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The Food and Drug Administration (F.D.A.) has posted a notice that Affymax and Takeda Pharmaceuticals have recalled their drug, Omontys, or peginesatide, designed to treat anemia. It has received 19 reports of a severe allergic reaction, where three patients died and others required medical intervention. The pharmaceutical companies have explained that hypersensitivity to the drug has been shown for 2 of every 1000 patients, and that the reactions have occurred upon the first dose. Those patients who have had more than one dose have not had an allergic reaction.

Prescription pharmaceuticals must undergo a development and approval process by the F.D.A. Before a drug goes on the market for sale, the company must test the product and provide the results of the test to F.D.A.’s Center for Drug Evaluation and Research. The drug must be shown to be safe and effective for its intended use. Benefits must outweigh the possible risks. The F.D.A. does not test the drug itself, it only looks at the data provided by the company. However, as discussed recently on this blog, some companies, like Celebrex, have withheld information from the public and the F.D.A regarding the effectiveness of their drug.

A patient who was harmed by a medical device or drug can find legal relief in Florida for the injuries suffered from a defective product. Knowledge of the testing practices and the science behind the creation of the drugs is essential in a successful civil action. Witnesses providing testimony in such a specialized field must have a background that shows they can competently testify about the subject matter. An experienced litigation attorney is needed to deftly challenge a drug company witness’s ability to testify about the testing method and what is considered safe in the industry.

Proving what compensation is needed can also be tricky and require specialized medical knowledge. Often, a defective medical product exacerbates an already present medical problem and someone who can pinpoint how an adverse reaction, like anaphylaxis, occurred and why it occurred is crucial. This type of testimony can influence how much compensation is awarded for past and future medical bills, past and future lost wages from missing work or the inability to return to work, loss of enjoyment of life, and past and future pain and suffering.

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The “wage theft” Miami-Dade County ordinance, enacted in 2010, has entered the national spotlight as an example of local legislation created to solve a problem that plagues much of Florida and other states around the country. The program was created to help employees recover funds that are owed by employers for a number of reasons. It is designed to especially aid those who exist on the fringes of society, excluded by a language barrier or illegal resident status.

The ordinance requires a minimum amount of $60 of unpaid wages to file a claim. The maximum amount of recovery in a claim for lost wages is three times the amount of unpaid sums plus administrative costs. Often, this recovery is used as a negotiating “stick” to influence the employer to pay the wages owed to the employee without a formal hearing. However, if a hearing is required it can take quite a bit of time to actually be held. Wronged employees may also use other alternatives to pursue their claims through civil action in state or federal court. These claims cannot be filed simultaneously with a local wage theft claim.

Part of the reason the local ordinance exists is because of lax requirements imposed on Florida’s employers at the state level. Florida no longer has a Department of Labor and has very low unemployment benefits. Generally, if wages are to be recovered it would be through a workers’ compensation action for lost wages due to an injury or death on the job.

Workers’ compensation is insurance coverage mandated by the state of Florida, designed to help workers receive much-needed financial assistance for the employee or employee’s family to pay for hospital bills, basic living expenses, education for a new field of employment, or funeral costs. Lost wages are calculated by looking at the average weekly wage the employee was making at the time of the injury or death causing accident. This number is calculated with a few multipliers set by the government, including an impairment rating. An injured employee must be seen by a doctor or therapist in an independent medical examination where an assessment is made determining whether the employee is partially or totally disabled, and whether this is temporary or permanent disability. Consideration is also given for the psychiatric stress caused by an accident.

An injured Florida employee is unable to file a personal injury suit against an employer when there is workers’ compensation since the employee with a qualified injury is guaranteed a type of recovery, dissolving the need for other avenues of legal relief. However, an injury may also be caused by the negligence of a 3rd party who is outside the workers’ compensation immunity or by a defective product made by a negligent company. An injured employee or their family may then file a personal injury or wrongful death action in Florida’s state or federal court.

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Recently in Florida, three people were shot while walking in an apartment’s public space by an unknown number of suspects. Two of three died from their injuries and one remained wounded. The apartment is in a gated residence. Crime in apartment complexes or other public spaces are common, and accountability and relief does not just come from the perpetrator of the crime, but from the owner of the premises.

