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Viagra May Cause CancerAs if erectile dysfunction were not harrowing enough. In March 2016 a published study concluded that the use of the drug sildenafil (Viagra), vardenafil (Levitra), and tadalafil (Cialis) “could promote melanoma in humans.”

As you probably know, melanoma is the most aggressive and most dangerous form of skin cancer. Melanoma develops when damage to skin cells (usually caused by ultraviolet radiation from sunshine or tanning beds) triggers mutations that lead the skin cells to multiply rapidly and form malignant tumors. Most people think of melanoma as dark, asymmetrical moles, and in fact melanoma can develop from existing moles, but melanoma can also form directly on the skin. Melanoma is often caused by intense, sustained exposure to ultraviolet light, the kind which causes suntans and sunburns. Melanoma has been estimated to cause over 10,000 deaths in the United States each year.

The Latest Study

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Transvaginal Mesh Warn LabelBetter late than never when it comes to warnings on potentially harmful medical devices, but the harm will only stop when the use of defective medical devices stops. Boston Scientific, a maker of transvaginal mesh and slings, is confronting the reality that its product can cause serious harm to patients. In June the company announced its products will carry a new warning label. Transvaginal mesh is used to treat common pelvic disorders in women, which you can read about here.

Boston Scientific is facing more than 36,000 product liability cases because of injuries the mesh has caused, including infections and erosion of surrounding tissue, according to the Minneapolis Star Tribune. Transvaginal slings are used as treatment for incontinence and surgical meshes are surgically implanted to strengthen tissue in women suffering from pelvic organ prolapse.

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Cobalt and Chromium from metal-on-metal hip implants
Over the years I have worked with many people who had hip replacement surgery. Many of these clients discovered high metal levels in their bodies from metal-on-metal (MoM) hip components. Often the person would let me know that she had her metal levels checked and that the blood work came back with abnormally high readings of cobalt, chromium, or other metals. Still, the treating physician would occasionally dismiss the blood work results. At least one doctor told a patient, “no one knows the effects of higher metal levels on the body. We haven’t studied the impact of metallosis sufficiently. It is nothing to be worried about at this point.”

Sadly, this isn’t true. And it’s not the best medical advice. There have been several studies over the years that looked at metallosis in the body derived from metal-on-metal hip components. The first incident of metallosis from MoM hip implants was reported in 1971. Since then, doctors have been reporting the higher incidence of metallosis in patients who received MoM artificial hip implants. Several scholarly studies have been conducted, including a recent one whose results were published this month examining the impact of metallosis on the cells of patients.

What Is Metallosis?   

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IVC Filter Bellwether CasesA “bellwether” is someone or something that leads others or shows what will happen in the future or is an indicator of trends. In the legal world a bellwether case is very important because it leads the way in how a large number of lawsuits may be litigated or settled.

Too Many Cases, Not Enough Resources

If there are many plaintiffs suing the same defendant for the same reason with similar facts there are different ways all these cases could be handled. They could,

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Last week I wrote about the dreaded post-trial life of a product liability lawsuit. If an injured person wins the jury trial, and particularly if the jury awards a large amount of money, the plaintiff should expect to face an onslaught of post-trial motions and the inevitable appeal to the next highest appellate court.

That is exactly what happened in one of the first important Depuy ASR Hip trials in California.

The Jury Trial

Depuy ASR Jury TrialOn March 8, 2013, a jury in Los Angeles Superior Court awarded $8,338,236.12 for a man injured by the failure of the Depuy ASR Hip. Loren Kransky alleged that the Depuy ASR hip components were negligently designed, that the components had a design defect, and that Depuy failed to warn him and his doctors about the potential risks involved in implanting the device.

After a five-week trial in 2013, the jury in the California case awarded Mr. Kransky $338,236.12 in “economic damages” and $8,000,000.00 in “pain and suffering” damages. Jurors in the case found that the device was defective at the time of sale, and that it injured the plaintiff. The jury found in favor of Mr. Kransky and awarded damages for medical costs and for emotional suffering and distress.

The jury did not award punitive damages to Mr. Kransky. The jury did not find that Depuy acted with fraud or malice, which prevented an award of punitive damages. Which was good for Depuy, as Mr. Kransky’s legal team aggressively argued for punitive damages in amounts that could have exceeded $100,000,000.00.

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Product Liability Appeal

To paraphrase Yogi Berra, your lawsuit ain’t over till it’s over.

