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Johnson & Johnson settles Washington AG’s pelvic mesh suit for $10m
Apr 23, 2019 | Massdevice
By Fink Densford
Johnson & Johnson has agreed to pay $9.9 million to settle a suit it faced from Washington Attorney General Bob Ferguson over a failure to include serious risks in instructions and marketing materials for surgical mesh devices, according to a Washington State Office of the Attorney General release. -
J&J to pay $9.9M to settle Washington state surgical mesh case
Apr 23, 2019 | Beckers Hospital Review
By Alia Paavola
Just before a trial was set to begin April 22 in Seattle, Johnson & Johnson agreed to pay $9.9 million to resolve a lawsuit claiming the company failed to warn patients about the risks of its pelvic mesh devices. -
Johnson & Johnson Settles 9.9-mln-USD Litigation With Washington State Over Surgical Devices
Apr 23, 2019 | Urdu Point (also in Xinhua)
By Zeeshan Aziz
U.S. leading medical goods manufacturer Johnson & Johnson (J&J) has agreed to pay 9.9 million U.S. dollars to settle litigation with Washington State, the state's Attorney General Bob Ferguson said. -
FDA Orders All Transvaginal Mesh Products Off the Market
Apr 23, 2019 | The Legal Examiner
By John Bair
Transvaginal mesh litigation ranks as one of the largest mass tort cases in U.S. history. Trial lawyers have taken mesh manufacturers to task after 100,000 women suffered injuries from having these defective mesh products surgically implanted to repair pelvic organ prolapse. Last week, a long-overdue move by the FDA put an end to all future surgeries using the products. -
After thousands of lawsuits, FDA bans mesh used in pelvic prolapse procedures
Apr 23, 2019 | JD Supra
By Patrick Malone
After years of patient complaints about injuries and tens of thousands of lawsuits, the federal Food and Drug Administration yanked from the market a surgical mesh widely used to repair pelvic conditions in women. -
Modi govt writes to J&J for details on surgical pelvic mesh after US ban
Apr 23, 2019 | The Print
By Himani Chanda
The Modi government has written to American pharmaceutical giant Johnson & Johnson asking it to furnish details of the number of surgical pelvic meshes it has imported into India in the last three years. -
Pelvic Mesh Judge Isn't Obliged to Probe Allegations of 'Self-Dealing' in Fee Fight—But He Might Dive In
Apr 23, 2019 | Law.com
By Max Mitchell
According to court watchers, allegations that arose recently in the contentious fee dispute should give any judge pause, and may lead Judge Joseph Goodwin, who is overseeing the vast pelvic mesh litigation, to call for further investigation of the claims before he allocates an estimated $550 million in disputed fees.
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Johnson & Johnson settles Washington AG’s pelvic mesh suit for $10m
Apr 23, 2019 | Massdevice
By Fink Densford
Johnson & Johnson (NYSE:JNJ) has agreed to pay $9.9 million to settle a suit it faced from Washington Attorney General Bob Ferguson over a failure to include serious risks in instructions and marketing materials for surgical mesh devices, according to a Washington State Office of the Attorney General release.
Approximately 14,000 women in Washington State have had surgical mesh devices implanted, according to the AG’s report, which estimates that hundreds of those women “have been adversely impacted so far, ranging from having to go back for another procedure, to having their quality of life impacted dramatically.”
The trial over the suit, which was filed by AG Ferguson in May 2016, was slated to begin today, according to the report.
In the suit, AG Ferguson asserted that Johnson & Johnson violated Washington’s Consumer Protection Act by “failing to include several serious, life-altering risks associated with its surgical mesh devices in materials for patients and doctors.”
Women in the state reported experiencing pain, suffering and life-altering complications that Johnson & Johnson allegedly knew were associated with the device, according to the AG report. Complications included chronic pain, pain during sexual intercourse, urinary issues and that the mesh devices were “very difficult and sometimes impossible to remove.”
“Johnson & Johnson’s knowing deception caused Washington women to suffer in deeply personal ways. I’m proud of my team for holding a powerful interest accountable for its egregious conduct — and look forward to providing millions of dollars in relief to assist those who were harmed,” AG Ferguson said in a press release.
