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Smith & Nephew Hip Implant Complications May Entitle You to Compensation

On June 1, 2012, Smith & Nephew initiated a voluntary worldwide recall of the metal liner in its R3 Acetabular System hip after a series of reports of loosening, pain, device failure, infection, metal sensitivity and dislocation in the hip replacement system.  Smith & Nephew is a London-based medical device manufacturer and the fourth largest manufacturer of hip implants in the United States.  The R3 Acetabular System was launched in the United States in 2009 and by 2012, over 7,700 devices had been implanted worldwide.  Unfortunately, the device experienced a higher than normal revision rate, with less than satisfactory clinical results as a total hip replacement device.  The device was marketed as durable and wear-resistant, however many of the implants have failed prematurely.

The Smith & Nephew R3 Acetabular System was alleged to have a design defect.  The implants have a metal liner made of cobalt and chromium, which release ions into the body.  These ions can cause tissue damage, destroy muscle and bone, and spread to other organs.  Cobalt also can cause heart muscle disease and bone or muscle deterioration around the implant.  As the muscles and bone deteriorate, the implants can loosen and cause the device to fail.  The complications can lead to metal poisoning as well.

Since the 2012 recall, numerous design defect and failure to warn lawsuits have been filed to compensate patients for actual medical cost, future medical expenses, loss of earnings and pain and suffering in the form of monetary compensation.  If you or a loved one has experienced device failure or complications from a Smith & Nephew R3 Acetabular System, you may be entitled to compensation and should have your case evaluated by a legal representative knowledgeable about these types of cases.

Do Men and Women Have Different Outcomes in Severe Traumatic Brain Injuries?

 

A recent IMPACT study to evaluate Traumatic Brain Injury (TBI) outcomes has disclosed that while age, race and education are all associated with outcomes, gender does not.  The IMPACT study analyzed Glasgow Outcome Scores at six months post moderate-to-severe TBI injuries.  Although past studies reported female outcomes with higher initial Glasgow Coma Scores and longer durations of post-traumatic amnesia, they also demonstrated equal Glasgow Outcome Scales post-rehabilitation.  At one year post-injury, women showed better memory and language skills, while men demonstrated better visual analytic skills. 

Gender differences with respect to injury, illness and outcome are not necessarily unique to TBI.    Several studies have shown decreased incidence of ischemic stroke in females, both in human work and experimental models.  In patients with subarachnoid hemorrhage, favorable outcomes were shown to be significantly better for females versus males at the 3 month follow up period and mortality was found to be significantly lower in one randomized clinical trial.

A 2010 study of Cornell University and Mount Sinai School of Medicine revealed that woman scored significantly higher than men on a test of visual memory after mile to severe traumatic brain damages.  Still, overall cognitive outcomes after Traumatic Brain Injuries does not differ according to gender, with the possible exception of memory functioning.

Serious Complications of Transvaginal Mesh in Over 11,000 Cases

Every surgery has risks, but complications with transvaginal placement of surgical mesh to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI) complications have caused serious injuries to thousands of patients.  According to the FDA, over 1,000 cases have emerged in the last three years, however there are over 11,000 cases pending against numerous companies.  Complications can include erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence.  Complications during insertion could also include bowel, bladder and blood vessel perforation during insertion.

Treatment of complications can include IV therapy, blood transfusions, drainage of hematomas or abscesses and even surgical revision surgeries to remove the mesh.

Several companies are facing thousands of lawsuits over the transvaginal mesh devices in state and federal courts, as well as in Canada.  One company, Endo Pharmaceuticals, Inc., has agreed to pay $54.5 million to settle some of the North American lawsuits and announced the settlement in a regulatory filing with the U.S. Securities and Exchange Commission.  In 2010, approximately 300,000 women underwent surgery for pelvic organ prolapse, with roughly one in three using mesh.  Approximately 260,000 women underwent surgery for stress urinary incontinence, 80 percent of which involved transvaginal mesh in 2010.  More lawsuits are expected to be filed in the coming years.