In a product liability case, most lawsuits end in a settlement. The plaintiff and the defendants work the case for a period of time, and eventually they sit down and hammer out a resolution to end the case. However, some product liability cases make it all the way to trial. I have written about jury verdicts in medical device and drug cases often on this site. Recently, for example, a young boy and his family won a whopping $70,000,000.00 verdict against Johnson & Johnson based on the boy’s disfigurement caused by the drug Risperdal. In that case, as in so many others, you may think that after years of litigation and after winning a complex jury trial that the plaintiff can finally leave the court system behind and get on with his life. But the case, sadly, may just be getting started. When medical device manufacturers and drug makers lose a big case with a large money award, expect them to throw the kitchen sink at you after the jury reaches its verdict. Let’s look a few things a defense team could do if it loses a big product liability case.

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Knee InjuryThe Zimmer NexGen artificial knee has been causing patients much pain and suffering over the past decade. Zimmer first instituted a recall of one group of NexGen components in 2010, and there have been other recalls in the years following. Many patients with the NexGen knees have suffered pain and an inability to maintain normal physical activity. The lawsuits of course followed.

In August 2011, to handle the growing number of lawsuits over the NexGen knee, a multidistrict litigation (MDL) site was formed in Chicago, Illinois and assigned to federal district court judge Rebecca Pallmeyer. The MDL is titled: In Re: Zimmer NexGen Knee Implant Products Liability Litigation, No. 2272 (1:11-cv-5468).

Do You Qualify for the Zimmer NexGen MDL?

The overarching requirement to participate in the MDL is (1) to prove implantation of the Zimmer NexGen knee components (with product stickers from the original surgery), and (2) to show through the medical records clear evidence of loosening. Loosening is when the artificial knee components begin to move in the patient’s leg and separate from the bone. This is not good. Loosening can be very painful. A loose artificial knee will cause major complications and eventually require replacement and revision surgery. When a patient complains to an orthopedic surgeon about knee pain after a total knee arthroplasty, the doctor will order an X-ray. The doctor will look for radiolucent lines, which are spaces between the artificial knee component and the patient’s bone. Essentially, small gaps occur because the medical device is not implanted tightly or securely to the bone. These spaces can cause serious problems for a patient with an artificial knee, and can be the first signs of an artificial knee failure. The spaces often fill with fluid or tissue which can cause additional loosening of the medical device.

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On July 1, 2016 a jury in Philadelphia sent a very loud and angry message to Johnson & Johnson. After a lengthy trial, the jury awarded a young boy who grew breasts after taking the drug Risperdal a staggering $70,000,000.00. This verdict is far and away the largest money judgment awarded (yet) to a victim of the drug Risperdal. As one of the attorneys representing the disfigured child stated, “this verdict is a game-changer.” I think he is right.

But let’s back up.

What is Risperdal?

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Genentech SettlementYou see ads for them all the time. Supplements, creams and pills that will help you lose weight, clear up your skin, improve your sex life or maybe do all of these things at the same time. Whether they’re in late night cable TV infomercials or spam email, you might think this kind of medical scam is perpetrated by small time operators making a fast buck. But scams can also be done by multi-billion dollar pharmaceutical companies (but in much more sophisticated ways), sometimes with potentially deadly results.

California based Genentech and its marketing partner OSI Pharmaceuticals will pay $67 million to settle claims that they misled doctors into prescribing a drug to lung cancer patients that the defendants knew would not work. Due to this highly corporate hucksterism some of these patients may have precious time robbed from them, dying earlier than they would have if they had taken more effective drugs. These allegations are in the settled lawsuit filed by a former Genentech employee. Federal prosecutors joined the lawsuit, reports the Los Angeles Times.

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Employee Recovering From Artificial Hip SurgeryMy second guest post was published today on the employment law website, The Spiggle Law Firm. Tom Spiggle runs a robust employment law practice in Virginia, and now and then he asks me to write posts dealing with legal issues that arise when a medical device or drug fails and threatens a person’s job or livelihood. In today’s post, I examine the protections an employee might receive under the Family Medical Leave Act when taking time off for hip replacement surgery or artificial hip revision surgery. You can read my article here: Will I Qualify for FMLA Leave If  I Need an Artificial Hip?

With FMLA, certain companies have obligations to provide protected time away from work while an employee undergoes, and recovers from, surgery. The last thing you need when dealing with an artificial hip or knee surgery is that you may not have your job when you are fully recovered and ready to return to work. Under certain conditions, such as the size of the company, the FMLA may serve to protect your job while you undergo surgery and rehabilitation. There are several limitations and exceptions to the protections under the FMLA, but it is important for you to understand your rights and determine if your job is protected by the federal statute while you recover from hip surgery.

Check out my guest post, and good luck.