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Recent Blog Posts in 2009

52 posts found. Viewing page 1 of 3. Go to page 1 2 3   Next
November 24, 2009
  Toyota and Lexus floor mats causing unintended acceleration
Posted By Steven J. Klearman

On September 29, the National Highway Traffic Safety Administration alerted consumers about Toyota and Lexus vehicles experiencing unintended acceleration due to the accelerator becoming stuck.

According to the NHTSA press release, floor mats in certain Toyota and Lexus models have caused the accelerator pedal to catch, causing rapid acceleration after releasing the pedal.

Toyota began mailing letters to owners of potentially affected vehicles. For the time being, NHTSA and Toyota urge vehicle owners to take out any removable floor mats. The mats should not be replaced with any other mat.

Toyota and Lexus vehicles affected by this consumer alert are:


  • 2007-2010 Camry
  • 2005-2010 Avalon
  • 2004-2009 Prius
  • 2005-2010 Tacoma
  • 2007-2010 Tundra
  • 2007-2010 ES 350
  • 2006-2010 IS 250 and IS350

Kurt Niland, of Beasley Allen Legal News offers more information on the recall and Toyota's remedial measures:

The recall is the largest ever for Toyota and the fifth largest recall of a consumer product in the United States.

Toyota formally notified the NHTSA of the recall in a letter on October 5. Owners of the recalled vehicles, which include eight Toyota models manufactured in the last six years, are being notified by first-class mail in a mailing that was sent out on Friday, October 30th.

This first mailing will alert owners to the potential dangers posed by the floor mats but will not announce a fix. When Toyota decides on a solution, it will contact owners about the availability of a free remedy in a second mailing.

Some early reports indicated that rather than focusing on the floor mats, Toyota was researching on-vehicle countermeasures such as a "smart pedal" that would tell the vehicle to ignore the gas pedal if the brakes were applied simultaneously. Such a measure, which is standard in most German-made vehicles and Chryslers, would enable drivers to regain control of their vehicles easily and instantly despite the cause of unintended acceleration.

However, retrofitting 3.8 million vehicles with smart pedal technology would be extremely costly. A modification to the pedal in the affected vehicles would cost as much as $440 million, according to a Tokyo Shimbun report cited by Reuters.

A recall involving redesigned floor mats, on the other hand, would cost about $100 million. New reports say that the latest Toyota recall will indeed be a floor mat fix of some kind.

Toyota's largest recall comes during its toughest financial time. The company expects to lose $4.7 billion for the year ending March 31 -- its second consecutive annual loss. The economic downturn and a poor exchange rate are obvious culprits, but according to Toyota President Akio Toyoda, the troubles run even deeper.

"Toyota has become too big and distant from its customers," President Akio Toyoda, he told journalists in Tokyo last month. "We are grasping for salvation," he added, after apologizing for an accident that occurred in San Diego last August, which investigators say was caused when a floor mat jammed the accelerator pedal in a Lexus ES 350. The horrific accident claimed the lives of a California Highway Patrol officer and three of his family members, finally prompting the massive recall.

Continue reading "Toyota and Lexus floor mats causing unintended acceleration" »

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November 18, 2009
  FDA Announces Safe Use Initiative
Posted By Steven J. Klearman

On November 4, 2009, the FDA introduced its "Safe Use Initiative," an effort to collaborate with the health care field to reduce the preventable harm resulting from medication use and misuse.

The Initiative is in response to the millions of consumers who are harmed each year because of the misuse of medications. The inappropriate use of medications can be a result of several factors, including (1) incomplete access to information, (2) unintentional misuse of medications, medication abuse, and attempts by people to harm themselves with medications, or (3) taking prescription drugs prescribed for other people.

Taking prescription drugs prescribed for other people is a serious abuse, as even one single dose of certain medications, such as opioid drugs, can cause severe harm or death to the person not prescribed the medication.

Through the Initiative, the FDA will work alongside health care professionals to identify drugs that are linked to preventable harm. The FDA intends to collaborate with health care professionals to (1) evaluate consumer medication information, (2) communicate about the risk of inadvertent overexposure to acetaminophen, (3) apply safeguards against surgery fires caused by alcohol-based surgical preparations, and (4) avoid contamination of multiple-use medication vials.

Continue reading "FDA Announces Safe Use Initiative" »

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November 17, 2009
  Exposing Myths About Medical Malpractice
Posted By Steven J. Klearman

The American Association for Justice, in its efforts to promote health care reform, has attacked health care reform opponents' arguments that reform will be a heavy financial burden on the health care system.

"All the facts and evidence show that tort law changes will do practically nothing to lower costs or cover the uninsured," said AAJ President Anthony Tarricone. "It's no wonder the tort reformers, insurance lobby, and other corporate front groups have to gin up lies and phony stats, since no legitimate data or research supports their claims. Our focus should be on reducing the 98,000 deaths by medical error that occurs every year, not limiting patients' legal rights."

The AAJ takes a look at the misconceptions behind the most common positions of health care reform opponents in its Five Myths About Medical Negligence:

  • Myth #1: There are too many "frivolous" malpractice lawsuits.

Fact: There's an epidemic of medical negligence, not lawsuits. Only one in eight people injured by medical negligence ever file suit. Civil filings have declined eight percent over the last decade, and are less than one percent of the whole civil docket. A 2006 Harvard study found that 97 percent of claims were meritorious, stating, "portraits of a malpractice system that is stricken with frivolous litigation are overblown."

  • Myth #2: Malpractice claims drive up health care costs.

