Drug Injury Attorney Blog

A recent New York Times article about the drug company GlaxoSmithKline's agreement to pay a $750 million settlement to the FDA caught my eye, as a defective prescription drugs attorney. The settlement resulted from a whistleblower's suit concerning problems with contaminated and ineffective products, which she said GlaxoSmithKline chose to ignore. Whistleblowers help protect us all by holding drug companies accountable for making profit-hungry decisions that put innocent people at risk.

Cheryl D. Eckard was a quality manager for GlaxoSmithKline. In that role, she warned senior managers, including top executives, repeatedly about serious problems with their Puerto Rico plant. She recommended recalls of defective products and warned that she would call the Food and Drug Administration. Instead of carrying out the recalls and protecting patients' health and safety, the company terminated her as a “redundancy” -- British for layoff -- in 2003. The Puerto Rico plant, which produced $5.5 billion of worth drugs each year, had contaminated air and water, products that were stored in rented vans, intravenous cancer drugs of uncertain sterility, and bottles that incorrectly mixed different types of drugs. FDA inspectors failed to catch all of these problems, and the company did not live up to its promises to fix the ones that the FDA did find. The plant was closed in 2009, seven years after Eckard found the problems.

As a result, GlaxoSmithKline sold tablets of the antidepressant Paxil CR that did not contain the drug’s active ingredient, even after Eckard’s warning. Other defective drugs made in the factory included the ointment Bactroban, the diabetes drug Avandia, the heart drug Coreg, and the acid reflux drug Tagamet. When Eckard notified the FDA and sued under the whistleblower law, the FDA launched a criminal investigation, and armed federal marshals seized nearly $2 billion worth of drugs in 2005. The $750 million settlement includes $150 million to settle criminal charges for knowingly selling adulterated drugs—the first successful case of this kind. It also involves $600 million in civil penalties. Of that $96 million will go to the Eckard for blowing the whistle, under the federal False Claims Act.

As a defective prescription medication attorney, I am glad that Eckard's whistleblower suit was successful. Her story shows yet again that we cannot rely on the FDA's inspections to keep us safe, even if the FDA is trying its best. Drug companies will not always correct their mistakes, especially when profits are at stake. That means public safety depends to some extent on drug company employees who have inside knowledge and honest consciences to hold their employers, or former employers, accountable. As the federal prosecutor quoted in the article noted, the public expects drugs to be safe and perform as expected. When drug manufacturers intentionally ignore safety warnings, they undermine public health as well as public confidence in the regulatory system.

After a defective drug makes patients sick, those who were harmed don’t have to rely on the FDA or individual whistleblowers to hold drug makers accountable. Civil as well as criminal laws allow individual patients who were injured, and their families, to hold manufacturers legally liable for their actions. Drug manufacturers are legally required to warn the public if they know about potential negative effects of their products. If they sell dangerous or defective drugs without warning the public, any patient who gets hurt by these drugs can sue the drug manufacturer for the costs and injuries they suffered because of its negligence. This can include damages for medical costs, past and future lost wages, lost quality of life, damage to personal relationships, and pain and suffering. It is simply unfair and immoral to trick patients into taking a dangerous drug by withholding information about it. Companies who do this have to pay the consequences.

Continue reading " GlaxoSmithKline Pays $750 Million for Selling Tainted and Ineffective Products " »

Research shows that while Effexor does treat major depression or anxiety disorders, it also can be very harmful to come off of the drug.

Withdrawal symptoms while attempting to stop taking prescription antidepressants is common, even expected. But some of the harmful effects of Effexor withdrawal are not just uncomfortable and scary — they can be downright fatal. The worst of the withdrawal symptoms include nausea, diarrhea and “brain zapping.” Brain zapping is when you feel like lightening bolts are going off inside of your head. Many people are also describing a sensation called "brain shivers."

Some patients become frustrated when doctors described their withdrawal symptoms with the term "discontinuation syndrome,” feeling that the term lessened the immensity and severity of their symptoms. Some patients even feel they are victims of false advertising because they felt that they weren't properly informed of these harmful effects before taking the drug. Some of the more common withdrawal symptoms include:

• insomnia/sleepiness
• ringing in the ears
• feeling agitated or moody
• a high incidents of headaches
• nightmares
• tremors

The declared brain zapping effect wasn't believed at first to be due to Effexor withdrawal, but continuous complaints from patients coming off of the drug have made the effect to be understood as a very common one. Some people also have complained of vision problems including blurred vision in the early days of withdrawal.

