Medical Implants are SEXY (and profitable)! FDA and Bad Ads.

No consistency for handling misleading health ads

By Sabriya Rice  | August 19, 2015

Since it launched in 2010, the U.S. Food and Drug Administration's “Bad Ad” campaign has received hundreds of complaints about potentially misleading or imbalanced drug advertisements.

Most recently it condemned a series of social media posts by reality TV star Kim Kardashian, in which she raved about relieving morning sickness with a pill she endorses.

But while drug marketing is subject to “Bad Ad” oversight, watchdog groups, clinicians and policy leaders say there's far less scrutiny for medical devices and other health services.

Modern Healthcare recently spotted an ad on the back of a bus in downtown Chicago that could be a good example.

“Diets don't work, get a lap band,” is the message from Dr. Fredrick Tiesenga, a surgeon with the Elmwood Park, Ill.-based weight-loss surgical center, New Hope.

Tiesenga supports the claims. Diets have about a 5% success rate for morbidly obese people, he said. “That's the same as the number of people who think Elvis is still alive. It's not really evidenced-based medicine to continue to send those people to dietitians.”

Though Tiesenga says the ad is intended for people with extremely high body mass indexes who have tried and failed multiple diets, others say the average observer wouldn't know that just by looking at the ad.

“It's misleading. He's making a definitive statement that diets don't work, which we know is not true. And it doesn't include any qualifiers,” said Dr. Bruce Lee, director of the Global Obesity Prevention Center in the Johns Hopkins School of Public Health.

Behavioral modifications, including dietary changes, are a major part of success after bariatric procedures, which cost, on average, between $20,000 and $25,000 in the U.S.

The worry is that those who are struggling with weight loss, upon seeing a message such as that might feel validated to ditch the diet, thinking they can eventually opt for surgery. “It's a very strong statement,” Lee said. “When I see an ad like that, I'm concerned about what the impact might be.”

Experts say misleading health information can be propagated as federal agencies continue to struggle with both the ability to monitor the deluge of ads and identify what counts as an advertisement.

The issue is not only complicated for federal regulators, but also for patients, said Dr. Yael Schenker, an assistant professor of medicine at the University of Pittsburgh. She coauthored a 2014 report in the American Journal of Bioethics that evaluated the ethics of advertising healthcare services.

“It's hard for people to figure out what is truthful,” she said. “It's very easy to mislead the public about something like healthcare where there is an imbalance in terms of access to information.”

To date, the FDA has received nearly 800 complaints through its Bad Ad campaign. It did not say specifically how many of those complaints ended in warning letters or corrective actions such as civil monetary penalties, injunctions and referrals for criminal investigation.

An FDA spokesperson said: "We don't track this metric, as the goal of the program is to raise awareness of misleading advertising and not to increase enforcement actions."

The FDA says complaints about medical devices are forwarded to the Center for Devices and Radiological Health, which enforces violations against federal ad regulations. The Federal Trade Commission may also take actions separately based upon its own jurisdiction.

But the article last year from Schenker and colleagues urged that without consistent oversight and standards, ads for general healthcare services continue to play on emotional, fear-evoking appeals that don't provide specific information about risks, benefits and costs.

Developing and enforcing new standards will not be easy, but the current health environment contributes to “an incoherent status quo,” they said, one where the industry is working to create high-quality medical systems while competing with marketing messages that might encourage patients to seek unnecessary care and dump clinicians who refuse to give it to them.

“We have to accept that advertisements are intended to be persuasive and are never going to present a complete or exhaustive list of risks or benefits,” Schenker said. “But there needs to be a unique set of criteria and oversight that is different from cars or cereal and other run-of-the-mill consumer products.”

For Michael Carome, director of the Health Research Group at the watchdog organization Public Citizen, the differences in advertising reflect a broader concern about pre-market FDA approvals, which are also different for drugs and devices. “The standards are much lower for devices than for drugs,” he said. “That dichotomy extends to advertising provisions.”
http://www.modernhealthcare.com/article/20150819/NEWS/150819898/no-consistency-for-handling-misleading-health-ads

Harmed patient not healed by $3.35M verdict.

J&J Failed to Warn of VaginalMesh Risks, Jury Says

By David Voreacos - Feb 25, 2013 11:44 AM CT  FiDA highlight

           

           

Johnson & Johnson (JNJ)’s Ethicon unit failed to properly warn of the risks of a vaginal mesh implant and made fraudulent misrepresentations to a South Dakota nurse who sued, a New Jersey jury ruled in the first verdict in more than 2,100 lawsuits filed over the device.

Jurors ordered J&J to pay $3.35 million to the nurse, Linda Gross, and her husband. Gross, 47, had 18 operations after the device was implanted.