Fact: According to the National Association of Insurance Commissioners, the total spent defending claims and compensating victims of medical negligence was just 0.3% of health care costs, and the Congressional Budget Office and Government Accountability Office have made similar findings.

  • Myth #3: Doctors are fleeing.

Fact: Then where are they going? According to the American Medical Association's own data, the number of practicing physicians in the United States has been growing steadily for decades. Not only are there more doctors, but the number of doctors is increasing faster than population growth. Despite the cries of physicians fleeing multiple states, the number of physicians increased in every state, and only four states saw growth slower than population growth; these four states all have medical malpractice caps.

  • Myth #4: Malpractice claims drive up doctors' premiums
.

Fact: Empirical research has found that there is little correlation between malpractice payouts and malpractice premiums paid by doctors. A study of the leading medical malpractice insurance companies' financial statements by former Missouri Insurance Commissioner Jay Angoff found that these insurers artificially raised doctors' premiums and misled the public about the nature of medical negligence claims. A previous AAJ report on malpractice insurers found they had earnings higher than 99% of Fortune 500 companies.

  • Myth #5: Tort reform will lower insurance rates.

Fact: Tort reforms are passed under the guise that they will lower physicians' liability premiums. This does not happen. While insurers do pay out less money when damages awards are capped, they do not pass the savings along to doctors by lowering premiums. Even the most ardent tort reformers have been caught stating that tort reform will have no effect on insurance rates.

For Five Myths About Medical Negligence in its entirety, click here

Continue reading "Exposing Myths About Medical Malpractice" »

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November 17, 2009
  Beware of Unapproved H1N1 Products
Posted By Steven J. Klearman

The FDA urges caution when searching for H1N1 products on the internet because many unapproved H1N1 products purport to prevent, diagnose, or treat H1N1.

The FDA warns consumers of the potential danger of these products and cautions consumers that they should use only FDA approved products from licensed pharmacies. The potential dangers of using unapproved FDA products include an "increased risk of suffering life-threatening adverse events such as side effects from inappropriately using prescription medications, dangerous drug interactions, contaminated drugs, and impure or unknown ingredients found in unapproved drugs."

Currently, Tamiflu and Relenza are the only two FDA-approved antiviral drugs to treat H1N1.

With unapproved products, you can't be sure what you're getting. For example, the FDA, in monitoring the web for unapproved products, ordered a shipment of what was purported online to be Tamiflu. The FDA received an an unmarked envelope postmarked from India. The envelope contained "unlabeled, white tablets taped between two pieces of paper." The tablets were analyzed, and it was determined that they contained talc and acetaminophen (fever reducer and pain reliever). The tablets did not contain oseltamivir, the active ingredient of Tamiflu.

Among the products that the FDA has targeted:

  • a shampoo said to protect against the H1N1 flu virus
  • a dietary supplement said to protect infants and young children from contracting the virus
  • a "new" supplement said to cure H1N1 flu infection within four to eight hours
  • a spray that claims to leave a layer of ionic silver on one's hands that kills the flu virus
  • several diagnostic tests that have not been approved to detect the H1N1 flu virus
  • an electronic instrument whose sellers claim uses "photobiotic energy" and "deeply penetrating mega-frequency life-force energy waves" to strengthen the immune system and prevent symptoms associated with H1N1 viral infection

For more info from the FDA, click here

Continue reading "Beware of Unapproved H1N1 Products" »

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November 10, 2009
  Nevada Supreme Court Reviews Dram Shop Liability
Posted By Steven J. Klearman

The Nevada Supreme Court addressed the liability of a hotel for injuries occurring in an automobile accident after evicting intoxicated persons from the hotel premises in Rodriguez v. Primadonna Company, 125 Nev. Adv. Op. No. 45 (October 1, 2009).

In Rodriguez, 17 year old Fabian Santiago had been drinking with his two adult uncles, Manuel and Daniel Garibay, on hotel property where they were checked in as guests. They became disruptive, and hotel security intervened. The hotel security officers' requested that Fabian and his uncles leave the property. Hotel security accompanied the three men as they retrieved their belongings. Manuel told another guest that the three of them were going to their car in the parking lot to "sleep it off." Manuel had not intended to drive, as he did not have valid license and he believed he was too intoxicated. When the men were escorted to their vehicle, Manuel told Daniel he was sober enough to drive. Hotel security personnel informed the men, seated in their car, that they had to leave the hotel parking lot and exit hotel property. After leaving the property, Manuel rolled the vehicle while driving at approximately 80 miles per hour. 17 year old Fabian suffered extreme spinal injuries and, as a result, is quadriplegic.

In addressing the claim of negligent eviction, the Court was faced with the issue of whether the hotel owed an affirmative duty to ensure Fabian's safety after he was evicted from hotel property. The Court reviewed Nevada law regarding intoxicated patrons:


  • In Nevada, hotel proprietors have the statutory right to evict from the premises anyone who acts in a disorderly manner or who causes a public disturbance in or upon the premises. NRS 651.020.[1]
  • In Nevada, commercial liquor vendors, including hotel proprietors, cannot be held liable for damages related to any injuries caused by the intoxicated patron, which are sustained by either the intoxicated patron or a third party, including when the intoxicated patron is a minor.
  • Nevada subscribes to the rationale underlying the nonliability principle--that individuals, drunk or sober, are responsible for their torts.

The Court concluded that "when a hotel proprietor rightly evicts a disorderly, intoxicated patron, the hotel proprietor is not liable for any torts that an evicted patron commits after he or she is evicted that result in injury." The proprietor does not have the duty to prevent injuries caused by the intoxicated patron that are sustained either by the patron or by third parties after the eviction has been executed.

