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.

Victims of C.R. Bard’s IVC filters got some great news two weeks ago. An Arizona jury in the first bellwether trial awarded a woman $3.6 million for injuries she suffered after Bard’s “G2” IVC filter broke into pieces in her inferior vena cava vein, requiring open heart surgery to remove the broken pieces.

The plaintiff, Sherri Booker, was implanted with Bard G2 IVC filter to prevent blood clots from reaching the heart and lungs. The problem was, the G2 moved inside her inferior vena cava (it is not supposed to move), then it broke apart. In 2014, she had to undergo open heart surgery. The surgeon was not able to retrieve all the broken pieces.

The Jury’s Verdict

After a lengthy trial the jury found that Bard was liable for a negligent failure to warn patients about the risk factors in using the G2 IVC filter. The jury also determined that Bard was not liable to the plaintiff for strict product liability design defect, strict product liability failure to warn, or negligent design.

The jury awarded Ms. Booker $2 million in compensatory damages and $2 million in punitive damages. The court was utilizing comparative negligence law, which assigns proportional blame for the harm caused. The jury found that Bard as the device maker was 80% responsible for the injuries, and that a radiologist who failed to discover a broken piece of IVC filter in a 2009 X-ray. Under comparative negligence law, therefore, Bard became liable for 80% of the compensatory damages award, for a total of $3.6 million. Punitive damages are not affected by a comparative negligence analysis, so the $2 million punitives award will stand.

Even with the reduction, it was a good result for Ms. Booker, and the verdict was promising for the thousands of IVC filter victims still awaiting trial or resolution of their cases. A second bellwether trial is slated to begin in May.

A C.R. Bard representative said he was “disappointed” in the jury’s verdict, but still maintained that the G2 IVC filters are useful medical devices that have saved lives.

Some History on the Bard IVC Filters

Bard began selling the “Recovery” IVC filter in 2002. This after Bard received approval to sell the device under the “510(k) process.” The name comes from a section of federal regulations that allows companies to sell products that are closely related to products already on the market. The 510(k) pathway, as I’ve discussed often, can lead to disastrous results. Anyway, the Recovery started causing serious problems pretty quickly, the main two that the Recovery filter would move or “migrate” in the inferior vena cava vein, and that it had a tendency to break apart. Bard conducted a study on the Recovery, found higher incidents of injury and death, and finally pulled the Recovery IVC filter from the market around 2005.

That same year Bard introduced the G2 IVC filter. The G2 was engineered from the Recovery technology, and it turned out that the apple did not fall far from the tree. An internal Bard memorandum noted serious issues with safety and function of the G2. Despite these internal concerns, Bard continued to sell the G2 filter and later the G2 Express filter.

Finally in 2010 Bard stopped selling the G2 IVC filters. One report estimated that 160,000 G2 filters were implanted in patients. One of those was implanted in Plaintiff Sherri Booker.

On May 18, 2015 the MDL involving Bard IVC filters was approved for federal court in Arizona, and injured people from all over the country can place their individual lawsuits in this MDL (MDL 2641).

I have written often on the problems associated with IVC filters, which you can read about here. If you have any kind of IVC filter implanted and are having problems, give me a call to discuss your legal options (919.830.5602). Good luck.

I would chalk up this court decision as a victory for any injured person dealing with the C.R. Bard IVC filter. I would also chalk up the decision as yet another example of the complexities of handling statutes of limitations in defective product cases.

As always, let’s take a step back. I have written about C.R. Bard’s potentially dangerous IVC filters, which you can read about here and here. In 2015 a multidistrict litigation (MDL) site was selected for lawsuits arising from injuries relating to Bard’s G2 Series and Recovery IVC filters. The primary complaints have been that the Bard IVC filters moved out of position and/or broke apart. Lawsuits mounted, and the MDL was formed.

Lurking in virtually every personal injury case is a statute of limitations defense. I wrote about statutes of limitations here. To recap, a statute of limitations is a law which limits the time when an injured person may bring a lawsuit for money damages. You miss the deadline, you lose your right to bring a lawsuit forever.

But as I have discussed before, determining when the clock starts running on your injury case is far from easy.

