In his cramped office, Mead reviewed all the data. Too many signs pointed to Bil Mar.
Mead determined it was time to get someone to the plant. He decided to send Dunne from Ohio. He reached her on Dec. 14 at the Lorain County Health Department, where she was going through patient files.
Usually calm, Mead could hardly contain his excitement, Dunne recalled.
"He said we'd really had a big break," Dunne said.
"He asked if I'd be interested in going to the plant."
Of course, she said enthusiastically. "It was an exciting moment," she recalled. "Something EIS officers live for. You get to play a pivotal role in public health by sleuthing out a very unusual pathogen. It's great to be part of that."
She boarded a plane for western Michigan.
Tuesday, December 15, 1998
Days Inn, Grand Rapids, Mich.
Carrying just the one travel bag she had taken to Ohio, Unne had arrived in Grand Rapids late the night before. By midday Tuesday, she was back at the airport holding a sign bearing the names of the investigators from the U.S. Department of Agriculture who were to join her in the search.
They headed to a nearby Days Inn and spent the evening until 11 going over evidence the CDC had compiled pointing to the Bil Mar plant, about 18 miles away in Borculo. Dunne shared details from an update Mead had dispatched by e-mail that day to health departments across the country. "Dear Colleagues," the Mead memo began. "The pieces of the multi-state listeria puzzle appear to be falling into place ..."
As of that day, the CDC had identified 37 people who got sick in eight states, including two known cases in Michigan. All had fallen ill between Aug. 2 and Nov. 30. All were all infected by the rare E-strain of Listeriamonocytogenes. The CDC's research had found a common link: Many of the victims had eaten hot dogs, and in particular Sara Lee brands.
There was a sense of urgency. As Mead noted, dangerous food was probably still out there.
"Hot dogs have a long shelf life (decades in my freezer)," he wrote, "and we have good reason to believe that cases are ongoing ...it is not clear that the company will feel that the data is strong enough to support a recall at this time. WE DESPERATELY NEED ADDITIONAL PRODUCT INFORMATION: brand names, establishment numbers, dates of production for both hot dogs AND deli meats. We ask you to please redouble your efforts to get this information."
A sense of urgency had also finally hit Michigan public health officials.
Test results had arrived from Cornell University proving that the two known Michigan cases -- Art Eberlein and the unidentified college student -- were part of the outbreak.
"At that point we started calling hospitals asking: 'Do you have any listeria samples you haven't reported? If you haven't sent them in, please do,' “said Frances Downes, then the state's acting laboratory director.
State law requires doctors, hospitals and laboratories to report all cases of certain diseases, including listeriosis, to the state, because they can be warning signs of a possible outbreak. But cases often go unreported, as was evident in this outbreak.
After calling Michigan's 15 largest hospitals, the state had uncovered six unreported listeriosis cases.
A total of nine Michigan cases ultimately would match the outbreak strain: Three adult residents of an Oakland County group home; a 5-year-old Detroit child; an elderly woman in Barry County; the Western Michigan University student in Kalamazoo; and Eberlein, O'Brian, and Andrzejewski.
It's possible that other Michigan listeriosis cases slipped through the cracks.
There was no way to know.
Wednesday, Dec. 16, 1998
Bil Mar Foods plant, north of Zeeland, Mich.
Dunne and the USDA investigators arrived at the plant shortly after 7:30 a.m. They were met by security and given down-filled coats, white overcoats, boots, and hair nets before being ushered into the plant.
All the layers made the inspectors look 40 pounds heavier. "We looked like obese doctors on rounds," Dunne said.
Dunne was struck immediately by the enormity of the task ahead of her.
"We walked all the way through the plant, and it seemed to take forever," she recalled. "The place was huge."
She saw overhead conveyors carrying boxes of meat throughout the plant. People were walking back and forth. Vehicles hauled boxes from one side of the plant to another.
"Everything seemed to be moving all at once, and I wondered how in the world does everything get orchestrated properly," she said. "It was all unbelievably complex, and I wondered if we'd ever find the cause of the outbreak."
The inspection team was escorted into a windowless conference room, where plant managers had questions for Dunne. They wanted to know why their plant was the target of an investigation.
