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Defective Drugs

Fosamax Litigation Continues
Fosamax Litigation Continues 150 150 admin

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.

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 admin

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 admin

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 admin

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 admin

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.