West Palm Beach Personal Injury Lawyer - Defective Products

Big Bird Weighed Down by Lead

John Hopkins — Thu, 02 Aug 2007 08:43:11 GMT

Fisher-Price is recalling 83 types of toys -- including the popular Big Bird, Elmo, Dora and Diego characters -- because their paint contains excessive amounts of lead. CNN reports that more than 967,000 toys have been recalled.

This is a unique recall since Mattel, the parent company to Fisher Price, maintains very high quality control standards and have had only one previous recall of a product. To their credit, Mattel apparently discovered the lead paint problem through an internal quality control inspection. Many manufacturers have such lax or non-existent quality standards that dangerous defects are either not discovered by the manufacturer or not reported by the manufacturer once discovered.

This is simply one of a series of product problems to come out of Chinese manufactured goods.

I am happy to see, however, a manufacturer such as Mattel who at least on the surface has demonstrated corporate responsibility in trying to protect a product even when they must disclose production problems.

Originally posted at InjuryBoard by John Hopkins

Its Not Just China--Castleberry Recalls 75 Brands

John Hopkins — Tue, 24 Jul 2007 12:58:21 GMT

China was criticised for bad pet food, poisoned toothpast and tires that they forgot to glue together. But, not to be outdone, enter Castleberry Food Company. They have issued recall of 75 different products; all apparently suspected of being contaminated with botulism.

Botulism contamination of canned, processed foods, in the US is extremely rare. That said, botulism can cause a severe, debilitating and sometimes fatal illness. The botulism latches on to certain proteins in the nerve endings and cause severe paralysis.

The diagnosis of botulism poisoning can be difficult; since the illness mimics several other different diseases and ilnesses. Treatment often includes respiratory support, surgery, gastric lavage and enemas.

Symptoms include blurred vision, double vision, slurred speech, difficulty swallowing, and muscle weakness.

The recall includes the following products:

1. 12-pack of 15-ounce cans of "Austex Beef Stew."
2. 15- and 19-ounce cans of "Austex Chili with Beans."
3. 12-pack of 15-ounce cans of "Austex Chili No Beans."
4. 12-pack of 19-ounce cans of "Austex Chili No Beans."
5. 15-ounce cans of "Best Yet Chili with Beans."
6. 15-ounce cans of "Best Yet Corned Beef Hash."
7. 15-ounce cans of "Big Y Chili with Beans."
8. 15-ounce cans of "Big Y Chili no Beans."
9. 15-ounce cans of "Big Y Corned Beef Hash."
10. 15-ounce cans of "Black Rock Chili with Beans."
11. 24-pack of 10-ounce cans of "Bryan Hot Dog Chili Sauce."
12. 24-pack of 15-ounce cans of "Bryan Corned Beef Hash."
13. 24-pack of 10-ounce cans of "Bryan Chili No Beans."
14. 24-pack of 15-ounce cans of "Bryan Chili No Beans."
15. 24-pack of 15-ounce cans of "Bryan Chili with Beans."
16. 10-ounce cans of "Bunker Hill Chili no Beans."
17. 10-ounce cans of "Bunker Hill Chunky Chili no Beans."
18. 10-ounce cans of "Castle Chili No Beans."
19. 15-ounce cans of "Castleberry's Beef Stew."
20. 15-ounce cans of "Castleberry's Brunswick Stew."
21. 10-ounce cans of "Castleberry's BUNKER HILL, ORIGINAL Chili NO BEANS."
22. 15-ounce cans of "Castleberry's CHILI WITH BEANS."
23. 12-pack of 15-ounce cans of "Castleberry's Chili No Beans."
24. 15-ounce cans of "Castleberry's Corned Beef Hash."
25. 10-ounce cans of "Castleberry's HICKORY SMOKED, OVEN ROASTED, WITH SKINS, BARBECUE PORK IN BARBECUE SAUCE."
26. 12-pack of 15-ounce cans of "Castleberry's Hot Chili with Beans."
27. 10- and 14.5-ounce cans of "Castleberry's BBQ Pork."
28. 10-ounce cans of "Castleberry's Sausage Gravy."
29. 10-ounce cans of "Castleberry's Chip Beef Gravy."
30. 15-ounce cans of "Cattle Drive Beef Stew."
31. 15-ounce cans of "Cattle Drive Chili with Beans."
32. 15-ounce cans of "Cattle Drive Chili no Beans."
33. 15-ounce cans of "Cattle Drive CHILI WITH BEANS."
34. 8-pack of 15-ounce cans of "Cattle Drive Chili with Beans."
35. 15-ounce cans of "Cattle Drive Chicken Chili with Beans."
36. 15-ounce cans of "Firefighter Chicken Chili."
37. 15-ounce cans of "Firefighter Chicken Chili with Beans."
38. 15-ounce cans of "Firefighter Chili with Beans."
39. 15-ounce cans of "Firefighter Chili no Beans."
40. 15-ounce cans of "Food Club Chili with Beans."
41. 15-ounce cans of "Food Club Corned Beef Hash."
42. 15-ounce cans of "Georgia Hash."
43. 10- and 15-ounce cans of "Goldstar Chili."
44. 15-ounce cans of "Goldstar Tex Mex Chili."
45. 15-ounce cans of "Great Value Chili with Beans."
46. 15-ounce cans of "Great Value Hot Chili with Beans."
47. 15-ounce cans of "Kroger Beef Stew."
48. 15-ounce cans of "Kroger Chili with Beans."
49. 15-ounce cans of "Kroger Chili no Bean."
50. 15-ounce cans of "Lowes Chili no Bean."
51. 15-ounce cans of "Lowes Chili with Beans."
52. 15-ounce cans of "Lowes Corn Beef Hash."
53. 15-ounce cans of "Meijer Chili with Beans."
54. 15-ounce cans of "Meijer Chili no Beans."
55. 15-ounce cans of "Meijer CORNED BEEF HASH."
56. 12-pack of 15-ounce cans of "Morton House Chili with Beans."
57. 15-ounce cans of "Morton House Corned Beef Hash."
58. 10- and 15-ounce cans of "Paramount Hot Dog Chili Sauce."
59. 15-ounce cans of "Paramount Chili no Bean."
60. 15-ounce cans of "Paramount Chili with Beans."
61. 15-ounce cans of "Piggly Wiggly Chili with Beans."
62. 10- and 15-ounce cans of "Piggly Wiggly Chili no Bean."
63. 15-ounce cans of "Piggly Wiggly Corned Beef Hash."
64. 12-pack of 15-ounce cans of "Prudence Corned Beef Hash."
65. 15-ounce cans of "Southern Home Chili with Beans."
66. 10- and 15-ounce cans of "Southern Home Chili no Bean."
67. 15-ounce cans of "Southern Home Corned Beef Hash."
68. 10-ounce cans of "Steak N Shake Chili."
69. 15-ounce cans of "Thrifty Maid Chili with Beans."
70. 15-ounce cans of "Thrifty Maid Corned Beef Hash."
71. 15-ounce cans of "Triple Bar Chili with Beans."
72. 12-pack of 15-ounce cans of "Triple Bar Chili with Beans."
73. 15-ounce cans of "Triple Bar Chili no Beans."
74. 12-pack of 15-ounce cans of "Triple Bar Chili no Beans."
75. 15-ounce cans of "Value Time Chili with Beans."

For more information on this subject, please refer to our section on Defective and Dangerous Products.

Originally posted at InjuryBoard by John Hopkins

China's Version of the FDA--Tough Place to Work

John Hopkins — Tue, 17 Jul 2007 09:56:36 GMT

China has certainly suffered its share of setbacks in the export of products to the rest of the world. They have allowed tainted toothpaste to leave their country and deadly dog & cat food to be exported. Most recently, it was discovered that Chinese tires were manufactured without including the material that binds the belts together.

China's response to this event has been essentially two-fold. They blame foreign media for over blowing the whole thing. They especially point to the West's media for concentrating on what they claim are isolated incidents:

"Some foreign media, especially those based in the U.S., have wantonly reported on so called unsafe Chinese products. They are turning white to black," said Li Changjiang, minister of the General Administration of Quality Supervision, Inspection and Quarantine.

If we consider the numbers of recalled products in the U.S., one might agree that we live in a crystal palace" and, perhaps, throwing rocks in this instance is a bit hypocritical. Our FDA allows the marketing of products repeatedly that are later found to be dangerous or not to meet expectations. These problems often stem from manufacturers' failure to fully test products or to misrepresent test findings, but those faulty products still end up in the stream of commerce.

