Ethicon ad 2019

Mesh Medical Device News Desk, September 13, 2019 ~ After a  two-week break, the state of California will resume its defective marketing case against healthcare giant, Johnson & Johnson. This is the second state to take J&J to trial over a trail of mesh-related injuries caused by its pelvic mesh products. Two other states are planning similar action. 

Healthcare giant, Johnson & Johnson, has asked the judge overseeing a $1 billion deceptive marketing trial to bring it to an end.

J&J filed a motion for judgment before the case went on an August 29 break. On that date, California Superior Court Judge Eddie Sturgeon said he will have an answer soon.

The case is set to resume in San Diego Monday, September 16.

The state of California sued Johnson & Johnson and its Ethicon medical device division alleging the company used deceptive marketing to induce nearly 50,000 women in the state to use their pelvic mesh implants, polypropylene mesh devices that are supposed to treat incontinence and prolapse.

(California v. Johnson & Johnson, case number 37-2016-00017229-CU-MC-CTL is being heard in the Superior Court of the State of California, County of San Diego).

Mesh News Desk is monitoring the proceedings via Courtroom View Network. The case is being heard before Judge Sturgeon with no jury present. It was expected to take about two months.

California claims J&J violated its Unfair Competition Law or UCL, which protects consumers against unlawful, fraudulent, and misleading advertising. This is different from the 107,000 product liability claims against seven mesh makers filed by injured women and consolidated in multidistrict litigation in West Virginia.

Women and their doctors were sold on the fraudulent practice, says the state, through sales representatives, brochures, and the IFU or Instructions for Use that come inside a medical device package.

Thousands of women have been left suffering with chronic pain and infection, mesh erosion and shrinkage, nerve damage, autoimmune disorders, and a return of their incontinence and prolapse.

Repeated surgeries to remove the permanent mesh implants are frequently unsuccessful and because they are blind procedures, often do more damage in the delicate area.

IFUs in the Garbage

Jason Zarrow, representing J&J

Representing Johnson & Johnson in the morning of August 29 was attorney, Jason Zarrow, who argued that the state had failed to make its case by failing to show that J&J intended to deceive or knew its marketing would deceive.

“Ethicon has a rigorous process to ensure health claims about its devices were substantiated, including the copy review process, the labeling committee. You heard from Dr Hinoul, you’ve also heard from Ethicon’s medical director when they approved the IFU they concluded they were adequate and complete for the surgeons who would use them.”

The IFU’s made their way into the garbage can, recounted Zarrow of earlier testimony in the trial that began Monday, July 15.  So IFUs are not actionable, he argued. They are a regulatory item.

Judge Sturgeon: “Must a surgeon read an IFU for it to be actionable?”

Zarrow: “A prudent surgeon bases his decision on medical training, literature, clinical experience, mentors and conferences. Ethicon did not deceptively omit the risk of complications. “

Minimal risks does not mean no risks, he added. All medical devices have risks but, quoting medical director Piet Hinoul, Zarrow repeated that the risk of severe complications is less than 1%.

Referring to the U.S. Food and Drug Administration (FDA), Zarrow argued “The people are asking this court to punish Ethicon for what the FDA said was sufficient enough to address potential risks,” said Zarrow.

Appearing during this trial was Dr. Adriane Fugh-Berman, a professor of Pharmaceutical and medical practices with Georgetown University. Testifying for the state, she told the court that industry alters study findings, either adding or editing out information to suit the goal of sales.

California Deputy AG Devin Mauney

Deputy AG Devin Mauney told the court, the false, misleading message was tightly controlled by J&J whether through the sales reps, brochures or IFUs. While women were told through their doctors that the mesh was safe and effective and the procedure was minimally invasive, J&J knew the full range of adverse events and complications that can be long-term and severe, but failed to disclose them.

J&J’s marketing materials omit the chronic foreign body reaction, shrinkage, contraction, infection biofilm, inflammation, and the fact that the mesh is not inert, he said.

J&J’s Prolift pelvic repair system

 

Judge Questions 

Judge Sturgeon had some questions – wouldn’t a surgeon in California understand that a listed complication of “pain” might also include chronic pain?

Mauney said risks were not known to practicing gynecologists until it was on the market. Dr. Piet Hinoul (Global Head of Medical Affairs of J&J) also testified chronic pain and acute pain have different treatment implications, which is not in the marketing materials and might affect a patient’s decision.

Half-truths are misleading, Mauney said.  “When you leave out key risks its misleading,” he said calling the actions part of the core deception.

Judge: “So a company brochure must list every possible risks?

Mauney:  “Not everyone but those that the consumer would want to know.

Judge: “Is there a number?

Mauney:  “The list Dr. Hinoul testified to what the company knew those would certainly be on that list.”

Judge: “Must a surgeon read the IFU? There’s’ been substantial testimony when the IFU comes out of the package they are thrown away.”

Mauney: “The law prohibits misleading materials in a product package, defendants are violating the UCL.  J&J, by referring doctors to the IFU, they are telling doctors you should read it and rely on this IFU even though its incomplete information.”

There was some question as to how many brochures were sent to California that contained the allegedly misleading message.

While J&J argues that many made their way to the trash, Mauney argued J&J can’t prove that and the court should assume they were distributed because that is the sales reps job, otherwise, “it just doesn’t make sense.”


Calculating Damages

The number of false messages disseminated is important because the state argues that the various means of messaging should each be considered a violation and fined at $2,500 per, including printed materials and IFU’s contained in every pelvic mesh kit.

J&J, a $71 billion annual company could face a potential fine of nearly $1 billion.

California is just one of four states to sue J&J over the distribution of its pelvic mesh products. The California consumer case was filed by former AG Kamala Harris in May of 2016.

Last April, on the eve of trial, J&J settled with the Washington State AG’s office and the resulting $10 million will be made available to Washington women injured by J&J’s pelvic mesh. Women who qualify should contact the AG’s office.

Kentucky and Mississippi have filed similar suits and J&J has reportedly signed tolling agreements with 47 state and the District of Columbia, opening the door to more lawsuits.

Estimates are Ethicon sold about 800,000 pelvic mesh devices in the U.S. between 2008 and 2014 and more than 2 million women have been implanted worldwide where J&J faces approximately 50,000 defective product lawsuits.

Pelvic organ prolapse (POP) meshes have been reclassified by the FDA as high risk and largely removed from the market.  Stress Urinary Incontinence (SUI) meshes remain on the market and J&J still advertises its family of TVT (tension-free vaginal tape) devices.  ###

LEARN MORE

California v. Ethicon Complaint, filed May 24, 2016

MND, Washington State Settles with J&J,  April 23, 2019

Washington State Complaint, May 24, 2016 here

Motion for Partial Summary Judgment, October 26, 2018 here

MND, Kentucky AG Files Deceptive Marketing Lawsuit Against Johnson & Johnson Over Surgical Mesh, August 16, 2016, here