Merck: Another Big Win For Big Pharma

shutterstock_1107829731-300x207In a recent federal court ruling, pharmaceutical drug manufacturers may now defend themselves against product liability lawsuits through preemption, which means that the FDA’s approval of a drug outweighs any state law claims questioning safety, effectiveness or labeling.

In 2009, the US Supreme Court allowed a Vermont woman to sue Wyeth (now owned by Pfizer) because the drug manufacturer didn’t include adequate warnings on the nausea drug Phenergan, which was administered to her by IV and caused her to lose part of her arm. She won the suit because there was no evidence the FDA would have disallowed a stronger warning had Wyeth chosen to put one on its label. But the court also said that if a drug manufacturer can prove the FDA would not have approved a labeling change, it would be impossible to adhere to both the agency’s requirements and a state law’s finding for a stronger warning.

Believe it or not, Merck won just such a case when a federal court judge determined that the drug manufacturer had tried to include a stronger warning on the drug Fosamax, used to treat osteoporosis. Merck claimed it had attempted to update its label to include a potential link between Fosamax and femur fractures, but the FDA didn’t approve the warning. Bernadette Glynn, a 58-year-old school teacher in upstate New York had taken Fosamax and suffered a fracture the following year. But there’s the catch: Merck’s attempt to update its warning occurred just prior to Glynn’s claims against the manufacturer, and she lost her case in court.

Last month, US District Court Judge Joel Pisano said that “preemption is warranted, because there is clear evidence that the FDA would not have approved a change to the precaution section of the Fosamax label prior to Mrs. Glynn’s fracture.” The FDA had sent several emails to Merck in 2009 warning the manufacturer that Fosamax may be considered “misbranded” if labeling changes were made prior to FDA consent. So in its usual incompetent fashion, the FDA’s procedures take precedence over public safety. It wasn’t until 2010 that the American Society of Bone and Mineral Research issued a report to the FDA to require Merck and other companies with similar drugs to Fosamax to strengthen their warnings to include a possible link between bisphosphonate drugs and femur fractures.

This ruling is disturbing, to say the least. It means the door is left open for drug manufacturers to use preemption as a ploy to avoid responsibility for their actions. However, according to a former FDA associate chief counsel and a former senior corporate counsel at Pfizer. “It is hard to know how many such circumstances there are out there. Certainly, pharmaceutical companies are trying to pigeonhole their cases into the “clear category” left open… In fact, the Supreme Court did not tell us in Wyeth v. Levine what quality and quantum of proof is needed to provide ‘clear evidence that FDA would have declined to approve a label change. So it is impossible to know exactly what impact the loophole will have going forward. While the Supreme Court majority in Wyeth v. Levine left this possibility open, I think they saw it as a very narrow opening that, presumably, would not apply in all that many cases.” Perhaps he’s right, but with a slew of high-powered, overpaid attorneys and political lobbyists on the side of Big Pharma, your guess is as good as mine.

Seating Mattered In Asiana 214 SFO Plane Crash

In The News

Just last Saturday, Asiana Flight 214 crashed at San Francisco International Airport. This horrible tragedy might further instill fear in those who hate to fly and make us all wonder if the skies are truly as safe as we’re told. On the other hand, it teaches us that even these types of crashes are survivable.

Over 300 people were on-board when the plane crashed on the runway and caught on fire. Sadly, two 16-year-old girls from China were killed and 181 people were injured, with at least 22 in critical condition.

According to the National Transportation Safety Board, only one in 1.2 million flights result in accidents. That’s not much comfort for the families of the deceased and survivors of the crash. However, what is comforting is the safety precautions airline passengers can take to prepare for such situations that could make the difference between life and death.

Professor Ed Galea of the University of Greenwich has 30 years’ experience researching how people react in emergencies, and says the seconds before the crash are the most important – and most dangerous. He claims we’re responsible for our own lives in such instances, and if we know what we’re doing, we have a far better chance of survival.

