We often go to the pharmacy, hand over the medication prescription given to us by our physician and assume that we will be given the proper medication. Not once do we take into consideration that the pharmacist will make a medication error.
There are a several types of medication errors that can occur that we should dedicate more time reviewing before assuming that the vial of medication you were handed is the proper medication you should take.
pills-tablets-1-1184376.jpgPerhaps a simple yet safe way of cross-checking is by taking a picture of your medication prescription before handing it over to the pharmacist. That way, when you pick up your medication you can compare the information on the vial with that of the written prescription that was provided by your doctor. If there are any concerns or questions, you can ask the pharmacist right then and there prior to leaving home with that medication.
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Recently, an investigative report from the national media blew the whistle on a West Palm Beach, Florida hospital that allowed underqualified and understaffed medical providers to perform heart surgeries on children and babies. The overall mortality rates of these children and babies was three times the national average which placed a spotlight on the deficiencies at the hospital. The revelations surrounding the St. Mary’s pediatric heart surgery department are both horrifying and disturbing. How is it possible that a hospital, presumed to be dedicated to the well-being and safety of its patients, be so ill-equipped for such a complex area of medicine? To make matters worse, those harmed by the failure of St. Mary’s to adhere to necessary standards are the most innocent and needy in our society.
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Because cosmetic surgery procedures are almost always elective surgery on the part of the patient, these types of cases are more difficult to litigate in front of a jury panel. Why? Because many jurors opine that in many cases, cosmetic surgery procedures are elective procedures to improve one’s appearance and not medically necessary or life- saving procedures. As such, when something goes wrong during these types of procedures, jurors scrutinize the case a little more, because many feel the patient put themselves into the situation by electing to have the procedure done when it may not have been medically necessary.

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Nonetheless, cosmetic surgery whether elective or not, shall still be taken seriously and when medical care during these procedures go wrong there can be serious life threatening results.
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On July 1, 2015, the Fourth District Court of Appeals issued a major decision affecting medical malpractice injury cases.

In the case of North Broward Hospital District v. Kalitan, the court held that the arbitrary caps on damages in Florida Statute 766.118 to be unconstitutional in medical malpractice injury cases.

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This decision was based in part on the Florida Supreme Court decision in McCall, et al v. United States of America which held that the caps were unconstitutional as applied to medical malpractice wrongful death cases.

The court further held that its decision was not limited to future cases but was also applicable to existing cases.
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The Da Vinci Surgical Robot, manufactured by Intuitive Surgical, Inc., is used in several medical specialties including: Urology, Gynecology, Cardiothoracic, Colorectal, Head & Neck, and General Surgery. Specifically, the Da Vinci Surgical Robot has been used for hysterectomies, prostate removal surgeries, gastric bypasses, gall bladder removals, and thyroid cancer surgeries. Unfortunately, numerous Da Vinci Surgical Robot procedures have led to lawsuits claiming patients have suffered serious life threatening injuries, and in some cases death. Said injuries include, but are not limited to, the following: peritonitis, sepsis, bleeding, perforated/punctured blood vessels, organs or arteries, burned/torn intestines, bowel injuries, bladder and ureteral injuries, and vascular injuries.
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The Da Vinci Surgical Robot was designed as a minimally invasive way for surgeons to perform certain surgeries. One of the primary benefits was its ability to provide surgeons a greater range of motion with the use of a joystick-like control. However, compared to surgery performed by hand, many physicians are uncertain as to the benefits of the procedure. Specifically, the Da Vinci Surgical Robot has many significant disadvantages. Primarily, the sensory feedback upon which surgeons rely is gone. The Robot cannot discern whether body parts are firm, bony, soft, or hard. Without this information, the wrong body part may be accidentally cut. Studies have indicated that on average the robotic surgery takes longer and subject patients are more likely to have post-surgical complications. Moreover, as a result of the Da Vinci’s modernistic approach, many physicians lack the required training, and are permitted to use the machine unsupervised after only a few training sessions.
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Fungal Meningitis is an infection of the protective membranes of the brain and spinal cord. Over the last few months, a deadly fungal meningitis outbreak has swept across the United States. Recently, both CDC and FDA investigations have established that the outbreak is directly related to contaminated epidural steroid injections produced by the New England Compounding Center (NECC), in Framingham, Massachusetts. The specific drug manufactured by NECC is a steroid called methylprednisolone. Currently, over 200 people across 16 states, including Florida, have been diagnosed with fungal meningitis linked to the contaminated injections. As of November there have been 23 reported deaths.

