Washington (CNN) -- On a sunny morning early last September, Susanna Gaxiola fed her husband a healthy breakfast of fresh cantaloupe in their Albuquerque, New Mexico, home. Her husband, Rene, a Pentecostal pastor and minister, had been fighting a rare blood cancer and he was eating fresh cantaloupe and other fruit daily.
Around the same time, Paul Schwarz ate fresh cantaloupe in his home in Independence, Missouri. Though 92 years old, Schwarz was still active and healthy, and ate fresh fruit often. And Dr. Mike Hauser, a podiatrist, also ate fresh cantaloupe with his family in Monument, Colorado. Hauser, 68, had been fighting myeloma, a blood cancer, but he was recovering well, even planning a bow-hunting trip in the mountains.
Within days or weeks of eating the cantaloupe, all three men became horribly sick, and all eventually died painful deaths. Their deaths were directly caused by the cantaloupe, which was contaminated with the deadly bacteria Listeria, according to health officials. After a months-long investigation surrounding the outbreak, CNN has found serious gaps in the federal food safety net meant to protect American consumers of fresh produce, a system that results in few or no government inspections of farms and with only voluntary guidelines of how fresh produce can be kept safe.
Gaxiola, Schwarz and Hauser were among the roughly three dozen Americans who died last winter after consuming the infected fruit. More than 110 other Americans across 28 states were sickened, many hospitalized, from eating the cantaloupe.
The 2011 listeriosis outbreak turned out to be one for the record books. It was, in fact, the most deadly food outbreak in the United States in nearly 100 years. It was the third-deadliest outbreak in U.S. history, according to health officials.
It should not have happened, and it could have been prevented, according to numerous food safety experts and federal health officials.
Among those most vulnerable to infections from Listeria are pregnant mothers, unborn fetuses, the elderly, and those ill with a compromised immune system.
Michelle Wakley was in her sixth month of pregnancy in September when she ate fresh cantaloupe in her home in Indianapolis. Within days she was rushed into a hospital emergency room, forced into premature labor from the infection ravaging her body.
"I wasn't feeling well, I had flulike symptoms," Wakley said. "I had a headache, but it was not a migraine. Every day when I woke up my head hurt. My legs were killing me. ... They ached. Kind of like when you get the flu, your body aches. It was painful! ...and I had chills. I should've gone to the hospital but knowing ... you get fluike symptoms when you're pregnant, I didn't go. and I felt awful. My teeth were chattering, I was hot and cold. I had sweats and dry heaves."
Wakley and her husband, Dave Paciorek, were startled when their baby daughter, Kendall, pushed her way out of her mother nearly three months early.
"It hurt so bad," Wakley said. "And the reason why it hurt so bad is that the baby was trying to come, because the infection at that point was pretty far into my bloodstream. ... That's why the contractions were so bad and so painful, (because) she knew she needed to come out to live."
Baby Kendall had to be whisked immediately into a neonatal incubator and attached on all sides to tubes and machines. She remained that way for weeks, with her parents unable to hold her.
"I remember that time that the doctor came in and he told us about the problems that that could happen with a baby that was born that premature, and it was devastating," Wakley said. "She could be blind, she could be deaf. She could have heart problems, cerebral palsy, ADHD, and the list went on and on. It was -- it was just horrible.
"And you think, a day ago we thought we were fine, and and now you're having the baby and she might not even live? It was just awful."
Today Kendall still is on 24-hour watch and needs to be fed through a tube in her stomach. There are still larger questions about whether other physical or developmental problems occur later.
And yet, baby Kendall and her mother are today among the lucky ones. They lived.
Last fall, as people began to die and fall sick, investigators from local health departments in Colorado and other states along with the Food and Drug Administration and the Centers for Disease Control and Prevention fanned out across two dozen states.
The investigators worked through the Labor Day weekend doing real scientific detective work and gumshoe reporting to find links to what was causing the sudden, deadly food outbreak. They interviewed people who were sick and relatives of those who died. The scientists collected samples of blood and samples of fruit still sitting in refrigerators. They collected fruit from stores and warehouses.
And the trail of evidence, the cantaloupes themselves, eventually led to a remote part of eastern Colorado, near the town of Holly, and a single farm known as Jensen Farms.
'Tragic alignment' of poor practices
Investigators and health experts eventually descended on Jensen Farms and would determine that the outbreak occurred because a pair of brothers who had inherited the fourth-generation farm had changed their packing procedures, substituted in some new equipment and removed an antimicrobial wash.
