In July, the FDA issued a Form 483 to Johnson & Johnson about the Lancaster plant. A Form 483 notifies a company that the FDA has found lapses in its manufacturing practices. Of the 12 violations of good manufacturing practices that the FDA found in Lancaster -- including faulty lab work, lax hygiene and recordkeeping, and failure to follow up on consumer complaints -- five overlapped with those cited at the Tylenol plant in nearby Fort Washington, Pennsylvania. The medications from the Lancaster plant were the subject of several kinds of complaints from consumers, including "mint-flavored Pepcid tablets mixed inside the same bottle as berry-flavored tablets" and "lack of effect" in one lot of products. In addition, the FDA report cited "unlabeled test tubes filled with product sitting out on a counter" and failure to "properly clean utensils used in the drug making process," suggesting that medications could become contaminated with foreign substances or with other medications. Staff at the manufacturing plant did not follow up to investigate and correct any of these problems, the FDA report said.

Since they did not follow up on the problems, staff at the plant would have been unable to find out whether there were serious safety concerns that consumers needed to know about. In my view as adangerous medication attorney, this is troubling from a consumer safety standpoint as well as legally, since drug manufacturers are responsible for warning consumers about any safety concerns related to their products. Consumers should continue to be wary of medications produced by Johnson & Johnson. If only one plant had these problems, we might be able to dismiss them as isolated to bad management at one site, but the problem appears to be much more widespread. Even though the medications manufactured at the Lancaster plant have not been recalled, a recall may still be coming. After all, the recalls involving the Fort Washington plant's medications were delayed in similar ways and have only gotten bigger as time has gone on.

These issues raise the question of what Johnson & Johnson has been doing instead of paying attention to its manufacturing practices. Have efforts to create new products or expand existing products' reach edged out the basic safety concerns that should be at the forefront of any medical manufacturing business's operations? Or, worse, could the company have intentionally ignored problems in order to avoid bad publicity? Ignoring safety for any reason would be dangerous, legally and morally. Consumers can be hurt by lax manufacturing practices, as KV Pharmaceutical here in St. Louis found out. And those who were hurt have the right to recover financial compensation from the defective product's manufacturer. Drug manufacturers who fail to warn consumers of risks that they know about can be liable in lawsuits filed by those consumers. This allows a consumer who incurs medical costs, misses work or is unable to work, or whose quality of life suffers because of harm caused by an over-the-counter or prescription drug to require the drug manufacturer to pay these costs.

Speaking as a href="http://www.jefflowepc.com/lawyer-attorney-1176136.html">pharmaceutical liability attorney, I believe it's good that FDA staff members and advisors are debating Avandia's risks, because that makes it more likely that they'll consider all relevant viewpoints. However, Thomas Marciniak, MD, an FDA staff reviewer, said that the debate over Avandia has turned into a turf battle between the drug's supporters and detractors, with some newcomers to the agency in the middle. Marciniak said higher-ups at the FDA reward positive assessments of drugs, while negative assessments lead to "endless meetings." Another FDA staff reviewer, David Graham, MD, pointed out that the members of the FDA advisory panel voting on Avandia's fate seemed to have been chosen to ensure a favorable outcome for Avandia. In addition, Graham alleged that higher-ups at the FDA leaked information to a popular medical blog about an Avandia study he had conducted in order to delay or prevent the study's publication.

It's unclear why the FDA wants to keep Avandia on the market, but it’s clear why GlaxoSmithKline, Avandia's maker, might be interested in doing so. We’ve already seen that the company is deeply invested in protecting Avandia. It's a profitable drug, and type 2 diabetes rates have been drastically increasing along with obesity rates. Obesity is considered a leading cause of type 2 diabetes. This means that GlaxoSmithKline stands to rake in increasing profits from Avandia as an increasing number of people need treatment for type 2 diabetes. From my perspective as a defective drug lawyer, this only adds to the questions about why the FDA seems to be protecting Avandia's place on the market.

