Product Liability Attorney Blog

Earlier this month, Intellipharmaceutics International inc. announced that the FDA had accepted its application to produce a generic version of antidepressant Effexor. Specifically, this filing targets the extended release (XR) version of the medicine.

At issue is the ANDA (abbreviated new drug application). Since this filing has been accepted, the application now will move to the FDA's more complete review process. There is, of course, no guarantee that the drug will pass this review, but having the ANDA approved is an important first step. Intellipharmaceutics officials stated they will begin efforts to prepare for commercializing the product, and are seeking a distribution partner for the United States.

This comes as sobering news for patients and attorneys involved in lawsuits related to side effects caused by this medication.

Effexor, in its original form, has been linked to birth defects when taken by pregnant women. Studies by Danish doctors found that medications similar to Efffexor could result in a 40 percent greater risk of physical deformities in babies. Risk of heart defects rose by as much as 60 percent in the same study, particularly among women taking the medicine during their first trimester.

Apart from very minor differences, generic medications are chemically identical to their parent drug. This means that any risks posed by the original medicine are highly likely to be carried forward in the generic formulation as well. Since the availability of generic alternatives increases the presence of the drug in the market, the risk of defects rises.

A recent case for a different drug, but a similar generic vs. proprietary situation, ruled that the original manufacturer cannot be held liable for damages caused by generic medicines. This means that manufacturers have no responsibility for a great many of the injuries their formula results in.

Reglan is a drug intended for short-term use to treat illnesses such as GERD and chronic nausea. It has been recommended for use only in short, 4- to 12-week cycles at most. However, studies have suggested that as many as 20 percent of patients on Reglan and derivative drugs have been prescribed them for much longer periods of use.

Reglan has been linked to the formation of Tardive Dyskinesia, a disorder characterized by a delayed onset of uncontrollable body motions. This can encompass facial tics and twitches, such as pursing the lips or being forced to blink rapidly. The motions can become distracting, exhausting and painful over time. Other movements can exist as well, such as in the extremities or fingers. It is highly difficult for someone with the condition to stop themselves from moving.

The seriousness also lies in the difficulty of treatment for this condition. Tardive Dyskinesia can continue for a long time after withdrawal from the medicine that originated it, and in some cases is even permanent. There are some tests that indicate certain medications might be helpful in treating the condition, but this is, of course, an additional expense, as well as an insult — having to be medicated to treat an illness brought on by a supposedly safe medication is never comforting.

Sadly, there are few other options available for controlling Tardive Dyskinesia and its derivative conditions. There hasn't been a serious study into alternatives such as high-vitamin diets, for example.

This is what makes the matter so very serious. When 20 percent of the population taking a drug is put on it for periods beyond the recommended time frame, and when the medicine is known to be linked to an uncontrollable, disorienting physical condition, something has gone very wrong. Clearly, tighter controls need to be placed on any medication that creates an essentially untreatable illness.

Another day, and still more evidence arises that the latest generation of birth control drugs for women might be unsafe to take. In some cases, there have been deaths as a result of blood clotting caused by the newer drugs, as claimed by a number of lawsuits.

Dawn Varrechio is the mother of four children, who found herself having trouble breathing when taking birth control medication Yaz. "It's scary to think that at 35 you could be gone, like that quickly," Varrechio said in an interview. The breathing trouble arose in January, and she went to the emergency room. Scared she might be dying and worried for her children, Dawn was diagnosed with blood clots in both lungs.

Another patient who blames her blood clots on Yaz suffered injuries from which she says she might never completely recover, and has expressed anger at the manufacturers.

All birth control pills are composed of hormones that can lead to blood thickening. However Yaz and Yasmin have been shown in a number of studies and lawsuits to lead to much greater blood clotting than earlier generation drugs.

In particular, two studies published last year by the British Medical Journal found that Yaz presents serious blood clotting risks — as much as six times that of earlier formulations.

Bayer, the maker of Yaz and Yasmin, insists that its products can be used safely when directions are followed, and maintains that Yaz and Yasmin are labeled clearly regarding the side effects raised in the lawsuits.

Lawyers arguing for the plaintiffs are making the case that these drugs and their generic variations should have stronger label warnings, perhaps as much as a black-box warning, which is the FDA's strongest category in such cases.

Perhaps in response to these claims, the FDA has ordered its own study into Yaz, Yasmin and derived generic drugs. The study is ongoing.

People have an instinctive tendency to trust those things they are familiar with. Acetominophen has been around for nearly 140 years in one form or another. However, its age doesn't actually mean it's particularly safe. Indeed, acetominophen has a very narrow toxicity margin; more than 1,000 mg in a roughly 4-hour period can cause strong liver toxicity. There are warning labels, of course, but the fact remains that it is still a potent, potentially dangerous drug.

