Articles Posted in Medical Device Liability

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In recent years there has been a lot of debate over the effectiveness of the Food and Drug Administrations’ medical device review system, i.e., the 501(k) process. Its critics say that the review system is not comprehensive enough and allows for the approval of unsafe medical devices. However, its advocates argue that a quick and easy approval process is necessary to ensure American patients can take advantage of the most advanced medical products available; a more involved review system would only mean more red tape for medical device companies.

In an attempt to find ways to improve its much-debated medical device review system, the FDA sought the advice of a panel of doctors and researchers from the Institute of Medicine (IOM). Over the years, the IOM has made numerous recommendations for improving government programs. However, in the case of the 501(k) process, the IOM’s recommendations were perhaps more severe than the FDA had anticipated. Rather than suggesting various ways the program could be changed, the IOM instead recommended that it be abandoned all together.

In support of its recommendation, the IOM panel stated that the 501(k) approval process was “flawed” and “does not really assess safety and effectiveness.” In order to obtain approval under the 501(k) process>, a medical device manufacturer must show that its medical device is similar to a device that is already on the market. The approval process was created in the 1970s to allow the FDA to quickly grant approval to those products shown to be similar to those already on the market. However, while it was meant as a temporary method to help grandfather in devices that were already in widespread use, the 501(k) process has become the standard for medical device approval.

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Over the years, medical advances have led to countless innovative inventions that have saved many lives. However, not every medical innovation lives up to its expectations. The recall of DuPuy’s metal-on-metal hip joint is a perfect example of a medical device that failed to delivery as promised.

The first artificial hip joint was developed in the 1960s and was made of a metal ball placed in a plastic cup, which were meant to replicate the thigh bone and hip socket, respectively. Then, metal-on-metal hip implant devices were developed in response to studies showing that metal and plastic hip devices were leading to bone loss in some patients.

The medical community believed the medical device changes made to metal-on-metal hip implants would revolutionize the future of artificial hips. Not only would the newer design lead to less bone loss in patients, but by replacing plastic with metal, the belief was that the new medical device would last longer than the original metal and plastic version. Medical professionals viewed metal-on-metal hip devices as the final solution to hip implant patients’ problems.

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Johnson & Johnson has announced that it will be dropping one of its medical devices from production – by the end of 2011, the company will cease manufacturing its drug-coated heart stents. The company explains its decision was due its decreasing market share in the heart stent category; Johnson & Johnson is looking to funnel the newly freed funds into developing other medical products.

Johnson & Johnson’s drug-coated heart stents were manufactured in conjunction with Cordis, its subsidiary. Cordis’s Cypher stent was the first drug-coated heart stent approved by the FDA. However, by the end of this year, it will no longer be manufactured. Likewise, Cordis will halt its research and development of a new stent, the Nevo stent.

The sale of drug-coated heart stents represents a $4 billion market, which previously had been divided between Johnson & Johnson/Cordis, Boston Scientific, Medtronic, and Abbott Laboratories. However, Cordis’s portion of that market has been decreasing. In 2006, Cordis made $2.6 billion globally from the sale of drug-coated stents, whereas last year it only made $627 million.

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A recent New York Times article reported that a new study indicated that in recent years the Food and Drug Administration (FDA) has not rigorously studied or tested many of its approved medical devices before clearing them for sale. The study specifically assessed many medical devices which have been the subject of major recalls over the past few years, such as mechanical ventilators, hospital infusion pumps, and external heart defibrillators.

Diana Zuckerman and Paul Brown, both with The National Research Center for Women and Families, headed up the study along with cardiologist Steven Nissen, M.D. of the Cleveland Clinic. The study, published in The Archives of Internal Medicine, focused on those medical devices that have since been labeled as high risk for recalls between 2005 and 2009. It found that most, if not all, of the medical devices were cleared for public use by the FDA without being first being tested. The FDA and a trade group representing medical device manufacturers called The Archives of Internal Medicine study flawed.

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Radiation therapy is a common treatment for a large range of cancers and has been responsible for saving, or at least extending, many peoples’ lives. However, the basic premise of radiation therapy involves targeting and killing cancerous cells in one’s body. And while properly administered radiation therapy can save lives, when hospitals and doctors administer too much radiation it can result in negative effects for the treating patient.

Overdoses of radiation is becoming more and more widespread amongst cancer patients. A recent report of Evanston’s Northshore University HealthSystem, a Chicago-area hospital, provided one such example. A 50 year-old mother of three was administered dangerously high doses of radiation when the hospital staff made radiology errors involving the administration of her radiation doses. The young Illinois resident went from an active, vibrant person pre-radiation to a virtual invalid post-radiation and now resides in an Illinois nursing home.

This woman was just one of three oncology patients who received an overdose of radiation at Evanston Hospital. All three instances of the radiation errors were allegedly the result of faulty linear particle accelerators. These accelerators are used to focus the radiation on the cancerous cells and are commonly used for stereotactic radiosurgery (SRS).

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Federal preemption of medical device liability lawsuits has been a volatile issue in recent years, with the courts typically preempting product liability lawsuits citing violations of individual state safety standards. However, in Bausch v. Stryker Corporation, et al., No. 09-3434, the issue was whether a product defect claim citing federal safety standard violations was also preempted by that product having federal approval. While a Chicago federal district court had dismissed Ms. Bausch’s claim, that decision was recently overturned by the United States Court of Appeals for the Seventh Circuit. That Court of Appeals decision permitted Mr. Bausch to pursue his claim in federal court.

The case facts of the Bausch medical device lawsuit involve a hip replacement 56 year-old Margaret Bausch underwent, during which she received a Trident brand ceramic-on-ceramic hip replacement system manufactured by Stryker Corporation. The prosthetic hip device ended up failing and required an additional surgery to have it removed.
The specific type of prosthetic hip Ms. Bausch received was approved for sale in the U.S. by the Food and Drug Administration (FDA), but was later recalled due to a failure to comply with federal standards. In her Chicago medical device lawsuit, Bausch’s attorneys cited Stryker’s failure to comply with federal standards during the manufacturing process of its prosthetic hip devices.

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Medicine is an area where new advances are being made on a regular basis that lead to better care and treatment for patients. However, this means that in some cases, patients who received older forms of treatment develop unforeseen complications, particularly in the area of Illinois defective medical devices. Consider the case of patients receiving metal-on-metal hip replacements. Once considered the norm, these types of hip replacements are now leading to an increase in problems for patients.

A recent editorial in The Journal of Arthroplasty, a medical journal for orthopedic surgeons, urge doctors to use metal-on-metal devices only with “great caution, if at all.” This comes on the heels of reports that metal-on-metal hip replacement procedures create tiny particles of debris that can damage soft tissue and bone.

Recent studies that estimated that anywhere from one to three percent of hip implant recipients could be affected by the problem, however, given the large number of people who have received metal devices the number could actually be dealing with thousands of patients in the United States who have been affected by defective medical devices.

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