To most people, Johnson & Johnson (J&J) is a respected company and the maker of popular consumer products. However, J&J has taken quite a hit lately with both its reputation and finances.

Specifically, J&J has been accused of causing cancer in thousands of individuals due to the alleged presence of asbestos in its baby powder products. As a result, tens of thousands of plaintiffs have sued J&J, with notable results amounting to billions of dollars.

Even though J&J has successfully survived or settled many of these cases, it only takes a handful of plaintiff wins to cause serious financial damage to the company. Because of this, J&J employed a sneaky and ambitious plan called Project Plato.

What Is Project Plato?

Project Plato worked by allowing J&J to create a new company (officially known as LTL Management) that would take on J&J’s talcum powder legal liabilities. LTL Management would then declare bankruptcy and treat any potential plaintiffs relating to the asbestos talcum powder lawsuits as creditors. This maneuver has been referred to as the Texas Two-Step.

Because LTL Management would have a relatively small amount of assets, these plaintiffs/creditors would likely receive less money than if they sued J&J directly. As for J&J itself, it would be free of the legal and financial risks from these talcum powder lawsuits.

It’s an ingenious plan, and you can read more about it in an earlier blog post I wrote. Yet the cleverness of the plan doesn’t stop it from being very unfair to potential asbestos baby powder victims. As you might imagine, plaintiffs weren’t happy about Project Plato and opposed its use.

Legal Opposition to Project Plato

LTL Management filed Chapter 11 bankruptcy in North Carolina, given the success of earlier schemes similar to Project Plato that were filed there. At the time of the filing, there were more than 38,000 lawsuits against J&J alleging its baby powder products contained asbestos which caused the plaintiffs’ ovarian cancers.

Fortunately for the plaintiffs, the North Carolina bankruptcy court moved the case to a bankruptcy court in New Jersey. Once the case got to bankruptcy court in New Jersey, the plaintiffs asked the court to dismiss LTL Management’s bankruptcy petition claiming it was not filed in good faith.

Turns out the “good faith” bankruptcy test that the New Jersey bankruptcy court would use was more generous to the plaintiffs than the equivalent test used by the North Carolina bankruptcy court. Coincidence? Probably not.

Despite this more lenient standard, the New Jersey bankruptcy court refused to dismiss LTL Management’s bankruptcy petition. The plaintiffs appealed the decision to the U.S. Court of Appeals for the Third Circuit (Circuit Court), which ruled in their favor and dismissed LTL Management’s bankruptcy petition.

Why the Circuit Court Struck Down Project Plato

If you’d like to get into the weeds and read about the nuanced legal arguments, feel free to take a look at the Circuit Court’s opinion. But in essence, the Circuit Court concluded that LTL Management did not file its bankruptcy petition in good faith because it was not in “financial distress.”

The Circuit Court recognized that a company can be in financial distress even though it wasn’t yet insolvent. By way of (strained) analogy, you didn’t have to be on the verge of death before you were allowed to go see a doctor.

But how much financial trouble did a company need to be in before it could file for bankruptcy in good faith? Answering that question was tricky, and in finding that LTL Management wasn’t in financial distress, the Circuit Court noted the key fact that despite LTL Management’s legal liabilities, it had access to $61.5 billion from J&J.

In other words, J&J was like a super-rich co-signer on a debt that LTL Management had to pay. So even though LTL Management’s creditors might not be able to get much from LTL Management, they could still recover money from J&J.

There was also the fact that despite a few notable legal losses, J&J handled many of the asbestos baby powder lawsuits against it. For example, J&J settled about 6,800 claims for a little less than $1 billion.

To put this in perspective, the $4.69 billion (later reduced to $2.1 billion) that ovarian cancer plaintiffs won against J&J was divided among 22 women. So while J&J was spending a lot of money to resolve the talcum powder lawsuits against it (J&J’s legal costs totaled between $10 million and $20 million per month), it wasn’t nearly as bad as J&J wanted the bankruptcy court to think.

What Happens Next?

J&J indicated that it would appeal, although it’s not clear if it will appeal to the U.S. Supreme Court or for an en banc review of the decision by the full Third Circuit Court of Appeals. Either way, J&J will face an uphill battle.

Assuming J&J’s appeal is unsuccessful, the dismissal of LTL Management’s bankruptcy petition is a major win for mass tort plaintiffs. However, things may not be over just yet.

