Tag: FDA

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.

For immediate assistance, click the CHAT LIVE button to your right.

Point-of-care testing is medical testing that produces results near the patient as opposed to in a lab. The benefits to point-of-care testing are almost infinite as necessary treatment can be expedited almost immediately through the use of rapidly returning test results. But with such beneficial and life-saving technology comes a great responsibility to protect patient safety and avoid medical errors. Medical malpractice attorneys support any and all initiatives aimed at protecting patients from POCT related negligence.

Medical Journal Calls Medical Providers to Task of Patient Safety

medical malpractice attorneys in nj and paPoint-Of-Care: The Journal of Near-Patient Testing & Technology released a special issue last month highlighting the need for increased vigilance to medical errors related to POCT. The issue contains editorials, research studies, and case reports that provide an overview of the policies in place for other medical providers which assist in assuring patient safety.

James H. Nichols, PhD, Professor of pathology at Tufts University School of Medicine in Boston and medical director of clinical chemistry for Baystate Health in Springfield, Mass, provided the issues introduction. In it he states:

“While the theme is patient safety, each article is different and the authors were not constrained to one format or question, but free to express their concerns and perceptions around the theme of patient safety and medical errors.”

The issue also features information on some of the most recent technological advances in POCT, including built in quality-controls and security measures which, in themselves, can help prevent errors. Presently, very few formal rules or guidelines exist when it comes to point-of-care-testing, but new standards are continuously being developed and the FDA is in the process of solidifying their own guidelines by performing assessments of POCT devices. Patient safety and identification, operator training, timely results, and system alerts were just a few of the topics mentioned in the journal regarding necessary focuses of error prevention.

Medical Malpractice Attorneys in New Jersey and Philadelphia

Medical errors claim the lives of patients everyday. The medical malpractice attorneys at Messa & Associates are in full supoprt of any steps medical providers take to help prevent those medical errors. If you or a loved one have been injured by any form of medical malpractice or negligence, contact the medical malpractice attorneys of Messa & Associates for a free consultation. Call toll-free 1-877-MessaLaw, or submit a free online inquiry form.

Let the New Jersey medical malpractice attorneys of Messa & Associates work to earn you the compensation you need and deserve.

new jersey philadelphia birth defects injuries attorneys cleft palate developmentBirth defects attorneys are often asked by their clients, “what caused my child’s cleft palate?” Unfortunately, there is little known about the actual cause of cleft lips and palates, but some information is known about certain contributing factors. A cleft (lip, palate, or both), which occurs in about 1 out of 700 babies born,is present where the palate does not fuse completely, meaning full development did not occur. Professionals know that there are a wide range of factors that can hinder development, like environmental factors, alcohol use, drug use, and genetics. Additionally, certain prescription medicines have been linked to an increase in the development of cleft lip/palates. So while there is no known exact cause for a cleft lip or palate, there certainly are contributing factors.

One Contributing Factor: Topamax (Topiramate)

One factor that contributes to the development of cleft lips and palates discussed above is prescription medicine. The drug Topamax, commonly used to treat migraine headaches and seizures, has been linked to increased incidents of cleft lips and palates. The FDA has recently announced its findings regarding the drug, and has downgraded it to Pregnancy Category D (meaning the drug has known pregnancy complications). There are legitimate uses for Topamax, but if it was taken prior to or during pregnancy it may be responsible for your child’s cleft lip or palate.

Birth Defects Attorneys of New Jersey and Philadelphia

If you or a loved one has taken Topamax during or prior to pregnancy and has given birth to a child with a cleft lip or palate you have legal options. Our experienced professionals are willing and able to secure your fair compensation for your child’s birth defect, which will surely make recovery easier. It is important to act quickly as there may be time restrictions on filing a claim. Contact the Mininno Law Office for a free case evaluation and consultation at (856) 833-0600 in New Jersey, or (215) 567-2380 in Philadelphia.

