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Big Tobacco Caught in the Back Draft of its Scorched Earth Litigation Strategy

Cal Warriner — Fri, 20 Nov 2009 09:20:46 GMT

Big Tobacco's pants are aflame today after suffering a 300 million dollar verdict in yet another defeat in its Florida litigation war. You see, knowing it has imposed more death and suffering than modern war, pestilence and aids combined, Big Tobacco's mantra has always been millions for defense and not a dime for restitution (and a few extra hundred million thrown in for political payola and advertising). Historically the strategy has worked. The big bully with its army of well healed, silver tongued lawyers could outspend, outmaneuver, and overwhelm wheezing customers and their lawyers. Tire them out, grind them into the dust, argue every issue, appeal every ruling and intimidate lawyers into not taking up the cause. No matter the cost, Big Tobacco had to make suing it so distasteful that smokers would just die and go away quietly. I mean, what would happen if all the sick smokers sued us at once? Right?

Today however, as Phillip Morris arrogantly thumbed its nose at yet another former customer who sat in the courtroom on oxygen, the strategy cost Phillip Morris 300 million dollars. Having once again turned its back on the opportunity to settle for for less than it paid one defense expert, Phillip Morris placed its fate in a gaggle of highly skilled cigarette lawyers from Chicago and San Francisco. The juries verdict, millions for restitution, to hell with your million dollar defense.

You see, the tide has turned in Florida. Instead of unleashing its army and unlimited resources on one poor smoker, Big Tobacco faces almost 8000 filed cases that are all proceeding concurrently. The cases arise from years of class action litigation in which a jury and ultimately the Florida Supreme court finally put an end to decades of Big Tobacco's dismiss, distract, deny and deceive strategy. No longer are Tobacco's slick litigators allowed to come to court ready to contest whether nicotine is addictive or whether it causes lung disease and cancer. Nor can the companies argue that their products were not defective or that they were not guilty of negligence and fraudulently lying to the consuming public about the dangers of cigarette smoking. Remember, as late as 1994 every tobacco company CEO stood before Congress and swore that nicotine was not addictive and that there was no medical proof linking cigarette smoking to cancer. Swallow lye to perpetuate the lie, no problem. Nope, the issue for the jury to decide in Florida is now what it always should have been. Is it the smoker's fault for buying the defendants' product and using it exactly as intended (quite ironic) or is it the product's addictive qualities manipulated so adeptly by Tobacco chemists that resulted in the smoker's disease? For the first time in the history of tobacco litigation, it's a fair fight. Recent history teaches when Big Tobacco can't poke, bite or hit below the belt, it is losing its shirt.

Since members of the now decertified Florida class have been trying their cases against Big Tobacco, the smoker has won eight of ten trials many in the multiple millions of dollars with today's 300 million dollar verdict being the largest. In each case, Tobacco has flatly refused to discuss settlement many times rejecting settlement offers of as little as $10,000. As a result, all of the smoker's litigation costs and attorney's fees are being tacked on to the verdict. Tobacco already faces over fifty trials next year with more being set every day. If past is prologue, the nicotine purveyors are in for disastrous 2010.

As the saying goes, all good things must come to an end. In Florida at least, the courts have put an end to traditional Tobacco defenses. When then will the companies spin to the financial industry about its exposure in Florida tobacco litigation end. The Florida Supreme Court's Engle decision is flawed, this verdict is an aberration; we intend to appeal; we feel good about our chances on appeal; we have plenty of resources to defend ourselves; lawyers will lose interest and Engle cases will just go away like the flight attendant second hand smoke cases did. Hogwash.

With this verdict, it's time that the financial markets woke up smelled the coffee. They need to start asking probing, hard questions. Can an industry that sells an addictive product that has killed millions and continues to kill hundreds of thousands each year cheat the fates indefinitely? Will the American public stand to have its children and its children's children addicted and killed by this evil industry?

Ironically, the litigation strategy that has served Big Tobacco so well for so long has exposed its biggest weakness. Tobacco cases are very winnable. They are even more winnable when filed en masse by just a fraction of its victims. Juries no longer buy Tobaccos' lies. Ironically, for less than the cost of corporate jet fuel, Big Tobacco could have resolved the entire Florida litigation. Now, it must live with the consequences of an archaic philosophy, hatched moons ago by dead men, each made rich by the very cigarettes that ultimately killed them.

Originally posted at InjuryBoard by Cal Warriner

Fighting the Good Fight -- Hormone Replacement Therapy Litigation

John Hopkins — Mon, 23 Nov 2009 09:53:49 GMT

They weighed profits against safety and profits won out. Women across the country lost and were forced to suffer with breast cancer. That is the conduct attached to Wyeth for their handling of hormone replacement therapy drugs (HRT).

