California Court Orders Coordination of a Growing Number of Cases Alleging Blindness and Other Serious Injuries

Santa Ana, CA December 13, 2007 — Twenty more products liability lawsuits* were filed this week against contact lens solution maker Advanced Medical Optics, Inc. in California state courts in Los Angeles and Orange Counties. The plaintiffs reside in California as well as numerous other states throughout the country. The lawsuits seek compensatory and punitive damages for serious injuries that the plaintiffs allege were caused by AMO’s Complete® brand of contact lens disinfectant solutions.

Complete® MoisturePlus™ multipurpose solution was voluntarily recalled by AMO on May 25 at the request of the Food & Drug Administration after the Centers for Disease Control linked the solution to an outbreak of serious corneal infections known as Acanthamoeba keratitis. The plaintiffs contend that AMO knew that its solution was ineffective against the organism that causes the infection, and even changed the formula in a way that actually increased the likelihood of contracting the disease, yet failed to warn consumers about the risk.

The new lawsuits add to numerous cases previously filed in California and other states. There are presently at least 48 separate lawsuits involving over 80 individual plaintiffs pending against AMO in connection with its recalled solution, including several class actions. “We anticipate that there will be many more cases filed as lawyers continue to evaluate the medical records of potential claimants,” said Mark Robinson of Robinson Calcagnie & Robinson in Newport Beach, California, one of three firms representing the new plaintiffs. Acanthamoeba keratitis is caused by contamination of contact lenses and lens cases with a common amoeba. It is often mistaken by doctors for viral or bacterial infections, but is more difficult to diagnose and treat, and is associated with a high rate of permanent vision loss and the need for corneal transplant surgery. “These are just horrific injuries,” added Robinson, who said that a number of cases involve children, including four of the newly filed lawsuits.

Four of the new lawsuits were brought by individuals who unwittingly used the product after it was recalled by AMO. “We have a growing number of clients who were never told about the recall,” said Michael Schmidt of The Schmidt Firm in Dallas, Texas. Schmidt pointed to the results of a CDC survey this past summer which showed that less than half of surveyed contact lens wearers were aware of the recall and that unwary consumers were continuing to use the product. More troubling, officials also reported that CDC received reports of at least four new cases of Acanthamoeba keratitis linked to use of the product after the recall went into effect. A spokesman for CDC reportedly called the continued use of the product by those unaware of the risk “a real tragedy.” On July 31, the official FDA website announced that the recall had been reclassified from “voluntary” to “Class 1,” which FDA reserves for cases where product use is associated with the “reasonable probability” of “serious adverse health consequences or death.”

The newest personal injury lawsuits follow a ruling by a California judge granting a plaintiff’s request, opposed by AMO, to have all current and future California lawsuits involving AMO’s solutions coordinated in a single court. “Coordination will create some efficiencies that should expedite discovery and trials,” said Thomas M. Moore of Moore Labriola LLP in Newport Beach, who also represents the new plaintiffs. Moore anticipates that the California Judicial Council (the administrative arm of the California Supreme Court) will soon assign a specific judge to hear all of the cases.

* Anders v. AMO 30-2007-00100195, Berardi v. AMO 30-2007-00100191, Carlisle v. AMO 30-2007-00100074-CU-PL-CJC, David v. AMO 30-2007-00100043, Mary v. AMO 30-2007-00100145-CU-LL-CJC, Greene v. AMO 30-2007-00100144-CU-PL-CJC, Grigg v. AMO 30-2007-00100071-CU-PL-CJC, Hathcock v. AMO 30-2007-00100047, Husain v. AMO 30-2007-00100075-CL-PU-CJC, Moore v. AMO 30-2007-00100149-CU-PL-CJC, Nelson v. AMO 30-2007-00100134-CU-PL-CJC, Phillips v. AMO 30-2007-00100045, Reyes v. AMO 30-2007-00100146-CU-PL-CJC, Rieder v. AMO 30-2007-00100194, Pyle v. AMO – 30-2007-00100189, Straub v. AMO 30-2007-00100048, Syfert v. AMO 30-2007-00100192, Welsh v. AMO 30-2007-00100051, Whetstone v. AMO 30-20007-00100065-CU-PL-CJC, Vargas v AMO LC 079919