A landlord can be held liable for a crime that occurs on his or her property by a third party if the crime is considered foreseeable and if the crime would have been considered preventable, had the owner put certain precautions in place. Much of the liability hinges on the relationship of the owner to the person injured on the property. If the injured party was a tenant or a guest of the tenant, or someone else invited onto the property by the owner, then the landlord has a duty to maintain a reasonably safe condition. They must also warn of any dangers that these same parties may not know themselves. However, if the people on the property were not invited, then the landlord does not have a duty to guard against third party crimes.

Florida courts have considered what is foreseeable. If other prior crimes of a similar nature have occurred on the premises, then that type of crime is considered foreseeable. (See Prieto v. Miami-Dade County, 803 So. 2d 780 (Fla. 3d D.C.A. 2001)). Also, if the area is a “high crime” area, where similar crimes occurred in temporal and geographic proximity to the apartment, then liability for a crime on the premises could be created.

Some Florida courts have extended beyond similar crimes or crimes that have occurred in a specific geographic proximity. The Fourth District Court of Appeals has allowed evidence of dissimilar crimes and the Third District allowed evidence of crimes in an area outside of the premises so long as they weren’t ‘substantial distances away’. (See Holiday Inns, Inc. v. Shelburne, 576 So. 2d 322, 331 (Fla. 4th D.C.A. 1991) and Lomillo v. Howard Johnsons Co., 471 So. 2d 1296, 1297 (Fla. 3d DCA 1985).)

Landlords are liable for accidents and injuries beyond criminal acts that occur on the premises. If an accident occurs because of damaged property or negligently maintained structures, then the landlord is also liable to any occupant or other invited guest. A landlord must maintain safe and healthy premises, and should not leave common spaces in disrepair. Poorly lit hallways or slippery stairs may contribute to a fall which can lead to expensive medical care.

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News of the now-infamous Carnival cruise ship, Triumph, has filled Twitter accounts, web pages, and air waves with tales of long lines for food and failed toilets. Pictures of disembarked travelers kissing the ground wearing Carnival robes marked the end of five days at sea floating in the Gulf of Mexico, following an engine room fire that knocked out power. Analysts and talking heads assessed the likelihood of success for those who choose to sue Florida-based Carnival for their week-long ordeal, pointing to the signed contract attached to the ticket that limits where you can sue and the liabilities of the cruise ship company owners.A cruise ship ticket contract is generally considered enforceable so long as it is fundamentally fair. In Carnival Cruise Lines, Inc. v. Shute, 499 U.S. 585 (1990), the Supreme Court upheld a contract clause that limited all law suits to Florida. However, a cruise line cannot contract away all of its liability, especially when it comes to personal injury. An 11th Circuit Court of Appeals case that originated from the Southern District of Florida, (Johnson v. Royal Caribbean Cruises, Ltd., 802 F. Supp. 2d 1316, (S.D. Fla., 2011)), pointed to 46 U.S.C.S. § 30509, which prohibits the owner or agent of a vessel transporting passengers between a port in the United States and a port in a foreign country from including in a contract a provision limiting the liability of the owner or agent for personal injury or death caused by the negligence or fault of the owner or the owner’s employees or agents.

In that case, Royal heavily relied on contract law as grounds for a summary judgment against a passenger who injured herself participating in an onboard cruise activity. She signed up to use a surf and boogie board simulator and signed an “onboard activity waiver” that released Royal and its employees from any liabilities resulting from injuries. The passenger injured her ankle while attempting to do a maneuver on a boogie board, which was against the safety guidelines for that activity on the ship. The lower courts initially agreed with Royal, but the Court of Appeals reversed, stating that the passenger could still sue the company as the ship clearly met the requirements of a vessel described in 46 U.S.C.S. § 30509 and her injury was the result of Royal’s employee instructing her to perform an unsafe maneuver.

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Jack3d, which is sold at health stores in Florida and across the U.S., has been at the forefront of concern as one of several dietary supplements that contain dimethylamylamine, or DMAA. Several companies use the main ingredient DMAA in dietary supplements advertised to maximize your energy, concentration, and metabolism. Dietary supplements are not regulated by the Food and Drug Administration (F.D.A.) in the same manner as food or medications. Dietary supplements are required to only have “dietary ingredients” and must be shown to be safe before they are marketed.

