For several years, there have been rising concerns about adverse events associated with use of fluoroquniolones, especially Levaquin.  According to documents filed in the Levaquin litigation, being coordinated in the United States District Court in Minnesota, the Japanese company (Daiichi Pharmaceutical Co. Ltd.) that developed both Levaquin and Floxin knew prior to approval of Levaquin for sales in the United Sates that the drug was likely to cause Achilles tendon ruptures . This risk was well documented in the early years after introduction as it was marketed throughout Europe and began to cause harm to patients.

The warning label for Levaquin has included mention of the possibility of tendon ruptures in the past, but such labels were obscure and never adequately warned patients or prescribing physicians of the magnitude of the risk or the fact that Levaquin was more toxic than other, similarly effective drugs.  Other than placing a warning in December of 2001, based on postmarketing surveillance reports in the PDR, indicating that this risk may be increased in patients receiving concomitant corticosteroids, especially in the elderly, the manufacturer did not provide any special label precautions. The manufacturer fell far short in their warnings, regarding the higher risks faced by older patients or those concomitantly taking steroids.

This is most unfortunate because deleterious effects of fluoroquinolones on tendons have been well documented since the 1980s .

Finally, in 2008, after more than 1,000 reports of serious tendon injuries and ruptures to the FDA, a Black Box warning (the highest level of warning) appeared on the label confirming that patients taking Levaquin are at greater risk for suffering a ruptured Achilles tendon.   Unfortunately, the label still fails to alert physicians and patients that Levaquin is more toxic than other similar drugs .

Levaquin is particularly risky for patients who are over the age of 60 and taking corticosteroids at the same time as Levaquin.  Studies conducted by the manufacturer  indicated that Levaquin was more toxic than Cipro; for example the study that Ortho McNeil completed in 2001, one that Johnson & Johnson completed in 2006 and another By Johnson & Johnson completed in 1993. Unfortunately, none of the studies conducted by these manufacturers were published in any noted journals . Undoubtedly, if this information were known to physicians in the Untied States, prescribers would have evaluated the risk differently and chosen one of a number of other antibiotics for treatment of their patients. As a result, doctors might have avoided subjecting their patients to the unnecessary pain and suffering associated with an Achilles tendon rupture and a host of other adverse events.

Beginning in 2002, Johnson & Johnson sponsored a study that showed that Levaquin may also be risky for juveniles ranging between age 6 months and 16 years . In 2007, investigators published the results of that study in the Pediatric Infectious Diseases Journal, and they found that the incidence of one or more of four predefined musculoskeletal disorders identified in non-blind, prospective evaluations (i.e., arthralgia, arthritis, tendinopathy, gait abnormality), was statistically greater in levofloxacin-treated compared with non-fluoroquinolone treated children.

Levaquin triggers cell death which causes tendons to become weakened and often rupture.  Most patients suffer ruptures of their Achilles tendon since this is the tendon in the body that suffers the most trauma with everyday, weight bearing activities, although the rupture of other tendons has certainly been noted in patients who have taken Levaquin.  The rupture of an Achilles tendon is particularly painful injury that requires extensive physical therapy and mobilization of the leg.  Unfortunately, older patients may never fully recover from a tendon rupture.

Our firm is investigating cases on behalf of injured victims resulting from these types of serious injuries.

As has been highly publicized, more than 50,000 patients who suffered heart attacks, strokes or died after ingesting Vioxx are now participating in a nearly $5 billion settlement program being administered through the federal court in New Orleans.  This settlement was announced after more than a year of secret negotiations and more than a dozen trials.  Just prior to announcement of the settlement, Merck faced the prospect of spending far more than $5 billion in order to continue its win-at-all-costs litigation tactics.  The Vioxx claims were submitted to a Claims Administrator over the Summer and partial payments began in August of 2008.  It is expected that all of the qualifying Vioxx claimants should have their claims reviewed and paid in full within the next 18 months.

In this study, the researchers reviewed medical records for nearly 75,000 patients treated at two hospitals over a ten-year period. The study noted that standard lab measurements of renal function were helpful in identifying patients most at risk for development of NSF.  Patients with a glomerular filtration rate (eGFR) of less than 15 were at highest risk, although NSF cases were also noted in patients with eGFR scores as high as 30.  This study is consistent with others that have confirmed that a wide range of patients are at risk for development of NSF, not just those patients with advanced renal failure.  The study noted that a shocking 8.8% of patients with an eGFR of less than 15 (and not undergoing dialysis) developed NSF. The study also concluded that patients receiving the highest doses of gadolinium faced the highest risks of developing NSF .

