Klein | Frank, P.C. is accepting cases against this defendant who sold extended automobile warranties that are not worth the paper they is printed on. These “extended warranties” may promise to reimburse you the full price you paid for it, if you don’t make a claim during the policy period.

What the telemarketers do not tell you is that the policy begins to run on a date much earlier than they represent, usually years earlier, so that when you call to get your money back, they tell you that extended warranty expired 2 or 3 years sooner than you expected. So, rather than buying a warranty that really extends the car manufacturer’s warranty, you have paid for a “warranty” that ran during the same time as the original warranty on your car and did not provide any additional benefits. To make matters worse, the critical dates are often omitted from the contract you receive and other important language is hidden in the fine print of the document.

This Defendant has entered into consent orders with the Attorney General’s office in Missouri relating to these money back selling tactics.

If you believe you have been damaged by CARHILL ENTERPRISES, INC. aka CONSUMER PROTECTION SERVICES of St. Louiscall us at 303-448-8884, we want to help you.  You may be entitled to three times the value of what you paid for the extended warranty plus attorneys fees.

Here is a link to a recent article in the Denver Post.

http://www.denverpost.com/mobile/ci_12442847

Here are good links on the scope of the issues with Carhill.

http://stlouis.bizjournals.com/stlouis/stories/2009/05/04/daily43.html

http://stlouis.bbb.org/article/10353

http://www.buyingadvice.com/auto-extended-warranty.html

http://www.consumeraffairs.com/news04/2008/03/cr_warranties.html

On another note, most of the states’ Attorney General offices are going after car warranty scam artist businesses for violating the Do Not Call Registry. These companies use automated telephone dialers to call all the phone numbers in an area code without regard to whether or not someone is on the Do Not Call Registry. Your telephone Caller-Id will show a fake number, an illegal practice known as “spoofing.” These calls are going to both home and cell phone numbers. And some of the people that are receiving the calls do not even own a car.

The AP(5/21, Yost) reports, “The Obama White House on Wednesday undid a Bush administration policy that used federal regulations to undermine a wide range of state health, safety and environmental laws” many of which “limited the ability of injured consumers to sue companies in state courts.” This is the latest move by the Obama administration to undo pre-emption policy. Kenneth Baer, communications director at the White House Office of Management and Budget, said, “When it comes to pre-emption, we’re saying no more of their approach.” Now, “the Obama administration will ask agencies to go back and find Bush-era regulations that contain pre-emption language in the preambles or in the body of the regulations and that are not justified by law.”

The Wall Street Journal(5/21, Mundy, Kendall) reports, “The memo didn’t name specific industries but it could affect a wide range of consumer products subject to both federal and state regulation.” The Chamber of Commerce’s Bryan Quigley said, “Allowing for more lawsuits will not create more jobs, except maybe for plaintiffs’ lawyers.” However, a statement by the American Association for Justice said, “The move will buttress ‘laws designed to give Americans basic rights to hold wrongdoers accountable.’”

BusinessWeek(5/21, Francis) reports, “Lauded by the plaintiffs’ bar and downplayed by some business groups, Obama’s decision reverses a highly charged Bush Administration practice and could help rewrite the legal landscape for everything from pharmaceuticals and beauty products to car safety equipment, mattress flammability, and food sweeteners.”

It;s long overdue that the rule of law rather than the rule of corporate political contributions prevail in the United States.

By GARDINER HARRIS

An official at the Food and Drug Administration overruled front-line agency scientists and approved the sale of an imaging device for breast cancer after receiving a phone call from a Connecticut congressman, according to internal agency documents.

The legislator’s call and its effect on what is supposed to be a science-based approval process is only one of many of accusations in a trove of documents regarding disputes within the agency’s office of device evaluation. Nine agency scientists complained in May to Andrew C. von Eschenbach, the F.D.A. commissioner, and the agency began an internal review. Dissatisfied with the pace and results of that review, the scientists wrote a letter to Congress in October pleading for an investigation, and the House Committee on Energy and Commerce announced in November that it would begin one. Last week, the scientists wrote a similar letter to President-elect Barack Obama’s transition team.

Agency documents that are part of the internal investigation, including e-mail messages, were provided to The New York Times. Details of the investigations have not previously been made public.