A major factor to determining your fate in such a crash is to sit as close to an exit as possible. Galea studied seating charts of over 100 plane crashes and interviewed numerous survivors. His research shows that survivors move an average of five rows before exiting to safety from a plane crash. Seats in the rear of the plane and aisle seats are also safer. And as people tend to “freeze up” in emergency situations, being prepared in advance for a crash can help trigger them to take the steps necessary for survival.

In 2012, the Discovery Channel filmed a test crash of a Boeing 727 in the Sonoran Desert that revealed bracing for impact increases your chances of surviving a crash. The plane was equipped with crash test dummies as passengers and some brave human pilots who bailed out of a hatch in the back of the aircraft just minutes before the crash. During the crash, the dummies seated near the front were the first hit, with the first seven rows being considered “fatal” incidents. Those sitting within five rows of an exit gave passengers the best chance of survival and/or escape. Also according to the test crash, flying debris could play a role in injuries and deaths of passengers sitting upright.

Ben Sherwood, author of “The Survivors Club – The Secrets and Science That Could Save Your Life” and president of ABC News says that most accidents happen within the first three minutes of takeoff or the eight minutes before landing. If you have a plan, pay attention, and act upon what you know, your chances of surviving are much better.

In recent years, the aviation industry has beefed up its protection for passengers with stronger seats, more flame retardant plane parts and improve firefighting techniques. Despite this most recent crash, there’s really no need to worry about flying if what the experts say is true. According to MIT International Center for Air Transportation Director John Hansman, Jr., “Riding on a commercial airplane has got about the same amount of risk as riding on an escalator.” Still, plane crashes do happen and can be horrific, as evidenced by Asiana Flight 214.

Monster Overdose: Are Energy Drinks Killing Teens?

Alex Morris died suddenly this year from cardiac arrest at the age of 19. He habitually drank two cans of Monster Energy® drinks each day for two years. His mother Paula believes energy drinks were the cause and immediately filed a lawsuit against Monster Beverage Corp. on June 25, 2013.

This is not the first time that Monster Energy® drinks have been sued as the cause of death for teenagers. The FDA (U.S. Food and Drug Administration) has reported as many as 5 deaths between 2009 and 2012 could be linked to Monster’s energy drinks. The FDA also linked 5-Hour Energy® drinks with 13 deaths.

Another popular highly caffeinated drink to make the news is Four Loko® – a caffeinated alcoholic malt beverage. This drink sent tons of teens to the hospital. After the FDA stepped in the company dropped caffeine from its products.

In an attempt to avoid negative publicity, Monster® has re-branded its energy drink as a ‘beverage’ instead of a dietary supplement so they no longer have to report deaths associated with the drink to the FDA. What a clever ploy – and one the FDA is likely to buy hook, line and sinker.

Over 20,000 ER visits 2011 involved energy drinks. However the FDA still doesn’t have to regulate energy drinks other than those that combine caffeine and alcohol.

A few US senators are now calling on the FDA to start regulating energy drinks. And the American Medical Association, which represents 225,000 U.S. doctors, has demanded that the Federal Trade Commission ban marketing of energy drinks to kids. This should get interesting.

If you or your child has been injured by a defective product, contact the expert Dallas product liability attorneys at Reyes Browne Reilley today. Consultation is free!

Monster Energy is a registered trademark of Hansen Beverage Company, Corona CA. 5-Hour Energy is a registered trademark of Innovation Ventures LLC (Living Essentials) Walled Lake, MI.

Generic Wellbutrin XL Antidepressant Recall

shutterstock_98508260-300x200If this post doesn’t spell out how truly incompetent the Food and Drug Administration is, nothing will. Last week, the FDA recalled the 300mg generic version of Wellbutrin XL. Why? Because it simply doesn’t work. What’s worse (but not surprising) is that the problem with this drug has been around for several years but the FDA chose to ignore it.

