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

The medical injury lawyers of Arnold & Itkin LLP released a new video on LawyerForYou.com that addresses the importance choosing the right lawyer if you or a loved one has suffered a serious injury or death as the result of medical malpractice or using a defective medical device or dangerous pharmaceutical drug. Medical attorneys Jason Itkin, Kurt Arnold and Lisa Sechelski discuss what attributes you should look for when choosing a medial injury lawyer and how Arnold & Itkin LLP goes the extra mile to provide true full-service care for their clients. In the video, you'll also hear from actual clients and learn why they chose Arnold & Itkin LLP.

The medical attorneys at Arnold & Itkin LLP help people injured by medical malpractice, defective medical devices and pharmaceutical drugs.

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The Houston trial law firm Arnold & Itkin LLP has filed five lawsuits against the makers of defective pain pumps and related medications based on claims that many of the company’s defective medical devices  are causing irreversible shoulder damage among patients. Currently, medical attorneys at Arnold & Itkin LLP represent 28 people who received pain pumps to manage pain following shoulder surgery. The pumps utilize a catheter to deliver continuous doses of medication directly into the shoulder. According to the lawsuits, pain pump manufacturers were denied approval by the U.S. Food and Drug Administration to use the pumps to mitigate pain in shoulder joints, but the companies continued to promote their use in that way. Many former pain pump users say the companies were negligent in designing, researching and selling pain pumps that they should have known were dangerous. The legal filings include claims of fraud, breach of warranty and products liability against the defendant manufacturers.

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Last week, U.S. Food and Drug Administration (FDA) officials held what the New York Times called a “rare” meeting to discuss the many controversies surrounding the agency's device safety record; medical attorneys think the meeting is past due.

The director of the FDA’s Office of Device Evaluation, Dr. Donna-Bea Tillman, called for an “all hands meeting,” to include all scientists in the device evaluation section. Shockingly, a meeting like this has not been held at the FDA in years. Then again, when you consider the agency's medical device safety record, it really is not very surprising.

The meeting is the most recent in a series of developments surrounding the FDA's record in approving devices. At least 9 scientists this year wrote to Principal Deputy Commissioner, Dr. Joshua Sharfstein, alleging that approval procedures in the device section were being "severely distorted." The letter also alleged that scientists at the agency, who were raising their voice against such unethical practices, were facing retaliation by FDA higher-ups. The matter has been serious enough to warrant a Congressional investigation. Soon, the Institute of Medicine could also begin probing these serious concerns about the device section.

Things seem to be heating up at the medical device section of the FDA. Two things are apparent at this point:

• There are serious failures in the medical device division of the FDA.
• These problems are not going to be solved by mere patch-up work.  Rather, the section needs a complete overhaul to root out unethical practices, and make approval processes corruption-proof.

Any changes that come about at the medical device division cannot be a day too soon.

Defective Medical Devices

It is the FDA's responsibility to protect American consumers from dangerous medical devices. If they fall down on the job and let corrupt individuals get in the way of important safety evaluations, we are all at risk.

If you or a loved one has been injured by a defective medical device, a medical injury attorney can help you recover physically, emotionally, and financially.

Contact a medical injury lawyer, at Arnold & Itkin LLP for a free consultation and to find the answers to any questions you might have.

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Across the country, support for the Medical Device Safety Act of 2009 is growing as medical injury lawyers, patients' rights groups, and the New England Journal of Medicine throw their combined weight behind it. The Act, which was introduced in March, aims to overturn the 2008 Supreme Court ruling that granted device makers immunity for injuries caused by U.S. Food and Drug Administration (FDA)-approved devices.

The Act was introduced by U.S. Representatives Frank Pallone Jr. (D-NJ) and Henry Waxman (D- CA), together with a similar bill, introduced by Senator Edward Kennedy (D-MA) and Patrick Leahy (D-VT). It seeks to nullify the Supreme Court's ruling in Riegel v. Medtronic. In that case, the Supreme Court ruled that patients could not file medical injury lawsuits against device makers under state laws, if the device had been approved by federal regulating authorities.

The new Act has spurred action from health and consumer groups, and has received backing from the American Bar Association. The Center of Justice and Democracy released a report, Hazardous Heart Devices and the Importance of Litigation, that offers a chilling look at the way heart device makers have used blatant cover ups to avoid liability for defective products. Even the venerable New England Journal of Medicine has thrown its support behind the bill, arguing in favor of patients' rights to full disclosure of the benefits and risks of a device and their right to hold a company accountable if it fails to disclose all risks associated with a device.

