In 2009 Mary McGinnis was implanted with the Avaulta Solo Support System and Align Trans-Obturator Yrethral Support System, two pelvic mesh products manufactured and sold by C.R. Bard, Inc. and other defendants. Ms. McGinnis was implanted with these mesh products in an attempt to treat Ms. McGinnis’ stress urinary incontinence and to provide bladder support. Shortly after implantation of the mesh, Ms. McGinnis began having severe pains from nerve damage and pain during sex. She had to undergo several surgeries to attempt to correct the problems.

Ms. McGinnis and her husband filed suit in 2011, alleging that C.R. Bard knew the pelvic mesh was unsafe at the time the products were implanted in Ms. McGinnis, and that Bard failed to warn doctors about the dangers of the Avaulta and Align pelvic mesh. At trial lawyers for Bard argued that the Defendants met all industry standards and requirements for placing the Avaulta and Align mesh products on the markets.

Compensatory Damages

On April 12, 2018, after a four-week trial, the McGinnis family finally got some justice. The jury in New Jersey state court awarded $33 million in compensatory damages. These damages were broken down this way: Ms. McGinnis received $23 million for her specific injuries, medical costs, and pain and suffering, and her husband received $10 million for his derivative “loss of consortium” claim. (Let me add here that loss of consortium claims can be substantial in these kinds of cases, as one of the key mesh injuries is pain during sex, often leading to couples abandoning marital relations altogether. That kind of injury has real value for most couples.)

Punitive Damages

On April 13, 2018, the jury returned to court to consider whether to impose punitive damages on C.R. Bard. Plaintiffs’ lawyers argued that Bard acted “maliciously” and in “wanton and willful disregard” for the rights of Ms. McGinnis and her husband when Bard placed these flawed products in the market. Ms. McGinnis’ lawyers argued that corporate profits should never take precedence over the health of patients. Again, Bard lawyers countered that Bard complied with industry standards, that $33 million (in compensatory damages) was compensation enough, and that anyway the vast majority of of medical devices reach the market without clinical trials. Therefore, said Bard, the jury should not impose punitive damages.

The jury then awarded the Mary and Thomas McGinnis $35 million in punitive damages. The two-day verdict reached $68 million. Of course it can never repair Ms. McGinnis’ internal injuries, the pain she suffers during intercourse, or her incontinence, but the money may at least provide the best medical care going forward and some comfort as she grows older.

“Most Medical Devices Do Not Undergo Clinical Trials”

As noted above, this was one of the main arguments offered by attorneys for C.R. Bard and the other defendants. Because so many similar mesh products were already on the market, Defendants argued, clinical studies on these new products were not necessary.

This is crazy talk. Clinical testing is critically important for new medical devices. And this is a major problem in our medical device device industry. It goes like this: ‘because this new product, let’s say a metal-on-metal (MoM) artificial hip looks very similar to an older, metal on ceramic hip, we don’t need to test our MoM hip. Let’s just put it on the market now, without testing.’ (Over a decade later, ask the many thousands of people injured by MoM artificial hips whether clinical testing was unnecessary.) The same holds for pelvic mesh, IVC filters, artificial knees, and virtually all other medical devices.

This subject is too important to ignore. If a company wants to sell a product that is to be implanted in a human body, the company should do all that it can to ensure that the product is safe.

Fortunately, the Avaulta and Align mesh products implanted in Mary McGinnis have been taken off the market. But not before thousands of women were severely injured by these flawed pelvic mesh products. Thousands of cases have been filed and more trials are scheduled for 2018 and beyond. I’ll keep you posted.

Note: This post was drafted from review of several news reports on the McGinnis trial.

Let’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 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.

more Finding a Qualified Expert Witness

Before an expert witness can testify as an expert, he or she must be qualified by the trial judge. You may have heard the name of this case before, but in most states the admissibility of expert testimony is governed by a Supreme Court case from the 1990s, Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579 (1993). The Daubert standard requires a trial judge to scrutinize all potential expert witnesses before the expert is permitted to testify as an expert. If the expert is qualified by “knowledge, skill, experience, training, and education,” the expert will be allowed to testify if:

(1) the information provided by the expert will help the trier of fact to understand the evidence or determine a fact in issue;

(2) the testimony is based on sufficient facts or data;

(3) the testimony is the product of reliable principles and methods; and

(4) the expert has reliably applied the principles and methods to the facts of the case.

The qualification of an expert is one of the biggest battles that a plaintiff will face in litigation. The plaintiff’s lawyer will argue aggressively for the qualifications of the expert and the relevance of the expert’s testimony. The defense will argue just as aggressively that the plaintiff’s expert is unqualified, and that even if the expert is qualified, the testimony will not be helpful for the jury to understand the case. The trial judge will ultimately have to make the determination whether to permit the expert to testify. It is one of the key decisions the judge will make in a product liability case.

I can’t stress this enough: your expert witness is a vital part of your case. If the expert does not have proper education or credentials, or if the expert fails to provide convincing analysis of the connection between the failed product and the injuries, then the judge will reject the expert and the plaintiff will lose her case.

This situation happened recently in the Zimmer NexGen knee case. On the eve of the second “bellwether” trial, Judge Pallmeyer rejected the plaintiff’s expert and granted summary judgment for the defendants. Among other things, the judge concluded that plaintiff’s proposed expert has not “given the court sufficient basis to conclude that his opinion is reliable.” (Order, p. 17) After years of litigation, the plaintiff was out of court.

Your Expert Must be a Good Communicator

Choosing the right expert is very difficult. First, you must find a person with the right kind of expertise for the particular case. This expertise must be of a kind that will survive a motion to exclude the testimony by the defendants (such as a Daubert challenge). If your expert survives that scrutiny, he or she will still need to be able to communicate effectively with a jury. And those jurors will likely have almost no understanding of transvaginal mesh or pelvic organ prolapse (although they will know a lot about it by the end of the trial). Your expert must be able to communicate complicated medical or scientific terms in a simple way so that jurors will understand the concepts. This is no easy task. Your lawyer must talk to several potential experts before hiring one to testify on your behalf. My favorite experts are natural teachers. They can take very complicated subjects and explain them so that my teenage son can easily understand them. When that happens, you often win over the jury.

Experts don’t work for free. Every expert will charge the plaintiff for the time it takes to review the case file, analyze the information, write an expert report, and testify. Beyond that, the expert will have to be paid for travel expenses, hotels, and other costs. But if you find the right expert, the expense will easily pay off. Good luck.

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.

What Happened at Trial?

After three weeks of trial in 2014, the jury returned a verdict in favor of Boston Scientific, effectively concluding that Boston Scientific’s warnings were not inadequate, and that the Pinnacle transvaginal mesh was not defectively designed. Importantly, the trial judge did not allow Ms. Albright’s legal team to present evidence of a “material safety data sheet,” along with FDA letters discussing the fast-tracked approval of the Pinnacle transvaginal mesh. It was this decision by the trial judge which prompted Ms. Albright to appeal to jury verdict.

What Did the Appeals Court Say?

On September 13, 2016, the Massachusetts Appeals Court agreed with Ms. Albright, holding that the trial judge should have permitted Ms. Albright to introduce this key evidence. The material data sheet contained information that polypropylene, which Boston Scientific used to manufacture the Pinnacle TVM, was not healthy for permanent implantation in women. The appeals court wrote in its opinion: “the jury did not have the complete picture of the information bearing on the safety of the Pinnacle device that BSC knew of . . . or should have known about.”

The appeals court also held that the trial court should have allowed the introduction of the letters from the FDA demanding that Boston Scientific conduct a post-market surveillance study of the Pinnacle TVM. The Massachusetts Appeals Court then remanded the case to the trial court for a new trial with the instructions permitting introduction of the excluded evidence. You can read the full appellate opinion here.