When faced with product problems, the Chinese government investigated and they represent findings of corruption in their version of the FDA. In the U.S., the response to findings like that might be to form a committee to investigate. In China, their response to product defect and corruption findings? They executed the former head of its drug regulation agency. I would say China's drug agency is a much tougher place to work than the FDA.

For more information on this subject matter, please refer to the section on Defective and Dangerous Products.

Originally posted at InjuryBoard by John Hopkins

What is the Solution?

Armand Rossetti — Fri, 06 Jul 2007 09:42:30 GMT

Most strains of Acanthamoeba will survive exposure to AMO's Complete MoisturePlus, Alcon's OptiFree Express and B&L's ReNu MultiPlus. Under testing conditions that reflect the "real world," none of those solutions are stellar performers, and only one is effective under certain conditions.

Recently, Complete Moisture Plus has been shown to be seven times more likely to have caused the most recent contact lens related Acanthamoeba outbreak, but just how much less effective is AMO's Complete than B&L's ReNu MultiPlus or Alcon's OptiFree Express solution?

Although Acanthamoeba keratitis (AK) is not a new phenomenon, it is a fairly recent one. The first AK cases were recognized in 1973. However, before soft contact-lens wear became popular, AK was extremely rare. As soft hydrogel lenses became more prevalent, exposure to Acanthamoeba led to an epidemic that began in the early 1980s, and the number of AK cases increased dramatically beginning in 1984.

By 1985, investigators had established a connection between AK infections and the use of contact lenses. As early as 1987 further studies revealed that AK occurred more commonly among men, as well as in contact-lens wearers who failed to disinfect their lenses as frequently as recommended, swam while wearing lenses, or used homemade instead of commercially prepared saline solution.

In January 1997, the CDC conducted a retrospective survey of 22 ophthalmology centers across the United States to determine whether the infection rate was increasing nationwide. By March 2007, the CDC had determined the existence of widespread, culture confirmed cases of AK, and that the most recent increase in cases had begun in 2004 and continued through 2007.

On March 16, 2007, the CDC began a multistate investigation to look for AK related risk factors. It was at this time that use of AMO's Complete MoisturePlus emerged as being most closely connected with the latest rise in contact lens related AK.

The most recent increase in the number of contact lens related AK cases raises certain questions: Why has this phenomenon occurred? Why is AMO's Complete MoisturePlus mostly to blame? Are other no-rub solutions connected with the outbreak, and to what extent? Is there anything that can be done to alleviate the AK problem?

Although the foregoing questions are broad, open ended, and cannot be answered without substantial investigation (certainly not in a blog), consider the following observations:

NOT ONE, SINGLE NO-RUB SOLUTION CAN CLAIM TRUE EFFICACY IN COMBATING AK, AND OF THREE NO-RUB SOLUTIONS RECENTLY TESTED, COMPLETE MOISTUREPLUS PLACED LAST

In its March 2007 edition, Optometry and Vision Science contained an article by Megan Shoff, et al. The Shoff article compared the variable responses of 14 different Acanthamoeba strains to three no-rub solutions, namely, MultiPlus (B&L), Complete (AMO, a spin off of Allergan) and OptiFree Express (Alcon). The investigators subjected each of the two sets of 14 strains to each of the three solutions to test survival rates at 3, 6, and 24 hours of exposure. One set was Acanthamoebae in the more vulnerable trophozoite stage, and the other set was Acanthamoebae in the much less vulnerable encapsulated cystic stage. The results were surprising.

According to graphs contained in the study, over 90% of exposed trophozoite Acanthamoeba withstood a 3 hour and 6 hour exposure to AMO's Complete (a less than 10% kill rate). ReNu was able to achieve only 12% in three hours and 14% in 6 hours. OptiFree was the stellar performer under these testing conditions, with a 31% kill in 3 hours and 42% in 6 hours. It took a 24 hour exposure for Complete to approximate a less than efficacious 6 hour exposure to ReNu MultiPlus.

Turning to the cystiform Acanthamoeba results, It took a 24 hour exposure for Complete to achieve an approximate two (2) % kill; this was a very poor result. The best that OptiFree could achieve was 18% kill in 24 hours (not 3 or 6 hours). Three and six hour exposure using Complete resulted in zero (0) % kill. Complete's performance contrasted with an equally paltry 2 - 7% kill range for ReNu MultiPlus and OptiFree Express. The results speak for themselves, but let's play fair and analyze the testing methods.