"It truly was an 'Aha!' moment," said Dr. James Gorny, the FDA chief investigator who led a team to Jensen Farms.
"We had melons from the grocery stores which were positive for Listeria, with the exact same genetic fingerprint as we found in all of the ill individuals. We had ill individuals with that same genetic strain of Listeria. We had food contact surfaces at the packing house of Jensen Farms with the exact same, genetically matched strain of Listeria. So we had lots and lots of evidence that this was ... as definitively as possible, a smoking gun, that this was the source of the contamination. ... The evidence is very, very strong in this case. Some of strongest I've ever seen."
Jensen Farms has been a fixture in the dry plains of southeastern Colorado since the early 1900s, when the first Jensen arrived from Denmark. Brothers Ryan and Eric Jensen inherited what was an approximately 160-acre farm from their father after he died several years ago, and they expanded it out to about 6,000 acres, growing cantaloupes along with hay and alfalfa and other grains.
The brothers grew up cultivating cantaloupes and knew the business by heart. But last year they decided to make a few changes, and it would cost them everything, along with lives of some three dozen Americans they never met.
"What turned the operation upside-down was some significant changes they made," said Gorny. "It was a very tragic alignment of poor facility design, poor design of equipment and very unique post-harvest handling practices of those melons. If any one of those things would have been prevented, this tragedy probably wouldn't have occurred."
But the story of what happened at Jensen Farms, and why no one stopped the sale and shipments of the cantaloupes, also sheds light on serious problems in the nation's fresh produce food safety net, and a voluntary system created by businesses to ensure a quality product, known as third-party audits.
Gorny and his team of experts from the FDA, the CDC, and other food safety experts would discover a multitude of problems at Jensen Farms, all tied to a series of changes that the Jensen brothers instituted in the packing shed on their farm just before the 2011 harvest.
The investigators said they found, among other things, a dripping, potentially contaminated condensation line allowing water to get onto the floor; water was pooling on the floor; sections of the floor had cut holes and jagged sides that were difficult to clean. Samples taken from the pooled water were positive for the Listeria that sickened people. On the rolling line where the melons moved, investigators found dirty equipment used to wash and dry the melons, and it could not be easily cleaned.
The FDA report stated that "several areas on both the washing and drying equipment appeared to be un-cleanable, and dirt and product buildup was visible on some areas of the equipment, even after it had been disassembled, cleaned, and sanitized." What's more, inspectors found that an older, secondhand washing machine designed for cleaning potatoes had been substituted to clean the melons.
"Because the equipment is not easily cleanable and was previously used for handling another raw agricultural commodity with different washing and drying requirements, Listeria monocytogenes could have been introduced as a result of past use of the equipment," the FDA report stated.
The equipment on the line, including rollers and pads that touched many melons as they passed by also yielded numerous positive genetic matches of Listeria, according to Gorny.
But there was also one other significant point, Gorny and many other food safety experts said. The change in procedures and equipment had also resulted in the removal of what had been used previously to decontaminate melons of bacteria; the farmers had removed their antimicrobial wash. Without it, melons that pass along the packing equipment and are placed in pools of water to rinse can cross-contaminate one another, and an entire production line can spread dangerous bacteria.
"That water can then become a source of contamination, so that if one bad melon gets into that system, you can imagine it can contaminate the water and basically contaminate every melon that comes after it," Gorny said.
The contaminated melons were shipped out and distributed across the country through an efficient system that took them to hundreds of supermarkets and retailers, and then into people's homes. The sick, the elderly and pregnant women were the most vulnerable.
Expert calls third-party audit system worthless
Since September, at least 30 people in the United States have died, many of them after suffering excruciating pain and some having gone into comas for weeks. One died as recently as March.
And every single death has been linked genetically to Jensen Farms, according to FDA investigators.
Although the CDC's official death toll stands at 30, CNN has confirmed death certificates giving Listeria as the cause in at least two other deaths linked to the outbreak. CDC officials say they plan to continue tracking victims and will update records later this year.
The cantaloupes, like much of the produce Americans eat, were not inspected by any government body. The reason is that the FDA simply does not have the money or the manpower to inspect all fresh produce on all farms. The agency is responsible for watching over some 167,000 domestic food facilities or farms, and another 421,000 facilities or farms outside the United States, according to FDA officials. But there are only about 1,100 inspectors to oversee these facilities, officials said.
