Drug Injury Attorney Blog

One of the hardest parts of dealing with injuries and damages caused by prescription medications is the difficulty in obtaining evidence sufficient evidence to convince people that you have a legitimate case. One reason for this is that all prescription medication have risks and benefits and you need to prove there were risks that the drug manufacturer knew about that were not disclosed to doctors and the public. Then there's the long process of verifying your medical history, getting information together, finding a representative you can trust, getting the case ready for trial and trying the case if it cannot be settled.

All of this, of course, takes time, but gradually such dangerous medicines begin to develop a history and track record that's hard to ignore. For example, consider the history of the troubled antidepressant category known as SSRIs. Selective Serotonin Reuptake Inhibitors regulate mood by preventing the brain from re-absorbing serotonin, which results in generally "good" feelings.

These drugs, such as SSRI poster child Paxil, have been known since 2005 to be associated with the development of birth defects. These defects have included such phenomena as malformed hearts and heads, brain and spinal cord deformities, clubbed foot and partial or complete closure of the anus. Though they vary in severity, each of these defects has serious implications for a child affected by them. These defects led the FDA in 2005 to rate Paxil and other SSRIs with a category D pregnancy warning.

In 2006, the FDA further required SSRI manufacturers to provide labeling warning about Persistent Pulmonary Hypertension (PPHN), a disorder in which children cannot properly breathe.

Other studies have looked back at previous data; one analyzed children born between 1997 and 2004. Of the approximately 12,000 babies examined, more than half had been born with a heart defect. Of those with such defects, a significant number had been exposed to SSRIs while their mothers were pregnant.

So while people might feel hesitant about seeking help, it should be noted that these medicines often do have a track record, and there is information out there that will continue to build up over time.

For those concerned with the potential damage caused by the proliferation of generic versions of dangerous medicines like Levaquin, there is some good news.

A U.S. Federal Court has ruled that India's fifth-largest pharma giant, Lupin, cannot market a generic formulation of Levaquin in the United States — at least not yet. The court upheld a ruling granting Ortho-McNeil's request to extend its patent protection on the medicine. This is, of course, not a final answer, as all protections do expire eventually, but it does mean that for a little longer at least there is a stop on the production of a generic version until December 2010.

Levaquin is an antibiotic used to treat infections that primarily of the prostate and for infections that don't respond well to other medications. However, it also has been linked to tendon deterioration that ultimately results in a tendon rupture, particularly in the Achilles tendons of the ankles. These conditions are often very painful, and can severely inhibit mobility. Some tendon ruptures take up to 12 months to heal when immobilized in a plaster cast.

At most, however, this is a temporary reprieve. Lupin is considered highly likely to file an appeal to a higher U.S. court. There is just too much money involved in Levaquin sales for any other decision; the drug has done $1.4 billion in sales in recent years. Even if the decision is upheld, though, the extension is only until the end of this year. At that point, it is unlikely that any further protections on the patent will be allowed, and companies such as Lupin will be permitted to make their generic offerings.

There are also other companies, such as generic manufacturer Mylan, that are eager to get in on the business. Their appeals have been denied as well, but it is unfortunately only a matter of time.

The Quincy Patriot-Ledger recently reported that the Food and Drug Administration issued a second warning to Braintree Laboratories about its manufacturing processes. Consumers had submitted 21 complaints to the FDA reporting that they found spiders, insects and insect parts in medications made by the company. Those products include multiple prescription gastrointestinal drugs. As a defective medication lawyer, I wonder what other aspects of the manufacturing process are laxer than they should be. The presence of insect and spider parts in Braintree's medications suggests that the company has not been as conscientious as their moral and legal responsibility requires them to be.

Five different products, all manufactured at the company's Holbrook, Mass., facility, were cited in the consumer complaints. The FDA had investigated the company in December and January and found significant violations of Current Good Manufacturing Practice regulations. Braintree Laboratories said that it would increase its monitoring of pest control, analyze consumer complaints more carefully, and determine the origin of the insects and spiders that consumers found. But the FDAsaid the company still couldn't say whether "facility or raw material quality problems were at the root of these complaints." The FDA is asking the company to submit its plan to find out where the contamination originated and to carefully monitor its raw materials and packaging suppliers. Braintree has 15 working days to either explain to the FDA how it is working to correct the violations or to ask for an extension. If it doesn’t respond, the FDA could seize its products, issue injunctions or withhold future product approval requests.