She explained the reasons and outlined what the investigators wanted to do. Then they got to work.
They scrutinized sanitation procedures, reviewed the steps taken to keep raw and finished products separated, and the hygiene practices of workers. They also took swab samples on equipment and surfaces, looking for listeria contamination, and shipped the samples off for testing. It would be at least a week before the results were back.
So they continued looking inside the plant for ways and places where listeria bacteria could have gained a foothold.
Bil Mar had a slaughtering operation and cooking operation in one plant.
In a large area dubbed "kill and evis," for eviscerate, workers slaughtered thousands of turkeys a day. The slaughtering operation had been around for decades, but Sara Lee had planned to phase it out in 1999.
Slaughtered turkeys are a bacteria haven, as are all raw meats; they can carry a scary assortment of disease-causing bacteria, from salmonella and campylobacter, to deadly E. coli and Listeria monocytogenes.
For that reason, workers were instructed to take care when moving about the plant, to prevent the spread of bacteria from raw to cooked foods. They were supposed to change their lab-like work coats when they moved from one place to another, rinse their shoes in iodine foot baths and stop at hand-washing stations.
At the hot dog production lines, Dunne watched the process in amazement as workers emulsified raw meat, squeezed it into skin-like casings, cooked them and packaged them.
"When I saw hot dogs being made, it turned my stomach, and I think it would turn most people's stomach," Dunne said. "But it wasn't a dirty process, and we found nothing to suggest the process was contaminated."
In making hot dogs and deli meats, two steps were crucial to make them safe.
First, workers needed to cook the products thoroughly. Proper cooking kills bacteria. Second, they needed to make sure the cooked meats were not exposed to contamination before they were packaged. Which meant the work surfaces that came in contact with food needed to be carefully cleaned and sanitized.
After two long days with the federal team on site, plant managers were growing uncomfortable with the intense scrutiny. The tension showed during a second meeting, Dec. 17, between plant officials and the inspection team.
Wednesday, December 16, 1998
Bil Mar Foods plant, north of Zeeland, Mich.
"During this second meeting, several members of the management expressed their concern over having a large number of people in white coats repeatedly walking through the plant and how it might impact on the plant's interests," Dr. Stephen Guryca, one of the USDA officials involved in the inquiry, later wrote in a memo.
But that same day, more evidence was pointing to the plant: The initial tests on the Ohio woman's hot dogs showed they were contaminated with Listeria monocytogenes. The CDC's lab needed another two days to complete genetic fingerprinting tests to determine whether it was exactly the same strain as that in the outbreak.
From Atlanta, Mead suggested to Dunne that she ask plant officials about any unusual events in the last six months -- plumbing problems, construction work or other interruptions in the regular routine.
As Dunne talked to plant officials, one thing stood out - a construction job done over the Fourth of July weekend.
A contractor removed a faulty refrigeration unit in the hot dog production area. It had been blamed for some of the condensation problems that federal meat inspectors had cited repeatedly.
The unit was so big that workers had to cut it into pieces to lug it out the door. They hauled out pieces through several corridors, including a main hallway that linked the hot dog production area with other production areas.
"When I was told this, I said, 'Wow, that's kind of important.' Then I talked to Paul, and he said, 'Wow, this is kind of important,' “Dunne recalled.
But Bil Mar managers saw things differently. "They said, 'This isn't really so different. We do construction work like this all the time,' “Dunne said. "And they believed they had taken all appropriate steps. They covered everything, shut down production and did a massive cleaning before restarting production."
But this work may have caused listeria bacteria to spread through the plant, Dunne and Mead believed. Their suspicions appeared supported by the plant's own records.
Dunne asked whether the plant was doing microbiological testing. At first she was told no.
But she then learned that workers had taken regular swab samples up until November. When she reviewed the test results, Dunne noticed cold-loving bacteria, which could include Listeria monocytogenes.
The number of positive samples remained high until the testing ended in November. Company officials later explained that they weren't overly concerned, because the tests showed only the presence of cold-loving bacteria in general and the plant was re-cleaned after each positive test.
