Medical Injury Lawyer Blog : Houston Medical Injury Lawyer & Attorney : Arnold & Itkin Law Firm : Pharmaceutical Injuries, Medical Devices : Texas, Dallas, Fort Worth, San Antonio

Bayer AG has begun the process of settling medical injury lawsuits regarding its Magnevist contrast agent; Magnevist contains gadolinium.

The company is one among several, including General Electric Company and Tyco International Limited, being sued over complaints that the gadolinium-containing contrast agent was responsible for causing a potentially fatal organ hardening disease, called Nephrogenic Systemic Fibrosis (NSF).  Since May 2007, the U.S. Food and Drug Administration (FDA) has required that gadolinium-containing contrast agents carry a black box warning.

Bayer’s Magnevist is used during magnetic resonance imaging scans to define tissues clearly. Gadolinium was approved for use in imaging scans in 1999, but the compound was found to increase the risk of NSF in patients who have weak kidneys. NSF is a rare debilitating disease that affects the skin, eyes, joints, and internal organs, causing them to harden. The disease can be fatal. Symptoms of NSF, include:

• Burning or swelling
• Tightening of skin
• Changes in skin texture
• Muscle weakness
• Stiffness in the joints

Since the link between NSF and gadolinium became clear, many patients seriously injured by the drug have hired medical injury lawyers to recover compensation for their injuries.

Bayer has begun negotiating approximately 40 cases that linked Magnevist contrast agents with NSF. Apart from Magnevist, there are 4 other contrast agents containing gadolinium - Ominiscan, OptiMARK, MultiHance, and Prohance.

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Critics of the U.S. Food and Drug Administration (FDA) have long believed that the agency should be split into two parts to ensure adequate safety processes for drug approvals and, in turn, fewer medical injuries. If President Obama’s recent actions are any indication of whats to come, these critics will soon have their wish.

Last month, President Obama appointed two health experts to top positions at the FDA. Former New York City health commissioner, Margaret Hamper, is the President's choice for the agency's commissioner; while pediatrician and child safety expert, Joshua Sharfstein, is the President's choice for deputy commissioner. Experts believe that the President's choice of two experts is an indication that he is in favor of splitting the FDA into two separate units.

FDA critics have long argued that the agency is overworked and simply unable to monitor the safety of the vast amounts of pharmaceutical drugs, medical products, and medical devices that come through its doors. The agency suffers from under staffing and a shortage of resources necessary to ensure drug safety. FDA officials, themselves, admit that the agency is unable to meet the changing demands of a globalized world, where pharmaceutical drugs are frequently sourced from foreign plants. In 2005, the FDA approved close to 3,200 applications for marketing of new medical devices. Yet, the agency has only a fraction of the scientist and researchers necessary to process so many applications. Because of this the FDA often has no other option, but to rely on the device makers themselves to disclose the risks of their products.

FDA Division Supporters

The drug industry has been quietly supporting a possible division of the agency, because it could result in faster approvals of pharmaceutical drugs. The FDA experiences frequent delays in its approval and review processes for pharmaceutical drugs due to its shortage of staff. However, medical injury lawyers would welcome an FDA split due to the possibility of more stringent monitoring of review processes and, therefore, enhanced safety of drugs and devices approved for promotion.  

In recent years the FDA has battled several food safety crises. Every time there is a contaminated batch of peanut butter or pistachios, the agency is forced to turn its attention to food safety. It has become increasingly clear that we cannot continue to expect the agency, responsible for making sure tomatoes and peppers are free of pathogens, to also be responsible for monitoring the safety of bone graft products, implantable cardioverter defibrillators and drug eluting stents.

If you've been injured through use of a defective drug, medical device, contact a medical injury lawyer at Arnold & Itkin LLP for a free evaluation.

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Already facing heat for its Medtronic lead and defibrillator injury scandals, the medical device major now faces new issues. An eminent researcher and spine surgeon at the University of Wisconsin admitted that he received payments from the company to the tune of $19 million to develop and promote the Infuse Bone Graft, among other things.

The researcher, Thomas Zdeblick, received payments over a 5 year period and, according to the Wall Street Journal, the payments were made to help in the development and promotion of spinal products, including the Infuse Bone Graft. These facts were revealed in a letter written by Senator Charles Grassley to the University, as part of his investigation in the conflict of interest arising from pharmaceutical companies' payments to doctors. The University of Wisconsin policies require doctors to reveal payments of up to $20,000, but does not require specification of payments beyond $20,000. The University policies on this matter are in line with the policies enforced by other universities and medical research centers. The University admitted that its medical disclosure requirements are inadequate and officials said they will be changing the rules to require doctors to specify exact payment amounts received from companies.

Technically, there is nothing wrong with Zdeblick's failure to reveal the $19 million he received over the years.  Zdeblick claims that he disclosed his financial relations with Medtronic to his patients and always has. However, this is Medtronic we are talking about, a company that has recently come under suspicion of encouraging off-label use, which is illegal. Just a few weeks ago, the family of a California woman who died after Infuse was inserted in her neck against FDA approved uses, filed a medical injury lawsuit against Medtronic for pressuring the doctor to use the bone growth product in an unapproved manner. The nexus between pharmaceutical companies and medical researchers is well known. However, it has increasingly been scrutinized by lawmakers and medical injury lawyers who would like to see scientists and researchers given more independence from the influence of pharmaceutical companies.

