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Statistics-Pie-Chart-01-21-10.jpgThis 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):

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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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Lawsuits involving Zicam have been consolidated for discovery under U.S. District Judge Frederick J. Martone of the U.S. District Court for the District of Arizona. These Zicam lawsuits involve claims that Zicam caused patients to lose their sense of smell or taste.

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People with type 2 diabetes taking the drugs Januvia or Byetta might have an increased risk of developing pancreatitis and pancreatic cancer.  Our law firm is handling lawsuits on behalf of patients who were taking Januvia, Janumet, or Byetta.

We can all agree that these drugs are good at fighting diabetes, which is an awful disease.  But there are a lot of drugs that fight diabetes.  These drugs might be a little cheaper than some.  But the problem with Januvia is that if it impacts the pancreas in a way that can cause it serious injury like pancreatitis, and even more seriously, pancreatic cancer.

Pancreatic cancer occurs when cancerous cells form in the tissues of the pancreas. The majority of pancreatic cancers start in what is called exocrine cells.

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Remember Wyeth v. Levine, U.S. Supreme Court decision that held federal approval of labels drug warning labels does not preclude lawsuits under state law claiming inadequate warnings? Well, the government, through the FDA, has now added a final chapter to that story.

Facts of Wyeth v. Levine

Wyeth v. Levine was a landmark U.S. Supreme Court case that involved a Vermont musician named Diana Levine who had her right hand amputated after being injected with Phenergan, an anti-nausea medication made by Wyeth, a pharmaceutical company that was later acquired by Pfizer.

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Kugel hernia mesh lawsuits are settling, thanks in part to a change in defense counsel. The products, manufactured by Davol, are defective because the plastic ring can break off, causing perforation and infections. Left untreated, these injuries can be fatal. Davol has since eliminated the use of the plastic rings, in favor of a bio-absorbable ring.

Now represented by the New York firm Reed Smith, Davol has signaled a change in thinking to a more reasonable approach—these can be very meritorious cases worthy of settlement, and the expense of litigation is unnecessary. There are about 1,000 cases in the Rhode Island United States District Court MDL, and about 1,200 cases in Providence state court (the manufacturer, Davol, is a Rhode Island company). Right now, 4 federal suits have been settled, and one state claim has been settled. This looks to be the tip of the iceberg, as the parties move toward the first scheduled federal court trial in March 2010. That will be followed shortly thereafter by the first state court case in June 2010. The settlements will probably come in rapid numbers, now that discovery is coming to a close and the trials quickly approach.

For more on Kugel Mesh lawsuits and settlements, see our prior blog post.

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Last week, we briefly mentioned the FDA’s new requirement of a black box warning (yes, we will continue calling it a “black box warning”). This week, we had a one day trial that turned into a three-day trial, so we’re just now getting to follow up on it.

The warnings will affect Pfizer’s Chantix (varenicline), GlaxoSmithKline’s Zyban and Wellbutrin (bupropion), and generic smoking cessation drugs (note—bupropion like Wellbutrin are often prescribed for depression and seasonal affective disorder). Besides the warnings, the manufacturers will be required to create patient medication guides to fully disclose the risks of neuropsychiatric symptoms. Symptoms to be on the watch for include: hostility, agitation, depression, suicidal ideation, and behavior changes not associated with nicotine withdrawal. Those medication guides will be given to all patients who have been prescribed the drugs. Finally, manufacturers are now required to conduct clinical trials to more fully explore causation.

The requirement comes on the heels of the FDA’s analysis of their MedWatch reports, which show that there may be a link between the drugs and suicidal events in patients with no history of psychiatric disease. However, the FDA first broached the topic of a potential problem back on November 20, 2007. See also the FDA’s recent newsletter on the topic here.

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The makers of Levaquin (generic: levofloxacin) are currently embroiled in litigation, with 83 federal cases consolidated before Judge Tunheim of the United States District Court for the District of Minnesota. Federal cases were transferred to Minnesota almost a year ago. Currently, the Court and the parties are working on case-specific discovery for agreed-upon cases, from which bellwether cases will be selected. Frequently, bellwether trials give the parties a good idea of what juries think of the litigation and often provide momentum for settlement of the remainder of cases.

As background, Levaquin is a form of antibiotic, primarily used to treat specific bacterial infections of the lung, sinus, skin, and urinary tract. Ortho-McNeil-Janssen Pharmaceuticals (part of Johnson & Johnson) now warns on their website:

IMPORTANT SAFETY INFORMATION FOR LEVAQUIN

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For two years, Florida attorney Frederick Schaffer has sought the answer to his lack of smell. He’s gone to doctor after doctor, searching for a solution and cause to the medical condition known as anosmia. He had a camera rammed down his nasal passage, as well as an MRI and a CT scan. He’s visited specialists. But he finally realized the problem when he saw the FDA’s recall of Zicam.

Schaffer’s claims really highlight what tort victims understand, but the general public often overlooks. Seemingly insignificant injuries often have a lifelong cost. Schaffer misses the smell of coffee (which most people use to help wake up). He misses his wife’s perfume. He misses the smell of his kids’ hair after they’ve taken baths.

The smell is also intricately enmeshed in our sense of taste. Imagine not being able to really taste homemade apple pie, much less smell it. Losing that one sense dulls the taste buds. And, if it can’t be corrected, that’s a lifelong condition. How much is that worth?