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The FDA’s oversight of drug safety

May 2nd, 2016 by

Recently, it has been noted that the Food & Drug Administration (FDA) is speeding up its review process for new drugs. This process allows for more drugs to enter the market, allowing for people to have access to an abundance of new medications to help their ailments. However, according to this article published to The Big Story, there have also been concerns about whether the FDA is failing to keep up with safety issues with those medications once they reach patients.

shutterstock_180415022There has been a new Government Accountability Office (GAO) report outlining the shortcomings of the FDA’s new system for tracking drug safety issues, including incomplete, outdated, and inaccurate information. In addition, the FDA is employing the use of mechanics to streamline the review process for drugs that treat deadly diseases, like cancer. FDA leaders have even been boasting about how quickly and efficiently scientists can approve experimental drugs, thus speeding the drugs’ path to market.

In 2015, there were 45 drugs that were the first of their kind approved to go to market, the highest number in 19 years. Additionally, the GAO found that the FDA has been late in reviewing more than half of the 1400 follow-up studies it had requested or required of drug-makers between 2008 and fall 2013. These studies are crucial to spotting safety issues that may not emerge until patients start taking the drugs.

The report has also clearly highlighted that the FDA is not performing its due diligence in tracking drug safety issues and post-market studies that are crucial in ensuring patient safety. The GAO also found that a quarter of all drug applications approved by the FDA used at least one pathway to speed review, based on data collected from late 2006 to 2015.

Overall, what does this mean to the consumer? It means that new, recently-added drugs on the market could pose a greater threat to those that take them. The drugs are not going through as tedious and detailed of a review process to determine if the drug is safe for mass consumption. This opens up the consumer to the unknown dangers and side effects of the drug.

If you’re looking for a Philadelphia dangerous drugs law firm, Villari, Brandes, & Giannone is your first choice. Our experienced attorneys have both a track record of success and are always available to answer your questions and address your concerns. So if you or a loved one have suffered from the negative effects of the FDA’s oversights, be sure to call Villari, Brandes, & Giannone by visiting our website or calling 888-729-2901 today!

 

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Avoiding Self-Inflicted Wounds: 10 Tips for Social Media for Clients

March 16th, 2016 by

shutterstock_126022781Social Media has become a useful part of everyday life.  We constantly spend a significant amount of our time sharing our lives with those online.  It’s now a part of society, and we don’t even think twice about using it.  However, in lawsuits, social media oftentimes becomes a disadvantage. Even joking between friends can possibly convince a judge and jury that a client is being dishonest.  At Villari, Brandes, & Giannone, we don’t want to see a client denied the compensation they deserve because of a simple mistake on social media. Therefore, here are 10 tips to help clients to avoid these self-inflicted wounds.

  1. Archive all content on current sites.
    1. Sometimes destroying possibly incriminating content is worse than the content itself. That is why it is important to preserve the current content on the sites.
  2. Deactivate or stop using social media altogether.
    1. If this is impossible or not an option, be sure to archive all old content and avoid any sort of post in regard to the case in the future.
  3. Turn on the highest privacy settings.
    1. Another option if deactivation of social media is not an option, at least be sure that your privacy settings are at the highest level so only friends are able to see content.
  4. Be aware of “friends”.
    1. Make friends lists so that only people you trust can see your photo albums and status updates. Additionally, you should review your “friends” and remove anyone that you would not trust.
  5. Make yourself invisible.
    1. You can remove yourself from search results by adjusting your internet visibility settings. You can even remove yourself from Google searches through internet privacy settings.
  6. Take down photos.
    1. After archiving, you should take down and un-tag any photos of yourself that are not simple headshots.
  7. Be cautious.
    1. Assume that anything and everything that you write on social media will be used against you. So, be very cautious with the information you share.
  8. Preserve all computers, tablets, and cell phones.
    1. Never dispose of a device, as it can be interpreted as an attempt to destroy evidence. It’s easier to argue over access rights, than to explain why your cell phone suddenly ended up smashed.
  9. Don’t send messages or information about a case.
    1. Don’t send messages or emails about a case, even with privacy settings. One careless message can destroy a case.
  10. Don’t join websites or web chat groups.
    1. Avoid dating sites, chatrooms, forums, or blog posts, as these can also provide ammunition to be used against you in a case.

