Product Liability Attorney Blog

Recently, a very large study conducted in Canada suggested that there is a strong link between the prescription of Paxil to patients 65 and older and the formation of cataracts. Encompassing 19,000 patients who were compared to a control of 190,000 patients, the study showed that Paxil could increase the risk of cataract formation by a dramatic 23 percent, nearly a quarter higher than the control group.

This all comes on the tail end of a series of major lawsuits, some resolved and some still pending, against the makers of Paxil. These suits didn't have anything to do with vision or cataracts, but rather with allegations that this medicine caused birth defects or suicidal ideation and actions. Ultimately, the makers of Paxil set aside more than $2 billion specifically for handling legal troubles ongoing to that date.

The point here is that as legal matters continue to bring attention to the difficulties with a particular medicine, that medicine is likely to come under more scrutiny in general. The nature of the process of scientific review means that the drug will then be at the center of a new host of observations, such as this new study linking it to cataracts and eye damage in elderly patients.

This is one of the hidden benefits of the litigation tool when applied against a big pharma company. It isn't just about seeking money for harm done, though restitution is often foremost on individual clients' minds. It's also about holding the companies accountable in general, and emboldening others to take action in response to harm that has been done to them. The more information that comes to light, the more consistently lawyers and legislators can bring pressure to bear against companies that are in many ways above conventional accountability. The information is all converging together to show the makers of Paxil that a few settlements are not going to close the case entirely.

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Bayer is releasing a new form of birth control pill called Natazia. Natazia is offering a new and daring approach, Bayer says; it works differently than other contraceptives. In short, it all sounds a bit like things we've heard before.

Yaz and Yasmin, when they came out, advertised themselves as a “different kind of hormone” with a series of advertisements that touted their efficacy at everything from stopping unwanted pregnancy to offering shorter periods and curing acne. They were marketed as wonder drugs that could do it all, and in a trendy, safe package to boot.

Of course, the FDA warned Bayer several times for promoting the drugs with misleading and dishonest advertisements. Bayer was found to have promoted their drugs for causes they weren't certified to treat, and for having implied the drug was uniquely safe compared to others.

Fast-forward a few years: Now we have studies performed in the Netherlands and Denmark that suggest these contraceptives might be responsible for higher blood clotting rates among patients who take them. In simple terms, this could have a direct impact on the heart and brain health of the patients — these clots can get into the heart or the brain, causing severe damage when the blood flow is blocked.

Now this new Bayer contraceptive is on the scene, promising to be different and more dramatic. But all pill contraceptives are based on the same basic treatment — hormones. If it's the hormones that are contributing to an increased clotting factor, then what exactly makes Natazia especially different? Yes, there's a combination of pills that must be taken instead of a single, risk-it-all medicine. And there is no immediate evidence that Natazia is particularly more dangerous than Yaz or older medicines. However, given the track record of Bayer in handling its previous information campaign, young ladies are well advised to seek out all the facts they can before jumping on board with the newest medicine.

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Paxil and other drugs in the SSRI class work because they do a specific thing and do it very well: They prevent the brain from reabsorbing the mood-elevating chemical serotonin, leading to an overall increase in someone's sense of well being. Thus, the general perception is that they work by stopping people from becoming unhappy.

However, recent research has brought this matter into question. Previously, a study was announced that suggested Paxil and related medicines might actually be altering the fundamental personality of the person, rather than simply treating a symptom. A further study recently conducted may well bear this out.

Researchers at the Lewis-Seglig Institute recently performed a study on the effect of a massive dose of Zoloft, a similar SSRI to Paxil, on yeast cells. The cells that survived the exposure were demonstrated to have been changed at a certain level by exposure to the drug.

This suggests that SSRIs such as Paxil and Zoloft may affect the body in multiple ways, and have several different paths by which they elevate a patient's mood and help them overcome depression. This news is, of course, good — more knowledge means that the medicines' effects can be better understood and refined. However, there is also room for caution and consideration about the results.

Currently, there are a number of lawsuits pending about the potential link of SSRIs and their sister class, SNRIs, to the formation of suicidal thoughts in the young and to the development of birth defects in the children of women who took antidepressants while pregnant. Many of the defenses against these accusations state that there is no clearly-demonstrated causal link between the medicines and these undesirable effects. However, studies such as these raise the point that we don't know all there is to know about this class of medicines, and that science may yet demonstrate the case more conclusively.

