Levaquin

Quote
Anonymous said:
I would like to say that I was 60 yrs. old when I was given levaquin for pneumonia. No one warned me of any side effects except that I might get diarriha. No one told me not to take this with nsaids. No one told me that I might have tendon damage for the rest of my life. No one told me that I would never sleep well again or have stomach problems for the rest of my life or that I would gain 30 lbs and never be able to take it off. This is poison that is hurting thousands of people. Yes, You're right in that it also helps people.
All I want to know is why in all the studies that they knew they would be hurting many people, why didn't they come up with some remedys for us? Would it have cost too much money to try to help us? I took good care of myself all my life so that I could enjoy my children and Grandchildren and this is what I got for it. My life has been destroyed. All because of a dr. who gave me the b ig gun meds for something that turned out not to even be pneumonia. Over two years later I'm still crippled from this poison.
Ask your people why they couldn't do enough research so that we didn't have to have our lives ruined.
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Man, am I tired of your obsession. I initially felt sorry for you, but you are a professional whiner, and will get no more sympathy from me. This drug saves peoples lives. It isn't poison, it is a life saver. Get that through your head, and move on. You might not even be real. Maybe you are a rep from another company with an agenda. Either way, I won't be reading your sob story again. This string is off limits. Over and out!
 




Anonymous said:
After reading through the old thread about Levaquin, and seeing the rampant misconceptions regarding this drug (and its parent class, fluoroquinolones), I now find that it is necessary to share my own experiences with Levaquin.

To start off, I am 24 years old, and was healthy prior to ingesting this antibiotic.
The first time I was given this drug was in December of 2003, and approximately 6 months later I partially tore a tendon in my shoulder during non-strenuous activity. This along a few other symptoms (joint pain, fatigue, muscle spasms, etc...) were never connected to the drug I was given by either myself or doctor; blood tests revealed nothing egregiously wrong, and my doctor was stumped. I recovered from my injuries, only to be given Levaquin again in December of 2004.

This time, it destroyed my life. I find myself now, over 13 months later, still nearly unable to walk due to severe tendon and nerve damage in my lower legs. I have been unable to walk for more than a few minutes at a time since January of 2005, and even standing is exceedingly difficult at times. I have now suffered from tendon problems in the following joints: feet, ankles, knees, hips, back, hands, wrists, elbows, shoulders (I would merely say all joints, but I think that I may have a toe or two which are still unaffected); I also have problems with every major muscle group in my body. The pain is indescribable, unbearable, and quite simply, cruel and inhuman punishment for the mistake of merely trusting the medical community.

The full list of my side effects (almost all of which continue to this day) is as follows:
Fatigue, severe muscle weakness/soreness, buzzing/pricking/vibratory sensations in lower legs (signs of neuropathy), popping/cracking joints, gastrointestinal problems, recurring ear pressure, difficulty finding/spelling words, severe pain/stiffness upon waking, burning pain in legs, heart palpitations/tachycardia, red/dry eyes, hair loss, brain fog, memory loss, inability to focus, mood disturbances, bouts of depersonalization/derealization, anxiety (unprovoked panic attacks, even while sleeping), depression, insomnia, electrical sensations in brain, jitteriness/shakiness, limited joint range of motion (almost every joint), cold extremities, mild occasional hallucinations, dizziness, nausea, dislocated fibular head below left knee (due to muscle weakness), periodic limb movement disorder, and others which are not easily describable in list form.

Many of you who read this may scoff, may attack me as ill-informed, or worse, a liar. I cannot change that, as mankind has a remarkable ability to ignore/disbelieve information that threatens one’s previous worldview. You are allowed to believe whatever you want, and so be it. But let me ask you this, if it was not Levaquin which caused me all of these problems, then what was it? And why did they begin occurring shortly after consuming that drug? Why are thousands of other people complaining of the exact same array of ailments after being exposed to this class of pharmaceuticals?

You can shield yourself by wrapping up snugly in disbelief, but doing so in no way changes the truth of the matter. Nor does it alleviate, prevent, or alter the suffering that we endure.

Anyone who reads this can easily choose to close to their minds to this, but what about their hearts, the basic essence of compassion and humanity which bind us as a species? People have come to you and said that they are suffering, and thus far the only retort I’ve seen is to attack them and their credibility rather than listen, try to learn, or at least offer some condolences (see the old thread for examples of the caustic replies). What do I have to gain by doing this, or making this all up? The victims of this are not ‘conspirators’, we are hurt, and seek justice. I ask for nothing more than recognition by those who perpetrate this, and help in stopping it. More importantly, what do you have to lose by listening? Market share and profit margin, the proverbial ‘bottom line’? If so, if these factors weigh more heavily on your mind than gross injustice and the cries of humanity, than I pray for you. It is too late for me, as I have already been hurt and only time may one day heal me, but if no one stands up, if education about these dangers does not proliferate, then more innocent people will end up like me today, tomorrow, and the next.