Because it can take up to a week to get results from tests that specifically detect Listeria monocytogenes, most plants use the more general tests that give results within minutes.
But Mead and his colleagues at the CDC immediately suspected that the work might have spread dust laden with listeria throughout the plant. The refrigeration unit became a suspect. There was one more thing. On Dec.19 the final results of genetic fingerprinting tests on the listeria from the Ohio woman's hot dogs showed they matched the E-strain fingerprint that was sickening people across the country.
While this was a critical link, it wasn't absolute. Because the package had been open and in the woman's refrigerator for months, it was possible the hot dogs became contaminated there and not at the Bil Mar plant.
Mead knew he needed more than a hunch about the construction dust and an open package of hot dogs if he were going to lobby for a recall of the millions of pounds of Bil Mar products that were still in grocery stores and people's homes.
"We were pretty sure we were right," Mead said. "But we knew it would be devastating if we were proved wrong."
As the toll of victims grows, the list of suspects is down to one processing plant in Borculo, Michigan, struggled with sanitation. A listeriosis outbreak begins in Tennessee, Ohio, New York and Connecticut.
SATURDAY, DECEMBER 19, 1998
St. Thomas, U.S. Virgin Islands
Steven McMillan had never been very good at vacations. This one would be no different.
As president and chief operating officer of Sara Lee Corp., McMillan had a reputation as a hard-driving executive whose performance tended to be as exact as his appearance.
In his monogrammed shirts, designer cuff links and perfectly draped suits, he had the look of a man who was permanently buffed and ready for corporate battle. He had recently announced record sales to shareholders at their annual meeting. In 23 years, McMillan had never failed to make his budget. It was a point of personal pride.
This particular vacation, to the Caribbean island of St. Thomas, had been planned for a long time, squeezed in between a board meeting in Europe and the normal crush of duties that come with leading a Fortune 500 company with $20 billion in annual sales.
McMillan and his wife, Kelly, arrived in the island town of Charlotte Amalie on Saturday, Dec. 19. It was a breathtaking sight: steep rocky shores and emerald green hillsides, floating in a sea of turquoise. And a perfect day: sunny, 83 degrees, the kind of day especially appreciated by a couple escaping the blustery winter winds back home in Chicago.
The McMillans were scheduled to board a cruise ship the next day. At least that was the plan, until McMillan called his office.
Up to then, McMillan had been given only a hint of the trouble that was brewing at Bil Mar. He had heard about it the day before, while attending Sara Lee's employeeholiday luncheon at the Four Seasons hotel in Chicago. About 15 minutes before McMillan was to address the gathering, he got a call.
"We may have an issue out at the Bil Mar plant," he remembers being told.
"Well, what have we done?" McMillan asked, in the deep voice that still carries a faint note of his Alabama upbringing.
He was told that the plant had quit shipping meat Dec. 17 after learning that federal officials suspected Bil Mar was linked to a growing outbreak of food-borne illnesses nationwide.
"I was told, 'You know, look, this may be nothing, but stand by,' "McMillan, 53, said in a recent interview with the Free Press.
At the time, the concerns didn't seem concrete enough to cancel the trip. But after calling the office from St. Thomas, McMillan was growing uneasy. He found out the Bil Mar situation was still unresolved.
He rattled off questions over the phone, wanting to know what federal officials were saying. "Nobody is really taking any positions," he recalled being told. "Just there is some suggestion that we could have a listeria problem at the plant."
The next day, Dec. 20, McMillan put his wife on the ship alone. He flew the 2,145 miles to Chicago, back to a problem that was rapidly growing into a full-blown crisis.
SUNDAY, DECEMBER. 20, 1998 Sara Lee headquarters, Chicago
While McMillan was in St. Thomas, other Sara Lee executives were holed up in intense meetings at the company headquarters, in the upper reaches of a black skyscraper near the Sears Tower.
The crisis team worked through the weekend, trying to determine how bad things were. The group included executives from the meat division, food safety consultants, public relations specialists and an epidemiologist.
They had also consulted Dr. Michael Osterholm of the Minnesota state health department, an expert in food-borne illnesses.
