By Matthew Goldstein

A Florida doctor and a medical consultant pleaded guilty this week to federal charges arising from a scheme to pressure hundreds of women to get their pelvic mesh implants removed. The effort was intended to increase the value of personal injury claims against the manufacturers of the medical devices.

The guilty pleas — by Dr. Christopher Walker on Friday and Wesley Blake Barber on Tuesday — bring to a close a criminal case brought two years ago by federal prosecutors in Brooklyn. The two men pleaded guilty to violations of the federal Travel Act, a law that prosecutors have used to pursue charges of bribery in the health care profession.

Mr. Barber, 51, could face at least four years in federal prison when he is sentenced in December by Judge Raymond J Dearie of U.S. District Court for the Eastern District of New York. Dr. Walker, also 51, who pleaded guilty to two counts, could be sentenced to at least eight years when he appears before the judge in January. Lawyers for both men are expected to ask for lesser sentences under the federal guidelines.

The scheme was one of the more unsavory sides of the mass tort case against a half-dozen manufacturers of pelvic mesh including Boston Scientific and Johnson & Johnson. The case has led to more than $8 billion in settlements for roughly 100,000 women in the United States. Dozens of personal injury firms also collected billions in fees in the process.

Prosecutors charged the two men in 2019 with participating in a network to get women from across the country who had pending personal injury claims against the device manufacturers to agree to hastily arranged surgical procedures to remove the implants. The pitch was that women who had the implants removed were getting bigger settlements than women who still had the implants inside them.

However, removing the implants, a synthetic product that can bond with a woman’s internal organs, can be tricky. Some women who had mesh removed were worse off, or no better, than they were before the operation. Many of the women lured by the network had the procedures done without getting a second opinion.

Mr. Barber was one of the architects of the scheme, according to prosecutors, and a firm he worked with helped arrange for the surgical procedures to be performed at outpatient medical centers in Florida — some in nondescript strip malls. The procedures were paid for with money from high-interest cash advances arranged by a group of so-called litigation finance firms. But the women had to pay the money back to those lenders after receiving the settlement proceeds.

The charging document filed by prosecutors in 2019 said the women had been unaware that Dr. Walker and others who had performed the implant removal surgery had paid kickbacks and bribes to Mr. Barber’s firm and others for the surgical referrals.

Brooklyn prosecutors filed the charges after an article in 2018 in The New York Times about how some women said they felt pressured into getting the mesh removed by a network of consultants, personal injury lawsuit marketers, lawyers and doctors. Most of the women said they did not fully understand what they had agreed to.

The use of mesh to strengthen weakened pelvic muscles that can cause the bladder, the uterus and other organs to sag into the vaginal area long has been controversial. After years of complaints from women about bleeding, leaking bladders, searing pain and other ailments, the Food and Drug Administration stopped the sale and distribution of pelvic mesh in 2019 for treating organ prolapse. By then, the mesh had been implanted in millions of women around the globe.

“Both defendants have admitted to participating in a reprehensible bribery and kickback scheme to exploit women across the country,” said Jacquelyn M. Kasulis, the acting U.S. attorney in Brooklyn.

Dr. Walker agreed to forfeit about $800,000, and Mr. Barber agreed to forfeit about $1.1 million.

Jodi Avergun, a lawyer for Dr. Walker, said that her client’s involvement in the scheme “was unfortunate” and that he “accepted responsibility for his actions in order to move forward and resume his career caring for patients.”

The criminal case may be over, but civil litigation continues. In December, a lawsuit filed on behalf of 188 women who claimed to have been victimized by the network was filed in a Florida circuit court. The lawsuit, which seeks monetary damages, named some two dozen defendants, including Mr. Barber, Dr. Walker and other doctors.

SALT LAKE CITY (Legal Newsline) – “Wilderness therapy” like rock-climbing can be considered health care for the purposes of litigation, the Utah Supreme Court has ruled.

Asked by a federal appeals court whether an injury that took place during a hike can be subject to rules governing medical malpractice lawsuits, the court on July 9 said yes. In the lawsuit at issue, a wilderness therapy company employed a health care provider who prescribed hiking, wildness experiences and learning outdoor survival skills as part of a therapeutic treatment plan.

It was a win for defendant Wingate Wilderness Therapy. It said plaintiff Jacob Scott missed the Malpractice Act’s statute of limitations by waiting more than two years after his 18th birthday to sue for injuries sustained climbing rocks during a hike when he was 17.

Wingate provides behavioral, substance abuse and mental health services to minors. Scott’s injury occurred during prescribed outdoor therapy, during which he and other “patients” asked to climb a 70-foot tall rock formation.

The supervising staff member provided no climbing gear, training or physical assistance. Scott made it to the top but had trouble making it back down. He slipped in snow 25 feet up and fell the rest of the way, shattering his left knee.

