Houston medical device injury attorneys mention that Johnson & Johnson (J&J) put its Gynecare Prolift vaginal mesh product on the market in 2005 as an “innovative and effective surgical option” intended for prolapse repair. J&J decided (apparently unilaterally) the Gynecare Prolift product qualified as an exception to the regular FDA approval process on the basis that it was similar to a medical device called the Gynemesh Prolene Soft Mesh that had already been approved by the FDA. But the differences, in our opinion, greatly outweighed the similarities.
Our Houston medical device injury attorneys note that even when a product qualifies for the FDA’s expedited approval process because it is based on a “predicate” to which it is substantially equivalent, the maker of the product still should file a 510(k) application requesting the expedited approval. Morgan Liscinski, an FDA spokeswoman, said that the FDA had never heard of the Gynecare Prolift product until 2007 when J&J cited it as a predicate in the application for another product. While both products received FDA approval in 2008, the spokeswoman’s statement would indicate that J&J had not even filed a 510(k) application for the Gynecare Prolift before marketing it to unsuspecting women in need of pelvic prolapse repair.
Reportedly, the J&J application citing Gynecare Prolift as a predicate for Prolift+M said that the Prolift product represented an “insignificant” change from the approved Gynemesh Prolene Soft Mesh product that it used as its predicate.
But the Prolene Soft Mesh product was intended to repair hernias and other connective tissues, while the Prolift was intended to repair full pelvic organ prolapses. Our Houston medical device injury attorneys point out that the difference in magnitude between the problems addressed by the products is significant. The complexity of the two problems is significant. And the difference in magnitude between the complications that the two types of repairs could cause is significant. And while the Prolift and Prolene products were composed of the same non-absorbable polymer material, the Prolift product also included special pre-cut mesh sections and instruments for surgeons to use in implanting the product.
The FDA received 123 complaints about the Prolift product between 2005 (when J&J placed it on the market without approval) and May 15, 2008 (when the FDA cleared the medical device for market). Our Houston medical device injury attorneys emphasize that the FDA approval came in spite of the high number of complaints. Since then, hundreds more complaints, some involving fatal injury, have been tendered to the agency regarding surgical mesh in prolapse repairs.
J&J is facing hundreds of lawsuits involving the mesh product. The amount J&J may be required to pay to settle all these suits could well devour any profits the company made by stealthily marketing the product without FDA approval. So the strategy of putting profits before patient health concerns might reveal some severe flaws. Let’s hope other medical device makers heed the warning.
The FDA had noted a high incidence of complaints involving surgical mesh implants to repair pelvic organ prolapse some years ago. But 2008 guidance from the FDA indicated that the products were safe for use. Yet in 2011, the FDA re-examined its stance on transvaginal surgical mesh implants after finding a fivefold increase in injuries, complications, malfunctions, and fatalities tied to the products. In September 2011, an FDA advisory panel urged the agency to reclassify transvaginal surgical mesh implants as high-risk medical devices that required human testing in clinical trials prior to approval.
The FDA’s vacillation on the risks of medical device products, the ability of companies like Johnson & Johnson to slip high-risk products past the FDA and onto the market without approval, and the FDA’s conduct in approving products with a high number of complaints has raised questions about the efficacy of the FDA approval process. Some lawmakers, medical professionals, and consumer groups are calling for review of and change to the process to protect patients.
And a string of high-profile medical device product recalls has eroded public confidence both in the FDA oversight process and in the medical device market. Our Houston medical device injury attorneys remind readers that J&J has also been plagued by recalls of over-the-counter medications and artificial hip implant products. Three J&J units have recently pleaded guilty in cases involving bribery and/or the illegal marketing of drugs. And a fourth J&J unit agreed to plead guilty on a marketing charge.
The Houston medical device injury attorneys at Denena & Points have been following on this website the controversy over the FDA approval process and surgical mesh to repair pelvic prolapses. If a medical device product has injured you, contact us for a free and confidential legal consultation to learn your available options for a full financial recovery on the harm you’ve suffered. You can call us toll free at 877-307-9500 or use our online contact features to schedule your free consultation/case evaluation.
