Glass Particles May Be Found in Generic Lipitor

According to a November 29 article by Katie Thomas in The New York Times, Ranbaxy Pharmaceuticals has stopped producing its generic version of Lipitor, pending investigation into the possibility of small glass particles being found in pills. The Food and Drug Administration announced the halt earlier that day. The FDA claims they have not received any reports of consumers being harmed. Thomas’ article sites a recall by the drug manufacturer earlier this month and extensive details on Ranbaxy manufacturing problems at its plants in the US and in India.

Roadway Conditions and Auto Accidents

Automobile accidents are caused by a number of circumstances ranging from driver neglect, impairment or recklessness, to roadway conditions involving weather, construction, obstructions or other circumstances. Unfortunately, automobile accidents happen every day and regardless of the circumstances, and even if you are only mildly injured, it is important that you call the police from the scene of the accident, and later obtain a copy of the official police report. Often the police officer may site opinion on who was at fault in such cases where there is clear evidence to determine the cause. This will help you in working toward receiving a settlement from your insurance company. In other situations, there may be no clear explanation and the underlaying causes are not very evident. When a roadway or roadway-related accident occurs, in addition to a police report and depending on the complexity of the circumstances, an accident survey should be additionally conducted, if possible, immediately following the accident, before debris is removed and traffic proceeds in the area. In some circumstances, law enforcement officials are equipped to quickly and accurately document the scene. In some cases, independent land surveyors or engineers may also be hired to assess factors relating to curves and grades in the road that may be a contributing factor. Measurements can be taken and scene mapping can be done as a means of determining if roadway defects or design flaws could be contributing factors to the accident. Forensic engineers are familiar with design regulations and maintenance requirements.  Injuries and property damages may make your case more complex. It may be in your best interest to hire an accident attorney before filing your claim. At Okun, Oddo & Babat, regardless of the circumstances, we are equipped to evaluate your accident case and potentially help you recover the highest compensation possible. Contact us for a courtesy evaluation.

Trampolines Recalled by Sportspower Due to Injury Hazard

The U.S. Consumer Product Safety Commission announced a voluntary recall involving Sportspower Parkside model TR-14FT-COM trampolines. The trampolines are 14 feet in diameter and were sold with an enclosure net. The trampolines have blue or light blue fabric on the safety matting and enclosure pole sleeves. The model number is marked on the packaging and instruction manual. These trampolines were manufactured in China and sold exclusively at Sports Authority stores nationwide from April 2007 through May 2012. Consumers should immediately stop using the trampolines. For more details visit CPSC website.

How Much Legal Authority Does the FDA Have, and Use in Regulating Drug Compounding?

Legal experts are engaged in a new debate over the Food and Drug Administration’s authority of the drug compounding industry and perhaps their failure to use it. The recent outbreak of meningitis and the shutdown of Massachussets-based New England Compunding Center have again surfaced this issue with law makers and it is raising the question on the need for criminal investigation. Laws and regulations surrounding the compounding industry and the pharmaceutical industry and role that pharmacies play in mixing medicine for individual patients – which is related from state-to-state – are sketchy. It is unclear how many people may be at risk from the use of potentially contaminated drugs and could be at risk for severe infection and perhaps wrongful death. Several drugs produced by New England Compounding Center are used during surgical procedures. The October 15 New York Times article “F.D.A. Warns of Further Risk From Tainted Drugs” explains in more detail.

Bariatric Weight Loss Surgery

Bariatric surgery is a surgical procedure performed to assist a patient in losing weight. There are different types of surgery that may be performed from a restrictive procedure where a band is placed around the stomach, or a more involved bypass procedure to modify the gastrointestinal tract. With each procedure, there may be different consequences. In the last several years the number of individuals opting for this type of surgery has greatly increased and with that increase, a number of cases and issues have been in the media including wrongful death caused by a defective surgical stapler and over 9,00 reports of complications made to the FDA.

