Omaha Personal Injury Lawyer

Pradaxa Users: Be Alert to Symptoms of Excessive Bleeding

John Inserra — Fri, 11 May 2012 15:54:00 GMT

At the end of last year, Pradaxa users were alerted to the risk of excessive bleeding linked to the use of the drug. While this risk is generally associated with blood thinners used to treat non-valvular atrial fibrillation, the problem—as the FDA acknowledged—is that the rate of excessive bleeding incidents has turned out to be higher than expected for Pradaxa.

While patients should not cease taking Pradaxa without the supervision of a physician, they do need to be alert to early symptoms of problems with Pradaxa. These symptoms include:

Unusual bleeding from the gums
Frequent nose bleeding
Heavier than normal menstrual or vaginal bleeding
Severe or uncontrollable bleeding
Pink or brown urine
Red or black stools
Bruises that appear or get larger without a known cause
Coughing up blood or blood clots
Vomiting blood or vomit that looks like coffee grounds

If you are concerned about your use of Pradaxa, you should carefully discuss treatment with your physician. They should be able to carefully advise you about what symptoms to be aware of and how you can monitor your use of Pradaxa. In addition, Pradaxa is processed by the kidneys, which means that by assessing your renal function, a physician can monitor your dosage of Pradaxa.

Originally posted at InjuryBoard by John Inserra

Focus on Bicycle Safety during National Bike Month

John Inserra — Thu, 03 May 2012 17:00:00 GMT

May is National Bike Month, and this year the National Highway Traffic Safety Administration and AAA are teaming up to launch the annual “Be a ‘Roll’ Model” public awareness campaign, with a focus on bicycle safety.

The focus of the Roll Model campaign is to get parents, grandparents, older siblings and caregivers to commit to demonstrating safe bicycling habits every time they get on a bicycle. This means:

Riding and driving with focus—never getting distracted
Riding and driving prepared—always expecting the unexpected
Putting safety first—always wear a bicycle helmet
Following the rules of the road—remember that a bicycle is required to follow motor vehicle laws , including all traffic signs and signals
Sharing the road—all vehicle drivers, cars and bicyclists, need to be aware and respectful of one another

On that last point—about sharing the road—Nebraska recently passed an important piece of legislation that will help to make the roadways safer for both bikers and motorists alike. Known as the “3 foot passing law”, the legislation requires every vehicle to leave a clearance of three feet between their vehicle and any bicycle or electric assistive mobility device (such as a motorized wheelchair) when passing. That bill was passed on April 4^th.

This type of legislation that requires motorists to give bicyclists a safe distance when sharing the road is crucial to making our roadways safer and increasing the use of bicycles as a safe and healthy form of transportation.

Throughout the month of May, there will be several bicycle events across the country, including Bike to School Day on May 9; Bike to Work Week from May 14-18; and Bike to Work Day on May 18.

Originally posted at InjuryBoard by John Inserra

Be a Part of the Solution: Take the Pledge to End Distracted Driving

John Inserra — Thu, 19 Apr 2012 15:30:00 GMT

April is Distracted Driving Awareness Month. This year, there is a very simple message for drivers across the country: One Text or Call could Wreck it All.

We all know that with schedules to attend to, children to take care of, work responsibilities, keeping home life in order, and the countless other activities, most of us are in a constant juggling act. Multitasking has become our norm. And many of us are hardly ever seen without our cell phone in hand, always at the ready to respond.

But multitasking behind the wheel spells danger. It’s as simple as that.

As attorneys with years of experience working with car accident victims, we know how painful and disruptive an accident can be. That’s why we are proud to have teamed up with 60 for Safety in order to share the important message about distracted driving with high school students and young drivers. Already, we have reached nearly 1,000 young drivers at local high schools.

But the fight to end distracted driving doesn’t end with a speech in a high school auditorium and it doesn’t end with young drivers. All of us have a role to play in making our highways safer and distracted driving will only end when we all make a commitment to this very simple idea: no more using electronic devices while behind the wheel.

Now—during Distracted Driving Awareness Month—is the time to make that commitment. So we invite you take a very simple pledge that will have a big safety impact for you and your loved ones:

Distracted driving kills and injures thousands of people each year. I pledge to:

Protect lives by never texting or talking on the phone while driving.
Be a good passenger and speak out if the driver in my car is distracted.
Encourage my friends and family to drive phone-free.

Originally posted at InjuryBoard by John Inserra

Consumers left in the dark about Hyundai’s potential seat belt recall

John Inserra — Fri, 13 Apr 2012 17:00:00 GMT

Owners of Hyundai Sonata hybrid vehicles need to be aware of a potential seat belt recall that hasn’t received much attention in the news.