I am not asking for a complete ban on these drugs, merely that they be used as a last line of defense (which is what they were originally designed/approved for) against resistant infections where they would mean the difference between life or death, and only then in cases where the patient is fully informed. Most, nearly all, of those who have been hurt were given these drugs before any others were tried, for diagnoses that did not require them. Pushing these drugs as first line agents by playing down their toxicity profile and claiming that they are ‘safe and effective’ is a moral crime if not a legislated one (yet).

I ask that all doctors be properly educated (by the pharmaceutical representatives they rely on) as to the inherent risks associated with fluoroquinolone use. Finally, I also ask the companies who manufacture these drugs to immediately send out ‘dear doctor’ letters warning of the following three facts: that fluoroquinolones can cause adverse reactions long after treatment has been discontinued, that these adverse reactions can sometimes be completely disabling, and that they can be non-abating. Merely the truth and nothing more…to save the health and lives of your fellow man.

Is this too much to ask in return for my life?
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Dude, do you really think any rep is going to say that? Get real. We are trying to SELL a product. We follow company direction, not cafe pharma direction. You are wasting your time typing your story here.
 








it has nothing to do with being a hypochrondiac. why can't you believe that thousands of us have been damaged by this so-called wonder drug. i was a totally healthy and happy and normal person when this happened. what the hell is wrong with you?
 




Anonymous said:
it has nothing to do with being a hypochrondiac. why can't you believe that thousands of us have been damaged by this so-called wonder drug. i was a totally healthy and happy and normal person when this happened. what the hell is wrong with you?
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You might have been healthy and happy, but you were never normal.
 




Do any of you poison sellers know why Canada would have a caution about giving levaquin to anyone allergic to pennicillin? When I asked about it it suddenly disappeared from the website for Janssen.
What have you been told. Many of the people suffering from adverse reactions are also allergic to pennicillin.
Is it possible that omn is keeping information from the public? and from you?
 




I am allergic to "pennicillin" and have taken levaquin 3 times for long durations. I am fine. In fact the AAO guidelines (which OMP has nothing to do with) list levaquin as a first line agent for patients with sinusitis that are allergic to "pennicillin."

Do you really think that your efforts here are making a difference? ATS guidelines just came out - why dont you go there and make your case. Really, no one here cares and you have come on WAY to strong to get any kind of support.
 








I am a physician and have had a severe adr to Levaquin including long term neuropathy, tendon and joint disorder and other numerous problems. I would never have believed it could happen. No one ever warned me of the toxicity of the fluoroquinolones. They just wanted me to give it for even minor infections so sales could go up. Since my own life altering adr I have met hundreds of others and over 50 in my own community wih serious life altering reactions to levaquin and the other quinolones. Many doctors are curtailing there prescriptions of Levaquin, Avelox, Cipro, etc as the word gets out. The FDA is aware and is deciding on how best to present this difficult situation. You reps may want to seriously look in to the huge numbers of affected individuals out there. If you think this is a minor problem then you have your heads in the sand.
 








I have been naive. I now understand that this is solely about money. I will never let a rep in my office or in my OR again. You are not professionals and don't care. I come on here as a physician and am mocked by a bunch of yes men. I don't care if you think I'm not a doc. The truth remains that I am and that many many patients especially the elderly are being injured by use of fluoroquinolones. Go ahead and tell yourself that I am not for real so that you won't have to face the fact that a drug you detail is injuring patients and you are failing to warn people. After reading the posts on this message board, I have a new low opinion of the pharma company and their army of reps. The fact remains that many of my colleagues are finding patients with serious long term reactions to the fluoroquinolones and knowing of my reaction they often call me and ask my opinion. They are not learning of the potential adrs from you, but from the patients that are injured.
 








Oh man, Avelox rep here, glad to see someone else has had to be subject to the obsesisve rants of this person. How dilluted is he/she? How hard is it to understand that, yes there are people who will have serious AEs with a FQ, but the same can be said of any drug. This person simply cannot understand that the number of people who are treated successfully with a FQ, many of whose lives are actually saved, is so exponentially greater than the poor unfortunates who are allergic, that their cries will unfortunately continue to go dismissed. Why isn't this person complaining to the IDSA or ATS?
 