There are occasions when social media can be an asset to a case, but those instances are few and far between.  Although you should consult an attorney before doing so, it is usually best to discontinue any social media presence during the length of a case.  However, do not delete any data or media that already exists. Make sure you show your attorney all social media you are involved in at the beginning of a case.

If you are looking for an attorney to represent your best interests, call Villari, Brandes, & Giannone. Our team of Philadelphia injury lawyers have represented thousands of clients in claims and lawsuits in Pennsylvania, New Jersey, Washington, D.C., and many other states around the country.  We are dedicated to fighting for those who have been unjustly injured and making sure that they receive the compensation they deserve.  Contact us or schedule a free online consultation now.

*All information in this blog was provided by “Alert: Ten Social Media Warnings for Clients” by Ken Shigley and Michael Wilensky, originally printed in Trial Magazine (Vol. 52, No. 1- January 2016).

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The Dangers of Dog Bites

March 3rd, 2016 by

dog-blogThe Dangers of Dog Bites

It’s no secret that people love their dogs. In fact, increasingly in recent years, dogs have become just as much a part of the family system as any other family member. Unfortunately, also more frequent are dog bites, because it’s so easy to exercise poor judgement when approaching a dog and startling it into aggressive behavior. According to a recent article, there are a lot of things that we do as humans that dogs actually hate, many times leading to a dog bite. We at Villari, Brandes, & Giannone want to make sure that you and your family are safe and protected from dog bites from a strange dog or even your own family dog. Here are some things you should know.

Dogs hate hugging.

Hugging might be misconstrued as an act of dominance by a dog. When one dog stands over another, or puts their paws on another’s back, it’s a display that they are asserting dominance. Therefore, when you place your arms around a dogs back or stick your face next to theirs, it can come across as challenging the dog. Even worse, kids love to hug dogs. It’s what they do. So it is incredibly important to teach children early on that hugging a strange dog is a no-no.

Patting the face and/or head of a dog.

It is a common misconception that dogs love having their faces and heads patted. Think about it, do you like be patted in the face repetitively? We would bet not. In the best case, it is uncomfortable for the dog and, at worst, it hurts. Plus, sticking your hands into the bite zone of a dog is a recipe for disaster. So, it is best to avoid these actions with dogs.

Walking up to a strange dog while looking them in the eye.

This one is a major dog etiquette mistake. Staring a dog in the eye is an act of dominance. In fact, getting into a stare-down with a dog can lead to some really dangerous situations. Whereas looking a human in the eye is considered polite and caring, looking a dog in the eye is a challenge. Even more so, if a dog is staring at you with wide eyes and not blinking, it’s a good idea to simply avoid that dog and walk away.

Teasing.

This one should be a no-brainer. Teasing a dog is never a good idea, and it certainly isn’t funny as many people think. Withholding food, pulling tails, barking at dogs, and teasing a dog that is clearly upset will land you with some new bite marks.

Overall, these general rules should be followed with dogs. However, the best rule to follow is to simply avoid any strange dogs, despite your initial impression of them. They might seem “friendly” but actually are feeling submissive or threatened.

Be sure to share these insights with your friends, family and loved ones (especially kids) to avoid any potentially dangerous situations. And, feel free to check out the article yourself for more tips on training your own dog to avoid biting someone.

However, if you or a loved one have suffered a dog bite, call Villari, Brandes, & Giannone. Our team of Philadelphia injury lawyers have represented thousands of clients in claims and lawsuits in Pennsylvania, New Jersey, Washington, D.C., and many other states around the country with such claims. We are dedicated to fighting for injured people and making sure they receive the compensation they deserve. Contact us now or schedule a free online consultation.

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Hospital Mishaps: Are They Avoidable?