For instance, despite ruling against the use of Project Plato, the Circuit Court left open the possibility of defendants in mass tort lawsuits using a variation of Project Plato. Any new approach would need to strike a delicate balance between giving the debtor company enough assets to avoid a fraudulent transfer claim, but not too much where it’s deemed to not be in financial stress.

Finally, we need to keep in mind that the Circuit Court’s decision, assuming it stands, only applies to federal cases in New Jersey, Delaware and Pennsylvania. Despite this limitation, the decision should still have some influence in other courts across the country.

For now, claims against J&J for alleged injuries caused by its baby powder products will likely continue. If you have any questions about bringing your own claim for injuries due to talc-based products containing asbestos, feel free to reach out to me.

Although talcum powder studies are ongoing, it has been established that some products that use talcum powder may contain small amounts of asbestos. And there’s a well-known link between asbestos and cancer (especially mesothelioma).

So where does Johnson & Johnson come in? Well, they’ve been one of the more prominent defendants in these talcum powder/asbestos cancer lawsuits. Let’s take a quick look at the baby powder litigation and then examine how Johnson & Johnson is planning to use something called “Project Plato” to deal with their recent legal and financial losses.

A Brief History of Johnson & Johnson’s Baby Powder Litigation

In 2018, Reuters published a story claiming that Johnson & Johnson (J&J) knew its baby powder products used talc that contained asbestos. In 2019, J&J voluntarily recalled some of its baby powder being sold in the United States.

A lot of people sued J&J and/or related entities claiming the products they used containing talc (such as baby powder) caused their cancer. Many of these cases are currently in the Johnson & Johnson Talcum Powder Litigation MDL, or multidistrict litigation, which is currently in New Jersey federal court.

A few of the cases against J&J have resolved, resulting in massive verdicts in favor of the plaintiffs. One of the most notable was a case from St. Louis where 22 women successfully sued J&J in 2018 and were awarded more than $4 billion in damages. On appeal, this amount was reduced to about $2 billion. Still, a remarkable amount.

As of 2021, J&J faced approximately $3.5 billion in legal settlements and judgments relating to its baby powder. This was bad enough, but it was just the beginning for J&J, with tens of thousands of cases still remaining. Seeing the writing on the wall, J&J allegedly thought of a new strategy to handle these lawsuits and gave it the code name Project Plato.

How Project Plato Works

Project Plato is a very clever strategy that takes advantage of federal bankruptcy and state corporate laws. The goal is to pay off baby powder cancer litigants for pennies on the dollar and prevent J&J from having to worry about future plaintiffs. The plan is still ongoing and it’s unclear if it’ll work as J&J plans, but here’s a rough overview of the process.

For step one, J&J shifted its headquarters to Texas. The reason would be to take advantage of one of Texas’ corporate laws that allows a corporation to divide itself into two or more companies through a process called a “divisive merger.”

In step two, J&J created a subsidiary called LTL Management. This would take on J&J’s legal liabilities relating to the baby powder asbestos litigation. However, it would have a relatively small number of assets to pay any legal awards or settlements. The rest of J&J would continue operating as the second company, yet it would no longer have to worry about any lawsuits from the talcum powder litigation.

The third step required LTL Management to file Chapter 11 bankruptcy, which it did almost immediately after being created.

Project Plato is currently in step four, which involves getting the automatic stay to temporarily halt the talcum powder litigation against J&J. It’s also during step four that J&J hopes the bankruptcy judge will approve LTL Management’s Chapter 11 bankruptcy reorganization plan which has a few special terms.

Namely, all baby powder cancer plaintiffs against J&J would have to make their case in bankruptcy court (instead of regular court) and fight for their share of $2 billion that J&J would give LTL Management to compensate the almost 40,000 current plaintiffs.

J&J would also get a non-debtor release, which would immunize it from getting sued by any future plaintiffs claiming they got cancer from using J&J’s baby powder or talcum-based products. So the $2 billion wouldn’t just be split among the almost 40,000 in current plaintiffs, but it would also be all that’s available for future plaintiffs, too.