Right now doctors agree that if you want to come off of Effexor, you should do it slowly and under the supervision of your doctor. Trying to do it alone or quitting cold turkey is not only dangerous, it can be potentially fatal. Even if you are taking a small amount of Effexor or taking a low dosage, you should not quit cold turkey. Talk to your doctor immediately if you experience any of the symptoms listed in this article. Not everyone will experience all of these symptoms but it is best to keep your doctor informed.

While Reglan has been used to help treat gastroesophageal reflux in babies and children, it also is prescribed for assisting with milk production in breastfeeding mothers.

Since it was discovered that Reglan use increases a woman's level of prolactin (which is the hormone that produces the milk), it has been prescribed for mothers in cases where the female doesn't produce enough on her own. It is NOT used to produce milk itself, but as an aid to help breastfeeding women increase their production; Reglan is not used in the cases of women that can't produce milk at all. Generally the dosage given to breastfeeding mothers is relatively low and is given in a one 10-milligram tablet that is taken three or four times a day for a period of about a week. By the second week, the drug is then weaned. This regimen generally is enough to get the milk to start to flow better in about 2-4 days.

Drug information about Reglan currently states that metoclopramide is actually excreted in human milk, and that it should be used with caution if it is offered to a breastfeeding mother. But as with all things prescription related, there are some dangers and/or potential side effects involved. Some of the common side effect can occur when the patient is taking Reglan, even if she doesn’t have a high-risk history. These side effects also can occur if you are taking another medication that could interact badly with Reglan. Some of the complications you can expect may include such as:

• tardive dyskinesia (TD) or other severe problems with your movement
• severe depression; this may be worse if you already suffer from post-partum depression or if you have a history of PPD
• neuroleptic malignant syndrome (NMS) which can be fatal
• fast or irregular heart beat

You should not take Reglan unless prescribed by your own doctor and never just take the drug from a friend as you may have a pre-existing condition that can make the side effects worse.

Many people question the controversy surrounding labels meant to inform patients about the risks of the medicines they are taking. After all, if the side effects are listed clearly, do the patients have a right to complain that they weren't informed? Isn't society at large supposed to understand that people need to read the fine print before committing to anything?

The problem with this argument is that it assumes the labeling is inherently clear and easy to understand. In the case of some medicines, this is not necessarily as cut and dried as “just read the fine print” would imply.

For example, consider the labeling of the powerful antibiotic Levaquin. Considered a big-gun-style medication intended to bring down particularly nasty infections that may not respond to other treatments, Levaquin also is associated with the risk of tendon ruptures. In fact, let's rephrase that — Levaquin is thoroughly documented as directly causing severe and often crippling tendon ruptures, especially in patients over 65.

Do you see the difference the language makes?

The “black box warning” that the FDA requires on all Levaquin literature says as follows: "Fluoroquinolones, including LEVAQUIN, are associated with increased risk of tendonitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs and in patients with kidney, heart or lung transplants (see Warnings and Precautions 5.1).”

Notice that it mentions tendon ruptures only after bringing up tendonitis. This is an irresponsible word game — the two conditions are not synonymous. Tendonitis is severe soreness requiring rest and anti-inflammatory medicines. Tendon ruptures are potentially crippling and severely painful injuries that often require opiate painkillers. In addition, what does “associated with” mean? It doesn't seem to make clear that the medicine has been demonstrated by strong evidence to cause this medical condition.

Coupled with the claims of many patients that their doctors prescribed the medicine without telling them clearly of all the risks, this is easily seen as something more serious than a case of consumer neglect.

I was interested to see that the FDA has announced that it is cracking down on unapproved uses of chelation drugs. These drugs, which bind to and remove heavy metals from the body, are prescribed legitimately to treat heavy metal poisoning. But the drugs have also been marketed for unapproved uses, most famously the treatment of autism. The FDA is disciplining these drugs’ makers for this in the wake of at least two deaths attributed to misuse of chelation drugs. As a pharmaceutical liability attorney, I believe it’s important that the public be protected from drug manufacturers' attempts to market their products for dangerous, unapproved uses -- which is ultimately about increasing their profits.

