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.