In April 2012, the F.D.A. issued a warning letter to ten manufacturers and distributors stating that they failed to submit a notification that DMAA is being used in their product as a New Dietary Ingredient. 42 adverse event reports had been submitted to the agency with complaints ranging from cardiac to nervous system disorders. DMAA is known to narrow the blood vessel and arteries, raising blood pressure that causes shortness of breath to tightness in the chest to heart attack. Manufacturers of these dietary supplements still insist that their products are safe.

Following the F.D.A warning letters, Drug Testing and Analysis published the results of a study that showed the DMAA found in the dietary supplements was not from a natural source. On the list of ingredients, it is often listed as sourced from geranium, but the researchers found it was indistinguishable from the synthetic version of drug. This finding highlighted the long-running debate for greater regulatory oversight of supplements
The public spotlight has landed on the DMAA product Jack3d after two men in the armed services died after using their product. The Department of Defense went as far as removing all products containing DMAA for sale in stores on military bases. One soldier’s family has filed suit claiming that the companies deceptively marketed the product as safe for use and not warning consumers about the potential health risks.

The basis of the family’s complaint lines up with Florida’s punitive damages requirements, which can be available in wrongful death suits. In a wrongful death suit, the defendant party is held liable as the cause of the death. Those who qualify to sue may recover compensatory damages ranging from loss of wages to medical bills. To recover punitive damages, the defendant party must be found to have acted with gross negligence or intentional misconduct. A party can sue to recover up to two million dollars if they show that the defendant party was motivated by financial gain, and that the managing director, agent, or officer in charge of decision making was aware of the dangerous nature of the conduct.

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Four children and one adult driver had to be taken to the hospital near Miami, Florida after a driver crossed the center-line and hit their shuttle van head-on. Two children were ejected from the vehicle, but were in stable condition, one child’s condition was unknown, and the fourth child and driver remained uninjured. The driver claimed he was having a heart attack, but that was subsequently shown to be untrue.

While the victims in this recent accident quickly sought needed medical attention, other insured Florida car accident victims may not think they need, or can afford, medical services. The latest version of the Florida Motor Vehicle No-Fault statute, recently made effective at the beginning of 2013, substantially changed the laws regulating Personal Injury Protection (PIP). Foremost among the changes, is the mandate for those injured to receive initial services and care within 14 days of the accident.

Follow-up care is allowed, but must qualify under the statute. The new version of the PIP guidelines delineates the medical care providers that can perform the initial evaluation and treatment. Massage therapists and acupuncturists were explicitly excluded. Once that treatment is administered, then follow-up care related to the underlying condition is permitted.

The amount of coverage you receive under Florida’s new PIP laws will depend on whether the condition is considered an “emergency medical condition”. If it is, then you can receive up to $10,000. If not, then the maximum coverage is $2500. An “emergency medical condition” must be so serious that without immediate care, serious jeopardy to the patient’s health, serious impairment to bodily functions, or serious dysfunction of a body part or organ will occur. The previous statutory coverage also went up to $10,000, but allowed up to 80% of all reasonable expenses for medically necessary services, 60% of disability for any loss of gross income and earning capacity per individual from inability to work that was proximately caused by the accident, and 100% of replacement services like lawn care or childcare.

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Florida’s Fourth District Court of Appeals recently echoed a lower court’s ruling that prevented an injured Florida man from holding his employer directly liable for his construction accident injuries. Florida grants immunity to employers since employees are covered under mandatory workers’ compensation insurance. Workers cannot pursue personal injury claims against the employer unless they fall under the narrowly tailored exception. In this case, the court maintained that the worker did not show the employer knew of the danger from prior occurrences, that he himself was unaware of any dangers, and that the employer actively misled the worker of the project’s safety.