His department had traced tainted hamburgers back to school lunchrooms, contaminated herbs to sewage-flooded fields in Mexico. The late King Hussein of Jordan, shortly before his death, even chose Osterholm to be his personal adviser on the issue of bioterrorism.
So when outbreaks emerged across the country, Osterholm tended to be in the loop. And having followed the listeriosis outbreak, he was convinced of one thing: the Bil Mar plant needed to get its products off the market immediately. Too many signs were pointing to the plant as the source of the outbreak, and Osterholm was concerned that more people could be harmed by further delay.
"At that point, clearly it was likely to be the hot dogs," recalled Osterholm, who has since left his state job to form a public health consulting company, which has not done any work for Bil Mar or Sara Lee.
When Bil Mar managers and Sara Lee officials called him around Dec. 17, he was candid: Get a recall started.
Osterholm's message was unsettling -- and the lone call for action at that point.
Bil Mar and Sara Lee officials were getting mixed messages.
Neither the USDA, which regulated the plant, nor the Centers for Disease Control and Prevention, which was leading the outbreak investigation, was willing to make that leap just yet.
Federal regulators and health officials had been scouring the Bil Mar plant for five days, taking samples and searching for evidence of what could have caused the outbreak. It would take another six or seven days for the results to come back and answer conclusively whether Bil Mar was the source.
That was frustrating for Sara Lee executives, as they pressed for advice on what to do. They were searching for firm answers, and had even dispatched a contingent to Washington that Friday for a meeting with Thomas Billy, the U. S. Department of Agriculture official in charge of meat plant inspections.
What was said in that meeting would later be a point of dispute.
Sara Lee officials would later say they came away from the meeting with the sense that the government wasn't sure whether a recall was necessary until the test results came back. Billy's staff would say he urged them to consider withdrawing product from the marketplace.
Whatever the case, Sara Lee officials say they were getting unclear signals. That made matters more complicated.
The last thing the company wanted was to leave products on the market that were killing people and making others sick. Yet the company also didn't want to damage a cherished identity by launching an unwarranted -- and costly -- recall, if Bil Mar wasn't the source.
At Sara Lee, the brand name is everything -- a guiding principle recited by top executives as if it were a sacred mantra.
The company reveled in a positive image. Leading business publications heralded Sara Lee as one of the best companies to work for in the United States. Ball Park was the nation's top-selling hot dog brand. Even the company's familiar slogan played on the warm feelings that Sara Lee had tried to cultivate: "Nobody doesn't like Sara Lee."
THE SAME DAY: SUNDAY, DECEMBER. 20, 1998 Centers for Disease Control, Atlanta
For Dr. Paul Mead and his colleagues at the CDC, the stakes were just as high. The health agency's reputation was on the line.
Mead, one of the top CDC officials investigating the outbreak, had grown increasingly convinced by Dec. 20 that the Bil Mar plant was the source of the outbreak. But without the test results from Bil Mar, he wasn't sure the evidence was strong enough to push for a recall.
"Crying wolf would have massive consequences," Mead said. "We'd have no credibility the next time there was an outbreak and we wanted a company to recall something."
The dilemma, he said, was the biggest of his career.
Mead was one of the CDC's top epidemiologists, an intense, wiry workaholic with a wry sense of humor. He had devoted his career to the pursuit of elusive pathogens, often flying off at a moment's notice to the suspected source of an outbreak.
One mission might take him to a cruise ship, another to an Indian reservation, another to a church picnic. Always, his job was to figure out what had made people sick.
His office at the CDC was cluttered with mementos collected on those trips. African masks. Mexican weavings.
Mead is not the type of space-suit-clad CDC sleuth often portrayed in movies. Like most epidemiologists, he wears street clothes and often works from a desk, instead of donning a plastic biohazard suit and breathing through tubes while handling killer viruses that threaten to wipe out whole cities.
While others do that work, Mead analyzes their findings and oversees staff in the field who track down victims and ask questions about what they ate and where they were before they got sick. Part of Mead's job is to reconstruct the chain of events.
With Christmas approaching, Mead was once again trapped at his desk, another crisis consuming him. He couldn't be around home to help his wife make holiday plans or do Santa's shopping for their two boys and one girl, ages 2, 4 and 7. Indeed, Mead would end up spending Christmas Eve in his office, working on the Bil Mar investigation.
