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

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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A series of e-mails confirm what medical injury lawyers have suspected for months now - that GlaxoSmithKline has been long aware of the side effects associated with the use of its diabetes medication, Avandia.

In 2007, a study by pioneering Cleveland Clinic cardiologist Dr. Steven Nissen, published in the New England Journal of Medicine, revealed that patients who took Avandia are at a higher risk of developing cardiac disease. Doctor Nissen studied the effects of Avandia use in more than 15,000 patients, monitoring 12,283 subjects in a control group. He found 86 cases of myocardial infarction in the group that was given Avandia, compared to 72 cases in the control group, and 39 deaths among Avandia users as opposed to 22 deaths in the control group. At the time, Dr. Nissen acknowledged that a few deaths in more than 15 thousand subjects may seem like an inconsequential number, but because the studies were conducted over a short period of time and because of the increased risk of heart disease in diabetic patients, the enhanced incidence of heart attacks in Avandia users was cause for worry. Glaxo was quick to refute the findings of the study. The company released a statement questioning the methods used by Dr. Nissen, but the FDA quickly issued a safety alert on Avandia.

Since then, the link between Avandia and heart disease has become stronger with more numbers of people killed and hundred of cases of heart failure. Now, reports indicate that the company was aware of the increased risk all along. According to reports, senior GlaxoSmithKline scientists wrote e-mails just before the publication of Doctor Nissan's study admitting that his findings were "very similar" to the conclusions reached by GlaxoSmithKline. The company, at the time, was under scrutiny because of the Vioxx scandal which associated Merck's painkiller with an increased risk of heart disease. The Vioxx concerns ended with the company withdrawing the drug and hundreds of medical injury lawsuits filed by patients who suffered heart attacks after taking Vioxx.  Desperate to avoid Merck's fate, Glaxo went all out to criticize Dr. Nissen's findings almost immediately after publication of the study. Avandia use has decreased dramatically since then, but it remains on the market and thousands of patients continue to take the drug.

Pursuing Medical Injury Claims

Pharmaceutical companies may often hide important safety information about their drugs in order to remove obstacles in their marketing plan. Such suppression of information may be grounds for a medical injury lawsuit against the drug maker in the event of injuries caused by the drug.

If you or a loved one have suffered heart problems after taking Avandia, you may have grounds for compensation. Contact the medical injury lawyers at Arnold & Itkin LLP for a free evaluation of your case.

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A judge in St. Paul, Minnesota has dismissed dozens of lawsuits related to heart injuries caused by Medtronic's Sprint Fidelis defibrillator leads, citing federal preemption of state laws on the matter. 

In October of 2007, Medtronic Inc., stopped sales of its Sprint Fidelis defibrillator lead wires after reports that they failed to function properly in the event of heart attacks. The leads are wires that connect the defibrillator to the heart. When the lead is fractured the defibrillator cannot send a life saving shock to the heart in the event of an impending heart failure. The broken wire can also cause a massive and painful shock to the heart. After reports of patient injuries and deaths resulting from defective leads, Medtronic was forced to withdraw them from the market. At the time of the recall, approximately 257,000 patients had been implanted with the Sprint Fidelis defibrillator lead. Since then the company has faced multiple medical injury lawsuits filed by patients across the nation who sustained injuries caused by the defective leads.

In a separate case in February 2008, the US Supreme Court ruled under a controversial doctrine known as "preemption" that FDA approval of a medical device would supersede any lawsuit filed against a medical device maker under state laws. The Bush administration has pushed for preemption of federal regulations over state laws which has been criticized by consumer rights advocates and medical attorneys for the unwarranted protection it offers makers of medical devices. Under preemption, an injured patient would not be able to file a personal injury lawsuit against a medical device maker if the FDA had already approved the device. This doctrine works on the assumption that the FDA can never be wrong in all its approvals and that patients should have blind faith in the agency's ability to ensure that only the safest products enter the market. Unfortunately, the FDA's record on maintaining safety in drugs and devices introduced into the American market give little cause for comfort. The agency has battled allegations from its own scientists that approval for medical devices is obtained through coercive techniques.

Medtronic Sprint Fidelis Lead Lawsuits

Thousands of people around the country who have been injured as a result of the malfunctioning leads have filed lawsuits against Medtronic Inc.  For the remaining who have yet to suffer injuries from the malfunctioning lead, the prospects for replacing the lead are bleak, as it involves an invasive and potentially dangerous surgery.

As is evident from this lawsuit dismissal in St. Paul, taking on major pharmaceutical companies who enjoy the protection of the government is not an easy task. The medical injury lawyers at Arnold & Itkin LLP have the solid expertise and experience, as well as the considerable resources that pursuing Medtronic defibrillator lawsuits requires. We can answer your questions and help you evaluate your options for possible compensation.

If you have been inured by the Medtronic defibrillator leads, contact a medical injury attorney at Arnold & Itkin LLP. 

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