Anonymous said:
I have been naive. I now understand that this is solely about money. I will never let a rep in my office or in my OR again. You are not professionals and don't care. I come on here as a physician and am mocked by a bunch of yes men. I don't care if you think I'm not a doc. The truth remains that I am and that many many patients especially the elderly are being injured by use of fluoroquinolones. Go ahead and tell yourself that I am not for real so that you won't have to face the fact that a drug you detail is injuring patients and you are failing to warn people. After reading the posts on this message board, I have a new low opinion of the pharma company and their army of reps. The fact remains that many of my colleagues are finding patients with serious long term reactions to the fluoroquinolones and knowing of my reaction they often call me and ask my opinion. They are not learning of the potential adrs from you, but from the patients that are injured.
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OMG....what an asshole! Thank God he isn't my doctor!
 




this thread as well as the one on the SGP board is a hoax. there's a class action lawsuit brought by former JNJ reps regarding levo promotion- their just fishing b/c they have no hard data. imagine what a good attorney could do with some of the statements on this board
 








The Potent Antibiotic Levaquin Has Been Tied to Painful Tendon Ruptures.

Levaquin (generic levofloxacin) is a powerful, prescription antibiotic made by Ortho-McNeil Pharmaceutical that has been linked to an increased risk of tendon ruptures, tendonitis, and other serious injuries. As part of the group of antibiotics called fluoroquinolones, Levaquin is commonly used to treat bacterial infections of the sinuses, skin, lungs, ears, airways, bones, and joints.

Tendons can rupture quickly, within hours of taking Levaquin, or may take weeks to develop. In some cases, patients feel pain and notice swelling or bruising in the area of the tendon, but some patients report seeing no symptoms of problems before they are injured.

FDA Warns Users of Levaquin About Risk of Tendon Ruptures!

Find out more: http://www.knolcentral.com/lev70/
 




Anonymous said:
The Potent Antibiotic Levaquin Has Been Tied to Painful Tendon Ruptures.

Levaquin (generic levofloxacin) is a powerful, prescription antibiotic made by Ortho-McNeil Pharmaceutical that has been linked to an increased risk of tendon ruptures, tendonitis, and other serious injuries. As part of the group of antibiotics called fluoroquinolones, Levaquin is commonly used to treat bacterial infections of the sinuses, skin, lungs, ears, airways, bones, and joints.

Tendons can rupture quickly, within hours of taking Levaquin, or may take weeks to develop. In some cases, patients feel pain and notice swelling or bruising in the area of the tendon, but some patients report seeing no symptoms of problems before they are injured.

FDA Warns Users of Levaquin About Risk of Tendon Ruptures!

Find out more: http://www.knolcentral.com/lev70/
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WARNING !!!!!!!! DO NOT CLICK ON THIS SITE: IT IS AN ADD FOR ATTORNEY LAWSUITS AND HAS MULTIPLE WINDOWS THAT ARE DIFFICULT TO CLOSE!!!!!!
 




FDA reviews this class as with all classes. It has been over 15 years since Levaquin came to market. Cipro came to market before. They were followed by Trovan No longer around due to life threatening side effect. It took the FDA less than 6 months to pull Trovan from the market. If there is a legitimate issue Levaquin would have and will be removed . That is not saying there are not side effects that is what the PI is for. In the past 12 years they have added Avelox and Tequin. Given these to medications make a far smaller portion of the prescriptions that are written they to are relatively safe. Pathogen are adapting, for the people that are posting to have Qunialones removed from the market. If this class is removed you would increase the number of Deaths due to Pneumonia and other respiratory illness by 10 fold we are talking 100s of thousands if not millions world wide. You have these superbugs that are evolving and this class is one of the only medications that is killing these pathogens. Look up MDRSP this is the future. The sad thing is some of these super bugs have evolved to resist even this class and if we do not come up with more potent antibiotics the most intelligent species will be extent by a single cell organism.
 