In 2012, jurors in Bakersfield California awarded $3.6 million in the first case over vaginal mesh devices.  They found the plaintiff and her husband were entitled to a total of $5.5 million due to medical expenses, pain, suffering and other damages resulting from her injuries.

In February, a jury awarded a South Dakota woman $3.35 million in compensation for her vaginal mesh lawsuit against Johnson & Johnson and an additional $7.76 million in punitive damages.  Her lawsuit was based on failure to warn and product misrepresentation and was the first verdict of the vaginal mesh lawsuits, alleging the product was defective in “design, manufacture, warnings and instructions”.   Her injuries led to 18 operations to repair the damage caused by the use of vaginal mesh.  Many other trials are scheduled against various manufactures over the next year that will set the parameters for future vaginal mesh settlements.

Patients who have experienced transvaginal mesh side effects may be entitled to compensation and should have their case evaluated by a legal representative knowledgeable about vaginal mesh cases as soon as possible since these cases have time limits which could bar claims not made in a timely fashion.

Is Flashing Your Headlights Protected by the First Amendment?

Have you ever warned another motorist approaching a speed trap by flashing your lights?  A driver in Ellisville, MO did and was ticketed for improper flashing of signals.  He chose to fight the ticket and refused to plead guilty, causing the Judge to ask him if he had heard of obstruction of justice.  Although the case was eventually dropped, the driver brought a civil rights lawsuit alleging that the act of flashing headlights constituted a form of protected speech.

In the face of ongoing public outrage over decreased privacy, this case alleged that the communication of flashing your lights was protected by the First Amendment.  The driver is being represented by the American Civil Liberties Union of Eastern Missouri, who claims this type of communication is no different than communicating the same message by radio or at a local gas station.

Other states have previously addressed this issue.  Tennessee and Utah have sided with drivers and in Florida, a state law was passed to ban prosecutions for flashing headlights.  Do you agree this rises to the level of free speech, or is it obstruction of justice to warn other drivers of impending speed traps ahead?

 

Are You Aware of the Risks of Your Generic Medications?

Thanks to a Petition submitted by Public Citizen to the Food and Drug Administration (FDA), a change may be coming in generic drug labeling.  At the present time, FDA regulations prohibit generic manufacturer’s from updating a product’s safety label too efficiently, creating a safety gap, as potential health risks may not be available to the public on a timely basis.

The new proposed rule would allow the safety information to be disclosed to the public while the FDA reviews the information.  With the current rule, generic or prescription name brand drugs can be on the market for several years before serious safety hazards are discovered, leading to doubts about whether the amount of time a drug has been on the market has anything to do with the safety of the drug.  Unfortunately, generic drugs, with lower prices, usually cause manufacturers to stop producing the name-brand drug, making the manufacturer less informed about the latest hazards of each drug.

In 2009, the Supreme Court issued a ruling which allowed people who are hurt by a brand-name drug to sue the manufacturer for damages.  However, in June of 2013, the Supreme Court issued an opinion stating an injured person does not have the right to sue for damages caused by the design of a generic drug.  Coupled with the 2011 Supreme Court decision that shielded generic manufacturers from lawsuits regarding improper labeling, an injured person has almost no recourse if the damages were caused by a generic drug.  The one exception to the rule would be for a company that has a flaw in its manufacturing process.  There is a small group of Senators who have proposed changing the FDA regulations so consumers are able to sue for damages caused by generic drugs.  Unfortunately, due to the recent Supreme Court rulings, there is currently very little accountability for generic drug companies.

