Is the drug you are taking or the medical device used during your treatment FDA approved? Strictly speaking, only drugs and life-sustaining or life-threatening “Class 3” medical devices, such as replacement heart valves and defibrillators, hemodialysis machines, orthopedic implants, which require the highest level of regulatory control due to the very high risk of using these, need to be approved by the U.S. food and Drug Administration before these can be marketed. Class 3 drugs and medical devices need to be subjected to a strict review process called “pre-market approval” (PMA) to prove that their benefits outweigh potential risks to patient health.
The product’s manufacturer should provide the FDA with scientific evidence from clinical trials which will show the product’s safety and effectiveness. Over-the-counter drugs, which are assumed to be safe, require less rigorous testing procedure, while herbs, vitamins and supplements do not need to be tested, unless these are used as active ingredients in a drug that necessitates FDA approval; due to this, supplements can only claim that they can be used for the promotion of health, not for the treatment of any specific disease.
“Class 2” medical products, such as X-ray machines, ultrasound scanners, powered wheelchairs, pregnancy test kits and contact lenses, also require regulatory control but not as stringent as in Class 3 products. Class 2 products need only FDA clearance before these can be sold. Also, instead of submitting the product to clinical trial, the product’s manufacturer only needs to convince the FDA that the product is “substantially equivalent” to one that has already been cleared in the past.
By “substantially equivalent,” it means that the product has, approximately, the same technical characteristics and intended use as an existing product. Passing this clearance process means that the product is “FDA listed” or “FDA cleared.”
Despite the tests and/or regulatory control, many defective and harmful products continue to find their way into store shelves to be displayed and bought by unsuspecting consumers. This usually happens after the manufacturer of a defective product hides information on the dangers associated with the use of their product or fails to warn doctors and patients about their product’s harmful side effects.
According to a Milwaukee injury attorney, medicine may be considered defective or dangerous because of: incorrect or misleading labels, poor manufacturing quality or flawed package design. If use of a defective product results to injury to consumer, then the pharmaceutical company and/or medical manufacturer should be held liable for the damages that their product has caused in those who used it.
Car accidents have been on the rise as of late. According to the National Highway Traffic Safety Administration (NHTSA), there are more than 30,000 deaths and more than 2 million injuries from motor vehicle crashes in the U.S. yearly. There are various circumstances that can cause car accidents. According to the website of Karlin, Fleisher & Falkenberg, LLC, the consequences of a car accident can be overwhelming. When involved in a car accident, here are some things that you need to do:
1. Keep calm
After a car accident, the driver can feel a wide range of emotions which is quite normal. At times like this, however, it is important to keep your cool so that you can better handle the situation.
2. Safety first
Before everything else, ensure that everyone is safe including that of the other driver and their passengers. If someone is hurt, get medical help or call 911 to check the injured person.
3. Take pictures of the accident
Once you have ensured your safety as that of everyone else, take pictures of the accident. They will come in handy in case there is case that will be filed. Take pictures of both vehicles as well as the scene of the crime.
4. Exchange contact information
Get the contact information of the other driver such as their phone number, address, insurance provider and policy number. Likewise, get the make, model, year, and color of the car.
5. Get in touch with your provider
After getting the information of the other driver, inform your insurance company that you have been in an accident. Ask them about your possible coverage and the potential costs.
5. File an accident report
Filing a police report can help facilitate the processing of your insurance claims. You can do the report at the nearest police station.
A car accident can be a stressful situation but nothing will happen if you do not stay calm. Follow these tips and you are assured of recovering potential damages from the accident.
Ovarian cancer is a potentially deadly form of the disease. In fact, according to Williams Kherkher, in the United States, ovarian cancer is considered the fifth most fatal cancer among women and the most fatal cancer related to the reproductive system. Unfortunately, the risk of developing this deadly cancer is often increased when a woman undergoes a hysterectomy or a myomectomy using a power morcellator. Power morcellators are drill-like devices that work by mincing up fibroids and other noncancerous tissue into smaller pieces that are removed through a small incision in the abdomen. However, these devices could also spread cancerous cells into other areas of the body, potentially leading to the development of ovarian cancer.