The latest recall involves medications that smell moldy or musty because they have been in contact with 2,4,6-tribromoanisole, or TBA, a pesticide and flame retardant chemical used in pallets for shipping and storing the medicines. According to Consumer Reports, people have reported "experiencing nausea, stomach pain, vomiting or diarrhea after taking the contaminated medications." Beyond those symptoms, the longer-term health ramifications of exposure to TBA are unclear. The medications recalled in July actually represent an expansion of the late 2009 recall; they were belatedly discovered to have been part of the same group of medications. Consumer Reports did not mention a reason for the months-long delay.

It's important to point out, from my point of view as pharmaceutical liability attorney, that there are two different kinds of problems being addressed by these recalls. That means that there's not just one thing going wrong in Johnson & Johnson's manufacturing plants, but a whole series of problems. While the November-January, June and July recalls relate to TBA contamination, the April and May recalls by McNeil relate to metal particles present in medications. There's also the serious issue of McNeil's having delayed informing the FDA of the problems until a year after the company knew about them.

The U.S. House Oversight and Government Reform Committee launched an investigation after the McNeil recalls were issued on April 30 to look into what Representative Edolphus Towns, D-NY, chairman of the oversight committee, called "wide-ranging problems at Johnson & Johnson.” This investigation might help protect consumers and get to the bottom of what caused 775 instances of "serious side effects" related to recalled McNeil drugs, including 30 deaths.

Consumers should not have to wonder whether they're better off suffering through a headache or allergies or taking an over-the-counter medication that could make them feel even worse. That's why the law requires drug manufacturers to warn consumers when their products aren't safe to use as intended. As we've seen, McNeil and Johnson & Johnson have a spotty record of complying with that requirement. But consumers don't have to just rely on the FDA to send warning letters and fix the problem from the top down. If a defective over-the-counter medication hurts someone who took it -- expecting that it would be safe -- that person can fight back against the drug manufacturer who failed to warn consumers of the drug's potential danger. The victim can sue the manufacturer for financial compensation for their injuries.

After all, the company itself cannot be relied upon to be completely unbiased in the reporting of the medicine it produces. In the case of Yaz, the story is incredibly one-sided. Media reports have focused heavily on how the medicine is simple, effective and almost trendy to take. Similarly, there are reports that it can help reduce or even cure young adult acne, as well as help manage weight. At the risk of sounding cliché, these are concerns that appeal directly to many young women, so the appeal of the drug immediately is apparent.

Any mention of its side effects, on the other hand, is few and far between. Recently a certain Broadway star sued because her experiences with Yaz led her to have a stroke at a very young age. This brought a great deal of publicity to the matter, but what about the young women who were exposed to these conditions before a star was? Why wasn't their story enough to warrant at least a warning label?

The issue is a difficult one. The studies that have been done aren't ironclad conclusive; more tests are required to make sure the science is accurate and inarguable, and these matters take time. However, it is increasingly clear that taking contraceptives such as Yaz can raise blood potassium levels. This, in turn, can create complications when other medicines, such as commonly prescribed NSAID painkillers, are introduced into a compromised system.

What's worse is that the symptoms are so quiet, and nothing can be done about them in some cases. The strain on the heart might not be noticed until a heart attack. In the meantime, patients are urged to talk to their doctors and see what their options might be.

Keith Webber, Ph.D., is the deputy director of the Office of Pharmaceutical Science in the FDA’s Center for Drug Evaluation and Research. This is the body that makes determinations on drugs' safety and warning labeling concerns. Webber was quoted on the FDA website as saying, “The approval of this widely-used antidepressant is another example of the FDA’s efforts to increase access to safe and effective generic drugs."

This is obviously the case. There is nothing inherently wrong with generic medications. Generic labels of acetaminophen, ibuprofen, lansoprazole, omeprazole and other drugs that are available over the counter indisputably have improved the quality of human life.

