In a 9-0 opinion, which can be found here, the Mississippi Supreme Court upheld a trial court’s denial of a motion to compel arbitration.

In Trinity Mission Health and Rehab, LLC v. Ruth Lawrence, Mrs. Lawrence sued Trinity over the death of her husband. Trinity moved to compel arbitration claiming that Mr. Lawrence had signed an arbitration agreement. Further, Trinity argued that Mrs. Lawrence had signed the arbitration agreement and had authority to bind Mr. Lawrence.

The Court rejected both arguments and found that Mrs. Lawrence’s claims can proceed to a trial on the merits in circuit court, not arbitration. The opinion is good news for those of us fighting against the continual erosion of our jury system and the emergence of arbitration.

Good job to the lawyers representing Mrs. Lawrence and who briefed the case to the Court — Trae Sims and Ben White.

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February 13, 2009 — Today, the company that caused a massive outbreak of salmonella food poisoning from peanut butter products — and may have caused numerous deaths — filed for bankruptcy. Peanut Corporation of America filed for Chapter 7 bankruptcy in the U.S. Bankruptcy Court for the Western District of Virginia.

In Chapter 7 bankruptcy, corporations liquidate their assets to create cash for creditors.

This bankruptcy will certainly affect the claims of people who have been injured by the salmonella outbreak and peanut butter recall. Injured persons need to move quickly to protect their rights.

If you’ve been injured as a result of salmonella poisoning from peanut butter, call us now at 601.376.9331 to protect your claim. Or, you can fill out the short submission form below, and we’ll get back to you within 24 hours, if not sooner — even on weekends.

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On January 20, 2009, Heartland Payment Systems, which provides payment and payroll solutions to some 250,000 businesses nationwide, announced a security breach in which private consumer information was potentially stolen. The Better Business Bureau states that Heartland processes more than 100,000,000 transactions a month.

The story is developing and Herrington Law, PA is staying current on those developments.

If you have reason to believe that your private debit/credit card and/or bank account information has been affected, please give us a call at 601.949.9456 or please fill out the short form below.

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In a matter of first impression, the federal Second Circuit Court of Appeals has ruled that a court, not an arbitrator, should determine the lawfulness of a class action ban in an arbitration agreement.

The decision in In Re: American Express Merchants’ Litigation can be found here.

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UPDATED: January 28, 2009: CNN cites the FDA in reporting that the Peanut Corporation of America knew in 2007 and 2008 that it had a problem with salmonella at its Blakely, Georgia plant. If you have questions about the peanut butter salmonella outbreak, please give us a call at 601.949.9456 or submit a case review form here.

January 23, 2009: The information below is quoted directly from the Federal Food & Drug Administration’s website.

A combination of epidemiological analysis and laboratory testing by state officials in Minnesota and Connecticut, the Food and Drug Administration (FDA), and the Centers for Disease Control and Prevention (CDC) have enabled FDA to confirm that the sources of the outbreak of illnesses caused by Salmonella Typhimurium are peanut butter and peanut paste produced by the Peanut Corporation of America (PCA) at its Blakely, Georgia processing plant.

Peanut butter is sold by PCA in bulk containers ranging in size from five (5) to 1,700 pounds. The peanut paste is sold in sizes ranging from 35-pound containers to product sold by the tanker container. Neither of these products is sold directly to consumers.

However, through its investigation, FDA has determined that PCA distributed potentially contaminated product to more than 70 consignee firms, for use as an ingredient in hundreds of different products, such as cookies, crackers, cereal, candy and ice cream. FDA’s report on its inspection of the PCA facility is available at this link: http://www.fda.gov/ora/frequent/default.htm. Companies all over the country that received product from PCA have issued voluntary recalls of their products. FDA has created a searchable database for these products, which can be found at http://www.accessdata.fda.gov/scripts/peanutbutterrecall/index.cfm, Identification of products subject to recall is continuing and this list is updated frequently.