Sadly, these unapproved uses have had some tragic results. A five-year-old autistic boy died of a heart attack while a Pennsylvania doctor treated him with chelation drugs, using an unproven theory that autism is caused by heavy metal poisoning. The child's parents sued the doctor and his medical license was suspended for three years. A two-year-old Texas girl also died of a heart attack attributed to chelation treatment.

Over-the-counter chelation drugs have also been marketed on the Internet to treat Alzheimer's disease, Parkinson's disease and heart disease. These drugs can cause kidney failure, dehydration and other serious health problems. A 2007 survey showed that 111,000 adults had used these treatments in the past year. The FDA sent warning letters to eight makers of these drugs notifying them that they are "unapproved drugs and devices," and that their sale is a felony. These eight sellers -- World Health Products; Hormonal Health; Evenbetternow; Maxam Nutraceutics/Maxam Laboratories; Cardio Renew; Artery Health Institute; and Dr. Rhonda Henry -- have marketed the drugs as dietary supplements. The FDA said that patients receiving legitimate chelation treatment should use only prescription drugs, under the care of a medical professional who can respond to any complications.

As a defective medication lawyer, I agree completely. Two innocent children should not have had to die from the unapproved, dangerous use of any drug, whether prescription or over-the-counter. The drug makers may have intended to make their products sound harmless when they marketed them as mere dietary supplements. But that's even more dangerous to unsuspecting consumers who are looking for medicines to help them, not make them even sicker. That kind of sneaky marketing is not just immoral, it's illegal, and I am pleased that the FDA is paying attention to it.

Drug manufacturers are required by law to warn consumers of their products' risks. If they fail to do so -- or, worse, hide their drugs' harmful effects -- the people that get hurt by using those drugs can sue. Victims of dangerous drugs can require the manufacturer to pay for their medical costs, lost wages from missing work or being unable to work, and diminished quality of life, which the manufacturer ultimately caused. Consumers who trust that a medication will help them should not have to bear all the consequences alone if they find that the manufacturer hid important information from them about the drug's risks.

Continue reading " FDA Cracks Down on Unapproved Uses for Chelation Drugs After Two Children Die " »

The FDA has issued warnings for people taking Boniva and Fosamax. Patients that are currently taking bisphosphonates (drugs used for strengthening the bones) are being warned that, ironically, the drugs can cause thigh fractures.

Both Boniva and Fosamax are used to treat osteoporosis. According to the FDA, both of the drugs increase the risks of patients’ suffering from rare femur fractures that only occur in about 1 percent of the reported cases of such fractures. This particular fracture takes place in the hip joint.

"We know from clinical trials that these drugs do prevent the common osteoporosis fractures,” says Dr. Sandra Kweder, the FDA's deputy director for new drugs. “The fractures we're talking about today are very unusual and rare."

Most of the patients that experienced the rare fractures complained of first experiencing pain and/or an aching in the groin when the fractures occurred. So far, it is not known if Fosamax and Boniva, which most commonly are prescribed for women experiencing menopause, are directly related to the femur fractures. Still, caution is being taken by ensuring that the potential risks are placed on the labels and pamphlets be given to patients that are taking either of the drugs.

The American Society of Bone and Mineral Research first published the report last month. In it, the report says that there are many explanations for the fractures. One of them is that the slowdown in cell turnover that seems to happen when patients take bisphosphonates may be what is leading to the patients ending up with weaker bones in some of the cases.

People who currently are taking Fosamax or Boniva are not recommended to stop taking them until they consult a physician. While the FDA says that most of the risks are posed to those that have been taking bisphosphonates for more than 5 years, there have been cases where patients have been taking it for more than 15 years. Right now there are no guidelines for how long these drugs should be taken and the FDA wants to do more research before making any suggestions as to how they should be used.

The popular acne drug Accutane, manufactured by Hoffmann-La Roche, has been linked to severe and even potentially deadly skin reactions, according to Health Canada. Accutane, which also goes by the generic name of isotretinoin, is used to treat severe acne problems.

"There have been very rare post-marketing reports of severe skin reactions," Health Canada officials said in a letter to health care professionals. "These events may be serious in nature and can result in hospitalization, disability or death.”

Accutane was released in 1982 to treat the worst cases of acne that can't be treated with other methods, including antibiotics. The Canadian Department of Health released the public advisory in February. People who have developed severe symptoms upon taking Accutane have suffered from such things as:

• Rashes, particularly when it is mixed with fever/malaise or conjunctivitis (red and inflamed eyes or pink eye)
• Blisters on the appendages or face
• Sores in the nose, mouth or eyes
• Peeling skin

It can take up to 3 days for the skin lesions to actually be seen on the body. Accutane has been prescribed for 25 years; since November 2009, there have been 66 reported cases of severe skin reactions like these in adults and kids worldwide. This number is based on a review of the company's global safety database.

