Author: Matthew Dolman

Risperdal is an antipsychotic medication approved by the FDA for the treatment of schizophrenia, bipolar disorder, and irritability related to Autism. Unfortunately, it seems that Johnson & Jonson- the drug’s manufacturer- has traditionally paid little to no attention to the FDA’s approved uses and instead encouraged medical providers across the country to prescribe Risperdal for non-approved uses. In fact, the federal government learned that Johnson & Johnson actually paid kickbacks to several doctors in exchange for the physician prescribing Risperdal, both for approved and unapproved uses- like treatment of dementia in the elderly.  In 2010, Johnson & Johnson began paying boatloads of money to settle lawsuits brought by the government alleging dishonest and unfair business practices.

Since that time, federal authorities have also investigated other techniques utilized by Johnson & Johnson to market Risperdal. To date, multiple lawsuits have been filed against Johnson & Johnson by both the federal government and private citizens alleging the pharmaceutical giant intentionally downplayed serious risks associated with use of the medicine it its advertising campaigns. For the past two years, Johnson & Johnson has attempted to negotiate a settlement agreement with federal authorities concerning misleading promotional techniques. Now it appears such negotiations have hit a stalemate.

One of the biggest risks associated with use of Risperdal is an increase in prolactin within the body. Prolactin is responsible for breast growth and milk production in females following childbirth. The increase in prolactin often caused by Risperdal can cause a wide range of breast issues including abnormal lactation for women and gynecomastia (male breast growth) and even impotency in men. Other side effects associated with use of Risperdal tend to arise mostly from prescribing the drug for off-label uses. In elderly patients for example, the FDA discovered that patients prescribed the drug may cause up to a 1.7% increase in death resulting from health problems ranging from heart disease to pneumonia.

As a part of the settlement agreement, federal authorities want Johnson & Johnson to admit that they knew of the increase in prolactin and its associated dangers, and that they specifically under-marketed these dangers when advertising Risperdal. Johnsons & Johnson is reluctant to make such an admission however, as they are also facing litigation from private citizens who have actually experienced these side effects. If Johnson & Johnson admitted to federal authorities that they knew of the side effects and undersold the risks, the thousands of private citizens suing the company would be able to use such statements against Johnson & Johnson in their lawsuits as well. It is easy to see how such an admission of wrongdoing could end up costing Johnson & Johnson significantly. The Wall Street Journal reports that the federal litigation alone could cost the drug’s manufacturers upwards of $2 billion.

For more information on the dangerous side effects associated with use of Risperdal, of if you or someone you know has experienced side effects following use of the drug, contact the experienced bad drug attorneys at Dolman Law Group for a free consultation and case evaluation. 727-451-6900.

Dolman Law Group is a Clearwater based Florida personal injury law firm that only represents plaintiffs. 

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The number of teenage drivers that admit to texting and driving is presently at an all-time high. In a recent survey, by Pediatrics Magazine, 44% of participating teenagers admit to texting and driving on at least one occasion during the month of April 2013. That percentage only reflects teenagers whom were willing to admit they text and drive. The numbers could be much higher. And experts believe that the actual number is well above 50%.

Texting and driving can be very dangerous. Many car accidents and fatalities are caused by texting and driving. In fact, drinking and driving is no longer the leading cause of death for teenagers. Texting and driving now kills more teenagers than anything else! Three thousand teens are dying from texting and driving related deaths every year. That is an alarming number.

 Shockingly, the same survey revealed that teenagers that do engage in texting and driving are more likely to not wear their seat belt, to drink and drive, and to ride with someone else that they know has been drinking.

Driving a car requires visual, physical, and cognitive skills. The safe operation of a car requires all of those skills focused to the task of driving- looking at the road, hands on the wheel, and thinking about one’s surroundings.  Text messaging while driving impairs all three simultaneously.  The driver’s eyes are darting back and forth between the road and the phone. They only have one hand on the wheel. Also, their thoughts are likely more engaged by the textual conversation that they are having rather than on their surroundings. The likelihood, and reality, that texting and driving can cause property damage, personal injury, and even are death are dangerously obvious. A study done by AT&T, a major cell phone provider, reveals that each text message sent and received takes a driver’s attention from the road for an average of five seconds. Anything can happen in five seconds. If a person is driving 55 mph, five seconds is the span of time it would take them to drive the length of a football field.

Testing and driving isn’t just a problem with teenage drivers. Although it is worst among teenagers, it is a problem that is ever growing across all age groups of drivers.  48% of teenagers report having seen their parents engage in texting while driving. And 27% of adults admit to having texted while driving.

In 2011, 23% of all auto collisions involved cell phones. Text messaging makes the likelihood of an auto collision 23 times greater than when the driver is not text messaging. And the risk is growing: 77% of young adults say they are somewhat confident that they can safely drive while texting. This just isn’t true. Similarly, 55% of young drivers say that it is easy to text and drive.  It is easy: easy to hurt yourself and others if you do it.

