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Bausch & Lomb Facing Class-Action Lawsuit from ReNu Lens Solution Recall

A new health scare has emerged for consumers of Bausch & Lomb’s ReNu with MoistureLoc brand contact lens solution and might include other brands of contact lens solutions.
ReNu with MoistureLoc was being pulled from U.S. store shelves at the request of Bausch & Lomb amid concern the contact lens solution may be linked to a fungal eye infection that can cause blindness.

The company also began placing advertisements in newspapers Friday suggesting consumers use another lens care solution for the time being. The ads feature a letter from Chairman and Chief Executive Ron Zarrella.

“We find ourselves in a position where the safety of one of our products, Renu with MoistureLoc manufactured at our United States plant, is in question,” the letter said.
Bausch & Lomb decided to pull ReNu Lens Solution as several U.S. retailers, led by Wal-Mart Stores Inc., Walgreen Co. and CVS Corp., were pulling the ReNu with MoistureLoc solution off their shelves on their own, and with pressure for a recall mounting.

The company stopped shipments of MoistureLoc in the United States on Monday when the Centers for Disease Control and Prevention said it was scrutinizing 109 reports of Fusarium keratitis infections in patients in 17 states over the last 10 months. Without eye-drop treatment the infection can scar the cornea and blind its victims. Symptoms can include blurry vision, pain or redness, excessive discharge and increased sensitivity to light.

“Both the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are investigating this situation. Inspectors from the Food and Drug Administration remained at Bausch & Lomb’s factory in Greenville, S.C., Friday, an FDA spokeswoman said. The inspectors have been scouring the plant for about three weeks and have so far found no evidence of contamination, Zarrella said.
“If there is a problem with our product, we’ll find it and we’ll fix it,” Zarrella’s open letter said. “If there’s not, when we come back you’ll be able to know with absolute certainty that we’ve taken every possible step to ensure your safety.”

While the bulk of the investigated cases are linked to ReNu, other solutions were used by some of the infected patients thereby raising the possibility that other products may also be involved.

The FDA is also advising soft contact lens wearers to follow all instructions and preventive hygiene practices carefully. “Microbial keratitis is a severe infection of the cornea. Risk factors for infection include trauma (generally with plant material), chronic ocular surface diseases, immunodeficiency, and rarely, contact lens use. There are an estimated 30 million soft contact lens users in the United States; the annual incidence of microbial keratitis is estimated to be 4-21 per 10,000 soft contact lens users, depending on overnight lens use. Fungal keratitis is a condition more prevalent in warm climates; in the southernmost United States, fungal keratitis comprises up to 35% of microbial keratitis cases compared with 1% in New York. The proportion of fungal keratitis due to Fusarium spp. also varies by region, from 25-62%.”

A newly filed class-action alleges Bausch & Lomb failed to disclose the possible link between ReNu with MoistureLoc and Fusarium keratitis once it learned of the problem among its users in Asia. Singapore health officials noticed an increase in reports of infection in January of this year. An investigation revealed 39 cases involving contact lens users from 2005 to February 2006. Cases of the infection have also been reported in Malaysia and Hong Kong.
Consumers wishing to return the product were directed to http://www.bausch.com or a toll-free number: 1-888-666-2258.

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Suspect tissue, bone given to Iowans

Risk of disease from the implants is low but doctors say patients should be tested.

January 26, 2006

A few dozen Iowa patients have learned their surgeons unwittingly implanted bone, skin or tendons that came from a tissue dealer suspected of stealing materials from human corpses that weren’t properly screened for diseases.

Federal investigators are looking into the possibility that the tissue could have been tainted with germs that cause ailments such as AIDS, hepatitis or syphilis. However, doctors who work with such grafts say the risk of transmission is very low.

Physicians at University Hospitals in Iowa City have asked 30 patients over the past two months to return for testing for exposure. Almost all have done so, and none came up positive for diseases. Dr. Vincent Traynelis, a neurosurgeon who handled many of the cases, said the grafts were tested and sterilized before implantation, which dramatically cut the chance that germs would be passed to the recipients.

A spokeswoman for Iowa Methodist Medical Center said the hospitals identified 11 patients who might have been exposed. The patients’ doctors were notified and asked to have the patients tested. A spokesman for Mercy Medical Center in Des Moines said several of his hospital’s patients also were affected. The University of Nebraska Medical Center in Omaha has notified 33 patients that their surgeons might have used tainted tissue. However, a hospital spokeswoman would not disclose if any of those patients were from Iowa.

