Tag: Food and Drug Administration

Personal Injury Lawyers: Medical Device Maker Agrees to Pay Penalty for Selling Unapproved Devices

new jersey personal injury lawyers, attorneys, philadelphia, medical malpracticePersonal injury lawyers at Messa & Associates, P.C. have recently come across news stating that Globus Medical Inc., a spinal implant manufacturer, will pay the U.S. Food and Drug Administration $1 million in penalties for selling its NuBone Osteoinductive Bone Graft product after the FDA rejected the device in 2009.

The FDA learned that Globus was distributing the NuBone Osteoinductive, despite being told that the medical device was not substantially equivalent (NSE) to legally-marketed products, during a September 2010 inspection. The company also ignored multiple warnings given by the FDA to stop selling the device, according to a commissioner for regulatory affairs.

The settlement requires Globus Medical to pay a $550,000 penalty fee and the company’s CEO, David Paul, to pay an additional $450,000 fine.

Personal Injury Lawyers: FDA Approval Process Required NuBone Osteoinductive Devices to Be Substantially Equivalent

The FDA currently uses two procedures to approve medical devices. Clinical trials are necessary to get approval for more critical devices. However, Globus Medical’s NuBone Osteoinductive is considered a medical device that poses a lower level of risk to patients. Therefore, Globus Medical was only required to show that the NuBone Osteoinductive was substantially equivalent to similar medical devices that are already on the market.

Personal Injury Lawyers in Philadelphia and New Jersey

The Philadelphia personal injury lawyers at Messa & Associates are experienced at handling cases involving pharmaceutical and medical device injuries. Our extremely skilled team of personal injury lawyers and medical experts is dedicated to ensuring you receive proper compensation for your personal injuries. If you have been injured by a defective medical device, a negligent medical provider, or have endured any other type of personal injury, contact the personal injury lawyers of Messa & Associates for a free consultation. Call toll free at 1-877-MessaLaw, or submit a free online inquiry.

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Topamax & Birth Defects: The Main Formations of Cleft Lip

Birth defects can occur following the birth of any child but certain activities and medications may lead to an increased risk. Topamax, a popular drug used in the treatment of migraines and epilepsy, has been shown to increase the risk of birth defects when taken by mothers during pregnancy. When Topamax is used while a woman is pregnant, research has shown that cleft lip and cleft palate are an increasingly likely result, which has led the Food and Drug Administration to upgrade their warning level.

Main Formations of Cleft Lip

new jersey philadelphia Birth Defects attorneys main formations cleft lipWhen a cleft does not affect the mouth’s palate structure it is referred to as cleft lip. Cleft lips can occur on one or both sides of the lip which are generally referred to as unilateral or bilateral clefts. The first category of cleft lip is known as an incomplete cleft. An incomplete, or partial, cleft lip occurs at the top of the lip. The cleft appears as a small gap or indentation that does not reach the nose.

The second major category of cleft lip is known as a complete cleft. When the cleft begins at the top of the lip and continues up into the nose it is referred to as a complete cleft lip. The complete cleft lip is generally more pronounced and a more serious version of cleft lip. Cleft lip occurs with there is a failure of the maxillary and medial nasal processes to fuse.

Birth Defects Lawyers in New Jersey and Philadelphia

If your child was recently born with a birth defect, such as cleft lip or cleft palate, and you believe that it may be attributed to your use of Topamax during pregnancy, it is possible that you have questions. Please 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 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.

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.

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 Birth Control is a Money Maker but is it truly Safe?

Every one might remember the catchy “We’re Not Gonna Take it” and “balloons” commercials for the Yasmin or Yaz Birth Control pill. We may even remember all the benefits the pill was said to provide the consumer with, but what we may not remember is the listing of the dangerous side effects the Yasmin or Yaz pill could cause. This is because the commercials for Yaz overstated the pill’s effectiveness and understated the serious side effects that go along with it. This violates the Food, Drug, and Cosmetic Act as well as the Food and Drug Administration’s guidelines.

The marketing by Bayer Healthcare for Yaz or Yasmin was great. It brought in millions of dollars for the company and it may have been some of the company’s best marketing. What the company failed to market or to take into consideration is that all birth control pills including this one have serious side effects including: blood clots, stroke, heart attack, and even death. These commercials failed to let consumers know the seriousness of these side effects and now the company may pay in a big way.

For more information on Yasmin or Yaz you may click on this link.

More info

If you or someone you love may have experienced a serious side effect from taking Yaz or Yasmin, please contact a medical malpractice lawyer right away. They will make sure you get the care you deserve and that your voice is heard.

Tylenol voluntarily recalls Some Medications due to Possible Contamination

Tylenol has recently decided to voluntarily recall more than a dozen infant and children’s medications due to possible contamination.  Bacteria was detected in one of the inactive ingredients and though it was not detected in the finished product, Tylenol decided to recall the products after consulting with the Food and Drug Administration as just a precaution.  B cepacia bacteria was detected in a portion of raw material that was not used in the finished product, but as a precaution Tylenol decided to pull any product containing this raw material from the shelves and recall it. These recalls were made between April and June of 2008 and include the following Tylenol products: Children’s Tylenol plus Cold MS suspension grape, Children’s Tylenol Suspension Grape, Children’s Tylenol Suspension Bubble Gum and Strawberry, Infant’s Suspension Drop 1 ounce grape, and Children’s Tylenol plus Cough and Runny Nose Cherry. The recall is only on liquid Tylenol products.

If you have questions about this recall, please call the McNeil Consumer Call Care Center at: 1-800-962-5357.

For more information about this and other recalls you may click here or here.

More info.

If you feel that you or a loved one has suffered due to a defective consumer product, please contact a Posted on Author Angela LeoneCategories blog, Dangerous DrugsTags , , , , , , , , , , , Leave a comment on Tylenol voluntarily recalls Some Medications due to Possible Contamination

FDA requires Strongest Warning Label on Nausea Drug

On Thursday September 17th the Food and Drug Administration required that the strongest warning label be placed on a nausea drug known as Phenegran. This new warning label is due to the fact that after Diane Levine took this drug through an IV push for migraine related nausea and it then led to infection and gangrene. This caused her to have to have her lower right arm amputated. She sued the drug company Wyeth claiming that the warning label was not sufficient enough to warn against the effects of this drug especially in an IV push. This case made it to the Supreme Court and won Diane 6.7 million dollars. This then led to the FDA requiring this strong warning. This will warn users and medical professionals about the possibility of gangrene and also to let them know that IV drugs should be used in low doses and low concentration. This warning is the FDA’s strongest and is called a “black box” warning. The Court agreed that having the Food and Drug Administration’s approval and new warnings help cut down on medical device lawsuits.

For more information on Food and Drug Administration and  improper warning labels you may visit:

This link.

If you or a loved one have experienced a situation similar to this or have been injured due to a medical device or product, please contact a defective product lawyer right away. They will help you fight for your rights to be heard and get the care you or loved one  deserve.