Whenever you hear someone talk about “their lawyer,” it is natural to wonder what the services of an attorney would cost. In many cases, lawyers’ fees are expensive, and in some instances, cost-prohibitive. When you are dealing with your child’s cleft lip or cleft palate birth defect, additional concerns, like the cost of a lawsuit, really have no place in your life. You are stressed enough as is, and providing care for your child is your number one priority. With this in mind, the caring and experienced birth defects attorneys of the Mininno Law Office want to draw your attention to the true costs of trying your Topamax lawsuit.

Topamax Lawsuits and the Cost

The FDA has recently upgraded their warning to pregnant women about Topamax (Topiramate) to a Pregnancy Category D drug, meaning that there are recorded instances of negative pregnancy effects from the drug. In this case, Topamax has been linked to an increase in the development of cleft lips and palates. Because Topamax can reasonably be assumed to be a contributing cause to these birth defects, the Mininno Law Office is willing to get you the compensation you deserve.

The Mininno Team

What is the cost? There is no upfront cost because the birth defects attorneys of the Mininno Law Office work on what is called a “contingency basis.” This essentially means that the Mininno Law Office pays all the expenses for trying the case upfront, and you do not pay a cent. In exchange, when you recover a judgment or settlement, the birth defects attorneys of the Mininno Law Office receive a percentage of the judgment. Essentially, the Mininno Law Office is paid only when you are, and you owe no money at all if no money is recovered. There really is nothing to lose by speaking with the birth defects attorneys of the Mininno Law Office to discuss your options.

Birth Defects Attorneys of New Jersey and Philadelphia

The caring birth defects attorneys of the Mininno Law Office are prepared to get the compensation that you and your family deserve for your child’s birth defect. If you believe that Topamax was a cause of your child’s cleft lip or palate do not hesitate to contact the Mininno Law Office at (856) 833-0600 in New Jersey, or (215) 567-2380 in Philadelphia. As always, we do not get paid unless you do, and we offer free case evaluations and consultations.

Topamax (Topiramate) is a drug produced by two divisions of Johnson & Johnson that is prescribed for two conditions; epilepsy and migraines. For both conditions, the drug is used preventatively. It can not relieve seizures or migraines already happening, but, taken on a regular basis, can help to prevent them from occurring. Off-label uses of the drug, for which Johnson & Johnson and Ortho-McNeil Neurologics were sued and found accountable, include bipolar disorder, alcoholism, obesity, infantile spasms, myoclonic seizures, and absence seizures. Professionals realize that because of the wide disbursement of the medication, many different people have been affected by its side effects, and need to be informed and warned about the dangers of its use.

What are the Dangers of Using Topamax?

new jersey philadelphia topamax topiramate cleft lip palate birth defects attorneysA recent FDA announcement warned that using Topamax has been linked to an increase in the development of cleft lips and palates by over 21 times the normal rate. This side effect manifests in women who have taken Topamax while pregnant, or before becoming pregnant, but during child-bearing years. Topamax has been classified as a Pregnancy Category D drug, meaning there is positive evidence of human fetal risk, but usage of the drug may continue if medically necessary. If your child was born with a cleft lip, palate, or both, and you took Topamax while you were pregnant, or before becoming pregnant, it may be responsible for the development of your child’s birth defect.

Our attorneys caution you to consult your physician immediately, if you have not already done so, to discuss what these new dangers mean to you. Please note, that you should consult your physician before discontinuing usage of Topamax, as there may be complications associated with a rapid discontinuance.

Birth Defects Attorneys in New Jersey and Philadelphia

If your child was born with a cleft palate/lip and you were taking Topamax before or during pregnancy you are wondering what are your legal rights. You may also be wondering what the cost will be to have legal representation. Our experienced professionals are here to help. Contact the Mininno Law Office for a free case evaluation and consultation at (856) 833-0600 in New Jersey, or (215) 567-2380 in Philadelphia. You and your child deserve compensation, so please do not hesitate.

We have been discussing cleft lip and palates in a variety of different topics on this blog, including surgery and medical care. However, it is important to know that there are other resources around the world (and web) that can be beneficial to helping your child overcome his cleft lip/palate birth defect. Our attorneys care about you and your family’s well-being and wish to provide a link to scholarship opportunities for students attending college.

