A recent court ruling will provide greater protections for passengers on cruise ships who are injured or suffer illnesses on board. On November 10, 2014, the United States Court of Appeals for the Eleventh Circuit found in Franza v. Royal Caribbean that passengers have the right to sue cruise lines for malpractice based on the actions of physicians and other medical professionals employed by these companies. For those who have been injured or have received substandard care on board a cruise ship, this ruling offers new hope for achieving a fair settlement. Consulting an experienced Houston personal injury attorney can provide the support these individuals and families need throughout negotiations and in the courtroom setting. Overturning Precedent The new decision overturns the precedent set by Barbetta v. S/S Bermuda Star, better known as the Barbetta rule, which provided immunity to cruise ship lines on the premise that passengers could not and should not expect an equivalent level of medical care and expertise on board as would be available on land. In recent years, however, many cruise ships have touted the abilities of their on-board medical staff as a selling point for their vacation packages. Modern medical advances have also increased the potential quality of care available on these vessels. These factors undoubtedly played a role in the ruling by the Eleventh Circuit Court of Appeals. For passengers who have experienced an injury at sea, the decision will open new avenues for pursuing compensation in the legal arena. The Case in Question Franza v. Royal Caribbean involved an injury to an elderly passenger on board the Explorer of the Seas, a cruise ship owned and operated by Royal Caribbean Cruises, Ltd. Pasquale Vaglio sustained an injury to his head while the ship was docked in Bermuda and was evaluated by the ship's nurse in the on-board medical center. The nurse failed to perform diagnostic scans and provided only minimal treatment; the on-board ship's doctor did not meet with Vaglio until almost four hours had elapsed since his injury. Due to this lack of ordinary medical care, Vaglio's serious injury went undiagnosed and he died approximately a week after the incident. Vaglio's daughter, Patricia Franza, sued Royal Caribbean in the Southern District of Florida; however, due to the Barbetta precedent, her case was dismissed. She then pursued her case to the Eleventh Court of Appeals. Far-Reaching Implications Injuries like the one that claimed Pasquale Vaglio's life are only part of the problem for cruise ship passengers. Outbreaks of illnesses have plagued cruise ship lines in recent years:
In the early hours of December 19, 2014, an oil rig fire and explosion in Oklahoma injured three workers, two of them critically, and killed two others. According to Sam Schafnitt, the Oklahoma State Fire Marshal's Chief of Operations, the rig was roughly two miles west of Coalgate, OK, and 100 miles southeast of Oklahoma City when the accident occurred. After the fire was extinguished, Occupational Safety and Health Administration (OSHA) investigators began trying to clarify exactly what caused the incident. Neither the employer, Dan D. Drilling, nor Pablo Energy, the Texas company that owns the rig, were available for comment. The victims are expected to seek representation by an oil rig accident attorney to protect their rights. Dangerous and Hazardous Employment The deadly Oklahoma oil rig explosion illustrates that oil rig workers have one of America's most dangerous and hazardous jobs. They typically work with highly combustible materials under dangerous conditions for 12 hour shifts that may continue for up to 14 days straight. Rigs are typically stationed several miles offshore, and although the Coast Guard is available to assist in emergencies, they are not close by. If the crew must abandon the rig, they do so using watertight life pods that are lowered into the water and can accommodate up to ten crew members. Once off the rig and in the water, the workers must wait for help to arrive. In a 2010 explosion in the Gulf of Mexico, a rig called the Deepwater Horizon exploded 50 miles off the Louisiana coast. Although 115 workers were rescued, 11 died. In 2008, the Bureau of Labor Statistics reported that 120 workers in the oil and gas industry had lost their lives that year, 21 of whom died while working in the oil and gas extraction business which includes those who work on offshore rigs. This explosion released millions of gallons of oil and the resulting oil spills inundated beaches all along the Gulf of Mexico, causing millions of dollars in economic damages to coastal businesses. Infrequent Occurrences With Deadly Consequences Oil rig accidents occur infrequently, but when they do, the consequences can be severe. Serious incidents can kill oil rig employees quickly and cost oil and gas companies millions of dollars. According to Greg McCormack, Director of the Petroleum Extension Service at the University of Texas, the oil and gas extraction business is a hazardous business, even though catastrophic events are unusual. Smaller oil rig incidents are more frequent. The Minerals Management Service, which oversees offshore drilling, reported that during the first five months of 2009, there were almost 40 oil rig fires and explosions. Although these accidents were considered minor and caused no injuries, there is still concern that they even happened. A Risky Business Oil and gas extraction companies manage risk on a daily basis. A 2005 explosion killed 15 workers and injured many others at a Texas City, TX, refinery owned by the energy company British Petroleum (BP). OSHA has already issued millions of dollars in fines to BP, and David Michaels, Assistant Secretary for OSHA, points out that even incidents where no one is hurt are raising safety concerns because people could have been hurt. He added that OSHA is "very concerned that the oil industry is not making the investment needed to run these refineries safely and workers are paying for it with their lives." Meanwhile, Houston work injury lawyers together with work injury attorneys in other states defend the rights of those harmed or killed in oil rig accidents. Given that President Obama expanded U.S. offshore drilling and survey results collected by the Pew Research Center show that more than half of Americans support U.S. offshore drilling, oil companies would seem to have solid support. However, when serious accidents happen, opponents such as an injured party's oil rig accident lawyer are quick to point out that a lack of adequate safety measures is to blame for workers being injured or killed.