The message from these statistics is clear. Don't text and drive. A number of major cell phone providers are teaming up to create a well-funded media campaign against texting and driving.  

Don’t text and drive.

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Tags: distracted driving, texting and driving

On May 6, 2013, Donald Budd Sutton of Madeira Beach crashed his 1993 Harley Davidson in the Bay Pines area of St. Petersburg. Sutton was driving his motorcycle down Duhme Causeway, attempting to turn onto the Bay Pines Boulevard triangle interchange. As he attempted to enter the median and negotiate his turn, Sutton lost control of his motorcycle and crashed into a metal guardrail, severing his leg.  After losing his leg to the guardrail, Sutton was thrown from his bike and landed in the road where he injured his head. He was not wearing a helmet and was air-lifted to Bayfront Medical Center for treatment of his life-threatening injuries. Police are still investigating the cause of the accident, but have stated that neither speeding or alcohol appear to have been factors in the motorcycle crash.

While motorcycles themselves are not necessarily any more or less dangerous than other vehicles, they provide little to no protection to the rider if an accident should occur. Therefore in addition to always wearing the proper motorcycle safety gear, bikers should be aware of the leading causes of motorcycle accidents and fatalities. Because not every accident is preventable, the best defense is to be aware of the dangers on the road and to plan a course of action for dealing with these dangers in the event of a crash.

As we’ve mentioned before, cars cause most of the collisions between motorcycles and automobiles. Of those collisions, the most common type is a motorcycle rear-ending a vehicle directly in front of them. We’ve all had that heart pounding experience in traffic when the vehicle in front of you suddenly slams on brakes. All we can do then is hit the brakes and hope we stop in time. This danger is no different for motorcyclists. The difference is that when a rider is forced into a hard brake situation, the likelihood of losing control of the motorcycle increases, and the likelihood of stopping properly decreases. Another big difference is that when motor vehicle operators are not able to come to a complete stop the end result can be just a small fender-bender, resulting in no injuries to either driver. For the motorcyclist however, there is really no such thing as a minor fender-bender. When the biker runs into the back of an automobile, he/she can be thrown from the bike into the rear of the car, or even over the car and onto the road ahead. These rear-end collisions account for roughly 56% of motorcycle crash fatalities.

Another common scenario between motorcycles and cars occurs when the car attempts to turn left in front of the motorcycle. Because motorcycles are much smaller than automobiles they can be difficult to see, especially in areas of high traffic or in times of low visibility due to rain or high glare (think 5:00 sunshine). Car drivers who do not give a second glance in the direction of oncoming traffic before committing to the left turn may a rapidly approaching motorcyclist they did not see the first time. This type of automobile-motorcycle collision accounts for about 42% of all motorcycle crashes, and is precisely the reason for the launch of the “Look Twice, Save a Life” campaign.

Even when no other vehicles are involved, road hazards still present a significant risk to motorcyclists. Road hazards can be anything from potholes and loose gravel to uneven lanes or animals in the road. While these hazards present risks to all drivers, they are particularly dangerous to motorcyclists because motorcycles offer far less protection to the rider who is forced to take a quick evasive action. It is because of these dangers that motorcyclists should always follow the speed limit. The risk of injury associated with losing control of the motorcycle is greater with every additional mile per hour travelled. If the rider has also been drinking alcohol before getting onto the motorcycle, the combination of these factors can be deadly. In fact, almost half of the single-rider motorcycle fatalities in the United States results from the combination of drinking and speeding. So what is the best way to avoid a motorcycle fatality? Never drink and ride and always wear your helmet!

For more information on motorcycle safety, or if you or someone you know has been involved in a St. Petersburg motorcycle accident, please contact the experienced motorcycle injury attorneys at Dolman Law Group for a free consultation and case evaluation. 727-451-6900

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After a recent health inspection, a St. Petersburg-based compounding pharmacy, The Compounding Shop, is recalling all of its sterile drugs due to contamination concerns. During the inspection, the Food and Drug Administration (FDA) found "exposed rust" and "numerous splattered brownish stains" on the compounding pharmacy's manufacturing equipment. Even though the Compounding Shop's injectable drugs and eye medications have not been linked with any reports of illness, the FDA has urged the company to take preventive action. “If an injectable drug product that is intended to be sterile is contaminated, it could result in a life-threatening infection in patients,” said Janet Woodcock, M.D., director, FDA’s Center for Drug Evaluation and Research. “We do not have reports of patient infections. However, due to concerns about a lack of sterility assurance at the facility and out of an abundance of caution, we have advised the firm to remove its sterile products from the market to protect patients.”

In its May 8, 2013 news release, the FDA alerted health care providers, hospital supply manager, and pharmacists of the Compounding Shop's questionable manufacturing practices which "potentially places patients at risk of serious infection." In an effort to avert potential infections, the FDA urges health care professionals to halt any administration of products made by The Compounding Shop to their patients and to quarantine its remaining stock.