In 1983, the Food & Drug Administration told Wyeth that human trials were necessary for the safe marketing of HRT medication, PremPro. Wyeth made the conscious decision to refuse doing the trials. Internal documents demonstrate that Wyeth refused to perform additional studies in order to conceal the risks associated with what they knew would be a drug, which would reap huge profits for Wyeth.

www.youtube.com/watch

Women such as Connie Barton and Donna Kendall demonstrated the courage to bring Wyeth into court to answer for their conduct. Jurors who have heard evidence related to Wyeth’s negligence and intentional failures have used terms such as “despicable” and "outrageous conduct” to characterize Wyeth’s behavior.

It was not until Wyeth was forced to admit the dangers of the HRT drugs that they finally took some action. When the study through the Women’s Health Initiative was terminated due to the development of breast cancer by participants, Wyeth’s hand was forced. What did Wyeth do? They “circled the wagons”; continued to deny their fault; and stone-walled women’s claims concerning the danger of their product.

Women such as plaintiffs, Connie Barton and Donna Kendall suffered the loss of their breasts and horrible consequences of cancer treatment because a corporation thought that profit was more important than patient safety.

Originally posted at InjuryBoard by John Hopkins

Adderall IR; Adderall XR: Are they from Shire, Barr, Teva, or Ranbaxy?

Armand Rossetti — Mon, 17 Aug 2009 15:01:00 GMT

Adderall is in the news today. Barr Laboratories (Barr) recalled lot #311756 of the powerful psychostimulant, indicating that consumers might receive exceedingly potent dosages due to oversized tablets.

To get a better idea of the complex under currents in Big Pharma, let’s discuss the pharmaceutical giant,Teva, a player by acquisition in the Adderall recall:

For 7.5 billion dollars, Israeli drug giant, Teva Pharmaceutical Industries (now the world’s largest generic drug manufacturer) acquired Barr Laboratories in 2008. Barr currently owns intellectual property rights to Adderall.

The average consumer might not be familiar with Teva as a drug manufacturer. However, due to numerous acquisitions and joint ventures, Teva is huge. As a result, the giant generic pharmaceutical concern has become the utmost patent copycat pharmaceutical player on the international scene.

Here are several examples of Teva’s acquisitions and agreements:

Teva and India’s largest generic drug manufacturer, Ranbaxy, reached an agreement in 2004 for Teva to ship its Quinapril HCL tablets.

In 2008, Teva and the Japanese generic firm, Kowa partnered for a 50-50 stake in Teva-Kowa, which would become a leading generic producer in Japan.

In January of 2009, Teva and Swiss based Lonza Group formed a joint venture to manufacture and market a portfolio of “biosimilars.”

On June 29, 2009, Teva and its partner, Antares, announced the introduction of a needle-free injector product.

Teva plans to spend another billion dollars to acquire Indian drug companies and to set up Greenfield manufacturing facilities.

In March of 2009 Stem-Ex, Gamida Cell-Teva joint venture product received the European Union’s orphan drug equivalent.

In fact, Teva is not afraid to challenge any drug company for the right to make generic copies of drugs. For example, Teva has challenged and prevailed over Novartis, concerning the right to manufacture a generic copy of Lotrel, even though Novartis’ patent is valid until 2017.

Win a few and lose a few.

In 2008, The Court of Appeals for the Federal District of New York ruled in favor of TAP Pharmaceutical in its quest to prevent Teva from infringing TAP’s patent for Prevacid.

The Barr-Shire Connection:

Last year, Teva acquired Barr, but not before Barr acquired Shire, plc’s intellectual property rights to Adderall.

Adderall XR (extended release) is the brand name for a mixture of extended release encapsulated amphetamine salts that Shire is still manufacturing and selling, and that physicians prescribe to treat attention deficit hyperactivity disorder (ADHD).

In 2006, Shire’s worldwide sales of Adderall XR were 864 million dollars. Then Barr applied for and received an abbreviated new drug application (ANDA) from the FDA that would permit Barr to manufacture a bioequivalent generic Adderall. After Bar received its ANDA designation for Adderall, Shire sued in New York’s Federal District Court for the Southern District to protect its patent rights.

In an effort to end the intellectual property tussle in August 2006, Shire and Barr reached an agreement whereby Shire would pay Barr a net amount of up to $102 million.

The structured deal had Shire paying Barr’s subsidiary, Duramed, up to $165 million; $25 million immediately and up to $140 million over eight years, described as compensation for product development. In return, Barr agreed to pay Shire $63 million as compensation for transferring Shire’s rights to Adderall IR (immediate release) tablets.

After the parties consummated their deal, Barr retained of exclusivity eligibility regardless of the patent suit. In return, Shire agreed not to release an authorized generic for 180 days, during which time, Barr would pay Shire a royalty. Thereafter, the Adderall license would be non-exclusive and royalty-free. In addition, Barr received the rights to Shire’s Adderall IR and the opportunity to purchase an innitial supply of Adderall IR from Shire.

The settlement removed Shire’s threat via lawsuit and created a protective intellectual property bottleneck. As part of the same agreement, Barr agreed to enter the market on April 9, 2009 (a date in between the earliest point that Barr could have entered the Adderall market and the time that Shire’s patent was due to expire). See pages 133-134 of: Testimony of C. Scott Hemphill, Associate Professor, Columbia Law School before the House Committee on Energy and Commerce Subcommittee on Commerce, Trade and Consumer Protection; Hearing on H.R. 1902, Protecting Consumer Access to Generic Drugs Act of 2007.