The documents show that front-line agency scientists, like many outside critics of the agency, believe that F.D.A. managers have become too lenient with the industry. In medical reviews and e-mail messages, the scientists criticize the process by which many medical devices gain approval without extensive testing. And in e-mail correspondence, they contend that an agency supervisor improperly forced them to alter reviews of the breast imaging device and others.

William McConagha, the agency’s assistant commissioner for integrity and accountability, said he was continuing to investigate the scientists’ claims. Mr. McConagha said that Dr. von Eschenbach had offered to meet with the nine scientists before Friday, his last day in office.

“We in the Office of Commissioner are extremely concerned about allegations like this,” Mr. McConagha said.

In the documents, Representative Christopher Shays, a Connecticut Republican who lost re-election in November, is described as having called an agency supervisor a year ago to express concern about the fate of a computer device that is supposed to help radiologists detect breast tumors.

The device, the iCAD SecondLook Digital Computer-Aided Detection System for Mammography, is used with screening equipment made by Fujifilm Medical Systems.

Fujifilm Medical is based in Stamford, Conn., the heart of Mr. Shays’s former district. In the documents, Mr. Shays is referred to as “Congressman Fuji.”

“I am the Fuji congressman because I represented that district,” Mr. Shays said in an interview Friday.

Mr. Shays said he had called the agency supervisor only to demand that the agency make a final decision, not that it approve the product.

He scoffed at suggestions in the documents that his call led the supervisor to overrule scientists and approve the device. “That would be idiotic for someone to approve something they don’t think should be approved,” he said.

A spokeswoman for Fujifilm Medical, Courtney A. Kraemer, said the company had called its “local Congressional offices to ask them to help us get clarification on the F.D.A. process.”

The dissenting scientists protested, according to the internal documents, that “iCAD never tested the device by the intended users (i.e. radiologists) under the intended conditions of use. This is the most basic and fundamental requirement of all F.D.A. submissions.”

An internal review said the risks of the iCAD device include missed cancers, “unnecessary biopsy or even surgery (by placing false positive marks) and unnecessary additional radiation.”

Ken Ferry, iCAD’s chief executive, said, “We have done all the appropriate testing to get the product approved.”

Mr. Ferry said that F.D.A. scientists were increasingly asking for more rigorous testing of devices, and that his company complied with those demands.

Diana Zuckerman, president of the National Research Center for Women and Families, said the Bush administration had “finally made the device approval process so meaningless that it’s intolerable to the scientists who work there.” Ms. Zucker, a longtime critic of the agency’s device approval process, particularly as it relates to breast implants, added, “Virtually everything gets approved, no matter what.”

The F.D.A. has a three-tiered approval process for medical devices that, depending on their newness or complexity, requires varying amounts of proof.

A growing chorus of critics contends that the agency requires few devices to complete the most rigorous of these reviews and instead allows most devices to be cleared with minimal oversight. In 2007, 41 devices went through the most rigorous process, compared with 3,052 that had abbreviated reviews.

According to internal documents, some scientists in the agency’s device division seem to agree with these critics. One extensive memorandum argued that F.D.A. managers had encouraged agency reviewers to use the abbreviated process even to approve devices that are so complex or novel that extensive clinical trials should be required.

For instance, Shina Systems, an Israeli company, applied for approval for AngioCt, a device that combines CT images with X-rays to help guide cardiac surgeons during angioplasty and stenting procedures. The company sought an abbreviated review, according to the documents.

An F.D.A. reviewer said the company should conduct a clinical trial to prove that the device works since it is novel and risky.

“Should the images be misleading,” Dr. Brian Lewis, an agency cardiologist, wrote in a memorandum, “F.D.A. could expect immediate misguidance of catheters and possibly puncture of coronary vessels or overaggressive, inappropriate or inadequate stent or balloon use.”

Nonetheless, an F.D.A. supervisor — after meeting with Shina representatives — pressed scientists to consider allowing an abbreviated review, according to the documents. The agency’s decision on the device is pending, according to the documents.

Dr. John Smith, a lawyer for Shina, wrote in an e-mail message that he would not comment on “ongoing regulatory matters.”