SOLUTION MANUFACTURERS HAVE USED EFFICACY TESTING THAT HAS NOT ACCURATELY REFLECTED "REAL WORLD" AK INFECTION FACTORS

The method that most manufacturers use to report their results is based on the decimal kill rate. Manufacturers will defer to the FDA, indicating that log reduction is the gold standard for testing. Until the advent of one step solutions, that may have been the case. However, solution manufacturers are considered experts in the field of eye care. And as experts, manufacturers may have to transcend and/or educate regulatory agencies that a different approach to testing solution efficacy might be necessary. For example, the Shoff study has used the 100% inactivation method, which purportedly had the following advantages over log reduction:

1. The method was rapid and allowed for a screening of a wider range of strains.

2. The investigators were able to separate the trophozoites from the cysts, yielding more accurate and comparative analyses. Inadvertently including cyst forms with trophozoites could seriously undermine experimental results.

3. The test actually mimicked the response to Acanthamoeba attached to a surface (which would better represent microbial attachment to contaminated contact lenses). Acanthamoebae colonizing a contact lens are buried in biofilm that might afford better protection from cleaning solutions.

4. The present testing method did not disturb cells by centrifuging or vortexing them. For example, centrifugation might not affect the survival of cysts, but might damage sensitive trophozoites.

5. The Acanthamoebae were not starved. They were tested while growing on bacteria, making them more challenging, which is more "real world."

In addition, the Shoff study was able to show that testing axenically cultured strains of Acanthamoeba, the way that manufacturers usually do, has two important limitations:

1. The axenic strains are selected in the laboratory and may not represent the "hardiness' of bacterized wild strains.

2. It is likely that Acanthamoeba on contact lenses are surviving in the biofilm on the lens surface, where you can find components such as; tear film, proteins, mucins, lipids and bacteria. This is a very different environment than is found in a "squeaky clean" axenic system.

The Shoff study also restated the truism that some strains of Acanthamoeba are harder to kill than others, and that it would be prudent to choose a harder strain of Acanthamoeba, before undertaking solution sensitivity testing.

As previously mentioned, older testing methods do not mirror actual contact lens wearing conditions. The Shoff study has stated that the inability to kill more than 20% of any strain of Acanthamoeba is disturbing. This important observation should foster the necessary research to find more effective and less toxic chemical disinfectants or to encourage an effort to formulate more effective solutions. The Shoff study sould also lead authorities to question the validity of current axenic testing methods, and to find acceptable alternative methods.

For more information on this subject, please refer to our section on Defective and Dangerous Products.

Originally posted at InjuryBoard by Armand Rossetti

AMO Urges Consumers to Dispose of Evidence

John Hopkins — Wed, 27 Jun 2007 09:54:15 GMT

The OCRegister reported that AMO and the FDA are "...urging people to dispose of Complete Moisture Plus Multi-Purpose solution...", which the CDC and FDA have linked to a rare and unusual eye infection. Acanthamoeba is an organism commonly found in water. Although most acanthamoeba infections occur in contact lens wearers, it is extremely rare; affecting only one or two wearers in every million contact lens users.

Although AMO persists in blaming the consumers for their own infections, it seems pretty clear that the Complete solution was not up to standards in resisting infection.

So, why do I raise the issue regarding AMO recommending that consumers dispose of the solution and their cases? The disposal of the solution and the cases reaps a potential benefit to AMO. I suspect that one of the things that AMO will expect from plaitiffs is to prove they used the solution; but, without consultation with an attorney, the public is being encouraged by AMO to destroy the very evidence that AMO will later expect the plaintiffs to produce in order to validate their claims.

Reports indicate that AMO may have known about the problems with the Complete solution ofr as long as two years and did nothing to warn the public. Should we trust that AMO is simply now looking out fo rthe best interests of the consumer by encouraging disposal of the evidence? I think not.

For more information on this subject matter please refer to the section on Defective and Dangerous Products.

Originally posted at InjuryBoard by John Hopkins

Two Questions that Concern AMO and Acanthamoeba Infections

Armand Rossetti — Tue, 12 Jun 2007 14:24:24 GMT

The cornea is the only tissue in the body that Acanthamoebae (or Acanthamoeba) can invade in individuals with healthy immune systems. Otherwise, those individuals can usually avoid Acanthamoeba infections that affect the skin, brain and lungs. This blog briefly addresses two questions: 1) Why is the cornea more susceptible to Acanthamoeba than other tissues in the body; and 2) How could a multipurpose disinfectant solution, such as AMO's Complete MoisturePLUS aid in promoting Acanthamoeba infection?

