Caffeine, hands down, is the most popular, legal and widely abused drug on the planet.  It’s in everything including: caffeinated snacks; soft drinks; alcoholic beverages; over the counter supplements; not to mention popular face cream and products that boast a remedy for cellulite. Caffeine is legal, but even too much of a good thing can cause harm.  Perhaps the fastest growing new line of caffeine containing products is energy drinks. Blogger and author of “Nutrition for Dummies”, Carol Ann Rinzler, examined the labels of the top three energy drinks. (more…)

In the last couple of years, it seems as if there has been an increase in the recalls issued by the FDA; contact lens solutions, tainted meat, poisonous vegetables, toxic toys and poisonous pet food to name just a few. In response to concerns over the recent headlines“Infant Formula from China Tainted by Chemical”, the FDA has issued a warning that toxic baby formula “even though it is not legally approved for importation” may have made its way into local markets here in the USA.

The concerning chemical in the formula is melamine. As some of you may recall Melamine is the same chemical associated with the massive pet food recall in 2007 after thousands of U.S dogs and cats were poisoned and killed after ingesting toxic pet food. It was later determined, according to veterinary pathologists, “that the combination of melamine and cyanuric acid caused crystals to form in the urinary tracts of animals” leading to their untimely death.

As we have seen in the world of dietary supplements, manufactures and suppliers in China use the” nitrogen rich” Melamine to make the product appear to be containing more protein than it actually does to pass  the standard tests for protein ingredient  in bulk foods. The additive Melamine makes the product “appear to be gluten” and they are then sold “as gluten” to pet food manufacturers U.S. and Canadian.

Melamine causes chronic toxicity and “Ingestion of melamine may lead to reproductive damage, or bladder or kidney stones, which can lead to bladder cancer”.
Although the press release by the FDA cited that there is no “known threat” it is also not “known” as to whether or not some of the contaminated product has found it’s way into specialty stores in the USA. Although not very reassuring, they do urge  “Individuals should contact their health care professional if they have questions regarding their infant’s health or if they note changes in their infant’s health status.”

There have been many reports in the past decade over contaminated baby food and formula ranging from salmonella to this most  recent contamination threat of formula found to contain melamine, which has been cited as the culprit in China for babies developing serious kidney problems. CBC News reported that spokesman Mao Qunan stated, the agency investigators concluded the chemical (Melamine) was added when the milk was purchased from farmers but gave no other details. Quanan said, 78 “suspicious people” were summoned for questioning. Sanlu Group, the major Chinese dairy that produced the formula, has recalled 700 tons of the products, the Xinhua News Agency reported. “China Health Ministry issued a statement “Those responsible will face serious punishment.” 

There is no question that technological changes have revolutionized discovery in civil litigation, particularly in cases where the parties seek large volumes of documents from their opponents. Medical device and pharmaceutical litigation come to mind. How to manage so-called “e-discovery” is on the minds and lips of many lawyers. In theory, e-discovery techniques should provide a discovering party with powerful weapons to ferret out litigants who cheat the system by hiding the ball. Unfortunately, this is not necessarily the case. Technological sophistication in the discovery process does not, by itself, guarantee integrity in the content of a party’s discovery responses. In fact, recent experience teaches that technology can be used improperly to increase the obstacle’s that a party faces in discovering the truth. For example, document or file formatting can reduce a discovering party’s ability to efficiently search documents for critical information.

I was recently reminded, however, that it is important to return to the rules of procedure occasionally as a source of protection against unprincipled discovery practices by well-heeled litigants and resourceful lawyers. In a recent case handled by our firm, the defendant produced more than two million pages of documents relating to the development and sale of a medical device. Although the production was in an electronic format, it was marked by a high degree of disorganization. It was very difficult to manage and highly trained personnel on our staff suspected that the coding and formatting of the documents had been designed to impair their usefulness. The modern-day equivalent of shuffling a pile of papers.

Courts have the power to deal with problems that arise in the brave new world of discovery problems. Many courts, however, lack the sophistication, experience or resources to handle important e-discovery disputes and problems. That’s where the rules of procedure can come in handy. Rule 34 of the Federal Rules of Civil Procedure (and most of the analogous state rules), for example, gives a producing party a choice. One choice is to identify its documents to correspond with the discrete requests served in a request for production. The other is to produce documents as kept in the “usual course of business.” In cases where there is a large volume of records, the party making a document request has a potentially significant advantage if the producing party’s responses identify how its production corresponds to the requests.