CALIFORNIA JUDGE REJECTS JOHNSON & JOHNSON’S DEPUY ORTHOPAEDICS REQUEST FOR A NEW TRIAL

A California Judge rejected DePuy’s request for a new trial, after a jury decision handed down in March left the medical device maker with an $8.3 Million award in a Los Angeles court.  The case was the result of the first Complaint to go on trial over the hip implants, which were alleged to be defective and improperly designed, manufactured and marketed.  The Judge denied the request as the Plaintiff had provided enough evidence to establish the products were defective in design according to Law360.com.  The lead physician designer of the product told jurors in the trial that he wouldn’t implant the device today.

In the second trial in Illinois, Johnson & Johnson’s DePuy was found not liable for any damages. DePuy defended the lawsuit by alleging the Plaintiff’s damages were not caused by the alleged failure of the medical device or design flaws, but rather from the Plaintiff’s own health issues.  Although the two verdicts were dramatically different, there remains good settlement value for remaining cases, some of which are estimated to bring settlements as high as $500,000.00.  DePuy Orthopaedics issued a voluntary recall for the ASR XL Acetabular Hip System in August of 2010.

This initial case leads over 900 complaints about the hip implants stemming from nearly 11,000 similar cases, which have been filed in a Multi-District Litigation case in the District Court for Northern Texas.

Can Depression Medication Decrease Your Pain Levels?

Although doctors have been prescribing antidepressants for pain for years, this practice is becoming more frequent.  The use of Cymbalta has been shown to be effective in certain cases of pain where anti-inflammatories, muscle relaxers and physical therapy have failed.  Cymbalta blocks pain signals making it the only antidepressant currently approved by the Food and Drug Administration for chronic musculoskeletal pain.  The drug is used largely after the healing process has begun in order to shut down continuing pain signals, sometimes described as chronic pain.

Antidepressants are classified on how they work and their chemical structure, which is why the antidepressants are moderately effective for the treatment of pain.  The dosage is started at a low dose and slowly increased, however is generally lower in dose than that prescribed for depression.  Normally, patients suffer few side effects from the use of antidepressants for pain.  If you think you may benefit from the use of antidepressants for your pain, consult your treating physician.

Chrysler Recalls Over One Million Jeep SUVs

CHRYSLER RECALLS MORE THAN ONE MILLION JEEP SUVS
The National Highway Traffic Safety Administration formally requested Chrysler to recall up to 2.7 million Jeep Grand Cherokee and Jeep Liberty SUVs in early June. At that time, Chrysler refused to initiate a recall, however last week the auto maker announced a safety recall on more than one million Jeep SUVs. The alleged problem is the location of the fuel tanks behind the rear axle, which causes a potential fire risk in a rear end crash. Although it appears that Chrysler’s opinion on the recall had changed, they actually ended up making a deal with the NHTSA which allows Chrysler to recall fewer vehicles than initially requested, while making no admission of a defect in the vehicles. This could make it more difficult for anyone involved in a fire or crash to sue Chrysler.

The agreement also does not require Chrysler to develop any new components. Chrysler has made concessions as well by agreeing to recall nearly 1.6 million vehicles, rather than fighting the action in Court. Chrysler won a similar lawsuit in the 1990s, however they no longer have the strength of brand that Ford and Toyota do, so they are not in as strong of a position to fight the recall. Whether the decision to compromise was made to avoid bad publicity, or out of concern for the consumer, Chrysler has agreed to address the problem.

How real is the danger if you have one of these vehicles? The Center for Auto Safety has documented at least three cases where young children in car seats died in a blaze after a Jeep was rear-ended. While Chrysler and the government work to resolve the issue of the recall, Inserra & Kelley urges you to keep an eye out for recall notices for your vehicle.

CYCLIST ASSISTED BY OMAHA CYCLING COMMUNITY

It is inspiring when we get to read about, or even experience the kindness of strangers, but even better when you live in the city and are able to experience that kindness firsthand by someone who shares your passions.  In Omaha, cycling has become a passion shared by many, and the City of Omaha has taken that passion seriously, especially in recent years as new bike lanes have been added to give cyclists even more opportunities to stay healthy and enjoy their passion.  Unfortunately, cyclists still must use the street system for commuting, accessing the trails, recreational trips and other purposes.

