NJ Jury Awards $15M in Ethicon Pelvic Mesh Verdict

Ethicon, Inc.’s Gynecare Prolift mesh

Ethicon, Inc.’s Gynecare Prolift mesh

 A Bergen County, NJ, jury awarded $15 million to a New Jersey woman who sued Johnson & Johnson after receiving a defective pelvic mesh implant in 2008 that left her in chronic pain

The jury found that one of the two Prolift pelvic mesh devices that plaintiff Elizabeth Hrymoc, of South River, NJ, received in 2008, was defective. It ruled that Ethicon, the Johnson & Johnson subsidiary that designed the product, failed to adequately warn the woman about the severe chronic pain she suffered.

The jury awarded Hrymoc $4 million for pain and suffering and $1 million for loss of conjugal affection, and assessed $10 million in punitive damages against Johnson & Johnson.

Thursday’s verdict is the second in a bellwether pelvic mesh case in New Jersey. It follows another for $11 million that was awarded in 2014. That verdict was later upheld by the Appellate Division, and the Supreme Court declined to take up the case.

The verdict came after nearly three weeks of argument and testimony in just the second pelvic mesh-related lawsuit to go to trial in New Jersey out of nearly 9,000 that are pending.

During opening arguments, plaintiffs’ attorney Adam Slater of Mazie, Slater, Katz & Freeman in Roseland, N.J., told the jury that the mesh used in the devices was defectively designed because it caused the mesh “sling” portion of the device to tighten and create tension in the pelvic area and that the mesh can harden and cause erosion.

For more, click NorthJersey.com.

Federal Mass Tort Docket Created for National Prescription Opioid Litigation

The U.S. Judicial Panel on Multidistrict Litigation consolidated more than 100 lawsuits filed by counties, cities and other parties against opioid manufacturer and distributors into the “National Prescription Opiate Litigation MDL No. 2804 earlier today.

The JPML assigned US District Judge Daniel Polster in the Northern District of Ohio to supervise the litigation. While the manufacturers had argued for consolidation in corporate defense friendly New York, and various distributors supported consolidation in West Virginia. The location of this MDL in Ohio, which has been one of the hardest hit states by the “opioid crisis” may have far-reaching implications toward the management and the final resolution of the onslaught of opioid claims.

The JPML said, “We find that the actions in this litigation involve common questions of fact, and that centralization in the Northern District of Ohio will serve the convenience of the parties and witnesses and promote the just and efficient conduct of the litigation.”

Defendants include AmerisourceBergen Drug Corp., AmerisourceBergen Corp., McKesson Corp., Cardinal Health, Inc., and Cardinal Health subsidiary The Harvard Drug Group, L.L.C

Plaintiffs include cities, counties, and states that allege that: (1) manufacturers of
prescription opioid medications overstated the benefits and downplayed the risks of the use of their opioids and aggressively marketed (directly and through key opinion leaders) these drugs to physicians, and/or (2) distributors failed to monitor, detect, investigate, refuse and report suspicious orders of prescription opiates.

All the actions involve common factual questions about the manufacturing and distributor defendants’ knowledge of and conduct regarding the alleged diversion of these prescription opiates, as well as the manufacturers’ alleged improper marketing of such drugs. Both manufacturers and distributors are under an obligation under the Controlled Substances Act and similar state laws to prevent diversion of
opiates and other controlled substances into illicit channels.

Plaintiffs assert that defendants have failed to adhere to those standards, which caused the diversion of opiates into their communities. Plaintiffs bring claims for violation of RICO statutes, consumer protection laws, state analogues to the Controlled Substances Act, as well as common law claims such as public nuisance, negligence, negligent misrepresentation, fraud and unjust enrichment.

The text of the transfer order is available at http://www.jpml.uscourts.gov/sites/jpml/files/MDL-2804-Initial-Transfer-11-17.pdf

Jury orders Bayer, J&J to pay $29 million in Xarelto lawsuit

Xarelto A Philadelphia state court jury on Tuesday ordered Bayer AG and Johnson & Johnson to pay $27.8 million to an Indiana couple over the drugmakers’ failure to warn of internal bleeding risks by its blockbuster drug Xarelto.

The verdict marks the first trial loss in litigation over Xarelto. Bayer and J&J have won three previous cases in federal court.