J&J reasons that this plan makes it more likely that plaintiffs who go to court for financial compensation for their injuries will get at least something. J&J contends that getting an almost guaranteed small amount of money is better for plaintiffs because they can avoid the risk of losing at trial. It would also give J&J finality to its baby powder legal woes. If successful, Project Plato would allow J&J to move on without constantly worrying about another talcum powder lawsuit decades from now.

Project Plato is a slight variation of something called the Texas Two Step, which has been successfully used by several companies (like Georgia-Pacific) looking to reduce and offload their mass tort legal claims.

Will J&J’s Plan Work?

No one knows for sure. Right now, the case isn’t going as well as J&J would have hoped. When LTL Management filed Chapter 11 bankruptcy, it chose to do so in North Carolina. Why? Because of that state’s history of favorable judicial rulings involving the Texas Two Step strategy. However, the North Carolina judge transferred the case to New Jersey.

As you can imagine, the plaintiffs aren’t happy about Project Plato and are doing everything they can to stop it. The New Jersey bankruptcy judge has scheduled a hearing for February 14, 2022 to listen to arguments from the plaintiffs (who are technically creditors in this bankruptcy proceeding) as to why the court should dismiss LTL Management’s request for bankruptcy.

Their primary argument would be that LTL Management filed Chapter 11 bankruptcy in bad faith. Specifically, that it was done as a way for J&J to avoid paying out the massive legal settlements and court judgments that have already been handed down, and with many more anticipated in the future.

A possible good omen for plaintiffs in the J&J litigation is what’s been happening with Purdue Pharma’s litigation involving its alleged role in the opioid epidemic. Late last year, a judge rejected Purdue Pharma’s proposed settlement and bankruptcy reorganization plan. The settlement and reorganization plan involved non-debtor releases that would have protected key individual defendants from personal liability. While Purdue Pharma’s strategy wasn’t the same as Project Plato, it was similar in that it tried to use the Bankruptcy Code to limit its legal liability in its civil lawsuits.

What Happens Next?

Over the next few months, we’ll see if Project Plato works for J&J. If it does, it would create a blueprint for any other company that faces mass tort lawsuits. This would make it much harder for plaintiffs to obtain compensation for their injuries. There’s even a proposed law in Congress to ban what J&J is trying to do.

In the meantime, if you have any questions as to whether you can receive compensation for injuries potentially related to using baby powder or other talc-based products, don’t hesitate to get in touch with me. And I’ll let you know if there are any major developments in J&J’s Project Plato.

During the course of surgery, a doctor may need to find a way to connect sections of organs or close wounds. One way to do this is through the use of sutures, a special type of thread. Another way is with the use of surgical staples. The Ethicon surgical stapler is pictured at right.

Doctors commonly use staples over sutures during surgery because they offer several advantages, including:

• Lower risk of infection
• Speed of insertion
• Reduced adverse reaction to surrounding tissue

Two of the major manufacturers of surgical staplers in the United States include Covidien and Ethicon. This blog post will focus on Ethicon’s staplers, in particular those involved in its most recent recalls.

History of Problems with Surgical Staplers

Despite their advantages, widespread use and overall general safety, surgical staplers and staples do not have a perfect operational record. They have caused a variety of problems for patients, including:

• Tissue and organ tearing
• Postoperative connection leak
• Hemorrhaging
• Hemorrhagic shock
• Fistulas
• Sepsis
• Bleeding
• Death

These problems can be caused by surgical staplers can malfunctioning in several ways:

• Misfiring of the stapler
• The stapler failing to fire
• Improperly formed staples
• The staple line opening

Countdown to Recall

As a result of these problems, various stapler manufacturers have recalled their products and the U.S. Food and Drug Administration (FDA) has made several announcements regarding these issues. Here is a brief timeline of recent events:

March 8, 2019: The FDA issues a letter to health care providers describing the adverse events associated with surgical staplers and staples. The FDA mentions that from January 1, 2011 to March 31, 2018, the FDA received reports that included 366 deaths and more than 9,000 serious injuries.

April 11, 2019: Ethicon issues a recall for circular staplers because they do not fire properly and fail to correctly form staples when fired. The FDA classified this as a Class I recall, the most serious type, as they involve devices that could result in death. This recall applied to approximately 92,496 devices in the United States.

April 23, 2019: The FDA issues draft guidance. This is a proposal for new recommendations for surgical stapler and staple manufacturers requiring they include additional information on product labels.