From my experience as a pharmaceutical liability attorney, I can say that this isn't the first time and it won't be the last time that FDA has had to prod a drug manufacturer to resolve quality issues that affect consumers. Within the last two months, I've written about three other companies whose manufacturing practices have been under FDA's scrutiny, including McNeil Pharmaceuticals, Teva Pharmaceuticals and KV Pharmaceutical. It's disturbing that adhering to FDA manufacturing standards seems to be so difficult for some pharmaceutical companies. I worry that the companies' apparently nonchalant attitude toward product contamination could be a sign that they are equally disinterested in their responsibility to warn consumers of potential negative effects of their products. Drug manufacturers have a legal responsibility to warn consumers and the FDA of any ill effects that could befall someone who uses their products -- e.g., severe side effects from the medication itself, or harm caused by contamination of the medication. When companies wait for the FDA to crack down on them before they clean up their manufacturing processes, they may not be meeting their responsibility to warn the public about the potential harm that their contaminated products could cause. That harm can be serious, up to and including a risk of death in some of the defective medications mentioned above.

Continue reading " FDA Cracks Down on Company Making Medications Contaminated With Insect Parts " »

Pharmaceutical giant Glaxo Smith Klyne (GSK) has begun a new test study of its controversial antidepressant Paxil using a group of 7-year-old Japanese children as the subjects.

GSK officials confirmed that the test has begun but have not commented on the study. The aim seems to be an attempt at casting doubt on the well-established risk of increased suicidal thoughts when young people take the potent medication.

Part of the controversy surrounding the study concerns its confusing criteria. Officially, the listed information says that this study is an efficacy test — in short, to determine whether Paxil works against a placebo as a control group. However, Paxil already is an approved drug. It has been demonstrated to help people with their depression. This is no longer an issue, so testing it again seems rather odd, unless you consider the company may be looking for some additional good press.

Notably, the study does not include a test against other antidepressant medications as a measure of suicide risk among the selected age group. Given that the drug already has been verified to work, why not test it against other drugs for the most famous problem associated with it? The only allowance the study makes for determining suicide risk is as a secondary aim. In other words, such info is "nice to know," but hardly the goal.

Further, the trial group doesn't seem to be large enough to allow for a truly representative sample. There are only about 130 children listed as participants. With approximately half in the test group and the other half in the control group, this means even small instances of unusual results can change the percentages dramatically. So in short, the study is pursuing something already known, with a sample group nowhere near large enough to provide telling results. Given the very real cases continually levied against GSK, one wonders what the point could be.

In a setback for patients affected by the gastro esophageal reflux disease medication Reglan, a federal court rules that Wyeth and Schwarz Pharma are not responsible for injuries suffered by taking a generic formulation of the drug.

Specific details are sparse, as the primary source for the announcement is the FDA, which charges a fee for access to full information. However, the basic judgment in the Texas case is that since the plaintiff took a generic version of the drug, the brand manufacturers are not responsible for the injuries that resulted.

The decision does leave open the option to bring a case against the specific manufacturer of the generic version, but ignores the potential responsibility of the original manufacturers who promoted the product despite its dangers.

Generic medications result when the patents on a particular medicine expire, allowing competitors to manufacture their own version in an attempt to cash in on a market established by the originators of the treatment. If a potentially harmful medicine such as Reglan survives legal challenges long enough for the patent to expire, then the chances of it harming others go up drastically as it becomes much more widely available.

Reglan has been linked to a serious medical condition known as Tardive dyskinesia. The disorder is characterized by a number of symptoms which are commonly not reversible. These are movement-based symptoms, such as uncontrollable movement in the arms, facial muscles, lips, legs, torso, hips and other parts of the body. Fingers often will twitch uncontrollably, disrupting fine motor control. Sleeping is difficult enough on some nights, and can be all but impossible when your body insists on moving constantly, without any control you can provide.