J&J, the world’s biggest seller of health-care products, didn’t defectively design the mesh and didn’t make fraudulent misrepresentations to Gross’s doctor, the jury ruled. Jurors decided that the company failed to warn Gross’s implanting surgeon. The verdict in Atlantic City state court came in the first trial of claims Ethicon’s Gynecare Prolift injured women.

“This verdict establishes that Johnson & Johnson and Ethicon failed to tell physicians and women the truth about the catastrophic complications that can result from the Prolift,” Gross attorney Adam Slater said in an interview.

Slater argued to jurors that company documents and e-mails showed Ethicon knew the mesh would cause pain and harm women. Gross blamed the mesh for constant pain that makes it hard to sit and for subsequent operations to remove mesh that hardened.

‘Doctors Knew’

J&J claims the Prolift is safe and effective and it warned of the risks.

“Our position is that the Prolift is a safe and effective product, that Ethicon adequately warned doctors of the risks, that doctors knew of the risks,” J&J attorney Christy Jones said in her closing arguments on Feb. 15.

Superior Court Judge Carol Higbee is considering whether to allow Gross’s attorneys to pursue punitive damages, which are intended to punish the company. If so, the same jury would hear evidence and decide whether to award such damages. New Jersey caps punitive damages at five times compensatory damages, which in this case would be $16.75 million. Jurors delivered their verdict on the fifth day of deliberations.

Gross sought $3.38 million for lost earnings and past and future medical expenses. She also sought unspecified damages for pain and suffering.

Difficult Removal

The Prolift, made of a polypropylene mesh, was inserted through an incision in the vagina. In August, J&J stopped selling four mesh devices in the U.S., including the Prolift. J&J, based in New Brunswick, New Jersey, said in June that it would end sales worldwide because the products lacked commercial viability, not because of their safety and effectiveness.

Slater claimed that Gross’s chronic pain and other health problems were risks Ethicon knew about before first selling Prolift in March 2005. Slater said Ethicon knew the device caused pain and often became exposed through the vaginal skin. He said it hardened in women’s bodies and was difficult for surgeons to remove.

Gross, of Watertown, South Dakota, testified on Jan. 31 that her life has changed dramatically for the worse since her mesh was implanted. She said she is in constant pain and can no longer sit comfortably, and she has prescriptions for 20 different medicines to help with her pelvic problems.

“Who you see standing here now is not who I was,” Gross told jurors. “I was eager and energetic, loved to go to work, loved to participate in church activities, school activities.”

Little Risk

Kevin Benson, the South Dakota surgeon who implanted her Prolift on July 13, 2006 to shore up pelvic muscles, was “so gung-ho” about the Prolift that she thought she needn’t worry. She understood from talking to Benson and reading a company brochure that she faced little risk and that the mesh could be removed easily, she said. Had she known all the risks, she said, she wouldn’t have chosen the Prolift.

Gross said she has had more than 400 visits to doctors and physical therapists for treatment, exams and tests, which have been “horrific.”

“I am fearful of dying because this pain is so bad,” she said.

On cross-examination, Jones sought to establish that before many of her surgeries, doctors warned that they may not help her pain. At one point, Gross shouted at Jones: “You’re trying to blame it on me, and it’s not right.”

Jurors saw the video deposition of Benson, who did three follow-up surgeries to remove portions of the mesh to help her with her pain. Other doctors also removed parts of her mesh.

During jury deliberations, the jury reheard testimony from both Gross and Benson. During the trial, which began Jan. 10, jurors also heard from 11 company witnesses and several experts on each side.

Johnson & Johnson shares fell 2 cents to $76.23 at 12:40 p.m. in New York Stock Exchange trading.

The case is Gross v. Gynecare Inc., Atl-L-6966-10, Superior Court of Atlantic County, New Jersey (Atlantic City).

To contact the reporter on this story: David Voreacos in Atlantic City, New Jersey, at dvoreacos@bloomberg.net

To contact the editor responsible for this story: Michael Hytha at mhytha@bloomberg.net

Accessing justice is a high barrier for patients who experience failed implanted medical devices. they are hurt and medically impoverished. The surgeons are not legally required to report "adverse events" to the FDA unless there is a fatality.  Registry of the devices (if there is any) is held in a proprietary silo and data of implants success/failure is obscured for patients making life-changing decisions.  The monumental failure of Johnson & Johnson both for DePuy MoM (metal on metal hips) and Ethicon surgical mesh were preventable if marketing had not led science.  Why is this not criminal?  It is defrauding the government because taxpayers absorb the expen$ive accountability that the industry does not. FiDA Failed Implant Device Allicance  Joleen Chambers