Child Injury Laws - By Jonathan Rosenfeld

As personal injury lawyers who are presently representing clients in matters involving injuries related to drugs with improper warnings and defective medical devices, we are proud to reveal the recent updates to these areas on our firm website. Recently we have expanded, web materials involving the following practice areas:

• Humira Neurological Injury:

In 2002, Abbott Labs introduced Humira to the marketplace as an injectable treatment for several medical conditions that primarily affected children and young adults. As a tumor necrosis factor inhibitor (TNF blocker), Humira joined a family of drugs that was designed to kill the TNF cells. TNF blockers are thought to reduce inflammation that is responsible for causing pain related to an underlying condition.

The full extent of the neurological risks that were known by Abbott at the time Humira was brought to market is still unknown. But, at the very least, there were indications of demyelination complications in patients in Humira’s clinical trials.

While the alleged demylination injuries related to Humira vary in their severity, the injuries stem from the destruction of protective nerve covering (myelin sheath) that encompassed nerve fibers in the brain and spinal cord. When the myelin sheath is destroyed, nerve impulses slow or even stop, causing neurological impairment such as:

• Vision loss
• Hearing loss
• Headaches
• Loss of sensation
• Seizures
• Muscle spasms
• Loss of coordination
• Paralysis

•  Accutate Bowel Disease Lawsuits:

For almost 30 years, parents have looked to Accutane and its generic derivatives to help their children with severe acne.

As it turns out, Accutane was effective treating the acne, however scientists are just now confirming many of the suspected side-effects that Accutane users had long complained of including severe stomach problems related to the drug.

The medical and scientific communities have now conclusively established that Accutane use has been connected to a painful, embarrassing— and downright life changing condition known as Accutane Inflammatory Bowel Disease, Ulcerative Colitis and Crohn’s Disease.

Inflammatory Bowel Disease (IBD) is a medical condition characterized by painful inflammation of the bowel that may contribute to: bowel bleeding, ulcers, bowel obstruction or a bowel rupture. Unlike common stomach or gas-related pain, IBD is a chronic condition with no cure....

• Topamax Birth Defects:

Women taking Topamax, a popular drug used to treat headaches and epilepsy, are more than three times more likely to give birth to a child with birth defects related to a child’s mouth such as: cleft lip or cleft palate compared with women taking other brands of epilepsy drugs. Researchers estimate that infants born to women taking Topamax have a 1.4% chance of a having a birth defect relating to their mouth.

As a result of these safety concerns, the FDA is requiring Johnson & Johnson, the manufacturer of Topomax and to incorporate stronger warnings about use and pregnancy.

In particular, Topamax has been associated with birth defects such as:

• Cleft lip
• Cleft palate
• Heart defects
• Facial deformities
• Deformed limbs

•  DePuy Hip Recall Lawyers:

In 2010, the FDA ordered the recall of very popular DePuy hip replacement systems (ASR XL Acetabular System and Hip Resurfacing System) after they discovered that a significant number of the devices were indeed defective and required a second corrective surgery to remove the DePuy product and replace it with a new device.

Aside from the actual design of the hip, critics also fault Johnson and Johnson, a subsidiary DePuy, for the type of materials used to manufacture their device. In some patients, the metal-on-metal design of the hip implant has produced situations where bits of the metal splinters off and gets embedded in the surrounding tissue resulting in:

• Pain while walking
• Pain when sitting or getting out of a car
• Pain in the hip, thigh or groin
• Joint inflammation

Rosenfeld Injury Lawyers remains committed to protecting the rights of the injured.  If you have a personal injury claim regarding a defective drug or medical device, we remain available to discuss your legal options.

A recent warning issued on the FDA’s Web site says Humira, a drug used to treat Crohn’s disease and other inflammatory bowel diseases, may put teens at risk for developing cancer.  

“The FDA continues to receive reports of a rare cancer of white blood cells, primarily in adolescents and young adults being treated for Crohn’s disease and ulcerative colitis, with medicines known as tumor necrosis factor (TNF) blockers,” the FDA said in its statement. “[We] believe the risks and benefits of using TNF blockers...should be carefully weighed when prescribing these drugs to children and young adults.”

Humira, first developed in 2002 by Abbott Laboratories, helps block “TNF,” a protein in the body that causes inflammation. (TNF stands for “tumor necrosis factor.”) Excess TNF causes common symptoms of Crohn’s disease, like abdominal pain and diarrhea. Other “TNF blocker” medications include Remicade, Enbrel, Cimzia and Simponi. TNF blockers are also referred to as “immunosuppressants,” since they decrease the body’s ability to fight off diseases and infections.