Product recalls now include some pet food products that contain peanut paste that was made by PCA. While the risk of animals contracting salmonellosis is minimal, there is risk to humans from handling these products. It is important for people to wash their hands–and make sure children wash their hands–before and, especially, after feeding treats to pets. Further information for consumers is located in the Frequently Asked Questions section located on this web site. The pet food products are also included in the searchable data base of recalled products.

Major national brands of jarred peanut butter found in grocery stores are not affected by the PCA recall.

FDA and CDC recommendations for consumers include:

* Do not eat products that have been recalled and throw them away in a manner that prevents others from eating them.
* To determine if commercially-prepared or manufactured peanut butter/peanut paste-containing products (such as cookies, crackers, cereal, candy and ice cream) are subject to recall, consumers are urged first to visit FDA’s website and check the searchable database of recalled products.
* For information on products containing peanut butter from companies not reporting recalls, consumers may wish to consult the company’s website or call the toll-free number listed on most packaging. Information consumers may receive from the companies has not been verified by the FDA.
* If consumers cannot determine if their peanut butter, peanut butter/peanut paste-containing products or institutionally-served peanut butter contains PCA peanut butter/peanut paste, FDA recommends that they do not consume those products.
* Persons who think they may have become ill from eating peanut butter are advised to consult their health care providers.

For Retailers

* Stop selling recalled products.

For Directors of Institutions and Food Service Establishments

* Ensure that they are not serving recalled products.

For Manufacturers

* Inform consumers about whether their products could contain peanut butter or peanut paste from Peanut Corporation of America (PCA). If a manufacturer knows their products do not contain peanut butter or peanut paste from PCA, they should inform consumers of that. For specific guidance: Guidance for Industry: Product Recalls, Including Removals and Corrections

The FDA will closely monitor these events by continuing to work with the firms on the details of their actions, conducting follow-up audits and inspections, monitoring the progress of the firms’ actions, working with state and local regulatory authorities, and notifying our foreign regulatory counterparts of products that have now been confirmed as having been distributed internationally.

Ongoing Investigation

FDA has collaborated with the Centers for Disease Control and Prevention (CDC) and public health officials in various states to investigate the multi-state outbreak of human infections due to Salmonella Typhimurium. An epidemiological investigation by the Minnesota Department of Health isolated and tested subsamples from an open five-pound container of King Nut peanut butter obtained at a nursing home where three patients were sickened by the outbreak strain of Salmonella Typhimurium. The Minnesota Health officials found the peanut butter contained the same strain of Salmonella Typhimurium associated with the illnesses linked to the outbreak.

Because it is always possible that the open container was contaminated by someone or something else in the environment, the FDA and the states began testing unopened containers of the same brand of peanut butter. King Nut distributes peanut butter manufactured by the PCA to institutional facilities, food service industries, and private label food companies in several states.

On January 19, 2009, testing by the Connecticut Department of Health of an unopened container of King Nut peanut butter showed that it too contained the same strain of Salmonella Typhimurium associated with illnesses linked to the outbreak. The fact that the Salmonella Typhimurium was confirmed in an unopened container of peanut butter indicates that peanut butter originating from the processing plant was contaminated.

FDA has initiated inspections at the direct consignees of PCA and King Nut and continues to follow the distribution points for products.

The FDA has no evidence to suggest that the Salmonella Typhimurium contamination originated with any other major manufacturing facility other than PCA. The PCA facility in Blakely, Georgia is not operating at this time and the company has recalled peanut butter and peanut paste produced from July 1, 2008 to the present.

The FDA and food manufacturers are working to identify products that may be affected, and to track the ingredient supply chain of those products to facilitate their removal from the marketplace.

For the latest information on the outbreak and the epidemiological investigation, including number of illnesses and a list of states reporting illnesses, go to the CDC web page at http://www.cdc.gov/salmonella/typhimurium/.