It is important to understand that the Pinnacle transvaginal mesh was “approved” for sale to consumers under the fast-track 510(k) process. I have written often about this streamlined procedure for getting products to markets, and you can read more about 510(k) here. My general view is that 510(k) has caused many problems, and that companies in some cases have used the 510(k) clearance procedure to rush products to markets.

So What Happens Now?

Ms. Albright has won a new trial. This doesn’t mean the two sides will pick a new jury on Monday. It can take months to get back on a trial calendar. Still, it is a big victory for Ms. Albright and for all women injured by Boston Scientific’s transvaginal mesh. With the introduction of the new evidence, Ms. Albright could win this second trial.

Albright v. Boston Scientific Corp.

Let 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.

more Attorneys Should Never Abandon a Case

This is not right. Plaintiffs’ attorneys should never abandon a case. If the case is fatally flawed and everyone knows it, the attorney must inform the client and has an obligation to dismiss the lawsuit. I understand Judge Land’s frustration for these clearly weak or abandoned cases. There are many reasons this behavior is bad for the legal system: it takes up time and money unnecessarily; it puts the client in a bad position with the court; and it also makes product liability lawyers look bad.

The Order

Judge Land, who oversees the Mentor Corp. Mesh MDL in federal court in Georgia, has been handling several motions for summary judgment over the past year. He has dismissed many actions based on the passing of the statute of limitations and for other reasons. He seems quite tired of it. He wrote that lawyers for plaintiffs in the MDL “are on notice that in future orders granting summary judgment in which no good faith basis existed for maintaining the action through the summary judgment stage, the Court intends to include an addendum in the order requiring counsel to show cause why sanctions should not be imposed. Thus, it would behoove counsel to take a close look at your cases and decide whether you truly have a good faith basis for proceeding; and if you do not, dismiss the case.” You can read the full order here.

Let’s unpack this. Judge Land is unambiguously issuing a strong warning to plaintiffs’ lawyers who do not closely scrutinize their cases and who fail to ensure that a fatal flaw does not exist in their cases. Quick example: let’s say there is a absolute deadline for identifying a medical expert who will testify that the transvaginal mesh injured the client. And let’s say that the lawyer let that deadline pass without finding a suitable expert. The lawyer must take immediate action: either he must file a motion requesting an extension of time to identify the expert, or he must dismiss the case without prejudice, or he must dismiss the case outright. Doing nothing is bad.

But Wait a Minute!

Now, a “good faith basis” for continuing a case is often in the eye of the beholder. And there are times when the passing of the statute of limitations is not at all clear. And sometimes it is the product manufacturer itself who makes the limitations period difficult to calculate.

A statute of limitations is a law which limits the period of time when you can bring a lawsuit for money damages for an injury. In each state you have a certain number of years from the date of injury, or the date of discovery of the injury, to file a lawsuit and recover money for your injuries. If you miss this deadline, you lose your right to bring the lawsuit forever.

But when does the clock begin to run? Let’s say you are a woman who received a transvaginal mesh implant. After a few months you began feeling new pains and other unpleasant symptoms. But the manufacturer kept insisting to everyone–the media, doctors, patients–that the TVM product was safe and effective. You visit your doctor and she says, “the manufacturer is saying the mesh is safe, so your pains must be coming from some other problem.” In that case (and it is very common) how can this injured woman know she has a valid claim against the manufacturer? The fights over statutes of limitation are often fierce, as I write about here. And they should be. If the defense wins the argument, the defendant has to pay no money for what might be a real injury to a real person. The plaintiff has ever right to fight back against this SOL defense. And should.

And I guess that is Judge Land’s point: if you are the lawyer for the plaintiff and you are facing a summary judgment motion, show up, make your case, fight for your client. Don’t abandon the client, and don’t leave a case behind you know to be fatally flawed. I agree.

But I also believe that judges need to be mindful of the unfair fight injured people face. No person injured by transvaginal mesh, or a failed artificial hip or knee, or an untested drug, can compete with the power and resources of a major corporation. I would like all plaintiffs’ lawyers to handle their cases competently, but I also would like to see judges give an injured person the benefit of the doubt in the face of this uphill struggle. After all, nowhere in Judge Land’s order does he say that these plaintiffs who lose summary judgment were not injured by the negligence of the manufacturer. Rather, the person was simply unable to pursue her claims based on a legal or technical defense.

In re Mentor Corp. ObTape Transobturator Sling Products Liability Litigation, No. 4:08-MD-2004 (M.D. Ga.)

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.

more New Warnings

The warnings include additional language to existing warnings concerning:

• “Erosion” and “ongoing pain” as possible side effects, and
• The company’s meshes and slings should be considered permanent implants because taking them out can be complicated or impossible but the new warnings also state treatment for erosion caused by the mesh may require at least an attempt at surgical removal of the device.

The company announced the warnings in June as part of “urgent” advisory letters sent in May to physicians worldwide. Those letters were followed by announcements from European regulators that publicized warning label changes. The changed warnings apply to:

• Five brands of transvaginal slings (Advantage, Lynx, Obtryx, Obtryx II and Solyx), and
• Three types of mesh (Uphold LITE, Pinnacle LITE, and Upsylon Y).

Boston Scientific states the changes to the warning label are a result of a review of data by company officials and Australian medical device regulators.

The patients harmed by Boston Scientific’s products make a number of legal claims including that its transvaginal mesh’s design and manufacturing are flawed, that it failed to warn of known dangers in the past, and that the company breached warranties and violated consumer protection laws.

Securities filings by Boston Scientific state it has settled about 11,000 of these cases without admitting liability or wrongdoing. One source estimates there are about 100,000 lawsuits by those harmed by vaginal mesh and more than 135,000 worldwide.

Counterfeit Raw Material

In addition to all the issues that arise when transvaginal mesh is manufactured to Boston Scientific’s specifications, the company may have used the wrong raw material in making some of its products, adding yet another complication for patients. The federal Food and Drug Administration (FDA) issued its own warning to physicians in April that it was investigating allegations Boston Scientific used counterfeit raw material for its transvaginal mesh, according to the Boston Globe.

FDA stated the company will conduct new tests on the safety and effectiveness of the product and the agency will review the results. Boston Scientific has denied that has used “‘counterfeit’ or ‘adulterated’ materials” in its medical devices.

The Takeaway

Warnings are a step in the right direction so patients can have a better idea as to the risks involved with TVM, but if the products are used anyway warnings won’t prevent harm to patients. Eliminating all risk of injury will occur only when transvaginal mesh is no longer used. That will only happen if:

• Manufacturers decide to step selling it,
• Doctors decide to stop implanting it,
• Patients refuse to use it, or
• The FDA decides to ban it.

Until then patients will continue to be injured by transvaginal mesh and lawsuits against manufacturers such as Boston Scientific will continue to be filed. These lawsuits not only compensate plaintiffs for the injuries they’ve suffered but they also increase the cost of doing business as usual for companies like Boston Scientific. They may eventually decide profits from selling transvaginal mesh aren’t worth the costs and stop selling these products.