However, this blog has kept track of the many continuing problems that are present in SSRIs and SNRIs like Effexor and Paxil. These problems have included the on-the-label acknowledged risk of increased suicidal thoughts and ideation, as well as a host of alleged links between pregnant mothers prescribed the medication and the formation of birth defects in their children.

Indeed, in the same press release where Webber cites the decision as part of the FDA's desire to make safe drugs available, more sobering information follows: Generic venlafaxine hydrochloride will have the same safety warnings as Effexor XR.

Considering this medication still has cases pending against it pertaining to both the current acknowledged problem of increased suicidal thoughts among young patients and the potential of birth defects caused by the medicine, it gives one pause to think that the FDA is promoting it as “safe and effective” when giving permission for generic use.

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Avandia already carries a black box warning, the FDA's strongest warning, that lets patients know the drug has been associated with heart failure. But in light of the two newly published studies, FDA regulators are questioning whether Avandia should be pulled off the market entirely because of its association with heart attacks. In one of the studies, published in the Archives of Internal Medicine, Dr. Steven Nissen of the Cleveland Clinic added 14 more studies to the 42 on which he performed a meta-analysis. This expanded and updated analysis confirmed his 2007 finding that taking Avandia increases the risk of heart attack. The Journal of the American Medical Association published another study, by the FDA's David Graham and others, that found that taking Avandia increased the risk of stroke, heart failure and death. Graham and his colleagues' study was based on their analysis of more than 227,000 Medicare records for patients taking Avandia or Actos (another diabetes drug).

From my perspective as a dangerous prescription drug injury lawyer, it's worrisome that so many patients' lives and health remain at risk while GlaxoSmithKline continues to deny what many studies have found. The FDA plans to consider Avandia's safety in a mid-July advisory committee meeting, and the agency has noted its concerns about the drug for several years now. It's unclear why FDA officials have not taken action against Avandia already. Internal FDA reports released by the Senate Finance Committee suggest that 500 heart attacks and 300 cases of heart failure could be prevented every month if Avandia patients took Actos instead, and some observers suspect that GlaxoSmithKline had declined to inform the public of these risks, even though the company had known of them for years.

Knowing how many things diabetics have to manage in their lives to stay alive and healthy, it's hard to imagine that a drug manufacturer would choose to put patients' lives at greater risk by withholding or denying information about a drug's safety. But that may be what is happening here -- and if so, it’s illegal as well as bad ethics. Drug companies are legally required to warn consumers of risks that may come with taking their drugs. If they don't, and patients suffer because they took a drug they thought they could trust, drug manufacturers can be held responsible for the physical, emotional and financial harm that results. Diabetes already carries an increased risk of heart and blood vessel disease, so it seems unlikely that patients and their medical caregivers would knowingly choose a drug that seriously increases their risks of heart attack and heart failure.

The news certainly has been good for plaintiffs in the Paxil birth defects cases so far. Just eight months ago, a jury awarded a $2.5 million settlement to the plaintiff in the first major test case, the Kilker trial. Now, GSK has elected to cease pursuing litigation in nearly 200 of the current cases, including nearly 100 that haven't yet formally gone to court. While the terms of the settlements are confidential, they clearly were satisfying to the plaintiffs involved in the matter.

However, cases remain pending that are due resolution in the fall. Additionally, there are complicated matters involving certain parts of the case, as minors are involved. This requires the intervention of the Orphan's Court, which is sure to make proceedings move cautiously.

There are, of course, plenty of reasons to be optimistic. According to representation for both sides, the plaintiffs and defendants have shown a willingness to work together, and GSK has avoided the stereotypical “not a penny” behavior one might expect from a pharmaceutical giant.