The issue is with model years 2011-2012 and involves the rear middle seat belt. When sold, the center rear seat belt in these vehicles included a release mechanism that detaches both the lap and shoulder portion of the belt at the lower anchorage point. This design does not meet Federal Motor Vehicle Safety Standards. Nearly 15,000 vehicles are potentially affected.

According to NHTSA information (see page 6 of the report), Hyundai dealers are replacing the center rear seat belts in the 1,600 vehicles in dealer inventory. But—and this is significant—they are trying to avoid taking any action with the 13,000 vehicles out on the road today. Hyundai Motor Company has filed a petition with NHTSA to avoid recall on the basis that “noncompliance…is inconsequential as it relates to motor vehicle safety.” While that petition is outstanding, Hyundai is not legally obligated to do anything for current vehicle owners. That means no owner notifications and no replacements or remedies until NHTSA has made its final decision.

It remains unclear what the non-compliant seat belt design actually means for vehicle safety or how a passenger would—or wouldn’t—be protected in a crash. But until those issues are resolved, consumers deserve to be aware that this issue exists and that it very well might be severe enough to warrant a recall.

Originally posted at InjuryBoard by John Inserra

Pradaxa linked to unexpectedly high number of fatal bleeding incidents

John Inserra — Tue, 03 Apr 2012 15:00:00 GMT

At the end of last year, the FDA caught the attention of thousands of patients when it issued new drug safety information concerning the link between Pradaxa and potentially deadly hemorrhaging. Pradaxa is a blood thinning medication that helps to reduce the risk of stroke for patients who suffer from a heart condition known as non-valvular atrial fibrillation. The drug was approved for use by the FDA in 2010, providing a substitute for the widely-used, but risky drug warfarin. But since then, a number of hemorrhaging incidents have called into question the safety of Pradaxa.

Atrial fibrillation (AF) is the most common type of persistent irregular heartbeat. Patients who suffer from this particular condition face a greatly increased risk of stroke. When the heart doesn’t beat strongly and regularly, there is a greater likelihood that a blood clot can develop and travel to the brain, which in turn results in a stroke. Often, patients with AF use medications like Pradaxa or warfarin to counter this risk. The anticoagulant drugs act as blood thinners to prevent clots from forming. Between obtaining FDA approval in October of 2010 and August of 2011, nearly 1.1 million Pradaxa prescriptions were filled in the United States.

But the use of blood thinners like Pradaxa carries its own risk: even a minor scrape or injury can quickly result in excessive and uncontrolled hemorrhaging. This was apparently known at the time of FDA approval, and studies even showed bleeding events occurred at the same rate for Pradaxa as compared to warfarin. But after Pradaxa went on the market, there has been higher rate of reported bleeding incidents than expected. The FDA continues to investigate why that is the case.

In the meantime, claims against the maker of the anticoagulant drug Pradaxa are starting to make their way into the court system. This last month, three plaintiffs filed suit in the United States against the German company that makes the drug, Boehringer Ingelheim. That company admits that in just one year of being on the market, Pradaxa was linked to 260 cases of fatal bleeding.

While the FDA investigation and litigation moves forward, patients are advised not to stop taking the drug without consulting their physician. But at the same time, patients need to be keenly aware of any adverse effects that indicate a bleeding problem:

unusual bleeding from the gums
nose bleeding that happens often
menstrual or vaginal bleeding that is heavier than normal
bleeding that is severe or you cannot control
pink or brown urine
red or black stools (looks like tar)
bruises that happen without a known cause or that get larger
coughing up blood or blood clots
vomiting blood or vomit that looks like coffee grounds.

Originally posted at InjuryBoard by John Inserra

The damage done by DePuy hip implants

John Inserra — Thu, 29 Mar 2012 09:20:00 GMT

It’s a fact of life: as we age, our bodies become less agile and aches and pains start to show up, sometimes leading to major changes in our quality of life. Activities once enjoyed become physically painful. Maybe because of injury, but often because of age-related conditions such as osteoarthritis or rheumatoid arthritis, our joints stop functioning as they once did and replacement surgery is suddenly on the table. Hip replacement surgery is one of the most common types of joint replacement procedures. Nearly 290,000 individuals each year undergo some type of hip replacement procedure, trying to restore their active lifestyles.