The historical reasons that the rulemakers created this choice are clear. One reason was to prevent discovery abuses via document production in “volume or disarray.” Another was to ensure production of documents “in the order in which the documents are actually kept in the usual course of business so that there is an internal logic reflecting business use.” “Second Report of the Special Committee for the Study of Discovery Abuse,” American Bar Ass’n Section of Litigation, 92 F.R.D. 137, 177-78 (1980).

Recent experience, however, teaches that some manufacturers use the “usual course of business” option to do exactly what the rule seeks to avoid, make document production in “volume or disarray.” In the case which I mention, the defendant took the position that its document production was made in the “usual course of business.” In fact, every page of the documents produced was examined, vetted and analyzed before the production took place. The defendant represented in court that a team of thirty to forty full-time outside lawyers was working on the production on a full-time basis. Free-ranging redactions, many with obviously material content, filled the production. Hundreds of thousands of pages were withheld on grounds of privilege. While the defendant was a large, sophisticated corporation with thousands of employees, there was absolutely no “internal logic” to its production.

As our frustration in working with the defendant’s production grew, I began to reexamine the purposes of the Rule 34 option and the decisions interpreting the rule. Despite the obvious importance of this issue, there is not a great deal of authority as to what constitutes production of records as maintained in the “usual course of business.” But some things are relatively clear. When a party makes this election, that party has the burden of proving that it has in fact produced its documents in as maintained “in the usual course of business.” Cardenas v. Dorel Juvenile Group, 230 F.R.D. 611, 618-19 (D. Kan. 2005).

One of the problems we were having was that the defendant had obtained internal records from different people it called “custodians” and purported to produce those records on a custodian by custodian basis. When the records were combined and produced to us, however, there was no apparent principle relating to their organization. At least one federal judge has found that this process is not authorized by Rule 34. In Scripps Clinic & Research Foundation v. Baxter Travelol Laboratories, Inc., CIV. A. No. 87-140-CMW, 1988 Westlaw 70013 (D. Del. June 21, 1998), the court explained, “Baxter . . . failed to produce the documents as they were kept in the ordinary course of business. The documents were gathered from many people and transferred to Scripps in an unintelligible manner. This is insufficient under Rule 34(b).”

Even once these failures are identified, it is very difficult to persuade a judge to do anything about it. In the case to which I refer, however, we were able to persuade the trial court that the remedy is to require the producing party go back and redo its production, by identifying those documents (and their Bates numbers) which correspond to the discrete discovery requests. The decision in Cardenas supported the trial court’s conclusion. Our defendant complained bitterly about the trial court’s ruling, particularly about the expense and effort associated with having to redo its responses to our substantial discovery requests. The interlocutory appeal that followed was dismissed.

I learned a few things from this experience. I was reminded of the importance of narrowly tailoring discovery responses. The more specific we are in our document requests, the more likely we will be able to help get the courts to pin down our opponents in providing responsive information. I also learned that we should never accept without corroboration the representations of our adversaries that their document production is based on the “usual course of business.” We should be careful about testing those representations when the need arises, and challenging them when they unduly and improperly complicate our efforts to find the truth.

You may want to put your fork down for this one. On August 5, 2008 the division of the USDA Department of Agriculture National Organic Program (NOP) governing Organic foods made an announcement “that 15 of the 30 accredited organic certifiers they recently inspected failed the USDA audit. It is clear that there are numerous violations of organic standards taking place in the U.S. and across the world” says Ronnie Cummins National Director of Organic Consumers Association.”

For those of you who are not familiar with the “engine” that runs the organic industry, allow me to provide a little history. In 1990 the Natural Organic Program was established as the “The Organic Foods Production Act of 1990”; as part of the Farm Bill a 15 member National Organic Standards Board (NOSB). The board comprised four farmers/growers, two handlers/processors, one retailer, one scientist, three consumer/public interest advocates, three environmentalists, and one USDA accredited certifying agent. Members come from all four U.S. regions.