The Washington Lawsuit

States 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.

more Key Allegations:

1. Defendants misled consumers through informational and marketing materials that misrepresented the safety and effectiveness of transvaginal mesh. (Complaint, p. 7)
2. Defendants did not conduct human trials prior to the initial sale of transvaginal mesh. (p. 10)
3. Defendants destroyed the underlying data they claimed supported the safety and effectiveness of their original mesh products. (p. 11)
4. Defendants misrepresented the safety history of the transvaginal mesh to doctors. (p. 11)
5. Defendants made misrepresentations about the mesh directly to consumers through advertisements, brochures, and other marketing materials. (p. 11)
6. Defendants’ marketing materials failed to disclose the possible health complications from implantation of transvaginal mesh. These health problems include incontinence, defecatory dysfunction, dyspareunia (pain during sex), dysuria (pain while urinating), fistula, hematoma, hemorrhage, pain to partner during intercourse, permanent urinary dysfunction, recurrence, pain, UTI, urinary tract obstruction, vaginal scarring, and worsening incontinence. (p. 12)
7. Defendants knew about these mesh health problems but did not report this information. (p. 12-13)
8. Defendants’ Polypropylene Mesh Products present risk of chronic bacterial infection. These infections can occur years after the mesh was removed surgically. (p. 14)
9. Polypropylene mesh degrades and oxidizes in the body over time. This can cause a reaction in the body which can cause chronic inflammation. (p. 14)
10. The transvaginal mesh cannot be removed effectively when the medical device fails. (p. 15)
11. Transvaginal mesh implantation may also cause cancer in women. (p. 15)
12. Defendants knew about problems with sexual function and shrinkage at least as early September 2006, based on the discovery of a Johnson & Johnson internal document. (p. 15-16) Despite this knowledge, J&J sold thousands of mesh products after 2006.
13. Defendants falsely claimed that their transvaginal mesh products were “FDA Approved.” (p. 16) Rather, the mesh products were cleared under the 510(k) equivalency process. (p. 17) I have written about the 510(k) process several times in this blog.
14. Defendants failed to update informational and marketing materials. (p. 18)

Washington State’s Individual Claims Against J&J:

Washington State brought the following individual claims against Defendants:

1. Misrepresentation and Omissions Regarding Safety
2. Misrepresentations or Omissions Regarding Efficacy (the ability to produce a result)
3. Failure to Update Information Provided to Consumers

The State of Washington asked the court to “decree” (to determine, conclude) that Johnson & Johnson engaged in all the bad acts listed in the complaint. It also asked that the court find that J&J engaged in “unfair and/or deceptive acts” in violation of that state’s consumer protection laws. Washington then asked for a permanent injunction which would prohibit Johnson & Johnson from selling transvaginal mesh products in Washington. It also asked for civil penalties for every violation of state law. And finally, Washington asked for “restitution to consumers.”

The Complaint is captioned: State of Washington v. Johnson & Johnson, et al. (Wash. Super. Ct., King Cty.), and is worth reading if you have the time.

Meanwhile, in California

Kamala Harris, Attorney General for California, also filed suit on behalf of California on May 25, 2016. Attorney General Harris stated that Johnson & Johnson sold almost 800,000 pelvic mesh devices nationwide between 2008 and 2014. According to AG Harris, 42,000 mesh products were implanted in California women during this period. On behalf of the citizens of California, Harris sued Johnson & Johnson, alleging false advertising and deceptive marketing of its transvaginal mesh. The lawsuit alleges that J&J failed to inform patients and doctors of possible severe complications and misrepresented the frequency of these risks.

Johnson & Johnson’s Blanket Denial of Wrongdoing

Remarkably, despite more than a hundred thousand serious injuries, thousands of lawsuits, millions paid in jury verdicts and settlements, Johnson & Johnson still contends the mesh product is safe and is the preferred treatment for certain female health issues. According to the Wall Street Journal, Johnson & Johnson responded to the states’ lawsuit by stating, “the use of implantable mesh is often the preferred option to treat certain female pelvic conditions . . . .” As I’ve said before on this site, this blanket denial is a dangerous game for Johnson & Johnson to play, particularly when intentional misrepresentations are alleged.

The Takeaway

An injured person often feels powerless when facing a huge corporation like Johnson & Johnson. And rightly so. No individual, standing alone, can absorb a long legal fight in the same way that a multi-billion dollar corporation can. But when a state gets involved, the fight gets fair. California and Washington can bring the full power of the state to the legal fight against J&J. These lawsuits are therefore a huge step forward in protecting women against future pain and injury from transvaginal mesh. I will keep you posted on key developments in both cases.

Note: Again, I am no doctor. Please call your doctor if you have transvaginal mesh implanted in your body and you have concerns about your health. The information in this post comes mostly from the State of Washington’s lawsuit, which is a public document. I encourage you to review it carefully for further information.

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.

But 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.

more

Loss of consortium claims can also extend to family members, particularly parents and children. A son could potentially bring the same “sailing” claim as did the husband in the example above. It is important to note, however, that the more remote the family relationship, the less likely any significant recovery will result. Spousal relationships remain the primary relationships for pursuing, and winning, loss of consortium claims. Also, if a couple goes sailing once a year, the claim becomes weaker and more remote.

A Little History

The loss of consortium claim has uncomfortable origins. It began as a claim solely for husbands, whose wives were considered their property (“chattel” they call it in the dusty law books). In the eyes of the law, say, two hundred years ago, having a wife was much like owning a cow (the word chattel derives from cattle). It went something like this: say a drunk doctor botched a surgery and a man’s wife died. The husband was a farmer and had five young children at home. He expected that woman to feed the family, take care of the house, and maybe even have sex with him on occasion. The husband would bring a claim for loss of consortium in much the same way as he would bring an action against another man who negligently shot one of the man’s cows. (I’m merely reporting this primitive historical mindset.)

Today, loss consortium extends well beyond the exclusive rights of 18th century men. Women (and mothers, and children) can bring claims for loss of consortium when a close family member has been injured and the person can demonstrate actual damage caused by the loved one’s injury.

Loss of Consortium in Mesh and Hip Cases

It is not difficult to see how failed medical devices can give rise to significant loss of consortium claims. One of the key injuries in a transvaginal mesh case is dyspareunia, which is pain during sex. Many women have complained that their transvaginal mesh implants have caused serious pain during intercourse. If a woman is in pain, she should not have sex (or at least she likely wouldn’t welcome such an activity). If a failed medical device like transvaginal mesh causes pain during sex, and she can no longer have marital relations, the husband is clearly one of the victims. In those cases, the husband should absolutely bring a loss of consortium claim.

The same holds for artificial hip cases. I mentioned the example above about the couple who could no longer sail their boat together. But the fact patterns where valid loss of consortium claims can arise are nearly endless. One couple I knew could no longer tend their one acre garden, which they had worked on together for more than fifteen years (giving much of the produce to soup kitchens and food banks). This lost shared activity could support a loss of consortium claim. Failed IVC filters, which I have written about here, can also potentially create a loss of consortium claim.

Many failed medical devices can cause serious injuries to a person, which then impacts the life of the spouse or a close relative. Your attorney should always check to make sure a loss of consortium claim is valid in your narrative of injury.

The Value of Loss of Consortium Claims

Despite the fact that loss of consortium in some cases can be a devastating loss for the loved one of the injured person, companies often fight against paying reasonable amounts of money for these derivative claims. To be fully compensated for a loss of consortium claims, the injured person and his or her spouse often must try their case and ask the jury to give careful thought to the loss of consortium claim.

And juries can be generous. In a recent transvaginal mesh case in Philadelphia, a jury awarded the husband $250,000.00 for his loss of consortium claim. In a 2014 transvaginal mesh case in Dallas, a jury awarded the husband $1,515,000.00 for loss of consortium and for loss of “household services.”

By contrast, in the recent Depuy ASR artificial hip settlements, the amount of money offered for loss of consortium was not substantial, but to participate in the settlement the spouse or family member had to sign on (and sign away their loss of consortium claim). Depending on the facts of each case, it can be a tough decision.

Typically, the lion’s share of the total damages in an injury case derives directly from the injured person’s suffering. Let’s face it, pain during sex—and all the other suffering flowing from failed transvaginal mesh—is more devastating to the injured woman than it is to the husband. Still, loss of consortium is a vital claim in any injury case, and your attorney should prepare a documented narrative around the injury suffered by the spouse or other family member.

