By: Sara Randazzo and Jonathan D. Rockoff
Plaintiffs’ lawyers have long solicited clients through television advertisements that warn of a drug’s potentially harmful side effects.
Now, a powerful congressman, backed by the leading doctors’ group and some drug companies, is pushing back, saying the ads are to blame for patients suffering harm or even dying after dropping treatment. Rep. Bob Goodlatte (R., Va.), chairman of the House Judiciary Committee, wants the ads to include a warning that patients should talk with their doctors before adjusting medication.
“Have you or a loved one been prescribed the blood thinner Xarelto as a treatment for reducing the risk of stroke?” one such advertisement begins, before detailing possible harms from theJohnson & Johnson drug and the prospect of compensation. “Remember, these drugs are linked to serious and potentially fatal health problems, including serious and sometimes fatal internal bleeding,” the spot concludes. “Call for more information and a free case review.”
J&J referred questions to John Beisner, who heads the mass-torts group at Skadden, Arps, Slate, Meagher & Flom LLP and has represented J&J and other drug companies. The ads “really are designed to scare potential claimants,” he said.
Mr. Goodlatte sent letters to state and national attorney bar associations last month calling on them to better regulate the ads. The push follows a recommendation made by the American Medical Association to include disclaimers in the ads not to make medical decisions without consulting a doctor.
The letters point to a recent review of safety reports to the Food and Drug Administration, conducted by J&J’s Janssen Pharmaceuticals business, that identified 28 cases of strokes and other serious side effects, including two deaths, of patients who health-care professionals say stopped using Xarelto after watching TV ads.
American Bar Association President Linda Klein said in a response to Mr. Goodlatte that while it is unfortunate if anyone suffered ill consequences by misunderstanding the ads, attorneys have a First Amendment right to advertise and the public benefits from knowing if drugs are potentially harmful.
Backers of the ads say the pushback is the latest attempt at tort reform by corporate interests and that lawsuits uncover dangers that drugmakers try to play down or hide from the public. They point to major civil settlements, such as Merck & Co. agreeing in 2007 to pay $4.85 billion over its pain medication Vioxx, and Takeda Pharmaceutical Co. agreeing to a $2.4 billion settlement in 2015 over claims that diabetes drug Actos allegedly caused cancer.
“I can assure you, lawyers have saved a hell of a lot more lives than they’re taking with these ads,” said Matt Daniel, a mass tort lawyer in Texas whose firm spends close to $20 million a year on TV advertising.
A TV ad seeks plaintiffs for mass-tort cases.
Xarelto was the drug most targeted by mass-tort TV lawyer ads in the U.S. last year, according to an analysis by data-analytics firm X Ante of data from Kantar Media CMAG. Lawyers spent an estimated $37 million on 128,800 national television ads related to Xarelto, Kantar data shows. That’s compared with an estimated $93 million J&J spent to advertise the drug in 31,370 TV spots. Local cable ads not captured by the data could boost the attorney spending, Kantar said.
The competing advertisements face different levels of scrutiny.
All drug-company advertisements are subject to FDA rules, including a requirement ads disclose a drug’s risk of side effects, and the agency can stop broadcast of an ad and seek changes if it doesn’t follow regulations. By contrast, the lawyer ads must conform to attorney ethics rules mandated by state bar associations requiring marketing to be honest and not fraudulent.
While the ads technically fall under Federal Trade Commission jurisdiction, the agency has never pursued an investigation or action against mass tort attorney ads, said Mary Engle, the FTC’s director of ad practices. “We have to target our resources,” she said.
Blood thinner Xarelto was the drug most targeted by mass-tort TV lawyer ads in the U.S. last year, according to an analysis by X Ante of data from Kantar Media CMAG.PHOTO: JANSSEN PHARMACEUTICALS
Elizabeth Tippett, a law professor at the University of Oregon who has spent several years researching the potential consumer harms of mass tort ads, said she has found no public ethics complaints brought by state bar associations over the ads since a 1985 U.S. Supreme Court decision involving drug-injury ads.
Critics say the lack of oversight has resulted in misleading commercials that raise consumer-safety concerns, an assertion plaintiffs’ lawyers dispute.
“If people were dying as a result of seeing legal ads, I would have heard about this a long, long time ago,” said Bob Goldwater, a mass tort lawyer in Phoenix who spends upward of $25 million a year on TV ads.
J&J faces 16,900 lawsuits in the U.S. brought by plaintiffs claiming Xarelto caused serious injury or death. So far, none have resulted in major payouts, though several bellwether trials are scheduled this spring as part of a nationwide consolidation of the suits.
Xarelto, approved in 2011, belongs to a new generation of blood thinners aiming to better balance keeping blood thin enough to avoid clotting but sufficiently thick to prevent bleeding episodes. It notched $2.3 billion in U.S. sales last year and helped J&J offset sales lost when older drugs faced generic competition. In 2015, 7.4 million prescriptions for Xarelto were dispensed in the U.S., according to the latest figures from QuintilesIMS.
Lawyers and others who follow the industry say that ads for any particular drug or device typically spike following FDA alerts about a new side effect, newly released medical research or first-mover lawsuits.
“Our clients don’t read the Journal of Medicine,” said Mr. Daniel. “They’re sitting at home on their couch feeling miserable. The only effective way to reach out is through TV ads.”