As is the case with many other generic drugs, the FDA approved this one with no testing whatsoever. The generic version of Wellbutrin XL comes in 150mg and 300mg doses. Apparently the 150mg dose works just fine. So keeping in line with their lackadaisical attitude toward consumer safety, the FDA made the assumption that if one dose works, the other obviously will too. The 300mg dose is prescribed for patients who have severe depression and anxiety. It was released on the market in 2006. Shortly thereafter, the FDA began receiving numerous complaints from patients.

The FDA is supposed to approve drugs based on its own studies. Instead, it often relies on manufacturers for this task. In this particular instance, Teva, the marketer of the drug which is manufactured by Impax Laboratories, was instructed to do the trial and didn’t, claiming “slow patient enrollment” as the reason. So in 2010, four years after approving the generic, the FDA did its own study which was completed last year. The study concluded that the 300mg dose of the generic version of Wellbutrin XL is ineffective because it doesn’t deliver enough of the drug.

The organization’s press release stated that “FDA has approved five generic versions of Wellbutrin XL 300 mg. Each of these generics was approved based on bioequivalence studies comparing the 150 mg strength of the products to Wellbutrin XL 150 mg. Studies were not performed directly on the 300 mg strength of the products. Rather, the bioequivalence studies were performed using the 150 mg strength, and the results were extrapolated to establish bioequivalence of the 300 mg product. FDA has determined that this approach is no longer appropriate to establish bioequivalence of 300 mg bupropion hydrochloride extended-release tablets to Wellbutrin XL 300 mg, and the Agency is revising its guidance to industry for how to conduct premarket bioequivalence studies in generic bupropion products.” The wording of the above implies that it WAS appropriate to make assumptions regarding generic drugs’ effectiveness, but is no longer. Not only was it totally inappropriate, it is appalling.

Antidepressants are normally prescribed at the minimum dosage and “ramped up” gradually to a higher dose. Imagine the repercussions for patients who took the 300mg dose. Many of these people have Major Depressive Disorder and experience severe symptoms of depression, including suicidal ideation. So one can only speculate that they felt not only disappointment, but complete despair when the 300mg dose made them feel no better or their symptoms continued to escalate.

Big Pharma and the FDA can’t continue with their current practices without serious backlash. Hopefully members of Congress will soon understand that if they don’t force regulation and oversight, their own careers may be in jeopardy as one day, the general public will no longer stand for allowing drug companies and the FDA to play Russian Roulette with their health.

Supreme Court Rules Against Generic Drug Lawsuits

supreme-court-rules-against-generic-drug-lawsuitsBig Pharma just keeps getting bigger and bigger, while the FDA grows more and more incompetent. Drug lobbyists have a powerful hold on our government and I don’t imagine that will change any time soon.

Just this past Monday, in a 5-4 ruling, the Supreme Court ruled that people injured by dangerous generic drugs cannot sue manufacturers over pulling those drugs from the market. But this is just another nail in the coffin for patients’ rights. A previous Supreme Court ruling protected generics from almost all lawsuits over their warning labels, while some states continued to allow lawsuits over product safety itself.

This most recent ruling concerns a woman whose skin burned off and turned into an open wound, resulting in permanent disabilities caused by a generic painkiller. Because the painkiller was approved by the Food and Drug Administration (FDA) which warned about the dangers of this drug, as did its label, lawyers for the drug company and Justice Department argued that her case should be “preempted.” They claimed that federal laws require the FDA to balance risks against benefits of drugs, and juries should not be allowed to question the FDA’s “expert” determinations. What expert determinations? So many drugs have been approved by the FDA only to be taken off the market due to serious injuries incurred by their victims. When doctors prescribe these drugs, they don’t tell patients, “Okay, I’m going to prescribe this drug, but you should know you may be seriously injured by it.” From our experience in personal injury law, rarely are patients warned of ANY risks. They rely on their doctors to make decisions on which drugs are safe.

But where do doctors get their information? From the drug companies, of course. Pharmaceutical reps are literally “drug peddlers” who give doctors free samples, espousing the fantastic benefits of the drugs they sell. I would venture to say that many doctors don’t take the time to research the dangers of these drugs for themselves.

