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The Food & Drug Administration has issued a Class I recall for LIFEPAK 1000 defribillators, distributed by Physio-Control Inc., one of the nation’s largest suppliers of defibrillators to hospitals, nursing homes, and first responders. According to Physio-Control’s website, the LIFEPAK 1000 is a portable Automated External Defibrillator (AED) designed for use by first responders on adults, children and even infants. The AED retails anywhere from $1400-$3100. AEDs are available to the public, but only with a prescription from a physician. It is also strongly advised that they only be operated by persons with formal training in CPR and AED usage.

Physio-Control voluntarily recalled the LIFEPAK 1000 after reports that the device experienced sudden losses of power. Although the devices can be restarted, every second counts in a cardiac emergency.

Recall Details, obtained directly from FDA.gov:

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In his February budget address, Governor Rauner discussed the need for reform of Illinois current workers’ comp program, saying that Illinois desperately needed jobs and that companies were being scared off from setting up shop in Illinois because of the current costs of our workers’ comp premiums. According to Rauner, the factor driving high premiums are lawsuits. In reality, Rauner is making a scapegoat out of the legal system when he should be examining the facts and properly putting the blame on insurance companies.

To help separate fact from Rauner’s fictional claims, we are sharing the following information, taken directly from a recent Illinois Trial Lawyers Association fact sheet entitled ‘Illinois is Good for Business.’

Illinois is Good for Business

Groups trying to assist corporations and other wrongdoers in avoiding accountability when they wrongly injure or kill people claim falsely that lawsuits and high workers’ compensation premiums are driving business out of Illinois. The reality is Illinois remains a strong state for business.

  • Illinois is headquarters to 37 of the nation’s largest companies on the 2016 Fortune 500 List. Of those companies, 22 rose in the rankings in 2016.1
  • Only three states have more Fortune 500 companies than Illinois. 2
  • There are 124 major corporations with their global headquarters in Illinois.
  • For three consecutive years (2013-2015) the Chicago area was named the country’s leading metro market for “new and expanded corporate facilities.”3
  • For three consecutive years (2013-2015) Illinois ranked third in the nation as a top performing state for capital investment attraction.4
  • Illinois has more workplaces per 1,000 residents than Indiana, Kentucky and Wisconsin.5
  • Between 2010 and 2016 Illinois gained 391,000 jobs, essentially the same percentage growth in Wisconsin and well above that of Missouri for the same time period. Illinois job growth exceeded Michigan and Ohio.6
  • Business costs in Illinois are lower than they are nationally and have been trending downward for the past few decades. Business costs are lower her than in states that have similarly large metropolitan areas, such as California and New York.7
  • Businesses in Illinois tend to pay less in taxes. The state’s tax burden has been consistently below that of the Midwest and national averages since the 1980’s.8
  • Utility costs in Illinois are about 15 percent below the national average and noticeably less than the regional average.9

 

Top 5 Illinois Businesses for 2015 10

Company Location Fortune 500 Rank 2015 Profit
Walgreens Boots Alliance Deerfield 19 $4.220 billion
Boeing Chicago 24 $5.176 billion
State Farm Bloomington 35 $6.229 billion
Archer Daniels Midland Chicago 41 $1.849 billion
Caterpillar Peoria 59 $2.102 billion

 

1 Fortune Magazine. http://beta.fortune.com/fortune500
2 Ibid.
3 Site Selection Magazine, March 2016. http://siteselection.com/issues/2016/mar/top-metropolitans.cfm
4 Site Selection Magazine, March 2016. http://siteselection.com/issues/2016/mar/cover.cfm
5 Illinois Economic Policy Institute. “Stop Saying that Illinois is Bad for Business.” January 26, 2016.
6 “The truth about job growth in Illinois.” Crain’s Chicago Business. March 19, 2016
7 State of Illinois Economic Forecast, January 2017. http://cgfa.ilga.gov/Upload/2017MoodysEconomyILForecast.pdf
8 Ibid.
9 Ibid.
10 Fortune; http://beta.fortune.com/fortune500

*Illinois has a flat personal income tax rate of 3.75 percent.  It is lower than the top tax rate of 40 other states – some which go as high as eight to thirteen percent.