The Cleft Palate Foundation’s College Scholarship

new jersey philadelphia birth defects attorneys cleft palate resourcesOur birth defects attorneys believe that the Cleft Palate Foundation is an invaluable resource of knowledge for families with members who have a cleft lip or palate, of any age. While the website itself is a great resource for knowledge, they also have an annual scholarship fund, and applications for the 2012-2013 school year are being accepted until January 1st, 2012. It is uplifting to see the past recipients of the scholarship as well, because you can see their corrective surgery, as well as the bright future ahead of them. Please submit your application to them and good luck with the selection process.

Birth Defects Attorneys of New Jersey and Philadelphia

Our professionals are available for your needs. If your child was born with a birth defect, like a cleft lip or palate, your legal rights may have been affected. For instance, the FDA has recently announced that Topamax (Topiramate) has been linked to the development of cleft lip/palates. If you believe that this drug may have contributed to the development of your child’s birth defect contact the Mininno Law Office at (856) 833-0600 in New Jersey, or (215) 567-2380 in Philadelphia for a free case evaluation and consultation.

The idea of having a surgery to correct a cleft palate or cleft lip has been discussed in a previous blog post and, in many cases, it is the correct decision for your child’s health. However, in cases where surgery may not be the best option due to health concerns or fears that the surgery will not be successful, there are other non-surgical treatment options. Our birth defects attorneys would like to highlight some effective, nonsurgical treatment options specifically targeted to help your child develop better speech.

Speech Bulbs and Palatal Lifts

new jersey philadelphia birth defects attorneys non surgical speech optionsOnce your child starts to grow, your doctor may want to discuss appliances that can be put in his or her mouth, to make speech easier. The speech bulb may be suggested, which is a plastic ball that fits into the velopharyngeal space, which is then attached to a plastic plate fitted to the roof of the mouth and held in place by wire clasps. The size of the bulb will vary depending on the size of the velopharyngeal space. The bulbs function is to stop air and sound from escaping the nose during speech. It is removed at night before bed.

Another appliance that may be suggested is a palatal lift. This is similar to a speech bulb, but is a wider, plastic paddle that extends back into the mouth and lifts the soft palate up, closing the velopharyngeal space. Your child’s care team should be consulted to see which, if any, of these appliances is appropriate.

Birth Defects Attorneys in New Jersey and Philadelphia

Many parents who have children with a cleft lip or cleft palate are often overwhelmed and, in some instances, confused about their legal rights and whether or not birth defects attorneys would even be needed. In some cases, there have been improper actions that may have lead to your child’s birth defect and contacting birth defects attorneys is beneficial to your family’s physical and financial health. For example, the FDA has recently announced that Topamax (Topiramate), taken during pregnancy or during child-bearing years, has been linked to an increase in the development of cleft lips and cleft palates. We are able to assist parents dealing with these issues. 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.

After your child has a palate repair surgery, most people would think that they are out of the woods and nothing else will have to be done. Unfortunately, approximately 15-25% of children born with a cleft palate will develop Velopharyngeal dysfunction (VPD). Our birth defects attorneys think that parents should be informed about the possibilities that may affect their child, and be able to react in a well-informed manner.

What is Velopharyngeal dysfunction?

new jersey philadelphia Birth Defects Attorneys Discuss Velopharyngeal DysfunctionVelopharyngeal dysfunction occurs when the open space between the back wall of the throat and the soft palate cannot be properly closed during speech. Unfortunately, this results in an unwanted escape of air or sound through the nose during speech. Essentially, this dysfunction may result in what is called hyper-nasal speech. The sounds that create speech come from both the nose and the mouth. When we speak, the majority of those sounds should come from the mouth alone. Closing the velopharyngeal space allows people to build pressure in the mouth and make the appropriate speech sounds. When a VPD is present, air comes through the nose that should not, and speech becomes too nasal.

In many cases, after surgery has been completed, or if surgery is not going to be undertaken, there are other options that can be explore. There are appliances that your doctor may recommend that can help alleviate these issues and eliminate the hyper-nasal speech problem.

