Moon Bounce and Bounce House Injuries Very Common

Posted on Friday, July 28th, 2017 at 4:25 pm    

Parents and children alike should exercise caution with moon bounce or bounce houses.   Injuries from regular play on these recreational and backyard toys is far more common than realized.  Injuries can include paralysis, traumatic brain injuries (TBI), broken bones and sprained or torn muscles.  12 deaths have been reported from these devices.  If the manufacturer of distributor knew or should have know about defects in the moon bounce house, then a wrongful death lawsuit may have been an option for the family whose child needlessly died from their injuries.

As one parent recounted in the article below;

Moon bounce injuries are more common than you might think. Here’s how to avoid them.

 https://www.washingtonpost.com/lifestyle/on-parenting/moon-bounce-injuries-are-more-common-than-you-mightthink-heres-how-to-avoid-them/2017/07/12/ecd47764-65a0-11e7-a1d7-9a32c91c6f40_story.html?utm_term=.e3e8a3461bad
July 13

(iStock)

There were just 20 minutes left in the party when it happened. My 10-year-old daughter Kelsea rushed up to me in tears.

“What’s wrong?” I asked.

“I bumped heads with another girl on the moon bounce and now my nose really, really hurts,” she cried. One look at her nose, and I knew this was no fleeting bump. There was a dime-sized divot in the bridge of her previously adorable nose, and she couldn’t breathe through it.

Two hours and one cat scan later, the ER doctor confirmed my sinking suspicion. “Yep, it’s broken,” he said. By then Kelsea’s nose had swollen so much that she looked like a ‘Star Trek’ character. “What’s ‘Star Trek’?” she asked.

That would have been funny, but right then, the pediatric ENT stepped into the room. “She’s going to need surgery to repair her nose,” he informed us.

The author’s daughter before and after her bounce house injury. (Ralph Alswang)

(Elisabeth Leamy)

By then, other mothers were sending me text messages asking whether Kelsea was okay. When I told them her nose was broken, many were shocked. “What a crazy, freak accident,” one wrote. “I can’t believe this happened on a moon bounce.” But it wasn’t a freak accident, and as a longtime consumer reporter, I should have seen it coming. Government safety officials and pediatric groups have been warning about the dangers of “inflatable amusements” for years.

The Consumer Product Safety Commission says 82,203 people were injured on inflatables between 2008 and 2013, more than 90 percent of those on moon bounces. (That number represents ER visits and doesn’t include scrapes and bruises dealt with at home.) And the rate of injuries has been growing over time, perhaps because moon bounces, also called bounce houses, are more common than ever, with even backyard versions available. Two-thirds of the injuries are to legs and arms. Fifteen percent involve heads and faces.

A study published in the journal Pediatrics reported that in 2010, a child got hurt on a moon bounce every 46 minutes.

“It is very common for us to see children in our emergency department who have been injured on moon bounces . . . especially during the summer,” said Katie Donnelly, an emergency room doctor at Children’s National Medical Center. “The case that I remember most vividly was two small children playing in a poorly secured bounce house. A big gust of wind came up and sent the whole structure tumbling quite a way. Thankfully, everyone made it out with only minor bumps and abrasions, but it could have been much worse.”

The authors of the Pediatrics study called bounce house injuries an “epidemic” and said the type and severity of children’s injuries are similar to that suffered on recreational trampolines. That’s significant, because in 2012, the American Academy of Pediatrics came out with advice that children should not play on backyard trampolines at all. Ever. “Pediatricians need to actively discourage recreational trampoline use,” the announcement said.

Few have suggested that children forgo the pleasures of the moon bounce altogether — I myself knew about the risks and let my daughter play on one — yet it seems like there should be national safety standards. There aren’t. Moon bounce manufacturers adhere to some voluntary standards, and the user manuals that come with them contain warnings, but most parents never see those warnings. So it’s up to us to be smart about this ourselves. Here are several safety suggestions from safety advocates and medical professionals:

One kid at a time. This one’s a real party killer, but studies show many of the worst injuries happen when multiple children play on a moon bounce at the same time. They get into collisions — like in my daughter’s case — or fall on one another.

All kids the same age/size. When kids do collide or fall on one another, the injuries are worse when they are of markedly different sizes. At our annual Fourth of July block party we now enforce separate “big kids” and “little kids” times on the moon bounce.

No kids younger than 6. The Pediatrics study found that more than a third of children injured on bounce houses are younger than 6. The CPSC says kids under 6 should not use trampolines. Parents could use the same guideline for bounce houses.

No touching. If multiple children are on a moon bounce at once, tell them to keep some distance from one another and to try not to touch one another.

No stunts. They’re called “bounce” houses, not “flip” or “somersault” houses, and bounce is all kids should do in them. “Flips and somersaults are the most common cause of spinal trauma,” Donnelly said.

Careful getting in and out. A significant number of moon bounce injuries happen as kids get on or off. So warn your kids about that and maybe give them a hand. It’s also a good idea to put padding outside the moon bounce exit.

Watch out for wind. We’ve all heard the dramatic reports of bounce houses picked up off the ground by wind. Proper anchoring can help, but if it’s a really windy day, better to ditch the bounce house altogether.

Safe surroundings. Whether you’re setting up a moon bounce yourself or have hired a company to do so, make sure it’s well away from walls, greenhouses, concrete surfaces, sharp objects or other areas of potential danger.

Beware of deflation. There have also been multiple reports of children trapped by heavy plastic when moon bounces suddenly deflated, which is a suffocation risk. Generators powering inflatables should have plenty of gas, and electric ones should be plugged into GFI-type outlets, according to the CPSC. But most of all, parents should keep an eye on their kids and get them out fast if the contraption starts to collapse.

Adult supervision. And finally, we parents should supervise to make sure all of the rules above are followed. At the party where my daughter was injured, at first we adults were vigilant about making sure there weren’t too many kids on the moon bounce at once. But as time went by, we relaxed — too much, apparently.

My daughter came through her surgery fine. Her nose looks like the cute one I remember. However, because of scar tissue, it will get stuffed up more quickly for the rest of her life. Still, we’re grateful it wasn’t worse. The CPSC knows of a dozen deaths involving moon bounces between 2003 and 2013.


Symptoms of Gynecomastia

Posted on Thursday, July 27th, 2017 at 11:55 am    

Gynecomastia is an enlarged breast tissue in males.

Glandular tissue of the male breast grows out and the male chest resembles a female’s breasts.  The hormones estrogen and testosterone have an imbalance and the scales tip towards the estrogen and breasts grow.  Adolescent usage of Risperdal can cause gynecomastia.

The main symptom is visible – enlargement of male breast.  There can be nipple disfigurement and tenderness on one side or on both sides.  Pain may sometimes be present.

 


Essure Birth Control Dangers

Posted on Wednesday, July 26th, 2017 at 10:44 am    

The Washington Post’s commitment to investigative journalism is highlighted in this lengthy article about the dangers of Essure, a female birth control device linked to injuries.  The FDA has received over 16,000 adverse events reports with Essure…

The battle over Essure

Some people see a breakthrough in female contraception. Others see a dangerous medical device.

Published on July 26, 2017

One night in April 2015, Keisha Carney tried to go to bed in spite of a bad toothache, which turned into an even worse headache — the kind that doesn’t let you sleep. “I couldn’t stand still. I was up walking around,” she says. She woke her husband, who called her dentist’s emergency line and then drove to a 24-hour pharmacy for pain medication.

The next morning, Keisha had an emergency appointment with the dentist, who looked in her mouth and shook her head. “She was like, ‘What happened?’ ” Keisha recalls. Her wisdom tooth was so infected it needed to be extracted. It was the first of five teeth she’d lose.

Carney, 35 at the time, had never had bad teeth; in fact, she was known for her huge pearly smile. Despite juggling work and a large family, including 8-month-old twins, the Dumfries, Va., resident was in good shape all around. “For some perspective, my wife is a unicorn,” says her husband, RW Carney, 37. “She’s one of those women who wore heels her entire pregnancy, no issues, no nothing.”

But suddenly lots of “little things” were going haywire with Keisha’s body, the couple recounts for me as we sit in their neat, airy suburban townhouse about 30 miles south of Washington. Her hair was falling out in clumps, she was having unusually heavy periods and severe cramps at odd times in her cycle, she was gaining weight and battling brain fog and severe fatigue — even when she’d slept.

Then, another problem cropped up: Keisha missed a period. This was strange, because seven weeks after her twins were born, Keisha’s obstetrician-gynecologist had inserted a “permanent contraceptive” device called Essure, made by Bayer. Keisha and RW had eight children between them at that point. “God has blessed us abundantly,” says Keisha. “We knew we were done.”

Keisha had originally asked to have her “tubes tied,” the common term for surgical sterilization. But she says her OB/GYN suggested Essure, a permanent contraceptive that had been developed in part to avoid the risk associated with the incisions and anesthesia used in tubal ligation. The brochure Keisha was given touted Essure as “the most effective method of permanent birth control available” — 99.74 percent. It described the device as two “soft, flexible inserts” that, in a “gentle, non-surgical” procedure, are passed through the vagina and cervix into the fallopian tubes. There, the inserts, which do not contain or release hormones, help generate scar tissue that blocks the tubes. “It sounded more natural,” says RW.

Though Keisha thought she had forever taken care of birth control, the feeling that she might be pregnant kept nagging at her. (She had used an alternative form of birth control for three months after she received Essure, as her doctor had told her to do. But because of a lapse in insurance coverage, she had not returned at that time for the medical procedure necessary to confirm her tubes had been completely blocked by the device.) So, she picked up a drugstore test to set her mind at ease. When it was positive, “I was devastated,” she says. “My husband had to literally pick me up off the floor.”