 

See Related Post:
Governor Rauner’s Budget Address Ignores Insurance Company Greed in Workers’ Comp Program

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As we await voting from the House on H.R. 1215, the bill that would limit your right to non-economic damages in excess of $250,000 for a medical malpractice lawsuit, we are obviously not thrilled to report that H.R. 985, another bill that also restricts civil rights, has been approved by the House.

H.R. 985, otherwise known as the Fairness in Class Action Litigation Act of 2017, attempts to severely limit the ability to file a class action lawsuit against corporations that have harmed or discriminated against Americans. Class action lawsuits are those that involve multiple plaintiffs with similar complaints against the same institution. An endless list of well-known class action lawsuits exist, many of which have changed the course of American history. For example, Brown v. Board of Ed., Roe v. Wade, Enron, and PG&E (famous for being the largest direct class action lawsuit in history and the inspiration for the film ‘Erin Brockovich’).

The bill has caused a stir among attorneys, past victims of corporate greed and negligence, and civil rights groups and advocates. It angered the American Bar Association enough to come out and state that this legislation requires a “nearly insurmountable burden for people who have suffered a personal injury or economic loss at the hands of large institutions with vast resources, effectively barring them from bringing class actions.”

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The Food & Drug Administration has issued the most severe type of recall, class I, for the Halo One Thin-walled Guiding Sheath by Bard Peripheral Vascular Inc. The sheath acts as a placement agent and guide for vascular corrective or diagnostic devices that are inserted through an incision in a patient’s leg. The recall states that the tip may separate from the device and that the sheath itself could kink and rip from the actual device when removed from the patient. Potential complications include bleeding, arterial and venous perforation, and even death.

Recalled product information from FDA.gov:

  • Product codes HAL545, HAL590, or HAL510F
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Late last year, stories began flooding the news about Samsung’s Galaxy Note7 phone, a device that bears more resemblance to a small tablet than a smartphone. Released just last August, by October so many complaints of spontaneously exploding phones had been thrown at the company that they decided to stop all sales of the Galaxy Note7 until they could determine the cause of the fires. In the same press release, Samsung implored all users to immediately turn off their phone and send back for either a refund or for an entirely different model. What many Galaxy Note7 users likely didn’t notice was that buried at the bottom of the phone’s box was a small 16 page booklet containing a paragraph stating that users could not sue Samsung. Instead, they were agreeing to binding arbitration as a means to settle any claim of injury or death arising from use of their product.

Teen Among Many Injured By Galaxy Note7

In Illinois, Michael Taylor, 19, went to sleep with his Samsung Galaxy Note7 on the charger next to his bedside. He woke up hours later to excruciating pain in his leg and to his smartphone on fire. The phone had exploded while charging, causing severe burns to the teen’s leg. When he consulted with an attorney in an attempt to sue Samsung for his injuries, it was discovered that hidden deep in a booklet seldom read by users, Taylor had unknowingly agreed to arbitration. Without knowing it, Taylor had waived his right to a jury trial, agreed to use an arbitrator chosen by Samsung to settle his dispute, and to pay Samsung’s legal fees if the arbitrator determined Samsung was not at fault. While that same part of the booklet also states that consumers can opt out within 30 days of purchase, it is hardly likely that most consumers would read a 16 page booklet of terms and conditions. Users assume that the products they purchase are safe and that they are protected by law should an injury occur from its use.  Instead of taking true ownership for the burns suffered by Mr. Taylor, Samsung hid behind the agreement they placed in the product packaging, stating that he agreed to abide by their arbitration process to settle any grievances.

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Last week, Illinois Governor Bruce Rauner gave his annual budget address to the state. In the lengthy speech, Governor Rauner spent most of the time addressing the need for job creation in the state and the reasons for businesses leaving. Spending only one sentence of his entire address on workers’ compensation, Rauner stated that high workers’ comp insurance costs are causing higher property taxes and businesses to leave Illinois. What Rauner didn’t say should speak louder than the few words he actually expressed. There’s one type of business that’s flocking to do business in Illinois. Our state has the most workers’ comp insurers of any state in the country. 332 insurers, to be exact.