Bard Lawyers Sought Rigid Framework For Statute of Limitations Analysis

In the Bard IVC filter MDL, C.R. Bard lawyers filed a motion seeking a bright-line test to identify the running of the statutes of limitation. The defense lawyers asked Judge David Campbell to adopt a strict procedure for this analysis similar to the procedure used in the Mirena IUD MDL. (Yes, there is an MDL for women injured by Mirena IUDs made by Bayer Pharmaceuticals.) The Mirena procedure was determined in the case titled Truitt v. Bayer.

more Truitt v. Bayer

In the Truitt v. Bayer case, the judge accepted the defendants’ proposal that the statute of limitations should begin to run in Mirena IUD cases based on the date the injured woman “learned that the Mirena [IUD] had perforated her uterus.” This event, according to the judge in Truitt, gave an injured woman adequate notice that she was injured and that she should begin to figure out if she had a defective product claim against the manufacturer.

The Truitt judge then set up a procedure for figuring out which plaintiffs’ cases should be dismissed based on the passing of the statute of limitations. Both defendants and plaintiffs would submit three-page letters arguing why each case should or should not be dismissed under the Truitt framework. Utilizing this procedure, thirty-one (31) cases were dismissed in the Mirena IUD MDL.

Admittedly, the Truitt decision had the advantage of simplicity. The medical records in most cases should show the date (or close to it) when an injured woman was told by her doctor that her uterus was perforated (that is, when her IUD poked a hole in her uterus). The thinking was that a woman would be told by her doctor: “Hey look. Something bad has happened. The IUD we placed inside you just punctured the wall of your uterus and we must perform surgery to remove the device.” (Or words to that effect.) The judge then also presumed that virtually every woman at that point would be savvy enough to begin an investigation into whether this punctured uterus was the result of a defective medical product.

I have no doubt the defense lawyers in the Mirena IUD cases were pleased with the Truitt decision.

There are problems with the Truitt decision. First, it presumes that a doctor clearly communicated to the patient that her uterine wall was punctured by her IUD and that she needed surgery. Second, it presumes that all women injured through the negligence of a medical device manufacturer like Bayer would know they had a claim against Bayer the moment their doctors mentioned that the IUD had punctured their uterine wall. These are big presumptions. Doctors are not always easy to understand. And it can takes months or years to figure out that you were the victim of negligence. Some people never figure it out. In my view, Truitt allowed several valid cases against Bayer to be dismissed unfairly. Sadly, I have had many calls from injured people who waited too long to call me about their (otherwise valid) case against defective product manufacturers.

Quick Example

Let’s say the defense lawyer brought a Truitt motion in a case in a state with a statute of limitations of three years. If the defense team could show (in a three-page letter) that the injured woman was told about her injury more than three years before she filed suit, the court would dismiss her lawsuit with prejudice. Even if the underlying claim was valid, and Bayer was negligent in manufacturing and selling the Mirena IUD, the injured woman would receive no compensation for her injuries.

Now Back to the Bard IVC Filter MDL

The defense lawyers in the Bard IVC filter cases wanted a Truitt type procedure for pinpointing the running of the clock on claims against Bard. Thankfully, Judge Campbell gave many solid reasons for rejecting this procedure in the Bard IVC filter MDL. The Order was entered on April 20, 2016 and is worth reading. Essentially, Judge Campbell concluded that figuring out when the clock starts to run on a defective product claim is very complex, and should not be reduced to three-page letters to the court. He then gave many examples of how a Truitt procedure could pose all kinds of problems and could yield inconsistent and unfair results.

Ultimately, Judge Campbell denied the motion and effectively rejected a Truitt analysis for considering statute of limitations defenses. This is a good thing for people injured by the Bard IVC filters. Nevertheless, the statute of limitations in each state remains a serious threat to your product liability claim. It is crucial that you find a competent attorney the moment you suspect you may be the victim of a defective product.

My firm is currently taking IVC filter cases in all states. (919) 830-5602.

Note: If you received any type of IVC filter, you should download the free app titled “IVC Filter Compendium” (http://www.ivcfilterapp.com). In this app physicians have compiled information on the different types of IVC filters, the complications that may arise, images of the different IVC filters, recommendations for removal of the filters, and other information.

In this post we look at the history of C.R. Bard’s problematic IVC filters, which sadly have caused many injuries and several deaths. In May 2015 a multidistrict litigation site (MDL) was selected for claims across the country arising from injuries relating to C.R. Bard’s “G2 Series” and “Recovery” IVC filters. But before we get to the Bard MDL, however, we have to ask, “well, how did we get here?”