The Court did recognize that hotel proprietors do have a duty to act reasonably under the circumstances. The Court stated, however, that in accordance with the principles underlying Nevada's rejection of dram-shop liability, so long as a proprietor does not use unreasonable force in evicting a patron, the hotel proprietor is not required to consider a patron's level of intoxication in order to prevent speculative injuries that could occur off the proprietor's premises.

Thus, although the hotel may have known that Fabian's step-uncle was intoxicated and could not safely drive, the Court concluded, "as a matter of law, that Primadonna did not have the duty to arrange safer transportation, prevent an intoxicated driver from driving, or prevent Fabian, a passenger, from riding with a drunk driver."

Continue reading "Nevada Supreme Court Reviews Dram Shop Liability" »

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November 05, 2009
  Nevada Supreme Court Rejects Anti-Stacking Rules for Concurrent Negligence
Posted By Steven J. Klearman

In Delgado v. American Family Ins. Group, 125 Nev. Adv. Op. No. 44 (October 1, 2009), the Nevada Supreme Court was faced with the question of whether the passenger in an automobile who is injured by the concurrent negligence of the drivers in a two-car accident "may recover under the permissive driver's insurance policy both liability benefits based on the policyholder's negligence and underinsured motorist benefits based on the other driver's underinsured status."

The plaintiff passenger had made a claim against both at-fault drivers' insurance policies and recovered the liability limits under those policies. She then made a claim against the permissive driver's underinsured motorist policy, alleging that the at-fault policies did not cover the extent of her damages.

The Court rejected the application of the anti-stacking rules under the Nevada case law. In Nevada, once a passenger has recovered under the vehicle owner's liability policy--whether that policy is the permissive driver's policy or the passenger's own policy--the passenger may not also recover under the owner's uninsured/underinsured motorist policy, although the guest passenger may stack their own UM/UIM coverage with the benefits they receive from the owner's policy. Baker v. Criterion Insurance, 107 Nev. 25, 805 P.2d 599 (1991).

Distinguishing the anti-stacking situation, the Court concluded that "a passenger who is injured by two concurrently negligent drivers may recover from both the permissive driver's single insurance policy liability benefits based on the permissive driver's negligence and underinsured motorist benefits based on the other driver's underinsured status."

The Court clarified that the antistacking rule under Nevada law was not implicated by this case. Thus, a passenger whose injuries are attributable to two jointly negligent drivers and who exhausts the liability limits of the permissive driver's policy without satisfying his damages may seek recovery under the permissive driver's underinsured motorist policy based on the other driver's underinsured status. 

Continue reading "Nevada Supreme Court Rejects Anti-Stacking Rules for Concurrent Negligence" »

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November 05, 2009
  H1N1 Preventative Measures
Posted By Steven J. Klearman

With the death toll from H1N1 rising in Nevada, we should all be taking everyday precautions to stay healthy.

The Center for Disease Control and Prevention suggests everyday steps to protect your health:

  • Cover your nose and mouth with a tissue when you cough or sneeze. Throw the tissue in the trash after you use it.
  • Wash your hands often with soap and water. If soap and water are not available, use an alcohol-based hand rub.
  • Avoid touching your eyes, nose or mouth. Germs spread this way.
  • Try to avoid close contact with sick people.
  • If you are sick with flu-like illness, CDC recommends that you stay home for at least 24 hours after your fever is gone except to get medical care or for other necessities. (Your fever should be gone without the use of a fever-reducing medicine.) Keep away from others as much as possible to keep from making others sick.

Other important actions that you can take are:

  • Follow public health advice regarding school closures, avoiding crowds and other social distancing measures.
  • Be prepared in case you get sick and need to stay home for a week or so; a supply of over-the-counter medicines, alcohol-based hand rubs * (for when soap and water are not available), tissues and other related items could help you to avoid the need to make trips out in public while you are sick and contagious.

More on Handwashing from CDC: Washing your hands often will help protect you from germs. CDC recommends that when you wash your hands -- with soap and warm water -- that you wash for 15 to 20 seconds. When soap and water are not available, alcohol-based disposable hand wipes or gel sanitizers may be used.* You can find them in most supermarkets and drugstores. If using gel, rub your hands until the gel is dry. The gel doesn't need water to work; the alcohol in it kills the germs on your hands.

Continue reading "H1N1 Preventative Measures" »

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October 01, 2009
  District Judge Bars Injection Regulations
Posted By Steven J. Klearman

Two weeks ago, the Nevada Board of Medical Examiners issued an emergency regulation to restrict the ability of medical assistants to perform certain injections, such as Botox.

As reported by the Las Vegas Sun, the regulations prohibited doctors from allowing medical assistants to inject "cosmetic fillers, chemotherapy, anesthetics or inflammatory drugs," stemming from "a controversy in Las Vegas about unlicensed medical assistants performing certain procedures that some argued should be left to a doctor."

However, on Tuesday, District Judge Kathleen Delaney issued an injunction to prevent the regulation from going into effect, based on the Nevada Board of Medical Examiners' procedures used to adopt the regulations. The Board violated Nevada's open meeting laws by not hearing all public comments before voting on the regulation.

The regulation was not to affect the administration of flu shots.

Continue reading "District Judge Bars Injection Regulations" »

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September 25, 2009
  Nevada Supreme Court Says Smoking Ban Constitutional
Posted By Steven J. Klearman

The Las Vegas Sun reported that the Nevada Supreme Court denied a challenge to the civil enforcement of Nevada's indoor smoking ban.

The criminal enforcement of the smoking ban had already been held unconstitutional, and the statutory basis for criminal enforcement has been removed from the statute.