The worker was employed by a construction contractor who was installing a nine-ton wall on the day of the accident. Safe installation of that size of wall depends heavily on favorable weather conditions and cannot be performed if the wind speeds are too high. Prior to the accident, the installation had been delayed due to high winds over 20 mph. On the morning of the accident the winds were determined to be safe enough to proceed. Testimony from the general foreman and one of the crane operators differed from each other. The foreman testified that he radioed to the crew and informed them of 16-18 mph winds, but the crane operator recalled being informed the winds were 12-15 mph. The injured worker provided conflicting accounts, some indicating that he was concern with the windy condition, but didn’t know what it was and nonetheless relied on wind speed confirmation from the general foreman.

The Court looked to the last 13 years of case law and legislative action surrounding the immunity exception and pointed out that no employee has been able to show with virtual certainty that the employer committed an intentional tort. Since the Court had to view the case in a light most favorable to the employer, the employer only had to show that none of the elements of the immunity exception existed. The Court conceded that even if they accepted the worker’s version of the installation, the employer would only be grossly negligent and not liable for an intentional act.

Workers’ compensation benefits are determined by a calculation that factors in the worker’s impairment rating, the regular wage of the worker at the time of the accident, and the cost of medical care and related costs, among other things. Benefits are calculated with statutorily-created multipliers, and may be capped at 104 weeks. The amount of compensation can differ greatly depending on whether the worker is deemed temporarily disabled or permanently disabled.

A personal injury claim of the same or similar matter will likely calculate the same types of costs like medical care and lost wages. However, unlike worker’s compensation, the negligent party may also have to pay for pain and suffering or punitive damages, depending on the level of egregious behavior.

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At the beginning of this year, a crane collapsed in the Queens borough of New York City, injuring seven people. The crane greatly damaged the building project, but left the other completed part of the residential building complex intact. The crane belongs to New York Crane and Equipment Company, owned by Jimmy Lomma, who was recently acquitted for manslaughter following the deaths of two people caused by one of his cranes in 2008.

The crane operator and contractor were both recently cited for five violations in the collapse. The Buildings Department pointed to the operator’s attempt to lift more than double the acceptable load. The operator also couldn’t see what was being lifted and moved materials outside of the approved zone. This contrasts with the recent construction accident at South Florida’s, Miami Dade College, where the cause of the collapse is still unknown and under an investigation led by OSHA (Occupational Safety & Health Administration).

The college was forced to close their West campus to ensure the safety of the students after four workers were killed. Many things could have caused or contributed to the multi-level collapse of the garage floors. Investigators began their assessment with whether it was the construction procedures that were faulty, or if it was something defective in the design that led to the collapse. Other concern include whether an adequate system of checks and balances was used as the structure was built and whether the plans themselves were confusing, thus leading to defective construction.

Construction accidents are tragic, complex events resulting in either serious injury or death. As the South Florida investigation shows, it can take awhile to even figure out what occurred and why it occurred. A 2012 appellate case from the New York Court of Appeals (Admiral Ins. Co. v Joy Contrs., Inc., NY Slip Op 04670, 2012) assessed whether the insurance company of the ‘excess policy’ for additional insured under the comprehensive general liability policy was obligated to pay based on the contractual language of the policy that excluded residential buildings.

A tower crane had also collapsed and killed seven people, injured many more, and damaged several surrounding buildings on top of the one under construction. The Joy Construction Company was insured with standard comprehensive general liability coverage and had the excess policy through Admiral Insurance, which began to submit letters to Joy denying any obligation to indemnify for several reasons. One of Admiral’s claims before the appellate body was that they weren’t liable because the building was for residential use, and that type of building was excluded from coverage. They also focused on whether they were obligated to cover entities who were alleged to have misrepresented themselves or were structured as an LLC. Ultimately, the Court of Appeals thought the case should move forward as there were issues of material fact whether the building was a ‘mixed use’ unit, thus not exclusively residential and excluded from Admiral’s CGL coverage; and that the LLC status of the companies seeking indemnification didn’t bar coverage.

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The Miami Herald recounted a horrific accident that took the life of a Miami father, killed by a suspected drunk driver. One witness saw the victim being struck and thrown into the air, but still had the wherewithal to call the police AND follow the alleged offender’s car (despite attempts to throw the witness off). The victim’s family will never be the same as they grapple with the shock, horror, and grief from this tragic death.