January 14th, 2016 by

One major societal concern over the past few years has been injuries sustained during hospital stays.  You would never think that you would end up with an injury caused by the very place that is meant to heal you.  However, it happens, and often.

According to this article by Jordan Rau, the rate of preventable hospital mishaps has leveled off after 3 years of steady declines, showing that hospitals are taking clear preventative steps to avoid many types of injuries.  However, hospitals still struggle with approximately 12 out of every 100 hospital stays resulting in infections and other injuries.  Some of the most common of those injuries, occurring a quarter-million times or more, are bed sores, falls, bad reactions to drugs used to treat diabetes, and kidney damage caused by contrast dyes.

Overall, complications are declining.  But they are only 17% lower than 2010, and the same as 2013.  It shows that some improvements are sticking, but the lack of further improvement raises concerns that it’s becoming harder for hospitals to further reduce the chances that patients may be harmed in their care.

If you or a loved one have experienced a hospital injury, contact the lawyers at Villari, Brandes, & Giannone. Our team of Philadelphia injury and medical malpractice lawyers have represented thousands of clients in claims and lawsuits in Pennsylvania, New Jersey, Washington, D.C., and many other states around the country.  We are dedicated to fighting for injured people, making sure they receive the compensation they deserve.  Take action, and contact us by scheduling a free online consultation or by calling 888-729-2901.

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Auto Accidents caused by the Holiday Rush

January 1st, 2016 by

The holidays are a time for joy and laughter.  We are meant to be spending time with family, appreciating all that we have.  So one wouldn’t expect the holiday season to be a dangerous time. But when it comes to driving and transportation during the holidays, danger is indeed heightened.  But how? Why?shutterstock_174256772

The two major causes of dangers on the roads this holiday are winter weather conditions and human mistakes.  The winter months bring along snow and ice, as well as increased and strengthened wind speeds.  Not only that, but winter boasts diminished daylight in addition to crumbling pavement and road conditions.  These instances we can prepare for and address with vigilance, patience, and a focus on the road.  However, sometimes human error of those around you is not so easily avoided.

We all feel the rush of the season.  There is so much stress put on us to get to our holiday destinations quickly or buy the perfect presents for loved ones.  This stress sends people into a distracted state of panic, often taking away their ability to focus, especially during potentially dangerous activities, like driving a vehicle.  Drivers are so focused on their destination or the stressors associated with the holidays that their distraction from driving increases during this time.  Driving requires vigilance, patience, and one’s full attention, all of which are rarely achieved during the holidays.

In addition to distraction, the number of drunk driving incidences increases dramatically during the holidays.  DUI arrests are at their highest between Thanksgiving and New Year’s.  All of those holiday parties have alcohol and lead to bad decision making.  Even more, people are more likely to drive while fatigued, only further increasing the risk on the road.

Unfortunately, these risks come with the holiday season, and it is up to us to be overtly alert and attentive when we are out on the roads.  But if you or a loved one have been injured as a result of a distracted driver, the lawyers at Villari, Brandes, & Giannone can help!  Our team of Philadelphia injury lawyers have represented thousands of clients in claims and lawsuits in Pennsylvania, New Jersey, Washington, D.C. and many other states around the country.  We are dedicated to fighting for injured people, making sure they receive the compensation they deserve. Contact us now or schedule a free online consultation.

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Hospital Falls: the Surprising Reality

November 18th, 2015 by

Surprisingly, a leading cause of injuries suffered while a patient at a hospital is a fall down.  In fact, hospital falls represent a major public health problem.  Common challenges that place patients shutterstock_168664106at risk for falls in hospitals include unfamiliar environment, acute illness, surgery, prolonged bed rest, medications, and the like.

Consequently, hospitals developed programs to prevent falls, usually categorizing them as “anticipated,” “accidental,” or “physiological,” with nurses typically playing a key role in the implementation of these programs since they are directly working with the patients.  However, despite these programs, there does not seem to be a significant reduction in the number or frequency of falls in the hospital setting.  Often this is due to inattention by nurses or an insufficient number of nurses on duty to tend to the patients in a time manner.