Galveston drug injury attorneys update their previous posting on the Qnexa approval debate. In a surprisingly one-sided 20 to 2 vote, an FDA advisory panel composed of medical professionals has reversed its previous rejection of the weight loss drug Qnexa due to safety concerns. The FDA panel contained 12 members from that earlier vote of rejection. 7 of those 12 had earlier voted against recommending approval of the diet drug Qnexa. 20 members of the current FDA advisory panel recommended FDA approval of Qnexa.
The FDA does not make its final decision on Qnexa’s application for admission to the U.S. marketplace until April. But our Galveston drug injury attorneys point out that the FDA usually follows the recommendations of its advisory panel. However, in 2011, the FDA significantly rejected another weight loss drug that had been recommended by its advisory panel. If the FDA follows the panel’s recommendation and approves Qnexa, Qnexa will be the first prescription weight loss drug the FDA has approved for the U.S. market since 1999.
Panel members and others interviewed for news reports about the panel’s recommendation seem to have based their approval primarily on the perceived need for more weight loss tools to address the obesity epidemic. It appears to our Galveston drug injury attorneys that the decision chooses to address the existing health risks from obesity at the expense of the potential health risks of the drug. Clinical trials of Qnexa showed heightened heart risks. In addition, women taking the drug experience a 2 to 5 times greater risk of producing babies with birth defects (primarily cleft lip and/or cleft palate).
The assurances of Vivus, Qnexa’s manufacturer, that it will conduct strict oversight regarding prescribing and use of the drug seems to have been sufficient to allay almost all panel members’ safety concerns. But at least one panel member was not hesitant to speak out about the drug’s dangers after voting “no.”
Dr. Michael S. Lauer, a cardiologist from the National Heart, Lung, and Blood Institute, cautioned strongly that the increased heart rate revealed in clinical trials of Qnexa is a warning sign of cardiac problems and could heighten the risk of heart attack in spite of the drug’s benefits. He stressed that other medical decisions taken on the basis of insufficient, but seemingly clear, evidence have later proven to be wrong at the cost of patients’ lives and health.
Vivus has said that it will take important steps to ensure the drug’s safe use, including:
Our Galveston drug injury attorneys emphasize that obesity is indeed a pressing health concern. About 36% of Americans are obese, with another 33% of Americans overweight. Approximately 5% of the nation’s population is morbidly obese. Obesity has been clearly shown to lead to diabetes and heart disease. Obesity is also thought to be a strong risk factor for osteoarthritis, dementia, stroke, and certain types of cancers.
But combating obesity and its related health problems with a drug that causes other health problems might not be the answer. The FDA panel recommended that Vivus conduct follow-up studies on the heart health of patients who receive the drug. If Qnexa does receive FDA approval, the expected widespread use of the drug should quickly show whether the panel’s balancing of health risks and benefits represented a correct choice. If they were wrong, sadly the data will come at the expense of patients’ lives and health.
For more information on Qnexa and its potential side effects, see our Galveston drug injury attorneys’ previous article discussing the Qnexa safety issue.
Our Galveston Jones Act lawyers have written before on the history behind the Jones Act. A central focus of the Jones Act is to ensure that a seaman has a seaworthy vessel in which to do his or her work. Under the Jones Act, “seaworthiness” can be read as “safety.” The Act intends to ensure the seaman’s safe working conditions.
Under the Jones Act, “seamen” covered by the Act are those employed in service of a waterborne vessel. Jones Act coverage does not limit itself to merchant marine crewmembers. Our Galveston Jones Act lawyers point out that he Jones Act also covers cruise ship workers (including stewards, cooks, and entertainers), employees of river cruise boats, tug boat and service boat crewmembers, barge workers, commercial fishermen, tanker men, offshore supply crews, and marine construction workers, among others.
Under the Jones Act, ships’ owners have an absolute, non-delegable duty to create and maintain a safe (seaworthy) working environment aboard their vessels. An unsafe condition or work practice that causes a seaman’s injury constitutes an instance of unseaworthiness, even if the rest of the vessel and shipboard working practices are completely sound.
