Free Report: Topamax Litigation: Understanding Your Rights

Topamax Litigation: Understanding Your Rights

Topamax is a medication marketed for the prevention of migraine headaches and for the treatment of the seizure disorder epilepsy.  Topamax is manufactured by a Johnson & Johnson subsidiary called Janssen Pharmaceuticals and it is one of the most commonly prescribed anticonvulsant medications on the market.

Topics covered in this report include:

  1. Topamax Litigation: Your Right to Compensation
  2. Topamax Litigation

Click here to read the whole article or download the PDF.

Free Report: St. Louis Pharmaceutical Liability: Even Over-The Counter Medications Present Risks

St. Louis Pharmaceutical Liability: Even Over-The Counter Medications Present Risks


Despite regulations intended to protect patients from dangerous medications, drugs with unexpected and serious side effects frequently come onto the marketplace.

Topics covered in this report include:

  1. Over-The-Counter Medications and Treatments can be Dangerous
  2. Manufacturer Obligations in Defective Product cases

Click here to read the whole article or download the PDF.

Free Report: Pharmaceutical Liability in St. Louis: Off Label Drugs Endanger Patients

Pharmaceutical Liability in St. Louis: Off Label Drugs Endanger Patients

Medications in the United States must be approved by the Food and Drug Administration. The purpose of requiring approval is to ensure that the drugs are tested for safety. Drugs are tested for a specific purpose among a specific population of individuals and are then approved for the medical condition for which they were tested.

Topics covered in this report include:

  1. The Risks of off-Label Medications

Click here to read the whole article or download the PDF.

Understanding FDA Recall Categories

The FDA may initiate a recall or a manufacturer may initiate a voluntary recall if it learns that a product has unexpected risks.
Learn more about FDA recall categories in this presentation.


Mass Torts in Defective Drug Cases

Victims of defective drug side effects or illnesses can also make a claim based on negligence or failure to warn them of risk.
Learn more about Drug Cases in this presentation.



Are Trucking Companies Regulated by the Federal Government?

Trucking companies throughout the United States are subject to strict regulations in order to ensure that they do not endanger the public as a result of negligent behavior or careless operation. Trucking companies are regulated by both state and local governments as well as by the federal government of the United States of America.

Trucking Companies and Federal Regulations

Trucking companies are required to comply with all federal regulations. The regulations that affect the trucking industry are generally set by the Federal Motor Carrier Safety Administration (FMCSA), which regulates not just commercial trucks but also other commercial vehicles that transport passengers, such as tour buses. The Federal Motor Carrier Safety Administration (FMCSA) has set a number of different rules and regulations for trucking companies that must be followed. These regulations include:

  • Limits on the number of hours that a driver can operate his truck for without a rest break. These are called hours-of-service limits and they apply to both long and short haul truck drivers.
  • Rules regarding licensing and training for truck drivers of commercial motor vehicles.
  • Requirements related to vehicle maintenance and inspection in order to ensure that all vehicles are regularly maintained and that there are no dangerous problems with the brakes or other truck components that could result in an accident occurring.
  • Regulations on the operation of commercial trucking companies including rules on when penalties can be imposed on companies who fail to follow safety rules and regulations.

These are just a sampling of the many different rules that the federal government has set for the trucking industry. When individual states set their own rules and requirements for commercial trucking companies, they may impose stricter requirements on companies operating within their

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states but they may not pass laws or rules that contradict those that have been set on the federal level. If the federal law imposes a requirement on a trucking company, that requirement must be followed.

The Importance of Federal Trucking Regulations

The federal regulations on trucking companies establish uniform rules that apply throughout the whole of the United States, which is very important as many trucks transport goods across state lines. The rules apply everywhere and are enforced to ensure that the truckers and the public are safe. If you or a loved one has been involved in a truck accident and federal rules of safety were broken, this breach of the federal rules can be considered clear evidence that the trucker and/or trucking company was negligent and is thus liable for losses caused by the negligence. An experienced truck accident lawyer can help you to determine if any federal laws were broken by the trucker or trucking company that caused your wreck to occur.

Topamax Birth Defect Award Upheld

In November of last year, a Topamax plaintiff was awarded $11 million in compensation.    The case, Gurley v. Ortho-McNeil-Janssen Pharmaceutical, occurred in Philadelphia Pennsylvania. Topamax appealed the decision, but Judge George W. Overton recently denied the defendant’s motion for a new trial and upheld the verdict.  The defendant who appealed was Johnson & Johnson, as Janssen Pharmaceuticals is the company’s subsidiary. medication pills

The fact that the verdict was upheld is good news for the family who was affected by serious complications from the anticonvulsant medication Topamax.  It is also good news for other plaintiffs who have pending claims against Johnson & Johnson for problems that the drug allegedly caused them.  While every case is different, drug companies are often more likely to settle claims after large plaintiff’s verdicts and large verdicts mean that juries may view Topamax birth defect cases favorably.

