Prescription Narcotics Causing More Harm Than Good?

shutterstock_143327605-300x331In the new ebook, “A World of Hurt: Fixing Pain Medicine’s Biggest Mistake“, New York Times reporter Barry Meier really hits home the fact that opioid prescription painkillers such as OxyContin not only don’t work for many people,they are highly addictive and can cause a myriad of health problems. Addiction to such drugs is often considered more socially acceptable because they’re considered “white collar” drugs, meaning they’re prescribed rather than obtained illegally – at least in most cases.

Most of us know these drugs are addictive and when mixed with other substances such as alcohol, can lead to overdose and even death. But what you may not know is that for many people, they simply don’t work, create psychological dependency and can cause depression of hormone production, lethargy, sleep apnea and much, much more.

Death from the overdose of narcotic painkillers is four times greater than it was even ten years ago. Now, around 16,000 people a year die from an overdose.

So why were narcotic painkillers the preferred choice for treating chronic pain? They’re less expensive than multidisciplinary methods such as physical therapy, and doctors get reimbursed quickly for prescribing these drugs. The good news is that through research and increased awareness of their dangers, more and more doctors are choosing safer alternatives to treat chronic pain.

Click here to purchase the book mentioned above.

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.

Driving Is Risky Business

Auto Accidents

driving-300x200Driving is probably the most dangerous activity in which most of us engage every single day. According to the Texas Department of Transportation, over 2,800 people were killed in auto accidents in Texas alone. The TxDOT also reported that October is the deadliest month and Saturday the most dangerous day to drive.

Nationally, fatal accidents on the roads totaled 29,757 in 2011. The U.S. Centers for Disease Control revealed that auto accidents are the #1 cause of death for people of ages 5-34 in this country.

Right now in North Texas, it’s mosquito season. Last year West Nile Virus was big news. Constant reporting on television and in newspapers warned of the immense dangers of this virus. In fact, it was such a scare, many North Texas cities went so far as to aerial spray toxic pesticides (called adulticides) while we are told to stay locked in our homes. Yet one’s chance of dying or even getting seriously ill from West Nile Virus are incredibly slim. So why are we so worried about mosquitoes and not the safety on our roads? Perhaps it is because driving is a necessity, and we simply take for granted that if we have somewhere to be, we must drive.

Or perhaps we’re just not as informed as we should be. It’s doubtful most people know that nationally, auto accidents account for approximately 110 deaths per day.

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.

The Dark Side of Generic Drugs

Dangerous Drugs

CEO Singh of RanbaxyDinesh Thakur was a whistleblower for the generic drug maker, Ranbaxy Laboratories in Gurgaon, India, 20 miles south of New Delhi. Due to his efforts, on May 13 of this year, Ranbaxy pleaded guilty to seven federal criminal counts of selling adulterated drugs with intent to defraud, failing to report that its drugs didn’t meet FDA specifications and intentionally making false statements to the government. Ranbaxy was ordered to pay $500 million in fines, forfeitures and penalties, which is the largest amount ever levied against a generic drug company. However, no Ranbaxy executives were charged with crimes. Thakur’s testimony as a whistleblower was also unsealed. Under federal whistleblower law, he will receive more than $48 million for his part in the exposure of the drug company’s wrongdoings.

Today Ranbaxy is the sixth largest generic drug manufacturer in this country, with more than $1 billion in US sales in 2012 and $2.3 billion worldwide. The company sells its products in more than 150 countries and has 14,600 employees.

The Ranbaxy case sheds light on the fact that generic drug manufacturers overseas can easily get away with breaking the rules. The FDA only relies on research data provided by the companies themselves, assuming that they will adhere to high ethical standards. Obviously, nothing could be farther from the truth.