The skin reactions that develop are called known as erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis. The department said that while there were other things that played into the cases, you just can't ignore the fact that there is an association between Accutane and severe skin reactions. If nothing else, you can't rule out the possibility. Right now it looks like the manufacturers of Accutane will ensure that the new safety information is include in the future.

According to the Associated Press, FDA officials have issued a warning that popular bisphosphonates drugs that treat osteoporosis may actually increase the risk to thigh fractures.

Patients taking bone-strengthening drugs like Fosamax and Boniva seem to be more likely to suffer a rare fracture of the femur. This fracture occurs just under the hip joint. The injury is so rare in fact that only 1 percent of femur injuries occur in this spot.

"We know from clinical trials that these drugs do prevent the common osteoporosis fractures,” says Dr. Sandra Kweder, the FDA's deputy Director for new drugs. “The fractures we're talking about today are very unusual and rare."

More than half of the cases that are reported to the FDA say that the patients taking Boniva and Fosamax complained of pain or an aching groin just before they experienced the fractures. Right now it isn't completely clear if the drugs are directly responsible for the fractures, but as a safety precaution, the FDA is adding the potential risks to the labels of these drugs. Also, manufacturers are required to give pamphlets explaining the potential risks of taking Fosamax and Boniva to their patients.

Bisphosphonates work by helping to slow down the loss of bone cells that can lead to osteoporosis. Prescription drugs that are currently in that category include Fosamax, Boniva, Actonel, Atelvia and Reclast. The FDA has said that the fractures "may be related to the use of bisphosphonates for longer than five years." They also said that there have been some patients that have been steadily taking these drugs for over 15 years.

For now, if you are a patient that is taking any of these drugs, you should keep taking them unless you want to be weaned off of the drugs by your doctor. FDA officials have stated that they will keep investigating the drugs safety so that they can ensure the correct recommendations for their use.

The fact that Levaquin is an antibiotic medication takes a lot of the fear out this particular drug. Given that it treats a variety of bacterial infections — including infections of the urinary tract, sinus, bladder, kidney and prostate — leads some patients to believe it is relatively harmless. But you can overdose on this drug; in fact, it can have extremely dangerous and potentially fatal effects on you.

The less severe symptoms of an overdose of Levaquin are breathing trouble, decreased activity, drooping eyelids, loss of balance or coordination, sweating, tremors and seizures. That alone doesn't sound too bad, but when you take into consideration some of the following more severe and potentially fatal reactions to an overdose, you may want to think twice before doubling up:

• damage to the liver, kidneys or pancreas
• double vision
• fatal hypoglycemia (low blood sugar)
• nerve damage in you hands and feet
• extreme anemia
• permanent blindness or colorblindness
• neuromuscular disease
• severe allergic reaction
• severe nervous system disorder
• spontaneous tendon rupture
• heart problems like cardiotoxicity

If you want to limit your chances of suffering through a Levaquin overdose, you should be sure to let your doctor know of any previous and current health problems or medications that you are taking. You should only use Levaquin as directed by your physician and with your doctor's supervision.

It is easy to take an antibiotic medication like Levaquin with a lax view, as generally the side effects are considered small, and severe adverse reactions like the ones mentioned in this article are rare. However, you do not want to be the exception to that finding. The fact is that while the drug is popular (it earned $1.6 billion in revenue in 2007 alone) and widely used, it can still be extremely dangerous and even fatal if used improperly.

As a defective medication lawyer, I wish that drug manufacturers would learn from one another's mistakes -- but as a recent report suggests, this does not seem to happen. Now that Johnson & Johnson has been thoroughly shamed for its lax adherence to safety protocols, Gilead Sciences Inc. has been warned by the FDA about problems with its contamination prevention and quality control procedures at its San Dimas, Calif., plant. A number of other drug companies have been in the news this year for lapses at their manufacturing plants, suggesting that consumers who use prescription and over-the-counter medications have reasons to be worried about their safety.