Additionally, the FDA is so underfunded and incompetent, the organization only tests a fraction of drugs on the market. And they do a highly ineffective job, as previous posts to this blog have indicated. So for attorneys to claim that jurors should not question the FDA’s “expert” determinations is, in a word, absurd.

Justice Sonia Sotomayer had a dissenting opinion (and one with which I agree). She said the company had the option to stop selling the drug altogether. But unfortunately, majority ruled and the Generic Pharmaceutical Association praised that ruling. According to GPhA President Ralph Neas, “The experts at the FDA alone have the scientific knowledge, regulatory experience, and complete data to make these decisions.” That statement would be laughable if it wasn’t just plain sad.

Crash In Burleson Texas Kills 4 and Injures 9

burleson-crashAs is far too often the case, police believe alcohol was involved in a four-car crash this past Saturday. The incident happened just before midnight on Burleson Retta Road and caused so much destruction that police closed off a quarter-mile of road with crime tape and police cars until Sunday afternoon.

A youth pastor was one of four people killed in this horrific four-vehicle collision. Sadly, Brian Jennings and two other “good Samaritans” were trying to help a stranded vehicle when another driver hit it on the dimly lit country road. Nine people were also injured and two of those are in critical condition. According to Linda Caram, the crash was so loud, her husband and she thought it sounded like an explosion. They literally had car parts scattered across their driveway. After hearing the crash, Linda and her husband received a call from a neighbor saying his wife and daughter were among those killed.

Although the names of victims have not yet been released, Alsbury Baptist Church confirmed that its youth minister Brian Jennings was among those killed. Jennings was a father of three, and had just left a party held in honor of his oldest son, who had graduated from Centennial High School in Burleson. Jennings was once a troubled teen who had turned his life around as an adult by helping others. Brian apparently loved video games, board games, dancing and making people laugh.

A mother and her adult daughter were also trying to assist the disabled vehicle when they were killed. The daughter was home visiting from nursing school. Her father had gone inside the home to bring in a mailbox that was destroyed in the crash. When he returned, he found his wife and daughter dead.

Three vehicles, including the disabled one, were in the westbound lane. The fourth car was headed when the crash occurred. Authorities are still investigating whether alcohol was a major factor in the crash.

If you have sustained injuries from a car or truck wreck, you may be entitled to compensation. Contact the the premier auto accident attorneys in Dallas at Reyes Browne Reilley Law Firm at 214-526-7900, or submit the short case review form on the right. Remember – you’re under no obligation to use our services, and we charge nothing if you do not win your claim.

Texting While Driving Is Deadly

Savannah-nash-300x167I’m not sure even where to start writing here. As a mother I was heartbroken to hear the news of the young sixteen-year-old girl named Savannah Nash who died this weekend as she ran her car into a tractor-trailer — an accident that investigators have found most likely was caused by her texting while driving. I cannot imagine the grief her parents are going through, but I can imagine that they likely warned her not to text and drive. I also realize young people rarely think anything bad will happen to them. I was young once too, and I know I didn’t always listen to warnings of danger either.

Now as a parent, my greatest fear is my children not listening to me about the dangers of distracted driving, although I warn them regularly. In fact, just last week after blogging about the staggering statistics of the dangers of texting and driving, I shared with my children the information I learned, hoping that if I continue to remind them enough, they will understand the serious nature of this issue. Specifically, I told them as we were driving down the highway at 55 mph that if I sent a text at that exact time it would be the equivalent of my driving the same speed blindfolded down the length of a football field. I figured it was a statistic they could understand.

I never imagined that so soon after, I would be following up that conversation with the news of young Savannah Nash’s driving accident. The fact is that however difficult it was for me to tell them about what happened or to write about it now, I hope that if I remind people to wait to answer that one text or email, everyone will understand.

While I’ve always known texting and driving was dangerous, my fear of the consequences has escalated greatly now that in my law practice I work with attorneys who represent people injured by distracted drivers. I see too often the devastation it can cause, yet each time I hear of another texting/driving tragedy, I am deeply saddened.

