PA Law Blogs » Product Liability Law

Why are Metal on Metal Hip Joints Dangerous?

Michael Monheit — Sat, 04 Feb 2012 02:17:37 +0000

Metal on metal hip replacements were designed to decrease the number of fractures suffered by hip replacement patients and to avoid other potential problems. However, in the past few years reports of potentially serious metal on metal hip replacement complaints have been reported.

The primary concern about metal on metal hip replacements is that tiny particles of metal may be released into the body as the metal parts of the replacement hip joint rub together when the patient moves. These metal particles can damage the bones and joints around the replacement which can then cause the replacement to fail and/or cause the patient pain. Additionally, it is possible that metal may be released into the bloodstream which may affect different parts of the body such as the heart.

So, are metal on metal hip joints dangerous? For some patients they may be and that is why you should talk to your orthopedic surgeon about your hip replacement options or about how to monitor the metal on metal hip replacement you already have implanted.

7 Serious Vaginal Mesh Side Effects That Could Change Your Life

Michael Monheit — Sat, 04 Feb 2012 02:15:02 +0000

You consent to vaginal mesh surgery with the expectation that it will improve your life. Yet, after surgery you find that you are suffering from problems you didn’t anticipate.

Not every patient experiences vaginal mesh side effects, and not every patient who does experience side effects from trans-vaginal mesh has the same problems. Yet, the following side effects are common and are important to know about if you have had, or if you are considering, transvaginal mesh surgery:

Dangerous Infections.
Internal bleeding.
Vaginal scarring or wall narrowing.
Mesh erosion through the vaginal tissues.
Significant Pain.
Painful sexual intercourse.
Recurrence of the prolapsed or incontinence or both.

If you have had transvaginal mesh surgery, please talk to your doctor about the symptoms you should report and about your risks. Additionally, contact an experienced medical device attorney who can advise you of your legal rights and help protect your recovery.

The Serious Health Effects of Spina Bifida

Michael Monheit — Wed, 09 Nov 2011 13:05:56 +0000

The common phrase to describe Spina Bifida is “split spine.” Babies born with this neural tube defect may face a wide range of serious health issues. During the early weeks of development, the spine may fail to completely fuse and the gaps in the vertebrae may adversely affect the spinal cord. Depending upon the extent of the damage, babies with Spina Bifida suffer paralysis of the legs and permanent disabilities. This potentially catastrophic medical condition has been linked to prescription drugs taken by mothers during the first trimester.

The types of prescription drugs most often linked to Spina Bifida are anticonvulsant drugs. Medicinenet.com’s list of drugs linked to Spina Bifida include folic acid, oxybutynin, Ditropan and Oxytrol. When a woman takes these types of drugs during the early stages of pregnancy, there is an increased chance of the baby suffering from Spina Bifida.

Symptoms of Spina Bifida range from a loss of bladder control and weakness in the lower extremities to complete paralysis of the legs. Other victims may suffer from hydrocephalus, or clubfoot. Prenatal screenings and second trimester blood tests can help diagnose this devastating condition. Early diagnosis is necessary to allow for effective treatment. It is common in these cases for complicated surgeries to help repair some of the damage to the spinal cord and to help prevent further damage.

The family of someone born with Spina Bifida may be able to pursue financial compensation for their medical bills and suffering. Drug manufacturers who produce prescription drugs that cause birth defects may be held accountable for their negligence.

Topamax Linked to Craniofacial Birth Defects

Michael Monheit — Mon, 07 Nov 2011 14:02:32 +0000

Topamax is an epilepsy drug that has a known correlation with birth defects and injuries. Many anti-epileptic medications have potential side effects for an unborn baby. So anyone who is pregnant or may be pregnant should discuss the risks of Topamax with their doctor.

Perhaps the most common birth defect linked to the use of Topamax is facial and oral malformations. Common facial defects include cleft palate and cleft lip. This deformation occurs during the formation of facial tissue. A cleft palate or lip may also result in problems with feeding, speech and ear infections.

Craniofacial defects are typically treated through surgery. Cleft palate treatment, for example, often requires multiple surgeries for the space in the roof of the infant’s mouth to be closed. These surgical procedures can be very complicated and expensive. During the process of correcting a cleft palate, a baby may face great difficulty getting proper nutrition as they often experience difficulties eating.

All drugs have the potential to do damage to an unborn baby. The growing evidence that Topamax can cause birth defects should be taken seriously by anyone who is pregnant or may become pregnant. It is crucial to discuss the many potential consequences of taking a drug like Topamax with a medical professional. A Topamax birth defect lawyer can help a family understand their legal options. In some cases, compensation may be available for the expensive medical procedures that are required to repair a birth defect.

What are Craniofacial Birth Defects?

Michael Monheit — Thu, 03 Nov 2011 12:57:43 +0000

A craniofacial defect is when a baby is born with bone or soft tissue defects on his or her face or head. Studies have shown that some craniofacial defects may be caused by prescription medication taken by the mother during pregnancy. Two drugs that have recently been linked to facial birth defects include Depakote and Topamax.