This is why continuing efforts to hold the pharmaceutical industry accountable remain so important, particularly in drugs that have been around for a long time such as Paxil. Paxil was introduced in 1993, seventeen years ago. It's a familiar medication, commonly prescribed, and if used as directed can have wonderful benefits — no one is contesting that it has been used successfully.

Yet just as with drugs like Tylenol and aspirin, the potential for harm remains high. Paxil has been linked to birth defects when taken by mothers in authoritative, peer reviewed studies. The link is not "possible," it is a demonstrated phenomenon. In many cases, there may be no side effects whatsoever, but that does not dismiss or invalidate the findings of studies published in such critical press as the British Medical Journal.

Consider that Glaxo — the company that produces Paxil — has paid nearly $1 billion dollars in lawsuits to settle claims related to its drug, according to court records and independent research. Billion is a figure dealt with by large banks, government institutions and other large bodies, yet this represents settlements paid out to individuals and families harmed by this medication.

In short, lawsuits related to drugs like Paxil aren't small matters, and they should not be quietly forgotten simply because of the age of the drugs involved. Indeed, we should look most closely at these long-lasting suits and cases, because they often can provide the greatest basis of evidence and the strongest validation for efforts to protect the injured and the consumer.

Approved for use in the United States in 2001 and 2006 respectively, Yasmin and Yaz are oral contraceptives (birth control) manufactured by Bayer Healthcare. The generic name is Ocella. Yaz is a low-dose form of Yasmin. Both drugs contain Ethinyl Estradiol (estrogen hormones) and Drospirenone (chemical progestin).

Following heavy marketing in the United States, Yaz became popular not only as a contraceptive but for treatment of pre-menstrual syndrome, commonly known as PMS, and pre-menstrual dysphoric disorder (PMDD).

In an eight-page letter dated October 3, 2008, the Federal Drug Administration (FDA) stated that the company's commercials served to "undermine the communication of important risk information, minimizing these risks and misleadingly suggesting that Yaz is safer than has been demonstrated by substantial evidence or substantial clinical experience."

Conditions Resulting From Use

Dangerous side effects have been associated with the use of Drospirenone, including thrombosis and hyperkalemia, as a result of the antimineralocortoid properties that accompany Drospirenone's diuretic formula. Potassium levels can go to dangerous levels and can lead to stroke, blood clots, deep vein thrombosis (DVT), pulmonary embolism (PE), liver or kidney failure, gallbladder disease, sudden cardiac death and other problems.

DVT is blood clots in the legs while PE is blood clots in the lungs and dehydration. The effects of PE, especially dehydration, can also lead to gall bladder disease or kidney stones. No other contraceptive in the United States uses Drospirenone in this manner.

Potassium helps to control cardiac rhythm and an imbalance of it is known to disturb the rhythm. Disturbing the heart's rhythm can result in heart attack, stroke, blood clots, DVT, PE and death. In fact, potassium is one of the drugs the government uses in executions.

Ischemic stroke, which is caused by an artery blockage, and hemorrhagic stroke, which is caused by bleeding in the brain, have both been reported by women who have used Yaz or Yasmin. These women had no prior health conditions yet suffered a stroke following the use of Yaz, Yasmin or Ocella.

Get Legal Help

Women who have suffered a serious injury as a result of using Yasmin, Yaz or Ocella, may qualified to receive compensation.

You can discuss your case with a qualified attorney at no cost to you. If a settlement is secured, they attorney will take a percentage of the total settlement and associated costs. You will never receive a bill, so you have nothing to lose.

Some of the most important studies are recent ones, if only for the immediacy of their information. One such study, completed in 2010 and published in the March issue of Pediatrics, suggests a link between babies exposed to antidepressants in the womb and certain developmental delays.

Specifically, the study examined delays in sitting up without support and walking for children exposed to the antidepressants in the second or third trimester, as opposed to children who were not exposed. Children exposed to SSRIs and Effexor, an SNRI, delayed sitting up as much as 16 days after unexposed children. In some cases they didn't walk until a full month later than the average for children whose mothers hadn't taken the antidepressants.

Similarly, the affected children had far greater difficulty keeping themselves occupied for more than 15 minutes, as opposed to unexposed children. According to researchers, this study suggests a "permanent or reversible effect of antidepressant exposure on fetal brain development." They further commented that the timing of exposure based on trimester might also have an effect.

This is, of course, in addition to other birth defects that have been linked to SNRI and SSRI antidepressants such as Effexor. These include brain and spinal cord defects, abnormally-shaped skulls, defects in the abdominal wall, clubbed foot, deformity of the anus and cleft lips or palate, or both. Some or all defects might be observed in children exposed to the medicines.