Let’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.

more Taylor v. Mentor Worldwide LLC (Middle District Georgia, Columbus)

Products: Mentor ObTape Sling Pelvic Mesh

Jury Award: $4,400,000.00 ($400,000.00 compensatory damages; $4,000,000.00 in punitives)

Date of Jury Verdict: February 18, 2016

Key Takeaway: First win for injured woman against Mentor Worldwide, LLC (which is owned by Johnson & Johnson), with a substantial punitive damages award.

Teresa Taylor is from Marianna, Florida. The Mentor ObTape Sling Pelvic Mesh was implanted in her body in 2004 to treat her stress urinary incontinence. Following implant surgery she began having physical problems, including lower back pain, vaginal burning, painful sex, and incontinence. The ObTape Mesh was surgically removed in 2011. Ms. Taylor filed suit in 2012.

After a nine day trial, the Georgia jury found that Ms. Taylor had demonstrated that the ObTape had a design defect, and that Mentor Worldwide failed to warn her physician of the risks involved in using the ObTape Mesh.

The jury awarded $400,000.00 in compensatory damages (for actual injury, actual pain and suffering), and a noisy $4,000,000.00 in punitive damages.

Among other findings, the jury concluded that Mentor Worldwide was solely motivated by “unreasonable financial gain” in marketing the product. The jury also found that Mentor had intent to harm Ms. Taylor. These findings supported the punitive damages award.

Unfortunately, Florida state law caps punitive damages at $2,000,000.00.

Over 350 ObTape cases remain in the Mentor ObTape MDL. Most of these cases will be settled, but a few may still reach a jury trial.

Mentor Worldwide sold the medical devices between 2003 and 2006. Johnson & Johnson purchased Mentor Worldwide in 2009.

Unless Ms. Taylor can now work out a settlement with Mentor and Johnson & Johnson, the defendants will likely appeal the verdict in the Taylor case. I will keep you posted on these developments.

Gross v. Ethicon, Inc., et al. (New Jersey Superior Court, Appellate Division)

Product: Gynecare Prolift Pelvic Floor Repair System

Appeal Decision: Appellate court in New Jersey upheld jury verdict in favor of injured woman totaling $11.11 million dollars. Court refused to disturb an impressive $7,760,000.00 punitive damages award.

Date of Appeal Decision: April 1, 2016

Recap of the Jury Trial:

In 2006, the Prolift transvaginal mesh was implanted in Linda Gross to treat pelvic organ prolapse. Following implantation, Ms. Gross suffered from mesh erosion, scarring and inflammation. Ms. Gross has eighteen surgeries to repair damage caused by the Prolift TVM.

In 2008 Ms. Gross filed suit in state superior court in Atlantic City, New Jersey. She brought claims against Ethicon, Inc., and Johnson & Johnson for failing to warn her and her doctor about the potential risks of using the Prolift transvaginal mesh product. Ms. Gross also brought other claims, including misrepresentation, defective design, manufacture, and instructions.

Following trial the jury found that the companies failed to warn Ms. Gross of the risks involved with the device, and that this failure to warn caused her injuries. The jury awarded $3,350,000.00 in compensatory damages and $7,760,000.00 in punitive damages. The total award was $11,110,000.00.

Ethicon, Inc. and Johnson & Johnson appealed the jury verdict.

Appeal’s Court Upholds Jury Verdict

In a huge (second) win for the plaintiff, Ms. Gross, the New Jersey Appellate Court upheld the jury’s verdict in a court decision issued on April 1, 2016. The grounds for appeal were complex, and I won’t try to report all the arguments here. But I will say that one key argument was that the learned intermediary doctrine should have applied. The doctrine goes like this: a manufacturer cannot be liable for negligence if it provides all necessary information to a “learned intermediary” (such as the implanting surgeon), who is then expected to communicate with the patient about the benefits and risks of a medical device. The appeals court ruled that it was not error to instruct the jury that the doctrine did not apply in Ms. Gross’s case.

Next, the appeals court held that Ms. Gross and her attorneys provided sufficient evidence to link the lack of adequate warnings about the pelvic mesh to the injuries Ms. Gross suffered. Ms. Gross’s surgeon testified that he would have spent much more time going over the risks involved if he had known about the problems of the Prolift mesh.

Finally, the appellate court held that the evidence presented was more than adequate to support the jury’s decision to award punitive damages.

This is the second big win for Linda Gross. Three years ago her team won a courtroom victory, and now she protected the court victory by successfully fighting off an aggressive appeal by Ethicon, Inc. and Johnson & Johnson. Perhaps this appellate victory will improve the settlement results for the many transvaginal mesh cases that are still in court system and unresolved.

For thousands of women, transvaginal mesh has caused more problems than it has solved. Women with TVM have reported infections, urinary problems, pain during sexual intercourse, scarring, bladder perforation, recurrence of pelvic organ prolapse or incontinence, and other problems. If you have a transvaginal mesh implant and now suffer unusual pain or other symptoms, you need to take action quickly.

moreMake an Appointment with your Gynecologist. If you believe your transvaginal mesh implant is causing you problems, your first priority is to get back to good health. As I tell my clients, your health decisions always come first, and those are between you, your family, and your doctors, and do not involve any attorney. So set an appointment with your treating physician, and let her know about the pains or discomforts or new “weird feelings” you are having. If it turns out the TVM has failed, you will want to have that information as soon as possible and you may need to schedule revision and repair surgery. But again, you need a good doctor to help you analyze your medical condition as soon as you become aware of something being “not quite right.

Start a Symptoms Journal. It is simple enough: when you first begin to notice sensations or pains which seem abnormal or unexpected, write down a brief description of the pains on a piece of paper or a notes app on your smart phone. The more detail the better—if the pain occurs when you are having sex (dyspareunia), note the kind of pain you feel, the location, and any other details. This journal may provide important information for your doctors but also for your attorney as he or she prepares a settlement package or a lawsuit. A woman who has been injured by transvaginal mesh can potentially recover money in a subset of “damages” known as “pain and suffering.” A pain/symptoms/well-being journal can provide valuable information to an attorney putting together the best case for you in the event you have a viable claim against a manufacturer for a failed TVM.

Gather Bills and Keep Records of Expenses and Missed Work-Time. Keep accurate records of all bills incurred and any out-of-pocket expenses you are paying for your surgery, recovery, rehabilitation, medications, etc. Manufacturers of defective transvaginal mesh may be obligated to pay the out-of-pocket expenses to a victim of a failed TVM. Also, keep detailed records of all time missed from your employment, including sick days which you were forced to use, and days out of work for which you lost compensation. Make notes for each day missed from work, and why you missed work (e.g., “Missed February 8-12 due to revision surgery at X hospital, recovery at home.”). It is important in the early stages to keep a file with any documentation you receive from your surgeons, your gynecologist, urologist, or primary care doctor, your pharmacist, and any other professionals who participated in your surgery or follow-up care.

Do Your Research. I would recommend starting with the U.S. Food and Drug Administration website (https://www.fda.gov/MedicalDevices/), a federal government website providing timely information on the latest recalls or problems associated with medical devices such as transvaginal mesh. Also, you may want to review the court website associated with the TVM you have implanted (or which has been removed in a revision surgery). Two multidistrict litigation sites for transvaginal mesh can be found on my Resources page. I also recommend going to established news outlets, such as The Wall Street Journal, The New York Times, The Washington Post, and other reliable publications. The New York Times has been quite effective in reporting on failed transvaginal mesh through its news, business, and health sections. Type in “transvaginal mesh” and read.