Depakote is a drug that doctors prescribe to patients suffering from epilepsy, seizures or mania. The Food and Drug Administration (FDA) warns that taking this drug during pregnancy can be detrimental to the health of the baby. One side effect of Depakote is an increased chance of the baby being born with a craniofacial defect such as a cleft palate or a cleft lip.

Topamax is also an epilepsy drug that is linked to craniofacial defects. The FDA reported in March 2011 that taking Topamax during the first trimester increases a woman’s risk of having a child with craniofacial defects by 21 times. Topamax is even three times more likely to cause a craniofacial defect than other epilepsy drugs.

Craniofacial defects include cleft lip (lip doesn’t completely form), cleft palate (roof of mouth doesn’t close), craniosynostosis (fused bones of the skull) and hemangioma (a red birthmark). Many of these conditions require multiple surgeries and the resulting expenses can cause immense financial burdens for the family.

Depending on the circumstances, compensation may be available for the family of a child born with a birth defect. If the mother of a child born with craniofacial birth defects took drugs such as Topamax or Depakote during her pregnancy, it may be in the family’s best interest to speak with an experienced defective drug injury lawyer to explore their legal rights and options.

Depression Drug Paxil Linked to Hydrocephalus

Michael Monheit — Tue, 01 Nov 2011 13:52:41 +0000

Hydrocephalus is commonly known as “water on the brain.” This birth defect can occur during development when cerebrospinal fluid builds and the pressure inside the skull increases. This serious birth defect may result in death, convulsions and mental disabilities. Recent studies have linked this devastating medical condition to the prescription drug Paxil.

Paxil is prescribed to patients suffering from depression. In 2005, the Food and Drug Administration (FDA) warned that women who take Paxil during the first trimester of pregnancy have an increased chance of their child suffering from hydrocephalus. Additional serious birth defects linked to Paxil include Gastroschisis, congenital heart defects and Spina Bifida.

United Healthcare Data estimates that nearly 6,000 babies of mothers who took paroxetine during the first trimester were born with serious risks of defects. Babies exposed to paroxetine had an even greater chance of suffering a serious birth defect than those exposed to other powerful anti-depressants.

Paxil is not the only drug linked to Hydrocephalus. The FDA’s list of drugs that may result in hydrocephalus includes: Vioxx, Remicade, Avonex, Humira, Methotrexate and Asprin. All drugs have the potential to cause damage to a baby but these drugs have proven links to hydrocephalus. The family of a child with this devastating birth defect may be able to pursue financial compensation for their medical expenses and long-term care costs.

An experienced product liability attorney can protect the rights of a family facing all the challenges of raising a child with birth defects caused by drug side effects. Holding a drug manufacturer liable for a birth defect is not an easy process but it may be necessary for the family to receive fair compensation for the substantial losses they have suffered. Families of children with hydrocephalus would also be well-served by reaching out to support groups and online communities that can help point them to valuable resources that can help improve the child’s quality of life.

How Do I Report My Transvaginal Mesh Surgery Complications to the FDA?

Michael Monheit — Mon, 31 Oct 2011 22:16:50 +0000

Recently, the U.S. Food and Drug Administration (FDA) released an updated safety communication that warned consumers and healthcare providers of the dangers that have been associated with the surgical mesh placement of mesh to repair pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Despite serious side effects that have been linked with the use of surgical mesh, it has not yet been recalled by the FDA. Among the severe complications that have been reported due to the mesh are mesh erosion through the vagina, infection, bleeding, and more. Read more about Transvaginal Mesh Implants.

Following transvaginal surgical mesh surgery, should symptoms last after their initial follow-up appointment or if complications arise due to the mesh, patients should immediately notify their healthcare provider. Additional surgery may be needed.

Adverse events related to transvaginal mesh surgery and surgical mesh should also be reported to the FDA to help them identify and understand the dangers related to these medical devices. If you have suffered due to surgical mesh, you should file a voluntary report to the FDA through its MedWatch program. You will need to include the following information in your report:

The name of the manufacturer
The product’s name, catalog number, lot number, and size
When the mesh was implanted, as well as reasons why the mesh was implanted
What type of procedure was done (anterior or posterior repair, sacral colpopexy, sling procedure for SUI, etc.)
The surgical approach for the surgery (abdominal, laparoscopic or vaginal)
If the mesh was removed, the date it was taken out
Specific post-operative symptoms suffered, with time of onset and follow-up treatment
Details regarding the adverse event(s) and whether any medical and/or surgical interventions were required

Learning about their legal rights from a Philadelphia transvaginal mesh lawyercan also help patients understand what they can do to hold a negligent physician or manufacturer accountable for their suffering.