A machine known as the Ladar6000, manufactured by the Alcon conglomerate of corporations headquartered in Texas, has been causing vision problems to the patients who underwent LASIK surgery using the custom algorithm settings on the machine. When surgery is done with the custom settings, as opposed to the traditional settings, some patients end up with a condition called “central islands.” This occurs when the cornea is not smooth, but has a “bump” in the cornea, similar to an island sticking up in a smooth body of water; hence the name, central islands. The trouble is that when light enters the eyes, the central islands change the way the light is directed into the eye causing vision problems. Central islands cause a number of problems including blurring, ghosting, double vision, sensitivity to light, poor night vision, or headaches. At this time, there is no known surgery to correct these problems and glasses and contact lenses have not been able to restore 20/20 eyesight.

On February 21, 2007, Alcon participated in a voluntary recall to dismantle the custom algorithms on the Ladar6000 machines. Unfortunately, a number of people had surgery before the recall took place and have suffered the consequences. Many of these patients may think that their doctors did some wrong, but that does not appear to be the case. Anyone who is concerned that their failed LASIK procedure was performed with the Ladar6000 machine should contact the lawyers at Klein | Frank, P.C. 

Any claim is time limited, and the statute of limitations will bar all claims.  Ladar6000 machines were used at a number of doctor’s offices in Colorado, and failed LASIK

Children and adults who suffer paraplegia, quadriplegia, spinal cord injury, amputation and brain injury often experience loss of self-esteem and confidence; some are also afflicted by depression. Many children and adults feel excluded from family activities as a result of their physical limitations.

Studies have shown that participation in sports can be used for rehabilitation purposes. Children and adults who participate in sports programs are able to regain their sense of accomplishment. Through sports programs, children and adults are able to reunite with friends and family. Children and adults share the bonds of camaraderie while engaged in activities with other differently-abled and able-bodied athletes. Sports and recreational activities allow children and adults to experience the exhilaration of competition as well as the lessons learned from defeat.

With advancements in equipment and training of instructors, ability or adaptive programs are found in many cities across the country. Programs can be found through Disabled Sports USA. Colorado has several ability or adaptive programs including a chapter of the National Sports Center for the Disabled (www.nscd.org) located in Winter Park.

The National Sports Center for the Disabled is one of the largest outdoor therapeutic recreation agencies in the world. Thousands of children and adults with disabilities including paraplegia, quadriplegia, spinal cord injury, amputees, and brain injured individuals can participate in such activities as skiing (single or tandem), ski racing, snowboarding, horseback riding, mountain biking (handcrank/handcycle or tandem), fishing, golfing, or rock climbing in order become educated about physical activities and learn more about themselves. Programs offered reach all levels of ability.

People suffing from paraplegia, quadriplegia, spinal cord injury, amputation, and brain injury should have as much access to sports programs and social activities so that they can become and remain productive members of the community. We are here to help those individuals access those resources.

]]> http://www.lawcolorado.net/blog/uncategorized/quality-of-life-resources-for-paraplegia-quadriplegia-spinal-cord-injury-amputation-and-brain-injury/feed/ http://www.lawcolorado.net/blog/consumer-recalls/the-fda-cannot-ensure-consumer-food-safety/ http://www.lawcolorado.net/blog/consumer-recalls/the-fda-cannot-ensure-consumer-food-safety/#comments Wed, 07 Jan 2009 19:24:56 +0000 bethklein http://www.lawcolorado.net/blog/?p=77

Many people, especially those with food allergies, read the ingredients on the label to be sure that the food they are buying is safe. But what happens when the labels don’t tell the whole story? Sometimes, it’s a trip to the emergency room; but sometimes, it’s death.

The Food and Drug Administration (FDA) is responsible for overseeing the majority of food products sold to the public. But all too often, the FDA relies on the food manufacturers to police themselves. Truly, the “fox guarding the henhouse.” Unfortunately, the government and industry often fail to take the proper steps to test and label food until someone is hurt. And since many of the products are marketed to children, that means a child needs to get sick, or worse, before something is done.

