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.

Yaz Prescriptions – A Matter of Trust?

Dangerous Drugs

shutterstock_110500937-300x343I don’t know how many countless mothers out there are told by their daughters’ doctors that they might consider putting their girls on birth control to help ease their menstrual symptoms. After all, birth control pills are known to reduce moodiness, fix acne, make periods lighter and diminish cramping. I also don’t know how many countless women have taken whatever random birth control pill their doctors have prescribed without a second thought.

What I do know is that I was once a teenager whose doctor prescribed birth control for my endometriosis, a condition that causes cells lining the uterine cavity to worsen a menstrual cycle, and I am now an adult woman who has taken birth control by choice. Come to think of it, although she is still young, I soon enough will be a mother with a teenage daughter whose doctor might suggest she too take birth control pills to help fix whatever hormonal problems may lie ahead.

As a woman who made the choice in the past to take whatever birth control pills my doctors prescribed without a second thought, I now realize how lucky I am that nothing bad happened based on that choice. Why would a decision from my past that required little thought be one of concern now? I wish I could say it was because as I get older, I make more informed decisions. Sadly, however, even an informed decision might not have helped me had I taken certain types of birth control.

I am an attorney that represents women who have been injured from taking Yaz, Yasmine or Ocella birth control pills, so I have heard firsthand what can happen when a woman does not get all the information she needs about the medicine she is prescribed. Many of the women I represent, often who are quite young, have suffered injuries simply because they took a pill prescribed by a physician.

Talking to women daily about their injuries resulting from taking these pills has given me a new awareness into the importance of having more stringent FDA testing for medications and the need for more adequate research prior to dispensing pills to the public. The women I talk to have suffered from blood clots, often having suffered deep vein thrombosis (DVT) or a pulmonary embolism (PE). Some women even have suffered strokes and more permanent debilitating injuries. The women often had to stay in the hospital for days or even weeks; their lives were forever changed.

I understand that my clients simply listened to their doctors’ advice. I also know there are other daughters, women and mothers who like me also listened to their doctors’ advice and took birth control pills assuming a prescribed medication would be safe to take. After speaking to countless women though who were injured when taking Yaz, Yasmine or Ocella, I now know that without better testing, many of the medications we take are not safe and can end up hurting innocent people.

If you or someone you know has been taking Yaz, Yasmin or the generic version, Ocella and experienced serious side effects, call the Dallas dangerous drug lawsuit experts at Reyes Browne Reilley now at 214-526-7900, email me, or fill out the case review form to the right of this page for a free consultation.

Jury Awards $285,000 in Bellwether Fosamax Lawsuit

Dangerous Drugs

This past Monday, a New York federal judge denied Big Pharma’s Merck & Co Inc.’s attempt to avoid paying $285,000 to plaintiff in a multi-district lawsuit based on the fact that the bone drug Fosamax causes jaw deterioration. Merck’s argument was that its warning label was adequate, but the judge didn’t buy it.

In February, the jury determined that Merck did not adequately warn plaintiff Rhoda Scheinberg that using Fosamax could cause osteonecrosis of the jaw. Of course, Merck claimed its label warned of the risk of this exact condition. However, Judge John Keenan ruled on the side of the plaintiff and rejected Merck’s motion, stating that “a warning is not automatically sufficient simply because it includes certain magic words. The quality of the warning matters.” Dr. Suzanne Parisian, an expert for Scheinberg, said the Fosamax label didn’t include information about the drugs limited effectiveness, and she wouldn’t have prescribed it if the label had warned that the longer you use it, the greater your chances of getting ONJ. Additionally, the language of the warning didn’t meet the standards proposed by the FDA, although makers of similar drugs had adopted that language on their labels.

In addition to the ONJ lawsuit, Merck literally faces thousands of lawsuits alleging Fosamax causes femur fractures. However last week, Merck won a ruling in this litigation when a New Jersey federal judge ruled that claims Merck failure to warn consumers about the risk of femur fractures are preempted by federal law. That was a win for Merck, but hopefully this and other Big Pharma companies will ultimately pay dearly for their wrongdoings – sooner than later.

If you or someone you care about has sustained injuries from a Fosamax, you may be entitled to compensation. Contact the premier DFW dangerous drug attorneys at Reyes Browne Reilley 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 case.

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.

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.

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.

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.

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.