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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The U.S. Food and Drug Administration (FDA) and Tri-State Hospital Supply Corporation have announced a Class I recall of several types of Centurion disposable trays and kits due to of defective packaging, which can lead to these products losing their sterility.

According to the recall notice, the disposable trays and kits have flawed package sealing that could compromise the sterility of the products. The trays and kits, which were distributed between November 2008 and January 2009, were used to insert catheters and ports. Health care professionals have been advised to remove the recalled products from their stocks and hold them until Tri-State Hospital Supply Corporation arranges to take them back. The FDA notice advises health care professionals and consumers to report any adverse reactions resulting from the use of the products. There is no information yet on whether these products have been responsible for any injuries or illnesses. Tri-State Hospital Corporation is a Michigan-based company that manufactures and distributes medical products throughout the country.

Medical products that are not properly sterilized or have a high risk of contamination due to poor or substandard packaging can lead to infections and illnesses. The use of sterilized products ensures that the risk of contamination is kept at a minimum. Defective packaging is usually the result of poorly monitored manufacturing and packaging practices. Tri-State has not yet commented on how the problem occurred, but it is likely that there was a less-than-stringent quality control process in place at the packaging facility.

Defective Medical Products

Lack of sterilization of medical products can expose a patient to infectious illnesses that can exacerbate medical conditions. Pharmaceutical companies are responsible for the quality of their products and any illnesses or injuries that result can place them at fault in a medical injury lawsuit.

If you have been injured by the use of a defective medical product, a medical injury lawyer can help you recover compensation. Contact a medical injury lawyer at Arnold & Itkin LLP for a free evaluation of your claim.

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Michigan has the somewhat dubious distinction of being the only state in the country to grant pharmaceutical companies immunity from medical injury lawsuits. That may soon change - on March 26th, the Michigan House of Representatives approved a set of three bills aimed at reversing that immunity.

This is the second time the Michigan House of Representatives has passed the bill granting pharmaceutical companies immunity. Of the three bills, the third aims to allow medical injury lawsuits retroactive to 1996, when then-Governor John Angler signed the law that gave the pharmaceutical industry immunity from lawsuits brought by patients harmed by U.S. Food and Drug Administration (FDA) approved products.

The law has been criticized by medical injury lawyers and patient rights advocates, and has been detrimental for thousands of medical injury victims unable to take action against these, often, negligent pharmaceutical companies. These people are victims of a range of defective drugs, such as:

• Paxil
• Avandia
• Heparin

What the law has done, essentially, is give pharmaceutical companies a free pass to market and promote their drugs (in the state) without any fear of consequences in the event of the drugs causing injuries or deaths. Patients injured by the drugs are currently helpless in the face of the law. At the time the bill was passed, proponents insisted that it would attract pharmaceutical investment in the state; that theory has since been disproved. Pharmaceutical investments and companies have moved out of Michigan in recent years, taking valuable jobs with them.

Georgia has since tried to emulate Michigan's example. Governor Sonny Perdue introduced a tort reform bill earlier this year that sought to prohibit medical injury lawsuits against pharmaceutical companies for products approved by the FDA. Better sense seems to have prevailed there; that bill was rejected in the Georgia Senate Economic Development Committee.

These instances of states attempting to block patients' right to file medical injury lawsuits against companies signify a dangerous trend. Michigan has one of the highest unemployment rates in the country and their drug immunity laws have done nothing to revitalize it. Other states should take note.

Medical Injury Lawsuits Hold Companies Accountable

The prospect of being held liable in a medical injury lawsuit is probably the biggest factor motivating drug companies to ensure that their products are safe for use. In the absence of such accountability, companies are encouraged to rush through drug approvals. The only people who suffer from this carelessness are unfortunate consumers.

If you've been injured by the use of a defective drug, contact a medical injury lawyer at Arnold & Itkin LLP to discuss your case.

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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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Under scrutiny for its failure to prevent unsafe pharmaceutical and medical devices from entering the American market, the U.S. Food and Drug Administration has been criticized by a government body in a report filed this week.

The U.S. Government Accountability Office (GAO) expressed doubts that Americans can expect adequate protection “from unsafe and ineffective medical products” from the FDA.  The GAO submitted its list of federal government agencies that are in need of improvement and the FDA made the list, which also includes the Treasury Department and Medicare. According to the report, FDA efforts to ensure the safety of the American consumer have been deterred not only by increasing globalization that has led to a large number of drugs and devices being made in overseas plants, but also because newer and more complex devices are being developed. Already bogged down by a lack of resources to handle such complex and technologically advanced products, the FDA also lacks access to databases that allow thorough and regular inspections of all plants, including the many overseas.  Other groups have also criticized the FDA's record in keeping dangerous drugs and devices out of the American market. The FDA acknowledges that there are holes in the system that need to be plugged if the agency is to be able to carry on its task of protecting American consumers.