Effexor and other SNRIs act slightly differently than Paxil and SSRI antidepressants. SSRIs only act on one neurotransmitter, serotonin. SNRIs like Effexor and Pristiq act on serotonin and norepinephrine. Both classes are used to treat major depressive disorders. Mothers diagnosed with depression while pregnant are advised to do careful research before going on an SNRI or SSRI antidepressant during late pregnancy, because of the potential risks.

Another class action suit has been filed against Johnson & Johnson, bringing allegations that the antibiotic Levaquin caused a Texas resident to suffer permanent tendon damage.

Thirty-one-year-old Lisa Presley filed her suit on April 8th in the Eastern District of Texas U.S. District Court. The suit names Johnson & Johnson, Ortho-McNeil Pharmaceuticals Inc. and Johnson & Johnson Pharmaceutical Research and Development LLC as defendants to Presley's claim.

The focus of the lawsuit is the claim that Presley's severe and permanent injury to her Achilles tendon was caused by taking Levaquin. All of Johnson & Johnson's Levaquin carries FDA mandated warnings, explaining the risk of tendonitis and tendon injuries such as tears or bursting when taking the medication. However, Presley asserts in her lawsuit that the risk of these potentially severe injuries is not accurately stressed by the labeling and literature associated with the product.

Levaquin, on the market since 1997, is part of the fluroquinolone class of antibiotics. It is a common tool used to treat infections such as bronchitis and sinusitis, as well as other bacterial infections such as prostatitis and upper urinary tract infection.

In her suit, Presley accuses Johnson & Johnson of negligence, failure to warn, fraud, breach of express and implied warranty, knowing violation of consumer protection laws in promoting a known defective product and unjust enrichment. She asserts that the entire class of fluroquinolone drugs is known to cause serious and adverse side effects, and that earlier versions have been withdrawn from the market while Levaquin has not.

The Texas native is asking for her medical expenses and loss of income to be reimbursed by the defendants. She also requests compensation for a number of factors such as her ongoing disability, disfigurement, anguish, pain and suffering and physical limitation.

Similar drugs in the same class, such as Cipro, have been known to cause similar effects to Levaquin.

According to recent studies, women who take Paxil during their first trimester are at an increased risk of their child developing birth defects. Two independent studies of women taking Paxil during the first three months of pregnancy showed those women were anywhere from one-and-a-half to two times as likely to have a baby with heart defects than either women in general or women on other antidepressants. Further studies showed a strong link between Paxil and persistent pumonary hypertension (PPHN), a rare but dangerous birth defect that can lead to organ failure and death.

The FDA issued an alert in 2005, warning consumers of the increased risk of Paxil for birth defects in the first trimester. The majority of the abnormalities were septal defects, which are holes in the walls of heart chambers which interfere with the healthy flow of blood. Such defects do range in severity from minor, self-correcting abnormalities to those which are quite severe, requiring surgical intervention.

The link to PPHN first was published in the New England Journal of Medicine a few months after FDA issued the alert on Paxil and its potential for defects. This study showed evidence that women using Paxil after the 20th week of pregnancy were six times more likely to have a child with PPHN than women who used no antidepressants.

PPHN is a serious condition that can prove fatal even with prompt diagnosis and swift intervention. Permanent damage to speech, hearing and the brain are often common even in those who survive.

The FDA has asked the manufacturer of paxil to change the drug's pregnancy category from C to D, which indicates that studies show there is a significant risk to the fetus.

source: http://www.adrugrecall.com/paxil/birth-defect.html

Jeff Lowe, a partner with the St. Louis law firm Carey, Danis & Lowe, was quoted in a recent Lawyers & Settlements article discussing the link between the antidepressant Paxil and birth defects.

In the April 27 article, Lowe urged mothers who took Paxil during the first trimester of their pregnancy and whose children were born with birth defects to consider contacting an attorney.

The primary birth defects linked to Paxil, made by GlaxoSmithKline, are persistent pulmonary hypertension of the newborn (PPHN) and cardiac defects.

Paxil is part of a class of drugs known as selective serotonin reuptake inhibitors. Lowe notes that initial studies did not find a connection between SSRIs and birth defects.

"Then some studies began finding a connection between Paxil and birth defects such as PPHN and cardiac defects. GlaxoSmithKline had a database they were keeping that was based on their own studies. In 2006, they published their online database, which demonstrated a higher risk in major malformations for infants exposed to Paxil in the first trimester. Additional independent peer reviewed studies confirmed the link.

"Paxil's warning was changed in 2005 [to include the risk of birth defects]. There was an FDA warning letter issued on December 8, 2005 and a Dear Doctor letter issued in September 2005."

Lowe noted that since the child is the one most impacted by the allegedly defective drug, in most states the time limits imposed on when suit may be filed often doesn’t begin to run until he or she reaches 18 or 21.

If you or a loved one has experienced a Paxil birth defect, contact the attorneys of Carey Danis & Lowe. We can help. Carey Danis & Lowe is a national law firm that represents individuals injured by America’s largest corporations.