As Mead reviewed the Bil Mar case on Dec. 20, he saw that the CDC only had circumstantial evidence. But it all pointed to Bil Mar.
The CDC had an open package of Bil Mar hot dogs contaminated with Listeria monocytogenes. Mead had surveys of nearly 100 victims, many of whom said they'd eaten hot dogs in the weeks before they got sick. Many recalled the brands of hot dogs they ate -- citing mostly Sara Lee brands. Finally, Mead had an open pack of chicken deli meat, made by Bil Mar and contaminated with the outbreak strain of listeria.
But was the evidence strong enough to recommend a recall?
MONDAY, DECEMBER 21, 1998 Sara Lee headquarters, Chicago
With McMillan back from the Caribbean, Sara Lee executives convened that Monday morning in the boardroom on the 47th floor. The image of Sara Lee founder Nathan Cummings looked on from an oil painting on the wall as McMillan and Chairman John Bryan tried to sort speculation from fact.
Tens of millions of dollars were at stake -- and, more importantly, lives.
The company's senior management committee assembled around a massive, polished wood table, big enough for 22 brown leather chairs. The committee normally gathered on Monday mornings to discuss sales results. Crisis management took over the agenda on this day.
They began a daylong search for information, hooking up on conference calls with Bil Mar plant managers as well as industry experts and epidemiologists. One crucial piece of the puzzle was still missing: the test results on meat samples taken from Bil Mar.
"We have no positive tests -- clearly no positive tests on product," McMillan recalled. "So the USDA, clearly appropriate in its protocol, was not in a position where they would have required a recall. We'd asked the CDC and their response was kind of, 'We don't do that. We don't suggest recalls.' "
Perhaps that was true, up to then. But whether McMillan was aware or not, the CDC that Monday morning was finally preparing to recommend a recall, even as Sara Lee executives were meeting.
Mead had directed a staff member to draft a memo to Sara Lee, urging the company to recall all hot dogs made after July 4, 1998 -- the day the refrigeration unit was removed -- and to consider recalling all deli meat made after that date, too.
In the three-page memo, dated Dec. 21, Mead outlined the findings in laborious, scientific terms, then came right out and said the evidence was strong that Bil Mar hot dogs had caused at least one case of listeriosis. Other evidence also suggested that hot dogs from many production dates were contaminated.
The memo struck a note of urgency about the danger of waiting for final test results. "By the time definitive proof is available," the memo said, "more illnesses and deaths will likely occur."
Mead says he informed a Sara Lee consultant on that Monday of his plans to send the recall recommendation to the company the next day, Dec. 22.
Mead's part of the tough call was made. The ball was now in the company's court. "We held our breath and waited," Mead said.
It's unclear what details of the impending memo from Mead were relayed to the Sara Lee boardroom that Monday. But by 3 p.m., the consensus among the Sara Lee crisis team was to wait a day and talk to more experts. The meeting adjourned.
Shortly afterward, McMillan and Bryan began to feel uncomfortable with the decision to wait.
"The chairman and I met degree that this proved to be accurate -- and we were being told it could be another six to seven days before we had tests back -- that's six or seven days in which people could be consuming product."
A recall would be costly. The numbers folks provided,in McMillan's words, a rough "back of the envelope" estimate of $50 million to $80 million.
As they weighed the final decision, McMillan says, Bryan and he decided to abide by a set of rules the rest of the way, no matter how rough the going got. "And the guiding rule would be that we would do nothing that would create any risks to health," McMillan said. "To a certain degree, that makes the decision-making process easier."
In the real-life McMillan and Bryan were taking a big risk. If they were wrong, and Bil Mar turned out to be innocent, the ramifications with stockholders could be devastating.
"And there was a fair amount of conviction we could well be wrong," McMillan said. "But I'd rather justify having been aggressive on the health side than try to justify seven days from now that, well, we were going to save the money and we left the product out."
So, McMillan and Bryan gave the go-ahead: Recall.
All that remained was to decide which products to pullback, and how many pounds. Which was not as easy as it sounds.
