Tag: FDA

Birth Defect Lawyers: Pregnant Women May Need Medical Alternatives

Following its inception and FDA approval, Topamax quickly rose to the top of the food chain. Birth defect attorneys note that the drug quickly became one of the most commonly prescribed pharmaceutical drugs to prevent migraines in the industry. Topamax is most frequently used to treat epilepsy and migraines. Recently, the Food and Drug Administration has categorized Topamax as a drug that can potentially present significant and unnecessary harm to a human fetus, potentially leaving expectant mothers in search of an alternative.

Women are Especially Susceptible

new jersey philadelphia birth defect lawyers pregnant women risk increase topamaxWomen frequently use Topamax because they are much more likely to suffer from severe migraine headaches as opposed to their male counterparts. In fact, women are three times more likely than men to encounter migraines. Women who are looking to become pregnant face an additional risk. In their childbearing years, the likelihood of headaches increases yet again, making women of this age extremely vulnerable. Therefore, it is quite understandable that many women would turn to a well respected product, such as Topamax, to alleviate pain. The problem that has now surfaced is that Topamax has been linked to certain birth defects such as cleft lip or cleft palate. Although Topamax is a proven commodity that deals well with ailments such as epilepsy and migraines, the risk of potential birth defects in pregnant women may lead them to search for alternatives. The FDA and birth defect lawyers both agree, Topamax should not be prescribed for pregnant women in most cases.

Birth Defect Lawyers in New Jersey and Philadelphia

If you recently had a child who was born with a birth defect and you suspect it may be attributed to your use of Topamax during pregnancy, you may be entitled to compensation. For questions about birth defects or potential legal action, contact the Mininno Law Office for a free case evaluation, or call for a free consultation at (856) 833-0600 in New Jersey, or (215) 567-2380 in Philadelphia.

Birth Injury Lawyers: A FDA Warning For Pregnant Women

new jersey philadelphia birth injury lawyers warning pregnant woman taking antipsychoticsThe U.S. Food and Drug Administration, (FDA), recently updated labeling for antipsychotics to alert female users in their third trimester of pregnancy that use of the drugs could have adverse effects on their fetuses, causing birth injuries or defects. A few of the drugs now displaying the warning label include Risperdal, Seroquel and Invega. The drugs are used to treat mental disorders, such as schizophrenia, bipolar disorder, anxiety disorder, or depression.

A statement released by the FDA said:

“Healthcare professionals should be aware of the effects of antipsychotic medications on newborns when the medications are used during pregnancy. Patients should not stop taking these medications if they become pregnant without talking to their healthcare professional, as abruptly stopping antipsychotic medications can cause significant complications for treatment.”

Birth Injury Lawyers in New Jersey and Philadelphia

If your child suffered a debilitation birth injury at birth and you are now faced with expensive treatments that will be necessary for the rest of your child’s life, contact the Mininno Law Office for a free case evaluation. You may also call for a free consultation at (856) 833-0600 in New Jersey, or (215) 567-2380 in Philadelphia. The birth injury lawyers at the Mininno Law Office are skilled and experienced when it comes to earning full and fair compensation for victims of delivery room negligence and/or birth injuries.

Let the Mininno Law Office team earn you and your family the compensation you need and deserve.

Zimmer Knee Attorneys Explain Knee Replacement Beginnings

As knee implant attorneys, we are blogging on the Zimmer NexGen knee replacement component which was the subject of an FDA recall . This is the first in a series of posts providing information regarding some of the Zimmer knee implant component parts. We hope these posts will be helpful to any knee replacement patient.

Zimmer Knee Background

new jersey philadelphia zimmer knee attorneys explain replacement beginningsOn September 13, 2010, the U.S. Department of Health and Human Services Food and Drug Administration issued FDA Recall No. Z 2409 010 entitled “NexGen Complete Knee Solutions MIS Tibial Components, Locking Screw and Stem Extensions” recall notice. This recall notice can be found at the FDA website.

This latest Zimmer recall was one in a series of knee joint replacement hardware recalls issues by the FDA. Zimmer’s track record over the years had been very good. However, this potential component problem is concerning to the medical community.

Given the sheer volume of knee implant patients who have had joint replacement surgery, it is fair to ask whether risks associated with knee implant surgery outweigh the benefits. This is the first in a series of posts that will discuss the evolution of knee replacement surgery in an effort to answer this question. We hope that this discussion may have particular interest to all patients who have had knee implant surgery whether or not the surgery involved the recalled Zimmer knee implant component.