After the shock wore off, Keisha went online and found a Facebook group called Essure Problems. She began reading post after post from its roughly 16,000 members (today the number is almost twice that). There were women who wrote about the kind of bleeding, fatigue, hair loss and tooth decay that Keisha was experiencing, which they attributed to allergic or autoimmune reactions to materials, especially nickel, in the device. There were women who reported that their devices had migrated out of their fallopian tubes and embedded in the uterus or punctured other organs. There were women who had decided to have the coils removed via surgery and reported winding up with complications from the operations, and often hysterectomies. There was even a subgroup of women who posted pictures of their “E-babies.”

Reading through the posts, Keisha began to think that all the strange “little things” happening in her body might be explained by a reaction to the device she had chosen for birth control. To begin with, she is so sensitive to nickel that she can’t wear her white gold wedding ring for more than a couple of days because it contains the metal. (She says her doctor didn’t ask if she was allergic to nickel; the doctor declined to discuss Keisha’s case for publication, citing privacy laws.)

Now she was devastated, scared and angry. Why had her doctor recommended this? And why hadn’t she done more homework before agreeing to it? “I blame myself for this part, that I never really thought about something foreign being in my body forbe the rest of my life,” she says.

Keisha Carney, here with son Malik, endured adverse effects that she attributes to Essure, before and during a pregnancy. Essure’s manufacturer, Bayer, says the device has been used successfully by hundreds of thousands of women. (Top image of Essure device by Edmund D. Fountain)

Nobody can say exactly how many women have had Essure implanted since the device went on the market in 2002. Bayer, which is headquartered in Germany, says that more than   750,000 devices have been sold worldwide and that sales “continue to grow.” (According to data from Essure clinical trials, device insertion fails anywhere from 4 to 12 percent of the time, making actual usage unclear.) In a telephone interview, Patricia Carney, director of U.S. medical affairs for Bayer Women’s Healthcare, pointed to the total sales number as evidence that “hundreds of thousands of women who’ve received Essure … successfully achieved permanent contraception without having to go through an invasive surgical procedure.”

In recent years, the Food and Drug Administration has received more than 16,000 adverse-event reports about Essure. These are official reports about symptoms, hospitalizations or diagnoses that patients, doctors, hospitals or a device manufacturer believe are associated with a device. They can prompt the agency to order a change in labeling, the addition of warnings or, in rare cases, the removal of a device from the market. Among the reports are nearly 9,000 surgical removals of Essure, mostly by hysterectomy. “That’s a lot of surgeries for a device that’s considered minimally invasive,” says Madris Tomes, a former FDA analyst. Although she and other experts in FDA law and regulation emphasize that there is no magic number of reports that will trigger an investigation, complaints can serve as an important signal to the FDA that it should take another look at a drug or device. (The FDA declined an interview for this article but responded to questions in writing.)

Carney helps son Mekhi, on the trampoline, with Malik’s twin, Khalil, center, and Malik; lunch for her crew.

Activism can make a difference as well. In 2012, a group representing the women who had coalesced on the Essure Problems Facebook page began contacting the FDA, asking for meetings. In 2015, the FDA held a hearing on the device, which, Tomes says, was probably a direct result of the women’s persistence. “There has to be a pretty big outcry for there to be a public meeting,” she says. In 2016, that hearing resulted in a “boxed warning” about possible side effects, including persistent pain and allergic reactions. Black box wtoarnings, as they’re commonly called, are among the strongest action the FDA takes to warn the public about potential dangers of a drug or device, and they are exceedingly rare for devices, according to Suzan Onel, a lawyer with Kleinfeld, Kaplan & Becker who has 27 years of experience in FDA device law. The FDA added the warning, it said at the time, because it believed “that some women are not receiving or understanding information regarding the risks and benefits of permanent, hysteroscopically-placed tubal implants that are intended for sterilization.”

The warning — coming 14 years after Essure went on the market and two years after Keisha had it implanted — was a major victory for anti-Essure activists. But it also left a number of unresolved questions: How did this device come to market? What made it so popular? And should women continue to use it? To find out, I interviewed 14 women who have or used to have Essure, doctors who both implant and remove it, medical device engineers and consultants, researchers, women’s health advocates, and FDA and industry representatives, including for Bayer. I also reviewed the company’s data, transcripts of FDA hearings, court documents, heavily redacted FDA filings obtained by Freedom of Information Act request, medical research, hundreds of Facebook posts and data from adverse-event reports.

“It seems every two or three years we have another controversy in women’s health,” says Steve Xu, a health-­policy researcher and Northwestern University dermatology resident who co-wrote a paper that found “significant weaknesses” in FDA approval of high-risk gynecological devices. “We have pelvic mesh, we have concerns with morcellators” — devices used during hysterectomies that can spread undiagnosed cancer. “And then with Essure, it’s like, here we go again.”

What is Essure?

Essure is a non-incisional, permanent birth control system that uses small devices to block the fallopian tubes.

Nitinol superelastic

outer coil

Polyethylene terephthalate

(PET) fibers

Stainless-steel

inner coil

Fallopian

tube

The device is placed into the fallopian tube with

a catheter.

Uterus

Inside fallopian tube

The outer coil is made with “shape memory” alloy Nitinol.

Body temperature causes the Nitinol to uncoil and expand.

PET fibers cause inflammation and scar tissue, occluding tubes.

Warnings of potential adverse events listed on Essure’s website include:

• Perforation of the uterus and/or fallopian tubes.

• Identification of inserts in the abdominal or pelvic cavity.

• Persistent pain and suspected allergic or hypersensitivity reactions.

• If the device needs to be removed to address such an adverse event, a surgical procedure will be required.

At a radiology conference in 1987, a doctor from Portland, Ore., named Amy Thurmond presented data on a technique she had pioneered to treat infertility: unblocking fallopian tubes using a tiny catheter guided by an imaging technique called fluoroscopy. After the presentation, Julian Nikolchev, a medical entrepreneur, approached her with a question: Couldn’t the technology be turned on its head for the opposite purpose? “He had the idea that there could be placement of a device or chemical in the fallopian tubes nonsurgically to prevent conception,” recalls Thurmond.

In 1988, Thurmond and Nikolchev began testing the idea in rabbits, whose fallopian tubes have a similar structure to those found in humans. Nikolchev worked with Silicon Valley engineers, patents show, and raised $35 million of venture capital, according to news reports at the time. In the early 1990s, he founded a company called Conceptus to develop and market what it would call a “non-incisional permanent contraception” device. (Nikolchev did not respond to interview requests.)

The prototype of Essure had a ribbonlike steel outer coil soldered to a tightly wound steel inner coil that was wrapped in polyethylene terephthalate (PET) fibers. The goal wasn’t for the device itself to block the tubes, but rather for it to stimulate what’s called foreign body response: The fibers would irritate or inflame the tissue, which would signal the immune system to surround the foreign body with cells that form scar tissue. This would encase the device and occlude the tubes, as researchers described in a 2001 study published in the journal  Fertility and Sterility.

Initial testing on 37 rabbits found that the device was highly effective in preventing conception when it was correctly placed and didn’t move. But that happened only about 60 percent of the time, Thurmond and Nikolchev reported in a 2004 paper in the Journal of Women’s Imaging.

For its first FDA-authorized human trial, which began in 1998, Conceptus kept the basic design but altered the metal coils to prevent them from moving, the 2004 paper explains. For its outer, ribbonlike coil, it chose a relatively new material in the medical device arena called Nitinol, which had been developed at the now-closed Naval Ordnance Laboratory in Silver Spring, Md. (coincidentally, the current location of the FDA). Nitinol, a flexible nickel-titanium “shape memory” alloy, as it is known, can be set to take a shape at a certain temperature, relax at a lower temperature and bounce back once warmed up again. For Essure, shape memory meant that the coils could be packed tightly in a slim delivery catheter. Once they hit body temperature, they would expand, allowing the PET fibers in the device to incite the “acute inflammation followed by chronic inflammation” that would generate the scar tissue and block the tubes, according to the 2004 paper.

While Nitinol had been used in medical devices since the 1980s, there were already published reports of failures with cardiovascular stents made of the material and of patients developing reactions to metal implants in general. According to Peter Schalock, a Boston-area dermatologist who has published extensively on metal hypersensitivity, reactions to implanted devices can include rashes or eczema, chronic inflammation and chronic pain, all of which are among the adverse events reported by Essure women.

Schalock and several experts in immunology or toxicology expressed concern at the 2015 FDA hearing that the nickel in Essure could be triggering allergic or autoimmune reactions, in which the immune system overreacts and attacks healthy cells. In addition to the issue of nickel, he and other physicians have raised concerns about the PET fibers used to incite the inflammatory response: “Maybe the inflammatory state goes a little wild,” Schalock told me. “The question is what’s driving it. Is it the Essure, or is the Essure waking up some sort of predisposition to autoimmune disease?”

I raised these questions with Bayer, which purchased Conceptus in 2013 for $1.1 billion. The company acknowledged in an email from its communications office that “a small amount of nickel is released from Essure” and said it would continue to analyze complaints about nickel sensitivity. Patricia Carney of Bayer says that tests for leaching in Phase I trials concluded that “the amount of nickel that comes out of the Essure inserts is actually far less than what comes out of most of the nickel-containing devices that are on the market.” In response to the possibility that the device could be causing autoimmune reactions, Carney points out that autoimmune disease is already common in women. “What we then have to tease out is why are women having these symptoms,” she says. “Because they’re happening in women both with Essure and without Essure.”