Savannah Nash will now be a poster child for the dangers of driving and texting – a role no one should ever have to take. Her parents simply let her drive to the grocery store at 4 in the afternoon; that was all. Her story reminds us that life is so fragile, and cars, while necessary and practical, are dangerous when people do not focus their full attention on driving.

I cannot repeat enough that distracted driving leads to nothing good. Distracted driving is an actionable crime and exponentially increases the likelihood of death or injury from a car accident. Please do not text and drive. We do not need any more examples like the one we got this weekend of why it is so dangerous.

If you or someone you care about has sustained injuries from a distracted-driver car or truck wreck, you may be entitled to compensation. Contact the tenacious DFW car crash attorneys at Reyes Browne Reilley Law Firm at 214-526-7900, or submit the short case review form on the right. Remember – You’re under no obligation to use our services, and we charge nothing if you do not win your claim.

Transvaginal Mesh and the Wall Street Journal

shutterstock_75459268-200x299The Wall Street Journal put out a timely article today entitled “Outcomes are Mixed for Pelvic Procedure”. I say timely because the product-liability lawsuits against five manufacturers of transvaginal mesh are in full swing, and as a female attorney who is handling mesh cases, this article most definitely caught my eye when it quoted a study published in the Journal of American Medical Association finding, “long-term benefits are limited for women who undergo an operation to treat a common condition called pelvic organ prolapse, which can lead to urinary problems and discomfort.”

The Journal explained that women facing Pelvic Organ Prolapse or “POP” discover that their uterus or vaginal walls have dropped post childbirth. In an attempt to cure women, doctors have surgically implanted synthetic mesh into the vagina to prop up or anchor female organs. POP also affects women whose bladders have fallen as a result of childbirth or menopause. Many women also have had surgery using the same synthetic mesh to sling up their bladders as a means to cure their incontinence.

Unfortunately, I have found when talking to countless women suffering from the aftermath of transvaginal mesh surgeries that the mesh actually exacerbated their incontinence rather than eradicating it. I also have found that not only do the women have increased problems with bladder function, but they also face regular urinary tract infections, ongoing yeast infections, and constant pelvic pain. Some women actually feel the mesh falling out through their vaginas. Other women are now celibate because of the pain the mesh causes them during intercourse. Innumerable women have told me that they are unable to leave their homes for long periods of time for fear that their “diapers” they are now having to wear will leak when prior to the surgery they did not have such problems. So while some may say that the “outcomes may be mixed” for women having transvaginal mesh surgery, it seems to me that the problems greatly outweigh the promised benefits of its use.

Reyes | Browne | Reilley is currently helping hundreds of transvaginal mesh and bladder sling victims and their families recover damages from their devastating TVM complications. If you or someone you know suffered injuries from this product, please call us and speak to a trial-ready medical device lawyer for a complementary and confidential consultation. You are under no obligation to use our services. Call us today at 214-526-7900, or submit the short case review form on the right.

Lower Drunk Driving Threshold To .05 Blood Alcohol Level?

shutterstock_13811443-300x200According to the Associated Press, a federal safety board just recommended that states should cut their drunken driving threshold by nearly 1/2, from .08 blood alcohol level to .05. Apparently research shows that the .05 standard has significantly reduced deaths in other countries. In fact, over 100 countries have adopted this .05 standard. Within ten years in Europe, traffic deaths related to drunken driving were reduced by more than half. So what does a .05 alcohol level mean to drivers? It means a woman weighing less than 120 pounds can get a DUI after one drink, and a man weighing 160 pounds can be hauled off for two drinks. A drink is considered 12 ounces of beer, 4 ounces of wine or 1 ounce of 80-proof alcohol.

The National Transportation Safety Board indicated it didn’t intend to prevent drivers from having a glass of wine with dinner. However, if one does have a drink or two, the safest bet is to not drive. The fact is that alcohol concentration levels as low as .01 can impair driving performance. Levels as low as .05 substantially increase the risk of fatal crashes, said the NTSB.