While details will still be emerging over the following days, limiting the liability of the manufacturer takes a significant tool out of potential lawsuits in the future, and sets a precedent that other judges might observe.

The role of birth control pills Yaz and Yasmin in the formation of blood clots is well-documented, and many people are familiar with the lawsuits pertaining to heart damage and pulmonary embolisms resulting from these two Bayer flagship drugs. Now there are growing concerns that these two hormonal treatments also may have a role in the development of painful and potentially dangerous gallbladder symptoms, as well.

The hormones in Yaz and Yasmin are thought to contribute to the formation of gallbladder symptoms along two vectors. The first is through increasing the body's production of cholesterol. Secondly, both medications are suspected to reduce the activity level of the gallbladder. Between higher cholesterol levels to deal with and a reduced capacity, the gallbladder then begins to form gallstones. While normally people can have gallstones without developing symptoms, these little deposits can and do cause severe inflammation to the organ. An inflamed gallbladder is a result of infection, which is never good for the body. In addition, it can result in excruciating levels of pain that are comparable to or even worse than kidney stones. This can leave people unable to work or function normally. This can sometimes be treated with antibiotics, but frequently a surgical procedure is needed to remove a stone-affected bladder. Of course, any surgical procedure is going to require a certain amount of time laid-up in bed, as well as cutting and rearranging.

If a patient has been on Yaz or Yasmin, which thicken the blood and can lead to clots, then the already-present danger of blood clots from being recumbent after surgery is potentially increased. Doctors are very good at what they do and often will make preparations for such eventualities, but they cannot anticipate everything so this additional risk is something to carefully consider. The issue of birth control-derived gallstones is not as present in the media as that of blood clots, but the two could be more intrinsically related than currently known, and the matter deserves further study and caution.

About a year ago, I wrote about the U.S. Food and Drug Administration's warning to healthcare providers about the risk of serious liver damage and failure in patients using propylthiouracil, a treatment for overactive thyroid. The FDA recently cautioned that this drug carries an even greater risk than had previously been thought and added a black box warning. The agency determined that a black box warning was warranted after receiving 32 adverse event reports, including 12 deaths and 12 liver transplants between 1969 and 2009. Even though these adverse events took place over the course of 40 years, the FDA decided that the events were serious enough that the public needed to be warned. As a defective medication lawyer, I applaud the FDA for helping to protect patients from unnecessary risks.

Propylthiouracil has been one of several available treatments for Graves' disease and other varieties of hyperthyroidism, which involves the overproduction of the hormone thyroxine. Hyperthyroidism is quite treatable and not usually life-threatening -- but from the FDA's finding, it appears that the treatment can be worse than the disease. While patients are advised not to stop taking propylthiouracil unless they are instructed to do so by their doctors, the FDA warns that because of the severity of the adverse effects they have seen associated with this drug, propylthiouracil should only be used by patients who are unable to use other approved treatments for hyperthyroidism. The other approved treatments include another drug called methimazole, radioactive iodine and surgery. Because methimazole is associated with increased likelihood of birth defects, propylthiouracil is actually recommended for hyperthyroidism patients in or before the first trimester of pregnancy.

Propylthiouracil is especially dangerous for children, and as of last year, 40% of children being treated for Graves' disease were receiving this drug. For all patients, the FDA recommends that propylthiouracil should be the last treatment that a patient tries, and patients who do take it are to receive a Medication Guide explaining the risks, as part of a Risk Evaluation and Mitigation Strategy (REMS) program under the FDA. Patients taking the drug are advised to contact their doctors if they experience signs of liver injury, like fever, loss of appetite, nausea, vomiting, tiredness, itchiness, dark-colored urine or yellowing of their skin or eyes.