Charlie Chi, who founded and is president of OtisMed Corp., recently pleaded guilty to three counts of misdemeanor fraud during an appearance before U.S. Magistrate Judge Mark Falk. The charges were brought by a pharmaceutical lawsuit attorney after the 45-year-old Chi sent knee replacement devices to hundreds of surgeons across the United States even though he was aware that the items were not approved by the U.S. Food and Drug Administration. For his actions, Chi could receive a maximum sentence of three years during his sentencing, which is scheduled for March 18, 2015. A total of 218 of the knee replacements were shipped in September of 2009, including 16 in the state of New Jersey. Additionally, OtisMed pleaded guilty to felony charges for circulating adulterated medical devices across state lines. The company is being hit with felony fines and forfeitures that are expected to reach almost $40 million. OtisMed must also pay some $41.2 million as settlement for civil litigation brought by a class action lawsuit lawyer because the company filed bogus claims to Medicare and other government insurance agencies. The settlement also forces OtisMed out of any federal health care programs for the next two decades. New Jersey drug lawsuit attorney Paul Fishman held a press conference after OtisMed's guilty pleas. He stressed the vulnerability of people who are seeking medical care. Fishman said that these patients were suffering and fearful, and they must be able to have faith that their doctors are using equipment that has met the FDA's standards for safety and effectiveness. He said that the public's trust was betrayed by Mr. Chi and his company. According to Fishman, the $80 million fine is nearly three times the total amount of revenue received by OtisMed for all of the cutting guides that the company sold. In a 40-month period between 2006 and 2009, OtisMed sold over 18,000 OtisKnee cutting guides that surgeons use while performing knee surgeries. Those sales generated revenue totaling over $27 million. The guides are supposed to assist in making accurate bone cuts for implanting prosthetic knees. OtisMed was purchased by Stryker in 2009. According to prosecutors, at the time, Stryker did not know about Chi's actions, and Stryker cooperated fully with the OtisMed investigation by the Justice Department. Stryker fired Chi not long after acquiring his company. Federal prosecuting attorneys claimed that Chi distributed the cutting guides despite objections by OtisMed lawyers and two other executives. The devices were being shipped a week after they were denied approval for distribution in the United States by the FDA. The prosecutors were not able to estimate how many of the cutting guides did not perform as expected. OtisMed's application to avoid testing the cutting guides was rejected by the FDA because the new guides were not substantially equivalent to an already existing device. To make matters worse for Chi, he allegedly held a conference call with OtisMed executives to discuss how to distribute the remaining inventory. He suggested moving them to a remote site, shipping them via his personal FedEx account and falsifying the shipping dates. Stryker executive Richard Adrian filed a whistleblower complaint against OtisMed under the False Claims Act that permits people to sue companies on behalf of the federal government. For his efforts, Adrian received a $7 million payment from the settlement fines. Health officials brought regulatory action against OtisMed in 2013. They warned that using the cutting guides could cause numerous problems for patients, such as instability of the joint, a reduction in mobility and the loss of motion or osteolysis. Any of those complications could necessitate revision surgery to fix the problem.