The duty to provide a seaworthy vessel includes ship owners’ duties to properly screen and train employees, provide non-defective equipment aboard the vessel, ensure safe work practices, develop and maintain safety policies and procedures, and provide safe routes to board and debark from the vessel as well as to and from workplaces within the ship,
Examples of some types of unseaworthy conditions that could cause seamen’s injuries include:
If you’ve been injured during employment related to a vessel, or you’ve lost a loved one to a work accident related to a vessel, you might be eligible to recover full financial compensation for your losses under the Jones Act. Contact our dedicated Galveston Jones Act lawyers for a free and confidential legal consultation to discuss the accident. We could review the circumstances of the traumatic event with you, and help you understand your legal rights and options for obtaining the just compensation your deserve for the harm you’ve suffered. Give us a call today at 877-307-9500 (toll free) or use our online contact form to schedule a free case evaluation by our experienced Galveston Jones Act lawyers.
It’s a nagging question with no reassuring answers. Our cruise ship injury attorneys note that the Costa Concordia disaster shows us that cruise ship passengers could be just as vulnerable today in the event of a major emergency as they were 100 years ago when the Titanic went down in the Atlantic Ocean.
Even the largest cruise ship is but a speck in an ocean. Our cruise ship injury attorneys point out that these ships, despite their awesome immensity, have shown themselves vulnerable to storms, fire, and collision damage just like other ships throughout man’s sea-going history. Designers, engineers, and safety experts use computer modeling and the latest technologies to continually improve cruise ship safety.
The list of challenges above illustrates that it’s not just the presence of advanced safety features that is critical. It’s the ability of passengers and crews to be able to safely and rapidly access and utilize these features in the event of an emergency. Our cruise ship injury attorneys caution that a full complement of the best lifeboats is of no help if the lifeboats are underwater before passengers and crew can reach them.
The cruise industry is currently seeing a downturn in passenger bookings as people reevaluate the safety of cruise ships in light of the Costa Concordia disaster. Lingering questions about whether large cruise ships can be safely evacuated in case of emergency are keeping potential passengers ashore.
The thorny problem of how to quickly and safely evacuate large and diverse groups of people from a sinking ship remains. Our cruise ship injury attorneys suspect that after the shocking example of the Costa Concordia disaster, the cruise industry might not be able to easily calm nagging doubts regarding crewmembers abilities to guide an evacuation or help vulnerable passengers.
Our Texas medical device injury lawyers have questioned before whether the FDA testing and approval process is all that it should be. Your safety rides on the answer to that question.
Recent media articles have chronicled the dilemma of 6 concerned U.S. FDA scientists and doctors who complained that certain approved and soon to be approved cancer screening devices could present safety hazards to patients. These FDA employees began to try to raise awareness of the safety concerns in 2007 by notifying members of Congress, the White House, and the Health and Human Services Administration.
The 6 whistleblowers used their personal email accounts to communicate their concerns, and they claim that the FDA monitored their personal email accounts at work and used the information obtained from that monitoring to target and harass them.
These Texas medical device injury lawyers note that subsequent actions by the FDA could end up supporting these current and former FDA employees’ claims. Two of the employees have been terminated. Two other contract employees have not had their FDA contracts renewed. Two of the 6 employees apparently remain at the U.S. FDA, but media reports do not clarify whether they still occupy their original jobs or whether they might have been moved to less responsible positions.
The FDA and most employers make it clear that employees using employer-based systems at work, even if it’s to send a personal email over a personal email account at lunch, have no expectation of privacy. Simply monitoring employee use of the systems is one thing. But using the information obtained to target and harass concerned whistleblowers is entirely another matter. Federal and state laws protect whistleblowers and some whistle blowing activities. This is because experience has shown that a brave whistleblower’s actions might preserve the safety and lives of many other people.
A constant stream of medical device recalls demonstrates that just because a device is allowed to reach the market and be used in or on your body doesn’t mean that the device is necessarily safe. Our Texas medical device injury lawyers remind you that recent years have seen major recalls on hip and knee implants, surgical mesh used in transvaginal prolapse repairs, and defibrillator devices, among others.
The dubious screening devices on which the whistleblowers tried to take action could negatively impact the health and safety of cancer patients and healthy patients obtaining preventative cancer screenings. Their brave attempts to come forward with their concerns could well save some lives.
But the actions taken by the U.S. FDA against these 6 concerned employees might indicate that the FDA is far more concerned with protecting its own interests than with protecting your health. Our Texas medical device injury lawyers have reached that conclusion before. And the FDA’s actions against the 6 whistleblowers tend to confirm our opinion. We would rather see the FDA act in a way that would change our minds and make us feel more comfortable that they care about our health and safety.