But be careful! I can’t stress this enough: The Internet can be a freaky place. I once saw a funny cartoon depicting a doctor handing a prescription to a patient with the caption, “take two of these before you Google your symptoms.” Indeed, within a matter of minutes on the Internet you can be reading about the worst possible outcomes in a failed transvaginal mesh case, outcomes which would most likely never happen to most people who have suffered a failed TVM. There is no requirement for truth on the Internet. People can write anything. If something sounds unbelievable on a website, it is probably false. So again, be cautious and skeptical when conducting research on the Internet. Verify.

Find the Right Lawyer. Many attorneys merely advertise but don’t litigate or even represent the people to whom they are marketing their legal services, and other attorneys throw up a laundry list of practice areas in which they claim expertise. As with any profession, some lawyers are good and some are not very good. You will want to find an experienced attorney who practices plaintiff-side product liability and personal injury law. It is a bad idea to let your nephew who just graduated from law school take on your transvaginal mesh product liability case. Take your time with this important decision.

Mark this down in the “It’s About Time” column.

On January 4, 2016, the Food and Drug Administration (FDA) finally made the move to reclassify transvaginal mesh medical products from Class II to Class III.

Surgical mesh is a medical product that has been used for more than sixty years and is intended to provide “additional support when repairing weakened or damaged tissue.” FDA News Release. It is typically a plastic lattice-type mesh that is surgically implanted around weakened, loose human tissue (such as a vaginal wall). While surgical mesh can be used to treat different kinds of problems, such as hernia, the mesh that has caused much of the current suffering and most of the lawsuits involves transvaginal mesh (TVM). Pelvic organ prolapse (POP), where organs fall from their normal position and press against the vaginal walls, is one of the conditions treated by TVM.

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A Class II device is considered a moderate risk device. It is higher risk than Class I (simple devices like a toothbrush), and requires greater regulation and control “to provide reasonable assurance of the device’s safety and effectiveness.” FDA. For example, condoms are Class II devices.

Class III devices are considered “the highest risk devices and are therefore subject to the highest level of regulatory control. Class III devices must typically be approved by FDA before they are marketed.” FDA. Class III devices are typically those that “support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential, unreasonable risk of illness or injury.” Heart valves, implantable pacemakers, and defibrillators are examples of Class III devices.

Now that transvaginal mesh is a Class III device, it will be subject to much tighter controls and regulation. This is a great thing, and overdue. The reclassification of TVM to Class III will require manufacturers (such as Ethicon, Inc. and Johnson & Johnson, C.R. Bard, Inc., Boston Scientific, American Medical Systems, and other companies) to submit premarket approval (PMA) applications “to support the safety and effectiveness of surgical mesh for the transvaginal repair of POP.” FDA News Release, January 4, 2016. Transvaginal mesh manufacturers will have thirty months (yes, that is two and a half years from now) to submit an application for pre-market approval for devices that are already on the market. Manufacturers of new TVM devices must submit this application before the company will be allowed to be marketed.

Between 2011 and 2015, the FDA received more than 20,000 complaints about TVM. The FDA has issued warnings, and in May 2014 the FDA proposed to change the risk classification to Class III and to require pre-market approval, which the current orders have now achieved.

Please note: these new FDA orders apply only to transvaginal mesh products used for treatment of pelvic organ prolapse. The orders don’t apply to mesh used to treat stress urinary incontinence and abdominal repairs of POP.

Remarkably, despite thousands of injured women and thousands of lawsuits, the FDA is not issuing a recall of the product. A spokesperson for the FDA stated that TVM poses “significant risks,” but that the FDA “does not believe banning surgical mesh for transvaginal POP repair is warranted at this time.”

I suspect a recall of transvaginal mesh will come eventually. In fact, it seems likely that transvaginal mesh products will be voluntarily removed from the market before the thirty-month deadline for submitting a pre-market approval application, because these manufacturers will not be able to demonstrate the products’ safety.

But even if I am correct and the recall happens in the next two and half years, it will be too late to help many victims of transvaginal mesh.

The takeaway: proceed with great caution before you move forward with transvaginal mesh surgery. If you are currently suffering from pelvic organ prolapse, or any other condition which may potentially be treated by transvaginal mesh, please have a long discussion with a trusted doctor about all your options before you choose TVM implantation.

And if transvaginal mesh has already been implanted in your body, and you are now suffering health complications, give me a call. Or call another lawyer you know and trust.

We’ve been looking at recent trial results in transvaginal mesh cases. In this (fourth) post we review two verdicts from October 2015, where juries concluded that the mesh manufacturers were not negligent. Thus, these injured women received no money for the failure of the transvaginal mesh. In a third case, decided on December 21, 2015, the jury awarded $12,500,000.00 to an injured woman. I will take a look at all three cases:

Cavness v. Kowalczyk et al. (Texas District Court, Dallas)

Product: Gynecare Prosima Pelvic Floor Repair System

Key Product Defendants: Ethicon, Inc. and Johnson & Johnson.

Jury Award: zero.

Date of Jury Verdict: October 5, 2015

Key Takeaway: A big win for Ethicon and Johnson & Johnson, defendants in the case.

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Carol Cavness was implanted with the Gynecare Prosima Pelvic Floor Repair System in April 2012. The transvaginal mesh began causing her serious health problems, including pain, incontinence, infections, bleeding, odors, and other problems. Eventually, the mesh product was partially removed in an “explant surgery.”

Ms. Cavness sued Ethicon and Johnson & Johnson, claiming that the companies were negligent in manufacturing and selling the transvaginal mesh. She also brought claims for design defects, manufacturing defects, and a failure to warn her and her doctors about the risk of the mesh product. She also sued her doctor and the hospital where the surgery was performed.

As with so many of the failed medical products on the market these days, the Gynecare Prosima product was approved for the marketplace under the 510(k) process, where a product can be approved for sale if an existing product that is substantially the same has already been tested and approved.

A major part of Ms. Cavness’ case was her claim that the polypropylene material was not appropriate for implantation in the human body.

The jury rejected Ms. Cavness’ claims, finding that Ethicon and Johnson & Johnson were not negligent and that Ms. Cavness’ injuries were not caused by the Gynecare Prosima transvaginal mesh product.

Carlson v. Boston Scientific Corp. (Western District North Carolina)

Product: Uphold Vaginal Support System

Jury Award: zero

Date of Jury Verdict: October 16, 2015

Key Takeaway: “Learned intermediary doctrine” is a formidable defense for product manufacturers.

Martha Carlson was implanted with the Uphold Vaginal Support System transvaginal mesh. She then suffered vaginal pain, incontinence, and sexual discomfort. She also alleged that the TVM shrunk and hardened inside her and could not be removed (explanted).

Ms. Carlson sued in federal court in North Carolina. The case was moved to the multidistrict litigation (MDL) venue in West Virginia. In the MDL, the reviewed Boston Scientific’s motion for summary judgment and awarded partial summary judgment in favor of Boston Scientific on the failure to warn claim.

As with the Frankum case, which I wrote about in a previous post, summary judgment was awarded to Boston Scientific (the TVM manufacturer) on the failure to warn claim based in large part on the “learned intermediary doctrine.” Again: a manufacturer (like Boston Scientific) cannot be liable for negligence if it provides all necessary information to a “learned intermediary” (in this case the implanting surgeon), who then must communicate with the patient about the benefits, risks, etc. The surgeon in Ms. Carlson’s case did not rely on the directions for use (DFU) with the Uphold TVM product.

The MDL transferred the case back to North Carolina, and in October 2015 trial was held as to Ms. Carlson’s negligent design claim and her breach of implied warranty claim. As with many of these cases, Ms. Carlson’s attorneys argued that the polypropylene was not a suitable material for implantation in the body, and that the rubbery material hardens and degrades when implanted.