In the last 40 years the organic community in the USA has evolved into a “multi-billion dollar alternative to energy and chemical-intensive industrial agriculture.” With the invasion of so called “organic corporations” as well as foreign importers, a number of practices have developed that not only violate “the spirit of organic integrity, but allow bogus, at times toxic, “organic” imports from foreign countries to degrade the “USDA Organic” label.”

In a recent audit by the USDA, violations were cited in relation to a French-based organic certifier, Ecocert, along with other certifiers. Quality Assurance International (QAI), North America’s largest “for profit” organic certifier, has recently come under fire  by the Organic Consumers Association (OCA). A recent article cites QAI ‘s  “loose” interpretation of standards allowing companies to “bend if not break the rules”.
Mark Kastel, cofounder of the Cornucopia Institute, a Wisconsin-based organic watchdog group, dubbed QAI the “corporate certifier of convenience for it’s propensity to certify most of the suspect large scale dairy operations that his organization is monitoring.” According to Kastel:
 “…many of these “factory farms which supply milk to Horizon (owned by Dean Foods) and Aurora Dairy (which markets under Woodstock Farms Brand) are skirting the rules by confining thousands of cows in feedlot-like conditions with minimal time grazing on pasture.”

QAI, Horizon and Aurora have responded that their interpretation of the Law is that cows must have access to pasture while ignoring the other rules that state that livestock living conditions must ”accommodate the health and natural behavior of animals which does not include being confined to a pen and feeding from a trough.” But the folks in Missouri were not buying it.

Several class action lawsuits have been consolidated into one suit against Aurora Organic Dairy Corp.; which is being accused of producing and  selling “bogus organic milk” that fails the Federal Standards in Aurora Dairy Corp Milk, No. 4:08MD01907 (E.D.Mo.).
“I know that the consumers went to great lengths to create and protect the organic label, and that’s what we’re trying to do now — is to protect the integrity of the label,” said David G. Cox of Lane, Alton & Horst in Columbus, Ohio, who is one of several plaintiffs lawyers involved in the milk class action”

As required by Law in the “National Organic Standards” USDA has called upon OCA and the organic community to implement a “Peer Review Panel” system, so that members of the organic community can police and organic standards on the part of producers, importers, and certifiers and report violations.
“As the USDA has admitted, “The National Organic Standards call for the Administrator of AMS (USDA Agricultural Marketing Service) to appoint members of a Peer Review Panel to evaluate the NOP’s adherence to its accreditation procedures and its accreditation decisions.” It’s time for the USDA to stop dragging their heels and begin the public process to set up an organic community “Peer Review Panel, so organic standards can be properly enforced.

For more information visit:

http://www.commondreams.org/archive/2008/08/08/10887/

http://www.organicconsumers.org/articles/article_13119.cfm

More than six years after the Women’s Health Initiative Study was suspended due concerns regarding the long-term health risks associated with the drugs new information continues to emerge. The newest evidence, published in the Archives of Internal Medicine, was noted in the Nurses’ Health Study, a study involving 51,637 postmenopausal nurses who provided data regarding their medical histories and use of HRT since 1976. In 2002, the researchers began to collect data regarding the prevalence of gastroesophageal reflux disease (GERD). 

In this study, 23% of participants noted GERD symptoms, but current and past users of hormones were at a greater risk.  It was also noted that HRT users who ingested the highest doses of the drugs or took them for the longest periods of time were more likely to suffer from GERD. The authors concluded that this condition may very well be triggered in part by hormone levels.  It was suggested that GERD be added to the growing list of known risks of HRT drugs (a list that also includes breast cancer, ovarian cancer, stroke, heart attack, and blood clots), and that these risks be carefully weighed against the benefits of taking the hormones by every patient before deciding whether to initiate therapy.  

Currently, more than 10,000 women are pursuing lawsuits against Wyeth, Pfizer, and other manufacturers of post-menopausal combination hormone therapy drugs such as Prempro and Premarin + Provera. 

The Mass Tort Team at Searcy Denney Scarola Barnhart & Shipley, P.A. is pursuing potential claims on behalf of injured victims. If we can provide you with additional information, please feel free to contact our firm.

In an effort to improve our nation’s beleaguered drug safety system, the Food and Drug Administration plans to post quarterly lists of drugs that are being investigated by the Agency due to safety concerns.  The FDA cautioned that the fact that a drug is included on the list only means that an investigation is ongoing and not that the drug has been determined to be “unsafe.”  This list is part of an overhaul of the FDA mandated by Congress in the aftermath of well-publicized drug safety failures, including Vioxx. 