For the Reuters article, click here.

11th Circuit Upholds $6.7 Million Transvaginal Mesh Mass Tort Verdict

law news, legal news, verdict, settlement

Pelvic mesh has been found to cause serious and permanent internal damage, significant pain, urinary incontinence, and repeated cases of pelvic organ prolapse.

The 11th US Circuit Court of Appeals upheld a $6.7 million award to a woman who experienced severe complications after having Boston Scientific transvaginal mesh implanted in her in 2008.

The case is one of 8,603 mass tort  actions consolidated before US District Judge Joseph R. Goodwin in MDL  2326, IN RE: Boston Scientific Corp. Pelvic Repair System Products Liability Litigation, in the Southern District of West Virginia.

Amal Eghnayem is one of four plaintiffs whose cases were consolidated for trial. After eight days of trial in 2014, the jury awarded $6,722,222 in damages to Eghnayem, $6,533,333 to Mania Nuñez, $6,766,666 to Margarita Dotres, and $6,722,222 to
Juana Betancourt. See Docket Nos. 1:14-cv-24061-JRG and 1:14-cv-24064-JRG.

Appeal fails

Boston Scientific chose to challenge Eghnayem’s verdict, and lost on all of its claims.

The case involved the Pinnacle Pelvic Floor Repair Kit, a transvaginal mesh prescription medical device manufactured and sold by Boston Scientific. After it was inserted, Eghnayem began to experience bleeding and pain during intercourse, incontinence, and pelvic pain and pressure. The mesh had exposed through her flesh and she had to have two corrective surgeries, which left her with diminished sensitivity.

She charged that the Pinnacle mesh was defectively designed and that Boston Scientific failed to warn about its dangers.

On appeal, Boston Scientific said that the trial court erroneously consolidated the four lawsuits arguing that individual issues predominated and the consolidation resulted in prejudice to the company. It also argued that the District Court improperly excluded evidence concerning the Pinnacle’s clearance through the U.S. Food & Drug Administration’s short-cut 510(K) process.

The appeals court shot down both arguments.

“Although each plaintiff’s proof of causation was necessarily different, generally differences in causation are not enough, standing alone, to bar consolidation of products liability claims,” the appeals court said. “And any danger of prejudice arising from the consolidation was reduced in this case, because the district court explained the consolidated nature of the trial to the jury and expressly instructed it to consider each plaintiff’s claims separately.”

The appeals court also ruled that the trial court had acted within its discretion in excluding evidence about the Pinnacle’s 501(k) clearance, which allows a medical device to come to market without undergoing clinical trials to prove that it is safe and effective.

“BSC claims that the evidence is relevant because the plaintiffs based much of their case on the theory that BSC didn’t perform sufficient safety testing,” the appeals court said. “But these points simply beg the question; because 510(k) is not a safety regulation, approval under that process cannot show that BSC performed sufficient testing or complied with applicable safety regulations.”

In a recent Form 10-Q filing with the U.S. Securities and Exchange Commission, Boston Scientific said that it had been named a defendant in more than 48,000 product liability claims involving its transvaginal mesh devices in the US, Canada and UK.

“As of July 26, 2017, we have entered into master settlement agreements in principle or are in final stages of entering one with certain plaintiffs’ counsel to resolve an aggregate of approximately 38,000 cases and claims. These master settlement agreements provide that the settlement and distribution of settlement funds to participating claimants are conditional upon, among other things, achieving minimum required claimant participation thresholds,” the filing says. “Of the approximately 38,000 cases and claims, approximately 14,500 have met the conditions of the settlement and are final. All settlement agreements were entered into solely by way of compromise and without any admission or concession by us of any liability or wrongdoing.”

Jury Awards $247 Million in DePuy Pinnacle Hip Mass Tort Trial

A federal jury in Dallas, TX, awarded six plaintiffs who were harmed by the DePuy Orthopaedics Inc. Pinnacle hip a total of $247.49 million in damages.

It was the latest bellwether trial, or test case, in In Re: DePuy Orthopaedics, Inc., Pinnacle Hip Implant Products Liability Litigation, MDL 2244. There are 9,226 cases before US District Judge James Edgar Kinkeade in the Northern District of Texas.

