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Wednesday, March 13, 2019

Fosamax Litigation Continues
 Fosamax Litigation Continues 150 150 CMZ Law Lufkin/Houston

Will the U.S. Supreme Court find Merck liable for failing to provide adequate warnings about Fosamax?

Fosamax is a prescription drug manufactured by mega-company Merck.  It was created to help treat osteoporosis and other diseases that cause bone loss.  Given that one in three women worldwide and one in five men over 50 will suffer from osteoporotic related fractures, Fosamax and other drugs like it are big business.  Fosamax claims that it will slow bone loss and improve bone density, but alarming evidence of the potential link between the drug and fractures has emerged. Now, thousands of Fosamax users have filed suit against Merck, claiming that the dangerous drug led them to suffer thigh bone fractures and the company failed to warn them of the risks.

As other claimants joined in the action against Merck, Merck sought dismissal of the claims.  Merck submitted evidence that it had notified the FDA back in 2008of a potential link between the drug and some bone fractures.  However, the FDA rejected its proposal to a warning label to the drug. It wasn’t until 2010 when the FDA ordered a revision of the labels to include a warning, which Merck did.

In federal court in New Jersey, Merck urged that the claims against it should be dismissed because the FDA rejected its proposed warning label, which it believes should exclude liability.  However, the 3rd Circuit ruled the case should proceed because the jury could find that the FDA would have accepted a properly worded warning concerning fracture risks.

The Supreme Court Takes Up the Case

Now, at the urging of President Trump, the U.S. Supreme Court has elected to hear the case. At issue will be the crucial question as to whether a pharmaceutical company can be liable for failing to warn drug users as to known risks when the FDA rejects its proposed warnings.  The issue is a crucial one that could have wide spread implications.

If the Supreme Court finds that Merck is relieved of liability, it could leave consumers crucially unprotected against potentially dangerous or defective drugs.  Individuals harmed by dangerous drugs that did not come with adequate warnings could be left without legal avenues, and product makers may further lose financial incentive to create comprehensive, up-to-date warnings.  On the other hand, most would agree that the FDA needs to be more proactive in issuing potentially lifesaving warnings when made aware of this need by drug makers. All of us should closely watch this case, which may have an impact on anyone who will ever take a prescription drug.

The Dangers of Xarelto
 The Dangers of Xarelto 150 150 CMZ Law Lufkin/Houston

What injuries have been linked to Xarelto?

Xarelto (rivaroxaban) is a drug released by Bayer Healthcare in tandem with Janssen Pharmaceuticals to thin the blood. Xarelto is prescribed to patients at risk of stroke or those with atrial fibrillation in order to prevent clots. The drug is also approved to treat those with deep vein thrombosis, pulmonary embolism, or individuals who have recently undergone surgery. Xarelto can prove effective in treating some illnesses, but evidence has now emerged as to Xarelto’s potentially dangerous propensities. Already, hundreds of defective drug lawsuits have been filed against the makers of Xarelto.

Xarelto Facts

Xarelto is one of the newer classes of blood thinners. It was initially introduced in 2011 as an alternative to the traditional blood thinner Warfarin. Xarelto is similar in nature to the blood thinner Pradaxa, which is now one of the most litigated drugs in the United States.

Xarelto’s Potentially Serious Side Effects

Xarelto has been linked to several serious and potentially even fatal side effects, including:

Heart arrhythmiaExcessive bleedingCoughing up bloodBlood pressure changesNosebleedsGastrointestinal bleedingRectal bleedingBrain hemorrhagingDeathThe immense dangers of Xarelto are largely linked to its lack of an antidote. When Xarelto was initially released in 2011, it did not have an antidote that could reverse internal or external bleeding that could occur due to surgery, an accident, or a side effect of the drug. Warfarin, on the other hand, has a reversing agent that can quickly stop the effects of the drug to stop bleeding fast. According to several lawsuits and safety officials, the makers of Xarelto did not adequately warn physicians or patients as to the lack of an antidote and the related serious risks of ongoing bleeding. Anyone who has suffered an injury due to Xarelto may be eligible to seek compensation from the makers of this dangerous drug. Injuries linked to Xarelto can inflict financial hardships on patients. Xarelto victims may be able to seek compensation for their medical expenses, lost wages, pain and suffering, and other ongoing disabilities stemming from the drug. Contact a defective drug attorney for an analysis of your legal rights and overview of your necessary next steps.
 Heart arrhythmiaExcessive bleedingCoughing up bloodBlood pressure changesNosebleedsGastrointestinal bleedingRectal bleedingBrain hemorrhagingDeathThe immense dangers of Xarelto are largely linked to its lack of an antidote. When Xarelto was initially released in 2011, it did not have an antidote that could reverse internal or external bleeding that could occur due to surgery, an accident, or a side effect of the drug. Warfarin, on the other hand, has a reversing agent that can quickly stop the effects of the drug to stop bleeding fast. According to several lawsuits and safety officials, the makers of Xarelto did not adequately warn physicians or patients as to the lack of an antidote and the related serious risks of ongoing bleeding. Anyone who has suffered an injury due to Xarelto may be eligible to seek compensation from the makers of this dangerous drug. Injuries linked to Xarelto can inflict financial hardships on patients. Xarelto victims may be able to seek compensation for their medical expenses, lost wages, pain and suffering, and other ongoing disabilities stemming from the drug. Contact a defective drug attorney for an analysis of your legal rights and overview of your necessary next steps. 150 150 CMZ Law Lufkin/Houston

What injuries have been linked to Xarelto?

Xarelto (rivaroxaban) is a drug released by Bayer Healthcare in tandem with Janssen Pharmaceuticals to thin the blood. Xarelto is prescribed to patients at risk of stroke or those with atrial fibrillation in order to prevent clots. The drug is also approved to treat those with deep vein thrombosis, pulmonary embolism, or individuals who have recently undergone surgery.

Heartburn Drugs May Pose Health Risks
 Heartburn Drugs May Pose Health Risks 150 150 CMZ Law Lufkin/Houston

Can I file a lawsuit against a pharmaceutical company if I am injured by a medication?

A recent clinical study by the Houston Methodist Research Institute indicates that a class of heartburn drugs, proton pump inhibitors or PPIs, put users at increased risk of heart attack, stroke and renal failure. These drugs, sold under brand names such as Prevacid, Prilosec and Nexium, may cause damage to cells in the arteries.

While PPIs are designed to inhibit acid production by cells known as lysosomes, the drugs may also prevent cells from dividing and reproducing, leading to plaque buildup in the walls of blood vessels. In addition to the risk of heart attacks and other maladies, cell damage in the arteries is also linked to dementia and cancer. In the study, where cells were exposed to the PPI Nexium that mimicked long-term usage, researchers also found chromosome damage that is associated with these age-related diseases.  Meanwhile, other heartburn medications known as H2 blockers – the active ingredient in Zantac, do not cause similar damage to artery cells.

One of the researchers involved in the study noted that this should have been detected by the pharmaceutical industry earlier. At the same time, he also suggested that many PPI users take these drugs on a long-term basis, contrary to FDA guidelines which limits the use of PPIs to four weeks at a time, three times a year.

For its part, AstraZeneca, the maker of Nexium, refuted the findings. The drug maker argued that this was not a controlled clinical study conducted in humans and that causation cannot be established. AstraZeneca also said it believes PPIs are safe, provide they are use according to instructions. However, the FDA previously warned (in 2010) that PPIs can have other adverse effects such as increased risk of fractures and low levels of magnesium in addition to the potential for cardiovascular problems.

While more research will be needed to evaluate the risks of PPIs, some users have begun to file lawsuits. In the end, pharmaceutical companies that provide medications to consumers have a duty to ensure these products are safe. If these drugs are found to be harmful, drug makers need to be held accountable. If you were injured by a defective medication, a personal injury attorney can help you obtain compensation.

New Jersey Drug Company Pleads Guilty to Selling Contaminated Ultrasound Gel
 New Jersey Drug Company Pleads Guilty to Selling Contaminated Ultrasound Gel 150 150 CMZ Law Lufkin/Houston

What was the ultrasound gel sold by a NJ drug company contaminated with?

Pharmaceutical Innovations Inc., a New Jersey pharmaceutical company based in Newark, has recently pleaded guilty to selling ultrasound gel contaminated with bacteria. The gel, used in scans, sonograms, EKGs and similar procedures, makes direct contact with the skin.

How the Case Began

The company was originally targeted by the FDA in 2012. At that time a Michigan hospital reported that 16 surgical patients had been infected with a bacterial pathogen associated with a particular batch of ultrasound gel from Pharmaceutical Innovations. It was found that all of the infected patients had undergone transesophageal ultrasounds during heart valve replacement surgeries which led investigators to suspect the gel as the contaminant. The hospital had then tested the gel and confirmed that it was, in fact, the source of the contamination.