April 24, 2019: The FDA issues a proposed order to change surgical staplers and staples for internal use from Class I medical devices to Class II medical devices. This change, if adopted, would allow the FDA to implement special controls to make the products safer.

May 30, 2019: The FDA holds an open meeting to discuss reclassifying internal surgical staplers and staples from Class I to Class II medical devices.

October 3, 2019: Ethicon issues a recall for Echelon Flex Endopath Staplers due to their failure to properly form staples. The FDA classified this as a Class I recall. More than 5,700 devices in the United States were subject to this recall.

Ethicon’s Most Recent Recall from October 3, 2019

Ethicon’s October 3, 2019 recall involved one product line, the Echelon Endopath staplers. Specifically, they involved the following products:

• Product code: EC60A – Echelon Flex 60 Endopath Stapler, Articulating Endoscopic Linear Cutter
• Product code: PCEE60A – Echelon Flex 60 Powered Plus Compact Articulating Endoscopic Linear Cutter
• Product code: PLEE60A – Echelon Flex 60 Powered Plus Articulating Endoscopic Linear Cutter 44cm Shaft Length
• Product code: PSEE60A – Echelon Flex 60 Powered Plus Articulating Endoscopic Linear Cutter 34cm Shaft Length

The lot numbers, as well as additional information concerning the identification of the specific products being recalled, can be found on the FDA’s Medical Device Recall website.

These staplers are being recalled because the stapler may have a component that is out-of-specification. This could create malformed staples, causing problems in patients. As of the date of the recall, Ethicon publicly acknowledged that the recalled products had caused seven serious injuries and one death.

Litigation Involving Ethicon Staplers

Some litigation has begun and it is ongoing. Concerning the products recalled by Ethicon on April 11, 2019, some individual lawsuits have begun, but are currently in the pre-trial stages of litigation.

As for the products recalled on October 3, 2019, there are few, if any, current lawsuits against Ethicon and Johnson & Johnson, Ethicon’s parent company. If there are any changes, I’ll be sure to let you know in an updated blog post.

Note: The information and images contained in this post were derived from FDA content and news sources.

Most of us pay our bills on time. If we break a neighbor’s rake, we promptly purchase a replacement. If our child dumps fruit punch on a friend’s carpet, we pay to have it cleaned. In fact, we don’t really think about these unwritten rules often; it’s just the right thing to do, so most of us do it instinctually: if we cause damage, we pay for the damage. But too often companies refuse to pay fair settlements to resolve product failure cases, even in the face of a mountain of evidence that (1) the product clearly failed and (2) the failure physically injured the person. For example, let’s say a sixty-eight year old retired schoolteacher learns her metal-on-metal artificial hip implant has failed; her doctor tells her that, in addition to the pain she feels in her hip and leg, she now suffers from dangerously high cobalt and chromium levels (a condition called “metallosis”). Thousands of other injured people have similar claims, but the manufacturer of the failed hip product simply won’t pay. Why not?

Well, I can’t know all the reasons, but let’s look at a few theories:

Companies Don’t Like to Pay Settlements

Companies do not like to pay claims, period. Companies are in the business of making money, not paying out money. Corporations are under enormous pressure to maximize value for their stakeholders, primarily those people who buy their stock. Paying out two billion dollars in settlements for a failed artificial hip is never good for the bottom line.

Companies Can Get Away with Not Paying

The playbook is no secret: when a company first receives complaints about a failing product, it almost always denies that the product is defective. When scholarly, peer-reviewed studies establish that the product is defective, the company invariably commissions its own studies on the product, and often those studies conclude that the product is safe or that the dangers have not been proven. When litigation begins, the company defends itself vigorously, because it is always the case that the company has much more money than any injured plaintiff and can use its superior financial position to grind down injured plaintiffs, even thousands of them.

Settlement Delays Are Profitable

Let’s say a defective product injures 12,000 people, and the company negotiated three billion dollars in a global settlement for the injured plaintiffs. And let’s say the company could pay today or, through artful delays, two years from now. Eight percent interest on three billion dollars for two years is four hundred and eighty million dollars ($480,000,000). That’s real money. If a corporation can delay settlement discussions for two or four or six years before finally paying out claims, the company comes out ahead.

