The Filutowski Law Firm, PLLC - Personal Injury Attorney, Employment Law Attorney, Auto Accident, Car Accident, Car Insurance
Jul
28
2010

Foreign Manufacturer Legal Accountability Act Will Provide Consumers Greater Protection

In response to a series of foreign manufacturer recalls, including Toyota vehicles, drywall and children’ toys, federal lawmakers are considering a bill that would allow U.S. consumers to effectively sue foreign product manufacturers in U.S. courts pursuant to the Foreign Manufacturer Legal Accountability Act of 2010.  The proposed bill was approved by the House’s Subcommittee on Commerce, Trade, and Consumer Protection.  Many trade experts predict that the bill will pass through Congress this year.

Similar legislation was proposed to the Senate Finance Committee in 2009, but received little attention in the midst of all the drywall and Toyota recalls.

The 2010 Act is intended to provide greater protections for consumers from foreign manufacturers who operate in countries with less strict safety standards and regulations than in the U.S.

The Act would require all foreign manufacturers and producers of products covered by the Act, with U.S. distribution, to establish a registered agent in the U.S.  This agent implicitly consents to personal jurisdiction and is authorized to accept service of process on behalf of such manufacturer or producer for the purpose of all civil and regulatory actions in State and Federal courts.  See H.R. 4678.  Any manufacturer or producer who fails to register an agent within the U.S. will be prohibited from importing into the U.S.

Continue reading Foreign Manufacturer Legal Accountability Act Will Provide Consumers Greater Protection →

Jul
27
2010

Nap Nanny Recalled After Infant Death

Parents: beware of the potential fatal hazards of the Nap Nanny.  A 4-month old was harnessed into the Nap Nanny, yet able to move into a fatal position while the Nap Nanny was used in a crib. 
 

 

 

 

The Consumer Protection Services Commission (CPSC) has issued a recall of 30,000 Nap Nanny products after receiving the report of the fatality and 22 reports of infants, primarily younger than 5-months-old, hanging or falling out over the side of the Nap Nanny despite most of the infants being placed in the harness. 

 

 

CPSC states the following about the Nap Nanny recall:

Infants can partially fall or hang over the side of the Nap Nanny® even while the harness is in use. This situation can be worse if the Velcro™ straps, located inside the Nap Nanny® cover are not properly attached to the “D”-rings located on the foam, or if consumers are using the first generation model Nap Nanny® that was sold without “D”-rings.

In addition, if the Nap Nanny® is placed inside a crib, play yard or other confined area, which is not a recommended use, the infant can fall or hang over of the side of the Nap Nanny® and become entrapped between the crib side and the Nap Nanny® and suffocate. Continue reading Nap Nanny Recalled After Infant Death →

Jul
26
2010

FDA To Review Amplify, Medtronic’s Experimental Spinal Fusion Device

 Medtronic Inc.’s experimental spinal fusion device Amplif, which uses a protein to promote bone growth, seeks approal by the Food and Drug Administration (FDA) tomorrow, July 27, due to a high incidence of cancer in its patients.   Amplify is designed to stabilize vertebrae in the lower back in patients with degenerative disc disease. The device contains an ingredient called recombinant bone morphogenetic protein-2, or rhBMP-2, which is designed to help the formation of new bone. RhBMP-2 is used in another Medtronic spine device known as Infuse that’s currently on the market. That device works in a different manner than the proposed Amplify device.

Bloomberg News reports: After two years, surgeries were successful in 61 percent of Amplify patients, compared with 56 percent for those who had standard procedures using a bone graft from the hip, the Food and Drug Administration said today in a report. Amplify resulted in successful operations in 44 percent of patients after five years, compared with 35 percent for standard care, the agency said. A higher number of cancer cases were seen in the Amplify group, FDA reviewers said in the report.