The Texas City work accident attorneys at Denena & Points explain some of your rights and limitations under Texas workers’ comp laws. Texas workers’ compensation statutes eliminate a worker’s right to sue an employer after being injured at work if that employer subscribes to Texas workers’ compensation insurance coverage. But workers’ comp helps you in other ways.
Texas workers’ compensation insurance is basically a “no fault” system. This means that if your were injured while employed by an employer that subscribes to Texas workers’ comp, then you are almost guaranteed to receive some compensation for your injuries.
There are some exceptions to this near-guarantee. If you were intoxicated at the time of the accident, if you were engaging in willful misconduct that caused the accident, or if you were working as an independent contractor at the time of your injury you are not covered by Texas workers’ comp provisions and you can’t collect financial compensation for your accident.
When a work accident has injured you and your employer subscribes to Texas workers’ comp coverage, workers’ comp will pay for the following costs of your injury:
But workers’ comp does not pay for more subjective losses like your pain and suffering or emotional trauma from the accident. The amounts Texas workers’ comp insurance will pay you all have capped, fixed maximums, and lost wages payments cover only a percentage of your actual wage. So some of your wages are indeed “lost” because of the accident.
Your workers’ comp payments rarely cover your actual losses from a work-related injury. In addition, employers and workers’ comp insurers will often contest your claim to find ways to reduce payment amounts or even to deny your claim altogether.
It is important to have a skillful Texas City work injury attorney to investigate your accident. Your attorney could help you determine if there were other parties were at fault in causing your accident and injuries. If third parties other than your employer have contributed to causing the accident, you might be able to sue them directly in civil court for compensation for the harm they have caused you. No fixed maximums govern civil court compensation awards, so the financial relief you receive from liable third parties could help make up the shortfall for your losses from the limited Texas workers’ comp payment amounts. Contact us today for a free consultation to learn about your options for making a full financial recovery for your injuries.
Every year, hundred of injured workers are wrongly denied workers’ compensation. Many others have their claims contested and their benefits drastically reduced by obdurate employers. Further numbers don’t know about their rights to seek compensation from liable third parties, and so they go without the compensation they need to survive financially after a serious workplace accident. Don’t let this happen to you. Don’t let anyone talk you out of getting the experienced legal help you need to protect your rights. A knowledgeable Abilene work accident attorney will ensure that you receive all of the compensation to which you are justly entitled by the extent of your losses from the accident.
Our Houston work injury attorneys point out that workers’ comp insurance is expensive for employers to purchase and maintain. This is especially true where the employer carries on an inherently dangerous work activity such as construction. So many Texas employers choose not to subscribe to workers’ compensation coverage. Being a nonsubscriing employer saves them a lot of money; at least until a serious on the job accident occurs.
If you’ve been injured on the job and your employer is a Texas nonsubscriber, Texas law allows you to file a civil lawsuit claiming the full costs of your injuries. In a civil lawsuit, you can claim compensation for all of your losses from the injury, including subjective injuries like your pain and suffering. (You can’t receive compensation for non-objective harm like pain and suffering under workers’ comp.)
Filing a civil liability lawsuit is a much more complex process than filing a workers’ comp claim. You will necessarily need the able counsel of a Houston work injury attorney to guide you to the successful conclusion of your civil lawsuit.
You face challenges in a civil lawsuit that you don’t experience under the workers’ comp process. For example, employers too cheap to purchase workers’ comp insurance will gladly spring for expensive defense attorneys if they will protect the employer from having to pay your claim.
The employer might also carry a private liability policy that aggressive insurance company employees will defend. The employer and his insurer mighty try to convince you that your claim is worthless and that you should sign a release of your claim. Don’t sign it. In fact, don’t sign anything relating to your injury or claim without your own Houston work injury attorney’s advice.
The employer and his insurer might also offer you a quick, but minimal, cash settlement in return for your release of your legal right to sue for the full worth of your claim. Don’t take the offer; any sum they offer you up front likely represents but a small fraction of the true worth of your claim.