History of Knee Implant Surgery

Knee replacement surgery was pioneered back in 1954 by surgeon L. G. P. Shiers. Research shows that Dr. Shiers was a true patient advocate and actually refused to patent his knee replacement technology. In doing so, Dr. Shiers gave up what could have been millions of dollars in royalties from the future sales of knee replacement technology. Instead, he traveled the world, teaching knee replacement surgery to other orthopaedic surgeons and medical students so they could pass on the benefits of knee joint replacement surgery to any patient who needed a knee replacement.

new jersey philadelphia zimmer knee attorneys explain replacement beginningsKnee replacement surgery, following the success and failures of hip replacement surgery, became more commonplace in the 1960s and the 1970s. It was billed as safe, effective, and an enormous benefit to any patient with osteoarthritis. Since that time, as with hip replacement surgery, knee replacement joint technology is constantly changing and modifying in an effort to improve patient outcomes in knee replacement patients.

Throughout the years, there have been many knee replacement part manufacturers (Zimmer, Stryker, DePuy, etc). These joint replacement manufacturers and others constantly compete to try and develop the “latest and greatest” knee implant components and techniques. The one constant challenge to all of these knee replacement manufacturers has been to limit the inevitable problems of implant loosening, wear and tear of the implant parts, and loss of the natural range of motion. As with all joint replacements, there still is not any suitable replacement for the body’s own anatomical structures.

Since the innovation of knee replacement surgery, there have been hundreds of thousands of patients who have undergone knee replacement surgery involving different techniques and various artificial knee components. Unfortunately, with each new “innovative” technology, there always is the potential for possible hardware failure problems, which could cause the patient to develop a new set of symptoms that conveniently replace the old ones. As a result, many patients who have undergone knee replacement surgery and have been subjected to these problems are left to wonder whether the surgery was worth it.

Knee Implant Attorneys in New Jersey and Philadelphia

If you have recently undergone a knee replacement surgery and your recovery process is taking far longer than expected, you may want to find out if there is a problem with your knee replacement. Contact the Mininno Law Office for a free case evaluation, or call for a free consultation at (856) 833-0600 in New Jersey, or (215) 567-2380 in Philadelphia.

For more information regarding the knee replacement concerns, visit the Mininno Law Office site dedicated solely to Zimmer knees.

DePuy Hip Recall Due to FDA Loophole?

As DePuy hip recall attorneys, we have heard many disturbing reports which place the blame for the DePuy hip recall squarely at the doorstep of the United States .

FDA “Approves” Implants by Default

Although most hip implant patients assumed that their hip replacement manufacturer (e.g., DePuy, Zimmer, Johnson & Johnson, Stryker, etc.) received approval from the FDA for their device, this assumption is not entirely accurate. new jersey philadelphia medical malpractice lawyers careless FDA approvalFor years, the FDA has permitted a regulatory loophole under FDA 510(k) which permits the release of new medical devices like the DePuy hip implant, Zimmer NexGen knee implant, and other medical devices, to be placed onto the market without first receiving a comprehensive review by the FDA. How? Because this loophole permits implant manufacturers, like DePuy, to obtain FDA approval if a medical device manufacturer shows that its device is “substantially equivalent” in safety and effectiveness to another FDA approved device.

Ironically, although DePuy claimed its ASR XL Acetabular or Resurfacing implants were “substantially equivalent” to other hip implants, DePuy was not required to make its product out of the same metals as already existing marketed hip implants. As such, reports have shown that the FDA never considered the effects of the chromium and cobalt metals used in DePuy’s hip implants. As a result, consumer advocates have argued that the FDA allowed DePuy to use – without any FDA testing- potentially hazardous metals in a medical device without proper oversight.

DePuy Hip Recall Attorneys in New Jersey and Philadelphia

The DePuy hip recall shows the potential danger in this process. What is the lesson? All potential hip implant patients should specifically ask whether their hip implant device has received formal FDA approval or was approved through the FDA 510(k) loophole. As a New Jersey and Philadelphia DePuy hip recall lawyer, we strongly encourage and current recipients of a DePuy hip replacement to contact the Mininno Law Office for a free case evaluation, or call for a free consultation at (856) 833-0600 in New Jersey, or (215) 567-2380 in Philadelphia.

Let the team at the Mininno Law Office earn you the compensation you need and deserve.

DePuy Hip Recall: What About the FDA?

As New Jersey and Pennsylvania Depuy hip recall attorneys, we have been posting various bits of information regarding the Depuy hip recall and its effect on recipients of the implant. We hope these posts have been helpful to not only patients who have experienced implant failure, but to all Depuy hip recall patients, regardless of whether or not they have experienced pain or symptoms associated with the DePuy hip implant failure.

Did the FDA Have Anything to Do With the Recall?

