Zestril Side Effects Lawsuit Information

Zestril Side Effects Lawsuit Information

Zestril Side Effect Injury Lawsuits

More than one-third of adults in the United States suffer from high blood pressure and consequent health disorders, according to the Centers for Disease Control and Prevention. About 70 percent of these use medication to treat hypertension. Zestril, Prinivil, and generic Lisinopril are among the most commonly used prescription drugs by hypertensive adults. However, ACE inhibitors, such as Zestril, can be fatal, and their side effects may lead to life-threatening conditions.

According to the QuarterWatch prescription drug surveillance report, Zestril accounted for the fifth highest number of side effect injuries in 2011. The FDA MedWatch program received at least 351 consumer and doctor complaints regarding serious Zestril side effect injuries. The Institute for Safe Medication Practices, which monitors, assesses, and reports prescription drug side effect injuries quarterly and annually has found more than 274 Zestril side effect injuries discovered by manufacturers during post-marketing surveys in 2011.

Zestril carries a FDA black box warning for serious angioedema and liver failure. The hypertension drug has also been linked to neurological problems, respiratory distress, birth defects, hyponatremia, severe allergic reaction, and a number of other health problems.

History Of Zestril

Zestril FDA Approval

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Pradaxa Side Effects Lawsuit Complaints

Pradaxa Side Effect Injury Lawsuits

Anticoagulant Pradaxa accounted for the highest number of prescription drug side effect injuries reported in 2011, according to the QuarterWatch report of the Institute for Safe Medication Practices. The FDA received 3,781 Pradaxa adverse event reports, including 542 deaths, 2,367 hemorrhages, 644 heart attacks, 291 kidney impairments, and 15 cases of liver failure, that year, which was almost three times higher than side effect injuries associated with Coumadin, the most reported Warfarin blood thinner.

A meta-analysis of MedWatch adverse event reporting system in 2012 highlighted that internal bleeding caused by Pradaxa side effects could pose a five-fold higher risk of death than any Warfarin-based anticoagulant. Pradaxa led to 956 side effect injury complaints, including 178 deaths, in the second quarter of 2012, which was far higher than 214 adverse events and 14 deaths linked to other Warfarin blood thinners reported during the same period.

History of Pradaxa

The FDA approved anticoagulant Pradaxa in October 2010 to prevent blood clotting in patients who undergo hip or knee replacement surgeries. The blood thinner produced by German drug maker Boehringer Ingelheim contains thrombin inhibitor Dabigatran, which forestalls the blood from coagulating. The drug is also used to treat patients suffering from non-valvular atrial fibrillation and at the risk of heart stroke.

Manufacturer Boehringer Ingelheim claims that Pradaxa is better than other Warfarin-based blood thinners used by patients and that there is no need for frequent tests to keep tab on blood international normalized ratio (INR). However, researchers have found that Pradaxa does not offer any significant benefit for patients already treated with Warfarin and those who have good INR. Rather, the drug has added health risks, such as hypertension, congestive heart failure, liver damage, and kidney disorders, which neutralize its benefits. There is no medication at present that can reverse the effects of Pradaxa in the case of internal bleeding, and this puts patients at the risk of death. In the last two years, Pradaxa caused over 500 deaths and more than 3,000 severe and debilitating injuries, making it one of the most unsafe drugs in the United States.

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Most Reported Drug Side Effects

 Most Reported Drug Side Effects

Drug Adverse Reaction Injuries Side Effects Drugs Most Reported for Side Effects

About 2 to 4 million US residents suffered from severe, debilitating, and fatal injuries caused by prescription drug side effects in 2011, according to the Institute for Safe Medication Practices, which monitors drug adverse events in the United States. The annual data published by its QuarterWatch surveillance program shows that the FDA got 179,855 serious drug side effect injury reports in 2011, which include 21,002 reports directly from healthcare professionals and consumers through the MedWatch system and 158,853 adverse events corroborated by manufacturers. The numbers released are 9.4 percent or 15,386 instances more than annual drug injury cases reported in the previous year.

