and arguments to support them; Roney offered one Motion and arguments to support it to the Magistrate:

1) Wendy's presented a Motion to Bar Testimony, under which Wendy's argued that under Fed. R. Evid.702 and Daubert v. Merrel Dow Pharms, Inc., 509 U.S. 579 (1993), Pickus must be prevented from refuting Wendy's argument that Roney suffered from relapsing thrombotic thrombocytopenic purpura (TTP) (a diagnosis that one of Wendy's three medical experts advanced based on a 2000 hospital admission of Roney, because no epidemiologic cluster occurred and Roney did not experience bloody diarrhea; TTP is a rare deficiency preventing a human system from cleaning blood of protein; an available test was not conducted on Roney), and from advancing his opinion that Roney suffered from hemolytic uremic syndrome (HUS) (based on her consumption of an uncooked Wendy's bacon cheeseburger infected with E.coli toxins and causing injury directly to the membranes of blood cells). Id. at *3-4. Both illnesses cause similar symptoms. Id.

Pickus stressed that Roney's 2000 TTP condition was induced by a medicine, Macrobid, supporting this argument by the fact that Roney recovered completely once her prescription was changed and that she did not suffer renal failure. Id. at *6. Wendy's then urged that Dr. Pickus should not be allowed to contest a diagnosis of TTP because he lacked first hand clinical experience with TTP, as evidenced through his confessions of ignorance as to the recurrent TTP ailment at a deposition. Id. at *4-*6. Pickus refuted this allegation with his subsequent research and his education. Id. at *6.

Next, Wendy's asserted that Dr. Pickus's methodology was flawed because of his lack of knowledge as to everything Roney consumed in the time period prior to her March 2001 hospitalization, and because he did not look into alternative sources of the E. coli at Roney's workplace. Finally, Wendy's claimed that Pickus's diagnosis of E. coli was erroneous as no conclusive evidence supported his view of causation (the final expert argument advanced by the last of Wendy's three experts); instead, Wendy's claimed, TTP or acute tubular necrosis (ATN) were supported. Id. at *6-7.

2) Wendy's presented a Motion for Summary Judgment, arguing that Roney had failed to present a genuine issue of material fact as to whether the Wendy's bacon cheeseburger proximately caused her infirmity in March of 2001. Id. at *10. Wendy's argued that Roney failed to show that the cheeseburger "more likely than not" proximately caused Roney's illness. Id.

3) Roney presented a Motion to Strike Wendy's Reply Statement of Material Facts and supporting affidavits of Smithfield Beef Group (owner of Moyer Packing Company in Souderton Pennsylvania), food safety director, Jennifer Stefanek due to improper response. Id. at *9.

Analysis

1) Under FRE 702, an expert witness can testify as to an opinion only where "(1) the testimony is based upon sufficient facts or data; (2) the testimony is the product of reliable principles and methods, and (3) the witness has applied the principles and methods reliably to the facts of the case." Id. at *4. Under Daubert, a four-factor standard is used to evaluate disputed expert testimony: "(1) whether the theory or technique can be and has been tested; (2) whether the technique has been subject to peer review and publication,;(3) the technique's known or potential rate of error; and (4) the level of the theory or technique's acceptance within the relevant discipline." Id. These standards were applied to the differential diagnosis technique used by Pickus; the Magistrate added that other probative factors showing reliability under specific facts and circumstances were allowed for consideration and emphasized the end conclusion of reliability as the dispositive consideration. Id. at *5.

A doctor's lack of clinical experience with TTP was analyzed to determine whether, despite a lack of clinical experience, Pickus was qualified to contradict a diagnosis by other qualified physicians who had had prior involvement with clinical trials and whether his familiarity with TTP through his education and practice satisfied the reliability standard for methodology in determining causation where, post-deposition, Dr. Pickus addressed the possibility of TTP and ruled it out. Id. at *6. The second point under the Motion to Bar Testimony required consideration whether Roney's consumption of undercooked hamburger was sufficient grounds to support Dr. Pickus's methodology in determining that the Wendy's hamburger and not another source of contaminated food caused Roney's illness. Id. at *7. No other family members became ill, and no other peers at Roney's workplace became ill. Id. Whether investigation of employment-based sources of E.coli or other food sources was dispositive as to the reliability of methodology was outweighed by the fact of consumption of an uncooked hamburger was analyzed. Id. Finally, notation that a diagnosis of acute tubular necrosis (ATN) had been previously excluded by Pickus because of inconsistent symptoms was taken. Id.

2) In ruling on Wendy's Motion for Summary Judgment, the Magistrate explained that proximate cause, normally a question of fact, could be determined by motion where, as a matter of law, the plaintiff's evidence contesting the motion would result in a judgment as a matter of law for the defendant at trial. Id. at *10.

First, the Magistrate noted that a culture is not required to allow into evidence the opinion of an expert for causation. Id. *5. Noting two complicating facts as to causation (that neither a culture testing positive for E. coli was accumulated by hospital medical staff, nor could the bacon cheeseburger at issue be tested because it had been thrown away by Roney), the Magistrate queried whether a reasonable juror could find that it was more likely than not, through the evidence presented, that the plaintiff was infected with E. coli O157:H7 from the Wendy's bacon cheeseburger without basing that conclusion on conjecture or pure speculation. Id. at *5, *10. The central considerations were the three prong issues of symptoms timing, lack of blood in the diarrhea, and the fact that there were no additional outbreaks. Id. at *7. Roney's medical condition was described as "symptoms consistent with roughly 15 percent of the known cases of E. coli O157:H7 induced HUS, and who reported ingestion of uncooked ground beef within the past 48 hours-known to be involved in 80-90 percent of such cases- and who is experienced severe gastric distress and is on a trajectory toward complete renal failure...." Id. at *10. For the plaintiff to prevail, these facts must show that Roney "more likely than not became infected with E.coli...from ingesting that uncooked beef." Id.

Holdings

1) The Magistrate found that a lack of clinical experience with TTP was not a bar on medical causation testimony where the medical professional has a background of education and research providing familiarity with a condition, and where the arguments presented by the opposing party were addressed through a reliable methodology. Id. at *6. Inexperience with a condition during a deposition is not preclusive of a medical opinion at trial where the medical expert subsequently addresses the possible etiology. Id.

To allow causation testimony, the Magistrate determined that Pickus's methodology was not flawed for failure to determine comprehensive consumption information, details that went to weight of argument instead of whether the testimony was admissible. Id. at *7. Furthermore, the onset of early symptoms and absence of bloody diarrhea, while not traditional, is merely atypical where uncooked or undercooked hamburger has been consumed and hemolytic uremic syndrome (HUS) symptoms are experienced, indicating E.coli infection. Id. at *8. In this case, Pickus used a sound methodology, providing an assessment formed upon differential diagnosis. Id. at *9. Wendy's motion was denied. Id.

2) The Magistrate found that a reasonably juror could determine that the bacon cheeseburger caused Roney's condition and, therefore, the Motion for Summary Judgment should be denied. Id. at *10-*11.

3) As the Magistrate did not modify or discuss Wendy's reply to the plaintiff's statements of material fact, and the Magistrate's ruling on the Motion to Bar Expert Testimony and recommendation for the Motion for Summary Judgment did not touch Ms. Stefanek's testimony, the Motion to Strike was denied as moot. Id. at *9.

The case was decided on March 17, 2006.