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In most of the Levaquin cases brought up so far, the information has revolved around lawsuits that have been filed by various patients affected by the dangerous antibiotic against manufacturers Johnson and Johnson. A new discussion has been opened up, however, that is taking a distinctly different approach. Forty-five-year-old John Fratti, a former Levaquin patient, has directly engaged the Food and Drug Administration to discuss what he considers inadequate efforts on J&J's part to fully inform people about Levaquin's black box warning pertaining to joint injuries and tendon ruptures.

Fratti's prescription of Levaquin has left him in significantly reduced health compared to just 4 years ago. Once reasonably fit, he now has to take numerous prescription painkillers to manage the pain from his injuries. There is even evidence to suggest that he suffered partial brain damage from the medicine. Thus, if anyone has a case to bring, it is Mr. Fratti, and to be sure he did file a lawsuit against the makers of Levaquin last year.

However, he isn't restricting his approach to the reparations he intends to receive from Johnson and Johnson. He recently made a formal presentation to the FDA about the nature of Levaquin's effects on his life, and the lack of information available about the dangerous side effects of this antibiotic. He stressed a desire to see the information pamphlet included with Levaquin contain more information about the black box warning and just what the warning means.

Showing that unusual approaches and out-of-the-box thinking can have a positive effect, the FDA stated that they were impressed with Mr. Fratti's arguments, and recommended he work with the FDA's Patient Representative Program. They also stated that they were definitively looking into his concerns and intended to address them directly, in the best way they could manage. This is an encouraging sign for people who have the intent and the skill to organize their resources and get the word out about Levaquin's true side effects.

The FDA first issued a safety advisory about Paxil in 2005, commenting on the potential relationship between the drug and birth defects when prescribed to pregnant mothers. The announcement came following the early results of a particular clinical study attempting to examine this very phenomenon.

It was early this year, nearly five years later, that Paxil's manufacturer finally settled out of court for an amount pushing into the billions of dollars on just such a number of cases, though the settlement was structured so that the company in no way accepted the claim that this medicine was specifically responsible for the defects.

As part of the announcement, Glaxo Smith Kline was asked to change the labeling on Paxil to indicate it had been moved from a category C pregnancy rating to a category D rating, reflecting the increased risk when taking the medicine during pregnancy. Yet again, in the recent settlement Paxil declined to take responsibility for the birth defects.

This half-decade of elapsed time, and the fact that Paxil is still on record denying the potential relationship between their medicine and the onset of birth defects, illustrates just how hard it is to resolve these kinds of cases.

They aren't as simple as a more direct criminal case, in which there is a specific event that happened with evidence lying about to be gathered. Even a retrospective study, wherein scientists simply look at existing data, takes a long time. For example, they would have to look at a number of women in a given population who gave birth. Then they'd need to see how many were or weren't on Paxil, then how many actually admitted to taking it consistently, and then how many had children born with birth defects — and even then they still have to compare and quantify the numbers.

Proper clinical trials, in which double blind studies are done specifically on women taking the medicine, are even more difficult to organize and take up a great deal of time.

So while it is not easy to look at the sheer scale of time involved in finding relief for these mothers and their children, it is perhaps easier to understand when considering the massive amount of effort required to get solid facts.

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A lot of talk following Yaz and Yasmin has revolved around the contraceptive Yaz, produced by drug company Bayer. The FDA cited Bayer two years ago for the twin offenses of promoting the drug for uses it was not yet tested or approved for, and for downplaying the potential risks of the medicine. Since that time, a number of cases have been filed alleging links between Yaz and rising blood potassium levels that have lead to heart attacks and strokes in women on the medicine.

The offense in question is covered by the FDA's Truthful Prescription Drug Advertising and Promotion program, also called the Bad Ad program. Bad Ads is an organized set of guidelines intended to hold pharma companies such as Bayer accountable in television and online advertisement.

Guidelines from the Bad Ad program cover a lot of ground, and should give consumers more ammunition when they see an advertisement they suspect breaches the guidelines.

For example, advertisements for prescription drugs are required to be accurate about the details, both positive and negative, for each medication. The commercials also can't go against the prescription guidelines set out by the FDA. Furthermore, only evidence supported by clinical trials should be used in the commercials. Thus the Yaz “Balloons” commercial fails on all three counts — it downplayed the potential risks that were coming to light (point one) and promoted Yaz for uses the FDA had not put its approval to (points two and three).