Hammonds v. Ethicon, Inc., et al. (Pennsylvania Court of Common Pleas, Philadelphia)

Product: Gynecare Prolift Pelvic Floor Repair System

Key Product Defendants: Ethicon, Inc. and Johnson & Johnson.

Jury Award: $12,500,000.00 ($5,500,000.00 compensatory damages; $7,000,000.00 punitives)

Date of Jury Verdict: December 21, 2015

Key Takeaway: A strong statement from the jury in support of the injured woman, Ms. Hammonds, with a large punitive damages award.

Patricia Hammonds was implanted with the Gynecare Prolift Pelvic Floor Repair System in 2009 to treat pelvic organ prolapse and stress urinary incontinence. You know what happened next: Ms. Hammonds began to suffer debilitating pain, particularly pain during intercourse, and other problems. She underwent revision surgery, but the pain and incontinence continued. The surgeon then attempted to remove the Prolift TVM but found that it was compressed near Ms. Hammonds’ bladder, and which likely was the cause of a hole (perforation) in the bladder. The Prolift TVM could not be removed surgically.

The Gynecare Prolift Pelvic Floor Repair System was approved for sale under the 510(k) process which I have written about repeatedly on this site. Check it out if you are interested.

The jury awarded Ms. Hammonds $5,500,000.00 in compensatory damages, which are damages related to actual loss and actual harm suffered by the plaintiff, and an impressive $7,000,000.000 in punitive damages, damages which serve as a kind of punishment to the negligent defendant, and is used as a tool to discourage negligent or other harmful actions in the future.

In any event, after the two defense verdicts from October 2015, it was encouraging to see a strong result for Ms. Hammonds in Philadelphia.

More transvaginal mesh information will follow in this blog. Stay tuned.

In this post, we continue our review of transvaginal mesh cases. We look at one (remarkable) jury verdict and one partial summary judgment decision in favor of the defendant from 2015. Many other cases are moving to trial. Going forward, I will keep you updated on jury verdicts and other key court decisions as they happen.

Barba v. Boston Scientific Corp. (Delaware Superior Court)

Products: Pinnacle Pelvic Floor Repair Kit Transvaginal Mesh and Advantage Fit Mid-Urethral Sling System

Jury Award: $100,000,000.00.

Date of Jury Verdict: May 28, 2015

Key Takeaway: A huge verdict for the plaintiff, Deborah Barba. This case was remarkable for the very high money award: one hundred million dollars, to a single woman.

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Deborah Barba was implanted with the Pinnacle Pelvic Floor Repair Kit TVM and Advantage Fit Mid-Urethral Sling System prior to 2011. These medical devices were implanted to treat Ms. Barba’s pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Like the other TVM plaintiffs I’ve written about on this site, following implantation Ms. Barba suffered severe pain, infections, sexual dysfunction, incontinence, prolapse, and vaginal wall erosion. She was forced to undergo corrective surgeries to fix the problems caused by the transvaginal mesh products. Apparently the surgeons were not able to remove all the TVM product, and parts of it were left inside Ms. Barba permanently.

Barba sued Boston Scientific in 2011, alleging failure to warn of the risks involved in the TVM, negligent manufacturing of the product, negligent design, breach of warranties, fraud, and punitive damages. Her case made it to trial on May 11, 2015.

The jury found that Boston Scientific Corporation negligently designed and manufactured the Pinnacle TVM and the Advantage TVM, and failed to warn doctors and patients of the risks involved in the implantation of the TVM products. The jury then awarded $25,000,000.00 in compensatory damages and a staggering $75,000,000.00 in punitive damages.

Of course, Boston Scientific has appealed the verdict. I will keep you posted on this appeal.

Frankum v. Boston Scientific Corp. (Western District Federal Court, North Carolina)

Product: Obtryx Transobturator Mid-Urethral Sling System TVM

Summary Judgment: Federal judge in North Carolina upheld prior MDL decision of partial summary judgment as to the failure to warn claim in favor of Boston Scientific.

Date of Decision: June 4, 2015

Key Takeaway: The Defense of the Learned Intermediary Doctrine

Quick back story: Bertie Frankum was implanted with the Obtryx TVM in 2009. She later suffered vaginal pain, pain during sexual intercourse, and bleeding. Ms. Frankum sued Boston Scientific in federal court in North Carolina for the usual claims: failure to warn of the risks of the medical device, negligence, manufacturing and design defects, and punitive damages. The case was moved to the multi-district litigation (MDL) venue for transvaginal mesh in West Virginia.

Once in the MDL, Boston Scientific brought a motion for summary judgment. Summary judgment is a tool for the lawyer to resolve a case in the client’s favor without going to trial. Essentially the motion asks the court for a judgment because there is no “dispute of material fact” and that the party should be awarded judgment as a matter of law. Thus, the lawyer will argue, “look judge, if you take all the facts we’ve gathered in this case in a light most favorable to the other side, my client still wins the case.”

Summary judgment can dispose of all claims, or it can dispose of some claims (known as partial summary judgment).

The MDL reviewed the motion for summary judgment and awarded judgment in favor of Boston Scientific on the failure to warn claim.

Summary judgment was awarded to the transvaginal mesh manufacturer based in large part on a legal defense known as the “learned intermediary doctrine.” It goes like this: a manufacturer (like Boston Scientific) cannot be liable for negligence if it provides all necessary information to a “learned intermediary” (in this case the implanting surgeon), who then has the duty to communicate with the patient about the benefits, risks, etc. The surgeon in Ms. Frankum’s case admitted that he failed to read the directions for use (DFU) with the Obtryx TVM product. This is what is known in the world of litigation as a “bad fact.”

Ms. Frankum therefore lost her claim for failure to warn. Fortunately she still has other claims that are moving forward against Boston Scientific.

Ms. Frankum then asked a federal judge in North Carolina to review the award of partial summary judgment. That judge upheld partial summary judgment as to the failure to warn claim. So Ms. Frankum now moves forward with her lawsuit against Boston Scientific, but without the failure to warn claim.

Key takeaway from decision: The learned intermediary doctrine can be a valid defense for medical device manufacturers like Boston Scientific. Always ask your doctor about the known risks for any medical product being implanted in your body, whether it is transvaginal mesh, an artificial hip, knee, or other device.

Note: Nothing in these posts should be construed as legal advice.

Transvaginal mesh lawsuits are finally getting their day in court. This is a good thing for the thousands of women who were injured, some severely, by the failure of the transvaginal mesh products sold by Ethicon (Johnson & Johnson), Boston Scientific, and other companies. In Part 1, we looked at three TVM jury verdicts from 2013 and 2014. In this post, we look at two jury verdicts and an appeal decision from November 2014.

Many other cases are moving to trial. In Part 3, I will discuss several jury verdicts from 2015.

more Eghnayem, et al. v. Boston Scientific Corp. (Federal Court, Florida)

Product: Pinnacle Floor Repair Kit Transvaginal Mesh

Jury Award: $26,744,443.00 to four women

Date of Jury Verdict(s): November 13, 2014

This was a case brought by four women from Florida who sued Boston Scientific Corporation for the failure of Pinnacle Floor Repair Kit (TVM). Among other claims, the four injured women alleged that Boston Scientific’s Pinnacle TVM was defectively designed, that Boston Scientific failed to warn the plaintiffs about the potential risks and dangers of the Pinnacle TVM, that Boston Scientific was negligent.

All four women were implanted with the Pinnacle TVM between 2008 and 2011. Following implantation, the women began to suffer serious injuries caused by the Pinnacle TVM, including scarring, damage to nerves, infections, and organ perforation. The Plaintiffs specifically alleged that Boston Scientific knew or should have known that the material used in the Pinnacle TVM—polypropylene—was not safe for implantation in the body.