Melissa Davis-Gilbert talks with her husband, Dan, before a hysterectomy to remove her Essure coils. Davis-Gilbert, a nurse from Havre de Grace, Md., had originally opted for Essure about a decade ago to avoid surgery. She says that after experiencing pain, fatigue, rashes, joint swelling, difficulty concentrating and respiratory issues, she decided to have the device removed.

Before selling Essure to the public, Conceptus had to submit the device to scientific and regulatory review by the FDA’s Center for Devices and Radiological Health. The Center, which was established in 1976 in the wake of the crisis over the Dalkon Shield — an intrauterine device that caused several deaths and generated thousands of lawsuits because of its design, materials and lack of testing — has different requirements for approval of medical devices than the Center for Drug Evaluation and Research, which reviews drugs. “The legal standard for approving a drug explicitly requires adequate and well-controlled clinical investigations,” says Patricia Zettler, former associate chief counsel for the FDA, who now teaches food and drug law at Georgia State University. In contrast, for devices, the standard is “reasonable assurance” of safety and effectiveness, she says, which is subject to interpretation.

Conceptus applied for approval of Essure in the category of Class III medical devices, which, according to the FDA, “are generally the highest risk devices and are therefore subject to the highest level of regulatory control.” This class goes through the most rigorous application process for devices, known as premarket approval. But it is also the only class of device shielded from most lawsuits, thanks to a 2008 Supreme Court decision that makes it difficult for patients to sue in state court for devices that have received premarket approval. In addition, the FDA granted Essure expedited review, a legacy of AIDS activism intended to speed access to potentially lifesaving therapies, in which the FDA puts a treatment at the beginning of a review queue and provides advice on clinical trial design. The FDA fast-tracked Essure, it said, “because this device offers significant advantages over existing approved alternatives.”

Although Class III devices are protected from most lawsuits and undergo the most rigorous approval process, they are not required to undergo randomized controlled trials — in which one randomly assigned group of patients gets the treatment, another group gets a different treatment, and the outcomes are compared. The FDA said in a written statement to me that it did not believe a control group was necessary for Essure because, at the time, “effectiveness and safety outcomes for laparoscopic tubal ligation were well known from years of clinical use” and could be used for comparison. Sanket Dhruva, a Yale University cardiologist and researcher of high-risk medical devices, strongly disagrees. “We all know the most rigorous data in clinical medicine is through randomization,” control groups and follow-through, he says. Ideally, he explains, the researchers would have given 1,000 women Essure and another 1,000 women laparoscopic sterilization and followed them for five years to compare rates of pregnancy, complications, hysterectomy and repeat surgeries. Without a real-time comparison, he says, “we just didn’t have the data.”

For its third, “pivotal” trial, the most important for achieving approval, Conceptus reported on 439 women. None of the women became pregnant, for an effectiveness rate of 100 percent — though Conceptus noted that “no method of contraception is 100% effective, and pregnancies are expected to occur in the commercial setting.” The company compared this to a long-term study of 10,000 women who elected tubal ligations, which found a rate of pregnancy of 5.5 per 1,000 for the first year. A “serious adverse event” — in which the Essure device perforated the fallopian tube, was expelled or wasn’t placed correctly — occurred in 4.6 percent of participants. After one year of use, according to the data, 9 percent of women reported back pain, 3.8 percent reported abdominal pain and cramps, and 3.6 percent reported painful sexual intercourse.

When asked if this was an acceptable number of adverse events, the FDA said in its response to me that Conceptus demonstrated “reasonable assurance that the device is safe and effective for its intended use.” It went on to explain: “In determining safety and effectiveness, the FDA weighs any probable benefit to health from the use of the device against any potential risk of injury or illness from such use.” One important benefit, according to the FDA, as well as many doctors and researchers, was that women seeking permanent sterilization could avoid surgery by opting for Essure. (It has been estimated that there are about four deaths per 100,000 surgical sterilizations, and a complication rate — involving bleeding, infection, organ damage or anesthesia reaction — of 1.6 percent.)

The fact that Conceptus had only followed the women for one year — the company itself noted that “the risks of long-term implantation [of Essure] are unknown” — also troubled Dhruva. A short-term study “might be okay if it’s a medication that you take for a week,” he says. “But we’re talking about a device that’s going to be implanted in a million people for the rest of their lives.”

In order to monitor any potential long-term effects of the device, one of the FDA’s conditions in approving Essure under expedited review was that the company would continue to follow the women from the pivotal study for at least five years. That data, which was submitted in 2008 but not posted by the FDA until 2014, reported that 92 percent of the 384 participants said overall comfort was “excellent” and 97 percent said they were “very satisfied.” But the company noted that 30 percent of the original study group could not be followed for the full five years. This was yet another weakness of the studies, says Dhruva, because if those women had a complication or got pregnant, the outcomes wouldn’t be reflected in the results.

Looking back on Essure’s clinical trials, Dhruva and two other Yale-based physician researchers took the FDA to task in a 2015 opinion piece in the New England Journal of Medicine, citing the “large numbers” of adverse events reported since the device went on the market, such as incomplete procedures, tubal perforations, pain and bleeding leading to hysterectomies, possible device-related deaths and likely a higher number of unintended pregnancies than previously disclosed. “We believe that these safety concerns, along with problems with the device’s effectiveness, might have been detected sooner or avoided altogether if there had been higher-quality premarketing and postmarketing evaluations and more timely and transparent dissemination of study results,” wrote Dhruva, Joseph S. Ross and Aileen M. Gariepy. When asked, the FDA declined to respond to the article. A Bayer representative said, “We disagree with many of the assertions in this article and remain confident that the benefits of Essure outweigh its risks.”

Dhruva, who has been researching high-risk devices for nearly a decade, says the Essure case is just one example of “substandard data” used for device approval. “And unfortunately,” he says, “I think a lot of women have suffered from consequences.”

OB/GYN Paul MacKoul performs a hysterectomy on Melissa Davis- Gilbert to remove Essure coils, shown adhering to a fallopian tube. Scrub nurse Karen Ricupero, first assistant Tito Fernandez and MacKoul during the surgery. These photos, and the one above, were taken, and are being published, with the consent of the patient and medical staff.

After its approval, Essure was welcomed with open arms by the women’s health community, which had been seeking an alternative to surgical tubal ligation — at that time the most common form of contraception for women over the age of 40. In 2002, “the availability of an easier, faster, safer sterilization technique” was a big advance, says Cindy Pearson, executive director of the National Women’s Health Network. This enthusiasm extended to physicians as well, and many became early adopters of Essure. “I saw it as a game-changer with respect to female sterilization,” says James Robinson, a gynecologic surgeon at MedStar Washington Hospital Center. He estimates that he implanted hundreds of the devices in the decade he served as an OB/GYN with George Washington University Medical Center and says he never had patients return with complaints.

Other factors might also have influenced doctors’ enthusiasm for Essure. For one thing, it takes less time to implant the device than to perform tubal ligation surgery in a hospital. Then there are the reimbursement rates. In 2011 documents created by Conceptus for its sales team, the company estimated that a doctor who inserted 60 Essure devices a year would net $66,747.78, or slightly more than $1,100 per device. By contrast, a physician is reimbursed about $510 by private insurance for surgical sterilization in a hospital, according to Amino, a company that uses U.S. insurance claims data to help consumers estimate health-care costs.

Barbara Levy, vice president of health policy at the American Congress of Obstetricians and Gynecologists and a former consultant to Conceptus, says the higher reimbursement rate is meant to cover office overhead and the equipment necessary to insert Essure, not to serve as an incentive for doctors to recommend Essure over tubal ligation. But Robinson argues that the rate does present an incentive, “and it’s supposed to.” He believes that the idea behind the Essure reimbursement rate is to steer doctors away from the more costly hospital-based procedure.

The problem with a procedure that reimburses well, Robinson contends, “is that everybody jumps onboard: ‘Oh, I’m going to do Essures and I’m going to pay my kids’ college tuition.’ ” But Essure isn’t appropriate for every woman, he says, and should be inserted only by doctors who understand and can manage the risks.

RW Carney watches as four of his children — from left, Malik, Khalil, Mekhi and Brianna — play with Diggy the dog. Mekhi was born after Keisha had the Essure devices implanted.

Like many of the women I spoke to, Angie Firmalino, 45, says that her doctor recommended Essure. Shortly after her 2009 procedure, which she says was excruciating, the Tannersville, N.Y., woman began having constant bleeding and pain. She developed joint problems that she attributes to an autoimmune response and had to have surgery to remove the coils. The operation left fragments behind and resulted in a hysterectomy. She’s still dealing with chronic pain, muscle weakness and blood circulation problems, which she also thinks are autoimmune related.

In 2011, Firmalino decided to start a group on Facebook to share her experiences with female friends. Then, strangers started requesting to join and “telling their horror stories, some worse than mine,” she says. Soon the Essure Problems group had hundreds, then thousands of women. They wrote graphic descriptions of their pain and blood loss, fatigue and weight gain; they posted pictures of their thinning hair and bloated bellies that could be mistaken for marking the weeks of pregnancy. And they shared the stranger symptoms: joint pain, sudden muscle weakness, skin rashes. “That’s when the talk started about what is this device made out of?” Firmalino says. “Then we discovered there’s nickel in the device. None of us knew.”

The handful of women administering the group began researching the device and submitting requests for federal records. One of the details that disturbed them was that the Conceptus vice president who presented the application to the Center for Devices’ OB/GYN devices advisory panel, Cindy Domecus, had been an industry representative on that same panel from 1995 to 2001. In 2002, when Domecus appeared before the panel on behalf of Essure, four of the panel’s nine voting members, including the chairman, were people she had served with. (Domecus declined to comment for this article.) When I asked the FDA about Domecus’s tenure on the panel, it noted that industry representatives cannot vote. However, Diana Zuckerman, president of the National Center for Health Research, which scrutinizes industry influence in health care, believes sitting on the panel gives industry members advantages by allowing them to build relationships and gain “a better understanding of how to influence the vote.”