Companies like GSK operate on budgets of billions of dollars. Amounts that seem like a lifesaving surplus to many plaintiffs are fairly small amounts to big pharma producers. More important to such companies is their reputation with the public and with agencies such as the FDA. Decades ago, the makers of Tylenol recalled their entire on-the-shelf product line because it became clear someone had tampered with the medicine and it was harming peoples' lives. They put client safety and their reputation first over profits, which is clearly the strategy that GSK has elected to pursue for the moment.

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Fourteen trials have been set to see review between now and January of 2011, all pertaining to Reglan and its side effects. Beginning April 19th, the first of the Reglan trials began in Birmingham, Alabama. Other states considering cases include Oklahoma, Arkansas, Colorado, Pennsylvania, North Carolina, West Virginia, South Carolina, Texas and California, according to the Jere Beasley Report.

Further, the signs are good for those patients involved in the lawsuits. The evidence is certainly on their side. TD has manifested in two fashions in Reglan patients, both of which can provide strong evidence for the plaintiffs in their pursuit of justice.

In the first case, the disorder presents temporarily. Some patients who are on the medication eventually develop TD, and after they stop taking the medicine it fades away. This shows a causal or at least correlated link — when taking the meds, patients display symptoms. In other cases, the disorder presents permanently or semi-permanently, as indicated in the black-box label warning ordered by the FDA. This demonstrates the potentially serious nature of what Reglan can do to patients, and is very likely to sway a jury through personal testimony from patients still demonstrating the symptoms of the illness.

So if you're considering getting legal help for a case related to Reglan, but feel that it's an issue no one is talking about, be assured that there are steps being taken and efforts being made.

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In the case of Reglan, warnings about the potential link between the medicine and Tardive Dyskinesia (TD) go back to 2004. However, most of the cases have only been set for trial in the last year or so. This leads to a discrepancy of perception: Weren't these people warned about it, and didn't they choose to take it?

However, consider that up until fairly recently, Reglan was only indicated by its parent company as linking to TD in .2% of cases. This is technically true, if you accept that the company is talking about doses taken in the short, no-more-than-12-week time span indicated on the label. However, in as many as 30 percent of cases, doctors had been prescribing Reglan for much longer periods. Correspondingly, the rate of those affected by TD was significantly increased.

Now, a great deal can be said about the doctors who prescribed Reglan for longer periods than indicated. However, the parent company was representing the information in a skewed way, giving the impression that the absolute numbers of patients was much lower than it actually ended up being. This raises doubts about the “weren't they warned?” argument.

The matter came to a head recently, with the FDA ordering a black-box warning put on all packaging for Reglan, stressing the potential effects of TD and mentioning that the ailment could be permanent. This occurred in 2009, four years after the initial warnings appeared. Thus, it is on good ground that most of the Reglan cases are going forward: There has been a disconnect in the matter, and it must be resolved.

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According to Bayer, the company marketing Gianvi has admitted that it falsely labeled the generic medication. For example, it claimed that the medicine contained Bayer's “technology” that extends shelf life. Let's lay aside the fact that a chemical pill cannot contain “technology,” only combinations of chemicals. This is more than a simple mix up; it means there's a drastic difference between the perceived shelf life of the medicine and the actual shelf life. This means more costs to be spent informing people of the problem, with no word on exactly how the information will be spread out to consumers.

Think about the recalls and information campaigns you've encountered lately. How many of them took the form of a genuine, informative commercial during prime time television or radio hours, where a large audience could hear about them? Now, how many do you recall that took the form of a small, badly-positioned flyer at the local drugstore?

This amounts to a further complication in the complicated generic question. Gianvi has the same risks of heart disease, blood clot and stroke that Yaz and Yasmin carry, yet it's marketed and advertised under a different name. Now the medicine is subject to a relabeling that focuses on the packaging, without further addressing the information that this drug has been linked to a number of cases, ranging from middle-class women to Broadway stars, of serious health complications. It results in a further muddying of the waters and a lack of quality control, all stemming from the rapid proliferation of the original medication in generic forms.