His lawsuit alleged negligence on the part of Wingate and its staff in allowing him to climb the formation in the first place, especially without gear or training.

But Wingate, in federal court, asserted it was a health care provider and that Scott had failed to file his lawsuit within the two-year statute of limitations contained in the Malpractice Act. Scott appealed, and the U.S. Court of Appeals for the Tenth Circuit asked the Utah Supreme Court for clarity on the issue.

Scott’s injuries arose “relating to or arising out of” his treatment, as the Malpractice Act says, the court ruled. It rejected hypotheticals from Scott’s lawyers like a patient falling in a hospital hallway on a puddle of soda.

“We reject Jacob’s argument that the hike and wilderness therapy component of Wingate’s program cannot be deemed ‘health care’ because it was operated by Wingate’s field staff who lack ‘medical licenses’ and ‘exercised no professional medical judgment when they allowed Jacob to climb’ the rock formation.

By Mark Behrens and Mayela Montenegro-Urch

S.B. 447, a piece of legislation being championed by the tort bar in the California Legislature, will dramatically increase lawsuit damages in survival cases.

In California, when a person dies from an injury caused by someone else, the decedent’s successors can file a survival lawsuit and recover damages that include out-of-pocket expenses, such as lost wages and medical bills, and any punitive damages that the decedent would have been entitled to recover had that person lived. Punitive damages provide a windfall to the recipient, because they are awarded to punish a defendant and deter tortfeasors.

Noneconomic damages, including pain and suffering, are not recoverable in California survival actions, because those damages are personal to the decedent, and not meant to compensate others. These awards also have a vindicatory element.

Indeed, the California Supreme Court held in Roby v. McKesson Corp. in 2009 that lower punitive damages are justified when accompanied by a large award for emotional distress because “the latter may be based in part on indignation at the defendant’s act” and may serve “as a deterrent.”

S.B. 447 overturns California’s long-standing approach. The bill adds pain and suffering, loss of consortium, emotional distress and disfigurement damages to punitive and economic loss damages in survival lawsuits if the cause of action accrues before Jan. 1, 2026.

California tort awards will skyrocket — not only because of double-dipping of damages that other states avoid, but also because the higher verdicts will be used to support more extreme punitive damages awards.

The U.S. Supreme Court has held that punitive damages must bear a reasonable relationship to a plaintiff’s actual or potential harm. With regard to S.B. 447, this means that as compensatory damages jump in survival actions due to the addition of noneconomic damages, the amount of punitive damages that is constitutionally permissible in a given case may jump too.

For example, in a survival action in which a plaintiff’s economic damages recovery is $1 million, if a court applies a 4-to-1 ratio for punitive damages, the plaintiff could recover up to $4 million in punitive damages, for a total recovery of $5 million today.

Post-enactment, if the same plaintiff recovered $1 million in economic damages and $1 million in noneconomic damages, the 4-to-1 ratio would permit a punitive damages award of $8 million, for a total recovery of $10 million — a massive increase in just one case, that could be repeated across serial litigations.

Skillful plaintiffs attorneys will no doubt point to the opportunity for higher compensatory damages and threat of much higher punitive damages to raise case valuations and extract larger sums from defendants. Defendants may have little choice but to pay, since the threat of an enormous award may be present in many cases. Noneconomic damages in most settings are unlimited in California and, unlike many other states, punitive damages are uncapped as well.

The prospect of much larger awards in survival actions — and the much bigger contingency fees that will come with them — must have plaintiffs lawyers salivating. And there will be a benefit for families that have lost a loved one due to another’s negligence.

Everyone else will pay the price. Sponsors of the bill have cast aside the “greatest good for the greatest number” approach to policy in order to provide unlimited recoveries to a few.

For example, state and local governments are frequently sued in civil actions, including in survival actions where a person has died from the negligent conduct of a government employee. If S.B. 447 passes, the cost to the public will be huge. To pay for this increased cost, California will either need to cut government services or raise revenue. California is already one of the highest-tax states in the nation.

California businesses are tiring of the Golden State’s anticompetitive approach to governing. It is no secret that businesses are leaving the state in droves, tired of high taxes, burdensome regulations and a lawsuit culture that does not exist in most other states.

The Hoover Institution estimates that 765 commercial facilities left California in 2018 and 2019. This does not count the many other businesses or workers that left during the pandemic, or that are planning to leave as remote work becomes widely accepted. S.B. 447 will lead remaining businesses to question why they should stay.

Further, the bill reinforces the perception that California’s civil justice system is not welcoming of job creators. A 2019 lawsuit climate survey for the U.S. Chamber Institute for Legal Reform by the Harris Poll ranked California near the very bottom of the country with respect to the fairness of the state’s legal system.