Plaintifff Amal Eghnayem was awarded $6,722,222.00 in compensatory damages.

Plaintiff Juana Betancourt was awarded $6,722,222.000 in compensatory damages.

Plaintiff Margarita Dotres was awarded $6,766,666.000 in compensatory damages.

Plaintiff Maria Nunez was awarded $6,533,333.00 in compensatory damages.

Unfortunately, the jury in this case did not award punitive damages. The jury determined that the plaintiffs did not prove that Boston Scientific was liable for intentional misconduct or gross negligence, which are requirements to trigger consideration of punitive damages.

Scott et al., v. C.R. Bard, Inc. (California Appeals Court, 5^th District)

Product: Avaulta Plus Transvaginal Mesh

Appeal Decision: Upheld award of $3,610,000.00 verdict to Christine Scott and husband

Date of Appeal Decision: November 19, 2014

Trial Court Decision: July 2012 (originally $5,500,000.00 verdict)

This was an appeal of a jury trial verdict reached in July 2012. An appeal is permitted to either side following jury trials. Usually, the losing person or company will appeal to the proper appellate court to argue that the jury verdict should be reversed, set aside, or altered based on mistakes of law that took place during the trial. In this case, C.R.Bard, Inc., manufacturer of the Avaulta Plus TVM, appealed after jury awarded $3,610,000.00 to Christine Scott and her husband.

The Avaulta Plus TVM was implanted in Ms. Scott in 2008 to treat pelvic organ prolapse (POP) and incontinence. After implantation she suffered vaginal mesh erosion and the TVM was eventually removed. She has since endured nine surgeries to remedy problems caused by the Avaulta TVM.

At trial, the jury awarded $5,500,000.00, but found the surgeon was 40% at fault and thus reduced the verdict against C.R. Bard specifically to $3,610,000.00. (This is known as comparative negligence, and I will explain comparative negligence in a later post.)

As is often the case when major corporations lose jury verdicts in trials over failed medical devices, C.R. Bard appealed the trial verdict. On appeal Bard argued that the theories of negligence which were submitted to the jury were erroneous (wrong) as a matter of law. Essentially, Bard’s argument was this: the trial judge instructed the jury on the law governing the case and got it all wrong, or wrong enough to prejudice Bard at the trial. (Bard also argued other issues on appeal.)

The California Appeals Court found that Bard was not denied a fair trial and that Bard’s negligence was supported by substantial evidence. Basically the appeal decision means this: there were no mistakes made at the trial level significant enough to void the jury verdict and order a new trial.

An appeal is a useful tool if the losing party genuinely believes mistakes of law were made at the trial level. However, deep-pocketed companies often use the technique of appealing verdicts they do not like as a means to delay payment of a large jury verdict to an injured person like Christine Scott. I’m not saying that it what happened here. But it happens often, and large companies are notorious for appealing a verdict they don’t like, even when they know winning the appeal is very unlikely.

Tyree et al. v. Boston Scientific Corp. (Federal Court, West Virginia)

Product: Obtryx Midurethral Sling Transvaginal Mesh

Jury Award: $18,500,000.00 to four women

Date of Jury Verdict(s): November 20, 2014

Four women brought lawsuits against Boston Scientific for the failure of the Obtryx Midurethral Sling Transvaginal Mesh; the lawsuits were joined for one trial in federal court in West Virginia. The primary claims against Boston Scientific were that the Obtryx TVM device was negligently designed and that Boston Scientific failed to warn the injured women and their surgeons about the risks involved in using the transvaginal mesh.

The women suffered infestions, vaginal wall erosion, inflammation, scarring, organ perforation, nerve damage, and other injuries following implantation of the Obtryx TVM.

Plaintiffs Jacquelyn Tyree and Carol Sue Campbell were awarded $3,250,000.00 in compensatory damages.

Plaintiff Chris Wilson was awarded $3,750,000.00 in compensatory damages.

Plaintiff Jeanie Blankenship was awarded $4,250,000.00 in compensatory damages.

The difference in monetary awards typically results from evidence showing the severity of the injuries suffered by the individual plaintiffs. Plainly, the jury weighed the evidence and concluded that Wilson and Blankenship’s injuries were more severe than Tyree and Campbell.

In addition, the jury found that Boston Scientific’s actions were fraudulent, malicious, oppressive, and/or willful and wanton, and on the basis of those findings awarded each plaintiff an additional $1,000,000.00 in punitive damages.

More transvaginal mesh jury verdicts will follow in Part 3.

Transvaginal mesh (TVM) is a plastic mesh product that is surgically implanted in women to repair or support weakened vaginal walls and other compromised tissue. Many women suffer from a condition called pelvic organ prolapse (POP), where an organ like the bladder prolapses from its normal position in the body and presses against the walls of the vagina. One of the main causes of this condition is childbirth. The FDA approved TVM for treatment of women with POP and other conditions like stress urinary incontinence more than a decade ago.

Sadly, TVM has caused terrible problems for thousands of women. Not only after transvaginal mesh was marketed and sold, women began complaining of different, often more serious problems. Complications include erosion of the vaginal wall, infections, urinary problems, pain during sexual intercourse, scarring, bowel or bladder perforation, and recurrence of pelvic organ prolapse or incontinence. Women have been forced to undergo surgeries to attempt to repair the damage done by transvaginal mesh. In some cases injured women have endured multiple surgeries.

The lawsuits followed. Fortunately for these (often severely) injured women, these cases are finally getting to trial and to jury verdicts. The good news is that some plaintiffs have received millions from juries for their injuries. But the TVM manufacturers have also scored victories.

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I’ve collected a list of TVM cases and the jury verdicts involved. Many other cases are moving to trial, and I will report on those outcomes when verdicts are reached in those cases, but this will give you a sense of what is going on with transvaginal mesh cases:

Gross v. Ethicon, Inc., and Johnson & Johnson et al., (Superior Court, New Jersey)

Product: Gynecare Prolift Pelvic Floor Repair System

Jury Award: $11,110,000.00 total award; $3,350,000.00 in compensatory damages, $7,760,000.00 in punitive damages.

Date of Jury Verdict(s): February 25 and 28, 2013

This was one of the early jury transvaginal mesh verdicts. Linda Gross brought claims against Ethicon, Inc., and Johnson & Johnson for failing to warn her and her doctor about the potential risks of using the Gynecare Prolift mesh product. Ms. Gross also brought a claim for misrepresentation of the product on the TVM brochure, as well as defective design, manufacture, and instructions.

Ms. Gross filed her lawsuit in 2008 in state superior court in Atlantic City. In 2006, the Gynecare Prolift mesh was implanted in Ms. Gross in 2006 to treat pelvic organ prolapse (POP), which I discussed in a previous article. Following TVM implantation, Ms. Gross suffered from mesh erosion, scarring and inflammation, among other things. Ms. Gross has eighteen surgeries to attempt to repair damage caused by the TVM.

The jury found that the companies failed to warn Ms. Gross of the risks involved with the device, and that this failure to warn adequately “proximately” caused her injuries. However, the jury also found that the device was not defectively designed, and also did not find fraudulent misrepresentation.

After compensatory damages were awarded, the trial judge permitted consideration of punitive damages. The jury then awarded $7,760,000.00 in punitive damages. The total award was $11,110,000.00.