The plaintiffs, all from New York, are Ramon Alicea, Uriel Barzel, Karen Kirschner, Hazel Miura, Michael A. Stevens and Eugene Stevens Jr. The jury awarded each plaintiff between $9.3 million and $20.63 million in past and future medical expenses and pain and suffering. It then added $28 million in punitive damages for each plaintiff against defendants DePuy and parent company Johnson & Johnson.

Metal-On-Metal Design

The plaintiffs were each implanted with a Pinnacle Ultamet metal-on-metal design hip prosthesis. Each proved that the hip failed prematurely and shed metal that caused pain, inflammation, and damage to soft tissue and bone tissue and required surgical replacement.

The jury found DePuy and Johnson liable for design defect, negligent design, inadequate warning, manufacturing defect, negligent manufacture, negligent misrepresentation, fraudulent concealment to both plaintiffs and surgeons and deceptive business practices.

It also held Johnson & Johnson liable for negligent undertaking as to each plaintiff, aiding and abetting tortious conduct by DePuy and giving substantial assistance or encouragement to DePuy for negligent manufacture.

DePuy stopped selling the Pinnacle hip replacement in 2013. It had been approved through the FDA’s short-cut 510(k) approval process. The 510(k) process allows manufacturers to get FDA approval to sell a medical product if it is “substantially equivalent” to a product that the FDA has already approved.

Due to increasing safety concerns, the FDA announced that it would require all metal on metal hip replacements to undergo extensive testing and studies to prove that it was safe for patients. DePuy cited the FDA’s decision as one of the reasons it is stopping sales.

The plaintiff’s counsel is Mark W. Lanier of the Lanier Law Firm in Houston. The Nov. 16 verdict was the third in favor of the plaintiffs:

  • In March 2016 a federal jury awarded five Texas plaintiffs a $502 million verdict that was reduced to $150 million.
  • In December 2016 a jury awarded six California plaintiffs a $1 billion verdict that was reduced to $542 million.
  • In 2014 a jury returned a defense verdict.


Plaintiffs Seek Mass Tort Court for Diabetes Drug Onglyza

Plaintiffs in 44 lawsuits pending in 24 different judicial districts have requested that the Judicial Panel on Multidistrict Litigation create a new mass tort docket in the Northern District of California for cases involving the diabetes drug Onglyza.

The motion by attorneys Timothy M. Clark and Lauren Welling of Sanders Phillips Grossman, LLC in Irvine, CA, requests that the cases against defendants Bristol-Myers Squibb and AstraZeneca be consolidated in new MDL No. 2809. The JPML meets to decide on November 30.

There are 22 MDLs pending in the Northern District spread among the 20
District Judges. National counsel for the defendants are based in San Francisco. More than half of the plaintiffs are represented by counsel from California. One of the three defendants named in these suits is based in San Francisco.

Another factor in favor of the Northern District of California is its proximity to the only other consolidated proceeding related to Onglyza and the injuries asserted here. Indeed, In re: Onglyza Product Cases, JCCP 4909 pending in front of Hon. Curtis E.A. Karnow in San Francisco.

Risk of heart failure

Onglyza (Saxagliptin) was introduced to the United States market on July 31, 2009, and Kombiglyze was introduced on November 5, 2010. The defendants developed their Onglyza drugs to market and sell them as treatments for type 2 diabetes. However, the use of Onglyza carries a significantly increased risk of causing heart failure, congestive heart failure, cardiac failure, and death from heart failure.

Type 2 diabetics have an increased risk of cardiovascular disease, which is the leading cause of morbidity and mortality in the patient population. With full knowledge of the susceptibility of type 2 diabetics to cardiovascular-related adverse events, the defendants allegedly developed Onglyza and Kombiglyze XR to market and sell them to type 2 diabetics to allegedly lower adverse complications associated with type 2 diabetes.

Saxagliptin works by inhibiting incretins, which enables the stimulation of insulin to continue longer than what naturally occurs after meals.

At no time during the development of its Saxagliptin drugs did the defendants perform adequate studies to determine if their drug, and its drastic alterations of the natural incretin hormone cycle, may cause increased risks of cardiovascular-related adverse

In December 2008, the FDA issued a memorandum — entitled Final Guidance for
Industry, Diabetes Mellitus: Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes. It stated that applicants of new anti-diabetic medications for the treatment of type 2 diabetes should demonstrate their products are not associated with an unacceptable increase in cardiovascular risk.

