There’s been a lot of press lately about whether the American public can believe all that it sees on the internet, or on the nightly news. Widespread concern has been raised about political misinformation, for instance, which can result in greater polarization between the parties or less trust in government. In many cases, however, the subject of misinformation is medical care, including the safety of FDA-approved or cleared medical devices and drugs. The result of this deception can be much more serious – including risk to health and even loss of life.
What is behind this medical misinformation? Often it is legal advertising — disguised to look like an FDA safety alert, recall, or other critical medical warning, but actually intended to drum up patients to join class-action lawsuits. The ads may not be placed by the lawyers directly, but by “lead generators” who are paid to find plaintiffs across the U.S. for the law firms.
The AARP noted
“[a] surge in television, radio and internet ads from law firms and lawsuit marketing companies is causing some patients to take serious risks,” including “stopping critical life-saving medications without consulting a healthcare practitioner.”
While the ads may resemble a public service announcement or have a quasi-official looking logo, the AARP cautions that they actually direct patients to contact a law firm, not a public health agency.
The New York Times ran a chilling article on how some plaintiffs’ law firms partner with marketing companies to place online ads to lure women into undergoing dangerous, unnecessary surgery to remove pelvic mesh implants, even though they had no problematic symptoms.
The Times observes that these “law firms — which are paid a percentage of any settlements — realized that women with the implants still in their bodies tended to receive smaller settlements than those who had them taken out.”
Women reported receiving unsolicited calls from marketers who knew their medical histories and directed them to selected surgeons for the removal process. Unfortunately, many women suffered medical harm in the process. And on top of medical injury, some patients were hit with big medical loans with double-digit interest rates for the unneeded surgery, to be paid out of any future settlement money. The Times added that this scheme, which could impact thousands of women, is “fueled by banks, private equity firms and hedge funds, which provide financial backing.”
Reed Smith’s James Beck has been covering this issue for the Drug & Device Law Blog, including the latest criminal indictment against a surgeon and personal injury litigation funder involved in the misconduct reported by the New York Times. James summed up the situation for me as follows:
In this instance, everyone was conspiring to make money at the expense of the medical device manufacturer – A rogue litigation funder set everything in motion to increase the size of the settlement pie, and thus its share of the take, by organizing multiple unnecessary surgeries. The plaintiffs wagered on the same increase by having the surgeries. The surgeon received above-market rates for performing the unnecessary operations and later testifying about causation. Secrecy, particularly hiding the third party funding, was essential to this scheme, since these arrangements would have raised huge red flags had the rules mandated disclosure.
So in light of this, what is being done to protect patients?
I am pleased to report that states are starting to take the lead on this issue. In fact, just today July 1, 2019, a new law went into effect in Tennessee – the first of its kind – that uses the state consumer protection statute to fight deceptive law firm “medical alert” ads.
Among other things, the new Tennessee law (SB 352/ Public Chapter Number 119) prohibits legal service ads on TV, radio, internet, newspaper, or other communication:
- Pretending to be a medical/health alert.
- Falsely using the word “recall” for a medical product.
- Soliciting clients who may allege injury from FDA-approved/cleared prescription drugs or medical devices unless the ad (1) warns patients not to stop taking a prescribed medication without first consulting with their doctor, and (2) discloses when the drug or medical device remains approved by the FDA.
- Failing to disclose that the advertisement is a paid ad for legal services, or that cases may be referred to a law firm.
Furthermore, the law makes it illegal to “use, cause to be used, obtain, sell, transfer, or disclose protected health information to another person for the purpose of soliciting an individual for legal services without written authorization from the individual who is the subject of the information.” In addition to other penalties under the law, intentional violation of the protected health information provision for financial gain is punishable by up to 10 years in prison and a fine of up to $250,000. Under the “crime/fraud” exception to the attorney/client privilege, the new law authorizes discovery into the misuse of protected health information.
Texas recently enacted its own state health care consumer protection law, SB 1189, which targets similar deceptive television ad practices by law firms and “client harvesters” – companies that generate and sell clients in bulk to attorneys. The law’s protections include barring any ad “that suggests to a reasonable viewer the advertisement is offering professional, medical, or government agency advice about medications or medical devices rather than legal services.” The author’s intent in introducing the bill, as explained in the bill analysis, is to address the significant public health risk and “negative health consequences as a direct result of the information contained in these misleading advertisements.”
I’d like to see all states to pass similar laws to protect their citizens from misleading, dangerous medical advertisements. In the meantime, the AARP offers the good reminder in the face of this misinformation:
“Your healthcare provider is the only person qualified to provide you with medical advice. They have weighed the benefits over the risks with your health history in mind.”
MedTech POV Podcast
Subscribe to MedTech POV with Scott Whitaker, a podcast covering the intersection of medtech and policy from every perspective.