Cleaning up oil spills may cost companies that are responsible for them more money now that the United States Department of the Interior's Bureau of Ocean Energy Management (BOEM) has increased the liability limit from $75 million to $134 million. That is a 79 percent increase and the highest amount that it can be raised to without Congress stepping in and changing how the legislation is written. However, this increase, which was proposed in February and will take effect in January, is good news to every offshore injury lawyer who represents injured offshore workers as a result of these types of incidents. "BOEM is taking an important step to better preserve the 'polluter pays' principle of the Oil Pollution Act and further promote safe and environmentally responsible operations," said Walter Cruickshank, the organization's acting director, in a statement. "This is needed to keep pace with inflation, which has increased 78 percent (since 1990)." Strangely, the Oil Pollution Act's liability limit is supposed to be readjusted every three years to keep pace with the inflation rate, but this has not been done since it was signed into law in 1990 with two exceptions, an increase in 2006 that only applies to tankers carrying crude oil and one earlier this year that relates to spills coming from onshore setups. Fortunately, BP waved this cap as it related to the company's role in the Deepwater Horizon oil spill in 2010. The organization may end up responsible for tens of billions of dollars in payments to affected residents, cleanup work, fines and legal settlements with Jones Act attorneys and their clients. However, companies responsible for these types of spills in the future may not wave this cap, which is why many are seeking to raise the limit to a significantly higher figure than $134 million. Repeated efforts had been made to increase the cap in the immediate aftermath of the Deepwater Horizon incident, but politicians could not agree on exactly where to place the limit, and no change was made. Many felt that the cap should be removed entirely while others believed that doing so would result in companies with fewer resources no longer being able to compete in the industry. However, politicians were able to pass legislation in a much timelier manner following the Exxon Valdez oil spill in 1989 as the Oil Pollution Act became law a year later. That piece of legislation's limit on how much money these companies are responsible for only applies to economic damage claims from affected organizations and every oil rig accident attorney who represents them. There is no limit to how much is spent cleaning up the spill. Also, the liability limit is removed entirely if the spill was the result of willful misconduct, gross negligence or a similar reason. One senator, Ed Markey, is going to continue to work on what he hopes will be the next step. "The Obama administration has now done what it can under the law to raise the liability for oil spills, and it is up to Congress to take the next step to hold oil companies fully accountable when they spill oil," Markey said in a statement. "We learned from the BP disaster that the fines and liabilities oil companies face for safety and spill violations amount to slaps on the wrist when compared to the damage they cause and the profits these companies keep." In 2010, BP started providing live broadcasts of the Deepwater Horizon spill to the general public after a congressional subcommittee chaired by Markey demanded it. Live video of the spill had only been available to a select few for 23 days prior to that point.
As suspected, a November 15 chemical plant accident in La Porte, Texas, could likely have been prevented if the proper inspections, equipment repairs and maintenance had been performed. The incident, which occurred at a DuPont chemical plant and resulted in four fatalities, involved the accidental release of methyl mercaptan, a highly flammable gas that is stored as a liquid but vaporizes at room temperature. In his testimony before Senate committees overseeing environmental and labor issues, U.S. Chemical Safety Board chairman Rafael Moure-Eraso reported the findings of inspectors who were sent to the plant immediately after the incident occurred. In news that is sure to cause raised eyebrows among Houston industrial accident lawyers and others whose work involves chemical plant disasters, it appears that a number of violations are to blame for the tragedy. According to Harris County medical examiners, the four workers perished due to asphyxiation. Based on the inspection's findings, here is how things most likely unfolded: When workers attempted to restart equipment in a multi-story part of the building, a clogged pipe leading from a methyl mercaptan storage tank forced the poisonous gas into nearby vents. The ventilation system has a history of problems concerning the buildup of liquids, and workers opened a valve in an attempt to drain it. Upon doing so, methyl mercaptan poured out. DuPont has gone on the record confirming that this is the most likely scenario. It is believed that more than 23,000 pounds of methyl mercaptan and, possibly, other chemicals, were released. Because methyl mercaptan vaporizes at room temperature, it immediately filled the enclosed building. Ventilation fans were not working at the time, and this undoubtedly exacerbated the problem. Still, even if they had been working, it is unclear whether it would have made a difference. What is clear is that although respirators are available in the facility, their use is not enforced. Workers routinely go without them, and that is what happened on the day of the tragedy. If the workers had been using