Lawsuit Update Center

The medical journal The Lancet is chiming in on the Avandia debacle. Back in 2009, The Lancet published a paper about the RECORD study (funded by Avandia manufacturer GlaxoSmithKline) which was widely criticized. The major complaint is that the article did not include the drop-out rate—without knowing which patients went off the drug, it is impossible to calculate the risk of Avandia-caused heart attacks. Now, The Lancet issued an editorial titled “Strengthening the credibility of clinical research.” It describes briefly the Avandia situation, likening the recent Senate Committee on Finance report to a John Grisham novel: “GlaxoSmithKline (GSK), intimidated researchers and manipulated the scientific process for commercial advantage.”

Here are some “talking points” from the editorial:

• At a time when some pharmaceutical firms have received record fines for misconduct, the saga of rosiglitazone [Avandia] tests the limits of tolerance

Two prominent Chicago orthopedic surgeons are calling for the recall of Zimmer’s NexGen CR-Flex Knee replacement devices. There has already been a recall of related devices to a part of the knee.

The porous femoral component (that is, the part of the replacement that covers the head of the femur, the bone that goes from the pelvis to the knee) is associated with a high rate of failure. The two Chicago surgeons calling for the Zimmer recall, Richard Berger and Craig Della Valle from Rush University Medical Center, have observed after two years’ of use that 36% of the implants were loose, and 9.3% were revised or set to be revised because of looseness and associated pain.

The doctors stated that “This component is still commercially available but should not be used for any patient.” They also questioned the fact that the product was released for sale to the public without clinical testing. Dr. Berger described the failure rate as “horrific.”

The first federal Kugel Mesh hernia repair lawsuit began in the U.S. District Court for the District of Rhode Island, yesterday. Plaintiff John Whitfield claims that the mesh, manufactured by Davol, Inc., was defective and broke after it was implanted, causing bowel obstruction, abdominal pain, nausea, permanent bowel injuries, and necessitating additional surgery.

This is the first of four bellwether trials, designed to give lawyers on both sides a sampling of how jurors will deal with the information and trial strategies. This may assist the parties to reach settlements in remaining cases after they learn the strengths and weaknesses of each side.

There are 1,300 other hernia mesh cases that are consolidated in the Rhode Island federal court MDL. An additional 1,774 cases are in Rhode Island state court, with the first trial expected later in the summer. Many of the hernia patches were recalled since 2004.

The Avandia debacle heats up, this time in the medical journal community. The editor of the premier medical journal, The Journal of the American Medical Association (JAMA) has taken other journals to task for their methods of publishing articles. Using the Avandia RECORD study as the example of the conflicts of interest rampant in the medical publishing community, the editor explains “concerns about preserving market share apparently trumped concerns about the potential for causing patient harm.” For the past ten years, JAMA has required:

…at least 1 author must show that she or he “had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Additionally, that author cannot be funded by any commercial funding source. The source for this criterion is the age-old Hippocratic Oath—that physicians, above all else, must do no harm. The JAMA editor understands that when industry pressures are brought to bear, physicians may be (and have been) influenced to in a manner inconsistent with good science. And the result is that people rely on bad studies, and patients take bad drugs with incomplete and faulty information. The editor further recommends that drug study data be freely available to academic researchers.

Not only will the editor’s suggestions (if enacted by other journals) provide a means to double-check data to ensure its quality, but it will provide an extra reason for scientists and researchers to do the right thing from the beginning, and to stay true to the scientific method.

If my Google Reader subscriptions are any indication, about 50% of the new blog posts across the web in the past couple of days have been about Avandia. This post is intended as a hub for basic information on Avandia and the status of the proposed Avandia recall.

Indications:
Avandia is used to treat type 2 diabetes mellitus. That type of diabetes, commonly called adult-onset diabetes or non-insulin-dependent diabetes mellitus, is reflected by high blood glucose and insulin deficiency/resistance. Avandia (rosiglitazone), as well as Avandamet and Avandaryl (two drugs combining rosiglitazone with either metformin or glimepiride), is intended to help the body use its natural insulin for better glucose control.

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Two contrasting Accutane lawsuit updates in the news today:

First, some background. Accutane is used to treat severe acne and has been associated with a host of problems: birth defects, inflammatory bowel disease, injuries to the liver, kidneys, nervous system, and pancreas, dermatological reactions, and even suicide. Roche stopped selling it last year after a 27-year run, citing competition from generics and the 5,000 pending Accutane lawsuits.

Plaintiff’s Verdict: $25.16 Million

In May 2007, Andrew McCarrell emerged victorious in a New Jersey Superior Court Accutane lawsuit against Roche Holding AG. Mr. McCarrell developed inflammatory bowel disease caused by Accutane. (View the full original trial on video, purchase required). That victory was short-lived, as the verdict was appealed and overturned because the trial judge should have allowed the defendants to present statistical evidence—that there were five million drug users.

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As you remember, Fosamax, Merck’s osteoporosis drug, is the subject of much litigation. The question presented is whether the drug causes osteonecrosis of the jaw, which is the death of jawbone tissue.

Judge Keenan, ruling over the federal Fosamax cases from his bench in the U.S. District Court for the Southern District of New York (Manhattan), decided that Merck was not entitled to dismissal of the Louise Maley case on the issue of specific causation (essentially, Merck argued that plaintiff could not prove that Fosamax caused her injury. This is different from general causation, which is the argument that Fosamax can cause injuries of this type). The plaintiff did not argue against the dismissal of her strict liability and warranty claims, however. Her case will proceed on a failure to warn claim. See the Order (hat tip: Shearlings Got Plowed). The Maley case will go to trial on April 19, 2010.