Medtronic, the world’s largest maker of heart-devices, has been trying to reinvigorate growth in its spinal products business, which accounted for 22 percent of the Minneapolis- based company’s $15.8 billion in revenue for its 2010 fiscal year ended in April. Spine division sales grew 3 percent to $3.5 billion last year. If approved, Amplify may add as much as $175 million, or 8 cents a share, to earnings in its first year, Leerink Swann analyst Rick Wise said in a research report today.

“We now put the likelihood of a positive panel recommendation at just 40 percent,” Michael Weinstein, a New York-based analyst at JPMorgan Securities, wrote in a note to investors today. “Cancer risk could trip up approval.”

Two-Year Data

After two years, 3.8 percent of Amplify patients had cancer, compared with 0.9 percent on standard surgery. The malignancy rate for Amplify increased to 5 percent after five years, compared with 1.8 percent for traditional grafts, according to the FDA report.

Medtronic shares fell 19 cents to $36.58 at 4:15 p.m. in New York Stock Exchange composite trading. The stock has increased 6.4 percent in the past 12 months.

Outside advisers to the FDA will meet July 27 to evaluate Amplify. The agency generally follows the recommendations of its advisory panels, though it isn’t required to do so.

“At the panel, we will present preclinical and clinical study data, along with expert opinion, that no plausible biological mechanism for cancer induction or promotion has been identified,” Medtronic spokeswoman Marybeth Thorsgaard said in a July 21 telephone interview.

‘Borderline’ Significance

The five-year rates don’t show a statistically significant increase in cancer rates between the two study groups, Weinstein wrote in the note. “However, the documents do note that this numerical difference comes close to reaching significance with the FDA describing it as ‘borderline,’” he wrote.

The advisers will focus on the clinical and statistical significance of cancer rates, especially pancreatic cancers, in current studies and determine whether additional evaluations are needed, the FDA said in its report.

The panel also will look at how the overall surgical success rates for the two study groups were determined and at a greater number of serious back and leg pain side effects reported by patients in the Amplify group, according to the documents. A successful surgery was defined as an operation in which the vertebrae or bones were joined together and stabilized.

About 660,000 back surgeries were performed in the U.S. in 2009, according to Millenium Research Group, a medical market research company in Toronto. In spinal fusion surgery, doctors use bone grafts in an area of the spine to lock together, or “fuse,” the area between two or more vertebrae to treat back pain cause by spinal disease and injuries.

Standard Surgery

A standard spinal-fusion procedure requires two surgeries, often done at the same time, Martin Yahiro, Medtronic’s senior director of clinical and regulatory affairs, said in a July 21 telephone interview. First, doctors operate to take a section of hip bone for use as a graft for the second procedure that repairs the spine, he said.

Amplify combines the company’s bone growth protein, known as rhBMP-2, with a ceramic device implanted in the spine for posterior spinal fusion through the patient’s lower back. The bone protein, marketed as Infuse, won U.S. approval in 2002 for anterior fusion surgeries, a lower-back operation performed through an incision in the front of the patient. It is also cleared for dental procedures and to repair lower leg fractures.

Infuse generates as much as $800 million in annual revenue for Medtronic, with sales unchanged the past two years, Weinstein said.

The Amplify product uses a higher dose of the bone mineral protein than the Infuse device, the FDA staff report noted.

Medtronic Study

In the two-year study of 463 patients that Medtronic used to seek approval of Amplify, those treated with the device had shorter surgical times, less blood loss, and needed fewer repeat operations compared with those who had the standard procedure, according to results published in July 2009 in the Journal of Bone and Joint Surgery.

If the FDA decides to approve Amplify, Weinstein said it is likely to require a large study after the product goes onto the market to assess cancer risk.

“The FDA is saying that the historical data on Infuse safety is of limited significance because you’ve upped the dosing by three times,” Weinstein said in a telephone interview. “So even if there’s not a significant cancer risk with Infuse, you’ve tripled the dosage and how do you get the FDA panel comfortable with that?”

Amplify’s advantage “seems to boil down to saving 20 minutes in the operating room,” said Richard Deyo, a spine expert at Oregon Health & Science University in Portland, in a July 21 telephone interview. Complications from the hip bone grafts “should not be trivialized but it’s not clear to me that there is a big problem there.” Deyo was not involved in Medtronic’s study.