Another concern for the women involved the nickel. The 2002 package label listed nickel allergy as a “contraindication” (meaning the device should not be used for patients with that condition) and included a directive that physicians screen patients for the allergy. The women learned, however, that in 2011 the FDA granted a Conceptus request that the contraindication be downgraded to a “warning,” which doesn’t require physicians to screen patients. (The current labeling includes a nickel warning. The FDA told me it used a warning rather than a contraindication because it “concluded that the data did not meet the threshold of known hazard.”)

Yet another issue the Essure Problems administrators believe got short shrift was removal of the device. A Conceptus representative testified at the 2002 hearing that taking it out would require cornual resection — removing the area where the fallopian tubes meet the uterus. But doctors have since found that’s “not easy,” says Myron Luthringer, a Syracuse, N.Y., OB/GYN who says he has removed hundreds of the devices. He explains that the coils are fragile and break apart, that the tissue in that area is difficult to repair and that PET fibers have often embedded in the surrounding tissue. For those reasons, he says, he tends to perform a hysterectomy, removing the uterus and cervix, as well as the fallopian tubes. Other physicians do as well. “We really advocate that the right procedure is hysterectomy,” says Paul MacKoul, an OB/GYN at the Center for Innovative Gyn Care in Rockville. But hysterectomy — and cornual resection, for that matter — require the very element many women who chose Essure were trying to avoid: surgery with anesthesia. “Anything that’s designed to be permanent is very difficult to take out,” notes MacKoul’s partner and fellow OB/GYN, Natalya Danilyants.

In 2012, the Essure Problems administrators began contacting the FDA, asking for meetings; first, they got a conference call, then a sit-down. A few months later, environmental activist Erin Brockovich launched a campaign against Essure, which led to media attention. In 2015, the FDA scheduled the public hearing before the Center for Devices’ OB/GYN devices advisory panel — the same one that had approved the device in 2002 (only one of the 2002 members remained). Such meetings are infrequent, though they are standard protocol when the FDA investigates complaints regarding a medical device.

At the Sept. 24, 2015, hearing on the FDA’s Silver Spring campus, 22 women testified about their symptoms and the impact they said Essure was having on their relationships, their sex lives, their ability to take care of their kids and their ability to work. The women also recounted how their concerns had been dismissed by physicians who told them there was no way the device could be causing their problems. One woman, Gabriella Avina, had participated in the clinical trials and spent years as a paid spokeswoman for Conceptus. “As I became the face of Essure women, my health was in a grave tailspin,” she said.

Amy Reed, an immunologist who was fighting a separate, personal battle against morcellators, told the panel, “Women are presenting just like you would see in a rheumatologist’s office — hair loss, rashes, joint pain, tired.” She called these “classic symptoms” of an immune system gone haywire. Her husband, Hooman Noorchashm, a surgeon also trained in immunology, pointed out that “this device is not designed to cure an incurable disease. … It’s a medical device that’s completely avoidable. And what I want to know from this panel is what percent harm are you going to accept: 0.1 percent, 1 percent, 5 percent, 10 percent? And how are you going to justify that?”

The panel members themselves had some tough comments for the FDA and Bayer, especially on the issue of nickel sensitivity. “How do we not have data on nickel allergy when we have a device that’s 55 percent nickel and 20 percent of women — approximate numbers — are known to be nickel allergic?” asked Schalock, the Boston-area dermatologist and expert in metal hypersensitivity, who served on the panel in 2015.

Fourteen months after the hearing, the FDA announced the black box warning, which alerts patients to reported device migration, perforation, persistent pain and “suspected allergic or hypersensitivity reactions.” The warning and a patient-doctor discussion checklist appear in the 27-page patient information booklet that all women considering Essure are supposed to receive, to be signed by both doctor and patient. (The checklist includes statements such as, “I understand that should my doctor and I decide that Essure should be removed after placement, an additional surgical procedure may be required. In complicated cases, my doctor may recommend a hysterectomy.”) The FDA also ordered Bayer to conduct another clinical trial, this time with a control group: 1,400 women will get Essure, 1,400 will have a surgical tubal ligation, and they’ll be followed for three years. The results are due in 2023.

Throughout the pregnancy, Keisha managed to continue working from home as an IT consultant; twins Khalil and Malik play.

The 16,373 adverse events related to Essure that were reported as of May 31 include accounts of devices that broke apart, migrated out of the fallopian tubes or punctured other organs; there are also reports of systemic autoimmune reactions, pregnancies (about 1,100), miscarriages and stillbirths. There are four reports of adult death, though the FDA notes that “confirming whether a device actually caused a specific event can be difficult based solely on information provided in a given report.”

These numbers are not easily found on the FDA’s website, or even by doing a search of its public database for adverse events, known as MAUDE. They came from Madris Tomes, the former FDA analyst, who left to launch her own search software, which she says is better at analyzing the agency’s raw data. The FDA does not dispute her numbers (it counts 14,919 medical device reports related to Essure through December 2016). Tomes is helping the Essure women pro bono.

In early May, Tomes and several women from the Essure Problems group met on Capitol Hill to rally support for the 2017 Medical Device Safety Act, which would eliminate the protection from state-court lawsuits that the 2008 Supreme Court ruling gave to Class III medical devices. (Despite the ruling, more than 5,200 women have petitioned to sue Bayer over Essure in five separate state courts, some of which have ruled that the suits can initially go forward, according to Holly Ennis, a personal injury lawyer at Ennis & Ennis who represents hundreds of women who say they were injured by the device. Many of these women are hoping the suits will lead to a recall. Bayer, however, notes that “to date, 23 cases in the Essure litigation have been dismissed in their entirety or significantly narrowed.”) But  the Medical Device Safety Act  isn’t likely to get traction. Last year, President Barack Obama signed legislation that  expedited the approval process for drugs and devices. President Trump has promised to make that process even smoother, and the House recently approved a bill that would ease reporting requirements for medical device manufacturers.

Much of the U.S. medical community continues to endorse Essure. The American Congress of Obstetricians and Gynecologists opposes the black box warning, citing a lack of “good, solid data,” as Levy puts it. Planned Parenthood, which spoke in favor of the device remaining an option at the 2015 hearing, still offers Essure at 18 affiliates. And many physicians and researchers, as well as the Center for Devices’ OB/GYN panel and Bayer, say Essure should stay on the market while further studies about its effects are conducted, because of the risks posed by the surgical alternative. Health-care watchdogs counter that there are other options available, such as IUDs,  as well as vasectomy, which does not pose the same surgical risks as tubal ligation. For its part, the FDA told me that it “continues to believe Essure is safe and effective for many women — but also that some women experience very serious and sometimes debilitating problems.”

Sales, meanwhile,  seem to be falling domestically: According to Athenahealth, a medical billing management company, sales of Essure among the 1,938 U.S. medical providers in its database who implant it have dropped by 70 percent since 2010. A Bayer representative said in an email that the company “will discontinue distribution for commercial reasons in most of the countries in Europe, Latin America and Canada and in the few markets in Asia Pacific where the product is commercialized.” The company attributes this to low sales, “nothing related to safety.”

Robinson, the MedStar doctor, still admires the technology and thinks Essure has been effective for most of the women who have it. But, he says, doctors should have taken the potential risks more seriously: “The last thing you should be doing is saying, ‘This is in your head, don’t worry about it.’ That’s the kind of crap that sends people over the deep end, and for good reason. We need to take responsibility for the things that we do.”

Two of Keisha Carney’s sons at home.

Twin pregnancies are notoriously difficult, but for Keisha Carney, her final singleton pregnancy was worse. She was constantly in pain — sometimes she’d be doubled over until the stabbing feeling subsided. She also had an ache in her lower back that would sometimes paralyze her for several minutes at a time. Little could be done to ameliorate her pain without potential danger to the baby.

There were more sleepless nights and continued hair loss — which she dealt with by wearing a wig or extensions, something she’d done for years anyway. She had root canals and enamel caps to try to save the teeth she still had. The changes in her mouth affected her connection with the outside world. “I stopped wanting to go out,” she says. “People think of you a certain way when you’re missing teeth.”

Throughout the pregnancy, Keisha managed to continue working from home as an IT consultant, though she was depressed and in pain. All she could do was wait until the scheduled Caesarean section, when, following the birth, her OB/GYN would remove the coils and her fallopian tubes. But after the baby — a small but healthy boy named Mekhi — was delivered, her doctor informed Keisha a “tiny fragment” of coil had been left behind. That meant Keisha, who had toddler twins, a newborn and surgery to recover from, had to undergo a hysterectomy. Her new surgeon found the fragment, as well as a larger piece of coil that had migrated outside of her uterus, near her colon.

Keisha immediately noticed changes after her hysterectomy. She says the stabbing pain stopped, her hair started to grow back and she has had no cause to visit the dentist. Still, her memory isn’t what it used to be, she has ongoing arthritis in her knee and ankle, and the ache in her lower back remains. “I worry it’s kind of like a thing that never ends,” she says.

Things are looking up in other ways. Mekhi quickly caught up in size to his older brothers — today they’re often mistaken for triplets — and the family is making things work. Yet the couple remain angry. “I really feel betrayed,” says Keisha. “I was only 36 and I’m having to have a hysterectomy?” She also thinks the FDA should be held accountable. “Whoever said, ‘Yes, we can put this on the market,’ sometimes I wish they would have to endure what we’ve gone through.”