CONTACT:

Robert H Hilley IV
Schmidt & Clark
(858) 688-0923
hilley@schmidtandclark.com
http://www.schmidtandclark.com

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Source | DOW JONES NEWSWIRES

By Jon Kamp

U.S. health authorities are concerned that contact-lens wearers are still using an Advanced Medical Optics Inc. (EYE) lens solution pulled from the market two months ago due to infection links, and that the company hasn’t done enough to raise public awareness.

At least four cases of the serious eye-infection Acanthamoeba keratitis have been connected to use of Advanced Medical’s Complete MoisturePlus solution since the late May recall, said Michael Beach, an epidemiologist with the U.S. Centers for Disease Control and Prevention. The CDC has found that many people are unaware of the recall.

The Food and Drug Administration, meantime, recently found that solution bottles are still on some retail shelves, said Tim Ulatowski, director of compliance in the FDA’s medical devices branch. The CDC believes there may also be millions of bottles still in the homes of contact-lens wearers.

Tough-to-treat Acanthamoeba infections can potentially bind people.

“We really want people to hear about this and check their medicine cabinets,” Beach said in an interview with Dow Jones Newswires Tuesday. “To me this is a real tragedy when people are still using the product after the recall.”

The recall has also led to product liability lawsuits against Advanced Medical. In a release Tuesday, law firm Schmidt & Clark LLP said four additional suits have been filed against the company in Orange County Superior Court in California, all brought by individuals alleging they contracted Acanthamoeba infections while using Complete MoisturePlus. The suits were filed by law firm Moore Labriola LLP.

Read The Full Article: http://online.wsj.com/article/BT-CO-20070731-715781.html?mod=djempersonal

[UPDATE 08/01/07] Recall of Complete MoisturePlus Multi-purpose Contact Lens Solution manufactured by Advanced Medical Optics, Inc. classified by FDA as Class I

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.

On August 1, 2007 the U.S. Food & Drug Administration announced that many consumers may not be aware of the May 2007 recall of Complete MoisturePlus Multipurpose Contact Lens Solution manufactured by Advanced Medical Optics (AMO) and continue to use the recalled product. Several cases of Acanthamoeba Keratitis have been reported to CDC that involve the use of AMO Complete MoisturePLUS after the recall was announced. Individuals who wear soft contact lenses should stop using the Advanced Medical Optics Complete MoisturePLUS product immediately, discard all remaining solution including partially used or unopened bottles. See the FDA Preliminary Public Health Notification dated May 31, 2007, for recommendations for contact lens wearers.

Learn More About Your Legal Rights: http://www.schmidtandclark.com/Complete-MoisturePlus/

Source | CDC

CDC continues to receive reports from ophthalmologists that cases of Acanthamoeba keratitis, a potentially blinding infection, are occurring in the United States.

Multiple cases of infection caused by Acanthamoeba have occurred since May 26, 2007, the day the FDA announced the outbreak and the manufacturer issued a recall of the implicated multipurpose contact lens solution. The contact lens user in at least four of these cases continued to use AMO Complete® MoisturePlus™ multi-purpose contact lens solution and subsequently developed symptoms after the recall.

CDC has also learned during the interview stage of its investigation of the outbreak that many contact lens users do not know that AMO Complete® MoisturePlus™ multi-purpose contact lens solution has been recalled from the market because of its association with Acanthamoeba keratitis.