The symptoms of fungal meningitis include, but are not limited to the following: fever; headache; stiffness of the neck; nausea and vomiting; photophobia (sensitivity to light); new onset of weakness or numbness in any part of the body; slurred speech; increased pain; redness; swelling at the injection site; and/or altered mental status. According to the CDC, the onset of symptoms in most patients has occurred from one to four weeks after receiving the infected epidural injection. However, please note longer and even shorter periods have been reported.
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According to the New York Times article, “Doctors at Hospital Chain Giant Performed Unnecessary Cardiac Work, Increasing Profits”, from 2002 – 2010 cardiologists at several HCA-owned hospitals in Florida were unable to justify many of the procedures they were performing. Many of the allegations related to unnecessary cardiac catheterization procedures. The subject hospitals include, but are not limited to, Cedar Medical Center in Miami, Lawnwood Regional Medical Center & Heart Institute, and Regional Medical Center in Bayonet Point.

Specifically, at Lawnwood Regional Medical Center & Heart Institute, half of the cardiac catheterization procedures were determined to have been done on patients without significant heart disease. Currently the United States Attorney’s Office in Miami has requested information concerning the medical necessity of interventional cardiology services at 10 of HCA-owned hospitals.

It has been alleged that the aforementioned procedures were motivated by financial considerations. However, HCA denies said allegations and remains steadfast on its focus of quality patient care. Currently, it is not known how many procedures were performed, how many patients have died, or been injured as a result of the aforesaid unnecessary medical treatment. Nonetheless, it is apparent that the problems are widespread and reach beyond just one physician.

Ultimately, patients may suffer irreversible damage as a result of unnecessary cardiac catheterization procedures, and the longer patients wait to seek legal or medical aid, the more permanent and damaging the effects can become. If you have been the recipient of a cardiac catheterization procedure at a HCA-owned hospital in Florida during the last 10 years, and are suffering and/or experiencing any adverse health conditions, please feel free to call our Florida Cardiac Catheterization lawyers at David J. Halberg, P.A. for a free consultation.
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untitled.bmpOur Miami-Dade Drug litigation lawyers have been following the developments with regard to Pradaxa. Pradaxa was released in October 2010 with great fanfare. It is an anti-coagulant drug, or “blood thinner.” Pradaxa is typically prescribed by your doctor for the treatment of a heart condition known as atrial fibrillation, or “afib,” that is not caused by a heart valve problem.

Atrial fibrillation, or “afib,” is an irregular heartbeat. It is one of the most common irregularities involving the atria of the heart. With “afib,” blood does not flow properly from the atria to the ventricle of the heart. Since the blood does not flow properly, there is an increased risk for the development of blood clots, and consequently stroke.

To treat “afib,” your doctor may have prescribed Pradaxa for you. Pradaxa was, and is, touted as being a major advancement over other anti-coagulants, such as Coumadin, as it requires less monitoring of blood levels. Unfortunately, however, it appears to have come with a different set of problems.

Pradaxa has been linked to an increased risk of life-threatening bleeding. During the first (3) months it was on the market, the FDA received more complaints about it than 98.7% of other drugs. Further, during the first year it was on the market it has been linked to more than 360 deaths due to internal bleeding. As a result, on December 7, 2011 the FDA announced it was launching a safety review of Pradaxa, only (14) months after it came on the market!

One of the little known facts about Pradaxa is that, unlike with other anti-coagulants such as Coumadin, there is no way to reverse its affect. In other words, there is no known drug or agent that can be administered to reverse the anti-coagulant effects of Pradaxa should bleeding occur, such as can be done with Coumadin.