However, civil enforcement of the smoking ban is constitutional, despite the challenge from Las Vegas businesses. The businesses challenged the provisions under the equal protection clause, as the statute exempts gambling areas in large casinos, certain taverns, and certain strip clubs.

In rejecting the challenge, the Supreme Court reasoned that the exemptions did not violate equal protection because they are justified by the fact that "minors are prohibited from gambling areas in casinos, unlike in smaller bars and restaurants where slot machines are "incidental" to their overall business."

Continue reading "Nevada Supreme Court Says Smoking Ban Constitutional" »

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September 25, 2009
  Insurer's Have Duty to Inform Insured's About Settlement Offers
Posted By Steven J. Klearman

The Nevada Supreme Court addressed the scope of an insurer's duty to defend under the implied covenant of good faith and fair dealing in Allstate Insurance Co. v. Miller, 125 Nev. Adv. Op. No. 28 (July 30, 2009).

The opinion considered when an insurer has a duty to inform its insured about settlement opportunities.

The Court held that an insurer's duty to defend includes a duty to "adequately inform the insured of settlement offers," including reasonable offers that exceed policy limits. An insured's failure to so inform its insured can be used as a factor in bad faith claims. The failure to inform can also serve as a proximate cause of damages to the insured.

See the entire opinion here

Continue reading "Insurer's Have Duty to Inform Insured's About Settlement Offers" »

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September 01, 2009
  Nevada Supreme Court addresses business defamation actions
Posted By Steven J. Klearman

The Nevada Supreme Court clarified business defamation in Clark County Sch. Dist. v. Virtual Educ., 125 Nev. Adv. Op. No. 31 (August 6, 2009).

The case presented the issues to the Court of whether "the absolute privilege applies to defamatory communications made by a nonlawyer in anticipation of a judicial proceeding," and "whether allegedly defamatory statements made about a business's product provide a basis for defamation per se or for business disparagement."

The Court concluded that in a business defamation action under Nevada law, "the absolute privilege affords parties to litigation the same protection from liability that exists for an attorney for defamatory statements made during, or in anticipation of, judicial proceedings."

Furthermore, "when allegedly defamatory statements concern a business's product and the plaintiff seeks to redress injury to economic interest, the claim is one for business disparagement, not defamation per se."

See the Court's opinion here.

Continue reading "Nevada Supreme Court addresses business defamation actions" »

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August 13, 2009
  AAJ Clarifies: MMSEA's Section 111 Does Not Require Set-Asides in Liability Cases
Posted By Steven J. Klearman

The Medicare, Medicaid and SCHIP Extension Act of 2007, or MMSEA, affects judgments and settlements involving Medicare liens. Plaintiffs and Defendant attorneys should be aware of the changes. The AAJ released a clarification about the MMSEA:

In cases involving Medicare beneficiaries, attorneys for both the plaintiff and defendant are required to report certain information to the Centers for Medicare and Medicaid Services (CMS). In addition, any case settlement or judgment must reimburse Medicare where the Trust Fund has made conditional payments for medical costs. Under the Medicare Secondary Payer Act, attorneys have been settling cases involving liability claims without completing a Medicare Set Aside (MSAs) to account for future medical costs. However, attorneys representing claimants in workers' compensation cases have been preparing MSAs on a case-by-case basis.

It has come to our attention that some defense firms and insurance providers are now claiming that CMS requires MSAs in liability cases pursuant to Section 111 reporting requirements included in the Medicare, Medicaid & SCHIP Act of 2007 (MMSEA), Public Law No. 110-173. This is false.

Section 111 contains reporting requirements for responsible reporting entities (RREs) only. Section 111 does not impact or change the requirements for plaintiffs' attorneys.

Moreover, statements from CMS, and other federal entities, make clear that the agency does not require set-asides for liability claims. Since the MMSEA's passage, CMS has held several Town Hall teleconferences to discuss the Section 111 requirements. During the March 24, 2009 call, Barbara Wright, CMS' Acting Director of the Division of Medicare Debt Management, made several statements reiterating that Section 111 has no impact on liability MSAs. For example:
- In response to a question as to whether liability set-asides will be required under Section 111, she said "the point is the set-aside process is totally separate from the Section 111 reporting process. As we've said in more than one call we don't anticipate changing our routine recovery process." (Transcript, pg. 24)
- When explaining that worker's compensation agreements use a formal review process which makes set-asides recommended, she said that was in contrast to liability agreements. Liability "does not have the same formal review process although our regional offices will consider review of proposed liability set-aside amounts depending on their particular work load and whether or not they believe significant dollars are at issue." (Transcript, pg. 24).

In addition, CMS also has released several Alerts explaining Section 111, which do not indicate any intent to require MSAs for liability claims. For example:
- "Unless you are a business entity which qualifies as [a required reporting entity (RRE) for purposes of Section 111, you do not need to initiate any specific actions in connection with Section 111." (CMS Alert, 2/23/09).
- "The new Section 111 requirements do not change or eliminate any existing obligations under the MSP statutory provisions or regulations." (CMS Alert, 2/23/09).

Moreover, the Congressional Research Service (CRS) provided Congress with an "objective and non-partisan analysis" analysis of the MMSEA. As there was no legislative history regarding the bill, the CRS research report is the most reliable analysis of the MMSEA, including the Section 111 reporting requirements.