As of December 31, the FDA had linked more than 20 cases of teen lymphoma to various TNF blockers. The type of lymphoma the FDA studied, commonly referred to as HSTCL (Hepatosplenic T-Cell Lymphoma) is particularly deadly for teens.

“HSTCL is an aggressive cancer and is usually fatal,” the FDA said in a statement in April.

In August, 2009 the FDA issued a “black box warning” for Humira, saying that users should be aware of “an increased risk of lymphoma and other malignancies in children and adolescents.” A black box warning is the most serious warning the FDA can require for a prescription drug.

Humira (also called “adalimumab”) is Abbott’s best-selling product, with more than $6.5 billion in sales in 2010. Humira accounts for nearly twenty percent of Abbott’s revenue.

Common side effects of Humira, listed on Humira’s official Web site, include:

• Rashes
• Upper respiratory infections (including sinus infections)
• Headaches
• Nausea

Other, more severe side effects, include:

• Tuberculosis
• Hepatitis B
• Allergic reactions
• Vision problems
• Heart failure
• Psoriasis

Humira is normally delivered by injection every two weeks, and costs approximately $1,500 per month, without insurance. 

Rosenfeld Injury Lawyers is currently evaluating claims for various types of injuries including, vision loss, demylination and other types of neurological injuries experienced following the use of Humira.

Related:

Research Supports The Connection Between Humira Usage And Development Of Cancer In Children

Multiple Lawsuits Claim Abbott's Humira Caused Permanent Nerve Damage

Humira Neurological Injury

As an expectant father, I really can sympathize with the deliemmas highlighted in Melinda Beck's Wall Street Journal article, "Can Mom's Medicine Hurt the Baby?"  Like most pregnant women, my wife is incredibly sensitive to how the foods she eats and the beverages she drinks will impact our developing fetus.  

However, I can only imagine how trying similar decisions must be fore expectant mother's who are prescribed medications for medical conditions they have-- both prior to and develop during pregnancy. Given the obvious lack of information available regarding pharmaceutical drugs' impact on both expectant mother and fetus, the information void-- certainly gives rise to feelings of hesitancy-- and fear. 

As a result many women are left to feel in the dark as even their own physicians have little concrete information to advise on which medications to take-- or avoid.  As Ms. Beck highlights these decisions are indeed very difficult simply due to the utter lack of public information regarding medications impact on developing babies.

The current drug-safety system for fetuses was created by the FDA, can be difficult for many women to understand as the system provides only generalized warnings based upon an irregularly created system of medical studies thay may only hypothosize as to a drugs impact on a developing fetus.

Using the data that does exist from studies related to drugs impact on the fetus, the FDA has established the following drug-rating safety system.

Category A: Drugs that have been demonstrated no harm on fetuses according to medical studies

Categoy B: Drugs believed to be safe for fetuses, but without widespread studies medical studies

Category C: Drugs with no information regarding fetus safety

Category D: Drugs that pose some harm to fetuses

Category X: Drugs that pose a severe risk of harm to fetuses and their is no reason for pregnant woment to take the medication

While the impact of drugs and other medications a mother takes during her pregnancy definately impacts, it is crucial that the public demand full accounability from all dru manufacturers as to their company-based studies related to complications and bith defects related to their drugs.

Related Child Injury Law Blog Entries:

Major Birth Defects Associated With Use Of Paxil During Pregnancy

New FDA Warnings Suggest Correlation Between Topomax And Birth Defects Including: Cleft Lip & Cleft Palate

I've written a lot about the serious problems associated with use of Topamax during pregnancy.  After all, the FDA ordered Topamax to be re-labelled and re-classified in March, 2011 in response to data suggesting a conclusive correlation between Topamax usage by pregnant woman and birth defects such as: cleft lip, cleft palate, Spina Bifida, facial defects and pediatric heart problems.

The swift decision to change the classification / labelling of Topamax is mainly due to the data collected by the FDA.  The FDA collects information about problems associated with all drugs in an Adverse Event Database.  According to the FDA's adverse Event Report database:

• There are 244 safety reports concerning Topamax users who believe their child was adversely affected by the drug
• 114 of the 244 safety reports (approximately 47%) are related to birth defects
  
  • 12% of adverse complaints are related to cleft lip / cleft palate
  • 12% of the adverse complaints relate to limb malformation such as: cleft hand foot defects
  • 11% of adverse complaints are heart related
  • 10% of adverse complaints relate to facial defects
  • 6% of adverse complaints relate to spinal defects

Off Label Uses Of Topamax

Topamax was originally approved by the FDA as a drug to treat epilepsy in 1996.  In 2004, the FDA approved Topamax to treat migraine headaches. 