The poll surveyed over 1,300 senior lawyers at many of the nation’s largest companies. In particular, participants in the survey voted California the worst jurisdiction in the entire country with respect to damages. California cannot fall farther than 50th as a result of S.B. 447, but its placement in the cellar will be cemented. California regularly ranks high on the American Tort Reform Association‘s Judicial Hellholes list. The streak will not be broken if S.B. 447 is enacted.

Of course, ordinary citizens will pay too. The public may soon realize that the deep pocket is their own pocket. If you own a car in California, your insurance premiums may jump. If you do business in California, you may face crushing lawsuits.

Shoppers may see higher prices. The sad fact is that the state’s least wealthy citizens will be hit the hardest by the hidden “tort tax” that will be baked into the cost of goods and services to offset the higher costs on businesses from S.B. 447.

Plaintiffs lawyers need not worry, however, that the damage they will inflict on other businesses and consumers will backfire on them. Conveniently, California common law holds that emotional distress damages are not generally recoverable in attorney malpractice actions related to litigation.

S.B. 447 should be rejected when this Senate-passed bill is considered by the Assembly. But room for improvement also exists if the legislation does advance.

For example, noneconomic damages in survival actions could be capped, as they are in medical malpractice cases in California. Providing an adequate, but not unlimited, noneconomic damage award to relatives of deceased plaintiffs would help create balance in the bill.

Additionally, the law could be amended to limit noneconomic damages in survival actions to cases directly impacted by the court backlog resulting from COVID-19.

Further, the window of time before the bill sunsets should be narrower — e.g., two years — and the sunset should apply to cases filed after that date. Application of S.B. 447 to cases that accrue by Jan. 1, 2026, is too broad, and allows the bill to apply to lawsuits filed for years after that date.

Finally, what’s good for the goose is good for the gander: Emotional distress damages should be allowed against plaintiffs firms for attorney malpractice related to litigation. But S.B. 447 should certainly not pass in its current form.

By Wes Rapaport

AUSTIN (Nexstar) — If you’re looking for a doctor in Texas, it seems you’re in luck.

Texas’ physician workforce is expanding at a record-setting pace, according to the Texas Medical Association. The ratio of patient-care physicians for every 100,000 people has increased every year for a decade, new data revealed.

The association reported the state’s number of newly licensed physicians bumped up 7.9% last year. Texas added 4,869 new doctors in 2019, which is 355 higher than the 2018 total of 4,514. Based on the new data, there are now nearly 190 physicians for every 100,000 Texans.

“Texas is doing a great job of welcoming new physicians and making it a good environment to practice medicine and take care of people in,” said Dr. David Murdy, of Baylor Scott and White Health’s Lakeway clinic. Murdy moved to Texas in 2018 from Wisconsin.

The doctor growth in Texas was spurred in 2003 by legislation that changed liability regulations, making it less likely for lawsuits against physicians and hospitals to be sued by patients. That enabling legislation was House Bill 4, the Medical Malpractice and Tort Reform Act, paired with constitutional amendment Proposition 12.

Dr. Stanley Wang, a cardiologist and sleep medicine specialist at Austin Heart, returned to Texas, the state where he went to medical school, after the law change.

“Medical liability was a big problem and the relief of it was a big attraction when I looked at where to go,” Wang said. “I think if you look at the statistics since the reforms were enacted, they really show a tremendous increase in the number of physicians coming to Texas, but not only that, the overall rates of physician growth has been higher than the rate of population growth.”

According to TMA, the rate of new physicians arriving in the state largely matched Texas’ population growth. Over the last decade (2009-2019) the rate of new doctors in Texas exceeded the rate of growth in the state’s total population.

“Our success at improving access for our patients is evidenced by the fact that three in four physicians licensed by Texas are from outside the state,” Dr. David Fleeger, TMA’s president, said.

“Physicians are drawn to Texas as a direct result of our medical liability reform victory,’ Dr. Fleeger said. “To sustain the improving physician-to-patient ratio, we must continue to advocate to protect that reform.”

While the trend means better access to care statewide, Wang and Murdy recognized the growth does not solve the discrepancy between urban and rural healthcare.

“It’s just farther to get to specialists and it’s farther to get to hospitals,” Murdy said. “It’s harder to have a concentration of specialties or high levels of services in disparate rural parts of West Texas in particular.”

“We still have some very under served areas in Texas including counties with zero or one doctor,” Wang said. “So there’s there’s some situations that still need to be addressed in terms of position recruitment and availability.”

By The Editorial Board

Tort lawyers often use the threat of jackpot verdicts to extort settlements from business targets. But when does a shakedown become criminal extortion? Last week the federal government charged Timothy Litzenburg for allegedly crossing that legal line.

Mr. Litzenburg, 37, made a name for himself at the Miller Firm in Virginia, where he was part of a team suing Bayer on behalf of a groundskeeper who said the weed killer Roundup caused his cancer. Trial lawyers profit by taking a hefty chunk of a settlement or damages. But when Mr. Litzenburg opened his own law firm last year, he allegedly had a different business model in mind.