Healthy contact lens users from across the U.S. were interviewed by CDC as part of the ongoing investigation. They were asked if they had heard of a recalled contact lens solution and, if so, could they identify the name of that solution. Among the 151 people interviewed:

• 52.3% (79/151) were not aware of the recall
• Among those who were aware of the recall, only 26.8% (19/72) could correctly name the recalled product
• Of 15 people who reported using AMO Complete® MoisturePlus™ multi-purpose contact lens solution in April 2007, 80% (12/15) were still unaware of the recall and were still using the product

While FDA moved swiftly and worked with the manufacturer to enact this recall, millions of bottles of the solution, purchased prior to the recall, might still be in the homes of contact lens wearers. We are concerned that this lack of awareness among the general public — as well as eye care providers — is leading to continued use of the product by those who had purchased it prior to the recall. (It is often sold in bulk packaging at warehouse stores and bottles have a long expiration date).

Help is being sought to get the word out:

1. Check your medicine cabinet for AMO Complete® MoisturePlus™ multipurpose contact lens solution.
2. Stop using the product immediately and contact the company at 1-888-899-9183 or on the AMO Web site for instructions on what to do with unused solution;
3. Discard all soft contact lenses used with AMO Complete® MoisturePlus™;
4. Discard all contact lens storage cases used with AMO Complete® MoisturePlus™;
5. Consult your eye care provider about choosing an alternative contact lens solution;
6. Visit your eye care provider if you experience any signs of eye infection, including eye pain or redness, blurred vision, sensitivity to light, sensation of something in the eye, or excessive tearing and;
7. Visit CDC’s Acanthamoeba Web site for further instructions on contact lens use and other information.

Santa Ana, CA (PRWEB) July 30, 2007 — Four more products liability lawsuits were filed yesterday against the manufacturer of Complete® MoisturePlus™ contact lens solution in Orange County Superior Court in Santa Ana, California (Case #07CC01330, #07CC01331, #07CC01332, #07CC01333). The product was voluntarily recalled on May 25 at the request of the Food & Drug Administration in the wake of data collected and reviewed by the Centers for Disease Control linking the solution to a serious corneal infection known as Acanthamoeba keratitis. The new cases add to a growing number of injury and class action claims arising out of the recall.

Read Full Text: Schmidt & Clark Announces Multiple Lawsuits Filed Over Recalled Contact Lens Solution

Litigation against Advanced Medical Optics Continues to Expand as Company Moves to Re-Enter the Multipurpose Solution Business

SANTA ANA, Calif.–(BUSINESS WIRE)–Four more products liability lawsuits were filed yesterday against the manufacturer of Complete® MoisturePlus™ contact lens solution in Orange County Superior Court in Santa Ana, California (Case #07CC01330, #07CC01331, #07CC01332, #07CC01333). The product was voluntarily recalled on May 25 at the request of the Food & Drug Administration in the wake of data collected and reviewed by the Centers for Disease Control linking the solution to a serious corneal infection known as Acanthamoeba keratitis. The new cases add to a growing number of injury and class action claims arising out of the recall.

The lawsuits, naming vision products manufacturer Advanced Medical Optics, Inc., and its former parent company, Allergan, were brought by Dolores O. Morse, PhD (#07CC01332), and Kelly Segerstrom (#07CC01333), both Southern California residents, as well as Jacqueline Grossman (#07CC01331) and Krista Nelson (#07CC01330), who are residents of Washington. All of the plaintiffs allege that they contracted Acanthamoeba infections while they were using Complete® MoisturePlus™ to disinfect their contact lenses. The cases were filed by Newport Beach-based Moore Labriola LLP, which also filed the first post-recall lawsuit against AMO on June 4 (#07 CC 01296). The plaintiffs are also represented by Michael Schmidt of The Schmidt Firm and Schmidt & Clark, both based in Dallas.

Acanthamoeba infections can be chronic, resistant to treatment, and often require surgical interventions such as corneal transplantation. They not infrequently lead to blindness. Morse and Grossman both underwent surgical procedures as the result of infection-related damage and have lost the use of the affected eyes. Segerstrom is hopeful she has gotten through the worst of her infection thanks to intensive treatments, but still experiences vision problems. Nelson, a 16 year-old, continues to fight her infection, which was diagnosed last November. She is believed to be the first minor to file suit against AMO since the recall.