After the defendants began selling and making substantial profits off their drugs for five years, they finally conducted a clinical trial for Saxagliptin. It found that  Saxagliptin users had a statistically significant increased risk of being hospitalized due to heart failure.

An FDA committee called on the defendants to add a heart failure warning to the drug in 2015, but no label change occurred until the FDA required a new warning to the drug label on April 5, 2016.

First Xarelto Trial Underway in Philadelphia Mass Tort Program

XareltoA trial over the blood thinner Xarelto, made by Janssen Pharmaceuticals Inc. and Bayer Pharma AG, is underway in the Philadelphia Court of Common Pleas, where more than 1,500 Xarelto bleeding claims have been centralized in a mass tort program.

Lynn Hartman of Indiana charges she suffered serious gastrointestinal bleeding after using the novel anticoagulant for a little over a year.  (Case No. 160503416)

During the opening statements, the plaintiff attorney Gary Douglas of Douglas & London asserted that the drug’s manufacturers manipulated clinical trial data and downplayed important safety information to make Xarelto appear safer and more effective than competing blood thinners, such as warfarin.

“Our firm is representing a number of plaintiffs who are pursuing similar Xarelto claims. We will be watching the Philadelphia trial closely for any developments that could impact our clients’ cases,” says Sandy A. Liebhard, a partner at Bernstein Liebhard LLP.

Xarelto Bleeding Allegations

Approved by the U.S. Food & Drug Administration in October 2011, Xarelto is jointly marketed by Bayer and Johnson & Johnson’s Janssen Pharmaceuticals subsidiary. The blood thinner is currently indicated for the prevention of strokes in people with atrial fibrillation; the treatment of patients suffering from deep vein thrombosis and pulmonary embolism; and the prevention of deep vein thrombosis in people undergoing hip or knee implant surgery.

Like other new-generation blood thinners, Xarelto has been touted as an improvement over decades-old warfarin. However, internal bleeding caused by warfarin can be stopped by the administration of vitamin K. There is currently no approved agent to reverse Xarelto bleeding.

Johnson & Johnson’s most recent earnings statement indicates that more than 21,000 Xarelto lawsuits have been filed in courts throughout the United States.

Plaintiffs involved in this litigation claim that the drug’s manufacturers downplayed the potential for Xarelto bleeding and wrongly promoted the drug as a superior alternative to warfarin. In addition to noting the lack of a reversal agent for Xarelto bleeding, plaintiffs take issue with the medication’s one-size-fits-all dosing regimen and dispute the defendants’ assertions that there is no need to subject Xarelto patients to routine blood monitoring.

The majority of Xarelto lawsuits are currently pending in a federal multidistrict litigation underway in the U.S. District Court, Eastern District of Louisiana, where three trials have already concluded with defense verdicts. There are 18,526 lawsuits pending before US District Judge Eldon E. Fallon in MDL 2592, IN RE: Xarelto (Rivaroxaban) Products Liability Litigation. Additional Xarelto bleeding claims have been filed in DelawareCalifornia and Missouri state courts.

Xarelto patients who allegedly experienced bleeding-related complications may be entitled to compensation for their medical bills, lost wages, pain and suffering, and more.

Defense Verdict in First Mass Tort Trial Over IVC Filters

Cook Platinum Celect IVC Filter

This is an update of our “First Trial Underway in Cook IVC Filter Mass Tort Case” published on 

A federal jury in Evansville returned a defense verdict in favor of Cook Medical, the Bloomington-based maker of medical devices, following a three-week trial over its blood-clot filters, which thousands of patients have complained are defective.

Doctors implant about 200,000 blood clot filters nationwide each year. The market for IVC filters is $435 million, according to market research firm Axis Research Mind.

The plaintiff’s case is underway in the first of three mass tort trials on whether Cook Medical Inc. is liable for selling a defective IVC filter that migrated through a blood vessel and punctured the plaintiff’s intestine.

“Defendants know its Cook filter was defective and knew that defect was attributable to the design’s failure to withstand the normal anatomical and physiological loading cycles,” the complaint states. The case is Hill v. Cook Medical, Inc., et al, 1:14-cv-6016.

