Articles Posted in Pelvic Mesh

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Medical device and prescription drug jury verdicts come rapid fire, with a few cases being tried at any given moment across the country. Below is a recap on three recent jury verdicts involving Ethicon pelvic mesh, the blood-thinning drug Xarelto, and the testosterone drug Androgel.

Pelvic Mesh (September 7, 2017)

Pelvic Mesh
Last week a Philadelphia jury awarded a seriously injured woman $57.1 million in damages caused by defective Ethicon TVT pelvic mesh. This was the largest verdict for a pelvic mesh lawsuit against Ethicon, Inc. and Johnson & Johnson (the parent company of Ethicon). The award included $7.1 million in compensatory damages, which encompasses pain and suffering damages, as well as a huge $50 million award for punitive damages.

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Pharmaceuticals Are Big BusinessPharmaceutical drugs and medical devices are big business. In 2014, Americans spent $3 trillion on healthcare. Medical device and pharmaceutical drug companies are scrambling to meet the demand for healthcare products and services which is great for business, but not always for the patient.

Despite large amounts of time and money spent on drug and medical device research and development, those drugs and devices don’t always work as intended. This often results in lawsuits. With so many patients taking a given drug or medical device, there are often thousands of lawsuits pending all around the country. In order to handle the cases as efficiently as possible, they are often consolidated into a multi-district litigation, or MDL.

Three notable MDLs that are ongoing and set to make waves in 2017 concern Pinnacle hip implants by DePuy Pinnacle Orthopaedics, the Xarelto blood thinner produced by Janssen Pharmaceutica and Bayer and pelvic mesh implants manufactured by a variety of companies.

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Woman with Transvaginal MeshLet’s say you are a woman in your forties, and the mother of three children. After the birth of your third child you began to suffer from pelvic organ prolapse. This condition occurs when an organ like the bladder drops from its normal position and presses against the walls of the vagina. You go to your gynecologist, who recommends implantation of transvaginal mesh (TVM), the net-like plastic product that was marketed and sold as a solution to the problem of pelvic organ prolapse. You have the surgery. Soon you begin to suffer new and different pain and new health problems. You undergo three revision surgeries to remove all the pieces of the mesh. But after the revision surgeries you still suffer from pain and incontinence. You call an attorney, who files a lawsuit against the manufacturer of the TVM product. A few months into the litigation, your attorney explains that you now need an expert witness.

Your attorney is absolutely correct: you will need an expert witness in virtually all product liability cases. And a good one. And fast. If you do not have a qualified expert witness who can make the connection between your injuries and the failed product, then in the eyes of the court you do not have a case.

Your Most Important Witness

Expert witnesses are critical members of the team that is built to win your product liability case. In fact, other than your choice of attorney, the selection of the expert witness will be the most important decision you will make to help you win your case.

Expert Witness in Product Liability Case

Expert witnesses are common in all kinds of litigation. In a simple car crash case, a treating doctor is almost always called to testify about the nature of the plaintiff’s injuries after the crash. In some car crash cases, a second expert witness will be called to explain why a car’s brakes failed, or why the car’s airbag did not deploy. Usually this testimony ends by showing causation, “and if the brakes did not fail, the driver would not have crashed into that oak tree and broken his arm.”

In a product liability case, the expert must be able to show causation, to make the connection between the failure of the product and the injuries the person suffered. If the injured person cannot show this causation through the testimony of a qualified expert witness, she cannot win her case. In the example at the top of this post, the expert will have to be able to testify that the new pains and the new health problems were medically caused by the failure of the mesh and the need for multiple revision surgeries.

But I’m getting ahead of myself.

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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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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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So maybe you’ve heard the news that Washington and California recently sued Johnson & Johnson for misrepresenting the safety of its transvaginal mesh (or “pelvic mesh”) products. I pulled the Washington lawsuit and read it. It is alarming. If Washington can prove the allegations in the complaint, it will be a damning indictment of Johnson & Johnson and the pelvic mesh industry generally.

The Washington Lawsuit

Washington State Transvaginal Mesh LawsuitStates can sue companies on behalf of their injured citizens. If the state’s attorney general decides that a “bad act” is harmful to enough citizens, her office can file a lawsuit on behalf of the state and the group of people who were injured. It is an important consumer protection function provided by the states. This is what happened in Washington and California a few days ago. The Washington Attorney General reported that 11,728 transvaginal mesh products were sold (and implanted) in women in the state. The attorneys general in those states filed suit against Johnson & Johnson and made a series of chilling allegations against the company for its marketing of transvaginal mesh.

Let’s look at some of the key allegations in the Washington State lawsuit. When I refer to “Defendants,” I mean Johnson & Johnson, Ethicon, Inc., and their related companies, who made and marketed several types of transvaginal mesh.

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Most people have heard of the claim “loss of consortium.” It comes from the root word consort meaning to associate, to spend time, to hang out with. The definition of the legal claim goes like this: loss of consortium is a claim for (money) damages by the spouse or close family member of a person who has been injured or killed as a result of the negligence or wrongful act of another person. It is a derivative claim, which means it derives or flows from the primary injury to the spouse or family member. Essentially, it creates a separate plaintiff (usually a spouse) and “piggybacks” off the injury to the injured person. A loss of consortium claim cannot exist without the recognized injury to the spouse or family member.

The Lost Sex Claim

People sometimes think of loss of consortium as the “loss of sex” claim. And in fact, one important injury under loss of consortium is that the primary injury prevented a loving married couple from enjoying intimacy and sexual intercourse in the same manner they enjoyed before the accident. Let’s face it, when intimacy is lost or diminished based on the negligence of others, people should be compensated. It’s one big reason we have the derivative claim.

Sailing CoupleBut loss of consortium extends beyond married sexual relations. Suppose a married couple were passionate about sailing and took sailing trips most weekends, but the failure of an artificial hip placed a married woman in a wheelchair and made it impossible for her to climb onto the sailboat. In most states a loss of consortium claim could be made that the loss of this treasured activity deeply damaged the quality of life of the husband. Similar claims can be made for couples who actively garden together, play tennis, travel, or even cook.

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(Part 6)

Woman Suffering From Transvaginal Mesh ImplantLet’s get back to a look at recent developments with transvaginal mesh lawsuits. In two big victories recently, a Georgia jury awarded $4.4 million to a woman injured by transvaginal mesh, and a New Jersey appeals court upheld an $11.11 million dollar jury verdict.

Transvaginal mesh (TVM) is a plastic mesh product that has been implanted in women for many years to support weakened vaginal walls. Many women suffer from pelvic organ prolapse or stress urinary incontinence, and makers of TVM have insisted that TVM could repair these medical problems. Unfortunately, not long after TVM was marketed and sold, women began complaining of serious health problems, including erosion of the vaginal wall, infections, painful sex, and bladder perforation. The lawsuits followed.

Now let’s take a look at a recent jury trial and an appeal decision of an earlier jury verdict.

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iStock_000016768061_Large-1Carlino et al. v. Ethicon, Inc., et al. (Pa. Comm. Pls. Ct., Philadelphia County)

Product:  Gynemesh TVT

Jury Award:  $13,500,000.00 ($3,250,000.00 in compensatory damages; $250,000.00 to husband for loss of consortium; $10,000,000.00 in punitive damages)

Date of Jury Verdict:  February 10, 2016

This case was brought by Sharon Carlino and her husband, Charles Carlino.  The couple sued Ethicon, Inc. and parent company Johnson & Johnson on several claims, the main one being that Ethicon failed to warn Ms. Carlino and her doctors of the transvaginal mesh product’s risks and potential dangers.

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