Drugs That May Cause Neural Tube Defects

Michael Monheit — Fri, 28 Oct 2011 14:37:50 +0000

Neural tube defects are birth defects that affect the brain and spinal cord. Perhaps the most well known neural tube defect is spina bifida. Spina bifida is when the fetal spinal column doesn’t close. This typically results in nerve damage and partial paralysis of the legs. Another serious neural tube defect is anencephaly. Anencephaly is when the brain does not develop. Babies with this tragic birth defect are either still born or die shortly after birth. New studies are showing that these neural tube defects can sometimes be caused by prescription medications.

On December 3, 2009, the Food and Drug Administration (FDA) issued a reminder to all health care professionals that some drugs result in neural tube defects when taken by a pregnant woman. The warning was specifically targeted at drugs containing valproic acid and devalproex sodium. The popular drug Depakote is one example of a medication that could have these devastating side affects.

All antiepileptic drugs have a number of positive and negative consequences. Anyone taking a drug such as Depakote would be well advised to discuss the risks if she becomes pregnant or is considering becoming pregnant. Depakote is not the only drug the FDA warns could result in neural tube defects. Other potentially dangerous drugs include Depacon, Depakote CP, Depakote ER, Depakene and Stavzor.

The family of a baby born with a serious birth defect would be well advised to discuss their legal options with a skilled birth injury lawyer. If the mother took a prescription during the pregnancy, there may be financial compensation available for medical expenses and long-term care costs. There is no way to put a monetary value on the life and future of a young family member. But a Depakote neural tube defects lawyer will have the skill, knowledge and experience it takes to help a family secure the compensation they need to offset the costs of surgery, treatment, rehabilitation and care associated with such devastating birth defects.

Who is Most Likely to Have Problems Related to Transvaginal Mesh Surgery for Pelvic Organ Prolapse?

Michael Monheit — Fri, 28 Oct 2011 14:08:20 +0000

In July, the U.S. Food and Drug Administration (FDA) released an updated safety communication that warned patients and healthcare providers alike of the dangers linked to the surgical placement of mesh to repair pelvic organ prolapse (POP). In certain surgeries, surgical mesh is permanently implanted to reinforce a patient’s vaginal wall to fix POP. This mesh can also be utilized to strengthen the urethra to treat urinary incontinence (UI).

Previously, in 2008 the FDA had released a warning disclosing the severe side effects and other complications that were linked to surgical mesh placed through the vagina to treat POP and UI (this process is also called transvaginal placement). A recent study prompted the FDA to issue an update warning healthcare providers and patients that the severe complications related to the transvaginal placement of surgical mesh are “not rare.” The study also found that it is not clear whether or not transvaginal POP repairs using mesh are more successful than other POP repairs that do not utilize mesh; and that the mesh may expose patients to greater risks.

According to the WebMD, in a study of close to 12,000, approximately 10 percent of women experienced mesh erosion within one year after the surgery. The study involved both biologic and synthetic mesh types. Previously, smaller studies had found rates that were as low as 1.2 percent. Certain surgical mesh complications have been described that may predispose a woman to suffering mesh erosion into their vaginal tissues. One study found that among 322 women that had had a 24-month follow-up after a mesh repair surgery for POP, undergoing a hysterectomy during the POP operation, in addition to being a smoker, increased the risks of mesh-related problems. Another study found that when mesh was transvaginal placed rather than through an abdominal incision, more mesh-related complications arose. Other risks related to transvaginal mesh surgery include the following:

Increasing age
Low estrogen levels
Size of mesh implant
Variations in surgical techniques

If you have suffered additional injuries relating to transvaginal mesh surgery, consulting with a transvaginal mesh lawyer can help you understand what legal options are available to you, based upon the specifics of your circumstances, as well as what types of compensation you may be eligible for.

Actos Related Bladder Cancer

Michael Monheit — Thu, 27 Oct 2011 12:55:41 +0000

The U.S. Food and Drug Administration (FDA) issued an initial warning to consumers in June of this year regarding the diabetes medication Actos (official name pioglitazone). According to the FDA, patients who used the drug on a long term basis (for one year or more) in significant doses showed an elevated risk of developing bladder cancer. The FDA also strongly cautioned any patients with bladder cancer, or a history of bladder cancer, to avoid the drug.

The medicine is prescribed to adults diagnosed with diabetes (type 2 mellitus) to help in regulating the level of a patient’s blood sugar. During the last ten months, the FDA calculated that around 2.3 people in the United States had prescriptions for Actos or other drugs containing pioglitazone. As part of the warning, the FDA has revised the safety information on the Actos label, and for all other labeling for related drugs, as well as on any patient informational materials.

A growing number of individuals affected by the new safety information started a class action suit this September against the drug’s manufacturer Takeda. The suit alleges that the drug company did not adequately research the safety implications of Actos and then failed to properly communicate the public on its potential hazards. Those taking Actos, or any products containing pioglitazone, should consult their physician immediately if experiencing urinary problems or irregularities, or any discomfort in the bottom back. Do you think you’ve been injured as a result of usage of the drug Actos (or other drugs containing pioglitazone)? Contact a dangerous drug attorney about your situation since you may be able to file an Actos bladder cancer lawsuit to seek compensation for damages.