Jennifer Block is a freelance journalist based in New York . Her book about women’s health in the age of empowerment will be published by St. Martin’s Press in 2018. This article — and an episode of “Reveal,” a public radio program and podcast from the Center for Investigative Reporting and PRX — was reported in partnership with the Investigative Fund at the Nation Institute. You can find the “Reveal” episode at revealnews.org/podcastbeginning July 29th. To comment on this story, email wpmagazine@washpost.com.


The Most Dangerous Highways in America

Posted on Tuesday, May 23rd, 2017 at 9:14 am    

The Houston Chronicle lists out the most dangerous highways in America.  The Houston Chronicle complied information from geotab.com.  Geotab.com has an interactive map showing the most dangerous highways in each state.

Texas grabbed one of the top 10 spots with U.S. 83, the Texas Vietnam Veterans Memorial Highway.

U.S. Highway 83 is extremely dangerous and averages 26 deadly vehicle crashes each year for the past decade.  It reported that Highway 83 saw 268 crashes and 36 deaths over the time period.  The report did not include how many of these car and truck crashes involved commercial trucks or 18 wheelers.

 

 


Trucking Industry Pressures

Posted on Monday, May 22nd, 2017 at 10:33 am    

The pressure and toil on long-haul truckers is laid bare in this New York Times expose of the trucking industry.

One of the most shocking statistics is that among the big trucking fleets there is 80% turnover each year.  Basically the big trucking companies start over with all new employees EVERY SINGLE YEAR.  With that kind of turnover and the lack of training, trucking crashes and accidents are tragically (and avoidably) inevitable.

Because of the lack of safety standards/regulations, truckers earn less in 2017 than they did back in 1980 (adjusted for inflation).

https://www.nytimes.com/2017/05/22/us/trucking-jobs.html?hp&action=click&pgtype=Homepage&clickSource=swiper-slide&module=second-column-region&region=top-news&WT.nav=top-news


Bounce House Injury Lawsuit

Posted on Monday, May 8th, 2017 at 3:54 pm    

1 dead as Spanish bouncy castle floats off; witnesses say it exploded

Updated 1:06 pm, Monday, May 8, 2017

A bounce house and inflatable slide went airborne at a church festival, injuring five children

Media: National Desk US

A 6-year-old girl was killed and six other children injured in Spain when a bouncy castle broke away from its mooring, soared more than 30 feet in the air and may have exploded, according to local reports aggregated by Time.

The children, between the ages of 3 and 11, were playing in the inflatable house Sunday at a restaurant in the northwest coastal town of Caldes de Malavella when the accident occurred. The Spanish news site El Paisreported that all seven were tossed out of the castle while it was between 32 and 65 feet in the air.

The town’s mayor told El Pais that witnesses said the castle floated up, and some heard an explosion, which ejected the children into the air. In addition to the the girl who was killed, two other children were seriously injured. The rest of the kids suffered only minor cuts and bruises, which would seem to contradict the account that they were hurled from the house at a height of 32 feet or greater.

It was not clear whether a gust of wind or another explanation was responsible for the bounce house becoming airborne.

Pieces of the inflatable reportedly were found about 120 feet away on the roof of the restaurant and in treetops.

According to the Child Injury Prevention Alliance, a child is injured in a bounce house once every 45 minutes, about 30 per day. The injuries often include broken bones and concussions.

High winds picking up and violently tossing the inflatable houses have increasingly resulted in severe injury and even death in recent years:

  • June 2011, Nassau County, New York: Three bounce houses were lifted and rolled by a gust of wind, injuring 13 people.
  • May 2014, South Glens Fall, New York: Two kindergartners were seriously injured when they fell from a bounce house after it was picked up by a wind gust that blew them as far as 50 feet into the air. One child landed on a parked car, and another on asphalt.
  • May 2014, Jefferson County, Colorado: A bounce house was blown 300 feet, throwing out a 10-year-old girl immediately. An 11-year-old boy was injured as the bounce house continued to be blown and flipped more than 300 feet.
  • October 2014, Nashua, New Hampshire: Two brothers, 2 and 3 years old, were hospitalized, the younger in critical condition, after the bounce house they were in at a Halloween festival was swept 30 feet into the air before crashing into an orchard. The bounce house owner was charged with several misdemeanors for operating improperly.
  • June 2015, Guangxi, China: A 3-year-old girl was killed at a birthday party when she fell from a bounce castle that was lifted by a gust of wind.
  • March 2016, Essex, England. A 7-year-old daughter who was fatally injured when a gust of wind carried off the bouncy castle she was playing in. Police arrested a 24-year-old woman and a 27-year-old man on suspicion of manslaughter by gross negligence.

From the Houston Chronicle at;

http://www.chron.com/world/article/1-dead-as-Spanish-bouncy-castle-floats-off-11129763.php


Dangerous Intersections in Houston

Posted on Monday, January 30th, 2017 at 10:25 am    

Houston drivers face enormous challenges with traffic and weather conditions changing rapidly throughout the day.  Houston drivers face semi tractor trailers or 18-wheelers coming from I-10, I-45, I-69 and Texas Highway 59.  All of this inbound and outbound traffic meets up in the Houston area around the 3 beltways, Interstate 610, Beltway 8 (the Sam Houston tollway) and Highway 99 (Grand Parkway).  Some of these car crashes are fatal accidents. Many of these car crashes and car accidents take place on the service roads and intersections to Beltway 8 (the Sam Houston Tollway).   The Houston Chronicle put together a list of the most dangerous intersections in the Houston area.

 

http://www.chron.com/news/houston-texas/houston/article/The-most-dangerous-intersections-in-the-Houston-10889249.php#photo-10812818


Talc or Baby Powder Causing Ovarian Cancer

Posted on Friday, May 6th, 2016 at 3:25 pm    

Disturbing jury verdicts totaling over $100,000,000 have been reported regarding Johnson & Johnson’s talc baby powder causing ovarian cancer.   The science regarding the talc and its ability to cause ovarian cancer has been accepted by two different juries.   Johnson & Johnson maintains publicly that its baby powder or talc does not cause ovarian cancer and responds to the jury verdicts with this video.  Information about the lawsuits regarding Johnson & Johnson can be viewed and explain how talc is a mineral and how it can cause cancer.  One of the massive verdicts was even discussed on a national TV show and its easy to see the concern on the TV hosts’ faces regarding the talc.


Highway 290 and Highway 71 Car Accidents

Posted on Tuesday, April 26th, 2016 at 12:26 pm    

Texas Highway 290 and Texas Highway 71 are two heavily used highways between Austin, Texas and Houston, Texas.  Both routes pass through scenic farmland including tranquil pastures and boucolic pastures.  The peaceful nature of 290 and 71 occasionally suffers dramatic interruptions in the face of horrific and often fatal car crashes.  These crashes sometimes involve 18 wheelers or tractor trailers hauling loads or sometimes just the semi itself.   Travel on Texas highways can be made easier by requesting free maps from the Texas Department of Transportation.

 

 


Trucks Are Getting More Dangerous And Drivers Are Falling Asleep At The Wheel. Thank Congress.

Posted on Wednesday, April 20th, 2016 at 9:45 am    

Trucks Are Getting More Dangerous And Drivers Are Falling Asleep At The Wheel. Thank Congress.

Michael McAuliff

Senior Congressional Reporter, The Huffington Post

ILLINOIS STATE POLICE
A scene from the Jan. 27, 2014 tractor trailer accident that killed one man and critically injured Illinois State Trooper Douglas Balder.
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WASHINGTON — Illinois State Trooper Douglas Balder sat in his squad car, its red and blue lights strobing into the frozen night of Jan. 27, 2014. He was about to be set on fire.

Balder had stopped to assist a Chicago-bound big rig that had stalled out in the rightmost lane of the Ronald Reagan Memorial Tollway. A heavy-duty tow truck and a bright yellow Tollway assistance vehicle were also pulled over, attending to the stranded semi.

Balder, a Navy reservist and father of two, had his heater cranked against minus-30-degree wind chill. He had positioned his 2011 Crown Victoria behind the Tollway vehicle and switched on his flashers. There were also flares sputtering on the pavement, and the Tollway truck was flashing a large blinking arrow and its amber hazard lights. Visibility on that clear, cold night was excellent — around 10 miles.

Renato Velasquez, who was barreling toward the stopped vehicles in a flatbed big rig loaded with three massive rolls of steel, didn’t see Balder’s flashers. He didn’t see the pulsing arrow or the flares. He didn’t change lanes or take any evasive action until far too late. Velasquez was falling asleep, a court would find later. His truck rammed into Balder’s squad car at 63 miles per hour, according to the National Transportation Safety Board investigation into the accident.

The impact crushed the Crown Vic’s trunk, exploding the gas tank and catapulting the patrol car into a roadside ditch. The three 14,580-pound steel coils chained to Velazquez’s trailer bed burst their restraints. One of the massive rolls struck the cab of the Tollway vehicle, instantly killing its 39-year-old driver Vincent Petrella and injuring Agron Xhelaj, the driver of the stalled truck who was seated beside him.

Balder had lost consciousness when his face hit the steering wheel.

“I woke up a short time later on fire,” he said. “Literally on fire. Burning alive.”

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In that moment, Balder didn’t know exactly what had happened. His squad car was half collapsed. The detonated gas tank was spraying fuel and flames through his cab. His only clear thoughts were of survival and of his wife of 14 years, Kimberlie. He yelled out her name.

“A certain degree of that was emotion at the moment, knowing that I might die, screaming to the last person you might love,” he said.

Balder needed to find a way to escape if he was ever going to see his wife and kids again.

He tried to start his engine, then tried to radio for help. Fire was spreading from around the partition behind him, burning his back, head and legs. He couldn’t open his door or window. He tried the switches on his armrest, and the passenger window miraculously cranked down.