Source

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With humility and eagerness, I am joining the faculty of Solo Practice University, a web-based, virtual law school where law students and legal professionals can learn the “how-tos” of practicing law. I will teach a course on class action litigation.

Class actions play a vital role not only in our civil justice system, but also in society as a whole. Numerous beneficial changes to industry practices, political governance, and civil rights have been achieved through the class action device.

It is indeed an honor to now have the opportunity to share with others all that I have learned about Rule 23 class actions. Mine will not be a theory course. From the initial client interview to trial and all points in between, we’ll discuss Rule 23 inside and out and you’ll obtain the tools necessary to successfully litigate a class action. Like all the other classes at Solo Practice University, this is a how-to course.

While class actions can be immensely complex and time-consuming, solo practitioners litigate them every day. Through this course, I hope to equip other solos, or law students thinking of going solo out of law school, to handle Rule 23 cases.

Thanks to Susan Cartier Liebel for extending this opportunity to me. I look forward to it. We’re going to learn a lot and, hopefully, have some fun while we’re at it.

Below is the video introduction to my course.

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On January 2, 2009, the Food and Drug Administration issued the recall below.

FOR IMMEDIATE RELEASE
January 2, 2009

Media Inquiries:
Siobhan DeLancey, 301-796-4668
Consumer Inquiries:
888-INFO-FDA

FDA Announces Class I Recall of Ophthalmic Surgical Device

The U.S. Food and Drug Administration announced a Class I recall of lot no. UD30654 of Healon D, an ophthalmic viscosurgical device (OVD) manufactured by Advanced Medical Optics Inc. (AMO) of Santa Ana, Calif.

OVDs are viscoelastic materials used to maintain space in the eye during surgery. Typically, OVDs are pre-packaged in a syringe and are applied using a small tube.

On Oct. 30, 2008, AMO voluntarily recalled all 4,439 units of Healon D lot no. UD30654 of Healon D, due to complaints of inflammation after eye surgery, including Toxic Anterior Segment Syndrome (TASS). At that time, AMO informed customers of the number and nature of adverse event reports associated with OVD from that lot, and included a fax reply form for quick communication.

However, as of December 3, 2008, AMO had retrieved only 964 units of the 1,450 that had been distributed in the United States.

AMO received 66 adverse event reports associated with the recalled products. Tests of this lot revealed elevated levels of endotoxin, which has been associated with post-operative intraocular inflammation and TASS.

TASS is a post-operative, acute inflammation of the anterior segment of the eye (the front third of the eye including the cornea, iris and lens). TASS has been linked to solutions and devices used during eye surgery, such as OVDs, intraocular lenses and irrigation solutions.

The FDA urges anyone in possession of any units from the recalled lot, whether units were purchased from the company or provided as a sample by a sales representative, to remove them from inventory, and contact AMO at 1-877-AMO-4Life to make arrangements for return. The lot number of the device is displayed on the side panel of each unit.

Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of this product to AMO by calling 1-877-AMO-4LIFE and to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

Online: www.fda.gov/MedWatch/report.htm
Regular Mail: use postage-paid FDA form 3500 available at www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD, 20852-9787
Fax: (800) FDA-0178
Phone: (800) FDA-1088

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Score another one for consumers. In Missouri, the state “Court of Appeals in St. Louis found that part of a mandatory arbitration clause in QC Financial Services Inc.’s loan contracts was both ‘procedurally’ and ’substantively’ unconscionable.”

QC Financial Service’s Inc. operates as Quick Cash, a payday lender, in Missouri. The court correctly noted that class action bans in cases involving what amounts to small claims serve to “immunize a defendant” and “paralyze consumers,” which is unconscionable.

The full story can be found here.

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Yesterday, the U.S. Food and Drug Administration issued a Class I recall of two devices: the Vibrational Integrated Bio-photonic Energizer device manufactured by VIBE technologies and the HLX8 device manufactured by Nebion LLC.