The concerns are related to a scandal last fall in the New York area. Authorities there say that a New Jersey company, Biomedical Tissue Services, paid funeral directors for access to corpses, then harvested body parts and used falsified documents to sell the grafts to legitimate tissue-and-bone processors. The bodies were not screened for diseases.

The scandal includes the allegation that the late TV broadcaster Alistair Cooke was among those whose tissue was taken without their families’ consent. In some cases, funeral directors allegedly replaced stolen bones with plastic pipes so relatives wouldn’t notice.

Most of the Iowa cases were spinal surgeries, in which cadaver bone grafts bridge the gaps between vertebrae. Other cases involved skin or tendon grafts.

A spokesman for Iowa’s only designated tissue-and-organ-procurement group said he hopes the uproar leads to tighter rules.

“I think it could definitely weed out some of the smaller tissue banks that are not necessarily doing things the right way,” said Paul Sodders, who represents the Iowa Donor Network.

Sodders said tissue donation is less heavily regulated than organ donation. For-profit companies are not allowed to trade in organs, such as hearts, kidneys or livers, he said. However, they are allowed to deal in skin, bones, ligaments and other tissues, he said.

Sodders said his agency meets stringent requirements for accreditation by the American Association of Tissue Banks. Among other things, the association requires agencies to prove they have family consent. Iowa Donor Network also only accepts bodies that have been referred to it by hospitals or medical examiners.

Sodders said patients should ask their surgeons if the grafts they use come from accredited tissue banks. In the cases in question, the answer apparently would have been yes.

Bob Rigney, chief executive officer of the American Association of Tissue Banks, said most or all of the grafts collected by Biomedical Tissue Services were processed by organizations accredited by his group. The accredited organizations trusted the smaller company, which was regulated by the state of New York and by the U.S. Food and Drug Administration, he said. The company allegedly fooled regulators by faking documents, Rigney said. “If the allegations that have been made are true, what these folks have done is outrageous.”

Rigney, who called the problems “an aberration,” disagreed with Sodders that tissue banks are less intensely regulated than organ-donation programs. He said all the grafts in question were tested for diseases before being sanitized. The original cadavers weren’t screened, as they should have been, he said, but other safeguards probably prevented any infections.

Originally published on 1/26/06

Web-link: http://www.dmregister.com/apps/pbcs.dll/article?AID=/20060126/NEWS08/601260367/1001

This article includes material from Knight Ridder News Service


Bone Transplant Allegations Have Recipients Rattled

Suits allege bone material was ‘harvested’ from cadavers and sold without families’ permission or testing for disease

Mary P. Gallagher
New Jersey Law Journal

Bone transplant recipients in Atlantic County, N.J., are pretty rattled of late.

In suits filed this month, plaintiffs charge that bone pieces implanted in them during surgery at Shore Memorial Hospital are of unknown origin — that they were pilfered from cadavers and sold without the consent of the deceaseds’ families or the protective screening required by law, leaving recipients exposed to risk of infection with HIV, hepatitis and syphilis.

The suits, Augustin v. Medtronic Sofamor Danek and Pieper v. Medtronic Sofamor Danek, come in the wake of recalls of bone and tissue products and investigations by the Food and Drug Administration and the Brooklyn District Attorney’s Office, which has reportedly been exhuming bodies in Brooklyn and Queens, N.Y., graveyards.

Suits have also been filed in Brooklyn by people who claim that the bodies of their relatives were carved up and sold without their knowledge or permission.

More litigation is on the way. Patrick D’Arcy, whose law firm is handling the Atlantic County cases, was planning to file more suits last week on behalf of bone and tissue recipients. One will likely feature a plaintiff who claims she tested positive for hepatitis C only a week or so after the surgery.

The allegations center around Joseph Nicelli, an embalmer, and Michael Mastromarino, an oral surgeon who operated Biomedical Tissue Services, a Fort Lee, N.J., company that supplied bone and tissue from cadavers for medical uses.

Nicelli, Mastromarino and Biomedical are defendants in the suits, along with Daniel George & Son Funeral Home in Brooklyn. Nicelli’s lawyer, New York solo Richard Medina, acknowledges that his client briefly owned the funeral home two or three years ago but says he does not know whether it was during the time of the alleged harvesting.

The defendants allegedly worked together to remove bone, tissue and body parts without permission or the proper protocols or papers.

Also named as defendants are Regeneration Technologies Inc. of Alachua, Fla., and Medtronic Sofamor Danek Inc. of Memphis, which were allegedly parts of the distribution chain by which suspect bone matter made its way from Biomedical to the hospital and into the spines of Gary Pieper and Heather Augustin. Those companies were at least negligent, and whether they knew what was going on will be determined by the litigation, asserts D’Arcy.