The Charges against Pharmaceutical Innovations

Pharmaceutical Innovations was charged with violating the Federal Food, Drug and Cosmetic Act. Prosecutors charged that FDA inspections of the facility indentified multiple breaches in accepted manufacturing practices. The FDA also said in court filings that the company had failed to resolve their manufacturing issues in spite of repeated warnings.

How the Case Was Resolved

Pharmaceutical Innovations entered a guilty plea in U.S. District Court in Newark to two misdemeanor counts of introducing adulterated medical devices into interstate commerce. The firm was fined $50,000 for the crime and forced to forfeit $50,000 (the approximate value of the defective product) to settle a civil lawsuit regarding its distribution. In addition, the company was placed on two years of probation.

 

Pharmaceutical Innovations also agreed to destroy products that have tested high for infectious bacteria in order to settle the civil suit. Company executives state that they’re now committed to maintaining compliance with all relevant regulations. An injunction has also been issued requiring that the company pay for regular inspections and certifications of its facility by independent experts and auditors.

U.S. Attorney Paul Fishman has stated that “Pharmaceutical Innovations shipped defective products that exposed hospital patients to dangerous bacterial contamination.” He went on to say that the plea agreement and civil settlement indicate that the company has accepted responsibility for the hazardous contamination and is taking steps to prevent any medical missteps in the future.  

Medical mistakes happen all too frequently, not only as a result of medical device failure or product contamination, but because of errors made by hospitals and medical professionals. If you have suffered as a result of a medical, surgical, or medication-related error while in a medical facility or at the hands of a medical professional, you should contact an experienced medical malpractice attorney as soon as possible so that you receive the compensation you deserve.

 

 

 

 

 

Invokana Linked to DKA and Kidney Damage in New Lawsuit
 Invokana Linked to DKA and Kidney Damage in New Lawsuit 150 150 CMZ Law Lufkin/Houston

Can you be compensated if you suffered from the serious side effects of a drug?

You are a type-2 diabetic and you need some help managing your symptoms. So, your doctor recommends a new drug that many of his patients have been having a good experience with. He tells you that there may be some side effects but you think to yourself “not me.” Think again! You start experiencing the symptoms of a blood disorder and having kidney problems and your doctor tells you it is from the medication you have been taking. What are your rights? Well, you can bring a lawsuit like a woman from Texas recently did after being seriously impacted by the new drug Invokana.

Invokana is a new type of diabetes drug that prevents some glucose from being absorbed into the body via the kidneys. The unabsorbed glucose is then released through in the urine. The woman began taking Invokana (canagliflozin) in October of 2013, shortly after it had been approved by the Food and Drug Administration and released onto the market. Soon after beginning the medication she claims that she became afflicted with diabetic ketoacidosis and serious kidney problems. After experiencing these symptoms she discontinued the use of the drug in November of 2013. 

She has since brought a lawsuit in a United States District Court in New Jersey. She named the drugs manufacturers, specifically Janssen Pharmaceuticals and their parent company, Johnson & Johnson, as defendants. She claims that the manufacturers should have been aware of the serious health risks associated with the drug and that they should have included appropriate warnings on the packaging.  It does seem like the manufacturers were aware of the possibility of the side effects after the FDA raised a concern about DKA. A report was also issued in 2014 regarding the kidney issues associated with the drug. The woman even goes as far to allege that she would have never used the drug if she knew of the possibility of these side effects. She is seeking $10 million in damages.

If you suffered personal injury as the result of the use of a defective drug or medical device, you should speak to an experienced Houston, Texas attorney today.

 

Premise Liability in the Neighborhood
 Premise Liability in the Neighborhood 150 150 CMZ Law Lufkin/Houston

Can I sue my neighbor for premise liability if I fall on their property?

Many individuals know that if they were injured at the grocery store, or have an accident at any other place of business, it is possible to file a personal injury lawsuit. But what happens if you are injured in a  slip and fall when you are visiting a neighbor? If a property owner was negligent in keeping the property safe, you may be able to pursue a premise liability lawsuit.