them, their odds of survival would have been significantly improved. DuPont is one of the largest chemical manufacturing companies of its kind, and it is generally regarded as one of the safest. Despite that, the La Porte plant has a long, troubled history regarding workplace safety. It was cited at least 25 times for state law violations, for instance, and the EPA has reported the facility to be non-compliant with crucial air emission and hazardous waste management standards. The agency has fined DuPont upwards of $100,000 for these issues. As previous reported, the DuPont plant in La Porte had gone seven years since its last OSHA safety inspection. Tragically, if an inspection had been performed more recently, there is a good chance that this Houston wrongful death in industrial accident incident could have been avoided. The men who were killed in the DuPont chemical plant accident were trying to escape. In fact, one came back in an attempt to rescue his brother, and he ultimately perished too. One worker escaped and recovered after being hospitalized. The surrounding area was deemed safe by inspectors, but that does not lessen the magnitude of this tragedy. The fact is that workers had reported ongoing maintenance problems and had complained numerous times about inadequate ventilation in the building. Still, DuPont took no steps to address these concerns, and it all came to a head on November 15. Without Houston industrial accident lawyers, incidents like these would occur even more frequently. Workers who are injured or killed in such incidents are more than statistics. To prevent similar accidents in the future, companies like DuPont must be held accountable. Clearly, based on what happened on November 15 in La Porte, we still have a long way to go.
The U.S. is experiencing a boom in oil production, but the poor condition of railroad cars used to transport crude oil to refineries has led environmental groups to sue the U.S. Department of Transportation (DOT) over its regulations. The tanker cars are old and weakened, resulting in ruptures and an increasing number of explosions; the worst thus far occurred in Quebec in 2013 with 47 deaths. The DOT has proposed improvements, but the oil and railroad industries are pushing back, and environmental groups want more. Meanwhile, FELA attorneys, acting under the Federal Employers' Liability Act, are working to protect railroad employees who must carry out their jobs amid dangerous conditions. In 2008, the DOT reported transportation of 9,500 railroad carloads of crude oil throughout the U.S. By 2013, that number rose to 415,000. The oil-rich Bakken area of North Dakota is responsible for a large portion of increased domestic production, and the benefits to industries and consumers are undeniable. Yet the Transportation Department warns that Bakken oil is more combustible than other crude oil -- a claim the oil industry denies -- and the DOT-111 tanker cars carrying it are not design or in the best condition to do so safely. Increasingly deadly consequences prompted two environmental groups to file a petition in July of 2014, calling for an emergency order to stop use of DOT-111 rail cars for transporting Bakken oil. The DOT did not respond, and Earth Justice filed a lawsuit in September on behalf of the Sierra Club and Forest Ethics. The DOT denied the original petition two months later. All stakeholders agree that replacing the railroad cars is necessary, but disagreement surrounds proposed timelines; safety regulations for new tankers; which group will pay for updates; and even the speeds at which trains should travel through populated areas. The effects on industry, residents and the environment are well noted, but there is little discussion about at-risk railroad employees who transport the volatile substance. Train accident attorneys are following ongoing developments in order to best defend their clients who are injured. One major issue is the Transportation Department's two-year timeline to phase out the old rail cars; they may also allow six years for deployment of brand new models. Environmental groups believe that is too generous and that it will put towns and cities near railways at risk. Yet the oil industry wants at least seven and as many as 10 years for replacements, saying that anything faster could affect overall production and cost consumers billions. The American Petroleum Institute says it can only replace 6,400 rail cars each year out of 68,000 needed. The Association of American Railroads (AAR) wants more time as well but disagrees with the American Fuel and Petrochemical Manufacturers, representing refineries, about various safety measures. One disagreement involves the thickness of tankers' outer shells, and the arguments exist over a 1/16-inch difference. Meanwhile, the railroads want the oil companies to pay for the changes, and the oil companies want the railroads to pay. Either way, the costs will eventually reach consumers. There is also disagreement about rail speeds in urban areas. Railroads voluntarily slowed to 40 mph from 50 mph near cities, but experts believe 30 mph is safer. At that speed, the AAR says that lost time and lowered capacity would cost too much, and they also fear losing business to trucking if speeds are reduced further. The increasing number of tanker explosions put railroad employees and residents near railways at the most risk. Ongoing agency and industry disagreements delay safer conditions, and while the DOT lawsuit may help, resolution will still take time. A railroad worker injury lawyer can assist any affected employee in the mean time, and members of the public can also seek specialized legal representation.