Despite the FDA’s investigation of Pradaxa, there are several hurdles to proceeding with a suit against its manufacturer. Among them, Florida has adopted the “learned intermediary doctrine.” This means that the manufacturer’s duty to warn of risks associated with a drug is directed to the doctor, not the patient. Nevertheless, the courts do recognize a cause of action brought by a patient on the basis that the manufacturer misrepresented information to the doctor, and the doctor relied upon the misrepresentation in prescribing the drug, such as Pradaxa, to the patient. See the court’s decision in Mardegan, 2011 U.S. Dist. LEXIS 89787.
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Our South Florida medical device litigation attorneys have been following the DePuy hip case implant developments closely. In August of 2010, DePuy Orthopaedics, Inc., a division of Johnson & Johnson, recalled its ASR XL Acetabular metal-on-metal hip implants. However, as early as 2009, the Food and Drug Administration notified DePuy that it was denying the company’s application to sell the implants domestically. Consequently, according to the New York Times article, “Hip Device Phaseout Followed F.D.A. Data Request,” it appears Johnson & Johnson executives initiated a product phaseout of DePuy ASR hip implants as early as 2009, in lieu of a complete recall, only weeks after the Food and Drug Administration requested supplemental safety data from the company.

In 2009, reports from countries outside the United States, illustrated the device was performing less productively and safely than data submitted by DePuy itself. On average, hip implants should last fifteen (15) or more years. Recently, research has surfaced indicating that DePuy’s hip implant failed up to 49% of time in the United Kingdom, and globally failed in patients within a few years of hip replacement. However, citing slow product sales, rather than factors related to safety, DePuy planned to phase out the hip implant globally by 2010.

Several design defects in the ASR hip implant can cause product failures, resulting in DePuy hip implants recall cases. Patients may suffer from “metallosis”, or metal poisoning. Metallosis is a condition associated with metal-on-metal implants. When metal-on-metal hip implants are used the two sides of the implant can rub together, and, in doing so, shed tiny metal particles shown to cause inflammation, soft tissue damage, and/or necrosis. Specifically, the ASR hip implant has cobalt and chromium elements which the Food and Drug Administration not only considers hazardous, but potentially carcinogenic. Other known problems include loose-fitting implants, friction transfer to the acetabulum, and hip implant dislocations. Moreover, design defects like the cobalt/chromium metal construction, shall cup depth, and exceptionally low angle tolerances can cause malfunctions leading to costly supplemental surgeries, known as “revision surgeries”, and/or additional hip replacements.

Presently, it is not known how many patients received ASR XL Acetabular metal-on-metal hip implant. However, according to the aforementioned New York Time’s article, in an eight year period, roughly 93,000 patients received the defective implant, one-third domestically. In Florida, cases are currently being filed that share factual issues surrounding whether DePuy is strictly liable for defectively designing and/or manufacturing the ASR XL Acetabular Hip System, and whether DePuy failed to provide adequate warnings concerning the device to consumers. See Barnes v. Bayside Orthopaedics, Inc., 2012 WL 162368 (M.D.Fla.). Ultimately, patients may suffer irreversible damage, and the longer patients wait to have the ASR revised, the more permanent and damaging the effects can become.

Strict liability in Florida extends to those in the distributive chain including manufacturers and other entities responsible for the sale of a prosthetic device. See Porter v. Rosenberg, 650 So.2d 79, 81 (Fla. 1995). Consequently, it is imperative to note that retailers, like manufacturers, can be held liable for injuries resulting from defective products. However, physicians are generally not subject to strict liability. Courts tend to treat healthcare providers akin to users as opposed to distributors. Moreover, in many product liability cases, including DePuy hip implants, choice of law rules may be a factor that needs to be considered. Under Florida law, a true conflict exists when two or more states have legitimate interests in a particular set of facts in litigation and laws of those states differ or would produce different outcomes. See Chapman v. DePuy Orthopedics, Inc., 760 Supp.2d 1310 (M.D.Fla. 2011). Choice of laws rules carry great significance, nor more than determining which state’s statute of limitations to apply. In Florida, the state has a four-year statute of limitations for product liability claims.
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