So, Plaintiff Maley survived where Bessie Flemings could not—Judge Keenan dismissed her case (set for trial this month) last November on specific causation grounds.

This is an old post with product liability statistics with a 2023 update with new 23 stats.

Back in June (Statistics, Part I), we reported on the U.S. Department of Justice’s Civil Justice Survey of State Courts, covering 2005 state court trials. Though official statistics have not been released by the DOJ for 2006 to 2009, a recent Bloomberg article, Jurors Turned Against Companies in 2009 Product-Defect Cases, analyzes last year’s product liability verdicts through the lens of the recession and general consumer distrust of Big Business.

The reporter, Margaret Cronin Fisk, notes the following for 2009 product liability lawsuits (which were not limited to just state courts):

On the last day of December, Plaintiff Merle Simon received a stunning present. The Superior Court of Pennsylvania (Pennsylvania’s first level appellate court) decided in Simon v. Wyeth Pharmaceuticals, et al. that the trial judges grant of judgment notwithstanding the verdict in 2007 was erroneous. The trial judge’s opinion was based on statute of limitations grounds and, alternatively, proximate causation. Here are the important dates:

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The benefits of CT scans often outweigh the potential risks of radiation exposure. But it is important to understand the dangers involved. Every year, there are over 70 million CT scans performed in the United States, and the FDA is investigating cases of overexposure to radiation from these scans. The amount of radiation received during a CT scan can vary depending on the type of scan, body part being imaged, and patient size, and is typically higher compared to other imaging modalities such as X-rays.  Effects of radiation exposure beside cancer can include reddening of the skin, loss of hair, flaky skin, cataracts, fatigue, dizziness, nausea, inability to eat, and tissue destruction.

This article contains important information about the risk of CT scans.  We need to know the risks.  But let’s be clear, too. The benefits of a CT scan usually outweigh the potential risks of radiation exposure, especially when it comes to diagnosing and monitoring certain medical conditions that, if not caught, will lead to further complications or exacerbation of the injury.  But if a CT scan is necessary, the radiation exposure is typically kept as low as possible while still obtaining the necessary diagnostic information.

But there are legitimate practical concerns:

1. Radiation Dose: The amount of radiation received during a CT scan varies depending on the type of scan, body part being imaged, and patient size. It is typically higher compared to other imaging modalities such as X-rays.  Of course, a CT scan usually give you more useful information than an X-ray for most conditions.   The cumulative effect of multiple scans can result in a significant increase in the radiation dose received by an individual, which can raise concern for the long-term risks associated with ionizing radiation exposure.
2. Cancer Risks: Ionizing radiation from CT scans is associated with an increased risk of cancer, particularly in children and young adults. Why? Their cells are rapidly dividing and therefore more sensitive to radiation damage.
3. Unnecessary scans: In some cases, CT scans may be ordered or performed more frequently than necessary, increasing a patient’s radiation exposure. This highlights the importance of careful decision-making and ensuring that CT scans are only performed when they are medically necessary.  (One big thing on my radar: will you find anything on the scan that might change the currently planned treatment?)
4. Vulnerable populations: Certain populations, such as pregnant women and their fetuses, are more sensitive to ionizing radiation and are therefore at increased risk of harm. The use of CT scans should be avoided in these populations whenever possible, and alternative imaging modalities should be considered.

CT Scans and Radiation

CT scans use X-rays to produce detailed images of the body, including bones, organs, and tissues. While the amount of radiation exposure from a CT scan is low, it is still considered a source of ionizing radiation, which can be harmful if the dose is too high.

The amount of radiation from a CT scan varies depending on the type of exam, the specific machine being used, and the patient’s size and anatomy. However, the radiation dose from a single CT scan is usually much lower than the amount of radiation people receive from natural sources over the course of a year.

But we are not out of the woods.  Radiation exposure is still a big deal.  It should be kept as low as reasonably achievable, especially for children and pregnant women, who are more sensitive to the effects of ionizing radiation. In many cases, alternative imaging tests that do not use ionizing radiation, such as MRI or ultrasound, can be used instead of a CT scan. If a CT scan is necessary, healthcare providers will consider the potential benefits and risks and only recommend the exam if it is deemed necessary. Doctors have to pay attenton to how the patient is positioned because that impacts radiation exposure.

It is fine line doctors have to walk.  We had a case where a boy died of an anuryusm because they didn’t bother to do a CT scan. You can say we blame the doctors either way.  I get that.  But the reality doctors have a duty to do what other reasonable doctors would do.

Radiation Is Cumulative

It’s also important to keep in mind that radiation exposure is cumulative, meaning that the more radiation you are exposed to over your lifetime, the greater your risk of developing cancer or other health problems. This is why it’s important to discuss the need for any medical imaging tests that use ionizing radiation with your healthcare provider, and to make sure that the benefits of the test outweigh the risks.

How CTs and Radiation Work

First, some background: CT scans (also called CAT scans, or computerized tomography) is an x-ray that uses radiation to visualize internal structures of the body through a cross-section of images (unlike the flat images of normal x-rays). One CT scan is equivalent to about 100 chest x-rays. One perfusion CT scan (used to examine blood vessels and often used to diagnose stroke or aneurysm) is equivalent to several hundred chest x-rays.
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