“As that cold air came in and swirled that air around, adrenaline set in, and I flew out,” he said. “The only other choice was to sit there and die.”

He tumbled out on the roadside, rolling in the snow to extinguish the flames that had already scorched more than a third of his body. By the time he stumbled around the back of the wreck and back up to the road, local police were arriving to help.

“You got this guy walking up with his skin hanging off his arm,” Balder said. “My pants were all burned off to the skin.”

He spent six weeks in a medically induced coma, three months in the hospital, and needed 10 surgeries and extensive, ongoing rehab to recover.
ILLINOIS STATE POLICE
Balder’s patrol car was completely burned in the accident.
Increasing Carnage On Our Highways

In the two years since the accident, Balder has had plenty of time to think about what happened to him — and why. On the simplest level, it happened because a criminally negligent driver pushed too hard and crashed. But it is also part of a broader trend of declining safety on the roads after decades of progress — a trend that the United States Congress has aided and abetted by loosening safety rules even as both truck drivers and trucks are being pushed to their limits, just like Renato Velasquez.

Truck-related deaths hit an all-time low during the economic doldrums of 2009, when 2,983 truck accidents killed 3,380 people. But as the economy has recovered, the carnage has been on the rise. In 2013, the most recent year for which finalized statistics are available, 3,541 wrecks killed 3,964 people — an increase of 17.3 percent in just four years. In 2014, the number of deaths resulting from truck accidents was down slightly, but the total number of crashes and injuries increased.
At the same time, Congress has been caving, very quietly, to lobbying from trucking interests that want to roll back, block or modify at least a half-dozen important safety regulations. Significant parts of the hauling industry have long opposed many of the federal rules governing working hours, rest periods, size and weight limits, and safety standards. When the Great Recession began in 2008, profit margins for shippers shrank and bankruptcies rose, prompting a desperate industry to step up its lobbying effort.

Perhaps, the trucking companies’ lobbyists suggested to Congress, trucks could haul loads heavier than the federal 80,000-pound limit, which would allow them to deliver more goods with each truck. Maybe they could have longer double trailers, increasing the limit from 28 feet for each unit to 33 feet — turning each rig into an 80-foot-long behemoth, as long as an eight-story building is tall. Or they could let truck drivers be more flexible with their rest breaks, which would allow them to work up to 82 hours a week instead of the already-exhausting limit of 70. Maybe trucking firms could reduce labor costs by hiring lower-paid drivers, younger than 21 — as young as 18. Maybe they could stop federal regulators from raising insurance requirements that were set during the Reagan administration. Maybe the federal motor carrier safety ratings for unsafe trucking companies could be kept secret.

Indeed, the trucking industry is trying to do all of those things. If they are successful, these changes would amount to the most significant overhaul of highway safety rules in decades. But most people don’t know such sweeping revisions are even being considered.

Asleep At The Wheel

The latest round of congressional wrangling started with a fight over snoring, or, more specifically, the obstructive sleep apnea that causes it.

For decades, mounting evidence has shown that sleep apnea, a common disorder, can cause perilous levels of fatigue in drivers, pilots, train engineers and others who need to remain alert at work. The airways of people who suffer from apnea close repeatedly while they sleep, interrupting their breathing dozens of times an hour. They often don’t notice the interruptions, but it leaves them exhausted and prone to doze off during the day. Behind the wheel of a large, speeding vehicle, the results are predictably catastrophic.

It’s not just a problem for truckers. As investigators sorted through a Dec. 1, 2013, Metro-North commuter train derailment in New York that killed four people, they found the engineer at the controls, William Rockefeller, had fallen asleep. His shift had recently been changed, which can cause sleep problems in itself, but he also had undiagnosed sleep apnea.

Since 2008, experts with the Federal Motor Carrier Safety Administration, which regulates the trucking industry, have recommended that drivers get checked for the condition and treated if necessary. The NTSB lists sleep apnea as a problem across the transportation industry, and often points to the Metro-North wreck as evidence of why the trucking industry in particular needs better regulation — its rules are the weakest of the major transportation sectors.

The risk of apnea rises dramatically with weight gain, and approximately two-thirds of all truck drivers are believed to be obese, according to a recent federal survey. Other studies have also found that truckers are much more likely to be overweight than workers in other fields. And extensive research links sleep deprivation to heightened crash risks; even moderate tiredness can impair a driver as much as being legally intoxicated. A recent Harvard study found truck drivers with obstructive sleep apnea are five times more likely to crash than their fellows.

To do a better job dealing with the issue, the Federal Motor Carrier Safety Administration floated a proposal in April 2012 that would have required overweight truckers to get checked for sleep apnea. The industry was livid. Some drivers claimed there was no evidence that sleep apnea raised the risk of crashes, while others alleged the proposal was a scheme to enrich sleep doctors.

Independent truckers are especially loath to admit a problem because treatment can take them off the road for a month or more. And sleep tests and treatment cost thousands of dollars for people with inadequate or no health insurance.

Despite acknowledging the problem and the need to deal with it, FMCSA backed off its push to update the apnea rules. Just a week after posting the proposal, the agency withdrew it, claiming it was published in error.

Going After Congress

The trucking industry did not let the matter drop, though. Instead, its lobbyists launched a pre-emptive strike.

Normally, when an agency like FMCSA targets a specific issue, it uses its existing authority to propose binding guidance. Taking this route — which the agency started to do with apnea — is easier than embarking on a full federal rulemaking process, which can take years, requires even more extensive input from the public and industry, and often triggers long legal battles.

Rather than taking the chance that FMCSA might resurrect its proposal on apnea screening, industry lobbyists approached allies in Congress to write a law that would require the agency to follow the longer, more cumbersome formal rulemaking course.

Trucking industry lobbyists sold the bill as a safety enhancement. In their telling, it sounded like truckers were asking regulators to come up with a way to screen for dangerous apnea, not blocking an effort to enhance screenings.

Members of Congress bought the spin. “I can only hope that the agency, which has a long docket, in fact gets to this rulemaking,” said Del. Eleanor Holmes Norton (D-D.C.) in a brief discussion on the the House floor. “I’m not sure why the agency was going to do guidance instead, but this is a very important issue. There have been accidents attributed to sleep apnea.”

Then-House Speaker John Boehner (R-Ohio) allowed the bill’s sponsors to bring it to the floor on Sept. 26, 2013, when the country was focused on the prospect of a looming government shutdown in the next four days. Safety advocates had little opportunity to raise objections. The bill passed with no opposition and was sent to the Senate. It passed the upper chamber a week later, in the middle of the shutdown, with no debate or even a roll-call vote. The legislation was slipped into a string of unanimous consent requests, lost among resolutions supporting democracy in Venezuela and recognizing Danish Holocaust survivors. President Barack Obama signed the law on Oct. 15, without comment, just before the government shutdown ended.

Less than two months later, the Metro-North engineer took a curve along the Hudson River in the Bronx at 82 miles per hour — 52 mph over the limit — while he dozed at the controls. Seven cars derailed. Three of the four people killed were ejected from the train. No one noticed that Congress had just made it more difficult to screen truckers for similar sleep disorders.
EUGENE GOLOGURSKY VIA GETTY IMAGES
In December 2013, a Metro-North commuter train engineer with undiagnosed sleep apnea fell asleep and caused a derailment that killed four people.
Congress Waters Down Safety Rules

Horrifying crashes have a way of focusing Congress’ attention on safety — at least while the headlines are bold and the corpses are fresh. The rest of the time, lawmakers tend to listen to industry groups, which warn of job losses and higher costs if their demands aren’t met. These conversations happen inside the cloister of legislative process, shielded from scrutiny. If what business wants doesn’t put health or safety first — and it often doesn’t — politicians try to meet the demand by adding provisions to much larger legislative vehicles, where they may be impossible to dislodge, if they are even discovered at all.

Consider this example.

In July 2013, the FMCSA enacted a regulation modifying an existing rule that says drivers must take 34 hours off after they hit certain maximum time limits working and driving. The new restriction mandated that truckers include two nights in that break, with no driving between 1 a.m. and 5 a.m. The new rule effectively cut the maximum hours drivers could work from 82 per week to 70. Studies show that humans get the best, most restorative rest while slumbering at night, and truckers face especially tough schedules, so the restriction forced drivers to have two restful, overnight periods in their break, which is known as a “restart.”

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But trucking lobbyists argued that making drivers sleep at night was more dangerous because it would put more trucks on the road in the morning hours, with commuters and school buses. The industry pointed to data that shows more accidents occur when there are more vehicles on the roads during the day. The lobbyists neglected to mention data showing that the rate of fatal accidents actually more than doubles during the overnight hours, even with vastly fewer automobiles on the roads.

As soon as the updated regulation went into effect, trucking groups demanded changes, but FMCSA, which had spent years working on the rule, wasn’t listening. That left the industry with the choice of pursuing an uncertain challenge in the courts, or appealing to Congress for relief.

By law, Congress can vote to disapprove a new executive agency regulation, such as the sleep rule, within 60 work days of the rule’s publication. If Congress doesn’t pass a disapproval resolution, lawmakers can propose specific legislation undoing the new rule, and hold hearings on the proposal in the relevant committee — in this case, the Senate Committee on Commerce, Science and Transportation.

Going through either of those processes is the transparent, above-board approach. But that path does not often get the trucking industry what it wants. For years, the late New Jersey Sen. Frank Lautenberg (D), a member of the commerce committee, blocked anything that he thought eroded highway safety, as did other safety-conscious members on the committee. Lautenberg’s successor, Sen. Cory Booker (D), has sought to take up that mantle.