Both manufacturers claimed that their devices could cure diseases as varied as cancer and migraines. If you or someone you know used one of these devices and suffered an injury, please call us at 601.366.1297 for a free consultation. Or, you may fill out a short, confidential submission form by clicking here.

FOR IMMEDIATE RELEASE
December 15, 2008
Media Inquiries:
Siobhan DeLancey, 301-796-4668
Consumer Inquiries:
888-INFO-FDA

FDA Announces Class I Recalls of Two Unapproved Devices

The U.S. Food and Drug Administration (FDA) announced a Class 1 recall today for two unapproved and uncleared devices whose manufacturers claimed could treat various medical conditions. A Class 1 recall means that there is a reasonable probability that the use of a device will cause adverse health consequences or death.

The manufacturers, VIBE Technologies of Greeley, Colo., and Nebion LLC of Los Angeles, Calif., claimed their devices treated conditions ranging from cancer to migraines. The FDA is concerned that based upon the original health claims made by the company, patients may forgo approved therapies, and that this could result in more severe illness or death.

“These recalls underscore the importance of taking action against manufacturers who make false medical claims for their devices,” said Daniel G. Schultz, M.D., director of the FDA’s Center for Devices and Radiological Health. “One of the FDA’s primary responsibilities is protecting consumers from harm that can be caused by manufacturers who try to sidestep the approval and clearance process.”
Vibrational Integrated Bio-photonic Energizer device

On April 11, 2008, the FDA issued a warning letter to VIBE Technologies stating that the agency’s November 2007 inspection of the facility showed that the company had not obtained FDA marketing approval or clearance for the Vibrational Integrated Bio-photonic Energizer (VIBE device), which claims to treat cancer, infections, and depression. The FDA also cited the company for substantial deviations from the current Good Manufacturing Practice/Quality System regulation.

VIBE Technologies initiated a recall of 840 VIBE devices in an April 3, 2008, letter sent to users. VIBE Technologies agreed to stop promoting and marketing the VIBE device, and will contact all those who had purchased it to ensure no other unsubstantiated medical claims are being made. The FDA has requested that the company update its recall notices to state that the VIBE device is not intended for the treatment of any diseases or medical conditions.

The FDA is aware of information that suggests that the VIBE device has been used in cancer patients. There is one death that occurred in a patient who used this device. However, FDA has not verified that there is any association between the death and the VIBE device.
HLX8 device

In June 2008 FDA inspected Nebion, LLC, which revealed that the company had not obtained FDA marketing approval or clearance for the HLX8 device, which claims to treat cancer, migraines, arthritis, and ruptured discs. The inspection also uncovered substantial deviations from the Current Good Manufacturing Practice/Quality System regulation.

Nebion recalled eight HLX8 devices on July 2, 2008, and notified their customers to stop using the devices immediately and to contact Nebion for their retrieval.

Nebion’s first recall letter did not address the potential risks associated with the HLX8 device, but the company has recently notified FDA that they will issue a second letter that identifies potential health hazards. The FDA has not received any reports of injuries or deaths linked with the HLX8 device.

Under federal law, products that claim to diagnose a disease or condition, cure, mitigate, treat or prevent disease, or that are intended to affect the structure or function of the body are devices subject to FDA jurisdiction and may require FDA approval or clearance prior to marketing. Premarket approval is the most stringent type of FDA device review and is for devices with a high level of risk, such as those that support or sustain human life. FDA clearance is for lower risk devices that are shown to be as safe and effective as a similar device already on the market.

Neither VIBE Technologies nor Nebion has demonstrated to the FDA that their device is safe and effective at curing or treating diseases as claimed.

Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of this product to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

* Online: www.fda.gov/MedWatch/report.htm
* Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
* Fax: (800) FDA-0178
* Phone: (800) FDA-1088

Health care professionals and patients can obtain further details about the recalls from VIBE Technologies at 970-356-9594 or Nebion LLC, at 310-215-6400.

