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

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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In a step long awaited by medical injury lawyers, the U.S. Food and Drug Administration (FDA) has announced it will ask makers of external defibrillators, pacemakers, and other medical devices to prove the safety and effectiveness of their products.

These devices, among others, were allowed into the market with very little testing in 1976, before the medical device law was passed. After the law was enacted, the FDA was supposed to determine which of the older devices needed retesting before the agency could give approval for new versions. The agency, however, failed to do so and, for years since, has continued to approve such devices without requiring rigorous safety testing. The agency recently began a review of two of its older device categories and will be sending notices to the makers of at least 25 other device types, asking them to submit product safety information to the agency within 120 days.

The device categories include several high risk devices like external defibrillators, pacemaker parts, and others that have been in the news for various medical injury lawsuits. With this, the theory that the FDA has stringent monitoring processes and should, therefore, be the sole arbiter of a device's safety, has been debunked.

Meanwhile, patients across the country who have been implanted with Medtronic's Sprint Fidelis Defibrillator leads, just one example of the FDA's failure to monitor the safety of devices, are living in anxiety that their devices could malfunction, leading to severe injuries. For these patients, every day that goes by could mean further deterioration of the lead that connects the defibrillator to the heart, and even more anxiety. The extraction process is high risk and not recommended; these patients are caught between a rock and a hard place. They cannot undergo surgery because it is risky, and they cannot sue the company because of the Riegel vs. Medtronic Supreme Court ruling, in which the court held that a device maker could not be sued for injuries caused by an FDA-approved medical device.

The FDA and Defective Medical Devices

For those of use who have never fallen for the theory that the FDA's "stringent" review processes can be relied on, and that device makers, therefore, deserve immunity from lawsuits relating to agency-approved devices, this move by the FDA is a welcome first step. However, thousands of patients who have been injured by the use of these minimally tested devices continue their wait to seek justice for their injuries.  

The medical injury attorneys at Arnold & Itkin LLP have extensive experience representing victims of injuries. If you have been injured by the use of a defective medical device, contact a medical injury attorney at Arnold & Itkin LLP for a free evaluation of your case.

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Supporters of the 2008 Supreme Court ruling that granted device makers immunity from medical injury lawsuits brought on by FDA approved devices, should rethink their position. According to the Wall Street Journal, a knee device maker engaged in unethical lobbying to obtain U.S. Food and Drug Administration (FDA) approval for its new device.

The approval for Menaflex implants, which are used to help knee injury patients, was given overriding objections by FDA scientists. According to FDA correspondents, several senior staff members of the agency complained that ReGen Biologics Inc., the company that manufactures Menaflex, pressured the agency to approve the device. Lawmakers have since gotten involved in the controversy with Senator Chuck Grassley sending letters to the agency as well as the device maker, calling for more information about interactions between the two. According to Senator Grassley, his investigation is based on emails that suggest the agency was overenthusiastic in its readiness to ‘’accommodate the company.’’ Menaflex received approval under the agency's fast track rules, in which clinical trials are not necessary.

It is not only ReGen Biologics Inc. and the safety, or lack of it, of Menaflex in question here. At the crux of the matter are the reliability and integrity of FDA approval processes. Email correspondence between staff members at the agency indicate that they removed certain lines from emails that could indicate ‘’special treatment for the device maker.’’ FDA critics are concerned about what they call the agency’s tendency to bow to device companies. The fast track process, in particular, has come under intense scrutiny. The process allows scientists to bypass clinical trials only when reviewing devices similar to existing ones. There is no explanation forthcoming about why Menaflex was approved under the fast track process considering it is the only device of its kind in the market. With the FDA behaving more like a corrupt government than the country's premier drug safety agency, it is fair to assume that medical injury lawyers will be kept busy for a while.

Defective Medical Device Lawsuits

Medical devices that are rushed through approval processes or approved through lobbying efforts may come with risks that can pose potential dangers to patients. These devices may not have had stringent review guidelines applied to them, which means their safety may not be thoroughly verified.

If you've been injured by the use of a defective medical device, and want to know if you are eligible for compensation, contact an experienced medical injury lawyer at Arnold & Itkin LLP.

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Georgia has introduced legislation aimed at protecting manufacturers of pharmaceutical drugs and medical devices from injury liability in a misplaced effort to attract these companies to the state.  If it becomes a law, the bill may have dangerous implications for Georgia residents who could have their options for liability claims severely limited.

Senate Bill 101 was introduced last week by Senator Bill Cowsert (R- Athens). The bill, which has the approval of Governor Sonny Perdue, aims to amend existing liability codes. Promoters are hoping to pass it before Atlanta becomes the venue for the world's largest biotechnology conference in May. Earlier this year, Governor Perdue unveiled the legislation at a meeting of the Georgia Chamber of Commerce, outlining his intention of making it harder for victims to pursue civil liability claims against pharmaceutical companies. Basically, the bill grants immunity to drug and medical device manufacturers from any medical injury lawsuits if the drug or device has already been approved by the Food and Drug Administration (FDA). It is no secret that the legislation is aimed at making the state's investment climate attractive to pharmaceutical companies who may consider setting up business there. As a spokesman for the governor confirms, the state wishes to pursue these companies aggressively to set up base in Georgia, and so, has dangled the civil liability immunity carrot in front of them.

Not surprisingly, civil justice proponents, patients' rights advocates and medical injury lawyers have been vocal in opposing any bill that grants immunity to pharmaceutical companies and medical device makers based purely on FDA approval of drugs or devices. As we have seen in recent years, many drugs and devices have been hastily pulled off the market after the dangers of using them came to light. All of these products had FDA approval. There are critics both within the FDA and outside the organization who claim its inspection standards and oversight procedures are far from adequate. In a scenario like this, passing legislation that relies purely on FDA approval to decide the validity of medical injury lawsuits is extremely harsh and unfair to patients. Beside, dangling the immunity carrot in front of pharmaceutical companies may actually prove counterproductive. The only other state that grants immunity to these companies is Michigan, which, contrary to being flooded with investment after the immunity law was passed, has actually found thousands of pharmaceutical jobs leaving the state.

Medical Injury Lawyers

Any time a state attempts to interfere with patients' rights to hold companies responsible for their injuries is a bad sign for civil justice in the country. Granting these companies immunity at the cost of patients' rights to protect themselves is a serious mistake, and one we hope Georgia won't make.

If you have been injured by the use of a defective pharmaceutical drug or medical device, contact a medical injury attorney 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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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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