Huskey, et al., v. Ethicon, Inc., and Johnson & Johnson, et al., (West Virginia Federal Court)

Product: Gynecare TVT Obturator

Jury Award: $3,270,000.00 in damages for Jo Huskey and husband

Date of Jury Verdict(s): September 5, 2014

Jo Huskey and her husband brought claims against Ethicon, Inc. and Johnson & Johnson for negligence, failure to warn, and defective design. Ms. Husky was implanted with the Gynecare TVT Obturator mesh product in February 2011 to treat her stress urinary incontinence. However, after the implantation surgery, Ms. Huskey suffered mesh erosion, pain, and “dyspareunia,” which is painful or difficult sexual intercourse. Ms. Huskey had revision surgery in November 2011, but SUI symptoms returned.

At trial, among other things, the Huskeys argued that the plastic “polypropylene” material in the Gynecare TVT-O mesh was defective and ill-suited for implantation in a woman’s body.

The jury awarded the couple $100,000.00 for medical costs, $470,000.00 for pain and suffering and mental anguish (past), and $2,500,000.00 for pain, suffering, and loss of enjoyment of life. Mr. Huskey was awarded $200,000.00 for loss of consortium. The total jury award was $3,270,000.00.

Unfortunately, the judge ruled prior to trial that punitive damages would not be permitted.

Salazar v. Boston Scientific, Inc., et al., (District Court, Dallas, Texas)

Product: Obtryx Transobturator Mid-Urethreal Sling System

Jury Award: $73,465,000.00 in damages, for Martha Salazar, her husband

Date of Jury Verdict(s): September 8, 2014

This was a big one.

Martha Salazar was implanted with the Obtryx Transobturator Mid-Urethral Sling System in January 2011 to treat incontinence. She later experienced pain, difficulty having sex, and nerve damage, according to the Salazars’ allegations in their complaint. Ms. Salazar was forced to endure several surgeries to attempt to repair the damage done by the transvaginal mesh product. She also walks with a permanent limp.

The jury found that a safer design of the TVM would have prevented or reduced her injuries, and also found a safer redesign was “economically feasible.” The jury also found that Boston Scientific was negligent in marketing the TVM device.

The jury then awarded $1,500,000.00 for pain and mental anguish, $10,000,000.00 for future pain and anguish, $750,000.00 for physical impairment, $5,000,000.00 for future physical impairment, $3,000,000.00 in future medical care, $1,700,000.00 for lost earning capacity. Ms. Salazar’s husband was awarded 1,515,000.00 for loss of consortium and loss of “household services.”

On top of those large sums, the jury then awarded a staggering $50,000,000.00 in punitive damages. Plainly, this case moved this Texas jury, and they decided to make Boston Scientific pay for the extreme suffering caused by the failed transvaginal mesh.

Unfortunately, in this transvaginal mesh case, Texas law operated to reduce the final money figure to $34.6 million.

More transvaginal mesh jury verdicts will follow in later posts.

You have probably seen news reports (or at least the flood of TV commercials from law firms) about the suffering caused by the failure of transvaginal mesh (TVM) products. This is a unique medical device failure “story” because of the large number of women who have been affected. It is estimated that transvaginal mesh is implanted in more than 200,000 women each year in the United States. And by early 2015 well over 70,000 lawsuits have been filed against transvaginal mesh manufacturers because of injuries caused by TVM. More lawsuits are being filed each week.

But let’s back up.

Surgical mesh is a medical product that “is used to provide additional support when repairing weakened or damaged tissue.” FDA News Release April 29, 2014. It is a plastic lattice-type mesh that is surgically implanted around weakened, loose, sagging, or otherwise compromised human tissue (such as a vaginal wall). While surgical mesh can be used to treat different kinds of problems, such as hernia, the mesh that has caused much of the current suffering and most of the lawsuits involves transvaginal mesh.

more Why Is Transvaginal Mesh Implanted In Certain Women?

Many women suffer from a condition called pelvic organ prolapse (POP), where an organ (like the bladder) drops (“prolapses”) from its normal position in the body and presses against the walls of the vagina. One of the main causes of this condition is childbirth. Obesity can also cause pelvic organ prolapse, as well as caesarean section surgery and menopause. Women may also suffer from a condition called stress urinary incontinence (SUI), which is a kind of urinary incontinence that occurs when a woman places a stress on her body, as when she is lifting a heavy object, exercising, or even coughing; these “stresses” put pressure on a woman’s bladder, sometimes causing involuntary loss of urine.

The solution to these problems was thought to be the surgical implantation of transvaginal mesh. The FDA approved the use of transvaginal mesh for treatment of women with POP and other conditions like SUI in 2002.

Serious Complications From Transvaginal Mesh Implantation

Unfortunately, transvaginal mesh has turned out not to be a fail-safe treatment for POP, SUI, and other problems. In fact, in many cases transvaginal mesh implantation has caused many more problems than the medical device has solved. Not long after transvaginal mesh was marketed and sold, women began complaining of different, often more serious problems. According to the FDA, complications include “erosion through vaginal epithelium,” which is when the mesh cuts into the tissue of the vaginal wall, and sometimes intrudes through the vaginal wall. Other women have reported infections, urinary problems, pain during sexual intercourse, scarring, bowel or bladder perforation, and recurrence of pelvic organ prolapse or incontinence. For a more in depth analysis of the problems associated with transvaginal mesh surgeries, check out the medical study published In April 2015 by the BMJ (formerly the British Medical Journal):

http://www.bmj.com/content/350/bmj.h2685.full.pdf+html (BMJ CONCLUSION: “Despite multiple warnings released by the FDA since 2008, use of mesh in pelvic organ prolapse surgery continues to grow. In this statewide comprehensive study comparing prolapse repair with and without mesh, mesh procedures were associated with an increased risk of urinary retention and reintervention in the following year. Our findings should help regulators, clinicians and patients better understand mesh safety and provide age specific evidence for risks and benefits.”)

Women have been forced to undergo surgeries to attempt to repair the damage done by transvaginal mesh. In some cases injured women have endured multiple surgeries. One woman suffered through eight surgeries, and a jury later awarded her $5.5 million, including $500,000 for the husband in a loss of consortium claim based on the fact that the transvaginal mesh had essentially ruined the couple’s sex life. I will discuss transvaginal mesh jury verdicts in later articles.

Mesh Products Were Approved Under the Dreadful 510(k) Process

The 510(k) process allows a manufacturer to notify the Food and Drug Administration under section 510(k) of the Medical Device Amendments Act of 1976 (MDA) of its intent to market a device (like transvaginal mesh) and to describe the new device’s “substantial equivalence” to a pre-MDA device. The FDA may then approve the new device for sale in the United States without rigorous testing as is required for new medical devices. This is how most of the transvaginal mesh products reached the market.

The FDA appears to have been slow to intervene. Finally, in April 2014, the FDA issued a warning about the potential risk for injury in transvaginal mesh implantation: “FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products . . . .” See FDA News Release:

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm395192.htm

The Key Manufacturers

There are at least nine companies that manufacture and sell transvaginal mesh products. Some of the bigger players in this medical device industry are set out below (with the actual mesh products in parentheses):

Johnson & Johnson, parent company of Ethicon (Gyncare Prolift and Gynemesh Prolene)

C.R. Bard (Avaulto Plus Support System)

American Medical Systems (AMS Prolapse Repair System)

Boston Scientific (Pinnacle Pelvic Floor Repair Kits and Proto Gen Mesh)

Proxy Biomedical Ltd. (Polyform Synthetic Mesh)

Mentor Corporation (ObTape Vaginal Sling)

Endo Health Solutions / American Medical Solutions (Apogee, Perigee, Elevate transvaginal mesh)

Several multidistrict litigation sites have been formed to handle the avalanche of claims and lawsuits, and many jury verdicts and settlements have already been reached. I will report further on this failed medical device, but as always, if you are feeling discomfort or pain or other symptoms after TVM implantation, check with your doctor, get a second opinion if necessary, confirm the TVM product implant, and protect yourself.