As any doctor or prescription drug lawsuit attorney can tell you, medications can be especially dangerous for pregnant and breastfeeding women. As a result, in December 2014, the U.S. Food and Drug Administration (FDA) announced that it would require drug manufacturers to explain the risks of their products in three categories: pregnancy, lactation, and male and female reproduction. Before this FDA decree, drugmakers would give each of their products one of the following ratings to denote the riskiness for pregnant and lactating women: A, B, C, D, or X. The trouble with that system, however, is that many consumers found those letters to be all but meaningless. Even knowledgeable buyers might not have understood the difference between, say, a drug marked "C" and one classified as "D." What's more, this system was too simplistic; it prevented people from being able to weigh a medication's benefits against its dangers. Under the new arrangement, a drug label's pregnancy section will describe all of the ways in which that medication could affect a woman and a growing fetus. The label will also direct consumers to any registries that have additional information on the drug and its effects. Previously, the FDA recommended that drugmakers provide the names of such registries, but it did not make doing so a legal requirement. For its part, the lactation section will describe how a medication could alter breast milk and the effects that the modified milk could have on a baby. Furthermore, the pregnancy and lactation sections will supply the results of the drug's animal and human tests. The reproductive section will explain how the drug could impact fertility, birth control measures, and even the accuracy of pregnancy tests. Drug labels have long included information on reproductive perils, but the placement of those warnings varied from medication to medication. By contrast, the positioning of these facts will now be uniform and easy to find. Consequently, many more people will read those details. When it announced this ruling, the FDA also issued a draft of a document that explains to pharmaceutical companies exactly how to format their new labels. Drug manufacturers were assigned a period of 60 days to review the directions and submit suggestions and criticisms to the FDA. The agency will scrutinize the feedback, make adjustments as it deems appropriate, and then release a final and binding version of the guidelines. Ultimately, the instructions are set to become law on June 30, 2015. This verdict has been a long time coming. In May 2008, the FDA began to review the issue of medication labels for women who are pregnant and breastfeeding. At that early stage, the agency proposed many of the guidelines that appeared in its 2014 decision. Moreover, this ruling is far-reaching given that American women take an average of three, four, or five drugs when they are expecting. Some of those medicines treat chronic conditions such as diabetes or asthma. In other cases, women take prescription medications to deal with problems that arise during pregnancy or lactation. Back pain is a common result of being pregnant for instance. As a result of this FDA resolution, it is likely that many healthcare providers across the country will reassess the medications that they prescribe for pregnant and breastfeeding women. However, it is important to remember that even when a drug company places an accurate warning label on a certain product, it could nevertheless be legally responsible for any harm that the drug causes. Therefore, in the future, it will still be important for you to contact an injury from prescription drugs lawyer or a class action lawsuit attorney if a medication causes you to suffer in any way.
