FDA Recalls Stryker Spine Oasys Midline Occiput Plate

The United States Food & Drug Administration (FDA) has issued a Class 1 Recall on the Stryker Spine OASYS Midline Occiput Plate, used as an implant in spinal surgeries.  The recall was issued as a result of reported fractures of the pin that connects the implant’s tulip head to the plate body.   On May 30, 2013, Stryker, the maker of the implant, had issued an Urgent Medical Device Recall requesting medical facilities to immediately stop using or distributing recalled lots.  In June of 2013, Stryker notified spinal implant surgeons to begin routine clinical and radiographic post-operative evaluation for patients with an implant.

The FDA recommends an urgent evaluation if a patient with an implant begins to experience pain, weakness or numbness.   After revision, Stryker recommends routine post-operative care and follow-up.

Stryker has learned that in cases where a post-operative fracture occurs in the pin that connects the tulip head to the plate body, serious side-effects can occur, including blood loss, nerve injury and the necessity of a revision surgery to attempt to replace a fractured implant.  Affected products were distributed between April 23, 2010 and February 12, 2013 and include an estimated 1,536 units in the United States and another 880 abroad.

If you or a loved one has experienced any of the above symptoms, contact an attorney experienced in evaluating these types of claims.  Compensation recovered can help pay for medical expenses, lifestyle changes due to disability, economic and emotional damages.

Granuflo/Naturalyte Litigation Demonstrate Potentially Devastating Effects for Patients of Dialysis

On March 29, 2012, the United States Food & Drug Administration (FDA) issued a Class 1 recall of a popular dialysis drug called GranuFlo, along with its sister drug Naturalyte.  According to the recall, these products can lead to “a high serum bicarbonate level in patients undergoing hemodialysis”.  This could contribute to additional side effects such as metabolic alkalosis, a significant risk factor which has been associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which could also result in heart attacks or cardiopulmonary arrest.

Evidence that Granuflo/Naturalyte could lead to such serious and devastating injuries, up to and including death, during dialysis led the FDA to take action in the form of a serious recall.  Unfortunately, these drugs still remain on the market, despite the fact that lawsuits have begun to emerge based on the terrible effects of the drugs.   Although not inherently dangerous products, NaturaLyte and GranuFlo can become lethal when mixed and administered incorrectly.  GranuFlo is the only acetic acid containing drug that also has sodium di-acetate.  The sodium acetate gets converted into bicarbonate by the patient’s liver, which results in increased bicarbonate levels beyond prescribed limits and causes an increased risk of metabolic alkalosis.

DaVita Healthcare, a national dialysis treatment provider that uses both GranuFlo and NaturaLyte during hemodialysis, is currently facing four class action lawsuits in the US District Court for the District of Colorado resulting from the adverse health effects associated with improper use of the drugs.  Both drugs are made by Fresenius Medical Care.   Lawsuits brought against Fresnius Medical Care are based on allegations that Fresnius knew about the possibility of adverse effects from its products but failed to warn doctors and facilities outside of the company.

If you or a loved one has suffered adverse effects during dialysis, please contact an attorney experienced in evaluating these types of claims.  Compensation recovered can help pay for medical expenses, lifestyle changes due to disability, economic and emotional damages, as well as funeral expenses for the worst cases.

Nebraska Lawsuits Emerge from Cyclospora Outbreaks

The second lawsuit has now been filed in Nebraska stemming from a multi-state Cyclospora outbreak from salad mix served at Olive Garden Restaurants.  The lawsuit was filed in Lancaster County, Nebraska on behalf of a pregnant mother-to-be who dined at Olive Garden in Lincoln, Nebraska.  Symptoms include diarrhea, vomiting, nausea, fever and chills, dehydration, loss of appetite and related weight loss. Cyclospora is diagnosed through a stool sample and treated with antibiotics.  The multi-state outbreak has reportedly affected over 86 Nebraskans and 535 cases throughout 18 states.

 The salad mix has also affected those who have eaten at Red Lobster locations.  The Cyclospora parasite has been traced back to Taylor Farms in Mexico, which ships to both Olive Garden and Red Lobster locations.  The parasite is spread by ingestion of food or water contaminated with feces.   If you are suffering from the symptoms of Cyclospora parasite listed above and have eaten at Olive Garden or Red Lobster recently, see your doctor to have a stool test completed.  An attorney with experience in claims dealing with food-borne illness can evaluate your claim.

Appeals Court Grants Plaintiff Day in Court

The Nebraska Court of Appeals has granted the mother of a deceased 15-year old a chance to present her case to a jury, reversing the dismissal of a lower Court.  The case stems from a crossing accident in which the plaintiff’s ex-husband was traveling in a car along with his 15 year old son and drove onto train tracks in December of 2007, failing to adhere to the warning lights and oncoming train’s horn in December of 2007.