Illinois a Favorable Environment for Insurers

In Illinois, profits for workers’ comp insurers have been on the rise since 2010. Since 2011, however, the dollar amount they’ve paid out for claims has decreased while their premiums have steadily gone up. So where is all the extra money going? It’s probably not a shock to hear that insurers are pocketing the extra income instead of passing on the savings to businesses in the form of lower premiums. Insurers are also empowered by state legislation that allows them to deny claims and cut back on available benefits.  However, businesses see workers’ comp as a necessary evil. By providing workers’ comp insurance, they are essentially free of responsibility for injuries sustained on the job. Governor Rauner hopes that by cutting back on workers’ comp premiums and payouts, companies will see Illinois as a favorable place to do business and will set up shop in the state.

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As any parent knows, teething feels like a phase that might never end. The constant irritability and tears have led many parents to turn to what feels like a safe, natural solution: homeopathic teething tablets. Amazon, CVS, Target, Walgreens and most major retailers used to carry at least one brand of the tablets, which claim to give parents and babies relief from the agony of teething. The Food & Drug Administration recently carried out their own laboratory studies on the tablets and found that many had high levels of belladonna, levels far surpassing what the label described. According to the FDA’s report, belladonna is a toxic substance that affects the central nervous system with inconsistent results that puts infants and children at unnecessary risk.

FDA Not as Strict on Homeopathic Medication Regulation 

It’s important to know that the FDA does have a say over homeopathic medications. The labeling, distribution, and sale of homeopathic medications is largely up to the manufacturer, distributor, and retailer and although the FDA has the ability to step in and oversee the labeling of these products, it rarely has done so. While it is unclear why the FDA finally decided to intervene, they made a strong point by urging all parents to avoid teething tablets. So strong that the products have become relatively hard to find in recent weeks. It is unclear as to whether or not news of 10 deaths and 400 teething-tablet reactions reported to the FDA were before or after the message the Administration released in late January.

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It has become a frequent headline in newspapers and on t.v. news: Americans found slumped over the steering wheel or found at home, dead from an opioid overdose. In August, 174 people overdosed on heroin over 6 days in Cincinnati. In those cases, most had used heroin laced with carfentanil, a fentanyl derivative that is used for tranquilizing large animals, such as those kept at a zoo. So how do regulated prescription drugs such as these end up in the hands of those who can abuse them?

This past December, the CDC released data that showed opioid addiction is here to stay in the United States. In 2015, 52,000 people died from an opioid overdose and more than half of these tragic deaths were caused by a legally prescribed or illegally obtained prescription. With all the regulations in place for prescription drugs in the U.S., one has to assume that there is a failure somewhere in the distribution system. How else could it be possible that 33,091, or 63%, of all opioid deaths were due to prescribed medicines?

A Trickle Down Effect

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In January, the Food & Drug Administration (FDA) issued a Class I Recall for Normal Saline Flush syringes made by Nurse Assist Inc. The syringes have shown a direct link to an antibiotic-resistant bacterial infection known as Burkholderia Cepacia (B. Cepacia). According to the Centers for Disease Control, B. Cepacia is not threatening when otherwise healthy patients are infected. For those patients with compromised immune systems, the infection can develop into a severe respiratory illness, making it particularly dangerous for those who have lung diseases such as cystic fibrosis. The infection arises from soil and water exposed to B. Cepacia and spreads through person-to-person contact, making it hard to contain in healthcare environments such as hospitals and nursing homes.

Saline flush syringes are used after medication is delivered through an IV in order to keep the entry point sterile and prevent infection. The introduction of an infection such as B. Cepacia can have serious consequences.

Recall Specifics

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The Food & Drug Administration has recently issued a Class I recall for Standard Offset Cup Impactors with POM-C Handle, a device used during hip replacement surgeries and manufactured by Greatbatch Medical. These devices, used in hip replacement operations in the United States between July 30, 2004 and December 22, 2015, were found to have non-sterile parts, which can lead to serious infection and even death.  Greatbatch reported to the FDA that there were nearly 3,000 patients who had a hip replacement using one of their cup impactor devices.  To view the model numbers that are listed under the FDA’s recall notice, please click here.

How to Know If You Have a Case

As anyone who has experienced a major surgery knows, you hope for the best possible outcome and to wake up better off than when you entered the operating room. If a medical product or device fails to meet basic safety standards in a surgical environment, the impact can be life threatening.

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