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FDA Report Details Hidden Medical Device Injuries

According to a Kaiser Health News investigation, the FDA has built and expanded a vast and hidden repository of reports on device-related injuries and malfunctions.Since 2016, the FDA has entered 1.1 million incidents into an alternative summary reporting repository. This is different than their MAUDE system, which medical experts trust to identify potential problems for patients. Currently, they must report deaths in MAUDE. However, they placed incidents about approximately 100 devices in this hidden repository. The types of devices include surgical staplers and balloon pumps snaked into vessels to improve circulation and mechanical breathing machines. Agency records provided to Kaiser showed that more than 480,000 injuries or malfunctions were reported through the alternative summary reporting program in 2017 alone.

What Does the FDA Say?

Kaise reports that the FDA has also opened many pathways to report injuries. Many of these pathways appear private or obscured. A registry exemption was created without any public notice or regulations. All the device manufacturer needs to do is request such an exemption. Such exemptions have been given to pelvic mesh and devices implanted in the heart.

After the reported 480,000 injuries or malfunctions in 2017, Alison Hunt, another FDA spokeswoman, said the majority of device makers’ “exemptions” were revoked. She continued by saying that a program took shape that requires a summary report to be filed publicly.

The FDA stated the alternative summary reporting program two decades ago. They wanted to cut down on redundant paperwork. Due to the under-reporting of device problems, they had an influx of thousands of reports each month. Since many of the reports looked similar, they proposed a solution. A device maker would seek an exemption to avoid reporting certain complications and would instead send a spreadsheet on a specific timetable of all injuries. Additionally, the public could see the list of the exempted devices. However, at some point, that list became private.

The Surgical Stapler

An example of the risks associated to these hidden databases is how doctors turned to surgical staplers. Although some had concerns, only 84 injuries or malfunctions were openly submitted. However, nearly 10,000 lived in the hidden database. The public databases reported 250 deaths related to staplers since 2001. One of the market leaders stated they used the reporting exemptions to file stapler-related reports.

Based on this reporting, the FDA has announced a plan to investigate surgical staplers and their safety. Dr. William Maisel said, “Improving the safety of surgical staplers and implantable staples is a top priority for the FDA, and we believe our forthcoming draft guidance to industry and planned advisory committee meeting will advance those efforts.”

What Does This Mean for You?

“The public has a right to know about this,” said Dr. S. Lori Brown, a former FDA official who accessed the data for her research. Dr. Brown told Kaiser that if doctors only rely on the public reports, they can easily reach incorrect conclusions. Other experts say that the FDA has handed over the regulations to the device manufacturers.

Your doctors generally take great care of you. But they rely on these systems when they choose the tools to help you. Although a doctor does not have to always talk to you about the procedures, you can ask questions. Some questions can include:

  • Has this device ever been subjected to human clinical trials? What information do you have about those trials?  Who sponsored the research?
  • Is the way you want to use the device “off-label”? Are there any warnings or contraindications on the device label?
  • Do you have any written information about this device? What about materials that do not come from the manufacturer?
  • What has been your personal experience with the device?

Your doctors want to help and you want the reassurance of your safety as you go through these procedures.

If you or someone you love has been injured after a medical procedure, contact the Law Offices of R.F. Wittmeyer, Ltd. today at (847) 357-0403 for a free consultation.

Construction Injuries Caused by Steel Beams

i beam

Accidents on construction sites can lead to some very serious injuries to the workers. Construction sites are dangerous work places and that involve hard physical labor and often includes powerful machinery. The nature of construction sites includes being in dangerous locations such as great heights and road side where the chances of accident are greater.

Due to its resemblance to an upper-case “I”, the most common steel member for building construction is the I-beam. Other names include a joist or girder. The beam has flanges that attach on either side of the central core component. The beam can weigh more than 400 pounds.

Accident in Evanston

On October 9, 2018 at 8:25 a.m, a steel beam fell 30 feet and tragically killed a construction worker in Evanston. Another worker was also critically injured. The two men, ages 55 and 27, worked near a nine-story apartment building on 811 Emerson Street in downtown Evanston. Suddenly, a beam fell as the crane tried to offload it. At the time of the accident, it remained unclear how the beam fell. However, news reports claimed it appeared that the crane may have lost balance as it unloaded the beam.

The beam hit the two men who were immediately rushed to the nearby hospital. Tragically, the 55 -year-old Davis Bialas was pronounced dead at the hospital. The autopsy states he died of enduring multiple injuries in the accident. The 27-year-old man was stuck under the beam and had to be extricated and then taken to the hospital in critical condition. He went through surgery.