Grounds for a Premise Liability Lawsuit

Premise Liability in the neighborhood claims arises from a variety of accidents such as tripping on ripped carpeting, falling on broken stairs, slipping on ice or snow, or tripping over a cracked sidewalk, among others. If you are invited onto a neighbor’s property, you have the right to expect a safe environment. If there is damage on the property or if it has been poorly maintained, and you suffer an injury, you may have grounds for a premise liability claim. Whether a property owner is aware of an unsafe condition and fails to repair it, or was not aware but should have been, he or she may still be held liable for your injury.

There are other factors, however, that may have contributed to your injury. If you were careless and caused your own accident, the homeowner will not be liable. For example, if you spilled water on the floor and didn’t wipe it up, you do not have grounds for a premise liability lawsuit.

Settling a Claim

If your neighbor is responsible for the injury and acknowledges this, it may be possible to negotiate a settlement without going to court. Moreover, many premise liability claims will be covered by homeowner’s insurance. While the insurance company may offer to settle the claim, many carriers prefer not to pay these types of claims and will look for ways to minimize any damages to which you may be entitled.

For this reason, you are well-advised to engage the services of an experienced personal injury attorney who can help you obtain the compensation that you deserve. If a settlement cannot be reached, it may be necessary to file a premise liability lawsuit against the property owner.

Johnson & Johnson to Pay $502 Million Over Flawed Pinnacle Hips
 Johnson & Johnson to Pay $502 Million Over Flawed Pinnacle Hips 150 150 CMZ Law Lufkin/Houston

What is the latest news over J&J’s hip replacement failures?

Medical device maker Johnson & Johnson was recently ordered to pay $502 million in damages to 5 patients over flawed artificial hip devices sold under the Pinnacle brand name. The defective devices were sold by J&J’s Depuy unit, and a federal-court jury in Dallas found that company officials were aware of the flaws but failed to warn patients and doctors. In a product liability case, failure to warn is a key element in a successful lawsuit.

Pinnacle Hip Flaws

The flawed Pinnacle artificial hips prematurely failed causing pain and suffering to the patients who also required additional surgery. The verdict is said to be the second-largest jury award in the U.S. this year, of which $142 million was in actual damages and $360 million in punitive damages. While punitive damages are designed to induce a defendant to change its behavior, this is not the first time J&J has been forced to pay damages for failures in hip replacement devices.

In November 2013, J&J and Dupuy paid over $2.5 billion to settle thousands of lawsuits over defective ASR hip replacement devices. The company recalled 93,000 of those devices worldwide in August 2010, after acknowledging 12 percent failed within five years. In addition to replacement surgeries, many of the patients suffered extraordinary medical injuries such as strokes and heart attacks or requires multiple hip replacements surgeries.

The Pinnacle verdict is the second trial of about 8,000 lawsuits filed against J&J and DePuy; J&J prevailed in the first jury case in 2014. The company stopped selling the devices in 2013 after the U.S. Food and Drug Administration toughened artificial-hip regulations. The plaintiffs in this case all received Pinnacle Ultramet hip replacements that failed after the devices leached cobalt and chromium into their bloodstreams.

The jury agreed that company officials knew the metal-on-metal design would cause such injuries but aggressively marketed the devices nonetheless. In short, the company earned billions in ill-gotten gains while misleading doctors and consumers about the dangers of the devices. For its part, Johnson & Johnson argues that it acted responsibly in designing and testing the devices and the Pinnacle replacements had a strong record of safety and effectiveness. The company intends to appeal the verdict and seek a reduction in the punitive damages.

Whether J&J will prevail remains to be seen and it appears the company will face additional lawsuits by patients who suffered similar injuries related to the Pinnacle devices. In the meantime, if you have been injured by a flawed medical device, an experienced personal injury attorney can help you obtain the compensation you deserve.

Top Causes of Truck Accidents
 Top Causes of Truck Accidents 150 150 CMZ Law Lufkin/Houston

Can I file a lawsuit if am injured in an accident with a tractor-trailer?

Sharing the road with semi-trucks and tractor trailers in unavoidable, so it makes sense to proceed with caution if you are driving along aside or passing a large truck. Because of their weight and length, trucks can be hard to navigate. Moreover, a tractor-trailer, even traveling at a normal speed, can take a long time to stop. That being said, truckers are required to exercise reasonable care when operating a rig not to injure other drivers.

Truck Accidents at a Glance

There are state and federal laws in place that require trucks to be adequately maintained and inspected regularly. In addition, truckers must have special licenses and comply with hourly driving limits. Even with all these rules and regulations in place, semi-trucks are frequently involved in accidents for the following reasons.