Ovarian cancer can be particularly hard to diagnose as the early symptoms can be nearly impossible to detect. According to the American Cancer Society, there are some recognizable symptoms that can develop later on including pain in the abdomen or pelvis, bloating, and weight loss. If you are experiencing any of these symptoms, especially if you are over 60, you should consult with your doctor immediately.
Power morcellators have been known to cause the development of other potentially deadly cancers in addition to ovarian cancer. These cancers include metastatic leiomyosarcoma, uterine cancer, uterine sarcoma, and endometrial stromal sarcoma. These dangers lead not only Johnson & Johnson, the makers of the morcellators, to recall the device, but for the FDA to issue a “black box” warning—meaning that the potential benefits of the morcellators were far outweighed by the threats. Unfortunately, these warnings came too late for many women who developed cancer from the procedures.
Your tires are your car’s direct contact to the road, which makes them vulnerable to easy wear out. Unfortunately, the website of Mokaram & Associates, P.C. warns that a worn-out tire can cause disastrous, sometimes even fatal car accidents. So, to ensure a safe and trouble-free drive, remember to rotate your tires regularly and rotate them properly.
How regularly is regularly?
How frequently you rotate your tires depends on many different things. Do you drive more often? Are you driving alone or with passengers? Are road conditions poor? If you’re always in for a long drive, or you are driving with higher load capacity or in poor road conditions, then you should be rotating your tires more often. If this is not the case, then you may rotate every 7,500 miles or six months, whichever comes first. The safest bet here is to rotate every time you change your engine oil, which you should do at least once a year.
Put your worn-out tires on the front.
While you should never be driving with a bad tire, there will always come a time when some of your tires will wear out more than the others. When this happens, it is important to ALWAYS put your best tires at the rear axle. This is true even for front- wheel drive cars. Why? The reason behind this is to prevent your car from tail spinning.
When driving on wet roads, mounting your tires with less traction on the rear would cause them to “surf” or hydroplane without you noticing it. This will cause your car to tailspin, and may even result in injurious accidents. On the other hand, when you mount your better tires at the back and your worn-out tires in front, you may feel if your front wheels are losing traction through your steering wheel, prompting you to take any action when needed. Also, most car safety features are located in the front (airbags, seatbelts), which means you are more protected in a headfirst crash rather than in a fishtail accident.
Several news outlets have been reporting that the biggest disaster to happen in California is expected to strike at any moment. Much of Southern California rests around the San Andreas Fault, and a recent explicatory study conducted by the U.S. Geological Survey, the Southern California Earthquake Center, the California Geological Survey, along with several other experts showed that a massive quake is likely to happen soon. As a result, scientists have been working on ways to predict how an earthquake of huge magnitudes will affect the sprawling cities and suburbs within the area.
ABC News reports that scientists have been working with local governments and first responders to come up with a realistic crisis scenario that can help them formulate a viable disaster preparedness plan. They imagine the next “Big One” to measure at magnitude 7.8 in the Richter scale. If the tremors last for 3 minutes, the earthquake could result in 50,000 injured victims and 1,800 fatalities. Damage to infrastructure could reach up to $200 billion.
While this situation is only a “what-if” scenario that’s meant to prepare local governments for the upcoming disaster, the U.S. Geological Survey cautions that an earthquake of similar proportions is likely to happen in California in the next few decades. In fact, the USA Today article notes that researchers estimate that theirs is a 46 percent chance that an earthquake at magnitude 7.5 or greater could occur in the next 30 years.
The worst thing about this news is the fact that earthquakes can’t be forecasted the same way we do hurricanes and storms. The only way scientists can predict earthquakes is by investigating patterns that develop through history. Science can offer rough estimates, but the only way to mitigate such a disaster is through sufficient preparation. The Southern California Earthquake Center outlines several steps that should be prioritized for such a scenario. Emergency response training, public earthquake drills, and the identification of vulnerable structures can do a lot to prepare a community for the upcoming quake. Urban planning is also an important part of disaster preparedness. With a natural hazard report, residents can be informed if their houses are in areas prone to earthquake damage. This can help them prepare to an adequate level.