On May 20, 2013, Thomas Burbach was using the street system on “L” Street to train for RAGBRAI, the annual bike ride across Iowa, when he was struck by a car, which immediately sped away.  Thankfully, he survived, despite massive injuries and complications from those injuries and is grateful to a fellow cyclist, Marshall Stewart, for stopping to render aid.  Mr. Stewart called 911, issued emergency first aid to prevent shock and distracted him from pain while they waited for an ambulance.  But Stewart wasn’t the only cyclist to come to Burbach’s aid after his hit-and-run.  The local cycling community has offered support and donations to help with his medical bills.

As much as the City of Omaha has progressed and decreased the number of bicycle-vehicle crashes since the 1990s, there are still around 250 per year.  According to Craig Kelley, co-founder of the Dundee Chain Gang Cycling Club and accident attorney, the new bicycle lanes in Omaha offer more room for bicyclists, but care and attention is still a priority for motorists in order to avoid accidents such as Mr. Burbach’s.

Inserra & Kelley wishes Mr. Burbach a quick and complete recovery!

TORNADO SAFETY IN THE MIDWEST

 

It was March 23, 1913.  Five twisters across Nebraska and Iowa killed 115 people in total.  At this time, there was no such thing as a tornado warning .  In fact, the first tornado warning system was made by United States Air Force Captain Robert C. Miller and Major Ernest Fawbush on March 25, 1948.  Time and technology brought sophistication to the tornado warning systems and today, Doppler weather radar can detect rotational funnel cloud formations earlier than is typically possible by trained spotters.  On May 29, 2013, the National Weather Service reported nearly a dozen tornadoes in south-central and southeastern Nebraska, however reported no injuries, which speaks volumes to the advances in warning systems.

Growing up in rural Nebraska, I learned at a very young age the dangers of the devastating winds and tornadoes.  I remember being ordered to the cellar when the warnings would come on our small television, where we could find blankets, a radio, flashlights and yes, even an old camping lantern and some matches and would wait out the storm.  Today we receive our warnings much more efficiently with the invention of computers and the internet, but how many of us actually know how to prepare for a tornado or stay safe once one is forecast?  The American Red Cross not only responds to these disasters, they offer safety tips and a free lifesaving tornado application available for download on the iPhone and Android.  Just search for “Tornado by American Red Cross” in your applications store.

You can prepare for a tornado by gathering important emergency supplies, such as food, water, medications, batteries, flashlights, and a portable radio.  If you are in a tornado watch, you will want to keep a close monitor on the television, internet or radio for updates that may warn you when your tornado watch is upgraded to a tornado warning.  A tornado watch means that conditions are favorable for a tornado, while a tornado warning means a tornado or funnel cloud has actually been sighted.  It is important to know the signs of a tornado.  Look and listen for a strong, persistent rotation in the cloud base, whirling dust or debris on the ground under a cloud base (as some tornadoes have no funnel), hail or heavy rain followed by either a dead calm or a fast, intense wind shift, or a loud continuous roar or rumble which doesn’t fade in a few seconds like thunder.

When a tornado is approaching, you should immediately take shelter in a basement or first-floor room or hallway.  Avoid windows and large, open rooms (such as a gym or an auditorium).  Seek protection by getting underneath large, solid pieces of furniture, such as a mattress or a solid oak table.  Avoid automobiles and mobile homes and if you do happen to get caught outside, lie flat on the lowest ground you can find while you wait for the storm to pass.  Avoid seeking shelter under bridges, as there can be deadly traffic hazards while the bridge actually provides very little protection against flying debris.  Stay away from trees, as they can be picked up by the tornado and tossed.  Most importantly, do not panic.  Crouch down and cover your head when you have found your safe place.  Tornadoes are a frightening reality of living in the Midwest, however if you stay alert, prepared and calm, you have a better chance of surviving the storm.