Fox Business further reports: 

Amplify will be reviewed by the FDA’s Orthopaedic and Rehabilitation Devices advisory panel on Tuesday. The FDA released a background summary of its review of the device on its website Friday.

The FDA said it was concerned about the systemic effects of rhBMP-2. The agency said there was a higher number of cancer cases seen in clinical studies of Amplify “that warrant further investigation.”

The FDA asked Medtronic to submit all studies involving use of rhBMP-2, which included studies conducted by Wyeth, now owned by Pfizer Inc. (PFE: 14.81 ,+0.22 ,+1.51%). The agency said an analysis of the studies showed 1.7% of patients exposed to rhBMP-2 had cancer compared to 1.3% of patients not exposed to the ingredient.

The FDA said the panel will be asked to comment on whether the increase is statistically and clinically significant. The panel is also expected to vote on whether it thinks Amplify should be approved.

Medtronic said it saw 13 cancer cases among patients who received Amplify, including two noninvasive skin cancer cases, compared to four cases of cancer in patients who underwent another spine procedure five years after undergoing surgery. The company said the difference in cancer rates was not statistically significant, meaning it could be due to chance.

Medtronic has proposed conducting a postapproval study to look at whether rhBMP-2 really increases the risk of cancer.

Medtronic’s Amplify underwent scrutiny in 2008 as well.

Copyright © 2010 The Filutowski Law Firm, PLLC. This post is intended for general information purposes only and should not be construed as legal advice or legal opinions on any specific facts or circumstances. An attorney-client relationship is not created or continued by reading this post. If you would like further information regarding the matters discussed herein, you may post a comment. If you need a consultation on a legal matter, contact Alexandra Filutowski.

Jul
25
2010

Prescription Drug Abuse On The Rise In The U.S.

Prescription drug abuse and addiction is prevalent in Hollywood.  Heath Ledger’s death, Anna Nicole Smith and her son’s deaths and now Brittany Murphy and her husband’s deaths.  Prescription drugs, when abused, are highly addictive and can be fatal. 

Anna Nicole Smith’s 2007 death was due to an overdose concoction involving nine various prescription pills.   Earlier this month the Los Angeles prosecutor’s office filed conspiracy charges against Anna Nicole Smith’s doctor, Dr. Sandeep Kapoor, for knowingly prescribing drugs to an addict. 

Addiction is not just prevalent in Hollywood, but is on the rise among the rest of the nation, as well.  Drugs are readily prescribed at most any visit to the doctor, leading to dependency.  According to the National Institute on Drug Abuse:

In 2008, 15.2 million Americans age 12 and older had taken a prescription pain reliever, tranquilizer, stimulant, or sedative for nonmedical purposes at least once in the year prior to being surveyed. Source: National Survey on Drug Use and Health (Substance Abuse and Mental Health Administration Web Site). The NIDA-funded 2008 Monitoring the Future Study showed that 2.9% of 8th graders, 6.7% of 10th graders, and 9.7% of 12th graders had abused Vicodin and 2.1% of 8th graders, 3.6% of 10th graders, and 4.7% of 12th graders had abused OxyContin for nonmedical purposes at least once in the year prior to being surveyed. Source: Monitoring the Future (University of Michigan Web Site)

Prescription drugs should be taken for medically necessary purposes only.  Consult a physician if you may have developed a dependency.  Do not operate machinery or a motorized vehicle when under the influence.

See Prescription “Drug Driving” Fatally Impairs.

Copyright © 2010 The Filutowski Law Firm, PLLC. This post is intended for general information purposes only and should not be construed as legal advice or legal opinions on any specific facts or circumstances. An attorney-client relationship is not created or continued by reading this post. If you would like further information regarding the matters discussed herein, you may post a comment. If you need a consultation on a legal matter, contact Alexandra Filutowski.

