Articles Posted in Product Liability

Around 22 complaints involving power morcellators are pending in 16 different U.S. federal courts around the country. Plaintiffs are now requesting a federal judge to centralize proceedings for Multidistrict Litigation (MDL). [2017 update: there was at Ethicon power morcellator.  It has already been dissolved.  The cases that settled in the MDL had high dollar amounts.  But there were only 42 cases.]  I touched on the issues surrounding power morcellators on more than one occasion, but let’s talk about where these cases are and where they are going.

Power Morcellator Lawsuits

Power Morcellator Litigation Heating Up

Power morcellators are surgical devices that are used to cut portions of the uterus into small fragments so they can be easily extracted through a patient’s stomach. Morcellators are utilized in laparoscopic hysterectomies where patients want to avoid traditional surgical scarring. Although morcellators are a great way of avoiding just that, the nature of the device and procedure often means that fragments of tissue are left behind after a procedure. Doctors and patients really didn’t worry about this too much because they were under the impression that the risks associated with leaving trace amounts of tissue behind were low.

Starting in 2006, however, pathologists informed a manufacturer of power morcellators, Johnson & Johnson, that their use has the potential to cause cancerous cells in the uterus to spread. Typically, these cells would have been contained in the uterus, but using a morcellator could break up cancerous fibroids in the uterus, increasing the risk of cancer spreading throughout the body. Granted, it’s not like every patient who undergoes a hysterectomy is faced with this risk. Current estimates suggest that about 1 in 350 patients who undergo this procedure have cancer cells contained within the uterus. So the incidence of cancer may be low, but considering that around a half-million patients have undergone a laparoscopic hysterectomy, around 1,500 patients were wantonly exposed to the risk of cancer.

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An interesting new piece of evidence recently came to light at a trial against Pfizer in Philadelphia. Internal memos suggest that Pfizer actually believed that Zoloft caused birth defects in pregnant women for years, perhaps providing the smoking gun that was missing in previous Zoloft cases.

The News

A jury in Philadelphia, PA is currently listening to evidence in a trial against Pfizer brought by the family of an 8-year-old girl, who was born with heart defects. The family’s suit alleged that Pfizer failed to adequately warn women that their antidepressant, Zoloft, might lead to birth defects. The 8-year-old girl in this case was born with congenital defects and malformations in her heart, which were allegedly caused by exposure to the drug Zoloft. In their lawsuit, the family specifically notes that the girl was born with a hole in her heart and has experienced several cardiac episodes over the years.

As part of their case, the plaintiff’s family identified internal reports by Francesca Kolitsopoulous, who is the associate director of Pfizer’s Worldwide Strategy epidemiology group. According to the evidence presented at trial, she specifically warned Pfizer executives about studies showing a link between Zoloft and heart defects.

The report suggests that she even recommended that the drug’s label be modified to warn users of this new information. Kolitsopoulous pinpointed a link between the drug and septal heart defects. This nugget of information is incredibly relevant to this case, given that it is the exact type of injury suffered by the plaintiff.

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Nearly 2,000 HeartWare Ventricular Assist Systems (VAS) are being recalled because of potentially faulty power supply connectors. The defect could lead to serious injury or death in the event that power failure causes the entire system to stop working.

The Recall

The FDA issued a Class I recall for certain VAS devices after receiving numerous reports of malfunctions. Luckily, most of the failures did not result in any damage, but there was at least one serious injury reported due to a power failure. A “Class I” recall means that the FDA thinks that there is a “reasonable probability” that the continued use of the product will lead to serious health consequences or even death. Obviously, this is a recall to take very seriously should you use VAS. Mechanically, the main issue is that power connector ports tend to wear down over time. Should they become worn down enough, the power supply would lose its connection to the system, effectively rendering the VAS useless. Patients have reported that the power supply connectors have become twisted or bent, which prevents them from connecting the device control unit to the VAS itself. You know how when you’re vacuuming and you round a corner too quickly, ripping the cord out of the wall and bending up the power cord prongs? That’s what is going on here. The stakes are just a little higher.

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I recently heard that if we all keep taking antibiotics we will be responsible for creating the “superbug.” The theory is that since the advent of antibiotics nearly a century ago, we have caused bacteria to become so resilient that normal antibiotics will be ineffective in the not so far future. Incurable infection and bacteria will purportedly run rampant through the streets, and I can only assume that our society and landscape will be a barren wasteland similar to that of Mad Max. Ok, maybe not that last part, but there’s no denying that there has been a serious proliferation of antibiotics. While these have revolutionized medicine and generally increased health on the whole, there are complications that can arise unrelated to the infections that antibiotics are prescribed to treat.

Recently, a group of antibiotics referred to as “fluoroquinolones” has been linked to permanent nerve damage. The risk is real, and the side effect is referred to as peripheral neuropathy.

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If you want an erection, Viagra seems to work. Over 23 million men a year can’t be wrong.  It is easy to joke about, but it is obviously a great thing for many men.  But for the last 16 years since Viagra received FDA approval in 1998, we have been trying to figure out what side effects Viagra has.  Because people have a right to balance their desire to keep an erection – and also consider the other drugs they might use – and the medication’s side effects.   We have heard lots of discussion of vision-threatening complications and hearing loss.  Now there is a new deadly concern:  melanoma.

Sildenafil citratre, more commonly known as Viagra, is used to treat erectile dysfunction (ED) by relaxing muscles and increasing blood flow to particular areas of the body.  Now, in a study recently published online in JAMA Medicine, it has been reported that men who have used Viagra for ED had a significantly elevated risk of melanoma.  Melanoma, the most dangerous type of skin cancer, is the leading cause of death from skin disease.  While melanoma accounts for less than 2% of skin cancer cases each year, it makes up the majority of skin cancer fatalities.  

The study, involving researchers from Harvard and Brown Universities, compared the medical charts of 26,000 men to see if cancer rates differed among those who took Viagra and those who did not.  The study revealed that men who had taken Viagra for erectile dysfunction had double the risk of developing melanoma than men who had not taken the drug.

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The concerns over the anti-seizure drug Potiga were given new weight by a new black box warning.  The problem is concerns of possible vision loss and blue discoloration of the skin that can be permanent.  The FDA says that anyone who considers this drug should get an eye examination both before initiating treatment and every six months during the course of the treatment.

Just as importantly, the FDA underscores the limits of this medication by essentially saying that this medication should only be used by those who have not done well with other options.  Why?  The risks of taking the drug are pretty high.  So it makes sense to make sure every other option has been fully explored with your doctor.  So this drug has its place, but only in those situations where Protiga’s benefits outweigh the risk.  Of course, this is true with every drug, but particularly so when the risks are what they are here.
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Plaintiffs’ counsel in the Aredia/Zometa MDL are asking the judge overseeing the coordinated litigation to remand the over 300 consolidated cases.

Why?  Discovery is not over.

Some people may not live to get their day in court

Promoted as an alternative to traditional spinal surgery, Medtronic Infuse is a bone morphogenetic protein (BMP) that is designed to encourage bone growth and fuse the gaps between vertebrae.

Infuse Bone Graft Side Effects

When Medtronic first initiated studies in 1999 on BMP, researchers discovered that 70 percent of patients developed unnatural bone growth called ectopic bone growth. In 2004, when the study was finally published, the dangers were deemphasized.