A second drug company called Impax was also on the ANDA side of the Shire-Barr patent lawsuit. Unlike Barr as first filer, Impax was a later filer and, therefore, had no eligibility for intellectual property exclusivity. As further compensation, Impax received cash for promotion of another drug.

Given the compression of competition due to the agreement, the FTC caught wind of the Shire-Barr-Impax agreement and opened an investigation in October 2006:

“The US Federal Trade Commission (‘FTC’) informed Shire on October 3, 2006 that it was reviewing the ADDERALL XR patent litigation settlement agreement between Shire and Barr Laboratories, Inc. (‘Barr’). On June 22, 2007, the Company received a civil investigative demand requesting that it provides information to the FTC relating to its settlement with Barr and its earlier settlement with Impax Laboratories, Inc. The Company is co-operating fully with this investigation and believes that the settlements are in compliance with all applicable laws.”

The Aftermath of it all:

Of course this whole intellectual property rights tussle died down, and in 2008 Teva acquired Barr, together with all of Barr’s intellectual property and manufacturing know how. But there is something else that might be important to note.

In the Adderall IR settlement, Barr agreed to provide manufacturing backup for products that might emerge from the development agreement. Right now, Shire manufactures the XR formula and Teva (through its division Barr-Duramed) manufactures the Adderall IR formula. Shire's Adderall XR formula is still patent protected until 2018. However, Duramed is free to manufacture the IR formula. And lest we forget, India’s Ranbaxy also produces a generic form of Adderall. If I recall correctly, the now Japanese owned Ranbaxy is also the company that falsified data on drug applications?

Consumer Confusion:

Internet discussion boards are replete with commentary concerning the different kinds of Adderall on the market, and the way that physicians go about prescribing that drug:

Comment #1 (orange or pink);

Comment #2 (Insurance decides and potent v. impotent);

Comment #3 (Barr or Ranbaxy); and

Comment #4 (A drug for wrong reasons).

It is pretty clear to see why something as simple as oversized pills might elude Big Pharma's quality control effort. There's probably too much wheeling and dealing taking everyone's attention off the ball; the ball being, consumer safety.

Originally posted at InjuryBoard by Armand Rossetti

Tobacco Held Responsible for Placing Profits Ahead of...Everything

Brenda Fulmer — Thu, 19 Nov 2009 17:16:34 GMT

Philip Morris suffered yet another blow in the latest post-Engle tobacco trial. A Fort Lauderdale jury rendered a verdict on November 19, 2009, for $300 million against the tobacco manufacturers on behalf of a living smoker who suffers from severe emphysema. The verdict included $246 million in punitive damages.

This verdict is one of a number of verdicts that have been entered in completed jury trials in Broward and Escambia Counties this year.

More than 8,000 claimants and their survivors have individual lawsuits pending in courts throughout Florida. These claims stem from the Engle class action which was filed in 1994 and resulted in a verdict of more than $145 billion after one of the longest trials in history. Currently, there are dozens of trials scheduled for 2010 in Miami, Fort Lauderdale, Bronson, Jacksonville, Gainesville, Bradenton, Tampa, Pensacola, and Daytona Beach.

Thousands of additional smokers and their survivors are hopeful that the current scheduling and budgetary problems facing the Florida court system are overcome so that they may have their day in court in the not too distant future.

Originally posted at InjuryBoard by Brenda Fulmer

Wyeth Must Pay for Practicing to Deceive

John Hopkins — Mon, 23 Nov 2009 16:27:38 GMT

Cases involving lawsuits against Wyeth (a division of Pfizer) are going to trial and juries are being permitted to hear all the evidence against Wyeth. The evidence is clear: Wyeth acted in a way that was negligent and at least one juror has characterized Wyeth’s conduct as “despicable”.

Studies now confirm that 200,000 women – our grandmothers, our mothers, our sisters and our wives – would not have suffered breast cancer but for their use of combination hormone therapy drugs.

The evidence has caused two juries to deliver verdicts for combined totals of over 10 million dollars in compensatory damages and over 100 million dollars in punitive damages. In a total of 10 jury trials, jurors have delivered verdicts to plaintiffs of over 30 million dollars in compensatory damages and over 160 million dollars in punitive damages.

Was Wyeth negligent in its placing Prempro on the market? Clearly, the evidence demonstrates and the jury verdicts ratify that Wyeth was negligent.

The evidence of Wyeth’s conduct in these cases is damning. As early as 1975, Wyeth was on notice that combination hormone therapy causes breast cancer. Wyeth did nothing and continued to market the drug and take in huge profits.

Wyeth took steps to try and downplay the risk of these drugs and made efforts to contain data from other institutions, which demonstrated the risk.

