Everyone makes mistakes -- even hospitals

Everyone has heard the clichés: “We’re all human.” “Everyone makes mistakes.” “Nobody’s perfect.”
Those answers are just fine when they come from a waiter explaining an overcooked filet or a child offering a reason behind a less-than-perfect spelling test. But when it’s your doctor?

The fact is that those go-to answers actually are valid, even for doctors … who are human … and therefore are not perfect … and sure enough, make mistakes, many of which fall under the umbrella of medical malpractice. But none of those answers does anything to appease the feelings of patients (and their families) who bear the brunt of errors ranging from the improper administration of medications to sponges (or other items) being left inside a body during surgery to surgery performed on the wrong part of the body. 

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FDA Issues Class-I Recall of Medtronic Brain Catheters

The U.S. Food and Drug Administration (FDA) announced a Class I recall of a brain catheter manufactured by Medtronic Inc. due to failures in the device that may result in serious medical injuries.

In February, Medtronic recalled the BioGlide Ventricular Snap Shunt Catheters that are used to drain excess brain fluid into another part of the body. The catheter is often used in the treatment of hydrocephalus, a condition in which excessive fluid forms in the brain. The company received reports that the catheters are prone to disconnecting. According to Medtronic, such failures could cause:

  • Vomiting
  • Nausea
  • Fatigue
  • Headache
  • Seizures
  • Visual problems

Medical Injury AttorneyAlthough the company says it has not received reports of death or serious injuries connected to the use of the catheters, the FDA has classified the recall a Class I. Generally, such a recall is issued when there is “a reasonable probability” that the use of a product can result in serious injuries or death. 3,000 catheters, distributed between 2000 & 2009 are affected by the recall.

The company has received nine reports of the catheter disconnecting. In these instances, the catheters disconnected from the snap base assembly, resulting in the need for emergency revision surgery.

The recall involves the following models of the catheter:

  • Inner Vision Snap Shunt Ventricular Catheter BioGlide (R: 25.44, 1.15, 4.73%) Catalog Number 27782
  • Snap Shunt Ventricular BioGlide(R: 25.44, 1.15,  4.73%) Catalog Number 27802
  • Snap Shunt Ventricular Catheter BioGlide (R: 25.44, 1.15, 4.73%) Catalog Number 27708

Patents who have questions have been asked to contact their doctors or the company.

Defective Medical Devices Can Cause Serious Injuries

By the time a medical device is found to have a serious defect, it is often too late for patients who have been injured, sometimes fatally, by their use. It is the job of the FDA and medical device companies to keep patients informed and to protect consumers from dangerous medical products. 

If you or a loved one has been injured by the use of a defective medical device, a medical injury lawyer can help you recover compensation for your injuries. Contact an experienced medical injury attorney at Arnold & Itkin LLP for a free evaluation of your case.

Patients March for Right to Sue Medical Device Makers

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). Medical Injury AttorneyIt 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.

FDA Issues Class I Recall for Baxter Colleague Infusion Pumps

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.

Medical Injury AttorneyIn 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.

Medical Device Maker Lobbied for FDA Approval

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.

Medical Injury LawyerIt 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.

Michigan Moving to Reverse Medical Injury Lawsuit Immunity for Drug Makers

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:

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. Medical Injury AttorneyPatients 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.

Law Makers Move to Return Patients' Right to File Medical Device Injury Lawsuits

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. Medical Injury LawyerOn 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.