Yaz, Yasmin and Gianvi, despite the established risks and dangers taking them compared to earlier-generation progestins, continue to be some of the biggest sellers for Bayer and the generic manufacturer Teva Pharmaceuticals.

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Lupron Depot is a long-acting drug that is injected into a patient's muscle tissue once a month, but its negative effects can last longer than patients want. According to the article, 21-year-old Christina Smith of Las Vegas has suffered severe anxiety, muscle pain, migraines, nausea and thyroid damage since her single injection of Lupron three years ago. She says her doctor told her only about "menopausal side effects." Several other women in the article had similar stories, which are backed up by some medical studies. The FDA is currently reviewing the safety of Lupron as a prostate cancer drug, after reports surfaced of a dramatically increased risk of heart problems, diabetes and convulsions. The prescribing information required by the FDA also warns female patients of decreased estrogen, leading to a risk of stopped menstruation, menopause symptoms and permanent loss of bone density. It also is not recommended for pregnant women because of an increased risk of birth defects.

Despite these many risks and negative experiences, manufacturers of leuprolide acetate have continued to market the drug for existing and new uses -- most notably, as a treatment for prostate cancer. But a former U.S. Food and Drug Administration medical officer has said that Lupron's manufacturer, TAP Pharmaceuticals, did not study the drug adequately before or after introducing it to the market, and he alleged that the company hid what it knew about risks of bone density loss, generalized pain, headaches, fluid retention, depression, and immune and nervous system problems, including spinal fracture, convulsions and paralysis. The company paid an $875 million settlement after the Department of Justice charged it with violations of the Prescription Drug Marketing Act and for overcharging and defrauding Medicare and Medicaid. The company had bribed doctors to prescribe the drug. A joint venture of the Japanese company Takeda Pharmaceutical and Abbott Laboratories, TAP was dissolved in 2008 and Lupron is now produced by Abbott. All of this makes me, as a defective prescription medication attorney, concerned about this drug's history.

The combination of TAP's behavior in marketing Lupron and the stories of the women hurt by Lupron should prompt the FDA to take a close look at this drug. Even if the FDA chooses not to ban or restrict the drug, patients who have been harmed by Lupron can make its manufacturer compensate them for the ill effects they have suffered. Drug manufacturers have a legal responsibility to warn the public of any potential negative effects of their products that they know about. If a drug company fails to warn the public and patients get hurt, patients can require the drug manufacturer to pay for the damage caused by its negligence. This can include medical costs, past and future lost wages, lost quality of life, damage to personal relationships, and pain and suffering. It is simply unfair and unethical to withhold information about a dangerous drug in order to protect profits, and the law recognizes that any company that does so should face the consequences of its actions.

The complaint, which began in state court but has since been transferred to federal court, states that Lindsey Whitener was prescribed the anti-nausea medication to help her cope with morning sickness that had persisted into her seventh week of pregnancy. The first trimester of a pregnancy is a critical time in the development of the child, making it a contentious period regarding the prescription of any strong medications. Their son, Lucas, was born with so many health problems and complications that he was hospitalized for a full six months after being born. He further suffers from permanent disability that his parents blame on the Reglan prescription.

As mentioned, this case is unusual in that it departs from the normal pattern of Reglan cases. However, the Whiteners claim that they have shown their case to a number of physicians since discovering Lucas' illness, and none has been able to rule out the involvement of Reglan in their son's birth defects. As such, they wish to have their day in court and demand answers from multiple sources.

The case is wide-ranging in its choice of defendants, as well. It targets the companies Pliva Pharmaceuticals, Barr Laboratories, Teva Pharmaceuticals and Watson Pharmaceuticals — all are generic manufacturers of Reglan. The suit also names the Rue de Sante Women's Medical Center and John McCrossen, presumably the hospital and doctor involved in prescribing the medication to Mrs. Whitener.

Last year, a federal judge ruled that the many Reglan cases currently pending would not be consolidated into a larger lawsuit, but would rather need to proceed individually. As such, the Whitener case will have to be presented in its own separate venue, and bears watching.