The feds say the extortion plot began in September when Mr. Litzenburg sent a draft complaint to “Company 1,” identified by the Wall Street Journal as Amsterdam-based chemical maker Nouryon. The lawyer said the company had created chemical compounds used in Roundup and “knew of the carcinogenic properties of these chemicals but failed to warn” users about the risks, the federal complaint says.

Mr. Litzenburg allegedly followed up his draft lawsuit threat with an offer, which he repeated in emails and recorded phone calls. The company could pay the plaintiff $5 million, enter into a $200 million “consulting arrangement” with him and his associates, and avoid what Mr. Litzenburg allegedly described as “the parade of horribles that has been the Roundup litigation for Bayer/Monsanto.”

“Another thing I can guarantee and warrant: in the absence of a so-called ‘global’ or final deal with me, this will certainly balloon into an existential threat” to the company, Mr. Litzenburg allegedly wrote in an email. The federal complaint says he warned that “defense costs and cost to ultimately resolve the thousands or tens of thousands of cases would be well into the billions, setting aside the associated drop in stock price and reputation damage.”

Mr. Litzenburg also allegedly said that “even if you guys win cases and drive value down,” there was unlikely “any way for you to get out of it for less than a billion dollars. And so, you know, to me, uh, this is a fire sale price that you guys should consider.”

If the company paid up, Mr. Litzenburg allegedly said he’d discourage others from filing future lawsuits. To deter plaintiffs, he’d even consider participating in a pre-trial deposition to which the company could bring its own toxicology experts, “and we ask the wrong questions,” creating a “transcript where I basically got whacked,” Mr. Litzenburg allegedly said in a recorded call. The transcript could be “kept in a vault somewhere to pull out if you ever got bothered by someone that didn’t know me or whatever,” he said, according to the complaint.

Instead of agreeing to Mr. Litzenburg’s alleged offer, the company called federal prosecutors. Mr. Litzenburg did not respond to our request for comment, but his lawyer told the press last week that his client isn’t guilty and that the charging document may contain inaccuracies.

Mr. Litzenburg will get his day in court, but the entire Roundup litigation is a stickup. The Environmental Protection Agency and international regulators have conducted extensive research and concluded that glyphosate, the active ingredient in Roundup, isn’t carcinogenic. That evidence hasn’t stopped three juries from imposing more than $2.4 billion in penalties. Judges have cut those cumulative damages to some $189 million, and the verdicts are being appealed. But Bayer faces Roundup lawsuits from some 42,700 plaintiffs.

Mr. Litzenburg may have figured he could get away with his alleged extortion because he’s seen first-hand the damage that junk-science litigation can do regardless of the truth.

By Mark A. Behrens

Plaintiffs’ attorneys are spending billions of dollars saturating the airwaves with advertisements that target prescription drugs and medical devices for lawsuits. Many of these ads are misleading and alarmist; some have led to the deaths of frightened consumers who stopped taking their medications after seeing such commercials. In 2019, Tennessee and Texas enacted first-of-its-kind legislation regulating ads for legal services. Critics of the new laws claim they violate plaintiff lawyers’ free speech rights while proponents find them important to protect public health.

After suffering from a deep vein thrombosis, a 45-year old man was prescribed life-saving medication by his doctor. Negative lawsuit ads about the product led the man to discontinue the medication without consulting his physician. The man suffered a pulmonary embolism and died.1

Unfortunately, this person’s story is not unique. For example, in 2016, the U.S. Food & Drug Administration received 61 reports from health care professionals whose patients discontinued or reduced their use of blood thinners after viewing lawsuit advertisements.2 Six of the patients died.3

This year, Tennessee then Texas enacted first-of-its-kind legislation to regulate misleading practices often found in plaintiff lawyer mass tort advertising.4 The laws take effect on July 1 and September 1, 2019, respectively.

This article discusses the problems with plaintiff lawyer advertisements that target prescription drugs and medical devices for litigation. The article then analyzes the new Tennessee and Texas laws. The article concludes by briefly responding to opponents’ claims that regulating misleading lawsuit advertising violates the First Amendment.

The Problem with Misleading Lawsuit Ads
Lawsuit advertisements that target prescription drugs and medical devices contain sensationalized information about the risks associated with those products. The advertisements often begin by flashing words like “medical alert” or “health alert.”5 The ads then attempt to bolster their credibility by incorporating images of government agency logos such as the FDA logo.6 Because the ads look legitimate, consumers may believe they are watching a public service announcement or receiving sound advice from a medical professional. What viewers are actually watching is fearmongering by plaintiff attorneys seeking to convince them to file lawsuits.