In the absence of FDA inspectors, food retailers and the industry have created the third-party audit system, in which auditors are hired by farms or facilities to inspect their premises and provide scores.
But many food safety experts, and some members of Congress, have assailed the audit system, saying it is unreliable and full of conflicts of interest.
Just days before the Listeria outbreak, Jensen Farms paid a private food inspection company called Primus Labs to audit their operation. Primus Labs subcontracted the job to another company, Bio Food Safety, which sent a 26-year-old with relatively little experience to inspect Jensen Farms.
The auditor was James DiIorio, and he gave Jensen Farms a 96% score, and a "superior" grade. On the front page of his audit at the farm, DiIorio wrote a note saying "no anti-microbial solution" was being used to clean the melons.
Dr. Trevor Suslow, one of the nation's top experts on growing and harvesting melons safely, was shocked to see that on the audit at Jensen Farms.
"Having antimicrobials in any wash water, particular the primary or the very first step, is absolutely essential, and therefore as soon as one hears that that's not present, that's an instant red flag," Suslow said. The removal of an antimicrobial would be cause for an auditor or inspector to shut down an entire operation, he said.
"What I would expect from an auditor," Suslow said, "is that they would walk into the facility, look at the wash and dry lines, know that they weren't using an antimicrobial, and just say: 'The audit's done. You have to stop your operation. We can't continue.'"
The auditor, James DiIorio, did not return CNN's calls. The subcontractor, Bio Food Safety, and Primus Labs, declined CNN's interview requests. Eric and Ryan Jensen, the young farmers who changed their procedures, also declined an on-the-record interview.
To some food safety experts, the third-party audit system the Jensens relied on is a joke.
"These so-called food safety audits are not worth anything," said Dr. Mansour Samadpour, president and CEO of IEH Laboratories, one of the nation's largest food safety consulting labs for industry. "They are not food safety audits. They have nothing to do with food safety,"
Samadpour said consumers should have no faith in the current system of farm audits, because farms pay for their own inspections.
"If this industry is sincere and they want to have their products be of any use to anyone, they should be printing their audit reports on toilet paper," Samadpour said. "People who are commissioning these audits don't seem to understand that they are ... not worth the paper that they're written on."
Some industry officials have confidence in the audit system, and some of the audits are rigorous and thorough. But the entire system is a voluntary patchwork of unregulated guidelines with no national standards or actual regulations. And, however flawed, it is what most farms rely on; the auditors are often the only people who have inspected fresh fruit or produce in some fashion.
Improvements may lie ahead
Gorny and his team of experts were the first FDA inspectors ever to set foot on Jensen Farms.
Samadpour said he finds that appalling.
"Too often we are willing to send paratroopers after something goes wrong and -- you know, we kill so many people," he said. "But the question is: Where were these guys before? Why should anyone be allowed to have a processing plant without the required amount of expertise, without having the food safety systems in place, (to) produce food and send into the chain of commerce? We have had failures at multiple levels."
Changes for the better in the food safety system and inspections may lie ahead. The federal Food Safety Moderization Act became law last year, and the FDA is currently writing new regulations to increase food inspections and push for better audits. But even under the new law, officials said, farms might only be inspected once every seven to 10 years. Consumer advocates doubt the new law is likely to solve all the problems in the system.
Back in Indiana, Michelle Wakley doesn't care much about the FDA, the private inspector or the audits. She and her baby, Kendall, got sick eating cantaloupe grown by farmers who, she says, should have known better, and who need to answer questions from victims' families.
"Why?" she asked. "They said that their facilities weren't clean. They said everything about the process was not done correctly according to the guidelines issued by the government. They they didn't use chlorine to wash the fruit with. They had dirty floors. The Listeria was found on the floors, on their equipment. There were so many things that they weren't doing correctly. Why? To save a dollar? People have died."
Bill Marler, a nationally known food safety lawyer in Seattle, represents Wakley and her husband, and many families of the victims who died from the cantaloupe who have filed multiple wrongful death lawsuits.
"Listeria is a really a nasty bug," said Marler. "Listeria gets into the bloodstream and it causes enormous problems. Most of these people who died, died very, very painful deaths. They had neurological symptoms, physiological symptoms, they suffered lots of pain, and in some cases it was like losing their minds. That just that shouldn't happen from eating fresh cantaloupe. It shouldn't happen."
Jensen Farms will likely now soon fall into bankruptcy, its assets sold to pay medical claims.
Most troubling of all, there is virtually nothing in place, no protective systems that could prevent this from happening again, someplace else.