Houston industrial accident lawyer Brad McClellan noticed something peculiar about the people seeking legal representation in cases involving workers' compensation benefits. The vast majority of those people were black or Hispanic, which made the attorney wonder if the workers were dealing with discrimination as well as on-the-job injuries. The Houston refinery accident attorney became curious to know if the state of Texas kept statistics on how minorities were handled. McClellan said that he thought minorities received harsher treatment during the workers' compensation dispute resolution process. He contacted the Texas Division of Workers' Compensation. The e-mail response stunned him. It said that there was no way to know if minorities were treated differently when they applied for benefits or became embroiled in disputes over their eligibility for benefits. The agency has not kept meaningful statistics on the race or gender of people with valid injury claims, called compensable injuries, despite a 1993 statute requiring them to do so. The agency acknowledged their records regarding gender and ethnicity were "inaccurate and incomplete." In fact, there is not even a field in the electronic application forms for the applicant's race. If applicants do not disclose their race, the claim will not be rejected nor will the approval process be stopped. If an employer or the injured worker does provide information on their gender and race, said a spokesman, the agency keeps it. However, that occurs infrequently. This situation has compelled state Rep. René Oliveira, who is chairman of the House Business & Industry Committee, to demand that the Texas Division of Workers' Compensation must compile such data as quickly as it can. This is the second time recently that the agency has not fulfilled its obligations under Texas law. Last summer, it was discovered that nobody was manning the phones at night for the 24-hour safety hotline. The agency said it had recently staffed the toll-free hotline around the clock. Oliveira said he intends to find out if any other required tasks are being ignored. He said he was disappointed that the agency was ignoring its legal obligations even if the tasks are challenging. McClellan said that data provided to him showed that when the law requiring the agency to keep records first was enacted, most of the claims mentioned the race and gender of the claimants. Now, less than 10 percent of claims contain the required data. In 2013, a study by the U.S. Bureau of Labor Statistics showed that Hispanics were more likely to die in a chemical plant accident or other on-the-job incident. Their unfamiliarity with English and American safety rules makes them more susceptible to accidents. Mary Vogel, the executive director of the National Council for Occupational Safety and Health, said that gathering racial data is crucial to their ability to put resources in the right places so that they do the most good. Texas is the only state in the U.S. that does not force private employers to offer workers' compensation or another form of coverage for workplace injuries. That is why Hispanic laborers are forced to go to emergency rooms if they suffer a work-related injury. Emily Timm is the deputy director of an Austin advocacy group for low-income employees called the Workers Defense Project. She said that some employers try to dissuade undocumented employees from reporting accidents. They falsely tell the workers that they do not qualify for the coverage. Bill Hammond, the CEO of the Texas Association of Business, said he was not aware that undocumented workers were pressured to not file injury reports. However, if that is the case, his group would actively try to stop it from happening.
The Fifth Circuit Court of Appeals of the United States upheld the verdict reached by the Western District of Louisiana in the McBride v. Estis Well Service LLC case, which stated that Jones Act attorneys may not seek punitive damages in cases determined by the Jones Act. The only recovery available to a seaman is for actual financial losses incurred due to the unseaworthiness of a vessel or drilling platform. The case was based on an accident that happened on Estis Rig 23, which was a barge containing a truck-mounted drilling rig in the Louisiana navigable waterway Bayou Sorrell. The truck fell over and killed Skye Sonnier. Crewmembers Saul Tochet, Brian Suire and Joshua Bourque were injured in the accident. Offshore injury lawyer Haleigh McBride filed a case for Sonnier's minor child claiming the rig was not seaworthy according to maritime law and that Estis Well Service LLC was negligent under the Jones Act. The action sought compensation and punitive damages from Estis, who owned and ran the rig and employed all four crewmembers. The injured crewmembers filed similar suits against Estis. When the cases were combined, maritime lawyers representing Estis sought to have the claims dismissed because punitive damages are not available in cases based on unseaworthiness or Jones Act negligence. The motion to dismiss was granted by the District Court, which disregarded the punitive damage claims. In the appeal, the Fifth Circuit Court of Appeals was asked to determine if the U.S. Supreme Court's decision in the case of Miles v. Apex Marine Corp. was valid and would be a precedent for the case against Estis. The Supreme Court decided that compensation was confined to pecuniary losses under general maritime law and the Jones Act. The crewmembers' attorney claimed that in Atlantic Sounding Co. v. Townsend, the Supreme Court heard a seaman's claim for punitive fines because the employer did not keep the equipment safely maintained. The court also held that the reasoning behind the decision in Miles was legally sound, and the Townsend case was clearly different. The Fifth Circuit Court of Appeals also decided that the Supreme Court's application of general maritime law and the Jones Act in particular in the Miles case were based on good law and could be applied to the wrongful death and personal injury case brought by the crewmembers of the Estis rig. It also held that pecuniary loss compensation is meant to make the plaintiff whole and that punitive damages were designed to punish the defendant for gross misconduct. The ruling meant that punitive damages do not fall under the category of financial losses and are not allowed under an unseaworthiness case based on general maritime law. Furthermore, there had been no other claims in which punitive damages were found to be pecuniary. For those reasons, punitive damages were deemed unrecoverable in the wrongful death and personal injury cases brought by the Estis crewmembers under general maritime law and the Jones Act. Six judges dissented. Circuit judges Stewart, Dennis, Barksdale, Prado, Graves and Higginson maintained that since punitive damages were obtainable under general maritime law prior to the passing of the Jones Act and since the Jones Act does not deal with unseaworthiness and does not limit its remedies, the option to sue for punitive damages should be available until Congress passes legislation stating that punitive damages should no longer be applicable under the Jones Act. Clearly, the Jones Act has had ramifications that were unforeseen when it was passed. Until Congress acts, however, the federal district courts will be making decisions based on the Supreme Court's verdict in the Miles v. Apex Marine Corp. case.