The FDA assures consumers that if they wish, they can report a violation anonymously. In the case of a commercial on television, this is often a good course of action because just alerting the FDA will prompt it to see the commercial and begin asking questions. On the other hand, should the suspected breach be discovered during a private presentation at a convention or meeting, then the FDA does encourage whistleblowers to provide contact information so the case can be followed up more effectively.

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Teens are one of the fastest-growing groups diagnosed with depression in the United States. The teen years often are some of the most turbulent in a person’s life; they have many of the responsibilities of an adult (and can, indeed, be tried as one if they commit a crime), but don't yet have all the privileges of adulthood. Their bodies are undergoing dynamic and exhausting changes, their social worlds are becoming more complex, and the need to make decisions about their future looms large. Oh, and the news is going on and on 24-7 about the disastrous economy, world events and social strife. Is it any particular wonder depression manifests around this time?

Studies are continuing to raise evidence that prescriptions of antidepressants may be altering the fundamental personality of the person taking them, rather than alleviating simple moods. Other studies are demonstrating the link between SSRI prescriptions and suicidal thoughts and actions. This is something that should be worrisome to doctors and parents.

Given the fact that antidepressants continue to be the most-prescribed drugs in the United States, the statistic that teenagers who receive SSRI prescriptions are more likely to consider or act on suicidal impulses should be equally chilling. In a study of 48 teens with depression, 58 suicidal events occurred — 10 more attempts at suicide than there were teenagers in the study, to emphasize the point. Nearly 60 percent of teens in the study expressed suicidal thoughts early in the case.

On the other hand, teenagers who received a combination of talking therapy and prescriptions did much better, and had shorter treatment times than patients who were relegated to one or the other. Perhaps it really is time to reconsider just how many of our teens we're prescribing these medicines to. Is it really necessary to emphasize a Prozac culture, or is it time that we took the fairly simple expedient of giving these young people someone they can talk to without judgment?

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The controversial SSRI antidepressant Paxil is once again under scrutiny, this time in a lawsuit filed by Louisiana residents Andrea and Brad Frischhertz. The Frischhertz both have filed individual lawsuits and one on behalf of their child. The lawsuits were filed on the 1st of July against GlaxoSmithKline (GSK), and on the 29th GSK asked and was granted a removal of the case to federal court instead of local courts.

Andrea Frischhertz claims in her suit that she was prescribed Paxil as a means of treating her depression during her pregnancy between 2004 and 2005. She further states adamantly that she questioned her doctor at length about the possible risks of an SSRI on her pregnancy, and that her doctor assured her Paxil was entirely safe.

Following the pregnancy, the Frischhertz baby was unfortunately born with birth defects that cannot be corrected, including the most significant — an underdeveloped cardiac septum. This weakness in the wall separating the chambers of the heart is a serious condition that easily could lead to physical disabilities and possibly death for the child.

Andrea claims she didn't immediately link the birth defects to the SSRI she was prescribed. She states that she only realized the potential link later, when she saw a 2009 commercial that explained the potential risks of Paxil to pregnant mothers.

The Frischhertzes are accusing GlaxoSmithKline of producing a product with defects in its design and construction, negligence and breach of warranty, as well as assorted failures to properly warn patients of the potential effects of the medicine. The compensation they are requesting includes the usual slate of damages in medical cases — they want recompense for the personal injury to their child, the medical expenses required to date and loss of income. Furthermore, they want acknowledgment of their mental anguish and distress and coverage for the court costs and fees required to bring the case to suit.

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A pair of additional cases in the ongoing litigation effort against the various manufacturers of Reglan and its generic formulations has been filed, this time in a New Orleans federal court. Attorney Allen Berger is representing both clients, who have filed against several different companies in this matter. The first is Leslie Keeper, who has filed suit against Qualitest Pharmaceuticals, and the second is Ellen Austin. Austin is filing complaint against three companies, specifically Actavis, Actavis Elizabeth and Watson Pharmaceuticals.

Both Austin and Keeper have alleged that they developed Tardive Dyskinesia as a result of being prescribed generic formulations of the antacid-control drug Reglan. Reglan is increasingly being demonstrated as a cause of this condition, which causes distressing and exhausting involuntary movements of the body. Furthermore, there is strong evidence that Reglan results in potentially permanent damage to the nervous system, as this condition never goes away in a significant percentage of patients afflicted with it.