We all face a certain amount of risk at any given moment. Whatever the place or situation, there’s no way to discount the possibility of an accident from occurring. You could be on the road or you could be doing your daily tasks at work. Regardless of the scenario, it’s incredibly hard to predict when an accident will take place. Still, there are some people who face greater risks than others. This is especially true for individuals working in manual labor industries like construction, transportation, and manufacturing.
According to the website of Williams Kherkher, many people with high risk jobs sometimes don’t understand how workplace accidents can quickly become devastating. These individuals can expect to walk away from an incident with some sort of injury that will greatly affect their ability to work and earn a steady income. According to the website of Spiros Law, P.C., common workplace accidents of this nature include injuries to the foot, leg, lower back, spine, neck and head. Sometimes, an accident can even lead to an amputation. Recovering from such injuries can take a long time and can be a great financial burden.
Fortunately, any financial concerns brought about by workplace injury can be resolved through workers’ compensation. After an accident, it’s extremely important to have your injury reported to your employer as soon as possible. This will help you expedite the process of attaining your workers’ compensation benefits once you’re ready to file your claim. Provide your employer with hospital paper work that can help them assess the extent of your injury to help them process your workers’ compensation claim.
The medical community relies on pharmaceutical companies to manufacture solutions that can help address the needs and concerns of patients. In an ideal scenario, the solutions provided by pharmaceutical giants contribute to advancing the health and well-being of a given community. However, the real situation proves to be a lot more complicated. There have been several cases when these companies offer up pharmaceuticals that are defective. In fact, it is commonly noted that defective pharmaceuticals comprise a huge majority of all product liability cases in the United States.
While the state of the pharmaceutical industry has undoubtedly improved in the past few decades, it can’t be denied that there is still room for improvement. There are still some drugs, medications, and medical devices that cause significant issues for patients using them. Sometimes, procedures during research and testing aren’t stringent enough to catch potential risks and concerns with a particular product. Sometimes, these risks don’t come to light until it’s too late. There have been plenty of occasions when a pharmaceutical solution has been approved by the Food and Drug Administration before any complication comes to light.
An example of such a pharmaceutical product is the power morcellator, a laparoscopic surgical tool used to perform minimally invasive procedures addressing reproductive and gynecological health issues. According to the website of Williams Kherkher, the morcellator has been used widely since the 1990s until recent developments showed that the tool can cause undiagnosed uterine cancer to spread and become exacerbated. Another pharmaceutical product under heavy scrutiny is the anti-psychotic drug named Risperdal. The website of the Risperdal lawsuit attorneys at Williams Kherkher pointed out that the drug used to treat schizophrenia, bipolar disorder, and irritability caused by autism has been found to cause serious side effects such as gynecomastia, hyperglycemia, Tardive dyskinesia, arrhythmia, and neuroleptic malignant syndrome. In some cases, the drug could also lead suicidal thoughts and tendencies.
Laser hair removal is a medical procedure that targets and damages the follicle of any unwanted hair in the face or the body, inhibiting—or at least slowing down—future growth. As a result, it has quickly become a popular option for women who are looking alternatives to hair removal methods that require a lot of upkeep such as shaving and waxing. As its name suggest, laser hair removal makes use of an intense light beam to target the hair growing in a specific area. It is one of the most sought after cosmetic procedures in the United States.
Undergoing laser hair removal is best for men or women that have unwanted facial or body hair that leaves them feeling self-conscious and unable to wear clothing that they’d like to try. According to the website of Bergman Folkers Plastic Surgery, laser hair removal can also reduce the occurrence of skin irritation caused by hair re-growth. The procedure also leaves a patient with smoother and silkier skin, as opposed to the usual bumpy and prickly aftermath left by razors and epilators. On top of that, the procedure can also make a patient’s skin tone and complexion look a lot more even.