Then what are some things you can do to protect yourself from suffering a fall while in the hospital?  The lawyers at Villari, Brandes & Giannone have compiled a list of some safety tips to help prevent falls while in the hospital.

  1. When you need help, use the call light or call bell.
  2. If you need to use the bathroom, ask the nursing staff for help, especially if you are unsteady. There should even be a call light on the bathroom wall for additional help.  Do not assume you can do it all on your own, especially given the effects of medications or prolonged bed rest that may have weakened your muscles or thrown off your balance.
  3. Do not be afraid to request a member of the nursing staff to remain in the bathroom with you to fully ensure your safety.
  4. If you are taking medicines that result in the need to use the bathroom often, make sure to ask for help when you get up. You may also consider using a commode or urinal.
  5. Take your time getting out of a bed or chair, particularly if you are taking medicines that cause you to feel dizzy or sleepy. Be sure to sit at the edge of the bed for a few seconds before getting up, and if possible have someone there to assist you to get up and then assist you to keep your balance.
  6. Use the nonslip socks provided by the hospital and wear them whenever you are up.
  7. While awake, wear your eyeglasses and/or hearing aid(s).
  8. If you need walking support, use walkers and canes. However, DO NOT use other common hospital room items for support, like bedside tables, furniture, IV poles, etc. because they are not stable and are often on wheels.
  9. Be sure that the nurse or other healthcare team member places the call light, telephone, water glass and all other important personal items within your easy reach from bed.
  10. Inform a staff member about any and all concerns you have for your safety.

If you are injured from a fall suffered in a hospital, you may be entitled to compensation. Hospitals may be held responsible for failing to properly ensure the safety of their inpatients.

 

If you have suffered from a serious fall injury, contact the lawyers at Villari, Brandes & Giannone. Our team of Philadelphia injury lawyers have represented thousands of clients in claims and lawsuits in Pennsylvania, New Jersey, Washington, D.C. and many other states around the country.  We are dedicated to fighting for injured people, making sure they receive the compensation they deserve. Call now or schedule a free online consultation.

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Risk Factor is Random, Just like a Lightning Strike

October 29th, 2015 by

Did you know that patient harm is the nation’s third-leading cause of death in the United States? There are at least 200,000 patients a year that die in a hospital from preventable errors and  complications related to their care. There are surgeons with the highest complications rate in ProPublica’s analysis that are still performing operations in hospitals nationwide.

There are always good and bad aspects of any hospital, but choosing the right one can protect patients from medical errors that injure or kill. Is allowing patients to see the surgeon’s track record an option? This would allow mistakes or complications to be exposed and aware oshutterstock_279677459f, and not something out of sight out of mind. More commonly than not errors in hospitals are caused by faulty systems, processes, and conditions that lead people to make mistakes or fail to prevent them. Making errors or mistakes is human, but we ultimately want to take care of them and not point fingers at individuals. Initiatives have been implemented to reduce harm. Some hospitals are using safety checklists for basic procedures, handwashing campaigns and urging medical team members to speak up when they see a problem.

There are hundreds of doctors from ProPublica’s analysis who have spotless records, but there is no such thing as a no-risk surgery. Every surgery comes with risks and possible complications, some being greater than others. When it comes to being among the percentile of patients tshutterstock_170837942hat incurs serious complications from routine surgeries, it’s, unfortunately, a matter of risk.

Many hospitals have changed practices to try and fix these complications and issues, implementing the data from ProPublica’s analysis as a reference. These changes have brought a dramatic improvement in surgeons’ results. Between 2010 and 2013 hospitals cut its complications rate in half. In turn, many surgeons who are improving have colleagues inquire how they can improve their own data.

It has worked out to be a beneficial resource. Working to improve the results is more beneficial than throwing the data out there for all to see, as somewhat of a public shaming. These surgeons are growing from their mistakes and, in turn, are making less.