UNITED STATES DISTRICT COURT
DISTRICT OF MINNESOTA
, )
)
Plaintiff, )
)
v. ) Civil Action No. ______________
)
JOHNSON & JOHNSON, ORTHO-McNEIL )
PHARMACEUTICAL, INC., and JOHNSON )
& JOHNSON PHARMACEUTICAL )
RESEARCH AND DEVELOPMENT, LLC, )
)
Defendants. )

COMPLAINT AND DEMAND FOR JURY TRIAL

Plaintiff ********("Plaintiff"), by and through his attorneys of record, hereby
files this Complaint and Demand for Jury Trial against Defendants Johnson &
Johnson, Ortho-McNeil Pharmaceutical, Inc. ("Ortho-McNeil"), and Johnson &
Johnson Pharmaceutical Research & Development, LLC ("Johnson & Johnson
Pharmaceutical" or "Johnson & Johnson PRD") (hereinafter, collectively
"Defendants"), and states of information and belief as follows:

I. INTRODUCTION

1. This case involves the fluoroquinolone antibiotic, levofloxacin.

2. Levofloxacin was designed, formulated, promoted, sold and distributed by
Defendants in the United States as Levaquin from 1997 through the present.

3. Levaquin was approved by the FDA for treatment of a variety of serious
infections. However, Defendants market Levaquin as a first line therapy for
common bronchitis and sinusitis infections, and for which many other, safer,
antibiotics are available.

4. As compared to other fluoroquinolone antibiotic drugs, Levaquin causes a
higher incidence of tendon injuries, including tendon rupture, especially in
persons over 60 years of age
and/or who are on corticosteroid therapy, none of which was adequately disclosed
to Plaintiff and his physicians.

5. Levaquin-induced tendon injury involves the degradation of the tendon tissue,
leading to severe and permanent injuries.

6. Plaintiff **** suffered a severe and debilitating tendon injury after his use
of the drug Levaquin.

7. This lawsuit asserts claims against Defendants for strict product liability
for manufacturing and/or design defect; strict product liability for failure to
warn; negligence; breach of express and implied warranties for the design,
manufacture, production, testing, study, inspection, labeling, marketing,
advertising, sales, promotion, and distribution of Levaquin; fraud; violation of
consumer protection and unfair trade practice laws; and unjust enrichment.

II. JURISDICTION

8. This Court has jurisdiction over this action pursuant to 28 U.S.C. §1332,
because the amount in controversy exceeds Seventy-Five Thousand Dollars
($75,000.00), exclusive of interest and costs, and because there is complete
diversity of citizenship between the Plaintiff and all Defendants.

9. Venue is proper in this judicial district pursuant to 28 U.S.C. §1391 because
the Defendants researched, designed, licensed, manufactured, tested, marketed,
distributed, and/or sold the prescription drug Levaquin within this judicial
district and because Defendants are subject to personal jurisdiction within the
State of Minnesota.

III. PARTIES

10. Plaintiff ********is a citizen and resident of *********.

11. Defendant Johnson & Johnson is a New Jersey corporation with its principal
place of business in New Brunswick, New Jersey.

12. Defendant Ortho-McNeil is a Delaware corporation with its principal place of
business in Raritan, New Jersey. Defendant Ortho-McNeil is a wh+olly owned
subsidiary of Johnson & Johnson.

13. Defendant Johnson & Johnson Pharmaceutical Research & Development is a New
Jersey corporation with its principal place of business in Raritan, New Jersey.
Defendant Johnson & Johnson Pharmaceutical Research & Development is a wholly
owned subsidiary of Johnson & Johnson and was formerly known as R.W. Johnson
Pharmaceutical Research Institute.

14. At all times relevant herein, Defendants tested, studied, researched,
designed, formulated, manufactured, inspected, labeled, packaged, promoted,
advertised, marketed, distributed, and sold the prescription drug Levaquin in
interstate commerce and throughout the State of Minnesota. At all times relevant
herein, Defendants were registered to do business in the State of Minnesota.

IV. GENERAL FACTUAL ALLEGATIONS

15. Levaquin, Defendants' brand name for the antibiotic levofloxacin, is a broad
spectrum synthetic antibacterial agent approved for use in the treatment of a
variety of upper respiratory infections, urinary tract infections, prostatitis,
and other bacterial infections. It was first introduced into the U.S. market in
1997.

16. Levaquin is in a class of antibiotics known as fluoroquinolones. The
original quinolone antibiotics were developed in the early 1960s and soon
revealed themselves as highly effective against common gram-negative bacteria,
but resistance developed rapidly. Twenty years later, in the early 1980s,
fluorinated derivates of the quinolones emerged, revealing a broader, more
potent antibiotic, effective against many different types of infections. These
so-called second generation fluoroquinolones included norfloxacin (Noroxin),
ciprofloxacin (Cipro), ofloxacin (Floxin), and pefloxacin (never marketed in the
U.S.).