As a defective drug lawyer, I wonder when the manufacturers of propylthiouracil began to realize that the drug had the potential to cause serious liver injury. The drug's effects have been tracked for 40 years, so it's unlikely that the FDA's black box warning has come as a big surprise. Perhaps since the drug is available only from generic manufacturers, none of these manufacturers felt that it was their responsibility to warn the FDA and patients of the seriousness of these risks. Speaking as a pharmaceutical liability attorney, I hope that this is not the case, since the law mandates that drug manufacturers warn consumers and the FDA about risks involved with their products.

Continue reading " FDA Slaps Black Box Warning on Hyperthyroidism Drug for Causing Severe Liver Damage " »

A recent $81 million settlehttp://www.jefflowepc.com/lawyer-attorney-1176136.htmlment between the Department of Justice and Johnson & Johnson's Ortho-McNeil Janssen Pharmaceuticals Inc. means sales reps for the company will be monitored with compliance officers who will observe and report on the representatives' behavior on the job.

The measure, part of a Corporate Integrity Agreement, calls for randomly-timed, full-day observational ride alongs, encompassing all therapeutic products and programs for the company. The compliance officials will observe all meetings the sales representative conducts during their work day.

Observations will end in a formal report, including the identities of the sales representative and the compliance professional, the date and time of the observation, any products promoted during the event, an assessment of the degree of the representative's compliance with Ortho-McNeil's policies and identification of any off-label promotional activity.

Specifically, any cases of improper promotion must be rigorously reported to relevant officials on an annual basis. Johnson & Johnson stated that ride along observations were already part of policy, but were simply not reported prior to the current agreement.

Other regulations will apply to sales representatives as well. They will require three hours of training on regulatory law and its penalties, as well as signing statements describing the scope of the work they are permitted to perform. The agreement also mandates a centralized system that tracks all presentation engagements by Ortho-McNeil personnel.

This agreement has been scheduled to remain in place for a five-year period. Violations and failures to comply will range from $1,000 to $5,000 dollars per day, depending on the severity of the infraction.

The primary aim of the agreement is to protect consumers from gross misrepresentation of products such as the controversial antibiotic Levaquin, a specific Johnson & Johnson brand. Promotional officials will not be permitted to downplay the serious potential risks in J&J products under this agreement.

http://www.jefflowepc.com/lawyer-attorney-1176136.html

One of the most frustrating aspects of any major pharmaceutical product liability lawsuit is the sheer slowness of the process. The legal system is designed to move slowly, in order to prevent rushes to judgment that don't properly reflect the facts. On the other hand, people who have been injured by drugs such as Levaquin are suffering now, and dealing with day-to-day pain and the results of ruptured joint structure and mounting expenses while they wait.

Consider that the biggest piece of good news for Levaquin users came late last year, in Illinois.

In September 2009, 15 new lawsuits were filed against a number of companies involved in the manufacture and distribution of Levaquin. These companies include Johnson & Johnson, Ortho McNeill Pharmaceuticals, J & J's Drug Research and Development and distributor Walgreens.

A motion was filed around the same time seeking to have all the suits brought together as a mass tort matter. There is a lot of power in a mass tort suit, forcing the manufacturers to deal with the issue on a larger scale, rather than simply making small, quiet, "go away" settlements and continuing to push their product.

The evidence against Levaquin remains compelling, as it has over the entire life of the drug as a product. Even as far back as 2001, the FDA demanded the medicine carry warnings explaining the risk to tendons and muscle structures. By 2009, the warnings had increased to the FDA's most serious black-box rating, reserved for some of the most potentially harmful medicines FDA still permits to be sold.

Despite this, the manufacturers downplayed the risk of tendon injury, claiming the drug has an excellent safety rating. Hopefully the move to consolidate these actions into a single, major class action suit will force more information into the light, and result in some of the injured patients getting their costs recouped.

source: http://www.articlesbase.com/law-articles/fifteen-additional-levaquin-lawsuits-filed-in-illinois-1264133.html

Despite repeated studies and claims from Bayer Healthcare that its birth control pills are safe, others argue that contraceptives like Yaz and Yasmin significantly increase the risk of blood clots and the potential dangers associated with them compared to other birth control pills.