If you or a loved one have suffered from preventable complications from surgery or hospital care, contact the lawyers at Villari, Brandes & Giannone. Our team of Philadelphia injury lawyers have represented thousands of clients in claims and lawsuits in Pennsylvania, New Jersey, Washington, D.C. and many other states around the country.  We are dedicated to fighting for injured people, making sure they receive the compensation they deserve. Call now or schedule a free online consultation.

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How to detect and prevent the most common birth injuries

July 1st, 2015 by

In the United States, one in every 9,714 babies is born with a birth injury. That means there are three newborns an hour entering the world already suffering. We know that these injuries stress parents enough; they do not need to be stressed by the costs to care for their injured baby additionally. It’s always important to be informed. Here we take a shutterstock_124023355look at the five most common birth injuries.

The brachial plexus is a set of nerves that controls the muscles of the arm. When these nerves are damaged, some or all of your child’s arm muscles may no longer work. This happens commonly during complex births. To amend this error, children need to participate in physical and occupational therapy or even surgery if the damage does not correct itself over time. Brachial plexus palsy often can be prevented by more careful maneuvering of the infant by physicians. Additionally, if it’s predicted that the baby will have a difficult delivery the mother should plan for a C-Section to help prevent brachial plexus.

Bone fracture; the name of this injury is self-explanatory, however, what many people don’t know is that this extremely common birth injury can be easily prevented. In assisted delivery, misuse of forceps and vacuum extractors are common ways this injury can occur. Physicians must ensure that they are placed properly on the baby’s head, otherwise it can cause damage to their fragile skulls.

Cephalohematoma is caused by damaged blood vessels and is defined by a collection of blood under the tissue that envelops the skull. Blood vessel damage often happens to infants during childbirth due to misuse of forceps; however, it can also occur due to the pressure of the vaginal canal on the infant’s head if the mother’s pelvic area is smaller than the baby’s head.

Caput succedaneum refers to swelling of an infant’s scalp, which appears as a lump or bump on the head shortly after delivery. Bruising, abnormal coloring, and an increase in the molding of head bones can also accompany the swelling. The most common root of this damage is from there being too much pressure on the head of a baby in the vaginal canal. It is very common in a long or hard delivery, because there is not enough amniotic fluid due to absence of the amniotic sac used to provide a cushion for the baby’s head over a prolonged time period. Your doctor should be aware of this and be prepared to utilize alternative ways to remove your child that will not hurt them.

Perinatal asphyxia results from an insufficient amount of oxygen intake for a baby before, during, or just after birth. The decreased oxygen intake can result in low levels of oxygen in the child’s blood, as well as too much acid in the blood. This causes them to have the symptoms of abnormal fetal heart rate, low pH levels, poor skin color at birth, low heart rate, weak muscle tone, and gasping or weak breathing. The key to preventing this damage is identifying the issue before it’s a problem. If this is a potential problem the mother can be given extra amounts of oxygen before delivery.

Birth injury or birth trauma claims are extremely complex to investigate and pursue in court. If your child has suffered a birth injury, your family needs an attorney well experienced in investigating and litigating these types of highly specialized cases. Our Philadelphia birth injury lawyers will investigate your case, determine if you have a claim, and guide you through the process of securing the support you need for your injured child. Call us today (610-729-2900) or schedule a free online consultation.

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Commercial train and bus accidents and disasters are horrific, to say the least.

May 21st, 2015 by

A horrid tour bus crash in Pisa, Italy left many dead and injured. The collision occurred when a truck traveling on the opposite side of the road lost control and crossed into opposing traffic, hitting the bus head on. The attorneys at Villari, Brandes & Giannone stepped up to represent the families of the four people who were killed, and to represent the twelve people who were seriously injured in the crash, all of whom were from the United States. While the Italian legal system was foreign to us, we gained a good understanding of it and its ability to provide for our clients because we took the extra step of retaining local counsel in Italy.