The employer and his insurer and defense attorneys will work with professional investigators to thoroughly examine your accident. They will be looking for ways to point the finger of blame back at you for the accident. This is because Texas workers’ comp laws penalize the nonsubscribing employer by leaving him only one real defense against your work injury claim. This is the “sole proximate cause” defense, and it means that your employer must prove that you were 100% responsible for causing the accident that harmed you. So a nonsubscribing employer and his defense team will leave no stone unturned in their attempt to make you appear entirely liable in the matter of injuring yourself at work.
They will look for witnesses to state that you appeared intoxicated or under the influence of drugs at the time of the accident. They will dig through your employment history for any questionable incidents. They will look for any evidence they can find that reveals past safety oversights or lapses in good judgment that could cause accidents. They will not hesitate to add insult to injury and drag your reputation through the mud to make you look like the sort of clumsy, incompetent employee who could barely make it through a single work day without bringing disaster down upon his own head.
Large sums of money are at stake and this is the employer’s only possible defense. While they go through your past history with a fine-toothed comb, members of the defense team will also be hounding you for statements. Have your own Houston work injury attorney handle all contacts with them instead. The defense hopes to get a statement from you that they can (and will) use against you to prove your own liability for your accident. Even innocent statements taken out of context can be twisted to mean just about anything. So don’t talk to your employer or his team; have your attorney do this for you.
You need an adept Houston work injury lawyer to counter their attack with a solid counterattack. The workplace injury lawyers at Denena & Points have more than 12 years of practical experience in fending off such assaults on our clients’ character. We’re versed in the legal concepts relating to the sole proximate cause defense, and we have a long track record of favorable client outcomes.
We could put our own investigative skills to work on your behalf to diligently locate and collect the evidence you need to combat the employer’s aggressive defense tactics. We could conduct the careful depositions of accident witnesses you need to point to the truth of the matter. We seek out video and photographic evidence that could shed some light on who is truly at fault for the accident. We work to obtain records regarding past safety violations or lapses on the part of your employer. In short, our goal is to do all that we can to ensure that you successfully establish your claim to full financial compensation for your harm. Contact us today for your free consultation.
In our winter newsletter, our Texas pharmaceutical injury attorneys wrote about the controversy over Actos, the widely prescribed diabetes medication produced by Asian drug giant, Takeda Pharmaceutical Co. Victims and survivors of victims have filed thousands of lawsuits against the company claiming that Takeda withheld information regarding the heightened risk of bladder cancer from taking the drug.
Plaintiffs also claim that the company failed to provide sufficient warnings to users of the risks of taking the drugs. Efforts are underway to consolidate the thousands of pending lawsuits to streamline the litigation process.
But Actos isn’t the only drug at the center of a mass of lawsuits. Zoloft, Paxil, Vioxx, and many more drugs with highly recognizable names form the center of a storm of litigation. Many of these lawsuits revolve around contentions that the manufacturers failed to warn of serious side effects, marketed the drugs for unapproved uses, failed to warn of particular dangers from long-term use of the drugs, or failed to warn of the potential for birth defects in babies born to mothers taking the drugs.
The bottom line is that many of the most widely used pharmaceuticals could present some serious dangers to large numbers of their users. And efforts to warn users of the dangers seem lacking to our Texas pharmaceutical injury attorneys. Sometimes the flaw lies in the science behind the drug. Sometimes the error rests in overly aggressive marketing tactics and ruthless profit seeking.
Part of the problem is that many people like to believe that a magic pill will cure them of years of bodily abuses and neglect. Patients willingly accept drugs without question. They don’t look for remedies like diet or exercise that might require more effort to implement than popping a pill.
Like most complex problems, drug safety is a multi-faceted issue that defies easy solutions. Our Texas pharmaceutical injury attorneys caution that as long as people want to rely on pharmaceuticals as magic cure-alls for their ills, the opportunity exists for profit-seeking companies to take advantage of this desire. The race to rush to market with the next big drug ahead of competitors might lead to cutting corners in scientific research, drug trials, or safety oversight. The negative effects of this market race on your health and safety might not be deliberate, but they could affect you just the same.
If you receive injuries or lose a loved one because of an undisclosed pharmaceutical side effect, you do have recourse. Schedule a free legal consultation with one of our experienced Texas pharmaceutical injury attorneys to discuss your case. We could help you recover just financial compensation from the drug manufacturer in recompense for your injury and loss.