CRS' analysis of the Section 111 reiterates that it is a reporting requirement, and makes no mention of the need for set-asides in liability cases. The Section 111 analysis states, in part: This provision requires an insurer or third-party administrator for a group health plan (and in the case of a group health plan that is self-insured and self-administered, a plan administrator or fiduciary) to (1) secure from the plan sponsor and participants information required by the Secretary for the purpose of identifying situations where the group health plan is or has been a primary plan to Medicare, and (2) submit information specified by the Secretary. If an insurer or third-party administrator for a group health plan fails to comply, then a $1,000 per day civil monetary penalty will be imposed for each individual for which information should have been submitted.

If CRS believed that the legislative language implies any Congressional endorsement of liability setasides, it would have been included in this analysis.

More information on the MMSEA can be found at the Centers for Medicaid and Medicare website

Continue reading "AAJ Clarifies: MMSEA's Section 111 Does Not Require Set-Asides in Liability Cases" »

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August 10, 2009
  More on the Medical Device Safety Act from the AAJ
Posted By Steven J. Klearman

The American Association for Justice reports about the hearing on the Medical Device Safety Act held last week:

Two years ago, Michael Mulvihill of Bettendorf, Iowa, was driving with his wife across the Midwest to visit his son, daughter-in-law, and grandchildren when he saw a blue light flash before his eyes. He felt his body shaking and thought it was from hitting road debris. He soon realized his heart defibrillator was malfunctioning and sending electrical shocks throughout his body while he was driving on the interstate.

His nightmare continues because he cannot hold the manufacturer of his faulty medical device accountable for their faulty product because of a U.S. Supreme Court decision last year that gave the manufacturer complete immunity. Today, Mulvihill will testify before the U.S. Senate Health, Education, Labor, and Pensions Committee, asking for Congress to pass the Medical Device Safety Act (MDSA), legislation that would restore the right of patients to hold manufacturers of medical devices accountable in court when their devices have malfunctioned.

Mulvihill had an irregular heartbeat, and was implanted with a defibrillator in 2006 to control his heart rhythm and pulse. The device intended to save his life nearly killed him and his wife when it malfunctioned while he was driving. The anxiety from the episode led Mulvihill into taking early retirement because his job required so much interstate travel.

A representative from Medtronic confirmed the device had shocked Mulvihill 22 times in 53 minutes. The wire that connects the defibrillator to the heart was recalled four months later after over a hundred reports of the lead malfunctioning had been reported to the Food and Drug Administration (FDA). However, because of a U.S. Supreme Court ruling last year, Mulvihill does not have any recourse to hold the manufacturer accountable.

In February 2008, the U.S. Supreme Court ruled in Riegel v. Medtronic that because the Food and Drug Administration (FDA) had approved a medical device through the pre-market approval process, patients injured by medical devices do not have any recourse to hold the manufacturers accountable. The Supreme Court ruled earlier this year in Wyeth v. Levine that patients harmed by prescription drugs can hold manufacturers accountable in state courts, creating a double standard between prescription drugs and medical devices.

"I relied on this medical device to save my life. Instead, the trauma I experienced because the device was not safe cost me my career and crippled my lifestyle," said Mulvihill. "Medical device companies should be held accountable for the safety of the products they produce and profit from. I am asking Congress to restore my right to seek justice for myself and medical device patients everywhere."

"Medtronic put profits ahead of patient safety. They were aware the device was failing at abnormally high rates but continued to market it, as alleged in lawsuits filed against the company," according to Wendy Fleishman, Mulvihill's attorney with Lieff Cabraser Heimann & Bernstein, LLP. "Medtronic should not receive the benefit of a judicial doctrine granting the company immunity."

Medtronic's Sprint Fidelis' lead, like Mulvihill's, is the subject of multidistrict litigation in U.S. District Court in Minnesota. In January, U.S. District Court Judge Richard Kyle dismissed over 1,400 patients' cases, citing the Supreme Court decision in Riegel v. Medtronic. The ruling stated, "The Court recognizes that at least some Plaintiffs have suffered injuries from using Sprint Fidelis leads, and the Court is not unsympathetic to their plight. ... Plaintiffs' remedy, therefore, lies with Congress, and not with this Court."

MDSA, sponsored by Sen. Edward Kennedy (D-MA), Rep. Frank Pallone (D-NJ) and House Energy and Commerce Committee Chairman Henry Waxman (D-CA), would restore the right to seek justice in state courts for victims of faulty medical devices like heart defibrillators, prosthetic knees, and hips.

"The Medical Device Safety Act is necessary to protect patients from defective devices and make sure manufacturers are held accountable," said Linda Lipsen, Senior Vice President of Public Affairs at the American Association for Justice. "The Supreme Court has affirmed that state law offers an important layer of consumer protection, and Congress should make clear that this applies not just in cases of pharmaceutical drugs, but also medical devices approved by the FDA that are later faulty or malfunction."

Continue reading "More on the Medical Device Safety Act from the AAJ" »

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August 05, 2009
  Senate Holds Hearing on Medical Device Safety Act
Posted By Steven J. Klearman

The U.S. Senate held a hearing yesterday regarding the Medical Device Safety Act, introduced in March of 2008 and aimed at clarifying that FDA approval doesn't preempt lawsuits against medical device manufacturers.

MedPage Today summarizes the bill and the reasoning behind it:

Under U.S. law, device companies are not liable for damages if their products cause harm as long as the device received premarket approval from the FDA.

But "FDA marketing clearance or approval of a medical device does not guarantee its safety," said William Maisel, MD, director of the Medical Device Safety Institute and a cardiologist at Beth Israel Deaconess Medical Center in Boston.

Dr. Maisel -- who chairs the FDA's Circulatory Advisory Committee -- said the FDA does an "exceptional job" of monitoring the safety of medical devices. However, the post-marketing data is an issue. He said it is "simply impossible" for the FDA to continue to monitor the safety of every medical device it has approved.