Wyeth sponsored a practice of “ghost writing” of medical literature that promoted combination hormone therapy like PremPro. In addition, Wyeth exaggerated the benefits of hormone therapy in these very same “authoritative” articles written by Wyeth employees or agents.

Wyeth failed to conduct further studies of HRT even after the FDA told them in 1983 that human clinical trials were the only way to ascertain the safety of their drug.

The trial of these cases and the verdicts after jury upon jury has heard the evidence is a classic illustration of the justice system as a method for consumer protection when no other system will accomplish it.

Wyeth would not listen to “the truth will set you free” and they now are paying for decades of profits gained “while practicing to deceive”.

Originally posted at InjuryBoard by John Hopkins

Prevention, Early Detection and Good Health

Rosalyn Sia Baker-Barnes — Thu, 19 Nov 2009 15:03:59 GMT

A new study released by the United States Preventive Services Task Force has women and doctors confused and torn over recent recommendations regarding what age a woman should receive annual mammograms.

For years, the American Cancer Society, physicians, and other government organizations, have recommended that women receive annual mammograms at the age of 40 to prevent breast cancer, which seemingly aided in the early detection of the disease. Now, the task force, a government panel of doctors and scientists, are recommending that most women wait until age 50 to get mammograms and then have one every two years. The study states that beginning to test for breast cancer at age 40 saves few lives and can even harm patients. They point out that if a mammogram gives a false positive, it can lead to anxiety, unnecessary additional testing and biopsies, and exposure to radiation. Mammograms typically produce false-positives in about 10 percent of cases.

Opponents disagree and feel that these new guidelines will only confuse and scare women from seeking the recommended testing. The American Cancer Society posted a statement on its website stating that it would continue to recommend annual screening for all women, beginning at age 40. “It (the guideline) is very confusing and that’s one of the things we’re worried about is that women are already confused, scared, and worried about getting a mammogram because of what they may find out,” said American Cancer Society spokesperson Mary Kathryn Walker.

Breast cancer survivors are also angry about the new guidelines saying that if they didn’t receive mammograms in their 40’s, they wouldn’t be alive today. The American College of Radiology and other experts condemned the change saying the benefits of routine mammograms have been clearly demonstrated and continue to play a key role in reducing the number of mastectomies and deaths. Breast cancer is the most common cancer and the second leading cause of cancer deaths in American women.

The task force guidelines don’t apply to women at high risk for breast cancer, including those with genetic mutations that make them more susceptible to the disease.

Diana B. Petitti, vice chairman of the U.S. Preventive Services Task Force says “We’re not saying women shouldn’t get screened. But we are recommending against routine screening. There are important and serious negatives or harms that need to be considered carefully.”

The task force’s guidelines also recommend against teaching women to do regular self-exams, something that that American Cancer Society has been touting for years. The practice was so heavily promoted at one time that the organization distributed cards that could be hung in the shower demonstrating the circular motion women should use to feel for lumps. Recently, the American Cancer Society and other medical groups have backed off promoting breast self-exams because of scant evidence of their effectiveness, even before the new task force guidelines were revealed.

Insurance companies are claiming that coverage will not likely change because of the task force guidelines. In the past, the guidelines issued by the U.S. Preventive Services Task Force, has influenced the stance Medicare and many insurance companies take on healthcare coverage. Opponents of the new guidelines fear that the findings could spur insurers to deny coverage of annual mammograms and breast tests given to women under 50. “Screening isn’t perfect, but it’s the best thing we have and it works,” says Dr. Carol Lee, a spokesperson for the American College of Radiology. She also suggested that cutting health care costs may have played a role in the recent decision, but task force vice chairman Petitti said the task force does not consider cost or insurance in its review.

Whether or not you believe women’s health is again under fire, it is important to know your family medical history and routine visits to your doctor are your best tools against any type of disease, including cancer. The new task force guidelines are just that, guidelines. Mammograms, like all medical interventions, have risks and benefits. These new guidelines will hopefully help spur conversations and assist women in making the best decision for their personal circumstances.

Originally posted at InjuryBoard by Rosalyn Sia Baker-Barnes

Heparin or Over Sulfated Chondroitin Sulfate? That is the Question.

Armand Rossetti — Fri, 07 Nov 2008 10:51:58 GMT

In its natural form, chondroitin sulfate (itself a glycosaminoglycan) is used as a natural dietary supplement for the palliation of osteoarthritis. In fact, natural chondroitin sulfate is not a blood thinner like its analog, “over-sulfated chondroitin sulfate” (OSCS). Heparin is also a highly sulfated glycosaminoglycan.

A large unregulated Chinese manufacturer, Changsou, made the cheap heparin-like OSCS, mixed it with raw heparin (cut the heparin), and then sold the adulterated heparin at attractive prices to well-respected drug companies like Baxter International. Early on in the discovery of the OSCS contamination, many severe allergic reactions while using contaminated heparin, including 19 deaths resulted. To get a better understanding of how events surrounding the OSCS contamination unfolded, let’s take a look at the following, brief news, scholarly journal and FDA alert timeline:

February 11, 2008:

FDA News released an advisory warning that Baxter’s multiple-dose vial heparin was kinked to severe allergic reactions. Baxter stopped manufacturing the product while the FDA continued to investigate the root cause of the product’s adverse reactions. However, rather than issuing a recall, the FDA compromised and issued recommendations to physicians who might have to use the product that Baxter had already distributed.