In 1983 The American Society for Metabolic and Bariatric Surgery (ASMBS) was formed and is the largest society for this specialty in the world. Part of the Society’s mission is to provide educational and support programs for surgeons and integrated health professionals and multidisciplinary teams as well as to improve care, advance the science and understanding of the surgery, foster communication between healthcare practitioners and patients and to be an advocate for health care policy. For educational resources, visit the ASMBS website.

Yet earlier this year Deputy Clay Chandler was awarded $178 million in a lawsuit against Memorial Hospital Jacksonville for medical negligence and fraud damages. According to a January, 2012 article in The Florida Times-Union, Chandler was severely incapacitated after weight loss surgery at the hospital in 2007. Now brain damaged and confined to a wheelchair, for eight days following his surgery he showed signs of complications where fluids from the bowl leaked into the abdomen. The report sites the surgeon’s inexperience and “failure to meet the hospital’s advertised accreditation” which the jury found to be acts of fraud.

The U.S. Food and Drug Administration website details the procedure, risks and targets weight loss claims. You can register to receive Consumer Update RSS feeds and email updates. Steven Silverman, director of the Office of Compliance in FDA’s Center for Devices and Radiological Health stated that “Consumers, who may be influenced by misleading advertising, need to be fully aware of the risks of any surgical procedure.”

If you or someone you know is considering Bariatric Weight Loss Surgery, you should become familiar with the standardization of bariatric surgery practices and guidelines, as well as the risks involved. If you have undergone a procedure and you have developed complications, contact Okun, Odd & Babat for a consultation.

Property Accidents Due to Negligence

Property owners have a legal obligation to keep their property safe and to warn visitors of potential hazards. In such cases where an accident is sustained on someone’s property due to negligence or a wrongful act, there are a number of questions that arise. Premises liability cases can be complex and victims typically need to learn about their legal rights and how to go about filing an injury claim. Incidents may involve workplace and construction site injuries, playground and amusements park accidents, school injuries, personal property slips and falls, restaurant, catering, parking lot or shopping mall mishaps. Incidents may also involve injuries at a camp or nursing home slips and falls. Victims of premises liability cases can incur many serious injuries including broken bones, brain injuries, spinal cord injuries, accidental drowning and in some cases, wrongful death. Owning property means taking responsibility for the safety of the people you invite onto your property. Whether you were injured at a retail store or any other commercial, residential or other premises, the property owner may be liable for your injuries.

It is most important that if you or someone you care about is involved in an injury on another person’s property that you keep careful and diligent records, and photos if possible, involving the scene of the injury and circumstances of the property which factored into the incident. Note any injuries, medical treatment or medications administered as well as the names of any individuals involved. In any situation, it’s best to consult with an attorney as quickly as possible to gain a full understanding of your legal rights and potential entitlement to compensation.
We can help you understand the statue of limitations involving your case, which varies from state-to-state, file charges, collect evidence and speak with the property owner’s insurance company and/or attorney. It is our job to give you a full understanding of steps involved in filing a premises liability case and to work on your behalf to recover appropriate compensation for injuries, pain, suffering, medical expenses or lost wages. The attorneys at Okun, Oddo and Babat are trained in the area of personal injury law. Contact us for a consultation.

Mold In Your New York City Apartment

What is Mold?
Molds produce tiny, invisible spores that float around until they find an environment in which they can grow. There are over one hundred thousand varieties of mold, with over 1,000 common in this country, and their spores are flying around all the time. Many molds are helpful (medicines and cheeses), many harmless, but some are dangerous to humans.

Many of your rights depend on the type of housing you live in or your type of tenancy. You may be subject to different laws and have different sets of rights than even neighbors in your own building. Learn which rights and responsibilities apply to you.

Where is mold usually found in New York City apartments?
Molds can grow on paper, wood, sheet rock / drywall, carpet, plaster, or any other surface that is kept wet or damp. The growths are most common in bathrooms, kitchens, basements, near chronic leaking areas (such as leaking risers and radiators, or roof leaks), and in newer buildings, in air ducts.

