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

Personal 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 … [Read more...]

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 When a cleft does not affect the mouth’s palate structure it is referred to as cleft lip. Cleft lips can … [Read more...]

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 Women frequently use Topamax because they are much more likely to suffer … [Read more...]

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 On 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 … [Read more...]

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 … [Read more...]

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 … [Read more...]

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 … [Read more...]

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 … [Read more...]

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 … [Read more...]