The settlement payment of $9.9 million will be used to assist women who received pelvic mesh implants, and comes in addition to any recovery those patients receive in a personal injury lawsuit.
The Washington AG’s Office said that it will announce a formal claims process in the future, but due to privacy protections the Office does not know names of the women implanted with the devices and urged them to reach out to a claims administrator.
In addition to the payment, Johnson & Johnson will be prohibited from making unfair or deceptive statements regarding surgical mesh devices and must disclose any further risks discovered associated with them.
In late 2016, Kentucky joined California and Washington state in suing J&J and its subsidiary Ethicon over its pelvic mesh products, accusing the company of deceptively marketing its treatments for female urinary incontinence and pelvic organ prolapse.
https://www.massdevice.com/johnson-johnson-settles-washington-ags-pelvic-mesh-suit-for-10m/
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J&J to pay $9.9M to settle Washington state surgical mesh case
Apr 23, 2019 | Beckers Hospital Review
By Alia Paavola
Just before a trial was set to begin April 22 in Seattle, Johnson & Johnson agreed to pay $9.9 million to resolve a lawsuit claiming the company failed to warn patients about the risks of its pelvic mesh devices.
The lawsuit, filed by Washington Attorney General Bob Ferguson in 2016, claimed J&J violated the state's Consumer Protection Act by failing to include the serious risks associated with the surgical mesh devices. Mr. Ferguson also alleges that Washington women experienced pain, suffering and life-altering complications that J&J knew about.
"Johnson & Johnson's knowing deception caused Washington women to suffer in deeply personal ways," Mr. Ferguson said. "I'm proud of my team for holding a powerful interest accountable for its egregious conduct — and look forward to providing millions of dollars in relief to assist those who were harmed."
Tens of thousands of patients have sued J&J over the surgical mesh products.
J&J didn't admit any wrongdoing.
https://www.beckershospitalreview.com/pharmacy/j-j-to-pay-9-9m-to-settle-washington-state-surgical-mesh-case.html
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Johnson & Johnson Settles 9.9-mln-USD Litigation With Washington State Over Surgical Devices
Apr 23, 2019 | Urdu Point (also in Xinhua)
By Zeeshan Aziz
U.S. leading medical goods manufacturer Johnson & Johnson (J&J) has agreed to pay 9.9 million U.S. Dollars to settle litigation with WashingtonState, the state's Attorney General Bob Ferguson said.
Ferguson said J&J's decision would avoid a trial, which was originally scheduled for Monday, for its failure to disclose serious risks in the instructions and marketing materials for surgical mesh devices, which were implanted in the bodies of about 14,000 Washington women.
The mesh devices are normally used for urinary problems and pelvic organ prolapse to keep organs from shifting from their normal position.
Ferguson said the women who used the mesh devices have suffered non-life-threatening but chronic and sexual pain as well as urinary issues.
J&J had known some of the most serious risks associated with the use of its mesh devices and the impact of these reactions that would exponentially increase due to the difficulty of removing them once implanted, Ferguson said.
"Johnson & Johnson's knowing deception caused Washington women to suffer in deeply personal ways," he noted.
"I'm proud of my team for holding a powerful interest accountable for its egregious conduct -- and look forward to providing millions of dollars in relief to assist those who were harmed," he added.
Ferguson filed a lawsuit against the American multinational medical devices and pharmaceutical goods manufacturer in 2016. He is also the first state attorney general to sue Johnson & Johnson over surgical mesh devices.
https://www.urdupoint.com/en/world/johnson-johnson-settles-99-mln-usd-litigat-603201.html
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FDA Orders All Transvaginal Mesh Products Off the Market
Apr 23, 2019 | The Legal Examiner
By John Bair
Transvaginal mesh litigation ranks as one of the largest mass tort cases in U.S. history. Trial lawyers have taken mesh manufacturers to task after 100,000 women suffered injuries from having these defective mesh products surgically implanted to repair pelvic organ prolapse. Last week, a long-overdue move by the FDA put an end to all future surgeries using the products.
The FDA ordered the two remaining manufacturers of transvaginal surgical mesh to stop selling and distributing their products. The move comes after Boston Scientific and Coloplast failed to provide evidence of long-term safety that’s required for class III products, which the FDA considers “high risk.”