If your child was born with a birth defect after exposure to Topamax during fetal development, it is important that you understand your legal rights. Carey, Danis & Lowe can help you to pursue a claim for compensation from the drug company for your damages and losses resulting from a Topamax birth defect. Call today to speak with a member of our legal team and learn more.

Topamax Case Results in Large Verdict for Plaintiff

The case in which the jury awarded $11 million involved a child who was born with a severe cleft palate after exposure to Topamax during fetal development.  The FDA and numerous medical studies have acknowledged that Topamax significantly increases the risk of this birth defect.

The child has already undergone multiple surgeries because of the severe cleft palate. Unfortunately, ongoing consultations with a plastic surgeon are necessary and the child faces additional procedures including dental and oral surgery. Speech therapy and auditory evaluations will be necessary and the child may require a rhinoplasty as well as psychological counseling because of the multiple procedures as well as the emotional challenges that the cleft palate presents.

Even with the surgeries, it is unlikely that the cleft palate will ever be fully corrected. As a result, the judge noted that the child is likely to experience ongoing difficulties in communication. Speech difficulties are also likely to become worse as a result of residual scarring following the multiple surgical procedures.

The lasting damage, coupled with accusations that the company knew of the risks of cleft palates as far back as 1997, mean that the damage award was justified and that it should stand. Drug companies must pay to fully compensate victims if their medications cause unexpected harm, and Johnson & Johnson is responsible here for the damage their product caused to the child and family.

Carey, Danis & Lowe can represent others who have been affected by dangerous drugs and defective medications including Topamax. Call today if your child suffered a cleft palate or other birth defects and learn more about how a St. Louis defective drug lawyer can help you.

Off-Label Drugs Endanger Patients

Off-label medications can be dangerous to patients because they can result in a patient suffering an adverse reaction or unexpected side effect.  A defective drug lawyer in the St. Louis, Missouri area should be consulted if you or a loved one is prescribed a medication and become sick as a result of the drug.  Carey, Danis & Lowe can represent you in a claim against the drug manufacturer so you can recover compensation for damages. Off-Label Drugs

The Dangers of Off-Label Drugs

Before a drug is approved and sold, it must be tested by the manufacturer and it must obtain clearance from the Food and Drug Administration (FDA). Drugs are tested for a specific purpose. For example, a medication may be intended to treat diabetes and will be tested to determine if it has a positive impact on the health of diabetes patients.

Once a drug is approved, doctors may prescribe the medication for any purpose that they believe will be beneficial to the patient. If the doctor thinks that a drug approved for one medical condition could help a patient with a different medical problem, the doctor can prescribe that drug to the patient. This is called off-label prescribing. According to WebMD, as many as one out of every five prescriptions written by doctors on an outpatient basis my be for off-label drugs.

While doctors are allowed to prescribe off-label drugs, drug companies are not allowed to market their medications for a purpose other than what the drug has been approved for.  Unfortunately, pharmaceutical companies sometimes break these rules. For example, a powerful narcotic painkiller called Subsys was approved by the FDA in 2012 but it was intended to be used by patients who were already taking painkillers virtually all the time, like cancer patients who were in serious pain.

According to a New York Times  article, the drug has now become a $100 million business.  Unfortunately, oncologists are also prescribing the medication in about one percent of cases and less than half of the prescriptions for the drug are written by pain management specialists. The remainder of the prescriptions are being written by general practice doctors and others who are not specialists in pain management including podiatrists and dentists. This means a powerful narcotic is frequently being prescribed to patients who may not need such a strong drug, even at a time when there are growing concerns about prescription pain killer abuse.

The New York Times indicates that several former sales-reps for the company have asserted that they were encouraged to market the medication for off-label use and that they were rewarded with higher commissions if they sold higher doses.

While there are no known reports of harm from these actions yet, it is clear that off-label drugs can have serious consequences.  As The Star recently reported, off-label prescribing of an anti-nausea drug to pregnant patients has resulted in babies being born with severe birth defects impacting the kidneys and the heart. At least two infants have been killed.

Getting Legal Help for Off-Label Drugs

If a drug manufacturer encourages off-label drugs to be prescribed, the pharmaceutical company could be liable for the consequences.  A defective drug lawyer at Carey, Danis & Lowe can help victims harmed by defective drugs and off-label drugs to pursue a claim for compensation. Call today or contact us online to schedule your free consultation.

