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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.

SHOULD MOTORCYCLES HAVE A SPECIAL EXCEPTION TO RED LIGHTS?

The Nebraska unicameral is currently exploring a proposed bill, introduced by Nebraska State Senator Paul Schumacher, which would allow motorcyclists to drive through red traffic lights if the rider had already waited at least two minutes for the light to change.  Advocates of the proposed bill suggest that traffic sensors are not triggered as easily by lightweight motorcycles as other vehicles, causing a delay in the change of the light for motorcycles.

The bill, LB 85, was introduced and indefinitely postponed, however its proposal offers an interesting perspective regarding the ability of traffic lights to “sense” traffic weighing less than 1,000 pounds.  An additional element of the proposed bill requires no other cars to be present as well as the two minute delay prior to travelling through a red light.  Opponents of the bill argue that the law would be too difficult to enforce as it would be nearly impossible to keep track of the two-minute time requirement.  In 2011, Illinois suggested a similar measure for cities with populations of less than two million.  The Illinois law passed in 2012.  South Carolina also passed a similar law in 2008.  According to USA Today, at least seven other states already have similar regulations.

Although not everyone agrees with the length of time spent waiting for red lights, is there really a good argument to be made for allowing motorcycles special exceptions to the rules of the road?  Will these types of proposed laws increase traffic accidents caused by violation of red lights?  Will liability be more difficult to prove in cases involving a motorcycle which runs a red light?  These are all considerations the Unicameral will have to consider in debating LB 85, should it be reintroduced in the future.

GRANUFLO SIDE EFFECTS ENDANGER THE LIVES OF DIALYSIS PATIENTS

 

Hemodialysis treatment can be an efficient way to replace loss of function in the kidneys; however it can also cause a number of side effects, such as low blood pressure, muscle cramps, itching, sleep problems, anemia, bone diseases and high blood pressure.   Patients could also suffer from pericarditis, high potassium levels, stiffness and fluid in joints and depression.   Many of these side effects are a result of the loss of electrolytes during the dialysis process.  One treatment which is effective at reducing the side effects caused by loss of electrolytes is the use of Granulfo, a drug originally seen as a safe treatment option due to its lack of volatile chemicals. 

Unfortunately, GranuFlo also has some very dangerous side effects of its own, and was recalled in March of 2012 because it contains more of a substance which converts into bicarbonate in the human body.  This additional bicarbonate can lead to heart problems and cause side effects including death, heart attack, low blood pressure, low potassium in the blood, low levels of oxygen in the blood, excessive carbon dioxide in the blood and cardiac arrhythmia (irregular heartbeat).

In the early 2000’s, GranuFlo was seen as the safest dialysate on the market.  However, increased use of GranuFlo and its sister product, NaturaLyte, led to a rise in the number of cardiac arrest complaints by patients who were treated with its usage in early 2012.   At that time, the drug was deemed unsafe for human consumption due to the increased amounts of bicarbonate in the body. In February of 2013, a widow filed a lawsuit in Alabama Northern District Court alleging her husband suffered severe injuries, including cardiovascular death, after receiving Granulfo.  In March of 2012, the FDA published a Class I recall of NaturaLyte and Granulfo due to the high serum bicarbonate levels, causing metabolic alkalosis, associated with cardiac arrhythmia that had the potential to culminate into cardiac arrest.  In January of 2013, an additional lawsuit was filed in the Louisiana Eastern District Court alleging the plaintiff suffered heart attack and stroke as well as severe pain and suffering, following hemodialysis treatment with Granulfo and/or NaturaLyte.

Fresenius Medical Care, the manufacturers of Granulfo and NaturaLyte, owes the users of these drugs a duty of care.  If you or a family member were exposed to the use of Granulfo or its sister product, NaturaLyte, and suffered a cardiac arrest or developed serious heart complications you may be entitled to compensation.  Inserra & Kelley is proud to offer a free initial evaluation of your case.  Contact us today to start your claim evaluation.