 The lower Court granted Union Pacific’s Motion to Dismiss based upon allegations that the negligence of the father was the sole proximate cause of the collision.  The plaintiff alleged that Union Pacific was also negligent by failing to remove the concrete signal base which the ex-husband’s vehicle was pushed into by the train upon impact.

 Although the lower court dismissed the case stating the state law in effect at the time of the crash required the father to be grossly negligent in order to be held liable for damages, the appeals court reversed the dismissal, stating a jury should decide the merits of the plaintiff’s claims that the concrete barrier constituted active negligence by Union Pacific.  The appeals decision stated that the matter of gross negligence was a factual dispute to be decided by the trier of fact, a jury.

Another Big Win for Vaginal Mesh Plaintiffs

The newest verdict in the lawsuits regarding vaginal mesh injuries brought an award of $250,000.00 in compensatory damages, in addition to $1.75 million in punitive damages.  However, under Georgia law, 75%  of the punitive damages award will be handed over to the state’s general fund.  The verdict sent a very clear message to C.R. Bard, Inc. that injuries caused as a result of defective products, failure to warn and “malice, fraud or wantonness” in mishandling of medical devices would not be tolerated.  Allegations in the case included egregious contentions that Bard officials put profits ahead of safety and ignored warnings about defects in the implants.   Bard argued that it had “no intent to harm” in the case.

In this case, the plaintiff’s injuries included perforation of her internal organs, vaginal scarring, pelvic pain, and pain during intercourse.  The damages to the plaintiff were so severe it required a revision surgery and caused significant negative impacts to her quality of life.

The New Jersey case is only one of more than 8,000 other claims against Bard.  Although an appeal is expected, Bard suffered a 1.7 percent drop in stock after the verdict.  This is the second large verdict against Bard, who suffered a $5.5 million verdict in California last year in the first ever vaginal mesh trial.  Under California law, Bard will only be liable for $3.6 million of the initial award.

Nebraska Supreme Court Rules Portion of Jury Award Taxable in Railroad Injury Case

In 2004, Eddie Heckman of Alliance was injured while working for Burlington Northern Santa Fe Railroad.  In 2011, Heckman was awarded $145,000.00 by a jury for his injuries.  Although the award was paid by the railroad, $6,200.00 was deducted for tax withholdings for the lost wages portion of the award.  Although the Box Butte County judge ordered the railroad to pay the award, and asked both sides to agree in writing that no amount of the award was considered wages, the railroad appealed.  The Justice Department filed an Amicus Brief as it alleged the ruling interfered with federal tax collection under the Railroad Retirement Act of 1974.

Heckman argued that the award had not been allocated, however the Supreme Court disagreed as lost wages were claimed in the lawsuit.  The Supreme Court found no authority to order the railroad to agree to an allocation of the settlement post-verdict.

Safety Precautions During a Traffic Stop

 

No one likes to get a ticket, but should you find yourself in the position of being pulled over by a Police Officer, it is important to know how to keep yourself and the Officer safe.  Remember that police get killed in traffic stops, usually as a result of a lack of safety precautions.  Pull over as soon as it is safe, but never stop on a curve or in an intersection.  Make sure you shut off your engine, stay in your vehicle and keep both hands on the wheel.  If you happen to get stopped at night, turn on the interior light.

You should keep your proof of insurance and drivers’ license easily accessible when you are in your vehicle, both for purposes of traffic accidents and safety stops.  However, do not get these items ready until the police officer asks for it.  If your insurance information is in your glove box or center console, make sure you tell the officer what you are doing before you reach for it.  If you have a concealed weapon in the vehicle, advise the officer of this and be prepared to present your concealed weapon permit.  If the officer does not advise you of why he or she pulled you over, it is okay to politely ask.  Make sure you are friendly, but respectful.  Never lie to an officer or be argumentative.  Do not make excuses, but you may offer explanations for any misunderstandings of the law.  Apologize for any traffic infraction and do not be confrontational. 

Remember that you are required to identify yourself during a traffic stop, but police do not generally have the right to search your vehicle without probably cause.  If an officer asks to search your vehicle, you do have the right to refuse under the fourth amendment to the Constitution.  You do not have a right to be physical with an Officer at any time.

Finally, you have the right to ask police questions regarding the traffic stop.  After the traffic stop, the Officer will return to his vehicle.  At that time, you are able to safely pull back into traffic.  Remember to signal when re-entering the roadway and consider the safety of other drivers as you resume your place in traffic.

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.