Another positive result of delays is this: some injured people just give up. Some plaintiffs may walk away, or accept a reduced offer, or lose interest, or may even grow old and die. There is no question that justice delayed is justice denied for injured people. Corporations understand this.

One Example: Johnson & Johnson

Recently, Johnson & Johnson has taken a harder line against paying settlements. One Johnson & Johnson defense attorney said that J&J is inundated with lawsuits and that if the company paid every claim it could get a reputation as an “easy mark.” In 2018 alone, J&J spent two billion dollars on settlements and attorneys’ fees. According to reports, J&J is defending 100,000 lawsuits involving hip implants, surgical mesh, baby powder, prescription drugs, and other product cases. One school of thought holds that the massive number of pending lawsuits is actually a deterrent to settlement for J&J.

Medical device and drug companies like J&J can get burned with aggressive no-settlement policies. DePuy Orthopaedics, owned by J&J, lost several huge verdicts in the DePuy Pinnacle hip litigation. And last year a jury awarded damages of $4.7 billion to a group of women who used J&J’s baby powder and were later diagnosed with cancer. There is no question that J&J could have settled with these 22 women years ago for a fraction of that jury verdict. (Of course, J&J has appealed.)

Then there is the loss of goodwill in this scorched-earth litigation strategy. According to a report in Law360, in 2016 J&J was considered the sixth most reputable company in the United States. By 2018 it had dropped out of the top 100. Goodwill matters.

Finally, one important reason for companies like Johnson & Johnson to pay valid claims is this: it is the right thing to do. When corporations offer safe products that improve people’s lives, they should make a lot of money selling the products. But when one of their products turns out to be flawed and harmful, companies should want to do the right thing and pay all the valid claims, promptly.

Note: References to individuals in this article are fictional and hypothetical and do not represent any current or former clients, or any other person. Information about Johnson & Johnson was distilled from online news sources, including Law360, which own their content.

But let’s back up.

What is Risperdal?

Risperdal is an anti-psychotic drug that was approved for limited use in 1993 to manage the symptoms of schizophrenia. According to multiple sources, in the years that followed Johnson & Johnson pressed the FDA for approval to treat other conditions, such as bipolar disorder and autism, and to permit use in children. Risperdal was soon prescribed for adults and children to treat attention deficit hyperactivity disorder, anxiety and depression. Treating these conditions using Risperdal is considered an “off label” use, which is the use of a drug in a manner unapproved by the FDA. Off-label use could involve using a drug to treat a condition which is not authorized by the FDA, or prescribing the drug to an unapproved age group. Shockingly, Risperdal has had horrific side effects in children. Among other symptoms, Risperdal can cause the growth of female breasts in male children, a condition known as gynecomastia. I have written about Risperdal often in this blog. You can check out those articles here.

The Case of Andrew Yount

Andrew Yount is a boy from Tennessee who was prescribed Risperdal in 2003 to treat attention deficit hyperactivity disorder (ADHD) and oppositional defiant disorder. At the time the FDA had not approved the drug for use in treating behavior disorders in children. Andrew was just five years old when he began taking the drug. A year after taking Risperdal, Andrew grew female breasts.

Andrew Yount is now in his late teens. He has had to deal with this embarrassing disfigurement for most of his life.

At trial, the lawyers for Andrew and the Yount family argued that Janssen Pharmaceuticals and its parent company Johnson & Johnson were aware of the risks of children growing female breasts but worked to downplay the risk involved. Despite the data showing a connection between use of Risperdal and the growth of female breasts in vulnerable boys, Janssen and Johnson & Johnson kept pushing the prescription to doctors and parents and children.

What the Jury Saw

The jury reviewed the evidence and concluded that Janssen and Johnson & Johnson failed to warn the Yount family about the risks of taking Risperdal. The jury also seems to have concluded that the defendant companies intentionally buried or falsified scientific evidence showing a link between Risperdal and gynecomastia. If this is true (and evidence supports the view), then it represents hideous behavior from the companies. The jury in the Yount case clearly saw this horrific corporate behavior and awarded Andrew Yount a huge monetary award. But just as likely, the jury got angry and awarded this money as a signal to Johnson & Johnson that this kind of corporate greed will be severely punished. The hope is that jury verdicts like this one will discourage Johnson & Johnson and all pharmaceutical companies to recommit to developing and testing and marketing safe and effective drugs.