What Kind of Injuries Can Result from an I-Beam?

Construction workers hurt on site have options available for recovery such as getting medical bills paid, being able to take time off work to recover from the injuries, to not being able to go to work at all due to the injuries or even switching to job that is less physically demanding.

If you are a construction worker who has been hurt at work or know someone who has sustained serious injuries and are trying to recover the serious medical problems, or going through the pain of injures and financial worries of paying your medical bills or other bills due to the lack of attendance at work, you need to contact an attorney right away. An attorney will provide you the option and help you understand your rights under the laws.

What Next?

Hiring an attorney will help in many ways. An attorney will examine your case and help determine how much cost you have incurred due to the accident. They will then determine is you are eligible to file a worker’s compensation claim or a third-party liability lawsuit. If you or someone you love has been injured by a falling I beam, call the Law Offices of R.F. Wittmeyer, Ltd. today at (847) 357-0403

 

Defense of Property – How Far is Too Far

In the first year of law school, students take Torts, a class focused on personal injury claims. In this class, students read Katko v. Briney, a 1971 case from Iowa. But what steps can one take to protect their property?

Katko v. Briney

In Katko v. Briney, Edward and Bertha Briney were tired of their nearly abandoned farmhouse being broken into during the hunting season. To stop these break-ins, Edward Briney secured a 20-gauge shotgun to an rod-iron bed in the back bedroom. Then, he fixed a wire around the bedroom door to the trigger of the gun making a makeshift spring-gun.

Sounds like a prank Bugs Bunny would pull on Elmer Fudd, right? A single month after Briney created his DYI security system, Marvin Katko was out hunting near the farmhouse. On past hunting trips, Katko had entered the farmhouse and others like it. He would find canned foods and other non-perishable goods. This time around, Katko accessed the house through the porch window and opened the bedroom door. When Katko did this, Briney’s shotgun-Rube Goldberg creation shot at Katko and hit him in the leg.

Though Katko did not need to get his leg amputated, a jury awarded Katko with $20,000 in actual damages and $10,000 in punitive damages. In issuing their decision, the Iowa Supreme Court stated that the Brineys used unreasonable deadly force in an attempt to defend their property.

[Read more…]

Should I Contact a Lawyer After a Nursing Home Fall?

nursing home fall

According to the Center for Disease Control (CDC), about 36% of hospital emergency room visits for long-term care residents are due to falls. The average assisted living facility accounts for 100 to 200 falls each year. Unfortunately, a nursing home fall can cause serious problems effecting the quality of life, disability, and reduced independence. Of course, as our population ages, the CDC estimates by 2030, nearly 3 million people will live in assisted living facilities.

About 20% of these falls can be prevented by improving controllable environmental factors. These factors include poor lighting, wet floors, and incorrect bed height. According to the CDC, only about 5% of seniors live in assisted living facilities, but they account for up to 20% of the deaths due to falls. But many times, the last nursing home fall was not the first fall. The CDC estimates that each elder citizen falls 2.6 times. In the end, about 1,800 senior citizen die each year from a fall.

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Cubs Dismissed as Defendant in Foul Ball Case

foul ball

As baseball fans enjoy the beginning of the baseball season with more snow than usual, one Cubs fan prepares for a different match-up.

On August 29, 2017, John Loos of Schaumburg was sitting on the first base line at Wrigley Field. Howeer, Loos suffered an injury when a foul ball hit him in the face, leaving him blind in one eye. According to Adam Loos, John’s son, he raised his hand to block his 60-year-old father from the foul ball. “It was rough,” said Adam Loos. “Someone I looked up to my whole life, I see the ball hitting him, hearing the sound … him falling on me, bleeding all over my shoes.” John Loos sustained a broken nose and six bones in and near his left eye.

In the original Foul Ball Case lawsuit, Loos named both the Chicago Cubs and Major League Baseball as defendants. Loos sought at least $50,000 in damages. He alleged that the Chicago Cubs organization was negligent in not providing enough spectator netting. He claims that could have prevented Loos’s injuries. However, Cook County Judge John Callahan Jr. sided with the Chicago Cubs and dismissed them from the lawsuit. According to Judge Callahan Jr., Loos and his legal team did not adequately demonstrate that the Chicago Cubs acted recklessly.

But the lawsuit is not fully dismissed.