Recently a Depuy hip implant patient asked us, “What does the federal government have to say about the Depuy hip implant recall?” As many know, medical devices, such as artificial hips, prosthesis, knee joint replacements, and other implants, are supposed to be regulated by the Food and Drug administration (FDA). According to its website, the FDA is charged with responsibility for:

“protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.”

new jersey philadelphia depuy hip recall attorneys examine fda approach Despite this responsibility, the FDA has not done much regarding the recall since July 17, 2010, the date they posted information on specific recalled devices. The recall contained DePuy technical data that listed all of the various sized component parts of the DePuy ASR hip replacement system. As for the reason for the recall, the FDA quoted Depuy, stating that the recall was caused by “notification to clinicians of new revision rate data/information regarding use of the device.” What does that mean? It means that DePuy and the FDA were receiving complaints that the hip implant was failing at an alarming rate, causing the necessity for revision surgeries to rise to a new and unacceptable level. These complaints started coming in shortly after DePuy was granted approval to market their device in the United States in 2003.

DePuy Hip Recall Attorneys in New Jersey and Philadelphia

Unfortunately, the FDA has not provided any additional information to patients about what to do next. In fact, the FDA website refers all inquiries back to Depuy’s home office in Indiana. As New Jersey Depuy hip recall attorneys, we urge the FDA to be more diligent in its reporting of consumer complaints regarding medical devices. The device was approved for use in 2003, and was on the market for 7 years before it was finally recalled. Had the complaints been investigated sooner, perhaps surgeons and potential Depuy hip implant patients would have thought twice about using this defective hip replacement product.

If you are the recipient of a DePuy ASR XL Acetabular hip implant system, or an ASR XL Hip Resurfacing System, contact the Mininno Law Office for a free case evaluation. You may also call for a free consultation at (856) 833-0600 in New Jersey, or (215) 567-2380 in Philadelphia. Our defective product attorneys are skilled in earning full and fair compensation for victims of negligent and defective manufacturing.

DePuy Defective Hip Implants; How Were They Approved?

A common question among consumers who suddenly find themselves affected by a product recall is, “What is the process for FDA approval?” As a DePuy Hip Implant Recall attorney, I hear the question quite often. Surprisingly, the process is rather simple for products such as hip, knee, and shoulder replacements and parts.

DePuy Hip Implant Approval Process

depuy hip implant recall attorneys in new jersey and philadelphiaAccording to the FDA, DePuy’s first step towards FDA approval is the successfull completion of a number of clinical testing procedures set up by the FDA. However, in this instance, DePuy was able to avoid FDA scrutiny and it’s screening process by using a legal ‘back door,” which allowed it to circumvent the normal approval channels. This legal backdoor is known as a “510(k),” which permits pharmaceutical companies like DePuy (a subsidiary of Johnson & Johnson), to avoid the normal screening process by claiming that their hip implants would be a “substantial equivalent” to other implant devices that have already been approved by the FDA. By claiming that their product was the “substantial equivalent,” DePuy was able to gain quick approval by the FDA to market and sell it’s ASR XL Acetabular hip implant system within the United States.

Unfortunately, the United States does not have an effective hip implant registry system to determine what the failure rates were for DePuy ASR hip implants and other substantially equivalent implants. This data had to come from the United Kingdom and Australia. Those hip implant registries demonstrated their ability to prevent patient harm. In both the United Kingdom and Australia, the registries were so successful in revealing data that showed the early and unacceptable failure rate of the DePuy hip implant system, DePuy phased out the hip implants long before the American recall. Now, given the debacle over the DePuy hip implant recall, the United States and the FDA are considering creating their own registry for implants, so that potential defects and patient harms can be identified sooner rather than later.

DePuy Hip Implant Recall Attorneys in New Jersey and Philadelphia

By cutting corners and dodging red tape, DePuy was able to skirt their responsibilities to their consumers. Had those implants been properly tested and assessed by the FDA, approval would have been halted and kinks worked out before patients could be harmed. If you or a loved one have been affected by a defective DePut hip implant, contact the Mininno Law Office for a free case evaluation. You may also call for a free consultation at (856) 833-0600 in New Jersey, or (215) 567-2380 in Philadelphia.

Let the team at the Mininno Law Office earn you the compensation you deserve.

Lasik Eye Surgery may help you see more clearly, but how safe is it really?

The Food and Drug Administration announced on Thursday October 15, 2009 that it will start looking into the negative effects associated with corrective laser eye surgery. Some of these negative effects may include blurred vision and dry eyes. The FDA is going to work with the National Eye Institute and the Department of Defense to investigate the amount of people that experience negative side effects after having this corrective eye surgery. This research will include patient questionnaires and clinical trials to help keep track of patients who have had the surgery. These procedures by the FDA will hopefully help in be able to better understand the effects of laser eye surgery and its long term safety, because it is still unknown. Approximately six million Americans have had this Lasik eye corrective surgery which reshapes the cornea, but the long term safety has been unknown. It is good that the FDA is investigating the negative side effects that people could experience, but it may have been better if they would have done this before six million people have had the surgery. There were years of complaints from patients and the FDA just now decided to step in and look at the problems. Part of this reason seems to be because these types of surgeries cost between a thousand to five thousand dollars to perform. It seems like yet again, money is put before patient care and safety. This is not the way it should be. Maybe the FDA should take a better look at its policies too. Patients should always come first.