The U.S. Food and Drug Administration (FDA) recently approved the first extended-release, single-entity hydrocodone pain medication with anti-abuse properties. Hysingla ER, produced by Purdue Pharma L.P., meets the FDA requirements for abuse-deterrent opioids. As any drug lawsuit attorney can attest, opioid abuse is a major problem. According to the Centers for Disease Control (CDC), fatalities linked to prescription painkiller abuse have risen to 17,000 per year in America, and the FDA is under pressure to take action. The administration approved a similar extended-release opioid called Zohydro last year, but the move was met with criticism because Zohydro lacks anti-abuse safeguards. Law enforcement officials and anti-addiction groups felt the drug should have been reformulated before its approval. Making Drug Abuse a Bigger Challenge In contrast with its competitor, Hyslinga ER has features that are expected to reduce the potential for abuse. The tablets are hard to break, dissolve and crush. Because they form a viscous, thick gel upon contact with fluid, it is difficult to prepare Hyslinga ER tablets for injection. While its chemical and physical traits make abusing Hysingla ER a challenge, they do not totally prevent it. Whether by deliberate misuse or accident, taking too much of the drug can cause a potentially fatal overdose. Opioid Therapy Basics Opioids are synthetic narcotics that produce opiate-like effects in the body and brain but are not derived from opium. Hydrocodone, a derivative of codeine, is the most commonly prescribed and abused opioid in America. The drug relieves pain by changing the way the brain and central nervous system respond to it. Traditionally, hydrocodone has been included in combination formulas such as Vicodin and Lorcet that also contain non-narcotic pain relievers like acetaminophen. Doctors prescribe combination drugs to treat pain from a wide variety of sources including migraines, arthritis, surgery and dental procedures. Some medical experts argue that because of their addictive properties, opioid-containing drugs should be reserved for patients in extreme, intractable pain such as those receiving end-of-life care or treatment for advanced cancer. Appropriate Use of Hysingla ER Unlike its popular predecessors, Hysingla ER contains a single narcotic component in a higher concentration. The FDA approves the drug for management of daily, long-term, around-the-clock pain control and in situations where other drugs fail to provide adequate relief. It is also appropriate for patients who cannot tolerate alternatives. Given the smaller but still significant risk of addiction, Hysingla ER should not be used on an as-needed basis or for short-term, minor pain relief. Drug Facts and Side Effects Hysingla ER's generic name is hydrocodone bitartrate. Available strengths range from 20 to 120 milligrams to be taken every 24 hours. Patients who have never taken opioid medications before should not be given more than 60 milligrams per day. Compared to immediate-release combination drugs, Hysingla ER contains larger amounts of hydrocodone, but the range of dosage strengths is comparable to that of other opioids. The drug's safety was tested in a clinical trial involving 905 people with chronic lower back pain. Additional laboratory studies supported the effectiveness of Hysingla ER's abuse-deterrent features. The most commonly observed side effects include nausea, fatigue, constipation, dizziness, headache, drowsiness and upper respiratory infections. Will Hysingla ER Really Help Deter Opioid Abuse? Time will tell whether the new drug will reduce opioid addiction and overdose fatalities, or become another familiar name to the experienced pharmaceutical lawsuit lawyer or class action lawsuit attorney. Post-marketing studies to evaluate the effectiveness of Hysingla ER's anti-abuse features and the drug's overall impact on community drug abuse risks are part of the FDA's requirements. Hysingla ER is also part of the ER/LA Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS), which provides education and resources to help healthcare professionals prescribe and handle opioid drugs safely and responsibly.