The lawsuits also allege that the companies named distributed false and misleading information. Both plaintiffs assert that the defendants did not provide accurate details about the potential side effects of the medication being prescribed, and did not make a good faith effort to sincerely warn about the potential dangers of Tardive Dyskinesia as a result.

No date has yet been set for the trial, but both plaintiffs are requesting a jury trial in the matter. Each plaintiff is seeking recompense in the form of medical expenses as well as coverage for pain and suffering, mental anguish and physical disfigurement. This is in addition to requesting a judgment to repay their loss of earnings to date, their loss of ability to earn in the future, their overall physical impairment as a result of the medication and, of course, the costs of the court proceedings and a certain portion of interest.

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In a recent article in Psychology Today, psychiatrist Mark Sichel discussed the potential link between overprescription of medications in the antidepressant category and the need for drug companies to sell their product and make money.

The first and core line of the article is, "Drug companies have been instrumental in promoting psychiatric diagnoses designed to market drugs."

This claim is a powerful one, and one that has many patients and caregivers concerned. Of course, as Sichel points out, there are many valid reasons to take an antidepressant. Clinical depression or a major depressive disorder can rob people of the energy to even function in their lives without some medical help. Bipolar disorder is utterly exhausting, and can drive sufferers to extreme lengths in order to survive their terrifying mood shifts. There is no disputing the role of medicine properly applied in society.

However, is it possible that we are overmedicating for our problems? Sichel raises the point that shyness is sometimes diagnosed as a mental disorder, and that the mourning process following a particularly heartfelt death is lumped in as major depressive disorder. Pharma companies do, of course, have a vested interest in demonstrating that their medicines are a balm for many different problems.

Couple this with the recent revelation that nearly a third of medical studies involving antidepressants are not published where they can be readily discovered by doctors or the public, and the picture becomes more sobering still. After all, these are medicines that have been suggested to cause serious birth defects and potential aggravation of suicidal thoughts in adolescents. We as a society would be right to stop and take a long, hard look at the companies that are promoting these medicines to us. It is not a crime to ask if we are overmedicating. This is not a matter of overreacting and refusing to vaccinate children based on one faulty study — antidepressants are one of the most profitable classes of drug in the United States and deserve our careful scrutiny.

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In the past months, an increasing amount of attention has been directed at antidepressants that are prescribed to pregnant women. Cases and studies linking these prescriptions to spontaneous abortions and miscarriages continue to grow, as do cases positing that this class of drugs has a hand in causing birth defects. One such birth defect is the particularly nasty PPHN, a condition in which the infant body cannot properly process oxygen once detached from its mother’s umbilical cord. It often requires surgical intervention, and easily can be fatal to the unfortunate newborn afflicted with it.

The problem is, depression is a serious and pervasive condition. It is not something that can be ignored, and telling someone to “just get over it” or “cheer up” is not a solution. There is increasing evidence that depression is affected by chemical imbalances in the brain. Add to this the fact that a woman's hormonal balance is always thrown into odd states by pregnancy. Pregnant mothers can swing between ecstatic and melancholy moods quite drastically. Pregnancy is exhausting, creating physical and mental strain, especially in a mother worried about the health of her child.

This kind of mental strain can affect the pregnancy. It's well known that infants are affected by the health of the mother, and if depression causes a mother to neglect caring for herself during the pregnancy, how can it be expected that this will not in turn affect the unborn child?

Thus, an outright ban on prescribing antidepressants in the SSRI or SNRI class is out of the question. But so is blanket permission to prescribe them to all pregnant mothers. Rather, the best course is for doctors to remember that each pregnancy is a unique combination of health, history and habits that need to be addressed on an individual basis. Patients also need to educate themselves about alternatives they can pursue so they can avoid an undesirable outcome.

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Warnings about medicines take a long time to get onto the labeling. Pharma companies understandably want to minimize the size of the warnings section on their best medications — why scare off patients? If the medicine works in the bulk of cases (and there is no argument that Reglan does so), why put so much emphasis on a rarity of occurrences? This attitude, coupled with the reluctance to come forward or lack of understanding that some patients display, is the reason that it takes so long for official recognition of certain conditions to come into being. In other cases, the company settles with the plaintiff, which is both parties' right, but on the condition that nothing further be said about the problem. Again, this delays the presentation of vital information to the public.