Jonathan Adkins, an official with the Governors Highway Safety Association said, “It was very difficult to get .08 in most states so lowering it again won’t be popular. The focus in the states is on high blood alcohol content offenders as well as repeat offenders. We expect industry will also be very vocal about keeping the limit at .08.” The term “industry,” of course, means the alcohol industry which has a huge lobby in government.

The Insurance Institute for Highway Safety estimated that 7,082 deaths could have been prevented in 2010 if all drivers on the road had blood alcohol content below .08. As this story unfolds further, it will be interesting to see how far the NTSB’s recommendations get at the state level. But the fact remains, drunk drivers need to stay off our roads at all costs.

If you or someone you care about has sustained injuries from a drunk driving accident in Dallas, you may be entitled to compensation. Contact the Dallas auto accident attorneys at Reyes Browne Reilley Law Firm at 214-526-7900, or submit the short case review form on the right. Remember – You’re under no obligation to use our services, and we charge nothing if you do not win your claim.

Zolpidem (Ambien) ER Visits On The Rise

ambienZolpidem is a prescription sleep medication that is sending more and more people to emergency rooms from its serious side effects. Never heard of Zolpidem? Well, I bet you’ve heard of Ambien. Zolpidem is the active ingredient in Ambien, Ambien CR, Edluar and Zolpimist. But the most common among these is Ambien.

I’ve heard countless stories of people doing some pretty crazy things on Ambien – like sleepwalking into a 7-11 while in their pajamas. I’ve also heard some horrific stories about terrible nightmares and hallucinations from taking Ambien.

According to a new federal report by the Substance Abuse and Mental Health Services Administration’s Drug Abuse Action Network (DAWN), from 2005-2010, visits to emergency rooms from the adverse side effects of Zolpidem increased by over 200 percent. The findings of this report are as follows:

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  • In 2010, there were 64,175 emergency-department visits involving zolpidem. Of these, 19,487 — or 30 percent — specifically involved adverse reactions to the sleep medication.
  • In 2005, there were just 6,111 emergency-room visits involving adverse reactions to the sleep drug. During the period 2005-2010, emergency-department visits involving adverse reactions to zolpidem rose almost 220 percent.
  • Women accounted for 68 percent of emergency-department visits related to adverse reactions to zolpidem in 2010. The differences between men and women fluctuated during the five-year period, but overall women made up a greater number of the zolpidem-related emergency visits in every year but 2008.
  • The number of emergency room visits made by women involving adverse effects of zolpidem increased by 274 percent from 2005-2010. Visits by men increased 144 percent.
  • Adults ages 45 and older accounted for 74 percent of all emergency room visits involving adverse reactions to zolpidem.
  • Patients ages 65 and older were the most common age group to seek emergency treatment for adverse reactions to zolpidem – 32 percent.
  • Patients ages 45-54 were the next largest group, accounting for 22 percent of all visits.
  • Of the total visits to emergency room visits related to adverse effects of zolpidem, 40 percent involved the sleep drug alone.
  • In 50 percent of the cases, one or more additional prescription drugs were involved.
  • The most common prescription drugs seen in combination with zolpidem’s adverse effects included narcotic pain relievers, antidepressants, anti-anxiety medications and other insomnia medications.
  • Research also has shown that older adults are at greater risk for adverse effects from sleep medications, including those containing zolpidem.
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In January of this year, the Food and Drug Administration issued a Zolpidem safety alert and announced it would require drug makers to cut in half the recommended dosages of medications containing zolpidem for women. The agency also recommended lowering the dosages for men, and urged medical professionals to warn all patients taking zolpidem about potential side effects. Sleep medications that contain zolpidem should be prescribed on a short-term basis only in severe cases of sleep disorders.

Big Pharma has once again created a monster with medications containing zolpidem. And as usual, rather than treating the problem, American doctors prescribe these pills to alleviate the symptoms.