The FDA sent the Sept. 21 warning letter because Gilead had failed to respond adequately to problems found by the FDA's inspections in January and February. One of the problems the FDA identified was that Gilead wasn't taking defects in its drugs seriously enough. For example, the company changed its manufacturing process for Viread, an antiviral treatment for patients with HIV that made $668 million in sales last year. After it made the change, the company began discovering "excessive amounts of defective tablets," the FDA said, but the company concluded that the changes to its manufacturing process were blameless.

This was not the only problem the FDA turned up. Reportedly, Gilead also didn't investigate the extent of the defects in the drug. A contract manufacturer had produced the drug, and Gilead packaged it. Multiple lots of the drug failed visual inspection, but Gilead just removed the defective pills and went ahead with packaging the rest, without trying to find out what had gone wrong and how to fix it. In addition, Gilead failed to ensure that sterile products remained sterile. Certain lots of the fungal infection treatment AmBisome, which made $300 million in sales in 2009, were processed in a room that wasn't approved as an aseptic setting. That medication was released for sale in the U.S. The FDA told Gilead that its "senior management" needed to set up systems that would ensure the identification and correction of problems and "assure the identity, strength, quality, and purity of their drug products."

Gilead is known for its HIV medications. Thus, the problems the FDA identified with Gilead's manufacturing processes suggest that patients whose lives are already threatened by HIV infections may face the additional threat of contaminated medications. As a dangerous drug attorney, I worry that situations like this point to a drug manufacturer's being more interested in profits than in people's health.

Victims who have been hurt by dangerous or defective medications can require the defective product's manufacturer to pay for the harm that they caused. The law requires drug manufacturers to warn consumers about risks that they know to be linked to their products. If they fail to do so, consumers who are harmed by the defective drugs can sue for financial compensation. A victim who incurs medical costs, misses work or is unable to work, or whose quality of life suffers because of harm caused by a drug can make the manufacturer pay these costs. According to the law, consumers who trusted that a medication was safe should not have to bear the consequences alone, if they find that the drug was unsafe. This is true regardless of whether the manufacturer knew about problems with the medication.

Continue reading " FDA Warns Gilead Over HIV Treatment, Other Meds Produced in Substandard Plant " »

It is common knowledge that the oral contraceptive known as Yaz/Yasmin causes blood clots (and, in some cases, venous thromboembolism [VTE]). But although side effects often are listed with the pharmaceutical information provided with any prescription drug, the actual label itself rarely possessed this information... until now. More than likely, Bayer's new label information is the result of negative press and pressure from the FDA.

Regardless of why the drug has a new face, Yaz is in agreement with the FDA. Bayer (the maker of Yaz) has updated its label and confirmed that there is proof that the risk in developing VTE in Yaz users is comparable to other combination oral contraceptives that contain levonorgestrel. What this mostly means is that the company is admitting to posing the same risk in Yaz as in other combination oral contraceptives.

The new label also provides information specific to drospirenone in contraceptive drugs. In fact, Kemal Malik M.D., CMO at Bayer HealthCare, has stated that "the FDA's thoughtful and balanced analysis will provide helpful information for healthcare professionals to use when they are providing guidance and counsel to patients."

This statement is in reference to the FDA's having weighed the evidence of the risks of using combination oral contraceptives and insisting that drug makers not underscore the importance of protocol methodology on the outcomes and research discoveries that are conducted in scientific studies of potential risks and side effects.

According to a U.S. study, the chances of experiencing thromboembolism while taking Yaz proved to be comparable to those using other combination oral contraceptives. On Yaz/Yasmin labels, you will see that Bayer also claims that the number of Yaz thromboembolism cases is small (1.2 percent of all cases), making the risk estimates and findings from scientific studies less than reliable.

As Bayer tries to stand behind Yaz, it also is trying to take a reasonable amount of responsibility for its own label information. Regardless of whether the FDA had a strong hand in that, the consumer will have easier access to what the risks and dangerous side effects of the drug are.

Avandia, the popular drug used to treat Type 2 Diabetes, has been taken off the shelves in Europe among information that links the drug to heart attacks.

In fact, research conducted in 2007 by the Cleveland Clinic shows that the risk of heart attacks increases 43 percent in users of Avandia (generic name: rosiglitazone). It also shows that the risks of suffering a cardiovascular death increased a whopping 64 percent. This information first was published in The New England Journal of Medicine by Dr. Steve Nissen.

What this Means for Americans

In the U.S., regulators have added more restrictions to the use of Avandia for the same reason. The FDA says that patients can only be prescribed Avandia now if their blood sugar levels can't be corrected with other medications.