A recent example is found with a young boy with a severe gluten allergy which prohibited him from eating foods made with wheat, rye or barley. His mother bought him Wellshire Kids’ Dinosaur Shapes Chicken Bites, which were labeled as “gluten-free.” Shortly after eating the chicken, the boy had a severe allergic reaction prompting his mother to give him a shot of a life saving drug and rushing him to the emergency room where he, fortunately, recovered. When this incident was brought to the attention of the manufacturer and the U.S. Department of Agriculture who oversees meat, poultry and eggs, neither would test the chicken bites and they remained for sale throughout the country with the incorrect label.  When testing was done by a large newspaper, gluten was found two out of two times. Sometime later, after there was another complaint by a consumer and moves by the regulators to tighten the “gluten-free” requirements, the company agreed to stop production until it could find a supplier that could guaranty that the batter used did not contain gluten; a guaranty that was not given by the original supplier.

Other popular foods marketed to children, Oreos, Pop-Tarts, Frosted Flakes, Jello and SpaghettiOs have all been recalled in recent years due to hidden ingredients that are responsible for allergic reacions. Sometimes, recalls take months and the food remains in the grocery store with no warning to purchasers. A young girl with a milk allergy was rushed to the hospital after eating muffins. The manufacturer was told and said it tested the product but found no milk in the muffin mix. Some months later, after a second report of an allergic reaction, the company tested the product again and found the milk in an ingredient it overlooked the first time; chocolate chips.  The recall took seven months before the product was pulled from the shelves.

Many companies do test their products and go to great lengths to be sure that the labels are accurate. But other companies do very little, or nothing at all, and the government does not require them to do testing.  Further, the recalls, if they take place, are on a voluntary basis determined by the manufacturer, not the government. And the recall notices often downplay the seriousness of the problem because the FDA allows the manufacturer to write their own recalls.

Typically, the U.S. Department of Agriculture does not test for hidden allergens such as peanuts or eggs because those ingredients are not themselves prohibited foods. Similarly, the FDA does not do its own testing. This ignores the fact that foods containing  hidden ingredients can be life threatening.

Of course, shoppers should continue to read the label and be cautious about what they buy at the grocery store. But this is certainly one of those when what you don’t know, can hurt you.

 In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, the court dismissed all 21 claims in the master complaint: (1) strict liability – failure to warn; (2) strict liability – manufacturing defect; (3) negligence; (4) negligence per se; (5) breach of implied warranty; (6) breach of express warranty; (7) negligent misrepresentation; (8) intentional misrepresentation; (9) fraud; (10) constructive fraud; (11) violation of the Minnesota False Statements in Advertising Act; (12) violation of the Minnesota Deceptive Trade Practice Act; (13) violation of the Minnesota Prevention of Consumer Fraud Act; (14) violation of the Minnesota Senior Citizen and Handicapped Person Consumer Fraud Act; (15) negligent infliction of emotional distress; (16) loss of consortium; (17) wrongful death; (18) survival action; (19) medical monitoring; (20) unjust enrichment; and (21) Medicare Secondary Payer Act.

That means that the entire master complaint - the entire MDL - is dismissed with prejudice.  The court made the following significant rulings:

(1) The Class I FDA recall that the Medtronic leads underwent did not deprive the defendant of its preemption defense. Slip op. at 14-17. A recall does not invalidate an in-force PMA, and in any event the recall could not affect the status of devices implanted before the recall occurred.

(2) Claims asserting manufacturing defects are preempted. Slip op. at 18-22. These claims do not “parallel” FDA manufacturing requirements because manufacturers have to develop their own quality control systems under what are “flexible” regulations. The “level of fine detail” necessary to establish an actual violation does not exist. Plaintiffs’ claims are would impose a level of detail “different from or in addition to” the FDA’s regulations. “Violation” is not a “magic word” that defeats preemption.