Despite its limited approved uses, Ortho-McNeil was illegally promoting Topamax to treat conditions such as bipolar mood disorder, alcohol dependence and weight loss for several years. 

In May, 2010 Ortho-McNeil plead guilty and and paid fines of more than $81.5 million for their off-label promotion of Topamax to broad range of people for which the drugs safety was never approved.

Certainly, the more information that comes to light regarding Topamax birth defects and marketing, it is becoming more apparent that scope of potential pharmaceutical claims against Ortho-McNeil and various generic manufacturer are indeed quite strong.  As we learn more about this troubling situation, I encourage you to give my law office a call or email us a contact form and allow us to begin an evaluation of your case.

Related:

Topamax Injuries: Drug's Impact On Effectiveness Of Birth Control May Have Contributed To Outburst Of Birth Injuries

New FDA Warnings Suggest Correlation Between Topomax And Birth Defects Including: Cleft Lip & Cleft Palate

May 21, 2010: Ortho-McNeil Pharmaceutical, LLC Pleads Guilty to Illegal Promotion of Topamax and is Sentenced to Criminal Fine of $6.14 Million FDA

FDA Drug Safety Communication: Risk of oral clefts in children born to mothers taking Topamax (topiramate)

Just last month, the FDA issued some fairly impressive warnings regarding women's use of Topamax during pregnancy.  In fact, the FDA re-categorized the drug from a Category C- Pregnancy Drug to Category D-- an important reclassification due to the scientific evidence linking Topamax usage with birth defects.

Like other drugs categorized as a Class D, the FDA has conclusively established the use of Topamax with "human fetal risk based on adverse reaction data from investigations or marketing experience or studies in humans."  However the FDA's Class D warning goes on to say that even with the known risks, the use of the drug may be acceptable if the pregnant woman has a medical condition that threatens her life.

In particular, Topamax has been associated with birth defects such as:

• Cleft lip
• Cleft palate
• Heart defects
• Facial deformities
• Deformed limbs

While some of these Topamax birth defects, appear to have been known by the medical community years before the stern warnings, I find it particularly troubling that an added side-effect of Topamax usage is the ineffectiveness of oral contraceptives taken by woman to avoid becoming pregnant.  

A study published in 1996, the same year the FDA approved Topamax for treatment for partial onset seizures, indicates that seizure medications-- such as Topamax may substantially increase the likelihood of a woman becoming pregnant while she is on birth control.

The net result of this important information is that many woman were likely taking Topamax before they knew they were pregnant in the first place.  Given the nature of fetal development, it is likely that many of the facial malformations and cleft palates are due to the mother taking Topamax during the vital first trimester when many of these features form.

As we begin the process of learning just how much Ortho-McNeil and other generic manufacturer had about this drug, I believe the drug's impact on the effectiveness of women's birth control medication will prove to be important as women begin to disclose the fact that they may never have intended to give birth to a child with birth defects.

Rosenfeld Injury Lawyers is in the process of evaluating Topamax (and generic equivalents) cases.  Please use our contact form or call us and we will return you call promptly. 

Related:

Effect of Topiramate on the Pharmacokinetics of an Oral Contraceptive Containing Norethindrone and Ethinyl Estradiol in Patients with Epilepsy.pdf By William E. Rosenfeld, Dennis R. Doose, Sally A. Walker, and R. K. Nay Epilepsia, 38(3):3 17-323, 1997

New FDA Warnings Suggest Correlation Between Topomax And Birth Defects Including: Cleft Lip & Cleft Palate

I recently met with a family who's teenage daughter developed multiple lesions on her lungs and significant vision loss after taking Humira for treatment of her Crohn's Disease.  

Turns out, her situation is not unique. A substantial number of children, teens and adults who have taken Humira for various types of arthritis and other types of inflammatory conditions have now developed cancer and other debilitating neurological complications within several years of their usage.

Lawyers are currently investigating how much knowledge Humira's manufacturer, Abbott Laboratories, had with respect the increased risk of cancer in the drugs users.  However, the medical community has now conclusively established a connection between Humira usage and cancer, infection and autoimmune disorders.