Meanwhile, with a new administration in power there are signs that a beefing up of FDA may be in the works. According to another report, House Energy and Commerce Democrats are planning to introduce new laws that give the country's premier drug safety agency greater powers to oversee pharmaceutical drugs and medical devices. Disapproval for the FDA's conduct has spilled over into criticism for just about anything the beleaguered agency does. Earlier in January, a slideshow that attempted to boost morale by comparing the FDA chief Janet Woodcock to Gandhi had lawmakers furious about the $1.5 million contract awarded to the consultant responsible for the creation of the slide show. Another point of criticism was that the slideshow contract was handed to a firm known for its contact with pharmaceutical companies. The FDA has, in recent years, also come under fire for its links to the pharmaceutical industry.

The agency's failure to guarantee the quality of pharmaceutical drugs and medical devices introduced into the market has left dozens of people dead and hundreds injured in recent pharmaceutical scandals. Some of these include Avandia heart injuries, contaminated Heparin and Paxil side effects.  

Medical Injury Lawyer

If you have been injured by the use of a defective pharmaceutical drug or medical device, you will need the representation of an expert medical injury lawyer to recover compensation. 

Contact a medical injury lawyer at Arnold & Itkin LLP for a free consultation.

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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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Johnson & Johnson - Merck Consumer Pharmaceuticals Company has recalled approximately 12,000 units of Infants' MYLICON® GAS RELIEF DYE FREE drops (simethicone-antigas) non-staining sold in 1 oz. plastic bottles that were distributed after October 5, 2008 nationwide. Infants' MYLICON® drops are sold over-the counter, in retail stores and pharmacies, as an anti-gas medicine to relieve the discomfort of infant gas frequently caused by air swallowing or by certain formulas or foods.

The company is initiating the recall in consultation with the U.S. Food and Drug Administration (FDA). Although the company claims the potential for serious medical events is low, they are implementing the recall to the consumer level as a precaution after determining that some bottles could include metal fragments from the manufacturing process.

According to a joint press release issued by Johnson & Johnson - Merck, any medical events that might occur as a result are expected to be temporary and resolve without medical treatment. However, the absence of manufacturing controls that would have prevented the contamination in the first place, may leave consumers justifiably doubtful of the risk assessment.

Get Help

When any foreign contaminant is ingested by an infant, there may be risk of injury.  Parents who have given the product to their infant and are concerned should contact their health care provider immediately. If this defective product was administered to your child and your child suffered medical complications or injury as a result, you may be entitled to claim compensation from those responsible. An experienced medical injury lawyer can explain your options.

The two lots of Infants' MYLICON® GAS RELIEF DYE FREE drops non-staining 1 oz. bottles included in the recall are:

Consumers can find the lot numbers on the bottom of the box containing the product and also on the lower left side of the sticker on the product bottle.

The recall does not affect any Original Infants' MYLICON® GAS RELIEF products (1/2 oz. or 1 oz. size) or Infants' MYLICON® GAS RELIEF DYE FREE drops non-staining (1/2 oz. size). The manufacturer has instructed retailers and wholesalers to return their inventories.

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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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The FDA issued a news release requesting that manufacturers of gadolinium based MRI contrast agents include a warning on the product labeling stating that patients with renal insufficiency who receive gadolinium-based agents “are at risk for developing a debilitating, and a potentially fatal disease known as nephrogenic systemic fibrosis (NSF)” or nephrogenic fibrosing dermopathy (NFD).  It also states that liver transplant recipients, individuals with chronic liver disease are also at risk for developing NSF / NFD if they are experiencing kidney insufficiency in addition to their liver condition.

In a healthy individual, gadolinium is removed from the body by the kidneys.  When the kidney functioning is compromised, the gadolinium remains in the body causing serious harm.  NSF / NFD can take weeks or months to appear in patients but once it begins the disease develops and progresses rapidly and can be fatal.  If you have undergone MRI or MRA and are experiencing any symptoms which may be related to NSF / NFD, you should seek immediate medical attention.

More information about gadolinium MRI contrast dye injury can be found on our Medical Injury Lawyer website.

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