Medical Injury Lawsuits

Medtronic, the company responsible for setting off the preemption debate, is standing firm in its belief that the FDA should be the sole arbiter of a device's safety. Determining safety of a device is the responsibility of the FDA and should not be left to "juries of laypersons," company representatives say. The company has managed to duck numerous medical injury lawsuits related to its defective Sprint Fidelis leads and judges around the country have used the Supreme Court ruling to dismiss many other medical injury lawsuits.

As things currently stand, patients can sue pharmaceutical drug companies for their failure to warn of risks that cause medical injuries, but cannot sue device makers. It is a strange and entirely incompatible state of affairs and the bill's supporters hope patients' right will be soon be reinstated.

If you've been injured by the use of a defective medical device, contact a medical injury attorney at Arnold & Itkin LLP for a free consultation.

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Boston Scientific Corp. recently announced, a malfunctioning wire in Cognis and Teligen defibrillators may result in an abnormal or unnecessary shock, causing serious medical injuries to patients.

Boston Scientific introduced the defibrillators last year in an attempt to grab market share from other device makers. The company expected sales from the two defibrillators to fast track growth this year. The safety warning, sent to cardiologists, seems to have put a halt on the company's plans, in addition to causing concern to thousands of patients who are implanted with the Cognis and Teligen defibrillators. The company says about 34,000 units have been sold since their introduction. The problem, however, is restricted to about 8,000 of these devices that come with respiratory sensors. The wires that connect the defibrillator to the heart are prone to malfunction which can result in one of two situations:

• The device may fail to operate properly, resulting in failure to emit a lifesaving electrical jolt to the heart when an abnormal cardiac rhythm is detected.
• The device may deliver an unnecessary electrical shock to the heart, resulting in severe pain and cardiac injuries.  

Wire problems with defibrillators tend to increase as the device gets older. The Cognis and Teligen defibrillators however are a relatively new entrant into the $11 billion defibrillator market. This is why the announcement, which warns of the device's susceptibility to early malfunction, surprised so many defibrillator experts. If these warnings seem all too familiar, it is because medical injury lawyers and patients who suffer from cardiac arrhythmia remember the thousands of injuries and 13 deaths caused by Medtronic’s malfunctioning defibrillators in 2007.

Defective Defibrillators

Considering the number of problems linked to these devices, it is fair to assume that there could potentially be malfunctions in defibrillators manufactured by other companies also. Cardiac defibrillator devices have been a blessing for thousands of patients who suffer from heart problems. However, manufacturing companies have been reluctant to inform the public about problems with the devices. To make matters worse, the U.S. Food and Drug Administration, which is supposed to screen devices thoroughly before approving them for marketing, has been slow to warn patients.

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

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The U.S. Food and Drug Administration (FDA) has issued a Class I recall for Baxter International's Colleague infusion pumps, but a prominent consumer advocacy group is criticizing the agency for its delay in issuing the recall.

The recall was made concerning Single and Triple Channel Volumetric Infusion Pumps, which are used to deliver fluids and drugs to patients. There is a malfunction in the battery and software of the device that can cause an interruption in the infusion. This defect is serious enough to cause injury or death, therefore, the recall assigned is a Class I.

In January, Baxter sent a letter to customers informing them of the failures in the pumps. The warning included an alert that the pump could overheat, resulting in fire and smoke if not properly cleaned. The letter also underscored the importance of proper battery care, pointing out that failure to do so could cause the device to malfunction.

Baxter issued a press release announcing the recall on March 11th; the FDA posted a recall notice on its website the same day, a full seven weeks after Baxter sent the letter to customers. The FDA has come under fire by Public Citizen for its delay in issuing the recall of the drug pump. The criticism is not new – medical injury lawyers have insisted that the FDA issue recall notices quickly and on its own, rather than waiting for companies to act first.

Colleague infusion pumps have been linked to safety issues for years. The FDA, in fact, has issued at least 7 Class I recalls for the pumps. The company stopped sales of the pump in the U.S. in 2005, but at least 200,000 of the pumps are currently in use in hospitals and nursing homes across the country. The malfunctioning, which can cause the pumps to stop pumping and overheat, has been blamed for at least 19 deaths. Sidney Wolfe, the director of the Health Research Group of Public Citizen has demanded that all existing Colleague Infusion pumps be removed from the facilities that continue to use them to deliver fluids and medication to patients. Baxter, however, insists that a full withdrawal, including removal of pumps currently in use, would lead to a shortage in the market.