Top 10 Drugs Reported for Side Effect Injuries

The Institute for Safe Medication Practices has identified 10 drugs that led the list of adverse events associated with prescription medication in 2011. Anticoagulant medication Pradaxa, produced by German drug maker Boehringer Ingelheim, tops the list, followed by warfarin-based anticoagulant Coumadin - manufactured and marketed by Bristol-Myers Squibb. Antibiotic Levaquin, Cipro, and Bactrim, chemotherapy drugs Carboplatin and Cisplatin, ACE inhibitor Zestril, anti-cholesterol drug Zocor, and antidepressant Cymbalta complete the remaining places on the list of 10 drugs most frequently reported for their safety issues, target of consumer groups, and subject to litigations.

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Stryker Rejuvenate Hip Replacement Implant Recall Lawsuit

 Stryker Rejuvenate Hip Replacement Implant Recall Lawsuit

Stryker Rejuvenate Hip Implant Lawsuits

On January 25, a Stryker Rejuvenate class action lawsuit was filed in a south Florida federal court seeking free treatment and medical monitoring for people implanted with the recalled metal hip replacement devices. Michigan-based Stryker Orthopedics recalled its metal Rejuvenate Modular hip implants in June 2012 following widespread reports of metal poisoning, local tissue reactions, pain, premature device failure, and early modular-neck junction corrosion attributed to its design defects. The FDA received as many as 60 complaints on the hip implant failure, metallosis, infection, and bone necrosis in the four months preceding the recall.  

An estimate released by Stryker Orthopedics in January 2013 puts the total costs the manufacture has to pay for personal injury lawsuits filed following the hip system recall at $390 million. The number of Stryker Rejuvenate hip lawsuits is expected to rise in the months ahead as more patients are coming forward seeking compensation for injury, pain, side effects, suffering caused by the device and reimbursement for medical and implant costs. In January 2013, the Supreme Court of New Jersey ordered for consolidated proceeding of all Stryker hip product liabilities filed in the state courts.

Stryker Rejuvenate Hip Implant: The System and Drawbacks

Stryker Rejuvenate hip implants were introduced in the United States in February 2010 following authorization through the FDA’s controversial 510(k) approval process. The procedure, which is being subject to strong criticism, permits introduction of new drugs or medical devices “substantially equivalent” to similar products already approved by the FDA for marketing and consumer use. Stryker introduced the Rejuvenate hip implants claiming that the system was similar to Profemur hip implants produced by Wright Medical Technology in design and offered superior intraoperative efficiency and flexibility.

The Stryker Rejuvenate hip implant system consists of the following three components

• A chromium-cobalt stem
• A non-metallic ball
• A titanium neck

The design of Stryker Rejuvenate hip implant system has been found defective and causes rubbing of metal components of the system against each other that discharges metal particles into the blood stream, putting users at the increased risk of metal poisoning. Many patients using these metal artificial hips have been diagnosed with high blood chromium and blood cobalt levels. Continuous and unusual fretting disables the metal parts early, and the devices last less than a quarter of the 15-year life span claimed by the manufacturer. Metal particles released from the artificial hip implants also cause infection, bone necrosis, and scar tissue and pseudotumor formation in and around the hip area.

The Wring Profemur hip implants with which Stryker Rejuvenate systems share design similarity have been subject to many lawsuits for their early failure, loosening of implants, consistent hip pain, and problem in walking or standing.

Stryker Rejuvenate Hip Implant: Major Side Effects

• Metallosis and toxicity
• Thyroid disorders
• Cardiovascular problems
• Hip area inflammation
• Metal poisoning leading to nervous system, gastrointestinal, cognitive disorders, vision and hearing problems, skin rashes, myocardiopathy, hypothyroidism, and death
• Sharp rise in cobalt and chromium ions in blood
• Peripheral soft tissue damage
• Nerve palsy and other side effects impacting normal nervous system functioning
• Device dislocation and chronic pain
• Premature device failure leading to secondary or revision surgery
• Bone necrosis and fractures

Stryker Rejuvenate Hip Implant Warnings

More than 17,000 complaints have been made through the FDA adverse reporting system, highlighting side effects and failure of metal hip implants in the last one decade. In May 2011, the FDA asked all metal artificial hip implant manufacturers, including Stryker, to conduct comprehensive safety assessment of its products fully reflecting safety concerns of consumers raised through complaints to the regulator.

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