“We expect the litigation to grow significantly over the next several months,” said attorney Michael Schmidt, who added that his firm represents numerous Acanthamoeba victims from across the Country. Schmidt noted that many of the victims are minors. “AMO specifically targeted teenage contact lens wearers, like Krista, in their marketing campaigns,” said Schmidt, who noted that young people appear to be particularly susceptible to the risks of ineffective lens disinfectants.

According to the lawsuits, studies published well before the product was recalled showed the disinfectant in Complete® MoisturePlus™ was vastly inferior to hydrogen peroxide as well as other multipurpose contact lens solutions on the market in eradicating Acanthamoeba. The plaintiffs allege that AMO was aware of the ineffectiveness of their product but concealed that information from consumers.

The new lawsuits come a week after AMO announced plans to re-enter the multipurpose lens solution business. According to recent press reports, the company says it will start distributing an “older” formulation of the recalled product as early as August. The product will reportedly feature revised labeling designed to improve safety, and will instruct users to manually rub their lenses during the cleaning process. AMO had previously represented to consumers that they could effectively disinfect lenses without a rub step, a practice considered unsafe by many optometrists and ophthalmologists.

Attorney Thomas Moore says his clients are concerned that consumers may be misled by the launch of the old AMO formulation and may incorrectly presume the solution is adequately effective against Acanthamoeba. “The label changes are all well and good, but AMO continues to ignore the root problem, which is the ineffectiveness of their disinfectant ingredient under real-world conditions,” says Moore. The solution will reportedly use the preservative polyhexamethylene biguanide, which is the same disinfectant used in the recalled product. “That ingredient in concentrations routinely used by AMO and Allergan has been shown to be ineffective against Acanthamoeba in many published studies,” says Moore, who added that if AMO wants to take a leadership position in the contact lens solution industry, “they should develop a disinfectant that works, and stop blaming consumers for infections which could be prevented with effective products.”

35 Million Contact Lens Wearers at Small Risk of Serious Conditions

For the country’s estimated 35 million contact lens users, cleansing and replacing their lenses becomes a routine that is just as normal — and seemingly safe — as brushing their hair or flossing their teeth.

Just ask Paige Reichardt, of Valparaiso, Ind.., an ABCNews.com reader who says she wore her contacts for 48 years without any significant eye problems.

That changed in November 2005, when she contracted an aggressive parasitic infection in one of her eyes called Acanthamoeba keratitis, a disease for which 85 percent of victims are contact lens wearers.

Reichardt shared her chilling story on the ABCNews.com discussion boards.

“I was told on the first day that I was diagnosed that they would try to save my eye,” she said. “So I knew from the start that it was serious.”

The treatment, like the disease, was serious. While doctors fought for her eye, she says, she endured a number of unpleasant therapies. One of her medications was a diluted version of the same chemical used in swimming pool cleaners. “You can imagine how that feels,” she said.

When the treatments failed, Reichardt endured four corneal transplant surgeries in five weeks as the disease spread and continued to destroy her eye, bit by bit.

“It’s a diabolical disease,” she said. “I felt like I was in a science fiction movie because there was no way to kill these damn things.” In the end, Reichardt lost her eye to the disease.

Her case was one of 138 across the country that sparked a voluntary recall of the popular Advanced Medical Optics Complete MoisturePlus Multi-Purpose Solution for contacts last week.

The company insists there is no evidence that its product is contaminated with Acanthamoeba, which is normally found in soil and fresh water but rarely targets humans. The Centers for Disease Control and Prevention has urged consumers, however, to throw away any bottles they still have.

It’s not the first time that contact lens solution has come under scrutiny; last year, investigators implicated Bausch & Lomb’s ReNu MoistureLoc solution in a rash of fungal eye infections that affected 164 contact wearers.