It is the first bellwether, or test case, of 2,897 cases before US District Chief Judge Richard L. Young of the Southern District of Indiana in MDL 2570, IN RE: Cook Medical, Inc., IVC Filters Marketing, Sales Practices and Products Liability Litigation. 

Cook Medical Inc. of Bloomington, Indiana, won FDA approval for its “removable” Celect blood clot filter in 2003 using the 510(k) shortcut procedure, as opposed to the more rigorous premarket approval (PMA) process. FDA approval through Sec. 510(k) of the Medical Device Amendments of 1976 merely requires that a new device is “substantially equivalent” to a predicate device — but not a review of its safety or efficacy as would happen in a premarket approval application (PMA).

Perforated intestine

Plaintiff Elizabeth Jane Hill of Dunnellon, Florida, had a removable Cook Celect filter implanted in her vena cava, a large vein carrying blood into the heart, before back surgery on Nov. 17, 2010. By March 23, 2011, doctors tried unsuccessfully to remove the filter. Hill developed severe gastrointestinal symptoms, fatigue, diarrhea, vomiting and abdominal pain.

She underwent an endoscopy that revealed the filter had perforated through her inferior vena cava and into her small intestine. She went to Penn State Hershey Medical Center, a specialized hospital where the filter was finally taken out. As a result, the vena cava was permanently narrowed at the removal site.

The FDA recommends removing temporary filters between 29 and 54 days after implantation. However, studies have found that 43 percent of Celect filters perforate the vena cava within two months.

Hill charges that Cook failed to tell doctors that the filter cannot be removed and that it poses a risk of migrating, perforating and damaging the major blood vessel.

“The Cook filter had a safety profile that was not as good as or better than its predicate device,” the complaint states. “Defendant’s statements regarding the safety of the filter were false and misleading yet defendants continued to promote the Cook filter as safe an effective even though the data available studies, literature and clinical trial did not support long or short term safety and efficacy.”

Class Action Bill Will Harm Consumers and Benefit Large Corporations

By Joseph Rainsbury, an appellate attorney in Roanoke, VA

Congressman Bob Goodlatte is the chair of the House Judiciary Committee. Earlier this year, he introduced a bill (H.R. 985) that, if passed, will deprive consumers of a valuable tool for combating corporate misconduct — the modern class action.

Goodlatte’s website says that his “Fairness in Class-Action Litigation Act of 2017” will “protect innocent individuals and small businesses who have become the targets of frivolous suits.” In reality, the bill will protect large corporations from meritorious lawsuits brought by consumers whom they have cheated and injured.

Class actions allow plaintiffs with similar claims to pool their litigation efforts against a single defendant. Suppose your cable company, without your permission, adds a $5 channel to your bill every month. It makes no economic sense for you to sue the cable company. Your attorney’s fees would dwarf any recovery. But if the cable company is doing the same thing to a million other customers, and you can join with those other customers in a single action, a lawsuit becomes economically viable.

Keeping large corporations honest

The real value of class actions, however, is not in the resulting recovery — which often is only a few dollars per customer. Rather, their real value is that the threat of such actions keeps large corporations honest. It deters them from nickeling and diming us to death.

Congressman Goodlatte’s bill, however, would kill federal class actions as we know them. Here’s how. For a class-action to proceed in federal court, the judge has to “certify” the class, which means he decides whether the plaintiffs’ claims have enough in common to justify their proceeding as a class.

Up until now, plaintiffs seeking class certification merely had to show “commonality” in one aspect of their case (e.g., they are all complaining about the same corporate misconduct). Goodlatte’s bill changes that. It requires that plaintiffs show commonality in all aspects of their cases, including damages. In opaque legalese, buried in the middle of the bill, it requires that the “entirety of the cause of action” satisfy the commonality requirement. Yet it is virtually never the case that class members have identical damages.

In the example above, the cable company might overcharge different consumers by different amounts, for different channels, or for different lengths of time. And where the class action involves corporate practices causing personal injuries, each class member is always going to be unique in terms of medical expenses, lost wages, pain, etc. Requiring commonality in all aspects of the class members’ cases would effectively destroy federal class actions as a way to police the misconduct of large corporations.