The trucking industry needed a detour. It looked for an alternate route through the Senate Appropriations Committee, and found Republican Sen. Susan Collins, who represents the trucking-friendly state of Maine. Collins added a provision temporarily barring FMCSA from spending any money to enforce its new rule and requiring additional study of the issue to a $54 billion transportation bill during an untelevised legislative markup in June 2014.

The under-the-radar move might have been the end of the new rule. But unlike with the apnea bill a year before, a headline-grabbing tragedy caught the nation’s attention shortly before the appropriations bill made it to the full Senate. Two days after Collins got her amendment included, an exhausted Walmart truck driver speeding along the New Jersey Turnpike slammed into comedian Tracy Morgan’s limo. The wreck killed Morgan’s friend James McNair and left Morgan and four others severely injured.
NTSB
Tracy Morgan’s limo van was crushed by a truck whose driver fell asleep at the wheel.
The crash generated headlines around the world, and once again focused the nation’s attention on the dangers of sleep-deprived drivers behind the wheels of 80,000-pound vehicles.

When the transportation spending bill came to the Senate floor on June 19, Booker was waiting with his own amendment to block that of Collins. He took up his microphone and delivered a blistering speech against the provision, forcing Collins to defend the measure. But before the bill went to a vote, Senate leaders pulled the measure from consideration, in part because of the sudden controversy.

Collins didn’t give up, though. When the nation was again facing a government shutdown in the winter, she managed to slip her sleep-rule provision into the so-called CRomnibus, a huge, unwieldy spending measure that needed to pass by Dec. 13 to keep the government open. No one outside of Congress knew that the trucking provision had been attached to the bill until lawmakers shoved their shambling creation into the light on Dec. 9, four days before it needed to pass. At that point, the measure could not be blocked, as it had been in the aftermath of Tracy Morgan’s crash. Like the sleep apnea rule a year before, it passed under the cover of a funding battle, much to the disappointment of safety advocates, including Morgan’s lawyer, Benedict Morelli.

“I don’t understand how in good conscience anybody could be pushing to relax the federal rules,” Morelli said. “The reason that they’ve been put in place is to make sure this doesn’t happen — and it happens a lot.”

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Shocking Headlines, Shockingly Often

Morelli is right: Accidents like those that nearly killed Balder and Morgan happen with startling regularity. For instance, last spring while Congress was again quietly targeting trucking regulations, a string of crashes showed vividly the consequences of overtired truckers pushing past their limits.

On April 22, 2015 a truck driven by John Wayne Johnson barreled through a line of cars backed up by an earlier truck crash on Interstate 16 in Georgia. Johnson killed five nursing students from Georgia Southern University headed to their last training shift of the year. Lawsuits filed over the wreck say he had sleep apnea and a history of falling asleep at the wheel. He also may have been looking at pornographic pictures.

On May 19, witnesses saw a tractor-trailer drifting between lanes as it neared a construction zone on that same Georgia interstate, near I-95. The driver, David Gibbons, 61, smashed his rig into the stopped cars and also killed five people.

On June 25, Benjamin Brewer, 39, spent 50 hours at work and was allegedly high on meth when he approached construction traffic on I-75 in Chattanooga, Tennessee. He was going so fast, his truck careened on for 453 feet after impacting the first car, according to the NTSB. He killed six people.

On July 23, trucker Ruslan Pankiv failed to notice traffic backed up at a construction zone on I-65 near Lafayette, Indiana. He plowed through the stopped vehicles, killing five people, including a mother, her two young sons and himself. Again, police suspected fatigue.

Those are just cases for which drowsiness was explicitly stated as a possible cause. Most independent experts believe fatigue-related wrecks are significantly undercounted since there is no roadside exam or blood test for drowsiness, and drivers are often reluctant to admit they were nodding off.

In the case of Renato Velasquez, he insisted he hadn’t dozed off, but he could come up with no other explanation his wreck. By the time the scientifically careful NTSB released its final report on Velasquez’s accident, on Feb. 9, 2016, he’d already been convicted and sentenced to three years in prison for driving while fatigued, ignoring federal rest rules, driving too fast and failing to yield.

What’s beyond debate is that hauling loads across America’s highways is a draining, exhausting existence. And it’s only gotten tougher since President Jimmy Carter and Congress deregulated the complex rules governing the economic side of the industry in 1980, making it much easier for new companies to get into the business and setting off a surge in competition.

The change was good for consumers, who saw shipping prices drop as lower-cost carriers pushed out unionized firms. And safety did not immediately suffer, because technology improved and both the government and carriers grew more conscious of the practices that reduce the risk of crashes.

But as unions vanished and the need for productivity and efficiency rose, pay for truck drivers plummeted. They now make less than they did in the late 1970s when wages are adjusted for inflation. And there are now tens of thousands of small, poorly financed new trucking companies that have great incentive to push drivers as hard as they can.

Those drivers, who are often independent and own their own rigs, have to cope with managers’ demands and all the safety rules that still exist, even as the close-to-the-bone industry leaves little room for error. Unpredictable hours, uncertain traffic, long stretches spent sitting alone behind a wheel, and meals that depend on roadside greasy spoons take a toll on drivers’ health. All that adds up to a circumstance that encourages drivers — especially the growing number who have strict drop-off and pick-up times set in their contracts — to take chances. And they do, frequently ignoring rest rules to make their schedules. Drivers for smaller outfits are especially likely to break the rules.

Renato Velasquez is a case in point.

His daughter Yesenia told NTSB investigators that her father had dreamed of driving big rigs. He had been a bus driver in rural Mexico, transporting workers to farms back in the ‘80s. He immigrated to the United States, and in 2007 earned his commercial driver’s license in Illinois. His first job driving flatbeds was at a company called M&A, where his brother worked, and where he learned the federal safety rules.

Velasquez told the NTSB he took a job with another firm, DND International, in 2011, after meeting the company’s manager, Dimitar Dimitrievsky. The company, one of thousands of small-time shipping operations that have proliferated since deregulation, employed 49 drivers. Those drivers logged 5.4 million miles in 2013, the year before Velasquez’s crash.

Velasquez seldom saw the boss, or any other workers, and was dispatched remotely, according to his interview with federal investigators. He and another driver said they would drop off their logbooks and other records at a box outside Dimitrievsky’s house once a week. There appeared to be little oversight or enforcement at the company, the NTSB concluded. Although Velasquez said he never got safety training from his employer, records say that he received at least a little, and the company did possess some of the required safety training materials. But DND also possessed a terrible, albeit remarkably common, safety record.

In the two years before the crash, DND drivers had been subjected to 289 inspections, according to federal records. Its drivers had been ordered off the roads 27 times, most often for hours-of-service violations — driving more than the legal limit. The vehicles themselves were found to be in violation 26 times in 131 inspections, a failure rate of 20 percent. The company racked up seven crashes between March 2012 and January 2014, causing one fatality and four injuries. Those stats meant that DND had alerts in two Behavior Analysis and Safety Improvement Categories (BASICs) that the FMCSA uses to rate companies and identify dangerous carriers. BASIC serves as the foundation for the agency’s Safety Measurement System — a system that the trucking industry despises. DND had poor scores in the BASIC standards for safe driving and driver fatigue. The chances of a firm being involved in a fatal crash jump by 93 percent when it has an alert on unsafe driving and by 83 percent when it has received a warning for excessive hours-of-service violations, according to agency data. And firms with two alerts have crash rates that are double the average among companies with no alerts.

Independent drivers like Velasquez and his colleagues are paid by the load, not by the number of hours they work. A decent living requires good loads. To get good loads, a trucker needs a strong relationship with his trucking company’s dispatchers, who take orders from shipping brokers and route them to available tractors. Trips that are longer, more time-consuming or force the driver to return empty — hauling “flying canaries” or “dispatcher brains” — can even cost a driver money. A DND driver named Stanford Dean told NTSB investigators that his loads weren’t even dispatched in the United States. They came from someone based in Macedonia.

“Do you know how difficult it is to make money?” Dean asked investigators who confronted him over discrepancies in his logbooks. “I’m a safe guy, but there’s issues sometimes,” Dean added. “There’s so many obstacles. If anybody tells you they roll 100 percent by the book, they’re lying to you.”

On Velasquez’s fateful run, he had a decent assignment from the dispatchers, hauling power cables approximately 450 miles from Illinois to Nebraska, for a $1,600 fee. On the way back he would stop in Cedar Rapids, Iowa, to pick up three steel coils that he would haul a little more than 200 miles back toward home, for a fee of $550. After gas, tolls and DND’s 20 percent cut, he would pocket about $1,000 for the out-and-back.

According to Velasquez’s logbook for the trip that killed Vincent Petrella, he followed safety rules. It says Velasquez left Hanover Park at 11:45 a.m. on Sunday, Jan. 26, carrying a 6,707-pound load of cable to the Omaha Public Power District in Elkhorn, Nebraska. The entries say he reached Des Moines, Iowa, at about 5:30 p.m., took a 45-minute break, then motored on to Elkhorn by 9 p.m., keeping his driving time well inside the 11-hour limit and his on-duty hours within the 14 permitted in a day.

But Velasquez’s logbook was a work of fiction.

Investigators would later learn how badly things went wrong for Velasquez, and how severely he broke the rules, leading to his deadly exhaustion.
Velasquez’s cell phone and toll records showed he didn’t set out on the trip until nearly six hours after the time he recorded in his logbook, and he kept driving well past the time that he claimed he had settled in for a night’s rest.

The problem was that this was a trip across the Midwest in the dead of winter, with a brutal deep freeze, snow, fog and whipping winds along the way. Ahead of Velasquez on I-88, two other trucks crashed at 9:43 p.m. in whiteout conditions, shutting down the highway for four hours. Velasquez wasn’t even out of Illinois at that point, and that traffic jam may have been his only rest in 37 hours. According to the truck’s engine records retrieved by the NTSB, the longest it was idle that Sunday night and early Monday morning was for less than three hours.