What causes mold to grow?
Mold grows in areas that are kept wet or moist, so simply cleaning up mold is insufficient if there continues to be a water leak, water build-up (such as after a flood), moisture build-up, or standing water (as in a basement). When mold spores land on a consistently wet surface, they then grow into the musty, mildewy-smelling orange or black yuck that is instantly recognizable as mold.  Mold growths are often a problem after a flood – either from sewage, a bad leak or very wet weather conditions.

When does mold become harmful to health?
According to the federal Environmental Protection Agency, the Centers for Disease Control, and the NYC Department of Health, most common molds that grow in small quantities are harmless for healthy people but obvious mold growths in homes or work places should be cleaned up immediately. Some types of mold  can be very harmful to humans, especially young children, the elderly, and those with compromised immune systems. Even healthy people can develop severe illnesses and allergies when exposed to large mold growths. Illnesses related to mold growth include allergic reactions (fever, itching, rashes, eye problems, breathing difficulties, etc), asthma, and severe respiratory problems. The Stachybotrys chartarum mold is particularly harmful, though not common but is perfectly suited to apartment buildings and houses with chronic leaks or floods. This greenish-black mold grows on substances with high cellulose content such as wall board, sheet rock, and other common building materials. Toxic chemicals released by the mold can, according to some medical experts, cause very serious lung problems. In large quantities, according to some sources, mold mycotoxins can induce allergies and chronic, severe health problems in previously healthy people.

Is it a violation for there to be mold in my apartment?
The city’s housing department will record mold growths as “C” class, or immediately hazardous violations. However, tenants continue to report that both the health and the housing departments are not very effective in forcing resistant landlords to both clean up mold growths and to keep the growth away. Tenants in some of New York City’s newer buildings have had severe mold problems either because of carelessly maintained air conditioning/heating duct work or because of uncorrected leaks.

What should be done when mold is found in my apartment?
Mold should be cleaned up, according to the NYC Deptartment of Health, with a mild bleach and water solution by a person who is not allergic or sensitive to the mold. Young children, especially babies, older people, pregnant women and anyone with asthma or other allergic or lung condition should not be involved in or around the mold or the clean up. The cleaning cloths should be discarded, and any thing that had the mold growing on it, such as carpets, curtains, furniture, paper, wall paper, plaster or sheet rock should also be discarded. The city’s health department has clear guidelines for cleaning up mold growths which should be followed. If your landlord is doing the cleanup, make sure his workers follow the guidelines. Obviously, very large growths should be handled by a trained contractor hired by the landlord.

What is my landlord’s responsibility to eliminate mold in my apartment?
Your landlord is responsible for properly cleaning up the mold and for repairing any conditions that are keeping the condition in your apartment wet. The source of the water build-up may have been a flood that was never cleaned up after (with standing water), a leaky pipe – including pipes between the walls, or pipes in adjacent apartments, roof leaks, or leaks coming from the outside walls in your building (which require pointing), or other causes. Repairing these problems are all your landlord’s responsibility, no matter what they cost.

Before any cleaning work is done the source of the water or moisture build-up has to be stopped. If there is a plumbing leak coming from the apartment above you and causing the drywall on your ceiling to develop mold, cleaning the mold in your apartment will not solve the problem, as the mold will soon re-emerge. Even replacing that section of drywall will be inadequate if the leak is not fixed, as the new drywall will soon become wet.

What if my landlord fails to clean up the mold?
Report the mold problem in your apartment or common building area to the New York City Department of Health. You should also report mold and any chronic leaks from pipes, improperly working drains, or roof leaks, to the New York City Department Of Housing, Preservation and Development. Be sure to date the letter, keep a copy and send it to the landlord either by certified mail or with a receipt of mailing.

If the landlord fails to act promptly, contact Okun, Oddo & Babat at 212-642-0950 to discuss further action.