For additional information on the effects of corrective laser eye surgery you may visit: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/SurgeryandLifeSupport/LASIK/default.htm

If you or a loved one has experienced negative side effects due to laser corrective eye surgery, contact a medical malpractice attorney right away. They will help you advocate for the medical care you deserve.

Bayer Warned by FDA for YAZ Testing Problems

The birth control Yasmin or Yaz has caused much controversy and concerns since it was first brought on the market back in March. Many people are concerned about the serious side effects of the pill and how Bayer seemed to have made these side effects not seem as serious as they are. Another thing that Bayer was warned about by the Food and Drug Administration or the FDA that they did not think was a serious problem was the testing of the quality of the pills. It measured the quality of its ingredients based on an average of several samples instead of reporting the individual test results of each sample like they should. Bayer then continued to ship eight batches of pills tested using this unapproved method to the U.S. The drug patches were reviewed after the FDA’s warning to Bayer, but Bayer says the batches shipped between 2007-2009 were not affected by this unapproved testing method. Since this warning, the FDA now requires that Bayer provide a full list of the shipments to the U.S. that may have used this average testing method and to require Bayer to come up with a plan to prevent the problem from happening again.  Bayer has produced many important medications that many people use and depend on daily. Maybe this method has not caused any real problems, but when it comes to the medicines we give ourselves as well as those we love, double checking does not hurt. It seems like this time Bayer may have gotten overwhelmed by the money they were making that they overlooked some safety measures. Safety however always needs to and should come first each and every time.

For more information on the Bayer testing methods for Yasmin, you may visit: http://www.app.com/article/20090915/NEWS/90915067/FDA+warns+Yaz++Yasmin+manufacturer+over+testing+problems or www.fda.gov

 

If you or a loved one has suffered possibility due to the side effects of Yaz or Yasmin, please contact a personal injury attorney right away. They will help get your case heard and help you get the care you need and deserve.

Yasmin: Are the Benefits worth the Serious Risks?

There have been many concerns and about the birth control pill Yasmin or Yaz.  Reports claim that it has many other benefits in addition to helping to prevent pregnancy.  Those benefits include claims that it helps with the symptoms of PMDD or premenstrual dysphoric disorder, helps with moderate acne and has been effective for Premenstrual Disorder or PMS, ovarian cysts, and ovarian cancer. What Yaz’s commercials and website apparently failed to disclose and understated were the serious potential side effects that can occure with this birth control pill. These risks and potential side effects include: blood clots, stroke, heart attack, weight gain, depression, and even in some very severe cases death.  Were these downplayed risks really worth the overstated benefits of taking Yaz?  The drugs manufacturer, Bayer clearly had its own bottom line in mind when it marketed this drug in the way it did and failed to inform people of the seriousness of the risks. Thankfully, Bayer is now paying the price by having new FDA regulations and recalls. So, the next time you see a Yaz commercial or information, make sure you consider whether the real benefits are really worth all the real risks.

For additional information on the Yaz pill, you may visit: http://www.yaz-us.com/index.jsp or http://www.drugs.com/sfx/yaz-side-effects.html

If you or someone you love has been a victim of a serious side effect due to the Yasmin or Yaz birth control pill, please contact a medical malpractice attorney right away. They will help you get your case heard and get the care you deserve.

Yaz Birth Control Concerns Continue

The birth control pill Yaz that once was all over commercials and online has being not only an effective form of birth control but also claimed to help with the symptoms of Premenstrual Dysphoric Disorder or PMDD has now made the news because of serious side effects and possible false claims. Yaz contains drospirenone and ethinyl estradiol. These levels of hormones have been known to cause some serious side effects that the Yaz commercials did not really seem to tell consumers enough about. Bayer’s company intentions were good and the marketing was great, but has it really been worth all the concern and controversy over the Yaz birth control pill now? Some consumers on Yaz are now scared or afraid to take it based on reports they have read or seen. Some people that are taking it now even say that it did not help them with their PDD symptoms as much as the ads and commercials claimed it would. Marketing is important and money is important, but consumer’s right to accurate information and proper warnings should always come first. Without a consumer’s trust, there is no product to sell. I believe Bayer has to regain their trust in many consumers that trusted the Yaz ads and commercials. They have a long way to go before they do.

For more information about the yaz pill, you may visit:  http://www.yaz-us.com/index.jsp or http://www.drugs.com/yaz.html

If you feel you or a loved one has suffered similar effects due to taking Yaz Birth control, please contact a personal injury attorney right away. They will hear your case and help you get the care and help you need.