February 16, 2008:

Because Changhou SPL had no drug certification, China’s drug agency did not inspect it. The US FDA said this week that it had not inspected the plant, either-a violation of its own policy-before allowing the company to become a major supplier of the blood thinner, heparin, to Baxter International in the United States.”

February 28, 2008:

The US FDA issued an alert to inform the public about reports of serious adverse events in patients who had received bolus injections of Baxter’s heparin. The FDA recommended not using Baxter’s heparin, but if there was no other source in an emergent situation to: not use a bolus dose; use the lowest dose necessary; closely monitor the patient for adverse events; and to consider pre-treating with corticosteroids or antihistamines before administering heparin.

The alert mentioned that Baxter, a major heparin supplier with over 50% market share, had withdrawn nine lots of heparin in January 2008 after receiving 350 adverse events, 40% of which were serious.

March 1, 2008:

Up until late February 2008, neither China nor the FDA had regulated China’s largest Heparin raw material ingredient producer, Changhou Scientific Protein Laboratories. The failure to regulate Changhou was a violation of the US FDA’s own inspection policy (CBS Video).

March 19, 2008:

China’s State Food and Drug Administration (SFDA) and the US FDA both identified OSCS in Baxter’s Heparin. The US FDA was investigating whether the chemical was purposefully or inadvertently added during manufacturing in China. The over-sulfated version of chondroitin sulfate does not occur in nature and must be manufactured. The FDA was attempting to determine whether the synthetic chondroitin sulfate was the cause of 19 deaths, hundreds of serious breathing problems and other reactions reported in the United States.

In March 2008, the US FDA knew that over sulfating chondroitin, which is substantially more abundant and available from a wide range of animal sources, was cheaper than processing raw heparin from pig intestines.

March 22, 2008:

China’s SFDA ordered its local bureaus to increase supervision over heparin production. Producers would now have to obtain raw material from registered suppliers. The US FDA called on importing countries to take responsibility for insuring heparin’s safety. China is the largest heparin material supplier in the world.

However, regulation would be a daunting task for the Chinese, because much of the then current supply chain included thousands of small workshops that gathered heparin from pig intestines and sold it to larger chemical companies (not drug companies) that produced the pure active ingredient in heparin. Here is a quote from the New York Times article:

“Much of China’s production of raw heparin begins in homes and tiny factories, where teams of three to five people transform pig intestines into a dry substance that is eventually sold to major pharmaceutical companies.

Most of the small factories are unlicensed and unregulated. They sell to traders and consolidators, who sell the raw heparin to companies like SPL that, purify it to produce the active ingredients. Many of them are not regulated by the Chinese drug agency, since they are considered chemical companies, not drug makers.

The active ingredients, in turn, are sold to pharmaceutical companies like Baxter that produce the finished drug.”

April 2, 2008:

After receiving notification from Scientific Protein Laboratories, LLC (SPL), Covidien, formerly Tyco Healthcare, voluntarily recalled its injectable heparin products.

April 20, 2008:

Baxter International had begun distributing contaminated heparin in November 2007. The contaminated heparin base had reached nine countries not including the United States. The US FDA had traced the contaminated heparin to 12 Chinese manufacturers. Now there were 81 deaths due to the contaminated heparin. Yet, the Chinese remained skeptical that investigators could make a connection between OSCS and the illness and deaths that had resulted.

The FDA still did not know where in the Chinese supply chain processors had introduced the OSCS, but the FDA was fairly certain that OSCS had caused the illnesses and deaths. Investigators had observed similar reactions in animal studies and had conducted in vitro testing that had confirmed that such reactions might occur.

April 23, 2008 (published in June 2008)

National Biotechnology published Oversulfated chondroitin sulfate is a contaminant in heparin associated with adverse clinical events, suggesting that traditional methods of analysis could not OSCS detect contamination:

“Given the nature of this contaminant, traditional screening tests cannot differentiate between affected and unaffected lots. Our analysis suggests effective screening methods that can be used to determine whether or not heparin lots contain the contaminant reported here.”

May 15, 2008:

Atrium Medical Corporation and Medtronic, Inc. initiated voluntary recalls for their contaminated heparin products.

October 18, 2008:

The FDA requested that US Marshals enter Celsus, an Ohio heparin Manufacturer and seize 11 lots of heparin contaminated with OSCS. The seized material had entered the US prior to import controls that were established earlier in 2008. Celsus President Case Van Gorp informed CNN that Celsus had quarantined the contaminated lots at least since April 2008, and had notified its customers of the problem in March.

The FDA had inspected Celsus in April and May, and that since then no contaminants had been identified in Celsus heparin products. However, the FDA had told Celsus that its actions to notify customers about the company’s contaminated heparin were insufficient to assure an effective recall.