Source: Metropolitan Council on Housing

Don’t Get Sick in July

It’s one of those secrets you normally don’t learn in nursing school: “Don’t go to the hospital in July.” That’s the month when medical residents, newly graduated from medical school, start learning how to be doctors, and they learn by taking care of patients. And learning means making mistakes. There’s disagreement in the medical literature about whether a so-called July Effect, where medical error rates increase in the summer, actually exists. But a 2010 article in the Journal of General Internal Medicine and a 2011 article in the Annals of Internal Medicine both found evidence of it. In an interview, Dr. John Q. Young, lead author of the latter review, likened the deployment of new residents to having rookies replace seasoned football players during “a high-stakes game, and in the middle of that final drive.” From what I’ve experienced as a clinical nurse, whether or not the July Effect is statistically validated as a cause of fatal hospital errors, it is undeniably real in terms of adequacy and quality of care delivery. Any nurse who has worked in a teaching hospital is likely to have found July an especially difficult month because, returning to Dr. Young’s football metaphor, the first-year residents are calling the plays, but they have little real knowledge of the game. This experience deficit plays out in ways large and small, but I remember an especially fraught situation one July when a new resident simply did not know enough to do his job and a patient quite literally suffered as a result.

The patient was actively dying. He was older and his death was expected. He had kept his cancer at bay for several years, but there were no more curative treatment options left and he had opted to die peacefully in his bed, surrounded by family. He had also wanted to die in the hospital, and his death was coming on quickly enough that the hospital decided to allow it. He was grumpy, charming, funny and impressively clear-eyed about the end of his life. During our brief, two-day acquaintance I developed a strong attachment to him.
Death came closer quickly on that second day and as it neared, his pain increased significantly. Dying from cancer often hurts. He needed oxygen to breathe comfortably, and because he was alert he fully felt the intense pain. I’m a nurse, so legally I cannot decide to increase a patient’s dose of pain medication, but I can call a physician and describe the patient’s distress. That’s part of a nurse’s job, but there is also a chain of command for getting medication orders, and another part of my job is adhering to that hierarchy.
I paged the first-year resident covering the patient. Since it was July he was an M.D. on the books, but he was brand new to actual doctoring. I explained things, but he would not increase the ordered dose. I paged him again. We talked over the phone, and I insisted. Then I pleaded. He would not up the dose.
Looking at the situation from his point of view, I understand his reluctance. I was asking him to prescribe a very large dose of narcotic, a killingly big dose if the patient was unused to opioids. The resident might have learned in medical school about pain during dying, but he had not actually been with a patient going through it. Seeing such pain — the body twisting, the patient crying out helplessly — is categorically different from reading about it.
I also imagine the resident had been taught to prescribe narcotics judiciously, perhaps even sparingly, and the amount of drug I was asking for was neither.
The patient’s wife was kind; his daughter, a nurse, forthright. They and he deserved better than they were getting, so I decided to take a risk. Ignoring the chain of command, I paged the palliative care physician on call. She and I had talked about the patient the day before.
I described the patient’s sudden lurch toward death, the sharp increase in pain and the resident’s reluctance to medicate the patient enough to give him relief. “Ah,” she said, “I was worried about that,” meaning that the patient might begin actively dying sooner than the medical team had expected. She ordered a morphine pump. I got the drug, loaded and programmed the machine. The patient died fairly soon after. He was conscious to the very end, and I can say he did not meet his death in agonizing pain.
A FEW hours later I ended up in the elevator with the new resident. He and I both started talking at once. Looking stricken, he apologized to me for having been busy, overwhelmed with several new patients. Knowing it is never easy to have someone’s footprint on your head, I apologized for having called in an attending physician. “I don’t usually jump the line,” I started to explain, when he interrupted me. “You did the right thing for the patient,” he said.
Such an exchange is rare. A nurse who goes over a doctor’s head because she finds his care decisions inappropriate risks a charge of insubordination. A resident who doesn’t deliver good care risks the derision of the nurse caring for that patient. Nurses aren’t typically consulted about care decisions, and this expectation of silence may lead them to lash out at doctors they see as inadequate.
The July Effect brings into sharp relief a reality of hospital care: care is becoming more specialized, and nurses, who sometimes have years of experience, often know more than the greenest physicians. We know about medicating dying patients for pain, but we know a lot of other things, too: appropriate dosages for all kinds of drugs, when transfusions and electrolyte replacements are needed, which lab tests to order and how to order them, whether consulting another specialist is a good idea, whether a patient needs to go to intensive care because his vital signs are worryingly unstable.
The problem can be limited by better supervision from senior residents, fellows and attending physicians, as well as by nurses. We need to acknowledge this fact, because admitting that new residents need help, and that nurses can and do help them, is the beginning of owning up to our shared responsibilities in providing care. For the good of our patients, nurses and doctors need to collaborate.