“Although the European Medicines Agency went further by actually (suspending) marketing of the drug, both regulatory decisions result in essentially the same outcome — virtually complete elimination of the use of this drug by patients around the world,” says Nissen.

The manufacturers of Avandia, GlaxoSmithKline, stand by the drug.

"The company continues to believe that Avandia is an important treatment for patients with Type 2 diabetes and is now working with the FDA and EMA to implement the required actions,” Dr. Ellen Strahlman, GSK’s chief medical officer, states.

Those actions include putting a severe warning and product box on all drugs that include rosiglitazone. For now, however, GlaxoSmithKline has stopped marketing Avandia as a matter of prudence. The company is not withdrawing the drug, but it is restricting access to it.

Right now, anyone currently taking Avandia is advised not to come off of the drug without the strict supervision of his or her doctor, because stopping can make controlling a diabetic’s sugar levels very difficult. There are other drugs on the market to help with diabetic sugar level control and it is recommended that diabetics attempt to control their sugar through those drugs before taking Avandia.

The FDA's Joshua Sharfstein, Principal Deputy Director, recently explained explains why the FDA isn't pulling the popular but controversial diabetes drug Avandia and instead leaving it available to patients who need it.

Sharfstein claims in an Oct. 3 interview with a Washington, D.C., station that there is no absolute assurance on the safety of replacement drugs that will be available any time soon. The FDA's recent decision to leave GlaxoSmithKline's Avandia on the market also has a tremendous amount of restrictions attached, he notes.

In order to prescribe the drug, physicians now must sign a statement that shows that they will be in compliance with the approved indications before giving the prescription. Patients also have to show in writing that they understand the potential risks involved in taking the drug. Since the drug is no longer being marketed in Europe at all, the FDA decided not to pull Avandia in Europe based on the (REMS) defining access and use restrictions.

The agency also wants to force GSK to start its own re-adjudication of data from the RECORD Avandia cardiovascular outcomes study. Any of the results could end up with new regulatory decisions, Sharfstein was careful to say. In addition, he explained that the FDA is concerned about Avandia’s risks but doesn’t consider the evidence to be definitive as of yet. The agency has issued this interim solution to the potential crisis in a way that allows it to keep getting more information before doing anything drastic, Sharfstein says.

With Avandia having been proven to help control blood sugar levels in Type 2 diabetics that don't get results from other drugs, this decision is important to those patients who would be out of options otherwise. The monitoring and full disclosure to patients of the drug's risks and potentially fatal side effects is about as good as can be expected — that is, until there is better treatment available that doesn't offer such life-threatening consequences.

This story is far from over. The debate over Avandia likely will continue as the lawsuits pour in.

According to a Bloomberg article, Mylan Inc. has been granted a temporary order prohibiting Apotex Inc. from selling a generic form of Paxil CR. Presided over by U.S. District Judge Joe Pisano and given by a Federal Court in Trenton, New Jersey, the order blocks Apotex from using, offering to sell, selling, shipping and launching generic Paxil CR.

Mylan's lawsuit in the case of Mylan Inc. v. Smithkline Beecham Corp. claims that Glaxo was allowing Apotex to sell the Paxil CR under the name paroxetine hydrochloride. This violated an exclusive licensing agreement that Mylan had with GlaxoSmithKline to sell copy of Paxil CR. Pisano set the hearing in the case for October 18, 2010, but not before granting the temporary order against Apotex.

Mylan currently is the largest U.S.-based generic drug company. Its lawsuit claims that Glaxo vowed that Mylan would be the only company selling copies of the drug Paxil CR in its controlled-release form as a result of a settlement agreement that was reached in 2007. This agreement was the result of a lawsuit that was filed against Mylan that wanted to block the sales of generic Paxil CR. The agreement also had provisos that would let other versions of the drug out on the market before the patent expires — a term of the agreement that Glaxo violated, Mylan stated. Mylan also claims that they were the first generic drug maker that went after regulatory approval for the 12.5 mg and 25 mg forms of Paxil CR since the regular forms of the drug already have many copies out on the market.

Mylan says the authorized generic version of Paxil CR would undercut sales and cause an "irretrievable loss in market shares and customers."

Sarah Alspach, a spokesperson for Glaxo, has stated that "Glaxo did not breach any contractual duties owed to Mylan and intends to defend these allegations vehemently."

