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XareltoYou’ve probably seen the commercials. The most vivid to me was the one with Arnold Palmer, Kevin Nealon, and Brian Vickers. They are playing a round of golf and speaking to each other in shockingly sophisticated ways about the many benefits and occasional side effects of the drug Xarelto. These guys sound like pharmacists or physicians, not athletes and comedians. It is a perfect example of direct-to-consumer pharmaceutical marketing.

Xarelto quickly became a blockbuster drug when it hit the market in 2011. Xarelto (or rivaroxaban) was approved for sale by the FDA in July 2011. It was supposed to represent the next major advancement in blood thinning (anti-coagulant) medication. Xarelto was developed to prevent serious conditions that sometimes arise after surgeries (such as artificial hip and knee surgeries). As an anti-coagulant, it was intended to prevent pulmonary embolism (PE) and deep vein thrombosis (DVT) and strokes. The patients Xarelto was intended to help were those with atrial fibrillation (or irregular heartbeat), who were a group of people more vulnerable to PE, DVT, and stroke after surgery. Eventually, the FDA expanded approval of Xarelto to treat all patients with PE and DVT and atrial fibrillation.

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Transvaginal Mesh Appeal
I have written about the maddening ways a product liability case can go on (seemingly) forever. An injured person may wait years to get to a jury trial. And then, if the individual wins the trial and the jury awards a substantial amount of money for the plaintiff’s injuries, the product manufacturer will appeal. You can read about appeals here. But the appellate courts are not there solely to protect big business. When the injured person loses her jury trial, she also has the opportunity to appeal. Often this is more difficult for the individual than it is for the large corporation, which has much more money and time, but appeals courts are there, in theory, for all of us, the powerful and the less-powerful. A week ago, an injured woman won her appeal and was granted a second opportunity to try her transvaginal mesh (TVM) case against Boston Scientific Corporation, which she had lost in 2014.

Let’s back up.

Boston Scientific’s Pinnacle Pelvic Floor Repair Kit transvaginal mesh was implanted in Diane Albright in 2010 to treat her pelvic organ prolapse (POP). Rather than make her well, the TVM caused her many other problems and serious injuries. In 2012 Ms. Albright sued Boston Scientific Corporation in Massachusetts over its failure to warn of the risks of the Pinnacle mesh product, as well as the defective design of the mesh.

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Transvaginal Mesh MDLLet me get right to it: Judge Clay Land has a point. On September 7, 2016, Judge Land issued a blistering Order in the Mentor Corporation ObTape Transobturator Sling Mesh multi-district litigation. In a nutshell, he wrote that he was fed up with frivolous claims. Judge Land stated that he will consider money sanctions against plaintiffs’ lawyers who file and pursue lawsuits in the MDL that they know have no merit or which suffer from some fatal flaw. A fatal flaw could be the passing of the statute of limitations, or the failure to find an expert who can testify that the transvaginal mesh product caused the specific injuries to the plaintiff. In those cases, Judge Land writes, the plaintiffs’ lawyers ought to know better, and should not bring the claim in the first place, or should at the very least dismiss the action when the lawyer discovers a flaw in the case which is fatal to gaining a recovery.

The worst transgression identified by Judge Land is when the product manufacturer seeks “summary judgment” in a particular case and the plaintiff’s attorney simply throws in the towel on the case and does not even bother to show up for the court hearing. In those cases, even though the plaintiff is inevitably going to lose the case, the judge and the law clerks and court personnel and defense attorneys still have to show up and do the work of handling and deciding the motion.

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FDA Open Meeting on Off-Label Drug Use

Communications between pharmaceutical companies and medical device manufacturers and physicians are highly regulated by the federal Food and Drug Administration (FDA), but the agency, as much as it may want to be, does not have the final say in all regulation. These companies have First Amendment commercial free speech rights (though they’re not as broad as the free speech rights individuals have) and there’s a tension between what the FDA wants companies to say, what these companies want to say, and what the courts say the companies can say.

The agency in late August published a notice of public hearing and request for comments concerning manufacturer communications regarding unapproved uses of approved or cleared medical products. The hearing will be held on November 9-10, 2016 in Silver Spring, Maryland, and in case you want to present information you must register by October 19. You could also send in written comments by January 9.

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1. Stop Taking Viagra.

ViagraThis is the safe and correct call. If you are diagnosed with melanoma, you need to focus on getting back to health. I suggest you stop taking the drug and schedule an immediate appointment with your dermatologist. In fact, I would say that even without a diagnosis of any skin cancer, you should ask your doctor (or a second doctor) if you should stop taking Viagra (or Cialis or Levitra). If a doctor you trust reviews your patient history and encourages you to remain on Viagra, fine.

2. Get Healthy

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California Product Liability LawsuitsCalifornia is a beautiful, diverse state. It has everything from wide, sandy beaches to snow-capped mountains, deserts, thick forests, wide open spaces and massive cities. It also has laws and a court system that’s seen as friendly to those injured by prescription medications. And after a recent court decision, more people in other states may be heading there to try their  product liability cases.

The California Supreme Court issued a decision in August which may encourage people harmed by prescription medications and medical devices from all over the country to file legal actions in the state. At issue is whether the state’s court system has jurisdiction over legal claims by people who’ve never been in California. In cases involving the drug Plavix, the answer was yes.

The eight lawsuits in question have 86 California residents and 592 people from 33 other states as plaintiffs. The defendant, Bristol-Myers Squibb, sought the dismissal of the claims by the 592 non-Californian plaintiffs.

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My clients who have been injured by a failed medical device like an artificial hip or knee or a problem drug like Viagra suffer in many ways. There is the physical, emotional and psychological suffering. But there is another form of suffering that is often as traumatic: financial suffering. A failed medical device may cause a client to lose his or her job, and the lost income and extra medical expenses can be devastating. The good news is, often these clients receive a large sum of money from a settlement or jury verdict when a medical device or drug injures them.

Clients occasionally ask my advice on how best to handle the new money that has come into their lives. Frankly, this is a happy conversation. But it’s also extremely important to get the answer right. The worst thing clients can do is spend down the money quickly and have nothing left a few years down the road when they still need money.

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Depuy Pinnacle Jury AwardIn March 2016 five people injured by the Depuy Pinnacle metal-on-metal artificial hip scored a huge courtroom victory. In that case a Texas jury awarded five plaintiffs $502,043,908.00 for injuries suffered by the failure of the Depuy Pinnacle hip. That figure was divided in different ways to the five injured people. Of that amount, $360,000,000.00 was awarded by the jury for punitive damages. The jury concluded that the Pinnacle hip sold by Depuy was defective and that Depuy knew about the flaws but did not adequately warn patients and their doctors of the risks. Like I said, this was a huge win. Unfortunately, the punitive damages award did not last long.

Judge Forced to Reduce Punitive Damages Award

Punitive damages are money damages, separate from compensatory damages, which are awarded by a jury and which are intended to punish or deter a bad-acting defendant and others from engaging in similar conduct. Judge Kinkeade, who is the federal judge presiding over the Depuy Pinnacle multi-district litigation (MDL), stated that he was bound by a Texas statute which puts a limit or “cap” on the amount of punitive damages a jury can award. Thus, Judge Kinkeade was required by law to reduce the punitive damages award, which a jury of twelve individuals, after a 42 day trial, thought was appropriate.

Thank You, Tort Reform!

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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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