Improper Maintenance

One of the main reasons for semi-truck accidents is that vehicle parts and components, including braking systems, engines, tires and trailers, are improperly maintained. A trucking company that fails to abide by federal laws regarding vehicle maintenance can be found legally responsible if an accident occurs.

Driver Fatigue

Because they are often paid based on miles and have strict delivery deadlines, truck drivers who work long hours and cover vast distances can easily become fatigued. Driver fatigue is serious problem in the trucking industry, even though federal regulations impose hourly driving limits on truckers and require drivers to take breaks.

Distracted Driving

While distracted driving is serious issue for all vehicle drivers, truckers are more prone to becoming distracted because of their long work schedules and the rigors of driving. While truckers are prohibited from using cell phones, the most common cause of distracted driving, truck drivers can also become distracted by tuning the radio, checking the GPS system, eating or drinking.

 

Inadequate Training

Trucking companies routinely pay drivers to complete trucking courses and are notorious for quickly putting them on the road. These drivers are typically paid less per mile than seasoned truckers, and  many new drivers lack the experience needed to safely maneuver these large vehicles.

Improper Loading
State and federal law regulate the weight of cargo on trucks, but may accidents are caused due to improper loading. If the weight is not properly distributed, a semi-truck can become difficult to maneuver or even jack-knife, leading to a deadly accident.

In spite of state and federal laws regulating the trucking industry, truck accidents frequently occur causing property damage, serious injuries and death. If you were involved in a truck accident that was due to the negligence of the trucker or trucking company, you should speak with a personal injury attorney who can help you obtain compensation for your injuries.

Death by Personal Injury: What Are the Chances?
 Death by Personal Injury: What Are the Chances? 150 150 CMZ Law Lufkin/Houston

Though we all know that death will eventually come to us and that, no matter how proactive we are about our health and safety, it may come suddenly and unexpectedly, we have no choice but to go living our lives. At times, we all experience anxiety about the risks inherent in the process. In a world where terrorist attacks have become all too common, we cannot help but worry about being attacked in the midst of any average day: in the mall, the airport, at school, at the movies, in the nightclub. Things that we do less frequently — like taking trips, going on daring adventures, undergoing surgery, living through extreme weather events — only raise our level of anxiety.

According to the National Safety Council, many of our worries are disproportionate to the risks involved.

Their annual list of Americans’ “Odds of Dying” gives us the statistical averages of our lifetime odds of dying from various causes. This list was compiled by using fatality data for the entire U.S. population. The reason for releasing this information, as stated by Deborah A.P.Hersman, president and CEO of the National Safety Council, is that “knowing the real odds of dying can empower people to make better choices and result in longer lives.”

Of course, not all personal injuries lead to death, but they may lead to painful or even disabling injuries. If you live in the Greater Houston Area and have suffered a serious personal injury due to the fault of another, you should be sure to contact a competent attorney promptly.

Odds of Dying

While most Americans worry more about dying during a commercial airplane crash than during a car excursion, they are actually 865 times more likely to be killed in a motor vehicle accident than in a plane crash.

Other statistics, some of which are surprising, include that:

  • We are much more likely to overdose on an opioid prescription painkiller (1/234) than to be electrocuted (1/12,200)
  • Falling is much more likely to take our lives (1/144) than a catastrophic storm (1/6,780)
  • The odds are much higher that we will die as passengers in a car(1/470) than that we will perish in a lightning strike (1/164,968)
  • We are in much greater danger walking down or crossing the street (1/704) than of being stung by a wasp, bee, or hornet (1/55,764)
  • Our chances of dying in an earthquake are far lower (1/179,965) than our chances of dying due to medical or surgical care or mistreatment (1/532)
  • We are far more likely to die unintentionally (1/31),by accidental poisoning for example, than we are to die from a deliberate assault with a firearm (1/358)

Of course statistics don’t have too much meaning except when they personally include you or a loved one. While hopefully we all take reasonable precautions in our daily lives, being injured is also unavoidable. If you have suffered a serious or even disabling personal injury during a vehicular accident, at the workplace or anywhere else due to the negligence of malice of another, you should contact a skilled and well-reputed personal injury attorney in your area. Having an expert attorney at your side can make all the difference in terms of your receiving the compensation you’re entitled to for your medical costs, lost wages, and pain and suffering.

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