The FDA has finally decided what to do about the serious heart risks to patients taking the diabetes drug Avandia (rosiglitazone). Given the increased danger of heart attack, stroke, and heart failure to 600,000 patients taking the drug, the FDA has severely restricted use of the drug, but it has not taken it off the market entirely. The European Union's European Medicines Agency has forbidden the sale of the drug in the EU. In my view as a pharmaceutical liability attorney, the EU's more cautious approach will probably protect more patients from serious harm. But I am glad that the FDA has at least restricted the harm that Avandia can do in the U.S.

The FDA has decided that use of Avandia can continue only for diabetics for whom other drugs have not worked. Most users will switch to different medications, and doctors will not be able to prescribe Avandia to new users without a detailed explanation of all the risks it entails. In addition, Avandia's maker, GlaxoSmithKline, is not allowed to market the drug. Avandia had been the best selling diabetes drug in the world in 2006, when its sales reached $3.2 billion, but once news of its dangers spread, they dropped to $1.2 billion in 2009.

Those billions of dollars in sales clearly were important to GlaxoSmithKline, as the company tried to suppress evidence of Avandia's problems and intimidate a cardiologist at Ohio's Cleveland Clinic who first publicized problems with the drug. Dr. Steven Nissen’s 2007 study, published in the New England Journal of Medicine, showed that taking Avandia increased a patient's heart attack risk by 64 percent, and Type 2 diabetes patients already are at high risk for heart attack. But GlaxoSmithKline insisted that Nissen was wrong, even though, as the U.S. Senate's investigation discovered, GlaxoSmithKline's own scientists privately acknowledged that Nissen's study was sound.

Nissen's research was central to Avandia's restriction by the FDA, but he says that he wishes that the FDA had acted on it more quickly. "I will sleep better tonight, but I will not sleep until I know that we've have improved how we handle these kinds of problems in the United States. We've got to fix the FDA," he said. An estimated 47,000 Avandia users suffered heart attacks, strokes, or heart failure between 1999 and 2009, a situation that Nissen described as "one of the worst drug safety tragedies in our lifetime. That's why Nissen says it's "essential to fully investigate what went wrong with the regulatory process to prevent this type of tragedy from endangering patients in the future."

As a dangerous prescription medication lawyer, I'm glad that there will be fewer patients who have to suffer because of Avandia. But it would be better if no one else at all were to be harmed by this drug. Those who already have been hurt by it have strong reasons to consider seeking financial compensation from GlaxoSmithKline, as does anyone who has been hurt by a dangerous prescription or over-the-counter medication. Drug manufacturers have a legal responsibility to warn the public and the government about the harmful effects of their drugs, and from what we know of the Senate's investigation, GlaxoSmithKline may have tried to do exactly the opposite. When a patient takes a medication about which the manufacturer has withheld important safety information, that drug maker can be held legally responsible for the harmful effects of its drugs.

Continue reading " After Long Debate, FDA Severely Restricts Use of Avandia in American Diabetics " »

Just for the sake of speculation, here are the symptoms of two similar conditions: Condition 1 is characterized by tremors, difficulty speaking and nervous tics. It often is associated with difficulty maintaining balance and posture. Condition 2 is characterized by tremors, difficulty speaking and nervous tics. It often is associated with difficulty maintaining balance and posture.

Each condition also has other symptoms that further research and discovery can shed light on, but the ones mentioned are the most common. They also happen to be identical. These are the symptoms for Tardive Dyskinesia and Parkinson's disease.

Tardive Dyskinesia is a neurological condition in which physical tics and uncontrolled body movements begin after a delayed period from the time a patient is prescribed Reglan. It most often affects patients older than sixty, who have been on the medication for an extended period of time — typically further than the 12 weeks recommended on the prescription instructions carried on the medication. Quick diagnosis is absolutely vital to recovery, because the longer a patient is exposed to Reglan, the more likely the condition will remain permanent.

However, Tardive Dyskinesia is easily and frequently misdiagnosed as Parkinson's disease instead. The presentation of symptoms is very similar between the two conditions, and doctors can easily mistake one for the other. This causes a problem, because the patient's original condition for which they were prescribed the Reglan will continue to be a problem. GERD is a consistent, long-lasting condition that Reglan is brought in to treat as a means of last resort. Thus, while doctors are trying to analyze and treat non-existent Parkinson's, the patient will continue to expose himself to the medicine causing his tremors in the first place.