Question 1:

How does Acanthamoeba invade corneal tissue?

Acanthamoeba is everywhere; it is found in water fountains, tap water, bottled water, freshwater ponds, thermal water, well water, Jacuzzis, swimming pools, aquaria, municipal sewage, ocean sewage, house dust, garden soil, sand boxes, garden vegetables, fish and air conditioners. This list is not exhaustive. Conventional treatment of water delivery systems will not necessarily kill all Acanthamoeba.

The answer to why Acanthamoeba has an easier time infecting the cornea seems to be connected with certain chemicals found on Acanthamoeba's outer membrane, one of which is called mannose binding protein (MBP). Researchers have long suspected and now have proof that MBP allows Acanthamoeba to bind to corneal cells.

Despite having help from MBP, however, Acanthamoeba usually have trouble binding to corneal tissue. This difficulty is evident because the eye has a natural defense mechanism found in tear film. Tears are usually loaded with beneficial chemicals, enzymes and antibodies that have complicated names, such as lysozyme, lactoferrin, and secretory IGA. In addition if you are normally healthy, just blinking your eye can protect you against Acanthamoeba infection. It may not seem obvious at first, but blinking increases the tear fluid volume that contains those Acanthamoeba fighting chemicals.

However, once Acanthamoeba overcomes the natural defense system and chemically sticks itself to the cornea, Acanthamoeba can begin to mount its own insidious chemical attack on the cornea. This Acanthamoeba attack is called a cytopathic effect (CPE), and that process leads to a systematic destruction of targeted corneal cells. Furthermore, if Acanthamoeba can gain a foothold on the cornea, and can use bacteria that are present as a food source.

To make matters worse, contact lenses can serve as vectors. A vector is a means of transmitting an infective agent from one location to another. In the case of Acanthamoeba keratitis, the contact lens, itself, can transport amoeba found in many locations, including contact lens cases, to the eye. Even if a lens case is Acanthamoeba free, a lens, coated with lens solution, containing chemicals that create a "friendly" environment for Acanthamoeba to thrive, can attract Acanthamoeba from almost anywhere in the environment.

It is also interesting that Acanthamoeba can live symbiotically with bacteria. Living symbiotically means that Acanthamoeba have the uncanny ability to "eat" some bacteria for nourishment, and process other bacteria through its system to create stronger, more virulent bacterial strains. Acanthamoeba can then deposit the more virulent processed bacteria on the corneal surface. Those bacteria then act as Acanthamoeba's "allies," mixing with tear fluid and weakening the cornea's natural resistance to all microorganisms, including Acanthamoeba. The enhanced organisms then continue to multiply, playing havoc relentlessly with the eye's chemical defense system.

Question 2:

What role did AMO's one step "no rub" solution, Complete MoisturePLUS, play in causing the recently reported Acanthamoeba outbreak?

The CDC estimated the risk of Acanthamoeba infection as being at least seven times greater for those who used CompleteÂ® MoisturePLUSTM solution versus those who used other solutions.

Let's start by looking at the mechanical and chemical aspects of corneal keratitis. It is well known that microtrauma to the cornea increases Acanthamoeba's opportunity to invade corneal tissue. Trauma also enhances the ability of most other organisms to attach themselves to or to otherwise infect the cornea.

Microtrauma causes tiny sores to appear as scratches or openings on the cornea's otherwise tough and impermeable surface. Microtrauma can occur as a result wearing ill-fitting contact lenses, from using multipurpose solutions that might be toxic to the cornea, from using incompatible contact lens-lens solution systems, or from a combination of all three plus other factors.

In addition to microtrauma, a biochemical imbalance caused by the presence of wear-contaminated multipurpose solution could disrupt the eye's defense mechanism. Stubborn, hard to remove solution components that remain on the lens, even after soaking, can lower the concentration of antibodies that would ordinarily combat Acanthamoeba's attempt to attach to and infect the cornea. Let's take a look at ingredients found in one-step solutions that might be contributing to biologically enhanced "chemo trauma."