For such an invasive procedure that has a long recovery period patients hope it is a once-in-a-lifetime necessity. That’s why recalls like the DePuy hip implant system recalls are so scary. In August of 2010, DePuy Orthopaedics, a subsidiary of Johnson & Johnson, issued a global recall of two of its hip implant devices. (Information from DePuy about the recall is available here.) The recall included the ASR XL Acetabular System, which is used in total hip replacements, and the ASR Hip Resurfacing System, which is used in a procedure aimed at repairing—but not replacing—damaged hip joints.

The primary reason for the recall was an unacceptably high failure rate of the implant devices. Nearly 1 in 8 recipients of a DePuy product—or 12%—needed a second, corrective surgery within five years of receiving the implant. That rate of failure is nearly twice the industry average. Before the recall was issued, nearly 100,000 patients had received one of these two products and now face an increased risk of having to undergo a much more complicated revision surgery if their implant fails.

In the wake of this recall, literally hundreds of lawsuits across the country have been filed against DePuy. And as that litigation moves forward, additional issues are being discovered. One of those issues—that has caught significant attention in the news—is the risk that metal-on-metal implants in general pose. The DePuy products are metal-on-metal, meaning the both components that mimic the ball and socket joint of the hip are made of metal. The design idea was that using metal components would increase range of moment and be more durable and long-lasting than traditional materials. But the research has been showing that metal-on-metal devices instead pose serious risks. The friction between the metal components means that small amounts of metal are constantly released into the blood stream, which can cause severe reactions in patients. This too can lead to revision surgeries, or at the very least, life-long monitoring for adverse effects.

Suffice it to say that the DePuy hip systems have been a nightmare for many patients. If you are a recipient of one of these devices, talk to your physician and your surgeon to learn about any concerns that may need to be addressed or issues that you need to be aware of. And if you have already suffered the negative effects of the faulty product, you may have legal recourse.

Originally posted at InjuryBoard by John Inserra

HR 5 Treading on States' Rights

John Inserra — Wed, 14 Mar 2012 18:00:00 GMT

The unending tort reform battle continues, this time at the Federal level on Capitol Hill as Congress gets ready to debate H.R. 5, a bill that would establish federal limits on damages in medical malpractice suits.

Known as the HEALTH (Help Efficient, Accessible, Low-cost, Timely Healthcare) Act, the bill proposes to cap damages in medical malpractice suits and put in place other controls that will limit lawsuits in the medical malpractice field. Specifically, punitive damages under the bill would be capped at $250,000, while certain fees and payments to attorneys would be limited, among other reforms.

This tort reform language of the HEALTH Act has been lumped together with language that would repeal the Independent Payment Adivosry Board (IPAB) that is a crucial component of ObamaCare. And it is expected that the House could take a vote on the bill as early as next week.

Debates about tort reform are certainly nothing new, but the HEALTH Act takes things to a new level by introducing tort reform at the Federal instead of State level. That makes this particular tort reform effort a Constitutional issue that calls into question the powers of Congress and states’ rights under the 10^th Amendment in the Bill of Rights. In other words, under the 10^th Amendment, individual states retain power over everything that has not been specifically delegated to Congress. That includes the power that states have over their own judicial systems and tort law. Attempts by Congress to mandate specific tort law and tort damages overstep the boundary of Federal authority.

Tort reform is a contentious issue. There is hardly national agreement over whether any amount of tort reform is wise and if it is wise, what that reform might look like. And there certainly isn’t conclusive evidence that tort reform is the correct strategy for controlling the costs of health care in the country. Those are important issues to be decided for sure—but they are not issues that should be decided at the Federal level. Tort law is a state issue and so is tort reform.

Originally posted at InjuryBoard by John Inserra

Join us in a nationwide campaign to end distracted driving

John Inserra — Fri, 24 Feb 2012 17:00:00 GMT

Distracted driving—as we’ve written about before—is a leading cause of auto accidents, resulting in thousands of deaths and hundreds of thousands of injuries every single year. And like many auto safety issues, solving the problem of distracted driving means changing driver behavior and attitudes.

One reason that distracted driving is such a widespread issue is because it encompasses a wide range of activities that don’t all seem that risky. But any activity that takes away a driver’s full attention to the road counts as distracted driving: chatting with a passenger, adjusting the radio or climate controls, grooming, looking up directions, grabbing a meal in the car, and of course the much-discussed cell phone use while driving.

This last behavior—using a cell phone while driving—has gained nationwide attention, even including a federal recommendation for states to legislate against the use of electronic devices while driving. But distracted driving in general is an epidemic that needs serious attention. It isn’t a problem that can be solved by adding better technology or safety features to cars. Much like getting people to embrace seatbelt use or preventing drinking and driving, combating distracted driving requires more driver awareness and education.