The complaints allege, among other things, negligence, strict liability, racketeering, misrepresentation, breach of warranty and infliction of emotional distress. Violations of the New Jersey Consumer Fraud Act and a federal statute, 42 U.S.C. 274(e), that outlaws trafficking in human organs are also alleged.


The situation came to light in September when LifeCell Corp., a human tissue supplier in Branchburg, learned of discrepancies in documentation from Biomedical. On Sept. 30, LifeCell voluntarily recalled products that had originated with Biomedical and contacted the FDA. Four other suppliers, including Regeneration Technologies, also recalled Biomedical’s products.

On Oct. 28, the FDA announced it was investigating whether bone, skin and tendons supplied by Biomedical came from human donors “who may not have met FDA eligibility requirements and who may not have been properly screened for certain infectious diseases.”

In addition to testing for specific diseases, suppliers are supposed to take medical histories and assess donors to guard against transmitting infections through transplanted tissue.

The FDA recommended that all doctors who implanted Biomedical materials notify their patients of the risk of illness and offer to test them for it.

D’Arcy says he has spoken with nearly 70 people who learned from doctors or hospitals that they received questionable bone or tissue. Their common refrain is “get this out of me,” he says.

Most of them, including Pieper and Augustin, had bone implanted during surgery for herniated disks that involved fusing the bone, making removal harmful, if not impossible.

And given the incubation times for some diseases, negative test results do not ease their minds. D’Arcy says Pieper is worried that he does not know whether old bone was placed in his back. Pieper, a construction worker from Mays Landing, was told he needed young bone for the three-level fusion or his back might collapse, says D’Arcy.

The cases present D’Arcy and his brother Andrew, who is also working on them, with such challenging problems as tracing the origin of the bones along a trail of allegedly false documentation and, where a client does fall ill, proving a link with the transplant.

Preadmission testing that shows a now-ailing client was healthy before the surgery should help, especially absent lifestyle or other risk factors, says D’Arcy: “I’d be comfortable proving that case.”

At least one other New Jersey lawyer is considering filing similar suits but is not sure.

Richard Bagolie, of Jersey City’s Bagolie Friedman, has spoken with about a dozen potential plaintiffs around the country, mainly bone recipients, none of whom has tested positive for the screened diseases.

“I’m still not convinced at the end of the day we’re going to be able to do anything with them,” he says, noting that the suits would essentially be over emotional distress and medical monitoring.


At the supply end of the chain are the two New York suits, filed in Kings County Supreme Court: Bruno v. English Brothers Funeral Home, No. 31715-2005, and Kogut v. English Brothers Funeral Home, No. 33691-2005.

They were filed about two months ago on behalf of families who claim they never agreed to donate pieces of their loved ones. The complaints accuse Mastromarino and Nicelli of “harvesting” corpses at English Brothers Funeral Home in Brooklyn.

Sanford Rubenstein, of Brooklyn’s Rubenstein & Rynecki, who represents both families, says they found out when police contacted them in the course of an investigation into forged consent forms that also misrepresented what killed the men. They both died of cancer.

Mastromarino’s lawyer, Mario Gallucci, says he has not been served with any complaints, but “these lawsuits will be routinely tossed out of court.” His client “owns a procurement company that followed FDA regulations and was audited every single year by the FDA as well as every single processing company that received tissue” and was not responsible for obtaining consent, he asserts.

Mastromarino is doing consulting work but expects to eventually return to “the business of selling tissue,” says Gallucci, of Helbock, Nappa & Gallucci in Staten Island.

Medina, Nicelli’s lawyer, says he has also not been served with anything nor has any law enforcement official subpoenaed him or tried to interview him. He calls the lawsuits “an interesting shot in the dark.”

Medtronic Sofamor spokesman Bert Kelly says the company had not been served but is recalling tissue from Regeneration Technologies, for which it is a distributor.

Regeneration Technologies’ manager of corporate communications, Wendy Crites, responded to a reporter’s request for comment by referring to an Oct. 14 press release about the recall and the steps routinely taken by the company to ensure tissue safety.

The Daniel George Funeral Home has no telephone listing. A call to the English Brothers Funeral Homes was not returned.

The Brooklyn District Attorney’s Office declines comment on what it terms an ongoing investigation, while the New York Daily News and other papers report that investigators are digging up coffins in area graveyards to determine, among other things, if the corpses are intact.

Originally published: 12/27/05

Web-Link: http://www.law.com/jsp/article.jsp?id=1135332308394#

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