Delayed Recalls Increase Risk of Medical Injuries

Thousands of patients in hospitals and nursing homes around the country are at risk due to defective medical devices like Colleague Infusion pumps that they depend on to receive lifesaving drugs and fluids. It is outrageous that these pumps continue to be used, even after the manufacturer admitted the device has serious flaws.

If you've suffered injuries due to the use of a defective medical device, contact a medical injury lawyer at Arnold & Itkin LLP for a free evaluation of your claim.

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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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In recent weeks, patients injured by Medtronic defibrillators have watched in pain as judges around the country dismissed their medical injury lawsuits. Law makers' recent plans to reintroduce patients' rights, give them reason to cheer.

Democratic lawmakers are working on plans to reintroduce legislation that would return patients' rights to sue medical device companies for their injuries. In February 2008, the Supreme Court ruled that patients injured by the use of defective medical devices, like Medtronic defibrillators, could not file a lawsuit against the company if the device had received approval from the Food and Drug Administration (FDA). Since then, judges around the country have cited the Supreme Court decision numerous times, using it as an excuse for throwing out hundreds of lawsuits including several against Medtronic. On February 17th, a judge in Wisconsin dismissed a lawsuit filed by a 63-year-old man who needed surgery to remove a Medtronic device after the company warned that the batteries may suffer from a sudden depletion of power causing it to malfunction. Earlier this year, a judge in Minnesota dismissed hundreds of Medtronic injury lawsuits brought by injured patients.

With the new administration, however, it seems like patients may have their right to sue companies like Medtronic returned to them. House democrats, Henry A. Waxman of California, who also serves as the chairman of the House Energy & Commerce Committee, and Frank Pallone Jr. of New Jersey, plan to introduce legislation that would nullify the Supreme Court ruling. Senator Edward Kennedy of Massachusetts and Patrick Leahy of Vermont sponsored a similar bill last year which could be reintroduced later this year.

At the crux of the Supreme Court decision last year was the belief that the FDA, as the country's chief drug and medical device safety agency, could be trusted to approve a product only after ensuring it was entirely safe to use. Since then, we have seen evidence of the agency's ineptitude, not only in the number of defective drugs that seem to enter the market like contaminated Heparin and Vioxx, but also through the whistle blowing efforts of its own staff who allege that the agency's approval processes are questionable. In this situation, where companies attempt to push their products through approval processes as quickly as possible and the FDA continues to lurch from one food and drug safety scandal to another, the only losers are patients who end up with no recourse to civil justice after they suffer injuries. Several lawmakers, medical injury lawyers, and patient advocates have strongly voiced their opposition to the 2008 Supreme Court ruling. With a new administration in power, however, it seems like change is finally coming to American civil justice.

Medical Injury Lawsuits

Going up against big medical device manufacturers like Medtronic can be intimidating. In conjunction with laws prohibiting your right to justice, however, it can seem impossible. Our team of medical injury attorneys can help you find the resources you need in such a situation.

If you have been injured by the use of a defective medical device, contact a medical injury lawyer at Arnold & Itkin LLP to learn how you can begin to recover compensation for your suffering.

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Earlier this year, a Minnesota judge dismissed hundreds of Medtronic injury cases, citing federal preemption over state law in medical injury lawsuits. It now appears that the judge failed to disclose that Medtronic has been a longstanding client of the law firm his son works for.

This provides a shocking and controversial twist to the litigation and offers a spark of hope to plaintiffs who's cases were dismissed. Judge Richard H. Kyle was appointed to preside over the lawsuit that included nearly 700 Medtronic injury lawsuits, brought by patients who suffered injuries from Medtronic Sprint Fidelis defibrillator leads. In January, Judge Kyle dismissed all Sprint Fidelis injury lawsuits citing a Supreme Court opinion that establishes the preemption of federal regulations over state law. Now, attorneys for the plaintiffs intend to cite potential conflict of interest because Kyle's son works for the law firm Frederickson & Byron, which has represented Medtronic for years. Judge Kyle insists that he did not see the need to reveal that fact, because his son's work involves criminal law and would, likely, not have had much to do with Medtronic. Plaintiffs' medical injury lawyers have made clear their intention to have Kyle disqualified from the case for his failure to reveal the relationship his son's law firm had with Medtronic. Meanwhile Medtronic, in an effort at damage control, has released a statement claiming that Judge Kyle’s son has never represented Medtronic, the world's largest medical device maker. It seams like this is not the last we will hear of the Minnesota Medtronic lawsuits.

Medtronic Sprint Fidelis Lead Injuries

Medtronic Sprint Fidelis defibrillator leads were the subject of a recall in 2007 when it became apparent that the defective leads could fracture, causing an electric shock to the heart. These lead fractures could also result in the failure of the defibrillator device to function properly and administer a life saving shock to the heart in case of an abnormal heart rhythm. At least 5 people have died from these injuries and hundreds have been injured.