Sen. Tom Harkin (D-Iowa), who chaired Tuesday's hearing, agreed.

"No matter how diligently and effectively the FDA does its job, it simply cannot guarantee that no defective, dangerous and deadly medical device will reach consumers," Harkin said.

The device company immunity stems from a 2008 Supreme Court interpretation of a 30-year-old law making the FDA the final arbiter of device safety.

In that 8-1 decision (Reigel v. Medtronic), the Supreme Court ruled that if a device received premarket approval from the FDA, individuals injured by the device may not sue the manufacturer for damages.

Drug companies do not enjoy the same protection. In March, the Supreme Court ruled 6-3 in Wyeth v. Levine that FDA approval of a drug does not shield its maker from lawsuits brought by patients injured by use of the drug.

So patients who are injured by a faulty medical device often have to cover the costs of their resulting medical treatment. The federal government would foot the bill if patient was covered by Medicare or Medicaid, Maisel said.

"Some might argue that we have two cash for clunkers program and this is one of them where the government is paying for defective devices," he said.

But Peter Barton Hutt, a food and drug attorney in Washington, disagreed with Maisel's view and said the FDA is in a better position to decide the safety and efficacy of a device than a jury.

"FDA is not perfect, but certainly a jury is going to be less perfect," he said.

Besides, he said, risk is inherent in all medical devices, and small numbers of patient injuries do not mean a device is defective.

"The fact that it hurts someone doesn't mean there's a defect. It may save 999 lives, but hurt the thousandth life. That doesn't mean it's defective," said Hutt, who served as chief counsel for the FDA from 1971 to 1975.

Allowing individuals to sue device companies at the state level -- which is what identical bills in the House and Senate would do -- would not improve device safety, Hutt said.

But giving injured patients the ability to sue provides a "powerful incentive to manufacturers to use the utmost care," Harkin countered.

Sen. Orrin Hatch (R-Utah) argued that exposing device makers to litigation would make the companies, particularly the small companies, afraid to produce new, innovative products.

The witness panel was lacking a representative from the device industry. However, a race car driver from Missouri told the committee how a spinal implant gave him a new lease on life, and urged the committee not to do anything that would stifle such innovation.

In a release, a spokesperson for Advanced Medical Technology Association (AdvaMed) said the bill would not improve patient safety.

"It will create more frivolous lawsuits and increase healthcare costs, and it will make it harder for small medical device manufacturers to invest in promising new technologies," said Stephen Ubl, president and CEO of AdvaMed.  

Continue reading "Senate Holds Hearing on Medical Device Safety Act" »

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July 29, 2009
  Doctors' Confusion over HIPAA
Posted By Steven J. Klearman

Los Angeles Times article by Lisa Zamosky comments on the confusion in doctors' offices regarding Health Insurance Portability and Accountability Act (HIPAA). The article points out that obtaining medical records is often harder for patients than the law allows:

Under HIPAA, consumers have the right to access records documenting their health conditions, diagnoses and treatments.

HIPAA also explains when healthcare providers can share protected health information with other people.

... [U]nder HIPAA, sending health information by fax is not prohibited. In addition, the law states that the provider must give patients the information they ask for in the format they request.

Trouble accessing medical records from doctors is a common complaint received by the Medical Board of California, which licenses and disciplines medical doctors.

Candis Cohen, a spokeswoman for the board, says physicians and their office staffs frequently confuse details of the HIPAA privacy law and, even with the best intentions of protecting patients' privacy rights and complying with the law, deny consumers access to their medical records.

The traditional medical culture doesn't help, policy and healthcare experts say, pointing out that, historically, doctors haven't valued patients' access to their own records.

"Some providers still have this paternalistic attitude that patients don't have the right to their own health information," says Joy Pritts, associate professor and director of the Center on Medical Records Rights and Privacy at Georgetown University.

A full listing of HIPAA regulations and consumers' rights under the law can be found on the Health and Human Services website, www.hhs.gov/ocr.

Continue reading "Doctors' Confusion over HIPAA" »

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July 13, 2009
  Swimming Pool Safety Tips
Posted By Steven J. Klearman

The Las Vegas Sun reported that a four-year-old boy drowned last Saturday in an apartment complex pool. The tragic incident marks the seventh child drowning this year in Nevada.

ABC reports that there are approximately 1,500 child deaths each year from drowning.

Although swimming pools offer fun and refreshment during the hot summer months, they are dangerous if proper caution is not used. Here are some tips from the American Academy of Pediatrics:

  • Never leave your children alone in or near the pool, even for a moment. An adult who knows CPR should actively supervise children at all times.
  • Practice touch supervision with children younger than 5 years. This means that the adult is within an arm's length of the child at all times.
  • You must put up a fence to separate your house from the pool. Most young children who drown in pools wander out of the house and fall into the pool. Install a fence at least 4 feet high around all 4 sides of the pool. This fence will completely separate the pool from the house and play area of the yard. Use gates that self-close and self-latch, with latches higher than your children's reach.
  • Keep rescue equipment (such as a shepherd's hook or life preserver) and a telephone by the pool.
  • Do not use air-filled "swimming aids" as a substitute for approved life vests.
  • Remove all toys from the pool after use so children aren't tempted to reach for them.
  • After the children are done swimming, secure the pool so they can't get back into it.
  • A power safety cover that meets the standards of the American Society for Testing and Materials (ASTM) may add to the protection of your children but should not be used in place of the fence between your house and the pool. Even fencing around your pool and using a power safety cover will not prevent all drownings.
  • Remember, teaching your child how to swim DOES NOT mean your child is safe in water. 
Continue reading "Swimming Pool Safety Tips" »

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July 08, 2009
  No "Heeding Presumption" in Failure-to-Warn Cases in Nevada
Posted By Steven J. Klearman

The Nevada Supreme Court refused to recognize a "heeding presumption" in strict products liability failure-to-warn cases, in its June 4 decision, Rivera v. Philip Morris, Inc.