Article by Theresa Brown
Published on July 14, 2012, New York Times Opinion Page
Part of a series on healthcare from a nurse’s perspective

. Theresa Brown is an oncology nurse and the author of “Critical Care: A New Nurse Faces Death, Life, and Everything in Between.”

Failure To Carry Out Emergency C-Sections

If mother or baby is at risk during delivery, medical professionals may opt to perform an emergency caesarean section, rather than continue with a potentially dangerous vaginal birth. However, what happens if an emergency C-section is needed, but is not carried out? Does this amount to medical negligence? And it is possible to claim compensation for the injuries medical errors have caused?

Why would an emergency C-section be performed?
Pregnant women are now free to choose whether they would like to have a vaginal delivery or an elective caesarean section. Studies so far have shown that in the majority of cases, women will consider their options and (unless otherwise advised by doctors) opt for a vaginal birth. However, there are occasions in which complications will arise during the course of a vaginal delivery, putting mother and/or baby in danger. This may occur if:
• The mother’s blood pressure drops to a dangerously low level;
• The baby’s heart rate shows signs of fetal distress;
• The placenta separates from the uterus prematurely (called placental abruption).
• The placenta is low down in the uterus (called placenta previa);

If mother and/or baby are at risk, doctors should be quick to assess the situation and acknowledge the need to transfer the vaginal delivery to an emergency caesarean section. This decision should be proposed to the mother and consent sought without delay.

What if an emergency C-section is not performed?
Nevertheless, there are sadly times when medical professional fail to act, even though there are obvious signs of complication. This can lead to devastating consequences, harming the health of both mother and baby. Injuries to the mother can include excessive blood loss, collapse and cardiac arrest, while injuries to the child usually arise due to oxygen starvation. These can be particularly serious and can even be fatal.

Claiming Compensation
If you or your baby has been injured because an emergency C-section was not performed when it should have been, you will have been the victim of medical negligence. We understand just how distressing this will be, as what should be a happy time for you and your family will instead be filled with pain and anguish.

As the victim of medical error, you will be entitled to claim compensation for the damage you have been caused. Although it will not undo the harm you have endured, you may want to consider taking legal action against the hospital in question. Contact Okun, Oddo & Babat for a courtesy evaluation. For immediate assistance, call us at 212-642-0950.

Author: Julie Glynn
Originally published, May 19, 2012

House Committee Approves Auto Safety Bill

The House Energy and Commerce Committee approved an auto safety bill where “automakers would be required to meet new safety standards to prevent unintended acceleration in vehicles” as well as “new rules for brake override systems and vehicle black boxes and tougher penalties for slowing down a recall. ”AP(5/26, Thomas).” The Washington Post (5/27, Whoriskey) reports that the bill seeks to make the National Highway Traffic Safety Administration’s oversight “more aggressive” and would prohibit NHTSA employees from lobbying activities, on behalf of automakers, within a year of their employment. Okun,Oddo & Babat will continue to monitor this bill, and will provide updates on its progress.