Conclusion:

While it is evident that the US FDA did pay close attention to developments concerning contaminated heparin after the problem arose, it is evident that the FDA did not do enough to prevent the possibility of such widespread contamination from occurring in the first place. However, the FDA is not alone in its inability to prevent such pharmaceutical manufacturing disasters. In addition to China, India provides a good example of a country that is not currently prepared to deal with untoward manufacturing problems. Here is an excerpt from “Story of Heparin Recall: What India can do?” published in the Journal of Postgraduate Medicine (one of the oldest medical journals from India):

“Traditionally very little is done to address drug safety issues in India by pharmaceutical companies. Implementation of amended Schedule 'Y' of the Drugs and Cosmetics Act, has not improved the situation yet. The NPP has achieved very little, if anything, until now. A lot needs to be done to put in place a pharmacovigilance system robust enough to verify such important medication safety signals as observed in case of heparin. Also, we are way behind the western countries in identifying safety signals to new drugs and quantifying the risks.”

Regarding the US FDA's inability to address foreign active ingredient supply problems, perhaps Susan Briones said it best in her essay, Heparin Recall: Another Crisis for China & the FDA:

“And what of the FDA’s own admission of failing to follow its own procedures? Can injured patients hold it accountable? -Probably not. The FDA is one of many overburdened, under-funded, and liability immune government agencies that let consumers fall through the cracks. This time, however, the result was the death of Americans. It is imperative that the FDA be better funded and managed so that inspections of production facilities outside of the U.S. can be done on a comprehensive level. The U.S. and Europe have been expanding their production of medical products globally for several years because it is cheaper to do so. Approximately 40% of drugs and 80% of their chemical ingredients are imported from countries like China and India that do not have ample inspection and safety procedures in place. According to Dr. Bryan Liang, an advisor to the Partnership for Safe Medicines, “the problem is only going to get worse as more materials come from suspect sources.”This is not news, however. The FDA knows it does not have the manpower or resources to inspect every overseas facility, as do Congress and the President, all of whom have been calling for more funding. Perhaps holding the FDA liable for the damages experienced by the harmed patients is the only way to prod our government into properly funding this all-important agency and keeping American consumers safe.”

Originally posted at InjuryBoard by Armand Rossetti

Profit Over Safety -- A $20 Decision

John Hopkins — Tue, 01 Dec 2009 10:04:27 GMT

A 46 year old woman is paralyzed when her sport utility vehicle rolls over and the roof collapses onto her. The manufacturer knew their SUV was prone to rollovers and in the event of a rollover, the roof was insufficiently reinforced to prevent the very injuries suffered by the woman. In the case, the woman alleges that a fix to the roof stability would have cost the SUV maker approximately $20 per vehicle.

This story sounds a great deal like a car prone to catching on fire and exploding when rear ended at relatively low speeds. In those cases, the auto maker consciously chose not to spend the money to recall and retrofit the vehicles. That decision unnecessarily cost many lives.

Oh, yeah, in both instances it was Ford. In the earlier case it was a little car called the Pinto and in this most recent case, a little SUV called the Explorer.

It boils down to making “business decisions” in the best interest of stock holders is what Big Corporations say. They are forced to weigh their overhead against the need for design modifications. They are charged with answering to stockholders who have hitched some portion of their financial future to these very decisions.

It boils down to making decisions that do not place profits over safety is what I say. Sorry Corporate America, but it should not be acceptable to place the public in peril of life or limb for $20. In fact, it should not be OK with anyone to have a 46 year old woman and mother of two children who will never walk again because it was not expedient or economical to either, first design or second retrofit a product to make it as safe as possible.

When Ford was hit with this jury verdict amounting to over $350 million for both compensatory and punitive damages, they appealed. The courts reduced the jury verdict to $82 million, for both compensatory and punitive damages. Ford cried foul and appealed; arguing that they made reasonable judgments in the design of the SUV and they should not be responsible for punitive damages.

When Corporate America demonstrates a conscious disregard for the safety of consumers, punitive damages are appropriate. When an industry makes billions marketing a 3000 pound object that moves at 70 mph “reasonable judgments” that include the failure to spend $20 additional for safety most certainly justifies these damages.

Originally posted at InjuryBoard by John Hopkins

Circulating Levaquin leaves the bloodstream, deposits in Achilles’ tendons, and alters tendon cells

Armand Rossetti — Tue, 02 Dec 2008 10:42:57 GMT

Both short and long term treatment with fluoroquinolone antibiotics may cause tendon matrix alteration that can lead to tendinopathy with subsequent rupture. Tendinopathy is newer all-inclusive medical term that encompasses tendonitis, tendonosis and tendon rupture.

Structure:

Tendons are tropocollagen connective tissue bundles that attach muscle to bone. Stress between bone and muscle is longitudinal. That is why chains of tropocollagen combine to make longitudinally arranged fibers that bundle together as fibrils. Groups of fibrils form endotenon covered groups of fascicles that have a loose connective tissue packing called the epitenon which also contains blood vessels. Here is a drawing.