A heeding presumption is a rebuttable presumption that allows a fact-finder to presume that the injured plaintiff would have heeded an adequate warning if one had been given.

The Court's reasoning:

In Nevada, it is well-established law that in strict product liability failure-to-warn cases, the plaintiff bears the burden of production and must prove, among other elements, that the inadequate warning caused his injuries. Because a heeding presumption shifts the burden of proving causation from the plaintiff to the manufacturer, it is contrary to Nevada law. Rather than demanding that the plaintiff prove that the inadequate warning caused his injuries, a heeding presumption requires the manufacturer to rebut the presumption that the plaintiff would have heeded an adequate warning by demonstrating that a different warning would not have changed the plaintiff's actions. While other jurisdictions have permitted this shifting of the burden of production, we are unwilling to do so.

See Rivera v. Philip Morris, Inc., 125 Nev. Adv. Op. No. 18 (June 4, 2009) for the full opinion.

Continue reading "No "Heeding Presumption" in Failure-to-Warn Cases in Nevada" »

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June 29, 2009
  New Laws in Nevada, effective July 1
Posted By Steven J. Klearman

The San Jose Mercury released a helpful list of changes to Nevada law taking effect on July 1.

Among the new laws detailed by the AP article are the following:


-- AB10 protects nurses against retaliation for disclosing problems that endanger patients at hospitals or other medical facilities; and SB229 seeks to ensure that foreign-trained doctors who get visas to work in "medically underserved" areas actually provide care in those areas.

-- SB307 calls for a study of Nevada's Medicaid system. The program provided insurance to an average of more than 180,000 people, including the elderly, disabled, children and pregnant women, in fiscal 2008.

-- AB389 is aimed at helping to prevent identity theft by making less credit card information available on printed receipts. The new law prohibits printing more than the last five digits of credit card numbers and expiration dates on copies of customer and business receipts.

Continue reading "New Laws in Nevada, effective July 1" »

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June 26, 2009
  Medicare, Medicaid and SCHIP Extension Act's New Requirements
Posted By Steven J. Klearman

The Medicare, Medicaid and SCHIP Extension Act of 2007, or MMSEA, affects judgments and settlements involving Medicare liens. Plaintiffs and Defendant attorneys should be aware of the changes. Section 111 of the MMSEA adds reporting rules, requiring defendants and insurers to report judgments/settlements with Medicare beneficiaries to the Department of Health and Human Services.

Section 111 of MMSEA is directed at identifying claims where Medicare has a right of recovery. The mandatory reporting requirements allow the Centers for Medicare and Medicaid (CMS) to identify those claims. Section 111 applies to Group and non-Group Health Plans, workers' compensation, liability insurance, no-fault insurance, and self-insurers. All entities which pay settlements, judgments, awards or other payments to Medicare eligible beneficiaries beginning January 1, 2010 are required to report the claim to CMS.

For more info, you can visit the Centers for Medicare and Medicaid website.

Continue reading "Medicare, Medicaid and SCHIP Extension Act's New Requirements" »

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June 24, 2009
  Law Aims to Strengthen Security of Personal Information
Posted By Steven J. Klearman

Senate Bill 227 adds new requirements for data collectors, aimed to provide increased security for consumers' personal information. The bill applies to data collectors who accept card payments for goods or services. It requires data collectors to comply with Payment Card Industry (PCI) Data Security Standards, or requires the use of encryption to protect personal information transmitted electronically.

The law, amending Chapter 603A of NRS, repeals NRS 597.970 and is effective January 1, 2010. 

Continue reading "Law Aims to Strengthen Security of Personal Information" »

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June 24, 2009
  2 Cases of E. Coli in Nevada, Nestle Raw Cookie Dough Recalled
Posted By Steven J. Klearman

The Las Vegas Sun reports that 2 cases of E. coli have been reported in Clark County, Nevada.

This comes days after the FDA issued a warning regarding Nestle Tollhouse raw cookie dough products due to the risk of E. coli. The warning cautions those who have purchased prepackaged cookie dough products to throw them away. Consumers should not even cook the dough, as the FDA warns that the bacteria may still get on consumers' hands and on cooking surfaces.

As of June 19, 2009, all of Nestle's prepackaged, refridgerated cookie dough products have been recalled. The products can be returned for a full refund. No other Nestle products have been affected.

Continue reading "2 Cases of E. Coli in Nevada, Nestle Raw Cookie Dough Recalled" »

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May 08, 2009
  Cases of Swine Flu up to Seven in Nevada
Posted By Steven J. Klearman

According to the Centers for Disease Control and Prevention (CDC), the total number of cases of Swine Flu in the U.S. is up to 896. Forty-one states have been affected, including Nevada, and two people in the U.S. have died from the virus. The three states with the most reported cases are Illinois, California and New York.

The CDC is responding to the situation by striving to reduce the spread and severity of the illness by providing information to help health care providers, public health officials and the public deal with the specific challenges associated with the illness.

Among the CDC's efforts is the PCR diagnostic test kit, developed to aide health officials in detecting the virus. The kits have been distributed to all states in the U.S. and to Puerto Rico, as well as internationally. The CDC predicts that distribution of the kits and better detection of the virus will lead to an increase in reported cases, and thus give the CDC a clearer indication of the severity of the situation.