Use of Humira (generic name Adalimunab and a similar drug Remicade) has been linked to a significant rise in the development of the following types of cancers:

• Lung tumors
• Skin
• Gastrointestinal
• Breast
• Lymphoma
• Leukemia
• Organ caners
• Melanoma

The medical assumption for the increased risk of cancer for Humira users is that as a TNF blocker (tumor necrosis factor), Humira severely suppresses the bodies immune system. In June, 2008 the FDA ordered a 'black box' warning be placed on the drug due to heightened risk of developing cancers.

If you or your child has developed cancer following use of Humira or Remicade, you may be entitled to pursue the a lawsuit or claim against the drugs' manufacturers for damages. Rosenfeld Injury Lawyers, always offers free legal consultation to perspective clients. Moreover, our services are free unless there is a recovery for you.  Talk with experienced Humira litigators today. (888) 424-5757.

Related:

Follow-up to the June 4, 2008 Early Communication about the Ongoing Safety Review of Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, Cimzia, and Simponi) FDA, August 4, 2009

FDA Investigates Link Between TNF Blockers and Pediatric Cancer

Questions and Answers - TNF Blockers 8/25/2009, FDA

Humira Neurological Injury

The medical evidence is mounting against pharmaceutical giant, GlaxoSmithKilne (GSK), regarding its knowledge of the increased rate of birth defects in children born to women who used Paxil during their pregnancy.  

Paxil is a commonly prescribed antidepressant drug that has been used by millions of people.  Paxil is part of a well known group of drugs known as serotonin reuptake inhibitors (SSRI's) that includes other anti-depressants such as Zoloft and Prozac.

As we learn more about GSK's knowledge of the dangers associated with the use of Paxil (also referred to as paroxetine) during pregnancy, over the past few years the Food and Drug Administration has issued several warnings regarding Paxil usage during all phases of pregnancy.

Birth Defects Associated With Paxil

The most prominent birth defects associated with the use of Paxil include atrial septal defects (ASD) and ventral septal defects (VSD)-- essentially heart and lung problems. Currently, research is underway to learn more about about Paxil's effects on the developing fetus during the various stages of pregnancy. 

There does appear to be a correlation between Paxil use and the following other birth defects:

• Spina Bifida
• Persistent Pulmonary Hypertension (PPHN)
• Cranial Birth Defects
• Neural Tube Defects
• Deformed Limbs
• Heart Valve Defects- atrial septal defects (ASD) an ventral septal defects (VSD)

Paxil Lawsuits Against GSK

Given the severity of the birth defects asscoiated with Paxil use and the fact that GSK failed to warn consumers about the potential problems, a number of lawsuits have already been against the drug maker.

Currently, there is no 'class' of that has been formed to pursue a case against GlaxoSmithKline.  Rather, lawsuits are permitted to proceed individually against the manufacturer.  Of the more than 800 indivudally filed lawsuits, GSK has already paid more than $1 billion to resolve a number of them.

If you were prescribed Paxil during a pregnancy and believe your child may have sustained birth defects, you may have legal rights for damages related to past and future medical expenses as well as other damages pursuant to the laws in the jurisdiction.  We would honor the opportunity to speak to you regarding your legal rights.  (888) 424-5757

Related:

Evaluation of the Risk of Congenital Cardiovascular Defects Associated With Use of Paroxetine During Pregnancy -- Einarson et al. 165 (6): 749 -- Am J Psychiatry (PDF)

Use of Selective Serotonin-Reuptake Inhibitors in Pregnancy and the Risk of Birth Defects (PDF) The New England Journal Of Medicine, June 28, 2007 Sura Alwan, M.Sc., Jennita Reefhuis, Ph.D., Sonja A. Rasmussen, M.D., M.S., Richard S. Olney, M.D., M.P.H., and Jan M. Friedman, M.D., Ph.D., for the National Birth Defects Prevention Study

Congenital Heart Disease Associated With Selective Serotonin Reuptake Inhibitor Use During Pregnancy — Mayo Clinic Proceedings (PDF) By CHRISTINA L. WICHMAN, DO; KATHERINE M. MOORE, MD; TARA R. LANG, MD; JENNIFER L. ST. SAUVER, PHD; ROBERT H. HEISE JR, MD; AND WILLIAM J. WATSON, MD

FDA: Information for Healthcare Professionals: Paroxetine (marketed as Paxil) July, 2006