The Achilles’ tendon is the largest tendon in the body and please bear in mind that it has a limited blood supply. The Achilles is also the strongest and toughest tendon and capable of lifting the entire body weight against a severely adverse leverage ratio.

Toxicity:

It is interesting to note that 7 – 10 days after a tendon injury, there is little or no inflammatory response. Likewise, 2 – 3 weeks after fluoroquinolone ingestion, no inflammatory cells are present.

The toxic effects of fluoroquinolones cause dysplasia (abnormal cell development and maturation) of a tendon’s collagen fibrils leading to a reduction in tensile strength (the tendon’s ability to stretch and not rupture). Reportedly, fluoroquinolones, such as Levaquin alter the amount of glycoproteins found in tendon cells and fragment nuclear DNA apoptosis markers. DNA fragmentation may explain fluoroquinolone-induced tendinopathy.

In addition, investigators have reported that fluoroquinolone drugs, such as Levaquin, can cause biochemical changes (affecting magnesium chelation). Reportedly, those biochemical changes interfere with the process that contributes to tendon healing (proteoglycan synthesis). As a result of those changes, Levaquin ingestion has the same physiological characteristics as tendon overuse, and that conclusion is evident because of the presence of giant cells and structural abnormalities in tenocytes (tendon cells).

Distribution:

Fluoroquinolones leave the bloodstream, deposit in tendons, and cause localized tendon toxicity (Meissner, A., Borner, K., & Koeppe, P. (1990); Concentration of ofloxacin in human bone and cartilage, Journal of Antimicrobials and Chemotherapy). Therefore, Levaquin takes up residence at the very site that it affects.

A Thought:

In light of all of the above, the FDA has extended marketing “pediatric exclusivity” to Ortho-McNeil for Levaquin based on five company-sponsored pediatric studies that the FDA requested.

Originally posted at InjuryBoard by Armand Rossetti

Zicam Nasal Gel: Questions about Efficacy, Risk of Use, and Timing of the Warning

Armand Rossetti — Fri, 19 Jun 2009 17:14:06 GMT

The three Zicam products included in the recent FDA warning letter that Matrixx received in June 2009 are:

Zicam Cold Remedy Nasal Gel (NDC 62750-003-10)
Zicam Cold Remedy Swabs (NDC 62750-003-20)
Zicam Cold Remedy Swabs, Kids Size (NDC 62750-003-21) (discontinued)

Zicam Cold Remedy Nasal Swabs and Zicam Cold Remedy Nasal Gel were both introduced in 1999 and each contain the active ingredient, zinc gluconate (10% ).

There are many questions to consider when analyzing the reason for, and the timing of the FDA’s warning. However, it might be best to take a brief look at whether zinc products such as Zicam Cold Remedy actually work as homeopathic remedies.

The trademark, Zicam, is taken from “Z” for zinc and I-CAM, a type of receptor site found on epithelial cells and in viruses. Purportedly, Zn2+ ions complex with intercellular adhesion molecular receptor sites on rhinovirus surfaces, and prevent cold viruses from binding to human cells. In other words, zinc allegedly prevents cold viruses from gaining entry to human cells and causing cold symptoms.

It all looks pretty simple and straight forward. However over the years, Zinc’s efficacy as a virus blocker has been the subject of notable controversy.

In 2000, Michael Hirt’s group published a study in the Ear, Nose & Throat Journal that suggested that zinc lozenges shortened the number of days from onset to the complete resolution of common colds. Hirt found that zinc lozenges reduced the duration of symptoms by 75%, which was consistent with the 85% figure that Hensley (in an unpublished zinc nasal gel study) had reported. However, another investigator found otherwise.

In 2001, Ronald Turner found that there was no significant effect, i.e., no difference in common cold duration between active zinc treated and placebo treated subjects. Turner noted that the infection rate in challenge volunteers was 93% while it was 90% the placebo volunteers. During the study, Turner measured signs and symptoms such as rhinovirus severity, nasal obstruction, and headache. In 2002 Samuel Yiu corresponded with Turner. While Yiu supported Turner’s challenge model, he found fault with the sample population number and protocol of the study. In his correspondence, Yiu also suggested that further evaluation was necessary in order to draw any conclusion regarding efficacy.

In 2004, Hulisz published an overview concerning zinc’s efficacy against the common cold Hulisz found that zinc attached to “I-CAM receptor sites found on retroviruses and on nasal epithelial cells. However, Hulisz also determined that there was a 24-hour window, beginning onset, for the most effective treatment to occur. A question might arise whether the average consumer can accurately determine when that window opens and when it closes.

Is nasal zinc treatment worth the risk? We have seen some evidence (above) that zinc may or may not work under certain circumstances. However, what is the risk of using nasal zinc products?