As of May 7, 2009, the number of reported cases in Nevada was up to seven. The two most recent cases were from Northern Nevada but officials say that the cases were mild and both patients have recovered.

On April 30, 2009, Governor Gibbons issued a Press Release urging Nevada residents to take extra precautions to avoid contracting the Swine Flu. Along with the traditional precautions of washing your hands and covering your mouth when you cough, the CDC has urged all U.S. residents to stay home from work or school if they feel sick, to avoid spreading the disease. 

Continue reading "Cases of Swine Flu up to Seven in Nevada" »

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April 30, 2009
  Bus Crashes Call into Question Federal Safety Standards
Posted By Steven J. Klearman

The Utah bus crash that killed nine and injured 43 others in January of 2008, was followed by an investigation into the cause of the accident. The National Transportation Safety Board (NTSB) concluded recently that driver fatigue was a contributing factor to the crash. More importantly, however, the Board concluded that the National Highway Traffic Safety Administration (NHTSA) failed to implement motorcoach passenger safety recommendations made by the NTSB in 1999 and that this failure was a contributing factor in the severity of the accident.

The recommendations made by the NTSB included on-board electronic recorders to monitor a driver's hours of operation and prevent fatigue, seatbelts to prevent passengers from being ejected in rollovers, stronger roofs and easy-to-open windows that don't shatter. Members of the NTSB are frustrated that the NHTSA has been so slow in implementing these safety standards. More recent accidents elicit the same concerns.

In January of this year a tour bus accident in Arizona killed 7 people and injured at least 10 others. It was reported that all but one of the passengers who died at the scene were ejected from the bus during the accident. It was also reported that the bus rolled at least once before stopping.

The bus accident that occurred just recently on April 29 in California killed 5 and injured dozens. Four of the passengers were ejected from the bus and fell over a guardrail some 60-70 feet onto a set of railroad tracks.

Both accidents call into question several of the proposed safety standards yet to be implemented by the NHTSA. Given that passengers were thrown from the bus in both accidents, it seems likely that the severity of the injuries sustained could have been mitigated if the NHTSA had implemented, at a minimum, the seatbelt regulations recommended by the NTSB a decade ago. 

Continue reading "Bus Crashes Call into Question Federal Safety Standards" »

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April 30, 2009
  Nevada Surgical Patients May be At Higher Risk for Infection
Posted By Steven J. Klearman

A nonprofit Consumer's Union issued a report April 27, 2009, stating that over a one year period, almost 100,000 patients were subject to increased risks of infection following surgical procedures because of hospitals' failure to follow proven prevention practices.

According to the CDC (Centers for Disease Control), surgical infections account for 20% of all hospital-acquired infections and 8,205 patients die from surgical infections annually.

The Consumer's Union found that 445 hospitals across the country were in low compliance for administering antibiotics before surgery, a procedure "known for nearly 50 years" to be critical for the prevention of infection.

Nevada made the list of states with the highest percentage of low compliance for the practice of administering antibiotics within one hour before surgery to prevent infection and the practice of stopping antibiotics within 24 hours after surgery to prevent complications that contribute to antibiotic resistance. With regard to the practice of administering antibiotics pre-surgery, 30% of Nevada's hospitals were in low compliance, and 57% of Nevada's hospitals were in low compliance of the requirement to stop antibiotics within 24 hours after surgery.

It is difficult to place these numbers into context because not all states require hospitals to report infection rates. According to the Union's report, twenty-five states now require hospitals to report these statistics but Nevada is not one of them.

According to an article published on RGJ.com, Renown Regional Medical Center and Renown South Meadows Medical Center both made the list of low-complying hospitals. Gayle Hurd, who is the administrator for best practices at Renown Health reported that the health system has increased its compliance percentages by 30 points over the last six months.

According to the Union's report, 40-60 percent of all surgical infections could be prevented by following simple infection prevention procedures.  

Continue reading "Nevada Surgical Patients May be At Higher Risk for Infection" »

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April 25, 2009
  Urge Your Senators to Vote YES to Protect Patients' Rights!
Posted By Steven J. Klearman

Bill AB 495 has made it to the Senate but further support is needed! The bill seeks to repair some of the harm caused by the KODIN (Keep Our Doctors in Nevada) legislation. Among other things, KODIN put a cap of $350,000 on damages for pain and suffering in medical malpractice suits. The Hepititis outbreak that occurred under the watch of Dr. Desai and his colleages has brought into serious question the amount of protection we should afford physicians when they are blatently negligent. Bill AB 495 will remove the cap on damages as well as some other protections that have proven beneficial for doctors like Desai in the past.

I thank those of you who contacted your representatives to urge them to vote yes on this bill. Now I ask that you contact your senators and urge them to do the same.

Dear Senator,
I strongly support Bill AB 495, which seeks to lift some of the obstacles for injured patients in medical malpractice suits. The KODIN legislation, which implemented these obstacles has caused irreputable harm to injured patients and has given unnecessary protections to doctors like Dr. Dipak Desai. I ask that you please vote yes for Bill AB 495.
Sincerely,
[name]

Terry Care, Chair tcare@sen.state.nv.us
Mark Amodei mamodei@sen.state.nv.us
Valerie Weiner vweiner@sen.state.nv.us
Maurice Washington mwashington@sen.state.nv.us
Allison Copening acopening@sen.state.nv.us
David Parks dparks@sen.state.nv.us
Mike McGinness mmcginness@sen.state.nv.us

Continue reading "Urge Your Senators to Vote YES to Protect Patients' Rights!" »

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