At the times they were introduced, in 2001 and 2006 for Yasmin and Yaz respectively, the progestin they were made from was considered safer than other forms of progestin. However, studies published by the British Medical Journal have cast doubts on this interpretation of the results.

The first study examined blood clot risks in Danish women in good health, between ages 15 and 49. Of the more than 4,ooo blood clot cases the study examined, more than half were related to the use of oral contraceptives with contents similar to Yaz and Yasmin.

The second study involved more than 3,000 women in the Netherlands, and found that the progestin that is used in Bayer's medications were more than six times as likely to be associated with blood clots than those women who took older contraceptives.

The consumer watchdog organization Public Citizen's Health Research Group has already put Yasmin on its "do not use" list because of other risks, specifically raising blood potassium levels. The agency advocates using older drugs prior to third generation drugs such as Yasmin or Yaz, as they do not show such dangerous risks as the newer drugs.

The U.S. FDA is investigating the drugs with ongoing studies. As of last November, the FDA has reported 993 cases of pulmonary blood clots, 487 of deep vein clots, and 229 of other clots, all associated with these two medications. Over 1100 lawsuits have been filed pertaining to Yaz and Yasmin. Most of these are centered in a major suit filed in Southern Illinois. Bayer also has to contend with multiple class action suits claiming everything from economic loss to personal injury, including having been challenged in Canada.

As a defective medication lawyer, I have closely watched the continuing reports of problems with drugs manufactured by McNeil Pharmaceuticals. In January, I wrote about the unsettling recall of products made by McNeil Pharmaceuticals, a unit of Johnson & Johnson. That recall involved over-the-counter medications that many of us know well, such as Tylenol, Rolaids, Motrin and St. Joseph Aspirin. Now, the FDA has issued a new recall for commonly used infants' and children's medications that McNeil produces, such as Tylenol, Motrin, Zyrtec and Benadryl.

Initially, the FDA said that the products involved in the current recall could have stronger concentrations than they were supposed to, or they could contain inappropriate inactive ingredients or tiny particles. Just a few days later, we began to see more damning reports, alleging quality and security lapses at McNeil’s Fort Washington, PA, manufacturing plant. A routine FDA inspection of the plant found that raw materials for the infants' and children's medications were contaminated with Burkholderia cepacia bacteria, which is often resistant to common antibiotics. The Center for Disease Control says that the bacteria can be harmful to people with weakened immune systems or chronic lung disease. The FDA was concerned that the contaminated materials could have been used in the products that were recalled, although McNeil says that its tests of those products did not show contamination. The FDA and McNeil both say that the chance of harm from using these products is remote, but they advise customers to stop using the recalled drugs immediately.

Unfortunately, McNeil has not given consumers a lot of reasons to trust its word. The earlier McNeil recall involved medications that had a "musty" smell and that gave consumers stomach pain, nausea, vomiting and diarrhea. It was suspected that the drugs were tainted with 2,4,6-tribromoanisole (TBA), a flame retardant and pesticide used in shipping pallets. The most disturbing part was that McNeil waited at least a year, rather than the legally required three days, after receiving complaints about the medicines before it fulfilled its duty to report the problem to the FDA. In the current case, McNeil appears to be equally unable or unwilling to meet its reporting duties; the FDA has faulted it for failing to report the contamination or recall lots of tainted medicines. And infants and children have less-developed immune systems than adults, so contaminated drugs could put them at serious risk of illness. We still don't know what those "tiny particles" are that McNeil initially cited as the reason for the recall, but there have been over 40 consumer reports to the FDA about dark flecks in the medications.

Now, the House Committee on Oversight and Government Reform plans to hold hearings to investigate McNeil and the FDA. As a pharmaceutical liability attorney, I would recommend that consumers who have been harmed by these contaminated drugs ask questions too, including ones about their legal rights in situations like this. Drug manufacturers have a legal duty to warn consumers and the FDA about risks that their products might pose, such as the risk of bacterial contamination that could cause infection. If McNeil knew about problems and kept them quiet, and consumers took their contaminated medications and became sick, those consumers could sue McNeil to recover all of the costs their illnesses.