If you have been injured by the Medtronic defibrillator leads or any other defective medical device, contact a medical injury lawyer at Arnold & Itkin LLP for a free evaluation of your claim. 

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Pharmalot has a report that's bound to be of special interest not just to medical injury lawyers around the country, but also to millions of Americans who have been implanted with a medical device. According to the report, a group of scientists at the FDA's Center for Devices and Radiological Health division have, in a letter to the House Energy and Commerce Committee, made dramatic charges about the "coercions" and "force" that they have been subjected to in order to speed up or bypass normal procedures before approval of medical devices.

The charges have been shocking enough to galvanize John Dingell, chairman of the Committee and Bart Stupak, Chairman of the Subcommittee on Oversight and Regulations to launch a probe into these allegations. According to the report, scientists were "ordered, intimidated and coerced" by higher-ups into modifying their recommendations for approvals in violation of standard FDA procedural practices. These coercion techniques included, the experts say, being forced to use unreliable evaluation processes, and accept data that was not procured through correct scientific means. All this was done, the letter alleges, to allow the faster approval of certain medical devices and products.

These allegations are deeply concerning to all citizens, but the tragedy is that this isn’t the first time frustrated scientists at CDRH have tried to bring this to the attention of FDA authorities. In May of this year, a similar letter with the same charge was sent to FDA officials, and in response, recommendations were made for the removal of some senior managers at CDRH. In that instance, investigating officers found "compelling evidence" that these charges were true. The fact that such allegations have been made again, this time in a letter sent to the ECC, indicates that the problem is more deep rooted than we think.

Corrupt FDA Practices and the Potential for Medical Injuries

Let's look at the implications of how this coercion of employees to rush through device safety approval procedures affects the ordinary citizen. Depending of course, on whether these latest charges are 100 percent true, and the number of years these unethical practices have been going on at the FDA, it's conceivable that thousands of people are walking around with unsafe, ineffective, or defective medical devices ranging from pacemakers and stents, to breast implants and intraocular lenses. The potential for injury through these devices is staggering, and the consequences for public safety are enormous.  As long as the FDA continues to play with the health of ordinary Americans, we can hope that pharmaceutical companies that benefited from these unethical practices will be kept in check by medical injury lawsuits and other actions brought on the part of injured consumers.

Building a Medical Injury Lawsuit

Medical devices can cause serious injuries not just through faulty design and manufacture, but also because of failure to test these devices properly, or to provide proper instructions for their use. Injuries from a defective product can include adverse reactions to the product and life threatening complications. 

Medical device litigation can be a complex and intensive process. If you have been injured by a defective device, you will need the help of an experienced medical injury lawyer to build your lawsuit. Contact a medical injury lawyer at Arnold & Itkin LLP for a free evaluation of your case.

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Terumo Cardiovascular Systems (Terumo CVS) has issued an urgent worldwide recall of its Tenderflow™ Pediatric Arterial Cannulae, a defective medical device, involving 21 lot codes (see information below). Terumo received five reports of difficulty retracting the introducer from the cannula. When the introducer cannot be retracted from the cannula, the cannula must be removed and replaced, a process that may lead to aortic damage, blood loss and/or death.

Tenderflow™ Pediatric Arterial Cannula Catalog and Lot Numbers Affected

When and how is the device used?

An arterial cannula is a disposable tube inserted in the aorta during many cardiac bypass surgery procedures and is used to perfuse the ascending aorta. The cannula is inserted using an introducer, which stabilizes the cannula during insertion and is then removed.

Where was the defective device distributed?

Terumo Cardiovascular Systems Corporation is a global manufacturer and marketer of medical devices for cardiac and vascular surgery. Terumo CVS distributed this product directly to 68 U.S. hospitals, and has notified all of the hospitals of the voluntary recall in a letter dated Oct. 16, 2008. The product was also distributed from distribution centers in Australia, Canada and Europe.

Terumo recalls the defective medical device

Terumo informed the U.S. Food and Drug Administration of this recall. The notification letter recommended that customers not use the product unless it is medically necessary.

Injured by the Terumo Arterial Cannula?

If you or a loved one have been injured by this dangerous medical device, you may be entitled to compensation from those responsible. Medical device manufacturers have an obligation to manufacture and distribute safe products. When they fail to do this, a medical injury lawyer can hold them accountable. If you have questions, contact a medical injury lawyer today for a free initial consultation. We can help you understand your options for claiming compensation.

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