Jul
25
2010

Prescription “Drug Driving” Fatally Impairs

The New York Times reported on July 24, 2010: Drivers on Prescription Drugs Are Hard to Convict  The Seattle Times reprinted it as: Prescription ‘drugged driving’ may be on rise

The accident that killed Kathryn Underdown had all the markings of a drunken-driving case. The car that hit her as she rode her bicycle one May evening in Miller Place, N.Y., did not stop, the police said, until it crashed into another vehicle farther down the road.

The driver could not keep her eyes open during an interview with investigators, according to the complaint against her, and her speech was slow and slurred. But the driver told police she had not been drinking; instead, the complaint said, she had taken several prescription medications, including a sedative and a muscle relaxant. She was charged with vehicular manslaughter and driving under the influence of drugs. The latter is an increasingly common offense, law-enforcement officials say, at a time drunken-driving deaths are dropping and when prescriptions for narcotic painkillers, anti-anxiety medications, sleep aids and other powerful drugs are rampant.

The issue is vexing police officials because, unlike with alcohol, there is no agreement on what level of drugs in the blood impairs driving.

The behavioral effects of prescription medication vary widely, depending on the drug and on the person taking it. Some, such as anti-anxiety drugs, can dull alertness and slow reaction time; others, such as stimulants, can encourage risk-taking and hurt the ability to judge distances. Mixing prescriptions, or taking them with alcohol or illicit drugs, can exacerbate impairment and sharply increase the risk of crashing, researchers say.

“In the past it was cocaine, it was PCP, it was marijuana,” said Chuck Hayes of the International Association of Chiefs of Police. “Now we’re into this prescription-drug era that is giving us a whole new challenge.”

Continue reading Prescription “Drug Driving” Fatally Impairs →

Jul
21
2010

Toyota Subpoenaed Over Potentially Faulty Steering Mechanisms

 

Today the American Association for Justice (AAJ) reported:

Bloomberg News (7/21, Ohnsman, Fisk) reports that a Federal grand jury in New York is compelling Toyota to “provide documents related to flaws in steering relay rods, the company said in a filing yesterday.” The piece alludes to NHTSA’s ongoing investigation into safety issues at the automaker, but notes that this issue “is separate from scrutiny of Toyota models for defects related to unintended acceleration.”

USA Today (7/21, Woodyard) reports adds that the subpoena may be linked to charges of “possible delays in a 2005 US recall of trucks over potentially faulty steering rods.” USA Today states that Toyota has been “dealing with cracking and breaking steering relay rods in the US for at least 11 years before” a 2004 recall in Japan. “It wasn’t until September 2005 that it recalled nearly a million similar trucks in the US.”

        The Los Angeles Times (7/21, Bensinger) characterizes the subpoena as an “expansion” of the grand jury’s investigations “beyond problems related to unintended-acceleration issues, which have led Toyota to issue more than 10 million recall notices worldwide since September. The Times notes that NHTSA is investigating “whether the automaker delayed the recall, a potential violation of federal law. … NHTSA officials say they are exploring the timing of the recall, which came nearly a year after a similar action in Japan for the same defect.” Continue reading Toyota Subpoenaed Over Potentially Faulty Steering Mechanisms →

Jul
20
2010

Zinc, Over-The-Counter Cold Remedy May Cause Permanent Loss of Smell

A study in the Archives of Otolaryngology (a journal of the American Medical Association) reveals that the homeopathic, over-the-counter zinc cold remedy, can cause severe loss of smell.  “In addition to concerns regarding the efficacy of intranasal zinc therapy, increasing evidence indicates that this medication may be linked to severe, potentially permanent hyposmia (reduced sense of smell) and anosmia (loss of smell),” the study says.

 

Copyright © 2010 The Filutowski Law Firm, PLLC. This post is intended for general information purposes only and should not be construed as legal advice or legal opinions on any specific facts or circumstances. An attorney-client relationship is not created or continued by reading this post. If you would like further information regarding the matters discussed herein, you may post a comment. If you need a consultation on a legal matter, contact Alexandra Filutowski.