At 4 p.m., a select group of crisis team members was called back to the 47th floor, this time to the Braque Room, so named because of the French painter's canvas that once hung there. It was part of a prized art collection owned by Sara Lee, part of which is now on world tour. The room was a smaller meeting chamber with floor-to-ceiling windows that looked out upon the steeple of what Chicago touts as the tallest church in the world.
One decision was obvious. They had to recall hot dogs, given the amount of evidence already pointing to them. And Sara Lee had other plants that could make them.
The harder decision was whether to recall the entire line of Sara Lee's signature premium deli meats made exclusively at the Bil Mar plant.
"The difference between recalling hot dogs and us recalling everything out of that plant is very significant," McMillan said.
Recalling deli meats would put Sara Lee out of that business indefinitely. The company had no other plants that could take over production.
But they couldn't take the risk, either for the public or the company's potential liability.
"So the safest scenario is to recall all of it," McMillan said.
TUESDAY, DECEMBER 22, 1998 Bil Mar Foods, Borculo, Mich.
By morning, USDA officials inside the plant had learned of Sara Lee's plans to launch the massive recall, one that could top out at 35 million pounds of hot dogs and lunch meats, more than any other meat recall in U.S. history.
Even with all the evidence gathered by the CDC, some USDA officials still were surprised by the decision. A daily USDA update, filed from the Bil Mar plant at 9:30 a.m., questioned the wisdom of any recall until all the test results were in. Without those results, the update said, a recall "may be premature."
By noon, Sara Lee had set up a toll-free hot line in anticipation of calls from worried consumers once the news got out.
Bil Mar issued a press release announcing the voluntary recall, noting that "specific production lots of hot dogs and other packaged meat products" might contain the listeria germ.
The recalled products included hot dogs and turkey franks, and a variety of deli meats such as ham, smoked turkey, roast beef and corned beef. They were packaged under numerous brand names -- Sara Lee, Ball Park, Mr. Turkey, Gordon Food Service and others -- but all carried Bil Mar's federal ID numbers: P-261 and 6911.
The press release explained that the company had made the decision after consulting with the USDA and CDC. The Sara Lee release stated: "The CDC has indicated that it is studying whether some of these products might contain the listeria bacteria."
That very morning, the CDC's memo to Sara Lee didn't mince words. "Strong evidence suggests that Ball Park brand hot dogs produced on September 17, 1998, at the Bil Mar plant in Michigan were the vehicle for at least one case of human illness from Listeria monocytogenes (LM). The outbreak strain of LM was recovered from the placenta of a woman who had a preterm delivery, and from an open package of hot dogs from this mother's refrigerator. The mother reports eating these hot dogs on October 5; pre-term delivery occurred on November 7, 1998."
The CDC memo went on to describe the sell-by date and packaging codes from the tainted hot dogs, showing that they were "produced on September 17, 1998, on the #2 retail frank line at the Bil Mar plant . . ."
The CDC memo also outlined evidence that implicated hot dogs and deli meats made on several other dates at the plant, and cited the mounting toll: 35 illnesses and four deaths in nine states, including Michigan.
The Sara Lee press release made no mention of that.
As for the USDA -- the primary watchdog over Bil Mar and all U.S. meat plants -- the department was content to let Sara Lee handle the duty of informing the public. The USDA issued no press release, contrary to its normal policy in such cases.
But at least the news was out. The question was, would consumers get the message in time?
WEDNESDAY, JANUARY 20, 1999 Riverside Methodist Hospital, Columbus, Ohio
For eight hours, Lisa Lee endured the pain of induced labor, knowing that one of the twins inside her was dead and the other had no hope of surviving.
Lee, 27, had been so excited about becoming a mother.
She had been pregnant five months. She visited the doctor regularly. She ate properly. She got plenty of sleep.
But then Lee started feeling sick. That was on Saturday, four days earlier. She sought treatment right away at the emergency room of Riverside Methodist Hospital in Columbus, Ohio, and from her own doctor. She was told it was probably just the flu and, after a night in the hospital, was sent home.
"They told me not to worry," she said. "Just drink lots of fluid and you'll be fine."