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 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.

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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.

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.