To this end, consider the following list of side effects from Drugs.com, a popular web source for information about medications. Seek medical attention right away if any of these severe side effects occur when using Reglan:

Severe allergic reactions (rash, hives, itching, difficulty breathing, tightness in the chest, swelling of the mouth/face/lips/tongue, unusual hoarseness); abnormal thinking; confusion; dark urine; decreased balance or coordination; decreased sexual ability; fast, slow or irregular heartbeat; fever; hallucinations; loss of bladder control; mental or mood changes (depression, anxiety, agitation, jitteriness); seizures; severe or persistent dizziness, headache or trouble sleeping; severe or persistent restlessness, including inability to sit still; shortness of breath; stiff or rigid muscles; sudden increased sweating; sudden, unusual weight gain; suicidal thoughts or actions; swelling of the arms, legs or feet; uncontrolled muscle spasms or movements (of the arms, legs, tongue, jaw, cheeks or twitching/tremors); vision changes; or yellowing of the skin or eyes.

You will see that toward the end of the side effect list there is a mention of swelling of the limbs and uncontrolled motions, but not that these are connected with Tardive Dyskinesia. Later in the article from which this quote arises the matter is addressed, but well down the page and after several lists of other matters given more importance. This shows the general lack of urgency in the public mind about the potential risks that this condition can cause when Reglan is taken for too long.

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People often wonder if their input into a major case like the numerous lawsuits versus Yaz and Yasmin will matter. This kind of hesitation is a result of not understanding just how powerful the cumulative effect of many stories can be. Yes, it is often the bigger stories — such as that of a young Broadway actress taking Yaz and suffering an unexpected stroke — that gain the most press. However, no celebrity can be so famous as to single-handedly force a company into accountability. That task lies with the many people who are consistently willing to come forward and give their stories concerning the matter.

Illustrating the power of cooperative effect, consider that it has been approximately two years since Yaz was advertised with a popular balloon metaphor commercial, where the balloons were marked with words such as “irritability” and the like. The comments section on the video, which is up on YouTube, is rife with commentary about personal bad experiences with the medicine. These include comments from women who heard bad press and are staying away from the contraceptive, as well as women who describe painful gallbladder problems and surgeries that were necessary after they took the medicine.

Yaz' manufacturers were cited for a failure to provide patients with sufficient information about the risks of this drug, and are being required to elaborate on the potential dangers of blood clots, heart complications, stroke and gallbladder damage that may result from extended exposure to the medicine. As of the time of this writing, more than 1,000 lawsuits are pending against Yaz and its various generic formulations. This is not a situation that Yaz can long ignore.

Another pharmaceutical giant, Glaxo Smith Kline, has set aside billions of dollars to deal with its associated lawsuits, and the makers of Yaz are sure to have their eyes on the mood of public opinion as touching on medical manufacturers.

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Much has been made of the effect Paxil has on unborn children, particularly during the first trimester of the mother's pregnancy. However, there is always more to the story than the obvious. For example, Paxil has long carried warnings that it has been linked to potential aggravation of suicidal thoughts, particularly in teenage patients. But a new study has recently been published, explaining that there are still more affects that antidepressants in Paxil's class may have on patients.

This study is interesting because it was administered to twins. Twin studies are important because they allow doctors to see the different ways that treatments affect closely-related individuals. Thus, even though the sample was fairly small at 240 patients, the fact that these patients were all twins allows for specialized data to be extracted, anyway.

The study divided the groups into patients put on Paxil, patients put on a placebo and patients who received talking therapy. The results followed expectations in one way, in that those patients who received therapy or medication did better than the control group on the placebo. However, the study wasn't simply measuring overall progress, but effect on certain traits, such as extraversion. The study showed that patients on Paxil showed markedly increased levels of extraversion versus the control group.

This may not seem like a problem right away; after all, if the medicine helps them be more outgoing, what's wrong with it? However, it does indicate that Paxil may not only be acting on the depression and its chemical causes. Instead, doctors are concerned that perhaps it's causing changes to the patient's entire personality. This would lend credence to the notion that the medicine can cause the formation and aggravation of suicidal thoughts in certain patients.

The study is too small to make any serious generalizations from the matter, but it does represent a new way of looking at the problem, and new information is always important in holding pharmaceutical companies to task in the effects of their medications.

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