Read Full Article: ABCNews.com - Are Your Contact Lenses Safe?

Do I have a Complete® MoisturePlus™ Recall Lawsuit?

The Products Liability Litigation Group at our law firm is an experienced team of trial lawyers that focus exclusively on the representation of plaintiffs in Complete® MoisturePlus™ recall lawsuits. We are handling individual litigation nationwide and currently accepting new corneal infection (keratitis), including Acanthamoeba Keratitis cases in all 50 states.

Click Here: Our Experience

Source | DOW JONES NEWSWIRES

The U.S. Centers for Disease Control and Prevention’s probe of an eye infection that knocked an Advanced Medical Optics Inc. (EYE) contact lens solution from store shelves in May has expanded to include more than 100 studied patients, and has not shown links to any other products, a CDC official said late Wednesday.

The latest data continues to show a link between the cases of “Acanthamoeba keratitis” and Advanced Medical’s Complete MoisturePlus product, however. When the CDC announced preliminary data in late May, the agency had assessed 46 people with confirmed cases of the eye infection. The agency has now ramped up to 102 interviewed patients, and Complete MoisturePlus remains the only lens solution seen as an issue.

“That is the only solution that comes up significant,” said Michael Beach, an epidemiologist with the CDC, and part of the team investigating the outbreak of Acanthamoeba infections, in an interview with Dow Jones Newswires.

The lack of further product connections is positive for Advanced Medical’s lens-solutions competitors, including Bausch & Lomb Inc. (BOL), Alcon Inc. (ACL) and Novartis AG (NVS) unit Ciba Vision.

The CDC does not plan to interview more patients beyond the 102 interviewed thus far, which means that if other infection risk factors do show up in the ongoing research, they’re more likely to involve issues such as lens-care habits rather than notices of product troubles, Beach said.

The CDC went public with preliminary findings in May because it wanted to warn people of issues with Complete MoisturePlus.

“The positive thing from my standpoint is the main public health intervention has been done,” Beach said.

Later findings may simply reinforce what the agency already recommends in terms of proper lens care and handling to ward off infections. Acanthamoeba is a common bug, though eye infections are rare, and eye doctors have been stressing that contact lens wearers need to practice better hygiene to defend themselves. Acanthamoeba infections can be devastating, potentially leading to blindness, and very tough to fight.

The CDC data so far have not indicated that water quality standards are behind increased infections, as hypothesized by researchers at the University of Illinois at Chicago, which has investigated local infections and brought the issue of increased infection cases to the CDC’s attention last year. The CDC also hasn’t seen silicone hydrogel, a material used in the most popular type of contacts on the market, show up as a risk factor thus far, Beach said.

The water and silicone hydrogel questions will be studied further with a new batch of “controls”, or healthy lens wearers who live near and are similar to infected people, that the CDC has been collecting for comparisons in its research, Beach said. The agency has found it harder than expected to collect controls and is cutting off the search now so that it can move on with its analysis.

A final report including a comparison to controls and a deeper look at risk factors is likely to be available in the next couple of months, Beach said. The number of infected patients studied in the final report is likely to fall below 102 due to the difficulty of finding matching control subjects.

The CDC initially matched up people with Acanthamoeba infections to controls collected during a different eye infection probe last year. The early data showed that people with soft contact lenses who had an infection were at least seven times more likely to have used Complete MoisturePlus, compared with healthy lens wearers.

Things haven’t changed much now that the number of infected people investigated has more than doubled, Beach said.

“We continued enrolling cases, and when you look at more cases, the same trend is there” in terms of the Complete MoisturePlus connection, he said. The agency still doesn’t believe there’s a product contamination issue with the Advanced Medical product, he added.

The infection probe last year involved a fungal infection that was linked to Bausch & Lomb’s ReNu with MoistureLoc lens solution, which was pulled from the market. Advanced Medical made an offer last week to buy Bausch & Lomb for $45 in cash and $30 in stock, competing with a $65-per-share offer from private-equity firm Warburg Pincus. A major Advanced Medical shareholder has gone public with concerns about the bid and plans to vote against a deal.