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There are a number of symptoms associated with a pulmonary embolism. If you are taking Yaz and you find yourself experiencing one or more of these symptoms, do not hesitate — go immediately to the doctor.

Symptoms include coughing up sputum (mucus or spit) that has blood in it. It can be reddish or just pink. Pains in the chest, especially those that radiate outward from the chest to a limb, are particularly indicative. Similarly present could be a rapid heartbeat or shortness of breath. Some patients of embolisms have reported an unexplained sense of anxiety, a clamminess or blue color to their skin, swelling limbs, low fever, dizziness and wheezing. Any of these symptoms could be serious, but in conjunction they should be considered an emergency.

The risk is not small. Nearly one in three women who suffer an undiagnosed embolism die from it. Even those who do not die could suffer heart damage, hypertension or even brain damage if the blood flow to the brain is interrupted. These side effects are nearly six times as common in women who take Yaz as in women who take older generation anti-pregnancy drugs, and yet it still remains one of the most popular and widely-prescribed oral contraceptives on the market today.

At the very least, any woman who has experienced this condition while taking the medication would be wise to consult a doctor, and consider all her options.

Part of the skepticism that surrounds Paxil and related antidepressants is the huge amount of good press the producers — in this case Glaxo Smith Kline (GSK) — give themselves, while downplaying their negative effects. The object isn't necessarily even to force GSK to close down, or to take Paxil entirely out of the market, but to rather demand honesty in advertising and a much more stringent set of guidelines as to who and who cannot be prescribed the medicine.

When GSK is busily promoting the drug, however, information can be difficult to sift through.

For example, consider the growing concerns about Study 329, an investigation GSK did into its antidepressant. The spin put on the article basically suggested that the results were positive and favorable. However, ongoing investigations have raised doubts about the accuracy of these claims.

Reports from 1998 indicate, for example, that GSK was aware the actual results of the study were negative, rather than positive. Attempts to investigate and call these matters into question were met with hostility. Furthermore, there is evidence that the entire article was ghostwritten. Ghostwriting (the method of hiring a professional writer to write the actual documents) is a valid practice in many cases, but one wonders why the research team didn't have anyone qualified to write up and publish their works.

GSK eventually had to admit that they had overstated the positive effects of its big name medication. In many ways, this story highlights the core difficulty of dealing with such companies. They can massage data and have in-house teams perform dubious evaluations, while investigations from outside are difficult and take expert hands.

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Sometimes the best way to get a perspective on something is to have a firsthand account from a patient affected by the disorder. To that end, consider the case of Joan T. Experiencing symptoms such as stomach pains and diarrhea, she went to her doctor. Believing Joan had Irritable Bowel Syndrome, the doctor prescribed Reglan, which Joan took for just more than a year.

"At first I had no problems with it,” Joan says of the medication. “Then, all of a sudden, I had uncontrollable movements. The doctors thought it was Parkinson's disease."

Parkinson's disease is a very serious illness. There is no known cure, and it can lead to severe complications. It is not by any measure a small consideration. There is a reason Michael J. Fox has poured millions of dollars of research into the illness. Imagine being told out of nowhere that you have this condition.

In addition to this, the involuntary movements interfered with an eye surgery Joan was scheduled to have to correct cataracts. Her head was moving so much they had to physically restrain her for the procedure. Again, these movements are not small, irrelevant things that can be ignored. Tardive Dyskinesia is serious and interferes with people's lives.

Ultimately skeptical, Joan researched the diagnosis of Parkinson's and came across some information about Reglan. Realizing it had a black label warning, she ceased taking the medication and within a short while the tremors and movements stopped entirely.

"You never saw somebody so happy as I was,” she says. “I haven't had problems with the movements since then... I wouldn't recommend Reglan to my worst enemy. It's horrible, having uncontrollable movements. You can try to hide them, but you can't stop them."