The information conveyed in lawsuit commercials may be unreliable. For example, in 2015, lawsuit advertisements told viewers that taking the anti-nausea drug Zofran during pregnancy could increase the risk of birth defects including cleft lip and cleft palate.7 Viewers were told to call “1-800-BAD DRUG” to potentially obtain “Substantial Compensation.”8 The FDA, however, found insufficient scientific evidence to support the claims, and a subsequent study confirmed that no connection exists between Zofran and birth defects.9

Lawsuit advertisements typically do not disclose the likelihood that a person will experience an adverse effect associated with the product.10 Without this critical information, viewers are unable to weigh the risks and benefits of treatment, or the impact of discontinuing or reducing the use of a medication or having a medical device removed.

Most lawsuit ads conclude with fine print that is too small and too briefly shown for viewers to read. This text often informs viewers that the advertisement is for legal services, that the sponsor is not an attorney but a company that specializes in generating “leads” for law firms, and that any legal work may be handled by others. Callers are sometimes routed to foreign call centers, who take basic information to screen claims. Very few of the ads advise viewers to speak with their doctors before discontinuing or reducing use of a prescription medication.

Lawsuit ads intentionally leave viewers—who may be potential plaintiffs and jurors—with the impression that a particular product is a “bad drug,” and may suggest that it has been recalled, even when the product remains FDA-approved.

How Significant is this Problem?
Lawyer spending on television advertising has grown at a rate six times faster than all other television ad spending.11

In 2018, the American Tort Reform Association estimated that $226 million was spent on television ads for legal services in the third quarter of 2018 alone.12 Total spending on legal advertisements (television, radio, and Internet) may reach $1 billion annually.13

Advertisements for lawsuits against manufacturers of prescription drugs and medical devices make up the largest share of legal services advertising on television.14

What are the Consequences?
One in four people who take prescription drugs have reported they would stop taking their medication immediately, without consulting a doctor, if they saw a lawsuit advertisement involving the drug.15

One recent study found that when viewers were shown two television commercials soliciting lawsuits targeting a reflux drug—one that purported to be a public service warning and another that clearly disclosed its purpose as a lawsuit advertisement—those who viewed the ad presented as a health alert were less likely to fill a new prescription or refill an existing prescription.16

An earlier survey of psychiatrists who treat patients for schizophrenia and bipolar disorder reported patients stopping their medication or reducing their dosages without consulting them first.  “More than half attributed these actions to lawsuit ads.”17

The American Medical Association has recognized that patients are more likely to discontinue prescribed medications after seeing television advertisements that “emphasize side effects while ignoring the benefits of the fact that the medication is FDA approved.”18

The targeted advertisements compromise the doctor-patient relationship. Patients who view negative advertisements perceive them as “medical advice, and they are often in direct contradiction to that of their physicians,” according to a North Carolina board certified vascular surgeon who testified before Congress.19 This leads patients to distrust their doctors and refuse sound medical advice—believing that the person giving them the advice had prescribed a drug that could harm them.

What is the Solution?
Tennessee and Texas recently enacted legislation regulating deceptive practices that are common in mass tort advertising.20

Both laws include provisions that ensure that viewers will understand that they are seeing a legal advertisement. All lawyer ads must indicate that they are paid advertisements for legal services. An ad may not be presented as a “medical alert,” “health alert,” “public service announcement,” or other similar phrase.

The new laws also prohibit legal services ads from using the term “recall” when a product has not been recalled by a government agency or through an agreement between a manufacturer and government agency. And the laws forbid the displaying of a government agency logo in a manner that suggests an affiliation with the agency. These provisions apply to lawsuit ads targeting any products that are regulated by federal or state agencies (e.g., consumer products and automobiles), not just prescription drugs and medical devices.

When a lawsuit ad involves a prescription drug, both laws require that ad to warn viewers not to stop taking the medication without first consulting a physician. In addition, the Tennessee law requires legal services ads to disclose that the subject drug or medical device remains FDA-approved (unless, of course, it has been recalled).

Both laws include provisions to make sure that these disclosures are not merely flashed in fine print, but that viewers are able to hear and read the required information.

There is an important distinction regarding the scope of the two laws. The Tennessee law applies to all advertisements, including television, Internet, radio, websites, newspapers, billboards, and all other written, electronic, or recorded information.21 The Texas law applies only to “television advertisements” for legal services.22

The laws also vary in how they will be enforced. A violation of the Tennessee law is an unfair or deceptive act or practice under the state’s consumer protection law.23 As such, Tennessee’s attorney general can investigate potential violations and enforce the law. In addition, individuals injured due to a misleading advertisement for legal services may bring a private action against the ad’s sponsor.