[Read more…]

Jacuzzi or Injury – How Medicare Handles “Dangerous” Nursing Homes

medicare

Imagine sitting in a large, luxurious arm chair next to a babbling waterfall fixed in Zen garden. As you look to your right, you can see a long hallway filled with rooms that lead to a relaxing Jacuzzi. To your left, another long hall lined with rooms leads to a lounge cluttered with every amenity you could think of (coffee, cookies, HBO access, the works).  The reception desk welcomes you to this inviting location.

While this scene appears to be one like a five-star hotel on Michigan Avenue, instead, a new trend among some nursing homes and other rehabilitation centers tries to lure new patients in order to gain Medicare benefits. However, although the amenities of the facilities seem top of the line and successfully entice patients, some nursing homes fail to provide the type of care comparable to their amenities.

Warning Signs

Although millions of Americans live at wonderful nursing home facilities with experienced and wonderful staff, some nursing homes give the rest a bad name. Several facilities hire unskilled nurses and workers and lack a sufficient number of doctors. Additionally, understaffing affects the rehabilitiation and medical care needs of the residents.

According to a study conducted in 2014 by the Department of Health and Human Services’ Office of the Inspector General, 22% of Medicare patients staying in a nursing home for a duration of 35 days or less experienced injury or harm from the medical care received. Additionally, 11% of Medicare patients endured some sort of temporary injury. The study stated that Medicare spent an estimated $2.8 billion on hospital visits and treatment for the injured Medicare recipients.

Hour to Hour Care

Most people typically picture a nursing home filled with older people needing hour to hour care. However, nursing home and rehabilitation centers alike welcome short term stays for anyone utilizing Medicare insurance. In fact, these centers are pushing to enroll more Medicare patients as opposed to Medicaid patients. Currently,  Medicare pays facilities 84% more for short term patients than Medicaid pays for long term residents.

With large percentage difference in payment, nursing homes and rehabilitation centers eagerly welcome Medicare recipients. But what is the difference between a Medicare recipient and a Medicaid recipient?

Medicare v. Medicaid in Nursing Homes

According to the Medicare.gov website, “Medicare is the federal health insurance program for people who are 65 or older.” Additionally, younger people with disabilities or for people with End-Stage Renal Disease can use Medicare

There are three kinds of Medicare plans:

  1. Hospital Insurance (Part A)
  2. Medical Insurance (Part B), and
  3. Medicare Advantage Plans (Part C).

In contrast, “Medicaid is a joint federal and state program that helps with medical costs for some people with limited income and resources.”

While these two benefit services are separate, it is important to note that a person can have both Medicare and Medicaid coverage. In terms of determining who pays first, Medicare.gov states that “Medicaid never pays first for services covered by Medicare.” Instead, Medicaid pays after Medicare and all other insurance coverage providers have paid.

Special Focus Status

Due to a growing number of Medicare recipients needing rehabilitation center and nursing home care, Medicare as begun to impose higher scrutiny on the facilities. Medicare officials note the number of Medicare recipients at a facility who have needed hospital care based on an injury. The federal government then places the facility on “special focus status.” This status is the highest and strictest forms of monitoring that is reserved for the poorest performing facilities in the nation. “Special focus status” facilities are required to either fix gaps in patient care while the government provides increased inspections or be threatened with losing Medicare and Medicaid funding. Facilities can also be punished with monetary fines.

Medicare Rights for Residents of Nursing Homes

The Medicare.gov website states that residents of nursing homes and rehabilitation centers have rights and protections under both state and federal law. Some of these rights and protections include:

  • Freedom from discrimination
  • Right of respect and dignity
  • Right to be informed on services and fees
  • Freedom from restraints
  • Right to manage money
  • Right to privacy, property, and living arrangements
  • Freedom from abuse and neglect
  • Right to proper medical care
  • Right to receive visitors
  • Protection against unfair transfer or discharge
  • Right to social services
  • Right to complain
  • The Right to see family and friends

Facilities must honor these rights granted to patients, and facilities that violate those rights that involve the proper care of patients are put on “special focus status.”

If you know someone who has had any of these rights violated by their nursing home, please contact the experienced nursing home lawyers at the Law Offices of R.F. Wittmeyer, Ltd. today for a free consultation.

How Does the Government Define a Dangerous Nursing Home?