Jul
20
2010

“Paycheck Fairness Act” Ensures Women Earn Equal Wages As Men

Today President Obama urged the Senate to pass the “Paycheck Fairness Act,” an addition to the 1963 Equal Pay Act, which prohibits racial discrimination.   Despite all advances women have made in the workforce, comprising over 50% of all workers, they continue to earn $.77 for every dollar a male counterpart earns. 

The Act was originally proposed by then-senator Hillary Chilton in January 2009.   The text of the senate bill can be found here.

Obama’s statement endorsing the bill: 

In America today, women make up half of the workforce, and two-thirds of American families with children rely on a woman’s wages as a significant portion of their families’ income.

Yet, even in 2010, women make only 77 cents for every dollar that men earn. The gap is even more significant for working women of color, and it affects women across all education levels. As Vice President Biden and the Middle Class Task Force will discuss today, this is not just a question of fairness for hard-working women. Paycheck discrimination hurts families who lose out on badly needed income. And with so many families depending on women’s wages, it hurts the American economy as a whole. In difficult economic times like these, we simply cannot afford this discriminatory burden.

Continue reading “Paycheck Fairness Act” Ensures Women Earn Equal Wages As Men →

Jun
28
2010

Airplane Food Prepared In Unsanitary Conditions Says FDA

USA Today reports today that: FDA report reveals airline food could pose health threat

Many meals served to passengers on major airlines are prepared in unsanitary and unsafe conditions that could lead to illness, government documents examined by USA TODAY show.

Food and Drug Administration (FDA) inspectors have cited numerous catering facilities that prepare airline food for suspected health and sanitation violations following inspections of their kitchens this year and last, according to inspection reports obtained through the Freedom of Information Act.

REPORT: FDA inspectors found live roaches

The inspections were at U.S. facilities of two of the world’s biggest airline caterers, LSG Sky Chefs and Gate Gourmet, and another large caterer, Flying Food Group.

The three caterers operate 91 kitchens that provide more than 100 million meals annually to U.S. and foreign airlines at U.S. airports. They provide meals for nearly all big airlines, including Delta, American, United, US Airways and Continental.

The FDA reports say many facilities store food at improper temperatures, use unclean equipment and employ workers who practice poor hygiene. At some, there were cockroaches, flies, mice and other signs of inadequate pest control.

“In spite of best efforts by the FDA and industry, the situation with in-flight catered foods is disturbing, getting worse and now poses a real risk of illness and injury to tens of thousands of airline passengers on a daily basis,” says Roy Costa, a consultant and public health sanitarian.

Conditions open the door to food-poisoning outbreaks, says Costa, a former Florida state food inspector who volunteered to review the FDA reports obtained by USA TODAY.

All three caterers say they work hard to ensure food is safe. And airlines say they monitor the food that goes onto their planes.

LSG Sky Chefs has “comprehensive and multilayered quality-control standards in place to ensure our customers receive safe, healthy and high-quality food,” says spokeswoman Beth Van Duyne.

Norbert van den Berg of Gate Gourmet says findings are taken “very seriously” and the company uses an independent auditor for quality assurance. Glenn Caulkins of Flying Food Group also says his company’s facilities are independently audited for quality assurance.

JetBlue spokesman Bryan Baldwin says the airline requires caterers to provide results of FDA inspections and does its own “impromptu” visits to their facilities.

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Sea-Tac based Gate Gourmet is the world’s largest caterer of airline food.

Jun
24
2010

Two Weeks Later: A Look at Washington’s New Cell Phone Law

Jeff DuBois of Seattle’s KiroTV News, speaks with a Washington State Trooper Keith Leary about the number of violators of the new law.  Suprisingly, most drivers are in compliance.  Also, police admit that it is difficult to discern whether drivers are resting their heads in their hands propped on the drivers’ door- or are talking on cell phones.  Washington State Patrol view the law as a safety measure, and not a revenue generator.