While the Texas law similarly provides that a violation of the Act is a deceptive act or practice, it limits enforcement to the consumer protection division of the attorney general’s office or a district or county attorney.24 The Texas law also includes a safe harbor that protects the sponsor of an ad from liability when it submits the ad to the advertising review committee of the State Bar before running the ad and the Bar finds that the ad complies with the law.25

Texans for Lawsuit Reform (TLR) issued this statement after the Texas bill was enacted:

The Texas Senate sent a strong message today that our state will not tolerate lawyer advertising practices that unnecessarily alarm Texans and create threats to public health to generate clients,” TLR General Counsel Lee Parsley said. “It’s unacceptable that Texans have suffered adverse health consequences or died because they were frightened into discontinuing use of a necessary medication by an advertisement for legal services….26

Consistent with the First Amendment
The Tennessee and Texas laws are likely to face First Amendment challenges.27 A Nashville plaintiff attorney who reportedly intends to challenge the Tennessee law has said the law “unfairly singles out lawyers and denies them their First Amendment rights, while placing no such limitations on pharmaceutical company or health care provider advertisements.”28 A Texas Trial Lawyer Association board member called the Texas law “an unconstitutional restraint on commercial free speech.”29

The U.S. Supreme Court, however, has long recognized that while states cannot bar attorney ads, “[a]dvertising that is false, deceptive, or misleading of course is subject to restraint.”30 The Court has upheld restrictions on attorney advertising that unduly influence injured people31 or misled the public.32 Because the Tennessee and Texas laws target misleading ads that often influence people who are ill or elderly, they do not violate the First Amendment.

Even when attorney advertising is arguably protected speech, the Court has found that narrowly tailored restrictions are permissible where there is a substantial interest in protecting the public.33 Laws that ban misleading lawsuit advertisements in response to reports of patient injuries and deaths do just that.

First Amendment objections from the plaintiffs’ bar and lead generators also ring hollow since the Tennessee and Texas laws are far less intrusive than the FDA’s regulation of pharmaceutical marketing. Direct-to-consumer advertisements for prescription drugs must present a fair balance between the potential benefits of a drug and its potential side effects. Manufacturers may not make exaggerated claims, cannot selectively present research or studies, and cannot use graphics or headlines in a way that is misleading.34 In contrast, lawsuit ads use these practices to convey misleading information, and have not faced scrutiny from the FDA, Federal Trade Commission, or state bar associations. Tennessee and Texas have simply mandated the minimum oversight necessary to protect the public. Their laws target specific misleading practices that would be illegal if used in advertisements associated with any other product or service.

Conclusion
Plaintiffs’ attorneys and lead generators use fearmongering ads to generate as many lawsuits as possible. The lawsuits stemming from these ads are intended to pressure businesses to settle mass tort cases regardless of the merits. The side effect, however, is that some viewers stop taking their prescribed medication or do not seek medical care that could help them. The public suffers the consequences of deceptive commercials for legal services. Tennessee and Texas are the first states to prohibit common misleading practices in lawsuit advertisements. Other states should follow.

Footnotes

1. Paul Burton & W. Frank Peacock, A Medwatch Review of Reported Events in Patients Who Discontinued Rivaroxaban (XARELTO) Therapy in Response to Legal Advertising, Heart Rhythm Case Reports, v. 2, issue 3, 248-49 (May 2016), at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5419767/.

2. See Cary Silverman, Bad for your Health: Lawsuit Advertising Implications and Solutions, U.S. Chamber Inst. for Legal Reform (Oct. 2017), at 25 (citing Letter from Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis, U.S. Food & Drug Admin. to Hon. Andy Harris, M.D., U.S. House of Rep. (2017)), at https://www.instituteforlegalreform.com/research/bad-for-your-health-lawsuit-advertising-implications-solutions.

3. Id.

4. Tenn. Pub. Chap. 2019-116 (H.B. 352) (to be codified at Tenn. Code §§ 47-18-5601 et seq.), at https://legiscan.com/TN/text/SB0352/id/1998216/Tennessee-2019-SB0352-Chaptered.pdf; S.B. 1189, 86th Leg. (Tex. 2019) (to be codified at Tex. Gov’t Code §§ 81.151 et seq.), at https://legiscan.com/TX/text/SB1189/id/2024451/Texas-2019-SB1189-Enrolled.html.

5. Silverman, supra note 2, at 1-2.

6. Id. at 13.

7. See Zofran Birth Defect Warning 1-800-BADDRUG Ad, at https://www.youtube.com/watch?v=nfG6d3bIrQs.

8. Id.

9. See FDA, Response to Citizen Petition of James P. Reichmann, Docket No. FDA-2013-P-0048 (Oct. 27, 2015) (denying citizen petition requesting that FDA reclassify Zofran to reflect a higher degree of risk when taken during pregnancy and to warn OB/GYNs that use of Zofran during pregnancy can lead to adverse maternal or fetal outcomes after closely review all available scientific literature and other data), at http://zofran.monheit.com/wp-content/uploads/2016/02/Citizen_Petition_DenialResponse_from_FDA_CDER_to_Mr_James_P_Reichmann_Redacted.pdf; see also Marlena S. Fejzo et al., Ondansetron in Pregnancy and Risk of Adverse Fetal Outcomes in the United States, 62 Reproductive Toxicology 134-37 (July 2016) (finding women who took Zofran during pregnancy for extreme morning sickness reported fewer miscarriages and pregnancy terminations and higher live birth rates than women who did not take the drug, and finding no support that Zofran increases the risk of birth defects), at https://www.ncbi.nlm.nih.gov/pubmed/27151373.