Velasquez couldn’t just pull in for some extra rest after the long night. A requirement of the delivery contract with the Omaha Public Power District was a punctual drop-off at 8:30 in morning. The driver logged in at the drop-off at 8:45 a.m. Records showed Velasquez departing at 9:20 for a 300-mile run to Cedar Rapids, where his pickup window for the three steel coils began at 4 p.m. He left at 5:15 with another 200-plus miles and four hours left to reach home.

But about an hour before he got that far, a truck that hauled containers from railways broke down ahead of him in Aurora, Illinois, just shy of Velasquez’s destination. It was owned by a firm called Michael’s Cartage that had alerts in four of the FMCSA’s troubling categories, including maintenance. Its drivers falsified work logs more than half of the time, according to an NTSB review. Just like with DND International, the numbers suggested the carrier was more than twice as likely to wind up in a crash. In this case, the Cartage truck became the hazard that Velasquez failed to avoid.

He never wrote down his final stop, at 9:20 p.m. — when he dozed off at the wheel and forever changed Doug Balder’s life.

Paying For Influence

The leader of the trucking industry’s campaign to tilt federal regulations in its favor is an alliance of the nation’s largest shippers called the Coalition for Efficient and Responsible Trucking, or CERT. Its most prominent members are FedEx and UPS.

Members of CERT have donated more than $13 million to federal election campaigns since 2012, and spent $80 million on well-connected lobbyists, according to a Public Citizen study from 2015 using data from the Center for Responsive Politics, as well HuffPost’s analysis of more recent congressional lobbying reports through the rest of the year. The American Trucking Associations, which advocates on behalf of the industry, spent another $8 million on lobbying and $2.4 million on elections. The Owner-Operator Independent Drivers Association, another industry group, has chipped in $3.5 million for lobbying and $790,000 on campaigns. It amounts to more than $20 million spent each year, solely to influence Congress.
Trucking industry lobbyists have the kind of access to decision-makers that safety advocates can only imagine. Among FedEx lobbyists alone, 37 of 51 previously worked in government, according to CRP.

Those influence brokers have been exceptionally busy and effective, securing victories on apnea screening in 2013 and the roll-back of sleep rules in 2014. In 2015, they aimed for much more. In the House, industry-friendly lawmakers were persuaded to add several policy riders to the annual transportation funding bill for 2016 in May, again bypassing committees and hearings, as Sen. Collins did with sleep rules.

Bigger And More Dangerous

Perhaps the most controversial of those measures was a scheme to take away the ability of states to set their own standards for the maximum lengths of double trailers. A federal law passed in 1982 required all states to allow doubles, with each of those trailers up to 28 feet long. Many states, particularly in the West, allow longer trailers. The new measure would have raised the federal limit to 33 feet for each trailer, and forced all states to accept them.

Companies such as FedEx and UPS have long sought to extend the length of trailers, because they often fill the 28-foot model with packages before hitting the 80,000-pound weight limit. Carrying more with each rig means greater efficiency, lower cost and more profit.
But larger, heavier trucks also mean more wear and tear on highways and bridges that are already poorly maintained. Weigh stations and other facilities handling trucks would also need to be renovated and expanded, often at taxpayers’ expense.

Law enforcement and safety advocates also warn that double trailers are already more dangerous than regular semis, with an 11 percent higher crash fatality rate.

“From a safety perspective, double 33-foot trailers are basically a disaster,” said Robert Mills, a Fort Worth, Texas, police officer who spent 13 years as a roadside safety inspector and is a member of the Motor Carrier Safety Advisory Committee, which recommends rules to the federal government.

Many truckers are not so pleased with the giant double trailers either, dubbing them “wiggle wagons” and “widow makers.” Some haulers, including the smaller conglomerates Swift and Knight, joined with the Coalition Against Bigger Trucks to oppose their larger brethren’s push to extend trailer lengths.

Even crashes of doubles where there are no injuries in the initial impact leave dangerous scenes for other drivers when they’re sprawled out across multiple lanes of traffic, said Balder, who is now working with the coalition.

But CERT, the coalition of shippers, is determined to get approval for larger trucks, and was behind a push in 2012 requiring the Department of Transportation to study the impacts of size and weight increases. The industry coalition believed, or at least argued, that those impacts would be negligible; research proving that would help their case. But before that study was even completed, the coalition got its provision allowing longer trucks added to the House’s version of the 2016 transportation spending bill. The DOT study, released in June 2015 two weeks after the House released the transportation bill, recommended against allowing larger trucks, saying the safety issues remained unresolved.
HANDOUT
Lisa Shrum lost her mother and stepfather, Virginia and Randy Baker, when their car was torn in half at an accident where a double-trailer blocked the road.
There were several other industry requests in that funding bill for 2016, including a measure that aimed to extend the suspension of sleep rules that Collins had won just six months earlier. Her suspension lasted a year and required regulators to look into the effectiveness of requiring two nights of sleep and whether there was any case for the trucking industry’s position. But rather than see that process through, the new provision changed the study mid-stream and called for gathering even more data — including the regulation’s impact on the longevity of drivers. Studying workers’ lifespans, of course, takes entire lifespans. That provision was signed into law with the 2016 spending bill that ultimately passed.

“They just basically want to stall this forever,” said Rep. David Price (N.C.), the top Democrat on the appropriations subcommittee that deals with transportation.

Another measure the industry pushed last year aimed to short-circuit federal regulators’ efforts to evaluate raising insurance requirements for trucking companies. Currently, carriers have to maintain the same $750,000 policies they did in the ‘80s. The industry’s argument is that independent operators would not be able to afford higher premiums — and indeed, DND’s margins were so close it shut down when its insurance company raised rates after the Balder crash. The industry argues that 99 percent of truck accidents do not generate such high damages. But $750,000 doesn’t begin to cover the costs a serious semi wreck incurs. For instance, a widower whose wife was killed and children severely injured by a dozing driver in 2010 won $41 million in damages. The family of James McNair, the comedian who died in the Tracy Morgan crash, settled for $10 million in March last year. A somewhat weakened version of the measure did pass, requiring regulators to evaluate a number of different factors before they adjust the insurance requirements.

Another industry-backed provision aimed to hide the BASIC safety measurements for trucking companies from public view, and bar their use in lawsuits. The lawsuit provision was dropped from the spending bill during negotiations, but the BASIC scores were in fact hidden and removed from the agency’s website. The industry used a Government Accountability Office study that found the safety system could do better in some respects to justify its position, but the two firms involved in the Velasquez crash had exactly the sort of poor safety scores that the BASIC system predicts make them more likely to be involved in accidents.

Despite the fact that these provisions will likely have an impact on the safety of nearly 11 million large trucks registered in America, they were all buried in legislation that Congress had to pass to avoid a government shutdown, with little to no debate about whether they were a good idea.

“The advocates of relaxing the rules or eliminating the rules, they see that and think this is their train to catch. … Not just wait on the normal process, or count on something as pedestrian as actual hearings or discussion, but to make a summary judgement and latch it on to an appropriations bill,” Price said.

There’s something else all the industry-backed measures have in common: They are deeply unpopular.

The Huffington Post and YouGov surveyed Americans on four of the proposals the industry has been pursuing through the backdoor: teen drivers, longer trucks, heavier trucks, and the relaxed hours-of-service rules. In every case, respondents to the survey opposed the moves — by large margins.
Indeed, when proposals to weaken trucking safety do get a up-or-down vote on their own, they generally fail. When the Senate’s version of the transportation funding bill came up for debate in November and October, an attempt to include the House’s requirement for states to accept 33-foot trailers across the nation was voted down each time. Similarly, an attempt in the House last November to amend the highway construction bill to hike truck weight limits failed convincingly, 187 to 236.

The trucking industry is certainly still trying, though. The backdoor approach is the easiest way for the industry to get around the safety restrictions that most Americans support. One initiative that it backed down on in 2015 was a bid to block states from enforcing regulations on rest and pay that are tougher than the federal government’s. Large haulers got the preemption added to the House’s highway construction bill, but couldn’t get senators to consent.

The trucking industry is back at it this year, adding a provision that would override state rest and overtime pay rules to a House bill reauthorizing the Federal Aviation Administration, which is currently operating on a stopgap measure that expires in mid-July. The Senate is working on a dramatically different version of that bill, which almost guarantees a situation where trucking lobbyists have thrived — a rush to finish a must-pass bill behind closed doors with a looming deadline and little ability to alter deeply buried provisions.

A Problem He Can’t Forget

For Douglas Balder, crashes are not just a byproduct of business and politics. His own near-fatal encounter is burned into his flesh and his memory.

While he can’t forget it, he also doesn’t want to. He’s read most of the 5,000-page NTSB investigation of his crash, and he still looks at the pictures of his destroyed squad car every couple of weeks. He said he doesn’t know why he wants to keep replaying that night.

“I’ve been asked that question before, and I can’t answer it,” he said.

But he does have an answer, really.

Balder joined the Navy reserves right after graduating high school in 1994 and has served tours overseas, including in Iraq and North Africa. He is the sort of person who walks in the St. Jude’s parade and donates blood. And he now has another reason to keep trying — a third child who was conceived and born after he was nearly killed on the side of that highway.

“We all take an oath to make things better in the long run,” he said. “And it’s got to be our focus now. I could easily have shriveled up in a ball and stayed at home and wasted away, but that’s not my mindset. That’s the military in me: You gotta move on — pick up and move on — and try to make a difference for the future. And I have to remind myself of what happened.”


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