The government puts a nursing homeon “special focus status” when

  • Giving a patient incorrect medication
  • Failing to protect patients from violent or bullying residents or staff members
  • Neglecting to tell the patient’s family or physician about injuries
  • Failing to provide adequate care by having a sufficient number of registered nurses and qualified doctors
  • Failing to conform to federal government regulations given to facilities to ensure safety of patients

Facilities can end their high watch status by fixing the issues stated by the federal government. However, of the 528 nursing homes in 2014 that lost their “special focus status,” 52% have relapsed into providing dangerous care, harming patients, or placing patients in serious jeopardy.

These relapsing violators are usually not placed back under “special focus status” and watch. Instead, the government imposes fines.However, facilities can continue to operate with unpaid fines and multiple penalties.

How to Research a Nursing Home

As a consumer, you can choose where you. Don’t just look at the Jacuzzis and Zen gardens. Ask about their hiring practices

And go to https://www.medicare.gov/nursinghomecompare/search.html to compare nursing home rankings and reviews and to make the best choice for you.

Pokemon Go: A New Distraction

25914117692_5d42261ac7_zRecently, Pokemon Go became one of the most popular apps of all time as users downloaded it over 100 million times. Needless to say, the game has become popular among adolescents who finally have a video game they can play outside, to the older generation who grew up playing and watching Pokemon. Now, everyone who has a smart phone can become a Pokemon trainer. Even with its popularity, there has been a backlash by concerned parents, drivers, and authorities. Recently, many people wonder how to play the game safely.

How Pokemon Go Causes Injuries

  • Not paying attention to their surroundings and run into something;
  • Walking around late at night and lacking awareness of the neighborhood
  • Not traveling in large groups when playing the game late at night;
  • Walking into the street chasing a rare Pokemon.

Pokemon Go and Crime

pokemon-1555036_960_720In order to play Pokemon Go, players have to get out of their house and walk around. Unfortunately, a lot of people keep their eyes glued to their phone instead of paying attention to their surroundings. Many people have heard about the stabbings and robberies that happened to people who were playing the game. Pokemon Go players become an easy target because they are not paying attention. They hold their phones in their hand (many thieves steal phones) and Pokemon Go players stay out late at night.

On one occasion, two young players were out playing Pokemon Go at 2am. Seven people confronted the players and demanded their wallets. One girl refused and they stabbed in the arm. Another incident occurred when robbers used lure modules to lure people into a trap. Lure modules can be seen by all players, and they bring Pokemon to the place that the lure module is set up. When the players arrived to the lure module, criminals rob them. Law enforcement agencies have warned people that the game could leave players vulnerable to criminals.

Distracted By Pokemon Go

Not only can being unaware of one’s surroundings lead to a robbery, but it can also cause someone to trip and fall and become injured. The game warns players to always pay attention to their surroundings when the game first starts up. However, many ignore those warning. One expert claims that injuries occur to distracted players while they walk. Two people who ignored the warning actually fell off of a bluff in California. The men were in their twenties, and they were trying to catch Pokemon when they fell off the side of the 75 foot bluff. Firefighters responded to the scene and took the injured players to the hospital where they suffered moderate injuries. According to the firefighters, the men crossed over a fenced area just to get to the Pokemon. Unfortunately, many other stories exist where players trespassed and injuries ensued.

Pokemon Go and Driving

english_pokemon_logo-svgUnfortunately, people are in fact playing this game while driving. Add this to the number of distractions for drivers, which could lead to more car accidents, especially since the game is growing in popularity and, according to fans, is very addicting. The AAA is very worried about the game since it sucks the player into the game and is more distracting than a text message. Although the game disables some features when the player is traveling over twenty miles per hour, accidents have still occurred because people have been playing the game while driving.

One accident occurred when a van struck a parked city police cruiser because he was playing Pokemon Go. Fortunately, the officers were standing on the sidewalk when the crash occurred, so none were injured. The body camera of an officer captured the  collision and the driver I heard in the video complaining about how he should not have been playing the game.

How to play Pokemon Go Safely

Pokemon Go is a great game. It brings people together, and people of all ages can play the game. Parents can finally rejoice because a video game has been invented that requires kids to go outdoors and play instead of sitting inside on a nice day. With that being said, there are a few things that every player should keep in mind:

  • Always be aware of your surroundings. It says that in the game, but make sure you do not trip over anything.
  • Do not trespass on someone’s lawn. Even if it is a very rare Pokemon.
  • Always travel with a group of people if you are going to go out catching Pokemon. A robbery is less likely to happen if you travel with a big group of people.
  • Do not run into the middle of the street chasing a Pokemon.
  • Finally, do not play the game while you are driving.

Follow these guidelines for a more enjoyable experience without injury. Gotta catch ’em all!