Our work began with an extensive investigation. The first person we turned to in the investigation was, of course, the driver who caused the crash. He was responsible for driving the truck into the wrong lane of traffic. He claimed to have done so because his tire blew out and caused him to veer into oncoming traffic. We knew that the particular tire in question had been known to cause problems, leading to product liability actions against the manufacturer. We hired appropriate experts in vehicle tire design, maintenance and failures, and ultimately learned that the tire blew out as a result of the collision and not due to any defect. After resolving that issue, attention was directed to the conduct of the bus driver, which was determined to be very reasonable in the face of the sudden emergency confronting him. Ultimately, the entire fault for this transportation disaster lay at the hands of the truck driver and his employer. Our firm quickly began negotiations with the defendants’ insurance carrier. Notwithstanding the significant limitations on the recovery of money damages under Italian law, our firm secured settlements for all of the victims of the disaster for several million dollars in all.

If you or a loved one were involved in a train or bus crash disaster anywhere in the U.S. or even in another country, call us today.  We have the knowledge and experience to get you justice and the compensation you deserve.  WE ARE ALREADY PROSECUTING LITIGATION AGAINST AMTRAK ON BEHALF OF VICTIMS OF THE PHILADELPHIA AMTRAK TRAIN ACCIDENT / DISASTER.  Please call us today if you or a loved one was on that train.

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Planning a Cruise? Make Sure You’re Informed about Potential Illness Outbreaks & How to Be Prepared

April 29th, 2015 by

This time of year many families are planning family vacations, many of which include ocean or riverboat cruises. Although not widely talked about, passengers on these ships or boats are all too often plagued by outbreaks of severe illnesses. Most recently, another outbreak afflicted a Celebrity Infinity cruise ship.

The Celebrity Infinity cruise ship departed on March 29th from San Diego and returned, with its final stop in Puerto Vallarta, Mexico, on April 13th. A severely debilitating gastrointestinal illness was reported to have affected 106 of the ship’s passengers, and six crew members. Upon the arrival of the ship, on April 13th, an environmental health officer from the U.S. Centers for Disease Control boarded the vessel to conduct an environmental health assessment and to evaluate the outbreak and response activities.

The CDC determined that the causative agent for the outbreak was Norovirus. Another outbreak was just reported by the CDC on a Royal Caribbean’s Legend of the Seas San Diego-bound ship. One hundred fourteen passengers and two crew members were reported ill with vomiting and diarrhea. The cause of that outbreak is unknown.

The effects of Norovirus are mainly infection of the stomach and intestines, and therefore it often causes severe gastroenteritis, with associated fever, vomiting and diarrhea. The risk of resulting dehydration and its consequences is high, thus posing a very serious health concern for babies, young children and the elderly, and those suffering underlying medical conditions such as high blood pressure, heart ailments, colitis and the like. The consequences are all the more worrisome when the ship is at sea and far from land-based emergency medical care.

Norovirus is closely associated with cruise ships, mainly because it spreads quickly and widely among people in small areas (such as the close confines of a cruise ship’s guest rooms, dining areas, casinos and recreation areas). There are more than 20 million cases of Norovirus reported each year. When on cruise ships, the virus is typically spread through physical contact with ill people or infected areas they may have touched – such as hand rails, door knobs, food buffet utensils, playing cards, poker chips, etc.

The best way to take precaution to prevent Norovirus or similar infectious illnesses is to wash your hands often, with warm water and soap. The CDC specifies to wash hands before and after eating and smoking, after using the restroom, and whenever you feel your hands are dirty. Limit physical contact if you can, and do not share drinking glasses and eating utensils. Avoid uncooked food as much as possible. As an extra precaution, pack soap or hand sanitizer and a spray disinfectant for surfaces, utensils and drinking glasses in your guest room and hand-held objects in your room – like the TV remote control.

Ultimately, if you or a loved one become ill on a cruise, please call us for assistance in recovering your out of pocket expenses for medical bills, your damages for having your vacation cancelled or cut short, and for any injuries or disability you may have suffered.

Sources: cnn.com, cdc.gov

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