 
(3) Warning claims, including post-sale duty to warn allegations, are preempted. Slip op. at 22-27. Preemption under the MDC is much broader than the Cigarette Act. Regulations that “permit” manufacturers to modify their warnings (the CBE regulations in the device context) do not save claims that would “require” such modifiications without being “different from or in addition to” those regulations. The conditions of the PMA itself did not impose any greater warning or reporting requirements than the FDA regulations themselves. Plaintiffs reporting-based allegations amount to a prohibited attempt at enforcing the FDCA - which is a form of implied preemption based upon 21 U.S.C. §337(a), providing for exclusive federal enforcement of the Act.
(4) Design defect claims are preempted. Slip op. at 27-29. The introduction of a new “safer” model does not create a duty requiring immediate withdrawal of prior versions, unless the FDA so requires. It did not, so there is no “parallel” federal requirement for the plaintiffs to hang their state-law claims on. “Adulteration” claims are either a restatement of preempted manufacturing defect claims or amount to prohibited private enforcement.

(5) Negligence per se claims are preempted for the same reasons that the manufacturing, warning and design claims are. Slip op. at 30-31.

(6) Breach of warranty claims (express and implied) are preempted. Slip op. at 31-33. Implied warranty merely tracks preempted manufacturing/warning/design claims. The 21 C.F.R. §808.1(d)(1) argument was rejected in Riegel. An express warranty of “safety” would require a jury to find the devices unsafe, which is what Riegel prohibits.

(7) Miscellaneous claims are preempted. Slip op. at 33-34. Derivative claims (consortium, unjust enrichment, consumer fraud) fail for the same reason as the claims from which they derive.

The Court was clear that the Plaintiffs had been wronged, but under the law as it exists now, Plaintiffs have no remedy.  Our firm will particpate in working with Congress in order to ensure that individuals who are injured or killed due to defective medical devices will have a remedy.

By: Carrie R. Frank

The holidays are here, Thanksgiving, Christmas and Hanukkah, New Year’s celebrations. All times when food is in abundance and our waistlines are expanding. Many people put “weight loss” high on their list of New Year’s Resolutions but when the new treadmill starts to collect dust, people often look for a “quick fix” to shed the unwanted weight. But beware; the Food and Drug Administration (FDA) just issued a new warning about the dangers of some diet pills.

The FDA has compiled a list of 28 diet pills and weight loss supplements that should not be used because they contain ingredients that are not listed on the label and could be hazardous to your health. Many of these pills and supplements claim to be “natural” or “herbal” or are new versions of “ancient remedies;” all words that imply that they are safe. However, what is not included on the label is that some of these products contain a controlled substance that is not approved for sale in the U.S. and a suspected cancer-causing agent. These products are often sold on-line and it appears that many come from China. The weight loss remedies include: Fatloss Slimming, 2 Day Diet, 3x Slimming Power, 5x Imelda Perfect Slimming, 3 Day Diet Japan Lingzhi, 24 Hours Diet, 7 Diet Day/Night Formula, 7 Day Herbal Slim, 8 Factor Diet, 999 Fitness Essence, Extrim Plus, GMP, Imelda Perfect Slim, Lida DaiDaihua, Miaozi Slim Capsules, Perfect Slim, Perfect Slim 5x, Phyto Shape, ProSlim Plus, Royal Slimming Formula, Slim 3 in 1, Slim Express 360, Slimtech, Somotrin, Superslim, TripleSlim, Zhen de Shou, and Venom Hyperdrive 3.0.

Most of these diet pills and supplements contain sibutramine, which is an appetite suppressant and is related to amphetamines. In some people, sibutramine can cause strokes, heat attacks and heart palpitations. Sibutramine is one chemical ingredient in prescription drugs used to treat obesity, but the FDA found almost three times the recommended dosage in the above pills. Some of these pills also contain phenolphthalein, which has been used as a laxative but is being pulled from the U.S. market because it is tied to increased risks of cancer. The labels do not list these ingredients, so consumers have no way of knowing what is in the pills or that the ingredients may get them a trip to the emergency room.

The FDA is trying to get the sales of these diet pills stopped and is considered other charges, including criminal charges, against some of the manufacturers. As one lawyer for the FDA said, “if it sounds too good to be true, it is likely to be too good to be true.” The only safe and effective way to lose weight is to put fewer calories in, and work more calories out, of your body.