The following drugs are included on the FDA’s list:

Drug and Use
 Concern
Suprane – anesthetic Cardiac arrest
Cymbalta – depression Urinary retention
Intelence – HIV Bleeding into joints (hemoarthrosis)
Carac and Kuric – skin creams Potential confusion due to similar names
Heparin – blood thinner Serious allergic or anaphylactic reactions
Humulin-R – insulin

Seroquel – bipolar disorder

R-Gene 10 – growth hormone

Nitrostat – angina Potential confusion over dosing instructions
Stromectol and Warfarin – anti-parasite drug and blood thinner Potential for drug interaction
Tykerb – breast cancer Liver damage
Revlimid – multiple myeloma Severe skin reaction (Stevens Johnson Syndrome)
Tysabri – MS Skin melanomas
Sandostatin LAR – abnormal bone growth Bowel obstruction (ileus)
OxyContin – pain medication Drug misuse, abuse, and overdose potential
Definity – cardiac imaging Cardiopulmonary reactions
Tyzeka – hepatitis Nerve damage (peripheral neuropathy)
Tumor Necrosis Factor (TNF) Blockers Cancers in children and young adults
Dilantin – epilepsy Serious skin reactions (“Purple Glove Syndrome”)

The FDA continues to rely upon a troubled adverse event reporting system in addition to reports from manufacturers in an effort to identify potentially-unsafe drugs.  The problem with this system is that it is believed that as few as 1% of safety issues with drugs are ever reported to the FDA by consumers and their physicians.  Also, the FDA’s antiquated guidelines do not require manufacturers to report every adverse event of which it may become aware, and such reporting is done on the honor system.  The new quarterly list will not include drug safety investigations that have been prompted by red flags received from clinical trials and studies. 

While the FDA’s efforts are to be applauded, they are only one piece of the drug safety puzzle.  The other very critical piece is the civil tort system.  Unfortunately, the ability of our court system to hold manufacturers accountable for dangerous drugs that harm consumers is currently under assault through back-door federalization and preemption efforts.  It is critical for the civil tort system to continue to play a role as an advocate for injured victims; an important part of the checks and balances.  The FDA has admitted the significant limitations to its ability to truly safeguard consumers from dangerous drugs, so it would be a travesty to remove the safety net provided to injured patients by the civil justice system. 

Judge Joseph R. Goodwin, a federal judge in Charleston, West Virginia, has been selected to oversee pre-trial coordination of the Digitek litigation.  Judge Goodwin will hold the first hearing to begin the ambitious process of organizing the discovery and pre-trial procedures for all of the Digitek claims on October 10, 2008, in Charleston. 

Digitek, also known as digitalis or digoxin, is a prescription drug that was recalled from the market in April of 2008 by manufacturers Actavis Totowa, LLC; Actavis, Inc.; Actavis US; Mylan, Inc.; Mylan Pharmaceuticals, Inc.; Mylan Laboratories, Inc.; Mylan Bertek Pharmaceuticals; and UDL Laboratories, Inc. 

Currently, more than 50 lawsuits have been filed against these manufacturers alleging personal injuries and wrongful deaths associated with a manufacturing defect in the recalled Digitek pills which led to excessive doses of the cardiac medication.  Digitek is prescribed to patients who have heart rhythm abnormalities such as atrial fibrillation, atrial flutter, and heart failure.  Patients who ingest excessive doses of the medication may experience visual changes, palpitations, irregular pulse, cold sweats, and other signs of digitalis toxicity, a potentially fatal adverse reaction.  

On August 28, 2008, I posted a story about Medtronic’s defective Sprint Fidelis defibrillator leads on InjuryBoard.com.

The story mentioned the difficulty surgeons would encounter in removing the defective Medtronic leads. In the meanwhile, the FDA and Medtronic have been cooperating to arrive at a workable interim solution to enable doctors to track down potential lead fracture. Today, the FDA approved Medtronic software update that gives doctors the capability of monitoring and identifying potential defibrillator lead fractures on a 24 hour basis. The ability to determine when and where lead fractures are occurring will benefit patients who may require crucial medical intervention.