There are several ways in which a monetary relationship between a researcher and a drug company can impact the safety of medical products. First, there is always the risk of drugs and devices being pushed for approval simply for financial gain.  A conflict of interest also exists when a doctor is paid by a company for developing a product and then goes on to promote the same product to patients; no one can argue that there is bias in a situation like this. The only party that suffers when unethical things like this happen are the patients injured by defective products and drugs and their families.

Medical Injury Litigation

Taking on big name companies like Medtronic Inc. requires the expertise of an experienced medical injury lawyer who has the resources necessary to handle your case. Here at Arnold & Itkin LLP we have successfully resolved many medical injury and defective medical product cases.

If you've been injured by the use of a defective medical product, drug or device, contact a medical injury lawyer at Arnold & Itkin LLP for a free evaluation of your claim.

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Medtronic Inc. is facing a lawsuit over the death of a California woman after a surgery during which the company's Infuse bone growth medical product was inserted into the neck. The lawsuit is the first for the company stemming from allegations that Medtronic indulges in promotion of off-label use of its bone growth product, a liquid protein sealed in a casing and inserted between the vertebrae.

The lawsuit is unusual in that it doesn't blame the doctor for the complications that resulted after 74-year-old Shirley Nesbit underwent the surgery to insert the bestselling bone growth protein in her neck. The FDA had recently warned doctors against use of the product in the neck, because of the possibility of respiratory difficulties. Nesbit underwent the surgery in August, a few weeks after the FDA's warning. She developed serious respiratory problems because of the pressure on her neck and throat.   Attempts to insert a breathing tube lost precious minutes for Nesbit, and she slipped into a coma, dying 9 days later.

Her family alleges in the lawsuit that Medtronic's representative who was present during the surgery, pressured the doctor to use Infuse in her neck, although the FDA approves it for use only in the lower back, and for certain dental applications. Doctors are not prohibited from using any medical product for applications that are not approved by the FDA, but companies are not allowed to push for off label use of the product, which is what Medtronic is accused of doing. Both Medtronic and the surgeon in question, deny any pressure to use Infuse. The company, no stranger to medical injury lawsuits because of its earlier problems with its defective Medtronic defibrillator devices, claims that representatives are sometimes present at procedures for support and advice to the surgeon. Making things worse for Medtronic are two whistleblower lawsuits by former employees that charge the company with paying doctors to use Infuse in ways not approved by the FDA.

Medtronic Encouraging Unapproved Use of Infuse

There have been several complaints about off-label use of Infuse, and patients have suffered obstruction of the airways leading to breathing problems after insertion. Lack of oxygen can cause brain damage in a patient. Patients often need tracheotomies to relieve pressure on their airways, and require respiratory and feeding support.

Infuse Medical Device Lawsuits

Medtronic is facing a Department of Justice probe into allegations of promotion of off-label use. However, for patients who have been injured because of such unapproved use, there is a way to obtain justice – through a defective medical device or product lawsuit against the company with the help of a medical injury lawyer. If you or a loved one has been injured by an off-label use of Infuse - meaning use of the product anywhere, except on the lower back or in oral treatments – then you may be entitled to compensation for your suffering. Contact the experienced medical injury lawyers at Arnold & Itkin LLP for a free evaluation of your case.

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CSI, USA, Inc. issued a voluntary nationwide consumer product recall of all lots of 1 ounce (28 g) tubes of 10% Benzoyl Peroxide Acne Cream with the following names: "DG Maximum Strength Acne Medicated Gel" (sold at Dollar General); "Kroger Acne Gel 10% Benzoyl Peroxide Acne Medication" (sold at Kroger); and "Equate: Medicated Acne Gel" (sold at WalMart).

These defective medical products are being recalled because samples of the products were found to contain bacteria identified as "Burkholderia Cepacia," formerly known as Pseudomonas Cepacia.

After conducting a thorough assessment, the company concluded that the risk of illness in healthy individuals following use of this product is very low. However, there could be an increased health risk of infections for individuals with cuts, scrapes, rashes or other compromised skin conditions; or those with weakened or suppressed immune systems.

When medical product manufacturers make and distribute dangerous or defective products, innocent people can be harmed. The skilled attorneys at Arnold & Itkin LLP can hold them accountable. If you have questions or would like to speak to an attorney, contact a defective medical products lawyer today. Initial consulation is free.

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Covidien has recalled ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles. The mislabeled syringe may result in patients receiving an overdose of as much as 2.5 times the intended dose, with serious health consequences, low blood sugar, and even death.

These syringes are sold only by Wal-Mart or Sam's Club pharmacies under the ReliOn name. The recall applies only to lot number 813900. The product was distributed from Aug. 1, 2008 until Oct. 8, 2008, and includes 471,000 individual syringes in 4,710 boxes.

FDA urges patients and health care professionals to check syringe packaging carefully for products with this lot number, not to use the product, and return the product to the pharmacy for replacement. The lot number can be found on the back panel of the 100 count syringe carton, or on the white paper backing of each individual syringe “peel-pack”.

If you or a loved one has been injured by this defective pharmaceutical product, you may be entitled to compensation. A medical injury lawyer can help you hold them accountable.  Contact a medical injury lawyer at Arnold & Itkin LLP. We can answer questions and help you understand your options.

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