Advanced Medical hopes to bring an older multipurpose lens solution product to store shelves by the end of the third quarter.

California Case Alleges Advanced Medical Optics Falsely Advertised Effectiveness of Product 

Santa Ana, CA June 8, 2007 — What is believed to be the first class action lawsuit brought in the United States against the manufacturer of Complete® MoisturePlus™ contact lens solution was filed today in Orange County Superior Court in Santa Ana, California (Case#07CC01297).  The product was voluntarily recalled on May 25 at the request of the Food & Drug Administration in the wake of reports of an association between the solution and serious corneal infections.

The lawsuit, naming ocular products manufacturer Advanced Medical Optics, Inc. and others as defendants, was brought by Nicole Lazar on behalf of California consumers who purchased the product but have not alleged physical injuries.   The case lawsuit seeks reimbursement of money consumers spent to purchase the product.  In addition, the action seeks reimbursement for the cost of replacing potentially contaminated contact lenses and lens cases as a result of FDA’s recommendation that these products also be discarded by anyone who has used them in conjunction with Complete® MoisturePlus™.   

The lawsuit alleges that AMO falsely marketed the solution as an effective contact lens disinfectant against infection-causing microbes.  The complaint cites CDC data showing that consumers who disinfected their lenses with Complete® MoisturePlus™ had a seven-fold increased risk of developing a sight-threatening condition known as Acanthamoeba keratitis as compared with consumers who used other lens disinfectant products.  The illness, which usually affects the corneas of contact lens wearers, is caused by a family of microorganisms most commonly found in soil and water.  The infection can be chronic, resistant to treatment, and often requires surgical interventions such as corneal transplantation.  It not infrequently leads to blindness.

Complete® MoisturePlus™ is one of a number of so-called “all-in-one” or “multipurpose” contact lens solutions developed as “more convenient” alternatives to hydrogen peroxide disinfectant systems.  According to the class action complaint, studies published well before the product was recalled showed that the disinfectant in Complete® MoisturePlus™ was vastly inferior to hydrogen peroxide as well as other solutions on the market in eradicating Acanthamoeba.   The class action alleges that AMO was aware of the ineffectiveness of their product but concealed that information from consumers who were led to believe that the solution was at least as effective as others on the market.

“Injured consumers will be able to bring their own individual cases, but there also needs to be a remedy for those who escaped infection, but were nevertheless persuaded by AMO’s marketing campaign to purchase an inferior product,” said noted Newport Beach attorney Mark P. Robinson, whose firm Robinson, Calcagnie & Robinson is acting as co-lead counsel on the case with Thomas M. Moore of Moore Labriola LLP, also based in Newport Beach.  Moore’s firm along with Schmidt & Clark in Dallas, Texas represent the plaintiff in he first personal injury case against AMO filed this past Monday on behalf of a San Diego man who developed Acanthamoeba keratitis and suffered sight loss after using the now-recalled Complete® MoisturePlus™ solution.   Robinson, Moore, and Schmidt say they are reviewing a number of potential claims and expect additional personal injury cases to be filed in the near future.

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California Case Alleges Advanced Medical Optics Product Led to Sight-Threatening Infection

Santa Ana, CA (PRWEB) June 4, 2007 — The Dallas-based law firm Schmidt & Clark announced today that it represents a Southern California couple in what is believed to be the first personal injury lawsuit brought against the manufacturers of Complete® MoisturePlus™ contact lens solution since the product was voluntarily recalled on May 25 at the request of the Food & Drug Administration.

Read The Press Release: First Complete® MoisturePlus™ Recall Lawsuit

Complete® MoisturePlus™consumers can learn more about the Complete® MoisturePlus™ Recall and Acanthamoeba Keratitis by visiting the following links:

>> Complete® MoisturePlus™

>> Acanthamoeba Keratitis