After reclassifying transvaginal surgical mesh as class III, Boston Scientific and Coloplast were required to submit premarket approval applications for their products and receive approval from the FDA to continue marketing their devices in the U.S. However, their assessments fell short.
“In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair POP,” Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health, said in a press release on April 16. “That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long term.”
The FDA cleared the first mesh device for transvaginal repair of pelvic organ prolapse in 2002, but the agency initially listed it as a class II or “moderate-risk” device. In 2016, the products were reclassified as class III after the FDA began seeing a major increase in problems related to their use for transvaginal repair. Amid the FDA’s warnings of the risks since then, the percentage of women electing to do these surgeries has decreased.
The FDA urges women who have had transvaginal mesh placed for the surgical repair of pelvic organ prolapse to continue with their routine check-ups and care. Patients should notify their health care professionals if they have complications or symptoms, which include persistent vaginal bleeding or discharge, pelvic or groin pain or pain with sex. For more information, visit the FDA’s advisory page.
https://milestone.legalexaminer.com/legal/fda-orders-all-transvaginal-mesh-products-off-the-market/
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After thousands of lawsuits, FDA bans mesh used in pelvic prolapse procedures
Apr 23, 2019 | JD Supra
By Patrick Malone
After years of patient complaints about injuries and tens of thousands of lawsuits, the federal Food and Drug Administration yanked from the market a surgical mesh widely used to repair pelvic conditions in women.
The agency has been slow to act on transvaginal mesh, which has been in use since the 1970s, with surgeons increasing its use in the 1990s. That in turn created an avalanche of complaints from safety advocates and women patients, who said the implant and procedure caused pain, bleeding, and scarring. This was not the surgical innovation, they said, that was supposed to remedy the pelvic tissue collapse that can cause the bladder or reproductive organs to slip out of place, causing pain, constipation and urinary leakage.
The FDA issued a series of increasing warnings about mesh, finally reclassifying it in 2016 as high-risk and ordering its makers to produce medical-scientific evidence about the device’s long-term safety.
Women sought action, instead, through the civil justice system, as the New York Times reported:
Litigation over …. transvaginal mesh … ranks as one of the largest mass tort cases in the nation’s history in terms of claims filed, number of corporate defendants and settlement dollars. Seven medical device manufacturers, including Boston Scientific and Johnson & Johnson, are paying nearly $8 billion to resolve the claims of more than 100,000 women.
In lawsuits and media reports, women told how they had to undergo repeated corrective surgeries because the mesh sometimes shifted out of place, puncturing internal organs or the abdomen wall. If surgeons needed to remove or reposition the mesh, they reported that too often it had melted into a hard-to-extract mess in surrounding tissues.
Women who have the mesh implants may need to take precautions, the Associated Press reported:
The [FDA] said … that women with the pelvic mesh should continue regular checkups. There is no need to have the mesh removed if patients are not having problems or symptoms. The FDA order applies to mesh that is inserted through the vagina with a small incision, not mesh inserted through the abdomen with a larger incision. About 1 in 8 women in the U.S. undergo some form of surgery to treat pelvic collapse problems, according to the FDA.
To be clear, though the mesh now is not allowed by the FDA for the larger and “more injury producing” pelvic prolapse procedures, the implant still can be used in urinary incontinence surgeries. There, small mesh implants have an “unacceptably high complication rate … in the range of 5 to 15 percent,” the newspaper noted, quoting a lawyer who has won big cases against the device makers.
The mesh mess has become part of a growing and infuriating catalog of medical mistreatments of women. Anguished patients recently assailed the FDA for failing to inform and safeguard them from risks with breast implants. The agency has been assailed for allowing on the market the Essure birth control implant — albeit with heavy restrictions — after women reported it caused pain, bleeding, and allergic reactions. The maker withdrew the device.
The FDA also has come under fire for its limp oversight of minimally invasive gynecological surgeries that are supposed to be faster, easier, and more convenient for patients, while causing them less scarring and complications. Instead, research studies have shown the procedures may spread cancers, especially if a tissue grinding device — a so-called morcellator — is used. The FDA has issued sharp warnings about the morcellator but has declined to ban it, and surgeons keep using it. The agency also has cautioned surgeons about using robot devices for mastectomies and other procedures still not FDA cleared.