Galveston injury lawyers mention that recent months have seen a series of fines levied against major pharmaceutical companies for practices that endangered your health and took multiple lives. The fines might seem large to an ordinary individual living on an ordinary budget. But the fines represent only a tiny, token fraction of the vast profits these major pharmaceutical companies reaped following their unethical marketing and testing of their drugs. Let’s look at a few examples.
An Argentinean judge just fined GlaxoSmithKline (GSK) some 400,000 pesos (that’s only about $93,000 in U.S. currency) for conducting illegal vaccine lab trials that took the lives of at least 14 Argentine babies between 2007 and 2008. That’s more than a dozen innocent children who won’t be celebrating their fourth and fifth birthdays this year. Reportedly, GSK recruited doctors who forced illiterate parents into signing over their children for the trials.
Johnson & Johnson (J&J), the world’s largest health products company, has been fined $1 billion by the U.S. government over the marketing of its ant psychotic drug, Risperdal, for uses unapproved by the FDA. This might sound like a huge fine, but it’s less than 1/3 of Risperdal’s peak sales just for the year 2007. For reference, Risperdal was the company’s best selling drug for some years. Risperdal brought in more than $24 billion in sales between 2003 and 2010. Once it lost patent protection, J&J began aggressively marketing the drug for unapproved uses in order to shore up its dropping profits. A criminal plea might still result from the government’s investigation in this case.
November 2011 saw a fine of $950,000,000 levied against Merck, another giant of the pharmaceuticals industry, for marketing its drug Vioxx using false advertising and deceptive marketing practices. Use of Vioxx was linked to about 27,000 heart attacks and cases of sudden cardiac death. Merck pulled the drug off the market in 2004 after marketing it for 5 years. Critics allege that Merck knowingly hid reports of these Vioxx-linked deaths from the public.
The unethical marketing practices and illegal lab vaccine trials of the big pharmaceutical companies present clear dangers to public health. Fines that represent miniscule amounts to these large companies do not serve to sufficiently motivate these companies to concern themselves with the health of those who might be affected by their products. Government needs to step up enforcement efforts with much larger fines and additional criminal penalties to keep these international behemoths from threatening your health in their quest for ever greater profits.
If a drug marketed for an unapproved use has injured you, contact our Galveston injury lawyers for a free legal consultation. You might be eligible for financial compensation from the manufacturer and marketer for the harm you suffered.
Since the recent wreck of the cruise ship Concordia, much has been made of the captain’s role in causing the maritime disaster. Attention has increasingly begun to focus on how Concordia’s captain abandoned his post as the ship went down and passengers and crew engaged in chaotic efforts to evacuate the sinking vessel and save themselves.
As long as records have chronicled human sea voyages, the accepted course of action for a captain, or Ship’s Master, has been to take charge of all situations and work to save his ship, crew, and passengers when the ship is in distress. There’s no requirement that a captain go down with a sinking ship, only that he remain until everyone else has been safely evacuated.
The Merchant Marine Officers’ Handbook states that a captain should be the last man to leave his vessel. The Italian code imposes a prison sentence of up to 12 years on a captain who abandons his vessel in the time of its distress. Captain Francesco Schettino of the Concordia now faces charges carrying just that possible sentence.
Job descriptions for ships’ captains, including cruise ship captains, maintain that the captain is responsible for charting safe navigational courses, ensuring adherence to responsible safety procedures, overseeing the safety of his ship, crew, passengers, and cargo, and taking charge of all situations that could affect their well being.
The captain of the Concordia failed to discharge that duty. Indeed, witness accounts indicate that he abandoned his duty precipitously once danger threatened. His abandonment of his post might have increased the dangers to passengers and crew of a poorly coordinated evacuation effort.
Injured passengers and crew, and those who lost loved ones in the disaster on the Tyrrhenian Sea, deserve just compensation for their trauma and losses. The captain, First Officer, and cruise line might all be at fault in the matter. The help of skilled maritime lawyers should help victims of the accident who are seeking justice and answers in this tragic case.
The Concordia disaster has already been compared to the Titanic disaster, to which it does in fact bear some striking similarities. Let’s hope that the tragic consequences of the negligent actions of the Concordia’s captain serve as warnings to other Ships’ Masters that will stave off such disasters for at least another 100 years.