Not a reform bill

It is distressing that this has been proposed by Congressman Goodlatte. His Class Action Fairness Act of 2005 provided welcome reforms to many of the unsavory practices of class-action plaintiffs’ lawyers. By conferring federal jurisdiction over class actions with aggregate claims of over $5 million, the 2005 Act allowed corporate defendants to escape notorious state-court “judicial hellholes” (such as Madison County, Illinois) where corrupt state judges systematically favored equally corrupt plaintiff’s lawyers. It allowed such corporations to get a fair hearing in federal court.

It is distressing that this has been proposed by Congressman Goodlatte. His Class Action Fairness Act of 2005 provided welcome reforms to many of the unsavory practices of class-action plaintiffs’ lawyers. By conferring federal jurisdiction over class actions with aggregate claims of over $5 million, the 2005 Act allowed corporate defendants to escape notorious state-court “judicial hellholes” (such as Madison County, Illinois) where corrupt state judges systematically favored equally corrupt plaintiff’s lawyers. It allowed such corporations to get a fair hearing in federal court.

Goodlatte’s current bill, by contrast, is not a reform bill. It throws the baby out with the bathwater. Are there problems and abuses in modern class-action litigation? Sure. But the correct approach is to make targeted repairs, not to junk the whole system. Contrary to the claims on Goodlatte’s website, the “Fairness in Class-Action Litigation Act of 2017” will harm, not protect, individuals.

Large corporations, no longer fearing class-action suits, will go back to chiseling consumers and introducing harmful products into the marketplace. So if the “Fairness in Class-Action Litigation Act Of 2017” passes, and the president signs it into law, you will know who to thank when you see that extra five dollar charge on your cable bill, when your loved one suffers a bad reaction to a mass-marketed drug, or when your airbag fails to deploy during an accident: your Congressman, Bob Goodlatte.

MDL Panel to Decide on Mass Torts Docket Nov. 30 for Equifax Litigation

The Judicial Panel on Multidistrict Litigation will decide on Nov. 30 whether to create a new MDL docket for the dozens of class action lawsuits filed against Equifax for allowing a massive data breach September 7, 2017.

Equifax joined plaintiffs in requesting the new MDL. The breach compromised the names, social security numbers, birth dates and credit card information of 143 million people. This information can be used to steal a person’s identity and commit fraud.

“The No. 1 crime in America is identity theft. It has surpassed drug trafficking,” said Micah Adkins of The Adkins Firm, speaking at the recent Mass Torts Made Perfect conference. “You’re much more likely to be a victim of identity theft than an auto accident.”

$200 million settlement is plausible

More than 100 consumer lawsuits charge that the company violated the Fair Credit Reporting Act (FCRA), which requires Equifax to “maintain reasonable procedures” to avoid identity theft. It allows for individual statutory damages of up to $1,000 per person, punitive damages, attorney fees and costs.

A global settlement of about $200 million is plausible, attorney Nathan Taylor told the Insurance Journal, based on the $115 million that Anthem Inc. health insurance company agreed to pay in June 2017 over hacking in 2015 that compromised about 79 million people’s personal information.

The motion was filed by Norman Siegel of Stueve, Siegal Hanson LLP of Kansas City, MO, John A. Yanchunis of Morgan & Morgan of Tampa, FL and Roy E. Barnes of The Barnes Law Group LLC of Marietta, GA.

They seek to consolidate 22 cases and any tag-along cases filed in US District Court in Georgia. Equifax is headquartered in Atlanta. Among the federal judges recommended by the motion are:

  • William S. Duffey, who is hearing one of the Equifax cases and who has overseen MDL litigation.
  • Thomas W. Thrash, who oversaw the Home Depot Inc. security breach. The company last year reached a $19.5 million settlement with consumers over a hack that exposed payment information of 56 million customers.
  • Amy M. Totenberg, who is presiding over data breach litigation involving Arby’s Restaurant. More than 350,000 credit and debit card accounts may have been impacted by a data breach in February 2017.
  • Richard W. Story, who is overseeing Ethicon Physiomesh hernia mesh products liability litigation in MDL No. 2782.

Equifax has a history of data breaches, including its W-2 Express website, which suffered an attack in May 2016 that resulted in the leak of 430,000 names, addresses, social security numbers and other personal information of retail firm Kroger.

Equifax reported to the New Hampshire attorney general of a breach that between April 2013 and January 2014, an “IP address operator was able to obtain the credit reports using sufficient personal information to meet Equifax’s identity verification process.”