In my practice, I see the harms that patients suffer while seeking medical services, including the ordeals that specialists put women through in the name of “innovation.” Yes, pioneering practices can change and save lives, and it is part of the medical culture for surgeons to be bold and aggressive. But patients should not be experimental subjects without their informed consent. This means they are told clearly and fully all the important facts they need to make an intelligent decision about what treatments to have, where to get them, and from whom.
Some patients may seek select surgeons and hospitals based on their reputations built on specialization or technique. And it is true that surgeries, unlike prescription drugs or medical devices, may not be subject to FDA oversight. But surgeons cannot have free rein in how they treat patients. Surgical colleagues, nurses, hospitals, regulators, and lawmakers need to be vigilant about doctors’ practices to safeguard the vulnerable from MDs excessive risk-taking. Medical scientists, with encouragement and support from agencies like the FDA, need to conduct rigorous studies about surgeries to show if they benefit patients.
As more women become doctors, maybe the field also will rid itself of what is dubbed the “Yentl syndrome” — the description, the Vox news site reported, of “what happens when women present to their doctors with symptoms that differ from men’s — they often get misdiagnosed, mistreated, or told the pain is all in their heads.” As Vox underscored, “This phenomenon can have lethal consequences,” for example, when women need heart care but don’t seek it because their symptoms differ — they may not, for example, experience as many men do a stabbing pain in the chest and radiating from an arm and shoulder.
Author Caroline Criado Perez has written a new book, “Invisible Women: Data Bias in a World Designed for Men,” that tackles the Yentl syndrome and more. It’s yet another reminder that we need to do much better with the medical care for half the world’s people.
https://www.jdsupra.com/legalnews/after-thousands-of-lawsuits-fda-bans-30387/
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Modi govt writes to J&J for details on surgical pelvic mesh after US ban
Apr 23, 2019 | The Print
By Himani Chanda
The Modi government has written to American pharmaceutical giant Johnson & Johnson asking it to furnish details of the number of surgical pelvic meshes it has imported into India in the last three years.
The government’s move has been triggered by the U.S. Food and Drug Administration (FDA) banon the transvaginal pelvic mesh last week.
“We have written to J&J to seek data on the number of mesh imported in India in the last three years. The company’s license expired last month (in March) and it also hasn’t submitted an application for renewal yet,” said a senior official at Central Drugs Standard Control Organisation (CDSCO), the national regulatory body for drugs and medical devices.
The mesh is a medical device popularly used to support the abnormal descent of the pelvis in women. It is a cloth-like piece of netting made of synthetic material that is used to provide additional support to weakened or damaged tissue; for instance, after childbirth or due to increasing age.
While the government is examining the data on sales of the transvaginal mesh in India, it has figured out that not many such products are available here.
“A majority of the licenses have already expired and never came up for renewal. We are also checking with domestic manufacturers about their latest production numbers but they are also not actively manufacturing this product,” said the senior official quoted above. “Moreover, mesh makers such as Boston Scientific and Coloplast (under scanner in the US) were never registered for the import of mesh in India.”
Various sellers at Indiamart.com, an online marketplace, do, however, claim to sell pelvic mesh.
“Our regulators approve import of notified medical devices on basis of US FDA regulatory approval as shortcuts. They have confidence in the regulatory processes of the USA and the European Union,” said Rajiv Nath, forum coordinator of the Indian Medical Device Industry.
“Hence, when these countries ban the sale of specific devices, Indian regulators also need to cancel import licenses (if any active) and otherwise, impose an official ban to protect the public.”
ThePrint reached J&J, through email, to confirm whether the company had received the letter from CDSCO but there was no response despite repeated reminders. This report will be updated when J&J responds.Controversial mesh products that J&J has launched in India
In India, J&J registered its product as “Gynecare Gynemesh PS” in 2011 but the licence expired in 2013. It renewed the license, which expired in 2016 and then in 2019.
While the product was launched as a transvaginal mesh, the company made significant changes in its controversial Gynecare product after increased complaints and class action suitsagainst it.
It changed the way that mesh is implanted, from a transvaginal approach to a transabdominal one.
“The product is no more available for transvaginal administration but we need to check if the doctors are still using it through vaginal insertions, which will be its off label use,” said the CDSCO official.