10. See Silverman, supra note 2, at 12.

11. Ken Goldstein & Dhavan V. Shah, Trial Lawyer Marketing: Broadcast, Search, and Social Strategies, U.S. Chamber Inst. for Legal Reform (Oct. 27, 2015), at https://www.instituteforlegalreform.com/uploads/sites/1/TrialLawyerMarketing.pdf.

12. See Am. Tort Reform Ass’n, Local Legal Services Television Advertising—2018 Quarter 3 (Dec. 2018), at http://www.atra.org/wp-content/uploads/2019/01/ATRA_Q3_Legal_Services_Ad_Spending_Report.pdf.

13. See Silverman, supra note 2, at 1.

14. Id. at 6.

15. See Lisa Rickard, Warning: Lawsuit Ads May Be Harmful to the Health of Americans, The Hill, June 23, 2017, at https://thehill.com/blogs/congress-blog/judicial/339057-warning-lawsuit-ads-may-be-harmful-to-the-health-of-americans.

16. See Jesse King & Elizabeth Tippett, Drug Injury Advertising, Yale J. of Health Pol’y L. & Ethics (forthcoming 2019), at https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3220066.

17. Silverman, supra note 2, at 3.

18. Jessica Karmasek, AMA: Lawyer Ads Are Alarming Prescription Drug Users, Jeopardizing Health Care, Forbes.com, July 21, 2016 (quoting Russell W. H. Kridel, M.D., an AMA board member), at https://www.forbes.com/sites/legalnewsline/2016/07/21/ama-lawyer-ads-are-alarming-prescription-drug-users-jeopardizing-health-care/#5809c7e9369e; see also Am. Med. Ass’n, Attorney Ads on Drug Side Effects H-105.985, Resolution 208, A-16 (June 2016), at https://policysearch.ama-assn.org/policyfinder/detail/Attorney%20Ads%20on%20Drug%20Side%20Effects%20H-105.985?uri=%2FAMADoc%, Attorney Ads on Drug Side Effects H-105.985, Resolution 208, A-16 (June 2016), at https://policysearch.ama-assn.org/policyfinder/detail/Attorney%20Ads%20on%20Drug%20Side%20Effects%20H-105.985?uri=%2FAMADoc%2FHOD-105.985.xml.

19. Testimony of Shawn H. Fleming, M.D., Novant

Health Vascular Specialists, Before the Committee on the Judiciary, Subcommittee on the Constitution, U.S. House of Representatives, Hearing on “Examining Ethical Responsibilities Regarding Attorney Advertising,” June 23, 2017, at https://www.govinfo.gov/content/pkg/CHRG-115hhrg29776/html/CHRG-115hhrg29776.htm.

20. Tenn. Pub. Chap. 2019-116 (H.B. 352) (to be codified at Tenn. Code §§ 47-18-5601 et seq.); S.B. 1189, 86th Leg. (Tex. 2019) (to be codified at Tex. Gov’t Code §§ 81.151 et seq.).

21. See Tenn. Code § 47-18-5601(1).

22. See Tex. Gov’t Code § 81.151(a).

23. See Tenn. Code § 47-18-5605.

24. See Tex. Gov’t Code § 81.155(a)-(b).

25. See Tex. Gov’t Code § 81.155(c).

26. Press Release, Texans for Lawsuit Reform, Statement on Senate Passage of SB 1189 (Apr. 11, 2019), at https://www.tortreform.com/press-release/statement-on-senate-passage-of-sb-1189/.

27. Maureen Leddy, Tenn., Texas Move to Restrict Content of Legal Services Advertisements, Trial News (Am. Ass’n for Justice) (June 6, 2019).

28. Id. (quoting Gerard Stranch).

29. Id. (quoting Craig Eiland).

30. Bates v. State Bar of Ariz., 433 U.S. 350, 383 (1977).

31. See Ohralik v. Ohio State Bar Ass’n, 436 U.S. 447, 464-65 (1978) (upholding restriction on soliciting patients at hospitals or accident sites).

32. Zauderer v. Office of Disciplinary Counsel of the Supreme Court of Ohio, 471 U.S. 626, 650 (1985) (upholding discipline when attorney ad for medical device litigation said “no recovery, no fee” when client would be required to pay litigation expenses); see also Cent. Hudson Gas & Elec. Corp. v. Pub. Serv. Comm’n of N.Y., 447 U.S. 557, 566 (1980) (“[F]or commercial speech to come within the First Amendment, it at least must concern lawful activity and not be misleading.”).