The pain pump is attached to a catheter, which was routinely inserted into the soft tissue near the affected joint. This use of the pump worked fine until the manufacturers of these devices started recommending that physicians could insert the catheter directly into the affected joint space and provide a much higher degree of pain relief. This was, of course, welcome news for physicians who always want to attempt to relieve or minimize the suffering of their patients. So all was good, then?

What pain pump manufacturers failed to tell physicians is that the Food & Drug Administration had never reviewed, let alone approved, the use of the pumps directly into the joint space. What the manufacturers should have known is that at least one of the manufacturer’s, McKinley Medical, asked the FDA to permit insertion of the devices into the joint space and the FDA asked for proof of efficacy. As far as we know, no data or evidence was presented to the FDA. Soon after this, Stryker Corporation purchased the exclusive rights to the pain pump from McKinley.

With full knowldge, the pain pump manufacturers failed to tell doctors that:

1. The FDA never cleared or approved the use of pain pumps to administer medications in a joint space
2. The safety of pain pumps for use in the joint space is unknown and has not been tested or otherwise established through proper studies; and
3. Medications commonly used in these pumps are reported to be harmful to cartilage
4. The FDA rejected proposed requests for a new marketing indication for use of pain pumps in the synovial cavity;

Studies seem to be reasonably clear that the use of the pain pump within the joint space causes potentially significant damage to cartilage . The damage caused by use of the pumps in the joint space often result in requiring full joint replacements and more.

The labels simply don’t deliver all the facts. For example, while all list caffeine as an ingredient, and most tell you exactly how much caffeine is in the drink, they also list guarana, a caffeine source, as a separate ingredient but don’t tell how much caffeine one gets from the guarana.’
It is virtually impossible to determine the caffeine content, to stay within the recommended maximum daily intake 250mg per day.

“Caffeine overdose can cause nausea, diarrhea, light-headedness and urinary frequency. Caffeine withdrawal even after moderate chronic intake may be associated with headache, nausea, nervousness, reduced alertness and depressed mood. Symptoms are most acute in the first 20-48 hours but they may persist for as long as seven days.”

With promises of weight loss and increased endurance; hundreds of  new products including the very popular Red Bull, Monster and Rockstar; “make up a $3.4 billion-a-year industry that grew by 80 percent last year” A pediatrician and nutrition expert at the Children’s Hospital at Montefiore in New York, Dr. Sandra Braganza, is worried about “the potential for accidents and alcohol poisoning” As she prepared to write an article about energy drinks for a pediatrics journal, she was surprised how little published research she could find on them. “The truth is, we don’t know what kind of effects these ingredients can have,” Braganza said of taurine, glucuronolactone and guarana. “We have to start doing more studies on this.”

CBS Associated Press recently reported that even after “Twenty-five states asked beverage maker Miller-Coors LLC on Wednesday to abandon plans for a new caffeine-infused alcoholic energy drink, Red Sparks; citing the product” a “recipe for disaster”, because adding caffeine to alcoholic beverages reduces drinkers’ sense of intoxication.”

These drinks target young drinkers who are especially vulnerable because of their limited judgment and risky behaviors in driving and other activities.  Julian Green, Miller-Coors spokesman responded  “the company still plans to release the drink on Oct. 1” and that “the federal Alcohol and Tobacco Tax and Trade Bureau, or TTB, has approved all formulas and labeling for Sparks.

Last week the Center for Science in the Public responded stating that “Miller-Coors decision to introduce Sparks Red defies increasing undeniable evidence from medical and public health professionals about the dangers of mixing alcohol with stimulants found in energy drinks”

In a separate lawsuit “St. Louis-based Anheuser-Busch said it would reformulate its brands “Tilt” and “Bud Extra” to remove the stimulants they contain as part of a settlement with 11 attorneys general”.

“Young people are taking caffeine to stay awake, or perhaps to get high, and many of them are ending up in the emergency department,’‘ said Dr. Danielle McCarthy of Northwestern University, who conducted the study “Caffeine is a drug and should be treated with caution, as any drug is.”
Parents should think twice before sending their children out the door with an energy drink, said Molly Morgan, a dietitian in upstate New York who consults with schools and talks to students, parents and coaches about energy drinks.

“My message to parents is moderation,” Morgan said.”That means one can a day or less, and view it as a treat, not part of a daily routine.”
The Center for Science in the Public Interest has been pushing for “mandatory caffeine labeling” as well as “more responsible marketing of such products”. No plans are on the horizon presently for any regulation by the FDA.

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.” 

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.