The other problem is that misdiagnosis does more than waste a patient's time and money. He also must begin a regimen of therapies and tests to treat and alleviate the impact of a disease he does not actually have. Finding out later that all their therapy has been for naught can be discouraging and infuriating.

Recently I wrote about Dr. Frances Oldham Kelsey, whose leadership helped the FDA establish scientific standards that drug companies had to meet before they could market their drugs in the U.S. Another article about the FDA in the New York Times recently caught my attention, as a dangerous drug injury lawyer, for its discussion of how the FDA has changed in recent years to become more transparent. The FDA's new openness with the public about how it decides which drugs to approve or not approve helps it to interact with the scientific community. It also holds the FDA accountable to protect the public from drug companies focused on profits rather than patient safety, even though the agency sometimes finds it difficult to do so.

Under the Bush administration, the FDA didn't publicly discuss its deliberations about drug approvals, and staff members were expected to present a united front once decisions were made. The agency also didn't conduct deep investigations into drugs' safety and effectiveness. Under Obama, competing views and disagreements among FDA scientists have been aired publicly. The FDA presents a less united front and allows the public to how complicated the matter of drug safety can be. Dr. Joshua Sharfstein, principal deputy commissioner for the FDA, said, “I think that FDA’s credibility really depends on being able to explain its decisions well. We can’t expect people to think that FDA has decided, therefore it’s the right answer.” In my view as a dangerous prescription medication attorney, the right answer is always protection of patients' safety and well-being rather than the interests of drug makers.

Even with the agency's new openness, patients should not rely only on the FDA to protect them from drug companies that market dangerous medications. The agency seems unsure of how to handle the complexity of its decision-making sometimes, and this can result in dangerous drugs being allowed to stay on the market. Questions about FDA decision-making processes have been especially pointed in the case of Avandia, the diabetes drug that is associated with heart risks. Dr. Steven Nissen's study showing Avandia's dangerous effects, about which I have written several times, prompted doctors, patients, and legislators to wonder why the FDA had not been the one to do this study. Nissen's study was not conducted according to the FDA's procedures for scientific evaluation of medicines. However, the FDA had in fact done its own study with the same results that Nissen found. The agency just hadn't made it publicly available -- so no one knew about it until Nissen’s study.

Even though the FDA is charged with ensuring drugs' safety and effectiveness, drug manufacturers also are legally required to warn the public about risks that their products might pose. That means that even if the FDA approves a medication for sale, the drug maker can be held responsible for any failure to warn patients. If a manufacturer knows or should have known that the medication could hurt people, and doesn't make this information public, patients who are hurt by this medication can sue the drug maker to recover the costs of their medical treatment, along with compensation for pain and suffering, loss of quality of life and past and future wages.

Continue reading " Avandia Decision Underscores New Culture of Openness at Federal Drug Regulator " »

Sometimes one really must wonder at the FDA's decision-making process for allowing drugs to be approved. The antidepressant market is one of the largest in the world at the moment, with SSRI and SNRI antidepressants accounting for billions of dollars in sales each year. The makers of Paxil set aside more than $2 billion dollars this year simply for handling the drug’s legal defenses. However, there is increasing evidence that antidepressants may not actually work as expected, and in some cases may work in ways that are not understood at all.

For example, most advocates of antidepressants cite the STAR*D trial, a study conducted by the government that seems to indicate that antidepressants are effective at treading depressive disorders. However, there is evidence that the results were skewed by improper testing. The main goal of antidepressants is to alleviate Major Depressive Disorder, one of the most serious depressive conditions. In STAR*D, it seems that patients with Minor Depressive Disorder were included in the study, which skews the results; the drugs are advertised for the treatment of MaDD, but MiDD is being included in the testing sample. This is the same idea as a major car company saying that their cars receive 30 miles to the gallon, when in fact their small cars get nearly 40 and their big cars get 25. The statement is technically somewhat true, but not accurate to the details.

Further, there are recent studies showing that SSRIs and SNRIs don't simply alleviate depressive symptoms, but fundamentally change the personality of the patient taking them. This, tied in with the indication that antidepressants can and do aggravate suicidal thoughts and attempts, is a matter to be viewed with more than passing interest. Indeed, it should be considered with alarm.

So, given that there is mounting evidence that antidepressants do not work as understood, why is the FDA still approving generic formulations and wider sales?