The FDA's inspection comes on the heels last year's outbreak of fungal meningitis. The Center for Disease Control and Prevention (CDC) linked the outbreak to three lots of medications used for epidural steroid injections produced by New England Compounding Center (NECC), a Massachusetts based compounding pharmacy. The medication produced by the NECC was administered to approximately 14,000 patients. As a result of the contaminated drugs, 55 people died and over 700 people were treated for persistent fungal infections.

After the NECC was forced to recall its contaminated drugs, the state of Massachusetts' Department of Public Health conducted numerous surprise investigations of other compounding pharmacies. Ameridose, a sister company of NECC, was also shut down over sterility concerns in October of 2012.

In response to the serious health concerns posed by sub-standard sterility conditions found in compounding pharmacy facilities, members of the United States House of Representatives and United States Senate requested briefings as a preliminary step for drafting legislation to heighten federal drug safety regulation. In the meantime, individual state officials, such as Maryland's Governor Martin O'Malley, aren't waiting for Congress to act. This month, Governor O’Malley signed into law a measure that will require Maryland-based compounding pharmacies to seek an additional permit in order to manufacture drugs, and it will also permit state health officials to conduct more thorough inspections. Additionally, out-of-state pharmacies will face more exacting oversight if they wish to sell their medication to health care professionals in Maryland.

Still, before Congress authorizes the FDA to tighten its regulation of compounding pharmacies nationwide, individual states have the choice of either waiting or being pro-active.

In regard to the medication distributed by The Compounding Shop, the FDA advises "patients who have received any products produced by The Compounding Shop and have concerns should contact their health care provider. Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA's MedWatch Adverse Event Reporting program at www.fda.gov/medwatch/report.htm.

For more information, call the Dangerous Drug Attorneys at the Dolman Law Group.

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Doctors prescribe  tovlaptan (Samsca) to treat patients with hyponatremia, when their blood sodium level is low. Hyponatremia can be caused by a variety of circumstances, and in severe cases lead to confusion and/or seizures. However, the danger of SAMSCA's side-effects may out outweigh its benefit.

On April 30, the U.S. Food and Drug Administration (FDA) issued a safety announcement, warning against long-term usage or high dosage of Samsca, citing serious repercussions to the liver that could lead to future organ transplant or death. The FDA warning came three months after the pharmaceutical company that manufactures Samsca, Otsuka America Pharmaceutical, Inc., released a letter to healthcare providers warning of significant liver injury associated with prolonged use of the kidney drug.

Otsuka America Pharmaceutical, Inc. released its January 22, 2013 letter in response to the results it obtained from three years of clinical trials. The  purpose of the testing was to determine any negative effects Samsca could cause.  Over 1400 patients suffering from Autosomal Dominant Polycystic Kidney Disease (ADPKD) used Samsca in double-blind, placebo-controlled clinical tests. These tests were conducted over the course of three years.

According to the FDA, Samsca "should not be used for longer than 30 days and should not be used in patients with underlying liver disease."

After conducting clinical tests on the effects of the drug, the FDA and Otsuka America Pharmaceutical, Inc. revised the Samsca's warning label to include the following information:

*Limitation of the duration of Samsca treatment to 30 days. (Dosage and Administration and Warnings and Precautions sections)

*Removal of the indication for use in patients with cirrhosis, a condition that involves scarring of the liver due to injury or long-term disease.  Use of Samsca in patients with underlying liver disease, including cirrhosis, should be avoided because the ability to recover from liver injury may be impaired. (Indications and Usage and Use in Specific Populations sections)

*Description of liver injuries seen in clinical trials of patients with autosomal dominant polycystic kidney disease (ADPKD).

*Recommendation to discontinue Samsca in patients with symptoms of liver injury.

If a person suffers not only from hyponatremia but also an underlying liver disease, Samsca has the potential to cause life-threatening liver injury. Samsca may impair a person's ability to recover from liver injury. In an effort to protect the people that use this medication, Otsuka America and the FDA instruct physicians to limit the duration of treatment in order to reduce the risk of possible liver injury. Indicia of livery injury include right upper abdominal pain, abdominal swelling or tenderness, difficulty breathing, blood in the urine or stool, nausea, vomiting, lightheadedness, faintness, fatigue, jaundice, rapid heart rate, and low blood pressure.

If a person taking Samsca has any of these symptoms, then physicians test for liver injury. If the tests indicate that liver injury is the suspected cause, the FDA recommends promptly discontinuing the use of Samsca, initiating hepatic treatment, and further investigating the cause of the symptoms. Only after Samsca is definitively eliminated as the cause of the symptoms should a patient resume the Samsca treatment.

For more information on claims involving Samsca, Risperdal, Mirena IUD and Actos among other defective drugs call the dangerous medication attorneys at the Dolman Law Group for a free consultation and case evaluation. 

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