Till February 2019, J&J’s Ethicon had around 34,800 vaginal mesh lawsuits where many women have named the company’s Gynecare TVT Abbrevo product as responsible for their injuries, according to ConsumerSafety.org, an organisation that provides legal help to individuals suffering the consequences of problematic medical devices.
The same product was also registered in India between 2014 and 2017. However, there is no clarity if the registration was renewed as data on the CDSCO’s website has not been updated for 2017 and 2018.
“We have written to the company to share the sales and imports of all pelvic mesh to gain further clarity,” the official said.
https://theprint.in/india/governance/modi-govt-writes-to-jj-for-details-on-surgical-pelvic-mesh-after-us-ban/225494/
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Apr 23, 2019 | Law.com
By Max Mitchell
Although allegations of fee-padding and self-dealing have roiled the pelvic mesh multidistrict litigation, the judge overseeing the consolidated lawsuits is under no obligation to investigate those claims.
But that does not necessarily mean U.S. District Judge Joseph Goodwin of the Southern District of West Virginia will turn a blind eye either.
According to court watchers, allegations that arose recently in the contentious fee dispute should give any judge pause, and may lead Goodwin, who is overseeing the vast litigation, to call for further investigation of the claims before he allocates an estimated $550 million in disputed fees.
“It seems to me the court more or less has to look into these allegations in deciding the fee dispute, and the fact that the court itself appointed this committee sounds like a further reason why the court should be interested in whether they’re behaving properly,” Rutgers University professor John Leubsdorf said.Infighting Over Fees
The allegations arose in court filings late last month—about two weeks after the fee and compensation committee and Daniel Stack, a retired Illinois state court judge appointed to review the fee allocation process, issued their final recommendations on how to allocate the fees among 94 firms each claiming they did work for the “common benefit” of the MDL.
Specifically, Roseland, New Jersey, attorney Adam Slater of Mazie Slater Katz & Freeman wrote in a March 26 objection that plaintiffs attorney Bryan Aylstock pressured the chairman of the fee and compensation committee, Henry Garrard, to boost the amount of attorney fees to Aylstock’s Pensacola, Florida-based firm, Aylstock, Witkin, Kreis & Overholtz, which ultimately got $10 million more. According to the objection, Aylstock threatened that his colleague, D. Renée Baggett, a member of the fee and compensation committee, would not sign off on its preliminary written recommendation if Garrard, of Blasingame, Burch, Garrard & Ashley in Athens, GA, refused to increase the fees for Aylstock’s firm.
Slater and fellow Mazie Slater partner David Mazie filed separate declarations insisting that Stack had relayed the information at a Jan. 3 meeting with them.
“Judge Stack stated that he ‘was sickened’ and ‘angered’ by this conduct, which he described as Mr. Aylstock pressuring the FCC chairman when he was particularly vulnerable,” Slater wrote in his firm’s objection. “Judge Stack explained that he could not recommend the far lower amount he believed Aylstock deserved since he was, as he termed it, ‘put in a box’ since the agreement with the Aylstock firm included assurance that Judge Stack would not reduce the agreed-upon award.”
The objection also accused Motley Rice of padding its bills in the mesh litigation.
“Similarly, Judge Stack stated that he believed that Motley Rice (like some others in the litigation) had inflated its contributions and had ‘padded’ its time with thousands of phantom hours,” Slater wrote. Stack told him that Motley Rice did that “in every litigation,” according to the objection.
Shanin Specter, of Kline & Specter, also filed a March 26 objection that raised similar concerns, contending that Stack “simply rubberstamped” the FCC’s recommendations.
When reached for comment Tuesday, Specter said the filings raise serious allegations, and that attorneys should have a right to appeal decisions regarding the fee dispute—an issue that is currently being disputed before the U.S. Court of Appeals for the Fourth Circuit.
“As we said in our filing, firms, especially Mazie Slater, have raised troubling concerns about what’s occurred in relation to the attorney fee issue,” he said. “Good lawyers are going to be deterred from getting involved in MDLs if they think that the rules can be changed in the middle of proceedings and there’s no right of appeal.”
Slater and Rice declined to comment about the dispute, and Aylstock did not return a message for comment Tuesday.