Even more disturbing is that fact that in spite of Ranbaxy’s fraudulent actions, drug regulators allowed the company to keep selling many of its products. The FDA even granted Ranbaxy rights to sell new generic drugs, the most profitable of which being a generic version of Lipitor. Within the first six months of the introduction of the Lipitor knock-off drug atorvastatin, Ranbaxy made $600 million in sales. But it gets worse. In November 2012, Ranbaxy recalled millions of pills after tiny glass particles were found in some of them. But the recall was only temporary, as the FDA allowed the company to resume manufacture of the drug in March of this year.

The IMS Institute for Healthcare Informatics revealed that our drug supply last year was 84% generic. Today, over 80% of active pharmaceutical ingredients for all US drugs are manufactured overseas, as are 40% of finished pills and capsules. The global market for generic drugs is an astounding $242 billion and that figure is growing exponentially. With healthcare reform now including millions more people and our aging population, this trend is bound to continue due to the low prices of generics vs. brand names.

In 2009, the Government Accountability Office proved that only 11% of foreign drug manufacturing plants were inspected by regulators. Conversely, 40% of US domestic ones are inspected. Over the last few years, the FDA increased inspections of foreign plants with its goal being to match those of domestic ones. But even if this happens, it’s an apples and oranges comparison, as foreign inspections can last less than a week and allow companies advance notice. Domestic ones can last up to six weeks with no advance notice.

There is a lot more to the Ranbaxy story but it’s only more of the same. The point is that the American public is clearly NOT safe when it comes to generic drugs. And staying true to form, the FDA does little to nothing to correct the problem. So is Big Pharma continually allowed to commit horrendous crimes? Ask the agency that’s supposed to protect us from these crooks – the Food and Drug Administration. Clearly, they fall short in the most blatantly irresponsible ways.

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.

Parents Miss Warning On Toddlers’ Cold Medicine

sick-child-200x299According to last month’s poll by researches at the University of Michigan, 42% of parents gave over-the-counter cough and cold medications to their children under the age of 4. Additionally, 44% gave them multi-symptom cough and cold medications. And 25% gave these toddlers decongestants. The survey comes a whopping five years after these drugs’ packages included warnings against using them in very young children.

In 2008, the Food and Drug Administration advised that these medications not be given to children under the age of 2. The previous year, an agency advisory committee had determined that children younger than 6 shouldn’t take these medications. It was even suggested that these medications didn’t help young children. The FDA said that some of the drugs might be associated with side effects and some deaths in very young patients, primarily due to overdoses.

Manufacturers followed the FDA’s advice and put warnings on their products’ boxes saying they shouldn’t be given to children under the age of four. Medications containing these warnings contain dextromethorphan, a cough suppressant, gauifenesin, an expectorant and the decongestants phenylephrine and pseudoephedrine. Medications with antihistamines warn against use in children younger than six. Major brand names of these medications include Novartis, Pfizer, Triaminic, Dimetapp and Robitussin.

The Consumer Healthcare Products Association represents makers of these over-the-counter medications. It said most cases of side effects involve children taking the meds without parental supervision. It went on to say that the drug facts panel should remain on the back of the packaging rather than the front. But of course, putting the warning on the front might mean parents would actually READ it.

In spite of these and other so-called efforts to alert parents, a study in 2010 published in the journal Child: Care, Health and Development found that about 1/3 of parents had never heard of the FDA’s recommendations. Of those who had, 1/3 planned to continue giving these meds to their children. A 2011 poll from the University of Michigan showed that 61% of parents with children 2 and younger had given them cough and cold medications. And yet another study recently published in Clinical Pediatrics found that 82% of 65 parents of children younger than 6 said they would use the medications. Almost 3/4 of those parents said they would administer the wrong dose. In fact, some parents read the instructions and just made up their own dose. So the misuse of these medications is not just the fault of the manufacturers, but some parents as well. Apparently parents become frustrated because there are not enough medications out there to help their young children, and out of desperation, use the medications designed for older children.

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 driver or alcohol-related car or truck wreck, 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.