For example, let's look at some of the ingredients found in Complete MoisturePLUS. In addition to other chemicals, Complete MoisturePlus contains hydroxypropyl methylcellulose and propylene glycol that serve as lubricants and Poloxamer 237 a "slippery" component (surfactant). Experts, including manufacturers who are always regarded as experts in their field, should be focused on whether remnants of one or all of these ingredients on used lenses are impossible to eliminate from the lens surface without rubbing.

If rubbing is necessary, a soaking only procedure would cause cumulative contamination of the cornea/contact lens/solution environment. Experts should also focus on: 1) whether any chemical components can cause chemical microtrauma; and 2) whether the Poloxamer 237, which itself is a reverse hydrogel, can react with the lens hydrogel to challenge the solution's disinfecting capability.

Perhaps one major reason for the Acanthamoeba outbreak has been the "no rub" obsession.

Certain one step solutions, which have been loosely advertised as "no rub" disinfecting solutions do not adequately clean contact lenses without rubbing. In the pursuit of market share, manufacturers have diminished the importance rubbing lenses for only a few seconds to eliminate stuck on contamination and rinsing them before soaking. It is a dangerous practice to deliberately downplay the importance of rubbing just to make a marketing point.

In fact, more than one manufacturer has been irresponsible in pursuit of glib marketing. As all manufacturers know or should know, most one step solutions may react unpredictably when used with the hundreds of different types of soft lenses on the market today. Manufacturers have not tested their solutions with each type of lens. Therefore, manufacturers should not have advertised, generally, that no rub solutions were cabable of cleaning all types of lenses. Manufacturers' failure to exercise more care before making such claims could be a major factor resulting in abnormal incidents of Acanthamoeba keratitis.

It makes sense, as well, that carrying polluted lens surfaces from the eye to the lens case for soaking, without first rubbing the sticky, contaminated remaining solution off the lens surface could endanger the delicate ocular environment.

In addition, it should have made scientific sense to manufacturers that failing to take a few seconds to rub lenses clean before soaking them was as bad a practice, if not a worse practice, than topping off lens solution in a lens case. Manufacturers should have realized (and probably did realize from the get go) the need to rub lenses when using a so called "no rub" solutions.

Rushing to be first in the marketplace of ideas in order to capture market share is no excuse for being careless.

What time and resources would manufacturers have had to expend to run tests to compare rubbing to no rubbing using consumer test groups? Methods for such testing had appeared in Optometry and Vision Science several years ago, together with a warning about the need for further no rub testing. Yet, manufacturers chose instead to release solutions without first conducting proper testing.

Recently, Bausch & Lomb's Director of Professional Relations, Dr. Christopher Snyder, recommended rubbing contact lenses before soaking them in ReNu MultiPlus multipurpose "no rub" disinfecting solution. In listening to Dr. Snyder's words, the message is clear. There is no such thing a totally effective "no rub" solution. Dr. Snyder has also expressed the long realized importance of rubbing lenses a second time, in Bausch & Lomb's Special Report, a Supplement to Contact Lens Spectrum.

More than three years ago, manufacturers such as AMO and Bausch & Lomb had ample opportunity to avoid grave danger to the public, and could have done so by admitting just how inadequate all one step "No rub" solutions were in fighting a wide spectrum of opportunistic corneal infection. The manufacturers could have at least alerted providers.

Knowledgeable providers usually instruct their patients not to top off solution in a lens case. Therefore consumers that are so instructed, become knowledgeable and must take some responsibility for their own actions for failure to follow instructions. However, by using slick advertising, manufactures continuously advised providers, whether sitting at roundtables, reading journals or taking continuing education classes, that one-step solutions were effective "no rub" solutions.

Therefore, those trusting providers had no reason to instruct their patients to perform effective lens hygiene by rubbing their lenses before soaking. Patients who were not properly instructed or warned cannot be held responsible for "bad hygiene practices."

Likewise, if patients are continuously bombarded with media advertising that portrays a lens solution as a breakthrough, one step, "no rub" solution, those consumers will not question the veracity of that statement, or discuss it with their providers. And the "no rub" advertising mantra then becomes gospel to consumers. Unwary providers add legitimacy to such advertising claims by unknowingly reinforcing manufacturer's untested misrepresentations, and handing out solution trial packs to their patients.

Early on, all one step "no rub" manufacturers should have done what Dr. Snyder is now doing...telling the truth. It is better to be tardy with the truth, than not following through at all in an effort to run for cover.