Over-the-Counter Medication Dangers

Over-the-counter medications can be dangerous to patients. While many assume that over-the-counter medications are low risk, the reality is that patients can become sick or even suffer fatal adverse reactions from taking a non-prescription drug. Manufacturers of these products need to alert their customers to risks of over-the-counter medication and can be held legally liable if a patient gets sick.  over-the-counter medication dangers

If you or a loved one is harmed by any type of defective drug or medication, it is important to consult with an experienced legal professional. A defective drug lawyer at the St. Louis firm of Carey, Danis & Lowe can provide you with the assistance you need in pursuing a claim for compensation.

Over-the-Counter Medication Dangers

Many different types of over-the-counter medication dangers have caused patients to get sick in recent year.  For example, some patients who took Tylenol suffered liver damage and sued the drug-maker.  Patients who took Aleve and Advil experienced birth defects if they were pregnant when taking the medication. Even individuals who used denture creams like Poligrip got sick and experienced neuropathy and zinc poisoning as a result of their use of the product.

Just recently, the Food and Drug Administration issued another alert about over-the-counter medication dangers. In this case, the warning dealt with popular acne products like Clean & Clear and Aveeno. The FDA warning extended to any acne medications containing the active ingredients benzoyl peroxide or salicylic acid. This included creams, gels and face washes.

The FDA alert indicated to users of these products that a severe allergic reaction could result. The warning was issued after the FDA received more than 131 different reports of adverse reactions from patients using acne-fighting products.  A spokesperson for the agency indicated that the labels on the acne medications did not properly alert users to the potential dangers. The purpose of the FDA warning is to ensure that people are aware of the over-the-counter medication dangers so they can respond quickly and get appropriate medical help if they experience side effects.

According to the FDA, an estimated 42 percent of patients who experienced adverse reactions started to show symptoms within 24 hours of using the acne product.  In 44 percent of cases, the patients required hospitalization to deal with the side effects and symptoms.

As Time reports, the symptoms associated with the adverse reaction to the acne medications commonly appeared to be signs of a severe allergic reaction.  Around 40 percent of the adverse event complaints made to the FDA involved patients suffering from breathing difficulties, low blood pressure, fainting, collapse, and tightness in the throat. Hives and facial swelling were also likely outcomes associated with the use of the acne-fighting products.

The recent FDA warning is an important reminder that just because a medication is over-the-counter and just because it is a topical treatment does not meet that it is without risks. Patients need to be aware of over-the-counter medication dangers as well as aware of the risks of prescription drugs. If you or a loved one experiences an adverse drug reaction, call Carey, Danis & Lowe for help pursuing a damage claim. Your consultation with a member of our legal team is free.

Understanding FDA Recall Categories

A Food and Drug Administration recall may be necessary when a drug or food product turns out to be dangerous.  A recall means that the product is removed from the market and/or an alert is sent out to the public to warn them of the dangers that the product presents to their health and safety. FDA recall danger

There are different categories of FDA recalls depending upon the severity of the risk that a product presents.  It is important to understand the categories and to be aware of recalls that occur so you do not accidentally continue to use a product that has been found to be dangerous. If a recall occurs and you believe you were harmed by the product before it was taken off the market, then you need to act. Carey, Danis & Lowe represents clients who are the victims of defective drugs and dangerous medical devices in the St. Louis area. We can help you to pursue a claim for compensation if you were harmed by a product that has been subject to an FDA recall.

FDA Recall Categories

There are three primary FDA recall categories:

  • Class I recalls are the most serious.  A Class I recall will occur if a product presents a substantial risk of serious and/or permanent harm to a patient’s health. For example, if a drug is suspected of causing cancer or a heart attack, a Class I recall may be appropriate.
  • Class II recalls are reserved for situations where there is a risk the product will cause minor medical harm or reversible medical harm. A Class II recall is appropriate if the chances of severe and/or permanent damage to health is very unlikely to occur.
  • Class III recalls are reserved for situations when using a product is not likely to have an adverse impact on health. If a product needs to be recalled due to a problem but its use is not likely to make patients sick, this is the appropriate type of recall.
  • Medical Safety Device Alerts may accompany a recall or may stand alone. The FDA will issue a Medical Safety Device alert if it believes that a medical device being sold to consumers may have side effects or risks that patients are not being adequately warned about.

The FDA can initiate a recall if it believes that consumers are at risk.  The manufacturer may also issue a voluntary recall if the company that makes a drug, medical device or other product believes that there is a danger associated with its use.

Getting Legal Help After an FDA Recall

When the FDA recalls a product or a manufacturer voluntarily recalls a product, this is a sign that there are serious concerns about the safety of the drug, device or other product.  If you or a loved one has been using the product and you have suffered an adverse reaction, you may wish to pursue legal action. The recall can help you to make your case that something was wrong with the product and that the manufacturer should be held accountable.

Contact a St. Louis defective product lawyer at Carey, Danis & Lowe after a recall to learn more about your options.