Garrard said he could not comment beyond the FCC’s court filings.
The FCC, however, has made counterclaims against the objecting firms, accusing them of collectively making false attacks and submitting bills “riddled with excessive entries, duplicative billing” and other problems.
Garrard also specifically called Slater’s account of Alystock’s fee request false, stating that he “has never felt taken advantage of by this firm.”
“The FCC evaluated the Aylstock firm’s submission by the same criteria as every other firm, which included the opportunity to provide and receive feedback and to be heard,” Garrard wrote.
The use of such “caustic rhetoric” was “unfortunate,” he added.
“It serves no legitimate purpose for these objectors to air personal grievances or what they apparently believe to be ‘dirty laundry’ regarding alleged conversations with FCC members or with the external review specialist save perhaps to embarrass or insult,” he wrote.
But it is unlikely that response will be the end of the dispute.
Objecting attorneys have since filed replies, contesting the FCC’s accounts. And, although the court has shot down previous requests for discovery regarding the fee allocations, on Monday attorney Benjamin H. Anderson of Anderson Law Offices in Cleveland filed a motion requesting a hearing.
“The eight members’ claims of having actually performed the work needed to justify their recovery of two-thirds of the common benefit fund are simply implausible and cannot withstand scrutiny,” Anderson said.
Anderson also did not return a call for comment.Where Can Courts Go From Here?
Several attorneys said that, although contentious fee disputes are commonplace in big cases, the allegations raised in pelvic mesh are outside the norm, and could lead to a variety of actions by the court depending on what allegations may get substantiated and what allegations might be shown to be false.
Court watchers noted that, unlike in class action litigations, there are no codified duties for judges presiding over MDLs to delve into the particulars of a fee dispute, and often courts simply follow the recommendations of the special master tasked with reviewing the dispute.
However, at least one attorney said there is some case law that might fall in favor of transparency, most recently a decision by U.S. District Judge Robert Kugler in In re Benicar Products Liability Litigation, which, earlier this month, issued an order saying, among other things, that all firms involved in the litigation will be given access to submissions made to the common benefit committee.
The statute governing MDLs is “barebones,” according to Penn Law professor Stephen Burbank, so disputes often arise about exactly what powers a court can exercise. Courts are also generally reluctant to redo the work performed by special masters who oversee fee disputes, but still, Burbank said, courts generally want to review fee submissions thoroughly.
“The incentives for passing and for unfair allocation on the basis of what I’ll call politics rather than effort are pretty high, and most judges know this,” Burbank said. “It would be very, very surprising if a judge in any context just accepted what a lawyer is proposing.”
Despite the lack of specific rules, courts generally seek to exercise broad discretion when it comes to fee disputes, Burbank said, and so a credible allegation of impropriety could set the whole fee allocation process back numerous steps.
“That might make me think, well maybe my assumption about the total amount is wrong,” Burbank said.
Among other things, judges facing serious allegations in fee disputes can hold hearings regarding the disputed hours and the rates, attorneys said. Courts can also call for further evidence and depositions, and, depending on the findings, there could even be disciplinary implications.
Ethics attorney Thomas G. Wilkinson Jr. of Cozen O’Connor said there is little oversight regarding what exactly a “reasonable fee” should be, but, knowingly making false statements can run afoul of ethics laws regarding candor to the court.
“Any kind of knowingly false statement to the court could have disciplinary consequences,” Wilkinson said.
Federal courts are somewhat limited in what they can do if a violation has been found to have occurred, and generally their options are imposing monetary sanctions, or revoking an attorney’s pro hac vice admission. Any proceedings regarding an attorney’s law license would have to first be initiated by the disciplinary body of the attorney’s home state.
Wilkinson said state disciplinary boards “most always will investigate further” if an issue has been brought to them via a judge’s opinion.
However, he noted that, without a request from attorneys, courts have no duty to sanction lawyers found to have run afoul of the ethics rules.
“There’s no duty on the part of a judge to send an issue to the disciplinary body,” Wilkinson said. “Even if the judge concludes there was a violation.”
https://www.law.com/2019/04/23/pelvic-mesh-judge-isnt-obliged-to-probe-allegations-of-self-dealing-in-fee-fight-but-he-might-dive-in/?slreturn=20190329032904
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