Lastly, as the FDA has found, and AMO has admitted by its recall, something is unreasonably dangerous about AMO's Complete MoisturePLUS. Manufacturers like AMO are in the best position to determine the reasons for that danger. Furthermore, AMO has had a duty for more than a year, to warn consumers and providers about that danger. As a result of not warning of the danger, AMO now has an obligation to compensate affected consumers for injuries that CompleteÂ® MoisturePLUS has caused.

It is time for AMO and other manufacturers in a like position to step up to the plate, before it's too late. A little manufacturer concern is worth a lot of consumer pain, injury and frustration.

Originally posted at InjuryBoard by Armand Rossetti

Its in the Water? Researchers Blame the EPA for Contact Lens Infections

John Hopkins — Mon, 11 Jun 2007 08:58:38 GMT

So, AMO and Bausch want to blame the EPA and the water for their problems with ReNuÂ® and CompleteÂ® contact lens solutions. Conveniently, researchers in Illinois stood ready with a study that gave the opportunity to blame the Environmental Protection Agency for the whole problem. The researchers, Drs. Tu and Joslin reported infections from acanthamoeba that were drastically higher than normal.

Given the fact that acanthamoeba is an extremely rare eye infection, the researchers must have found the need or desire to affix blame. They apparently speculate that the cause of the increased infections is in the water. They opine that the EPA's lowering of chlorine in water systems is to blame.

The Chicago Tribune has reported what is the more likely cause in both the ReNuÂ® outbreak of fungal infection and this most recent CompleteÂ® outbreak of acanthamoeba:

The statistics show that something in AMO Complete MoisturePlus helped create those special circumstances for infection; people who got the infection were seven times more likely than healthy soft contact users to have used the AMO product. But Roy said that for now, the reason for that gap remains a mystery.

Originally posted at InjuryBoard by John Hopkins

Contact Lens Solution Linked to Acanthamoeba Keratitis

John Hopkins — Wed, 30 May 2007 09:12:52 GMT

On May 25, AMO (Advanced Medical Optics) announced a recall of their "No Rub" solution, CompleteÂ® MoisturePlus â„¢ Multipurpose Solution. Although the company stands by its product and casts the blame on contact lens wearers who "improperly store, disinfect or handle" their contact lenses, the CDC forced them to recall the solution

This recall is not so distant from Bausch & Lomb's recall of ReNu with MoistureLoc, which caused serious injury to many contact lens wearers. AMO's press release states they have known since January of 2005 about at least 46 patients who claimed to have contracted a unique form of keratitis from the AMO solution. This keratitis is called "acanthamoeba keratitis (AK)". From all indications, AMO delayed as long as Bausch did in coming forward and recalling the product; potentially exposing an untold number of unsuspecting contact lens wearers to this painful eye infection that can cause permanent vision loss or blindness.

In 2004, the eye infection first occurred in more than a dozen people against the normal count of one or two in a year. Dr. Elmer Tu, an ophthalmologist at the University of Illinois, Chicago, along with other doctors attended around 35 patients from May 2003 to September of 2006, 55% of whom were infected due to usage of AMO's solution.

One must wonder what corporations who suspect problems with their products are thinking when they wait one, two, or more years before warning the public about a potential hazard provoked or caused by their product. We wonder how much injury must occur before corporate dollars are sufficient.

Originally posted at InjuryBoard by John Hopkins

Big Tobacco, Scorched Earth Tactics & the Engle Case

John Hopkins — Tue, 06 Feb 2007 17:05:07 GMT

The Florida Supreme Court has issued its mandate in the Engle v Liggett case. This case involved a class action by Florida smokers against Big Tobacco. Florida smokers who qualify as "Engle class members" must now take some action against Big Tobacco in less than one year. The Supreme Court made certain findings of fact and law that may place Big Tobacco at a distinct disadvantage and Florida smokers at an advantage--if Florida courts make Big Tobacco get to trial swiftly. The court made some of the following findings:

1. that smoking cigarettes causes aortic aneurysm, bladder cancer, cerebrovascular
disease, cervical cancer, chronic obstructive pulmonary disease, coronary heart disease, esophageal cancer, kidney cancer, laryngeal cancer, lung cancer, complications of pregnancy, oral cavity/tongue cancer, pancreatic cancer, peripheral vascular disease, pharyngeal cancer, and stomach cancer;
2. that nicotine in cigarettes is addictive;
3. that the defendants placed cigarettes on the market that were defective and unreasonably dangerous;
4. that the defendants concealed or omitted material information not otherwise known or available knowing that the material was false or misleading or failed to disclose a material fact concerning the health effects or addictive nature of smoking cigarettes or both;
5. that all of the defendants agreed to misrepresent information relating to the health effects of cigarettes or the addictive nature of cigarettes with the intention that smokers and the public would rely on this information to their detriment;
6. that the defendants agreed to conceal or omit information regarding the health effects of cigarettes or their addictive nature with the intention that smokers and the public would rely on this information to their detriment;
7. that all of the defendants sold or supplied cigarettes that were defective;
8. that all of the defendants were negligent.