In the early 1970’s, Federal Motor Vehicle Safety Standard 216 was established which provided the minimum guidelines for roof strength. FMVSS 216 provides that the roof of a passenger car had to withstand 1.5 times the vehicle’s weight or 5,000 pounds, which ever is less, under the test parameters established in the standard. For many cars, and most sport utility vehicles which are heavier than cars, this standard was woefully inadequate. And since it was only a minimum standard, the auto companies had no motivation to utilize their engineering talent to make a better product. Untold numbers of people have been killed and paralyzed when the roof crushes in on them during a rollover accident. For over thirty years, despite changes in technology, changes in vehicles, and changes in knowledge and awareness, the auto manufacturers have fought improvements in this standard. Finally, the move is underway to increase the roof crush standard, but even the new proposed standard (2.5 times the vehicle weight or 10,000 pounds) may not be enough to protect people in larger sport utility vehicles. Further, the proposed standard may contain a “preemption” clause which could prevent people who get injured from roof crush to pursue litigation since this is a federally approved standard, even though this is a only a minimum standard. Further, this new standard would likely be “phased in” so that the auto manufacturers would only need to have the new and improved roofs on some cars in each year until their entire line is improved. In the meantime, people will continue to get hurt.

Tied in with the inadequate roof crash standard is the often unknown fact that there is no FMVSS guideline regarding rollover or stability. The auto manufactures may argue that the above roof crush standards, as well as other standards regarding occupant crash protection, apply to rollover crashes since the Federal Motor Vehicle Safety Standards provide the minimum guidelines for all occupant protection. But a stability standard should not wait until the vehicle rolls over to determine if it met the standards, such a standard would establish the guidelines to prevent a vehicle from rolling over in the first place. Sport utilities vehicles are designed to be higher off the ground. This design, coupled with a width that is often too narrow for the increased height, creates an SUV that rolls over in emergency avoidance maneuvers (such as swerving to avoid something in the road) when other cars of better design would simply slide out so that they could be safely brought to a stop. Historically, the auto manufacturers have argued that the SUVs must be designed high and narrow to allow for off-road use, all the while marketing these SUVs to soccer moms as the perfect, big, strong, safe, family car. Further, the technology is available to make SUVs safer. Electronic stability control (ESC) is a computerized program that applies different throttle or braking to each individual wheel to help regain control of a vehicle once the vehicle starts to go out of control but before it rolls over. It has proved to be very successful in preventing rollovers from occurring and everyone would agree that it is best to keep a car on its wheels. Yet, despite having the technology for ESC, manufacturers have resisted putting it in all its vehicles arguing that the cost is prohibitive. This is despite the fact that SUVs, one of the best sellers and money makers for the auto industry, would be made considerable safer with this technology.  

The “buckle up for safety” campaign began in 1960’s when people began to understand the significant benefits that seatbelts provided in protecting occupants in a crash. No one would argue that seatbelts have come a long way since then and have improved greatly over the years. But could it have been better, faster? The answer is yes. As technology has advanced, seatbelts have also been redesigned. But auto manufacturers have resisted putting new designs in cars for years after they become available. As an example, the benefits of shoulder belts were known long before they were mandated in cars. And shoulder belts in the front seats were around for years before manufacturers began to put shoulder belts in the outboard rear seat positions even though the anchor points were available and people, especially children, might be spared devastating injuries from only having a lap belt. Then, even more years passed before the manufacturers would put shoulder belts in the center rear seat position. Another advance in seat belt technology is a pretensioner, which tightens a seat belt in the instant of a crash to prevent the seat belt webbing from spooling out, or loosening, which in turn helps hold the occupant snuggly to the seat. Pretensioners have been around since the 1980’s, but only in foreign cars such as Mercedes and Volvo. In the 1990’s, auto manufacturers began installing pretensioners in the front seat of their luxury cars but not until around 1998 and later did pretensioners become mainstream equipment in the average priced cars. So people in the less expensive SUVs that were rolling over did not reap the benefits of a pretensioner which was in the luxury sedan that was more stable.

And unbeknownst to the American consumer, some American manufacturers were installing pretensioners in cars they were selling overseas as those countries had more stringent standards than here in the U.S.

While some people believe “you get what you pay for” why should existing safety technology only be available to those who can afford the newest and most expensive cars?  Should socio-economic factors dictate a person’s likelihood to survive an “accident”?  Further, should we really encourage industry to pour millions into lobbying for obsolete technologies when we can all live safer and better?