That’s why Inserra & Kelley is proud to announce that we will joining up with hundreds of trial attorneys across the country in a nationwide effort to educate young drivers on the risks of distracted driving. The safety campaign is a joint effort of 60ForSafety and End Distracted Driving and hopes to reach out to more than 100,000 student drivers during the month of April. Volunteer attorneys will present educational and informative talks about the risks of distracted driving and offer simple steps that drivers can use to ensure that both they and those around them work together to end distracted driving.

In the Omaha-metro area, attorneys from Inserra & Kelley will be sharing this important message at high schools and with civic groups. We hope you will join this campaign to make our roads safer and make a personal commitment to eliminate your own distracted driving habits.

Originally posted at InjuryBoard by John Inserra

CPSC Launches Rulemaking Effort to Address Firepot and Gel Fuel Safety

John Inserra — Thu, 16 Feb 2012 07:10:00 GMT

Last summer and fall, decorative gel Firepots hit the news for a number of severe burn injuries—and even casualties—caused while using them. The number and severity of the injuries sparked a voluntary recall, the launching of an investigation by the Consumer Product Safety Commission (CPSC) and finally a mandatory recall involving nine different manufactures and 2 million units of gel fuels. Now, all of this is culminating CPSC action to more precisely regulate—or potentially ban—Firepots and gel fuels.

In December, the CPSC announced that it approved the publication of an advance notice of proposed rulemaking (ANPR), the first step in a rulemaking process aimed at improving the safety of gel fuels and firepots. The CPSC’s rulemaking efforts are in response to the high number of reported serious injuries and deaths related to the use of Firepots and Gel Fuels. The CPSC states in the ANPR that as of September 30, 200 it was aware of 76 incidents just between April 2010 and September 2011, resulting in 2 deaths and at least 86 injuries, with over half of the victims requiring hospitalization.

The background information provided in the ANPR details some of the most severe burn incidents involving Firepots and Gel Fuels, describing “explosion”-like events, creating “fireballs”, when consumers tried to refill an apparently empty pot while it was actually still burning. Other incidents involved explosions while trying to light the Firepot or exploding fuel containers. When these events do happen, the gel-like characteristics of the fuel make burns to the victims particularly severe and difficult to extinguish with normal measures like “stop, drop and roll” or using water.

While these products carry labeling warning that the product is a flammability hazard, the CPSC found that “these warnings do not effectively address the hazards posed by gel fuel.” Additional warnings about proper use, when they were used, were not obvious enough, instead being buried among a list of generic warnings. And, consequences were not clearly spelled out. The packaging and marketing of gel fuels—in water bottle-like containers advertising “eco-friendly” and “non-toxic”—likewise under-emphasizes the severe risks of these products.

Those are some of the issues that the CPSC is aiming to address. The rulemaking process may culminate in the issuing of a safety standard for this class of products or, if no standard can be said to be adequate, the CPSC could ban the products entirely. As part of that process and in addition to its own investigation, the CPSC invites public comment on the rulemaking process. For this particular situation, comments will be accepted until February 27.

Originally posted at InjuryBoard by John Inserra

Pfizer Recalls Birth Control Pills

John Inserra — Mon, 06 Feb 2012 17:00:00 GMT

On January 31, 2012, Pfizer announced a voluntary nationwide recall of a million packs of oral contraceptives. The recall affects both the brand-name Lo/Ovral-28, and the generic Norgestrel and Ethinyl Estradiol Tablets. Both of these drugs are marketed and labeled by Akrimax Rx Products, carrying the label of that company on the packaging.

According to the FDA press release announcing the recall, Pfizer took action after their own investigation revealed that some packages of the oral contraceptive may contain the incorrect amount of active-ingredient tablets and that the tablets in the packages may be out of sequence. The problem has since been remedied, but not before 28 lots of the drug were packaged and put on the shelves. The FDA announcement includes a list of all lot numbers that were affected. That same press release also has photographs to help patients identify if their product is included in the recall.

Typically these birth control pills contain 21 white pills with an active ingredient and then seven pink pills that are inert. The effectiveness of the contraceptives depends on the pills being taken in a specific sequence. Simply taking the pills in the wrong order—which is much more likely in the recalled packages—can eliminate the contraceptive effect of the pills and increase the likelihood of pregnancy. While there are no other health risks, the FDA advises users of the product to begin using a non-hormonal contraception immediately. In addition, patients prescribed these birth control pills should immediately notify their physician and return the product to the pharmacy.

Originally posted at InjuryBoard by John Inserra