Source

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If you or someone you know is currently taking Avandia, please read the article below for important information. If you believe you have been injured as a result of taking Avandia, please contact us immediately at 601.366.1297 or you may submit a short form for a free consultation by clicking here.

Safety risks higher with Avandia than Actos: study
Mon Nov 24, 2008 10:17pm EST

By Julie Steenhuysen

CHICAGO (Reuters) – Older diabetics who took GlaxoSmithKline’s Avandia to control their blood sugar had a higher risk of death and heart failure while on the drug than those who took Takeda Pharmaceutical’s Actos, a drug in the same class, U.S. researchers said on Monday.

They said the head-to-head comparison confirms prior analyses finding Avandia carries greater risks than Actos, particularly in older diabetics.

Surprisingly, the study found no difference in heart attack and stroke risks. But since 75 percent of diabetics die from heart-related causes, the researchers think heart attacks and strokes likely contributed to the overall increased deaths in the Avandia group.

“We hypothesize that many of the deaths were due to myocardial infarction (heart attack) and stroke,” Dr. Wolfgang Winkelmayer of Brigham and Women’s Hospital in Boston and colleagues wrote in the Archives of Internal Medicine.

Recent analyses of clinical studies found Avandia raised the risk of heart attacks, which has sent sales of the drug plummeting. An analysis of studies on Actos, meanwhile, suggested it reduced the risk of heart attacks and strokes.

Both Avandia, known generically as rosiglitazone, and Actos, known generically as pioglitazone, raise the risks of heart failure and carry strong warnings on their labels.

“Altogether, the picture people got was it looks like rosiglitazone might be associated with badness and pioglitazone is neutral and even beneficial,” Winkelmayer said in a telephone interview.

“For me, that left an important question open. What if you happen to directly compare those two treatments together.”

He and colleagues studied Medicare claims data from 28,361 U.S. patients older than 65 years who began taking either rosiglitazone or pioglitazone between 2000 and 2005.

ANOTHER PIECE OF THE PUZZLE

They checked for overall risk of death while taking the drug, as well as heart attacks and heart failure and other side effects in this population of older diabetics.

Of those studied, 14,260 began treatment with pioglitazone and 14,101 with rosiglitazone.

“Those who started with rosiglitazone had a 15 percent increased risk of dying from any cause compared with pioglitazone,” Winkelmayer said. They also found patients on rosiglitazone had a 13 percent great risk of heart failure compared with those on pioglitazone.

“The interesting part is that we didn’t find any difference for the risk of stroke or heart attack,” he said.

Winkelmayer thinks this may be because older diabetics are less likely to survive a heart attack or stroke. “This hypothesis we cannot test because we don’t have any cause of death data for these patients. It remains speculation.”

Glaxo disputed the findings. “This new study is inconsistent with evidence from randomized clinical trials and has significant limitations,” said company spokesman Jeff McLaughlin in an e-mail. He said the company’s long-term data suggest no increased risk of death for people taking the drug.

Safety issues raised by the study could be because of differences in the study populations, McLaughlin said, and a randomized clinical trial was the best way to settle safety questions.

Winkelmayer said the study was not a randomized clinical trial, which is the most reliable type of study, but he said the characteristics in both study populations were surprisingly similar, making the comparison quite strong.

“I think it’s one more piece of the puzzle,” he said. “It will contribute to a more compelling picture that will inform policymakers with regard to how to move forward.”

Last month, two major medical groups dropped Avandia from the list of recommended treatments for people with type 2 diabetes, the most common form of the disease.

Some 23.6 million U.S. children and adults have diabetes, according to the American Diabetes Association. Type 2 diabetes is closely linked to obesity.

(Editing by Will Dunham and Cynthia Osterman)

Source

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