Naturally, Janssen and J&J have stated they will appeal the verdict.

Other Risperdal Cases

I wrote about the Austin Pledger trial from last fall, which resulted in a $2.5 million verdict and which you can read about here. Other Risperdal trials have yielded jury awards ranging from $500,000.00 to $1.75 million. One jury trial ended in a defense verdict for Janssen and Johnson & Johnson, though I would not put much stock in that outcome, as plainly the plaintiffs are winning many more of these cases than they are losing. After this latest huge loss in the Yount case, Johnson & Johnson would be wise to consider settling many of the more than 1,500 cases still in the pipeline. Another Risperdal case goes to trial in Philadelphia later this month. I’ll let you know how it turns out.

The Takeaway

For much of my life I have mainly believed that pharmaceutical companies develop and market drugs with the overarching goal to improve and extend the lives of patients. But this is not always the case. Sometimes a company can become blinded by greed. Companies may then push an untested drug onto the market, or even sell a drug it knows to be unsafe. So be skeptical. Do some research. Ask your doctor many questions about the latest drug she wants to prescribe for you or your child. Get a second or a third opinion. You can never eliminate all risk, but you can at least learn how a product reached the market, whether it was adequately tested, and even whether lawsuits have been filed against the drug maker.

The case is titled A. Y. v. Janssen Pharmaceuticals, Pennsylvania Court of Common Pleas (No. 130402094)

Photographs for illustrative purposes only.

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.

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.

I don’t drink the Kool-Aid. I distrust simple answers, group-think, zealotry. I can’t stand when people make sweeping generalizations about the absolute evil of one side and the unconditional good of the other side. I don’t usually spend much time with plaintiffs’ attorneys who think every corporate decision is an act of violence and malfeasance. I am convinced there are two sides to every story (even if, often, one side of the story is weaker).

Medical Devices and Drugs Have Saved Many Lives

So it is with my law practice. I do not believe major companies are evil, that they are out to hurt people, that all the conspiracy theories are true. I am convinced the life-cycle of a medical device or drug begins with a beautiful idea: to develop a product that will save lives, that will make people more active, that will help people and not hurt them. In fact, virtually all medical devices or drugs are first developed by one or a few smart people attempting a solution to a pressing health problem.

And these medical devices and drugs have saved lives. And as a society we have to create an environment where doctors and scientists and corporations have the freedom and the opportunity to build new medical devices and new drugs to solve vexing health problems.

more But Corporate Greed is Real, and Dangerous

But something sinister occasionally happens on the road from inspired surgeon with a new idea to the release of 100,000 medical devices into the marketplace. Greed happens. Corporations rush products onto the market without proper testing (you can read about the flawed 510k medical device approval process here). Sales departments see huge profits on the horizon if only the product can get to the market right now. Marketing departments spend massive amounts on television commercials, Internet advertising, print ads, and access to doctors. Corporate leaders occasionally ignore clinical trials which show alarming evidence of harmful side effects and instead push the product to market with the knowledge that the product may hurt innocent people.

My Fight This is what I fight against. I fight for the people injured by the negligent or intentionally harmful acts of big corporations. I hate reading yet another white paper about a product that was released to the public even though the company had compelling evidence that the product had design flaws that could injure or kill patients. I hate this. And I will keep fighting corporations who do this to people.

My Challenge

So when corporations across the board do the right thing, when they properly test their devices and drugs, when they make decisions on new products based primarily on public health and not on immediate corporate profits, then there will be no work left for me to do. I will be out of business. I can then go back to teaching or maybe start a new career renting windsurfers at the beach. It would be an easy trade-off.

When corporations consistently put public safety and the public good over naked profiteering, I will stop representing individuals injured by flawed medical devices and drugs. I will stop practicing product liability law. I truly hope they put me out of business for good.

Job Security

Sadly though, I believe I have chosen a career path with job security. Each year, products flood the market that are inadequately tested and seriously flawed, and as the months pass hundreds of people come forward with horrific stories of permanent injuries, debilitating pain, lost jobs, and diminished lives. I hate these stories. When these people are no longer unfairly injured by failed products I will gladly “find myself a rock and roll band / That needs a helping hand.” Until then, I fight.

Call me if you need to talk about a possible product liability case: (919) 830-5602.