In 1938, amidst a polio epidemic that prompted physicians to arrive at ways to prevent the poliovirus from spreading, Smith submitted a study to the Canadian Medical Association Journal that addressed epithelial treatment with 1% zinc sulphate. Although zinc sulphate is not exactly the same as zinc gluconate, it seems evident that both are severe irritants at higher concentrations.

In his basic science study, Smith found evidence that zinc sulfate at 1% destroyed the three types of cells in the olfactory sensory epithelium that gives humans the ability to smell known in scientific circles as “anosmia.” More importantly, those sensory cells disappeared forever because they cannot regenerate. Instead, regular non-sensory epithelial cells replaced those sensory cells.

Given all of the above, it is not unreasonable to question whether the risk of using nasal zinc treatment might outweigh the benefit of receiving such treatment. After all, the FDA’s concerns about reported adverse events of anosmia were underscored by published scientific literature that provided evidence, such as the 1938 Smith study, showing a connection between intranasal zinc and anosmia.

Next we should question when the risk of using Zicam gel nasal spray became obvious.

As early as October 2003, Zicam, LLC and parent, Matrixx Initiatives, Inc. became defendants in a lawsuit that alleged that the plaintiff had lost his sense of smell after only a single treatment with Zicam. In fact by 2004, large numbers of similar complaints prompted the FDA to inquire about Zicam’s safety.

As time progressed, claimants continued filing complaints, alleging that treatment with Zicam nasal spray (a gel) had caused loss of smell. It is interesting to know that that FDA was not regulating homeopathic zinc preparations such as the Zicam Cold Remedy.

Later on in February 2006, Matrixx settled 340 anosmia-related Zicam lawsuits. Then, as previously mentioned, more than three years later on June 16, 2009, the FDA issued a warning letter to Matrixx . The warning letter notified Matrixx that it had crossed the line when making efficacy claims for its self-declared “homeopathic,” nasal zinc products. Therefore, Matrixx could no longer qualify those products as being homeopathic preparations. According to the FDA, Matrixx had taken a step further and was actually marketing new drugs intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease, all without FDA approval. As required before marketing Zicam Cold Remedy Nasal Gel and Swabs, Matrix had not submitted a new drug application (NDA), and it had not participated in the FDA approval process. As a result, the FDA suggested that Matrixx promptly remove Zicam Cold Remedy nasal products from store shelves.

To this day, however, Matrixx maintains its original position that Zicam nasal preparations are scientifically proven to be safe and efficacious, and that they do not cause anosmia. Yet, only three days after receiving the FDA warning, Matrixx issued a message, suggesting, among other actions, that consumers discard any previously purchased Zicam Cold Remedy Nasal Gel or Zicam Cold Remedy Gel Swabs.

These precautions are all “good and well,” but at what point should consumers have received a formal manufacturer’s warning concerning the possible danger associated with nasal application of Zicam Cold Remedy? Would the right time have been in 1999, when Matrixx introduced Zicam nasal zinc products? How about in 2003, when plaintiffs allegedly suffering with anosmia filed 340 lawsuits? Should Matrixx have issued a voluntary preliminary warning in 2004, when the FDA began investigating complaints; or should Matrixx have then instructed consumers concerning proper application and use?

It seems plausible that Matrixx might have issued a voluntary warning in 2006, when it settled 340 Zicam lawsuits for 12 million dollars. In fact, George Eby submitted an article to Alternative Therapies in 2006 that contained the following statement:

“We contend that it is unethical to introduce any potentially permanent anosmia-inducing agent such as zinc or other heavy metals into the interior of the nose in a manner that could result in contact with the olfactory region to treat a temporary discomfort such as a common cold or allergy. We found no reason to recommend intranasal zinc gluconate or zinc orotate lozenges in treating common colds. (Altern Ther Health Med. 2006;12(1):34-38.) [Emphasis added].”

In 2006, additional information about the danger in using Zicam gel continued emerging. For example, the Denver Naturopathic Clinic issued a Zicam caution in 2006; the clinic provided a well reasoned opinion why Zicam was not homeopathic, and at least one clinic had raised a question about Zicam’s efficacy.

Maybe after receiving 800 aftermarket consumer complaints involving anosmia, the FDA might have suggested that Matrixx issue a warning in 2007 or 2008. What standard would be necessary to analyze whether a warning was warranted?

Perhaps Justice Royal in McClain v. Metabolife, 401 F.3d 1233 (11^th Cir. 2005) mentioned the difference between assessing consumer risk (a lower, more encompassing standard) and determining scientifically based causation (a more demanding and higher standard):

“The FDA will remove drugs from the marketplace upon a lesser showing of harm to the public than the preponderance-of-the-evidence or the more-like-than-not standard used to assess tort liability. The methodology employed by a government agency results from the preventive perspective that the agencies adopt in order to reduce public exposure to harmful substances....”

Therefore in Matrixx' case, it should be reasonable to conclude that whenever that lesser showing of harm occurred, and I suspect that it occurred at least a few years before 2009, Matrixx should have issued a voluntarily warning, or the FDA should have suggested that it do so.

Originally posted at InjuryBoard by Armand Rossetti