Who Pays? College Sports-Related Injuries

Sports-Related InjuriesThe roar of the crowd, the competition and comradery, and finally, the thrill of victory – the driving reasons behind why most college athletes join a sports team on top of being a student. Parents are usually excited that their child has the opportunity to be seen by professional scouts and attend school on a scholarship but lurking in the back of most parents’ minds is the possibility that it could all be taken away if their children suffer sports-related injuries. But at the end of the day, only 1% of college athletes continue on as a professional and only 2% of all high school athletes received a scholarship to play college athletics. Most college athletes are doing it for the love of the game.

Unfortunately, from sprains, strains, and pulled muscles to runner’s knee, concussions, and heat-related illness, there are a wide range of injuries that have become commonplace in college athletics. Due to added media pressure based on concussions and college athlete fatalities, new regulations and precautions have been implemented by the NCAA to minimize the frequency of sports-related injuries but eliminating them altogether, especially in contact sports, is impossible. An athlete who suffers a sports-related injury may need surgery, physical therapy, or ongoing treatment to restore him back to health, let-alone to be able to play again. This raises an important question: when college athletes get injured, who pays?

 

 Who Foots the Bill when College Athletes get Injured?

 

2000px-NCAA_logo.svgAccording to the NCAA bylaws, student-athletes are required to obtain insurance coverage for sports-related injuries with limits up to $90,000. Individual colleges are obligated to verify that their athletes have sufficient coverage before they are permitted to play. Regardless of the severity of the injury, once the student-athlete incurs eligible medical expenses exceeding the NCAA’s $90,000 deductible, their Catastrophic Injury Insurance Program will pick up the bill, up to $20 million. Covered events include games or competitions, official team activities, practices that are organized by the school, and conditioning. Nevertheless, financial and legal issues can arise when the injury requires long-term care that is not covered by NCAA insurance, especially if it prevents the student-athlete from playing or working. Additionally, serious legal implications follow when a coach or member of the athletic department pressures a player to return from an injury before he is fully recovered. Recently, at the University of Illinois, after a report was released that found extensive mistreatment of former football players by a former coach, the athletic director was fired.

The National Association of Intercollegiate Athletics (NAIA), a smaller college association, offers a similar catastrophic insurance plan for all of its students who participate in club or intramural sports. The student must meet a $25,000 deductible first but the NAIA has no provision mandating that student-athletes have insurance. That means an uninsured, injured student-athlete could potentially have to pay $25,000 out-of-pocket before the NAIA’s $5 million policy will pick up the rest. The NAIA does offer an exclusive insurance plan for its students and athletes that aims to provide an affordable means of obtaining comprehensive health insurance coverage.

 

Common Sports-Related Injuries and How to Prevent Them

 

Concussions

football-557565_960_720Arguably the most publicized of the sports-related injuries, concussions have topped the list of injuries that the NCAA is trying to create plans to protect their players. A concussion is a serious brain injury that can occur in any sport when the athlete suffers from a blow to the head or body.  Although a concussed patient who does not lose consciousness may not even realize he has suffered from a concussion, often student-athletes do not report their injury for fear of losing play time. The National Collegiate Athletic Association (NCAA) has published rules to help protect players from concussions, especially in football where concussions are most common.  It requires all players wear both helmets and mouth guards and declares that the play is immediately ‘dead’ if the ball-carriers helmet comes off. The Association has also impressed the manta, “when it doubt, get checked out” to all of its student-athletes in order to encourage reporting.

Heat-related Illness

A more common sports-related inury is caused by the heat. Intense exercise in hot and humid weather conditions can cause dehydration and increase the risk of exertional heat injury. Although deaths from heat illness are rare, exertional heat stroke is the third leading cause of on-the-field sudden death in athletes. A student-athlete with a history of exertional heat illnesses or who has is not in great shape, has a higher percentage of body fat, or is reluctant to report medical problems is especially prone to heat-related illness. To prevent heat-related illness, monitor your fluid intake while engaging in physical activities to ensure that you are staying adequately hydrated. Be aware of the warning signs of exertional heat injuries including excessive dry mouth or thirst, dizziness, fatigue, or ceasing to sweat in conditions that would normally cause you to. These are all signs of heat injuries that should be recognized and reported quickly to ensure that a more severe illness, such as heat stroke, does not result.

About the Firm


Ronald F. Wittmeyer, Jr. practices plaintiffs' personal injury law at his office in Arlington Heights, Illinois.

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