Bard Recovery IVC Filter

In 2002 C.R. Bard received approval from the FDA to market the Recovery IVC filter. The Recovery received approval for marketing under the dreaded 510(k) approval process, which I have written about often. Soon after the release of the Recovery filter, reports of injuries and deaths began to occur. The primary issues were that the Recovery filter moved (doctors call it “migration”) and broke apart much more often than other IVC filters on the market. After many of these alarming results, C.R. Bard arranged for a study to be performed on the Recovery filter, and this study, published in December 2004, concluded that the Recovery filter created a significantly higher risk of injury and death in patients compared to other IVC filters available to physicians and patients. The report qualified its findings by noting that given the “flaws in the data” (whatever that is) it cannot say conclusively that the Recovery filter presents an “excess risk”; the report nevertheless concluded that further investigation is “urgently warranted.”

Despite this dire warning, C.R. Bard continued to sell the Recovery filter. It finally discontinued the Recovery in 2005. But this action was too late: as many as 20,000 people still have the Recovery IVC filter implanted in their bodies to this day.

Bard G2 and G2 Express IVC Filters

In 2005 C. R. Bard introduced the G2 IVC filter. That same year C.R. Bard circulated an internal memo in December 2005 expressing concerns with the safety and functionality of the G2 filter. The Bard Memorandum noted that the G2, much like the Recovery filter, had problems with perforation, tilting, and moving. Despite this information, C.R. Bard kept selling the G2 filter. In 2008, as part of the G2 Series, Bard introduced the G2 Express, which has also been found to move, tilt, migrate, and break apart.

more Advance Knowledge of Problems Opens Door to Punitive Damages

I need to pause briefly in the Bard IVC filter saga to explain why the commissioned study and later the internal memorandum on the Recovery and G2 filters is so damning for Bard. It is one thing to actively market a medical device to the public when the company is unaware of its problems. It is another (and awful) thing to market a device when the company has access to valid evidence that the medical device carries unreasonable and potentially serious health risks. In those cases, courts usually permit punitive damages claims to be included in lawsuits against the manufacturer. Punitive damages are separate money damages awarded by a jury and which are intended to punish, reform, and/or deter a bad-acting defendant and others from engaging in similar conduct. And in fact, several judges have permitted punitive damages claims to go forward against Bard with respect to their IVC filters.

Now back to C.R. Bard and the G2 Series filters.

C.R. Bard continued to market the G2 Series IVC filters until 2010. It has been reported that over 160,000 of the G2 Series filters were implanted in patients, many of whom still have the device inside their bodies. And some of these filters are breaking into pieces, traveling toward the heart, tilting out of position, puncturing veins and doing other really bad things.

Public Cannot Rely on Medical Device Manufacturers

Dr. William Kuo is an Interventional Radiologist at Stanford University Medical Center. He has also developed surgical technique for removing IVC filters, even those that have migrated into precarious parts of the body. He had this to say in an interview with NBC News:

“What we learned the hard way is that we can longer rely on medical device companies to do what’s in the best interest of the patient. And we can no longer rely on the FDA to properly regulate these devices.”

Quoted in “Why Did Firm Keep Selling Problem Blood-Clot Filters?” by Tim Sandler and Stephanie Gosk, NBC Health News, December 31, 2015.

This is a stunning statement. Frankly, it is refreshing to hear this perspective from a surgeon, and it underscores the key role lawyers must play in protecting the public from flawed medical devices and drugs. If corporations won’t police themselves, and if the FDA either can’t or won’t protect the public, then only lawyers are left to hold these companies accountable.

FDA Dropped the Ball

The FDA has a tough job. With more than 6,500 medical device companies in the United States and many thousands of medical devices on the market, I can imagine that FDA Investigators feel as if they are forced to play whack-a-mole every day of the week. That said, it appears the FDA has really dropped the ball too often in the past ten years, and certainly with C.R. Bard’s IVC filters.

As a result of this unhappy history, many patients have been harmed and some have died. And the lawsuits have followed. The MDL involving C.R. Bard, Inc. was established on May 18, 2015 in federal court in Arizona, but injured people from all over the country can place their lawsuits in the Arizona MDL (you can read about the process of transferring your medical device case to an MDL here.) The cases in the Bard MDL focus on allegations of defective design, misrepresentation in marketing, and failure to warn doctors and patients.

Note: If you received any type of IVC Filter, I encourage you to download the free app titled “IVC Filter Compendium” (http://www.ivcfilterapp.com). In the app physicians have compiled important information on the different types of IVC Filters, the complications that may arise from IVC filter implantation, images of the different IVC filters, recommendations for removal of the filters, and other key information. It’s downloadable as a phone application or to your personal computer.