33. See Fla. Bar v. Went for It, Inc., 515 U.S. 618, 626-29 (1995) (upholding Florida Bar rule that prohibited lawyers from sending direct mail to victims and their relatives within 30 days of an accident or disaster).

34. See generally 21 C.F.R. § 202.1(e)(5)-(7).

By Dana Elfin

BOSTON — Private equity is increasingly pouring money into medical device mass tort litigation, including ads soliciting plaintiffs for lawsuits, panelists at The MedTech Conference in Boston said on Tuesday.

Many of these ads feature FDA’s logo, making them look more like public health alerts, which can alarm less informed or often elderly television viewers.

In 2018, there were 117,000 of these TV ads and an estimated $36 million in spending; in 2019, those numbers grew to 269,000 TV ads with an estimated $83 million in spending, according to X Ante, which surveys trends in mass tort litigation advertising and marketing.

And the TV ads are often part of a multimedia campaign that also includes radio, online and newspapers.

“They’re not the guy sitting at the office in front of a bunch of law books saying, ‘Hey, give me a call if you need to file a lawsuit,’” X Ante President Rustin Silverstein said. “A lot of them look like public health warnings, even government public health warnings.”

“It’s whack-a-mole; it really is,” panelist Aviva Wein, assistant general counsel, products liability, at Johnson & Johnson said.

Yet few people are aware these ads or the lawsuits they’re soliciting are often backed by third parties.

Third Party litigation funding occurs when investors, often venture capitalists, take a stake in the outcome of litigation. Historically, few courts have required plaintiffs to disclose that funding, said Rebecca Wood, former chief counsel at FDA. Nor do the ads, which are often disguised as medical alerts, generally disclose who’s behind them.

“Without these kinds of disclosures, courts and other parties and have no visibility into the whole third party funding, even if the funders function as a real party in interest, or guide the litigation,” Wood, now at Sidley Austin, said.

“These ads are increasingly part of a 360 degree strategy that can have significant implications for the defendant as well as for the reputation of a sponsor, and a product. And they can lead to interest from government regulators and legislators,” she said.

Mesh, hips make the top 10
The top 10 products targeted by mass tort TV ads from January to July include hernia mesh, IVC filters, military earplugs, hip implants, pelvic mesh, knee implants, surgical staplers, Essure birth control, intrauterine devices including Mirena and Paraguard, and breast implants.

“They are always looking for new targets to go after to generate more lawsuits and more jury awards and settlements,” Silverstein said.

And these ad campaigns often forecast litigation risk. “The ads generally start about two months before the MDL [multidistrict litigation],“ John Brenner, chief litigation counsel at BD said. In the case of IVC filters, “we went from an annual case count of about 20 to 30 cases to . . . about 8,000 cases now” he said, even though the filters have a failure rate of less than 1%.

“Advertising drives claims and then claims really distort the system,” he said. Currently, about 50% of the federal docket in this country is in MDL mass torts, he said.

BD and other companies were involved in the transvaginal mesh litigation, the second largest MDL in history, with 100,000 cases before one judge in West Virginia.

Judges frequently in dark about funding
The litigation funding business is about a $5 billion industry, J&J’s Wein said. Because many of these ads are backed by third-party litigation funders, these lawsuits — and the ads soliciting claimants against device companies — are not bound by traditional funding constraints.

And courts dealing with these suits are often unaware of how the mass tort litigation is financed.

“In the context of mass tort  litigation, it’s now Goliath versus Goliath, and the courts don’t realize that at all and members of Congress don’t realize this at all,” he said.

Policymakers are looking at the issue on both the state and federal level. Backed by interests like the U.S. Chamber Institute for Legal Reform, Sen. Charles Grassley, R-Iowa, is sponsor of the Litigation Funding Transparency Act, which would require plaintiffs’ lawyers to disclose third party litigation funding in class actions and in multidistrict litigation.

Some states are also looking at regulating the advertising, including in Texas and Tennessee. The Texas law, which took effect Sept. 1, focuses on lawyer ads for prescription medication and medical device litigation and imposes civil penalties for violations under the state’s Deceptive Trade Practices Act. It requires ads to disclose they’re a paid legal advertisement, not a public health warning, and list the identify of sponsor of the ad.

UPDATE: Sept. 26, 2019: AdvaMed’s chief operating officer and general counsel Christopher White applauded the Federal Trade Commission on Wednesday for sending letters to seven legal practitioners and lead generators expressing concerns that some television advertisements that solicit clients for personal injury lawsuits may be deceptive or unfair under the FTC Act. “AdvaMed is pleased to see that the FTC recognizes misleading legal advertisements jeopardize patient safety and health. We agree with the FTC -— health ads must be science-based. Health care decisions should be based on truthful and science based information in consultation with physicians, not fear-inducing misleading advertisements,” White said.