Continue reading " FDA and Congress Investigate Contamination and Other Problems at Johnson & Johnson " »

In recent news, there has been a trend for doctors in neonatal units across the United States to prescribe metoclopramide — brand name Reglan — to treat premature infants for gastrointestinal disorders. This has lead to serious concerns from consumer safety groups. Specifically of concern is the fact that Reglan has never been approved for use in infants.

Reglan was approved for very short term uses by the FDA, with terms limited to no more than three months. It was approved in 1979 for the treatment of gastric disorders. However, the FDA issued a black box warning in 2009, stating that Reglan and its generic forms had been linked to tardive dyskinesia (TD), a disorder that involves involuntary movements, especially of the lower face. A black box warning is the strongest sanction the FDA can impose on a medication. Further studies have showed Reglan is the leading cause of TD among patients who have the disorder in the USA.

Prescription of metoclopramine in neonatal units began approximately 10 years ago, when the only other medicine available was pulled for safety reasons. Those most at risk of developing TD are the elderly and women, but there are concerns about Reglan's effect on infants. There has never been a major study done on Reglan's impact on children, which makes researchers nervous.

According to one attorney, "many doctors and patients are still not aware of the significant risks associated with its use. Because Reglan has been on the market for over 30 years, many physicians assume the drug is safe and prescribe it for various off-label uses. Perhaps the most troubling of these is its use to treat premature babies whose bodies are already extremely frail."

An off-label use is any use of a drug outside its primary function, such as the use of Tramadol to treat restless leg syndrome instead of as a painkiller.

The U.S. Food and Drug Administration has issued a warning to Teva Pharmaceutical Industries Ltd.'s Parenteral Medicines unit about manufacturing problems that contaminated an anesthetic. As a dangerous drugs attorney, I am dismayed to read that another drug manufacturer has been less than scrupulous with their manufacturing processes. Last month, I wrote about the legal and financial troubles at Ethex Corp., whose parent company is KV Pharmaceuticals here in St. Louis, arising from manufacturing problems that the company admitted that it tried to cover up. Parenteral Medicines would be wise to correct the problems that the FDA points out right away, for its own sake as well as the sake of patients.

Teva Pharmaceutical is an Israeli generic drug manufacturer with a manufacturing facility in Irvine, Calif. In December, the FDA had warned Teva that it needed to correct a problem with vials of propofol injectable emulsion, a general anesthesia drug that it produced. The drug was contaminated with bacterial endotoxin. Endotoxin contamination in pharmaceuticals can be extremely dangerous to patients, as it can lead to fever, lowered blood pressure, and septic shock, a serious medical condition with an approximately 50% mortality rate. Patients who undergo general anesthesia do so for medical procedures like surgery, which already exposes them to risks of complication and infection, so it is vital that they not be exposed to additional unnecessary risks from contaminated pharmaceuticals. In late April, the FDA rebuked Teva for allegedly releasing the contaminated lot of anesthesia and failing to correct the problem. The lot of contaminated propofol was recalled, but the FDA found more problems with Teva's manufacturing practices. It said Teva hadn’t done microbiological testing of rugs or raw materials, and had insufficient cleaning and sanitizing practices.

I have seen enough cases in my work as a drug defect lawyer to believe that making money and saving time are often higher priorities for companies than making sure drugs are safe. The Ethex Corp. case that I wrote about in April was an extreme case, but other drug manufacturers have also faced FDA warnings -- as well as lawsuits from patients who were harmed by defective drugs. Drug companies do not answer only to the FDA; they also are legally responsible to the people who use their drugs expecting that they will help them, not make them sicker or kill them. Patients who have been hurt by medications that manufacturers falsely represented as safe can make the drug manufacturers bear the costs of the harm they caused. Drug makers have a legal responsibility to warn the public and the FDA if their drugs carry risks, and if they do not do so, the law holds them accountable by allowing those harmed to sue.

Continue reading " FDA Rebukes Teva Pharmaceutical for Lax Manufacturing Practices " »