Birth Defects Attorneys in New Jersey and Philadelphia

Giving birth to a child with a cleft lip or cleft palate begs the question,”Do I need the assistance of birth defects attorneys?They are necessary when a birth defect is caused by a deviation in the standard of care. For example, contacting our experienced professionals would be beneficial to you and your child if Topamax (Topiramate) was taken during pregnancy. The FDA has recently announced that Topamax has been linked to an increase in the development of cleft lips and palates. 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.

new jersey philadephia birth defects attorneys anti bullying adviceYour child has a cleft lip and is about to start school and you are nervous that he or she may be the victim of a school bully. Our caring birth defects attorneys want to help you get ready for this. It is in any parent’s nature to want to nurture their child for as long as possible and shield them from the cruel outside world. Now that your child is school aged, this is less and less an option and you should be focusing and preparing your child for school and the social interactions that comes with it. As we all know from our school experiences, children can be cruel (although we are not suggesting that all children are). It is not to say that bullying will happen, just that it can happen, and you should take steps to prepare your child to deal with it in a positive way. We wish you and your child a happy school year and want it be as successful as possible.

Helping Your Child Understand Their Situation

It is important for your child to understand his or her condition in a way that helps them communicate to others what is different about them, as curious children may ask. Explaining this in a way that children can understand will be beneficial to your child and expose other children to the differences in people. Take the opportunity to make your child feel special and help him or her understand what is different (and special) about them.

It may go without saying, but taking photographs as your child matures is helpful so they can see their physical history and see it as “normal.” These photos document changes and help children have an opportunity to ask questions about their condition in a non-threatening environment.

In the case of a negative social interaction with another student, many parents get angry and want to confront the other child’s parents right away. Before you do, ask your child to express his or her feelings about it and try to understand what happened. Use this is a segue to discuss the birth defect in a positive way and ask how your child would like to proceed. Obviously, there are going to be situations where confronting the other parents is necessary, even if your child does not want to. But in some situations, letting kids work out their own differences, with a little adult help, can be beneficial.

Birth Defects Attorneys in New Jersey and Philadelphia

In many cases, parents of a child with a cleft lip or palate ask if they need the services of birth defects attorneys. Due to the nature of the birth defect, lawyers would do little good. However, the FDA has recently announced that Topamax (Topiramate) has been linked to an increase in the development of cleft lip/palates. If you believe that Topamax may be involved with your child’s cleft palate/lip 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.

Unfortunately, when a child is afflicted with a birth defect like a cleft palate or cleft lip, there are other physical manifestations of the birth defect that must be dealt with. One of the major physical issues confronting children with cleft lip/palates is that they may need serious dental attention. The cleft usually occurs between the cuspid (eye tooth) and the lateral incisor. Possible dental issues include: a missing lateral incisor, two lateral incisors on both sides of the cleft, poorly formed teeth (with misshapen crowns and/or roots), and displaced teeth. We want you to be informed about the potential issues related to your child’s unfortunate birth defect and be able to take the appropriate actions.

Your Child’s Dentistry Needs

new jersey philadelphia birth defects attorneys topamax cleft lip dental optionsAlthough this may seem overwhelming, children born with a cleft lip/palate can still have healthy teeth. Proper cleaning, good nutrition, and fluoride treatment is necessary. The teeth should be cleaned with a small, soft-bristled toothbrush, as soon as the teeth are visible. Early evaluation is critical, with many dentists recommending the first visit being scheduled at one year of age, or in some cases, even sooner. What dental work your child needs will be determined by the dentist, which can be as simple as preventative care, or can be extensive including dental surgery.

It may be necessary for orthodontic care to be sought, even before the child has any teeth. This is to assess facial growth and plan for the child’s short and long term dental needs. If the teeth do not fit together correctly, braces will most likely be necessary.

Birth Defects Attorneys of New Jersey and Philadelphia

Parents who have children with a cleft lip or palate are often confused about their legal rights and whether or not birth defects attorneys are necessary. In many cases, birth defects attorneys are not necessary, because the cause is usually natural. However, the FDA has recently announced that Topamax (Topiramate) has been linked to an increase in the development of cleft lips and palates. In this situation, it would be beneficial to contact the Mininno Law Office: Our experienced and caring birth defects attorneys off a free case evaluation and consultation. You may call 856-833-0600 in New Jersey, or 215-567-2380 in Philadelphia.