If you are considering a laser hair removal procedure, there are a few other considerations you’ll need to take note of. While the procedure results in plenty of benefits, it’s important to note that not every patient is the perfect candidate. For one, laser hair removal requires multiple treatments in order to produce the desired outcome. For people with very thick hair growth, it might take more than the average of 3 to 8 sessions to achieve permanent hair loss. The procedure is also particularly effective for people with dark hair and light skin. The contrast between hair and skin color is important because the laser uses pigment or melanin to detect the hair. It will be a lot more difficult for patients with darker skin, or patients with light skin and hair color.
There is very little risk involved in laser hair removal. The most common side effects are skin irritation and pigment changes. There are rare occasions when the procedure can lead to blistering, scarring, and other notable changes in the texture of the skin. When this happens, don’t hesitate to contact your dermatologist or cosmetic surgeon right away.
Car accidents are an all too common occurrence in roads across the United States. As a result, there has been a massive and on-going campaign urging commuters to prioritize traffic safety, particularly through following through on important regulations and policies. One safety practice frequently pushed by both government and non-government organizations is the use of seat belts. According to the Centers for Disease Control and Prevention or CDC, seat belts reduce incidents of serious injuries and fatalities by about half. The website of the Abel Law Firm also points to the numbers gathered by the National Traffic and Safety Administration showing how effective seat belts can be. According to the NHTSA, seat belt use saves approximately 9,500 lives every year.
Seat belt use is a simple way both drivers and passengers can prevent the devastating effects caused by most vehicular accidents. It shows how important such a simple apparatus can be. However, there are also rare occasions when seat belts can cause harm and leave the opposite of its intended effect. This happens when the seat belt installed in a vehicle is defective. According to the website of Habush Habush & Rottier S.C. ®, this happens when manufacturers become negligent and fail to impose more rigorous safety nets.
Defective seat belts are known to cause a variety of injuries. In a collision, wearing a tight or ill-fitting seat belt leaves a person vulnerable to compression injuries in the chest and abdomen. Meanwhile, seat belts that are too loose or are made from weak materials and fail to hold in an impact can lead to a host of serious injuries. When a defective seat belt comes loose, the occupant can end up suffering from a host of injuries typically associated with car accidents: bone fractures, concussions, internal trauma, and spinal cord injury. Depending on the strength of the impact, these injuries can lead to devastating outcomes like paralysis, disability, and even death.
Vehicular accidents happen all too frequently in the United States. However, a growing trend shows how these accidents can quickly become devastating for the victims involved. As reported by USA Today, data shows that hit and run accidents—crashes where the driver at fault flees the scene without providing any information—are on the rise in the last couple of years. The article cites data from the National Highway Traffic Safety Administration showing an upward trend in the occurrence of such accidents leading to fatalities. A total of 1,274 fatal hit and run accidents were reported in 2009. The stats rise to 1,393 in 2010 and then to 1,449 in 2011. Personal injury lawyer, Ali Mokaram, would probably note that pedestrians are at most risk to such accidents, since the human body is ill-protected against oncoming automobiles. Pedestrians make up approximately 6 in 10 of fatally injured victims.
Considering these facts, it’s easy to see that hit and run accidents are incredibly devastating and tragic. Even the victims that fortunately survive such a crash are left to deal with life-changing consequences and no party to hold accountable for their suffering. As emphasized by the website of Pohl Berk Attorneys, drivers who flee the scene of a crash leave their vulnerable victims to face the initial damage alone. To make matters worse, it could be extremely challenging to find any information that can help identify the offending driver. As such, it’s extremely important to get the police to respond to the accident right away. Victims that have not been severely injured by the accident should also try their best to gather as many identifying details about the driver responsible for the crash. Anything from the clothes they have on to a few digits of their license plate number can prove to be helpful for police officers responding to the emergency.
Another step in the process could be to contact a legal professional. Victims and their families have legal options that can help them find closure and hold the driver responsible for damages they’ve incurred. Filing a personal injury lawsuit can help victims and their families recover losses through compensation for medical costs, funeral services, and other financial burdens that come from such a devastating situation.