Sudden loss of a loved one or witnessing a terrible death has an unimaginable impact on one’s life. No subsequent actions, including verdicts in the justice system, can ever replace a person or erase the event from history. Sometimes though, in the midst of a crisis, you need help to guide you through the bureaucratic and financial consequences of such a mired circumstance. Friedman, Rodman & Frank have aided others in their time of need, whether it was applying for social security benefit or making the other party take responsibility for the actions through a civil action.

4280 pedestrians were killed in 2010, according the National Highway Traffic Safety Administration. In Florida, between 2006-2010, 5,737 people died from an alcohol-related crash, and 15,635 were injured. The consistent number between 2006-2008 caused government officials to create the Florida Impaired Driving Coalition to examine what could be done to lower the number of injured and killed Floridians. They plan to reduce the 5-year average by 5% each year by improving DUI enforcement and prosecution, increasing DUI prevention training, and enhancing DUI impairment legislation.

With the rising accessibility of mobile devices, distracted driving has also become a concern for Florida’s Department of Transportation. The 2012 Strategic Highway Safety Plan chose to focus on distracted driving because 5,474 people were killed and 448,000 were injured as a result of distracted driving. A Georgia man was recently killed in Florida after he hit a distracted driver’s vehicle left in the middle of the highway. The distracted driver dropped her cell phone and attempted to pick it up, while driving. She flipped her car and exited the vehicle to call 911. The man hit her car, left his vehicle, and then was hit by an on-coming semi-truck.

While mobile phone use has been headline driving news, there are many other ways a driver can become distracted and cause an accident injury or death. Fatigue has been shown to be as large of an impairment as alcohol intoxication. Florida instituted the “Ronshay Dugans Act“, which dedicates the first week of September to educating law enforcement and the public about the hazards of driving while tired. Other educational programs and initiatives like “Put it Down” work to educate the public to change hazardous habits like texting while driving.

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The tragic wreck that killed 32 passengers and crew off the coast of Giglio, Italy, has led the cruise industry to create ten new safety policies. The main change is for passengers to undergo “muster drills”, or passenger emergency drills, before the boat leaves the dock, as opposed to within 24 hours of departure.

In 2011 there were 922,491 total vessels registered in Florida. 742 boat accidents were reported to the Florida Fish and Wildlife Conservation Commission. If you have been injured in a boating accident, whether it was a cruise ship or privately owned boat, contact the Florida maritime lawyers at Friedman Rodman Frank & Estrada, P.A. They have taken on several Florida-based cruise ship companies for injuries that have happened on and off board, and are here to help you, even if you live elsewhere.

The amount of chaos and confusion that resulted from the Costa Corcordia captain’s negligence is overwhelming. Passengers and affected businesses have filed suit against Costa Crociere’s parent company, Carnival Corp., which is based in Miami, Florida. Some have run into logistical problems, as many have already been turned away saying that the only forum available to file suit is in Italy. Carnival Corp., in turn, has alleged in other related civil suit documents that the passengers’ injuries are partially or wholly to blame due to their own negligence.

Carnival Corp., has had a large part in the history of forum clauses – clauses often printed on the back of tickets that says the purchaser agrees to settle a dispute in a forum that the ticket issuer has listed. In Carnival Cruise Lines, Inc. v. Shute, 499 U.S. 585 (1990), the U.S. Supreme Court ruled in favor of forum clauses that are not obtained by fraud or overreaching. In the underlying case, a couple from Washington state bought tickets to a cruise from Carnival Corp., based in Florida, that started in California and ended in Mexico. The wife sustained injuries when she slipped and fell on a deck mat while the boat was at sea off the coast of Mexico. The couple filed suit in her home state, and Carnival claimed that, per the forum clause, they had to file suit in Florida. The couple countered that they were physically and financially incapable of filing suit in Florida.

The lower, appellate court sided with the couple, agreeing that the couple would be denied their day in court, given their limitations, and that the forum clause was not “freely bargained for”. The Supreme Court disagreed, saying that it was a standard commercial clause, that Carnival Cruise Lines has the right to limit the forum for suit, and that this particular clause did not appear to discourage cruise passengers from pursuing legitimate claims. They did note, however, that all forum clauses are subject to scrutiny and should be fundamentally fair.

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