Almost sounds as if Big Tobacco has finally met their match; but this brings up the "scorched earth" approach to defending lawsuits and Big Tobacco is the most proficient practitioner of this craft. To set the stage for this, let's look at the most classic definition of this theory of warfare:

A scorched earth policy is a military tactic which involves destroying anything that might be useful to the enemy while advancing through or withdrawing from an area. Apparently a translation of Chinese (Jiao Tu), the term refers to the practice of burning crops to deny the enemy food sources, although it is by no means limited to food stocks, and can include shelter, transportation, communications and industrial resources, which are often of equal or greater military value in modern warfare, as modern armies generally carry their own food supplies. The practice may be carried out by an army in enemy territory, or by an army in its own home territory.

Big Tobacco is famous for this strategy. In the context of litigation, it essentially means they and their armies of lawyers will do nearly anything and, some have claimed, anything, to destroy the plaintiff and the plaintiff's case. All is fair in the heat of the battle? Well, maybe, but some claim that Big Tobacco's scorching of the earth exceeds the measures employed by even the most ruthless adversary. They have been known to employ delay tactics in hopes that the plaintiff will die before the case can reach trial; they have been known to drag their feet to the point of violating court orders in an effort at delaying cases from reaching the courthouse for years. They have allegedly, in the past, withheld evidence to avoid the presentation of documents clearly demonstrating deceitful and fraudulent practices.

In fact, one of the very famous warriors against Big Tobacco's tactics when he went after them, Richard Scruggs said, "This was an industry that had never been beaten, that had literally defied the judicial system and the regulatory system for decades, and yet was killing millions of people. You know, it was just a challenge that cried out for somebody to do it."

Another respected Big Tobacco adversary, former Attorney General of Mississippi, Mike Moore, said: "Because they come after you. And they did. They sent former attorneys general, hired as lobbyists, to every attorney general in this country. They sent business representatives, industry representatives, not just tobacco, but whatever state it was in. In Louisiana, they sent a chemical industry and oil industry to the state attorney general, said "You better not do this or we are coming after you." You know, "It's bad for business." I mean, in my own state, my governor sued me."

So, what will Big Tobacco do with the plaintiffs who pursue them in the "Engle" class of cases? Probably the same approach. They know they have a group of sick, elderly and infirmed smokers or ex-smokers. My guess is they have already crunched the numbers and have calculated the length of delays needed in order to allow a sufficient number of the Engle class plaintiffs to die or become worn out with the litigation.

Some of the greatest trial attorneys in the State of Florida; in fact, some the best trial attorneys in the country are coming together to further the fight on behalf of injured victims of Big Tobacco. For the first time in history Big Tobacco will face thousands of individual lawsuits and a cadre of skilled trial attorneys that they have never had to face before at one time. That is the good news for the Engle class victims.

Originally posted at InjuryBoard by John Hopkins

Fiery Train Crash in Kentucky

John Hopkins — Tue, 16 Jan 2007 15:40:40 GMT

Reports of several train cars crashing in Kentucky have apparently closed highways and forced mass evacuations of schools, businesses and homes in Bullitt County, Kentucky.

It appears that several of the derailing train cars were carrying flammable liquids, which resulted in explosions and flaming liquid flowing along ditches at the train crash site. CBS reports that the wreck involved (4) locomotives and 80 rail cars. CBS also siad that this was the second crash in two days:

It was the second fiery train crash in Kentucky in two days. On Monday, four runaway rail cars struck two parked locomotives in central Kentucky, catching fire and spilling a chemical that prompted a limited evacuation.

Apparently the previous train wreck involved four runaway rail cars somehow struck a parked locomotive, according to AP reports. Supposedly, the cars contained butyl acetate. That train wreck resulted in explosions as well.

Originally posted at InjuryBoard by John Hopkins