Blog Posts in 2012

35 results found. Viewing page 1 of 2.

Litigation Update: Fosamax -- Femurs and Jaw Bones

Fosamax: Femur Fractures In the recent months, millions of pages of documents have been reviewed and numerous depositions were taken of key Merck employees. The discovery process has been going well. ...
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Stormy Days

My wife and I recently moved to Houston. We bought a house there in March, about a month before our wedding. Expecting the house to be empty, we were surprised to discover a large crate in our garage. ...
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Chemistry 101: Fresenius' GranuFlo Associated with Sudden Cardiac Death

GranuFlo is a dialysate (A.K.A concentrate or bath). The purpose of a dialysate is to clean the blood, control PH and correct metabolic acidosis in dialysis patients. It is comprised of 3 fluids: 1) ...
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Metal-on-Metal Hip Failures: The Crisis Expands

A report by the New York Times has estimated that over 500,000 patients in the United States are recipients of metal-on-metal hip implants. Patients who have had these hips fail typically experience ...
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Stryker Rejuvenate Hip System Recalled: Lawsuits on the Horizon

On July 6, 2012, orthopedic products manufacturer Stryker issued a voluntary hip recall for its Rejuvenate Modular and ABG II hip implants. These devices have been associated with a range of ...
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FDA Investigates Fresenius' Failure to Warn on GranuFlo and Naturlyte Dangers

On June 27, 2012 the FDA issued a Class I recall for two Fresenius dialysis products: Naturalyte Liquid Acid Concentrate and Naturalyte GranuFlo Acid Concentrate . Yet the most alarming and sobering ...
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Steve McQueen and Mesothelioma

In recent weeks, the Hollywood press has reported that there could be a film based on author Marshall Terrill’s book Steve McQueen: Portrait of an American Rebel . For those of a certain generation, ...
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Metal-on-Metal Hips - Summer Developments

Several significant developments have emerged in the metal-on-metal hip litigation and health crisis in the past few months: First, nearly three years after the initial DePuy ASR hip recall from ...
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Common Sense Supports Congress' Push to Reform Medical Device Approval Process

A new bill, HR 3847, has been pending in the House since February. Its purpose is to give the FDA enhanced authority when approving new medical devices. Specifically, it would permit the FDA to reject ...
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Fresenius Recall - Naturalyte and Granuflo

If you’ve recently undergone dialysis, you might have been given the recalled dialysates Naturalyte or Granuflo. Both dialysates were recalled by the FDA on June 27, 2012. Experts estimate that over ...
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More Transvaginal Mesh Taken Off of the Market

After the Food and Drug Administration (FDA) ordered C.R. Bard to conduct clinical trials on the Avaulta transvaginal surgical mesh, C.R. Bard was to prepare a study proposal for FDA approval. ...
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Pradaxa Blows Away the Field in 2011 FDA Adverse Drug Events

2011 was Pradaxa’s first full year on the United States prescription drug market. Last Pradaxa (also known as Dabigatran) generated sales of $829 million dollars in the USA. The drug achieved ...
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Lines in the Sand: DePuy and Johnson & Johnson Take Hard Line Stance over Pinnacle Metal on Metal Hip Failures

When the DePuy ASR hip crisis escalated in 2010, DePuy Orthopaedics (a Johnson & Johnson subsidiary) took certain measures to assist affected patients, such as setting up a process to handle and ...
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Johnson & Johnson Ignored FDA Order to Stop Selling Mesh: When Will They Learn?

According to Bloomberg News , Johnson & Johnson continued to sell one of its vaginal mesh implants for nine months after the FDA told it to stop marketing the device. In a letter on August 24, 2007, ...
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FDA Expects New Bill To Rake $6 Billion

On Tuesday, the senate passed a bill that enables the FDA to assess fees on foreign drug manufacturers and renew fee agreements with domestic makers. The measure is expected to rake $6 Billion over ...
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Timber! The Fall of Imprelis

According to the New York Times , DuPont is processing claims totaling hundreds of millions of dollars in relation to the herbicide Imprelis. DuPont had pulled the product after only a few months on ...
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Johnson & Johnson's Ethicon Plans to Withdraw Several Mesh Systems from the Market

In a June 4, 2012 letter, Johnson & Johnson announced that it will cease sales of four of its Ethicon pelvic mesh product systems. Johnson & Johnson has requested approval from the Food & Drug ...
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Fosamax: FDA Conducts Review Confirming Long-Term Use Has No Benefit

The Food and Drug Administration (FDA) has conducted a second analysis of bisphosponates, including Fosamax. In 2004, the FDA’s first analysis linked Fosamax (alendronate) , a prescription drug ...
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Pradaxa - Trading One Problem for Another

Pradaxa (generic name dibigatron) is an anti-clotting drug invented and manufactured by Boehringer Ingelheim Pharmaceuticals. Boehringer Ingelheim is a German company with offices around the world, ...
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Consumer and Manufacturer Costs for Surgical Mesh and Metal-on-Metal Hip FDA Clearance

When a physician tells you that a medical device can improve your life, most people assume that the device has been tested for safety and effectiveness. However, this is rarely the case. In fact, most ...
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Again & Again: Johnson & Johnson Disregards Patient Safety

As the hip implant and transvaginal mesh litigation against DePuy and Johnson & Johnson moves forward more is discovered about how the companies conducted their medical device business. Just days ...
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Business as Usual: Johnson & Johnson Puts Profits Over Patient Safety

Within the last two months, we have learned how Johnson & Johnson handles its medical device business. It puts profits over patient safety. Johnson & Johnson has sold and marketed several devices with ...
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DePuy's Delay Carries a $3 Billion Cost

In the past several weeks several news outlets have reported significant developments with regards to DePuy, the subsidiary of Johnson & Johnson responsible for the metal-on-metal hip implants that ...
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Pradaxa & Boehringer Ingelheim - With Great Profits Comes Great Responsibility

Boehringer Ingelheim Pharmaceuticals is a well known German pharmaceutical company with offices around the world, including the United States. Recently, the company announced that 2011 was an ...
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When Will Regulators Listen? Orthopaedic Surgeons Call for a Ban on Metal-on-Metal Hip Implants

The BBC reported yesterday that expert orthopaedic surgeons in the United Kingdom say that metal-on-metal hip implants should not longer be used. The high failure rates of metal-on-metal hips and the ...
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35 results found. Viewing page 1 of 2.