17. Although considered highly effective at killing certain bacteria,
fluoroquinolones have long been associated with serious side effects. Indeed,
many fluoroquinolones have been removed from the market due to intolerable
adverse events. For example, Omniflox (temafloxacin) was removed from the market
in 1992 because of low blood sugar, kidney failure, and a certain rare form of
anemia; Raxar and Zagam were removed because of QT-interval prolongation among
other things; Trovan was removed from the market due to severe liver toxicity;
and most recently, Tequin was removed from the market in 2006 amid reports of
severe blood sugar reactions such as hyperglycemia and hypoglycemia.

18. In sum, though fluoroquinolones may share certain pharmacological
properties, their safety profiles can differ immensely.

A. OFLOXACIN – THE FIRST GENERATION OF LEVAQUIN

19. To understand the pharmacological properties of Levaquin, one need look no
further than to Levaquin's older brother, ofloxacin (Floxin), also manufactured
and distributed by Defendants.

20. Both Floxin and Levaquin were created and developed by Daiichi, Japanese
Company who holds the patent on both agents. Daiichi assigned the patents to
Defendants and
gave Defendants an exclusive license to manufacture and market both its
fluoroquinolone compounds in the United States in return for royalty fees.
Daiichi licenses levofloxacin to Aventis for manufacture and market in European
counties. To date, Levaquin remains one of Daiichi's best selling
pharmaceuticals.

21. Daiichi ensured that the post market surveillance of levofloxacin would be
tracked world-wide by creating an international database to keep track of
adverse events. This database ensured that Defendants could not ignore the post
market experience of levofloxacin in other countries.

22. Ofloxacin was first introduced into the Japanese market in September 1985.
Defendants introduced ofloxacin, under the brand name Floxin, in the United
States six years later, in 1991.

23. Even before ofloxacin was marketed in Japan, Daiichi began researching
products that could be the successor of ofloxacin. Daiichi wanted to develop a
newer fluoroquinolone in order to be more competitive with Cipro and the other
fluoroquinolones by developing a drug with the same or better characteristics of
ofloxacin that could be used both orally and by injection.

24. After many derivatives of ofloxacin were explored and synthesized, Daiichi
isolated what is now known as levofloxacin. Levofloxacin is a purified version
of one optically active form of ofloxacin, more specifically the L-isomer.

25. Accordingly, ofloxacin and Levaquin are pharmacologically very similar - in
fact, so similar that Defendants alleged in their New Drug Application for
Levaquin that the safety profile of Levaquin would be expected to mirror that of
ofloxacin.

26. Unfortunately, while Levaquin did closely follow the safety profile of
ofloxacin, Levaquin was worse with respect to certain adverse effects, including
tendon toxicity.

B. EPIDIMIOLOGY OF FLUOROQUINOLONE TENDON TOXICITY – OFLOXACIN IS MORE TENOTOXIC
THAN THE REST, AND THE ELDERLY AND USERS OF CORTICOSTEROIDS ARE AT A HEIGHTENED
RISK

27. Tendonitis as a side effect of fluoroquinolones was first reported in 1983.
The first case of Achilles tendon rupture was reported in 1991 in conjunction
with pefloxacin – a fluoroquinolone that has never been approved in the U.S, in
part due to its teno-toxicity. Potentially due to pefloxacin's early use in
France, by 1994, Dr. Pierfitte et al. identified over 100 French patients with
fluoroquinolone tendon disorders (mostly pefloxacin), and was able to observe
that tendon injury occurred more frequently in patients over 60 and especially
in those who had received steroid therapy.

28. Although the Achilles tendon was affected the most, and bilaterally in many
cases, Dr. Pierfitte reported that other tendons could by implicated as well.
Accordingly, the French regulatory body was one of the first to notify
physicians and their patients about the risk of fluoroquinolones-induced tendon
injury. Additionally, as a likely result of Dr. Pierfitte's published
observations, pefloxacin became severely restricted in use by 1995.

29. Once pefloxacin became restricted, Defendants' first generation ofloxacin
emerged as the most tenotoxic fluoroquinolone on the market.

30. One of the first published reports regarding the tendon toxicity of
ofloxacin was published in 1995 in the British Journal of Clinical Pharmacology
(Wilton, L.V., Pearce, G.L. Mann, RD, A comparison of ciprofloxacin,
norfloxacin, ofloxacin, azithromycin and cefixime examined by observational
cohort studies. Br J Clin Pharmacol 1996; 41:277-284).

31. In the Wilton report, an analysis of prescription event monitoring data in
the United Kingdom (a country where pefloxacin was not approved for market)
revealed that ofloxacin was more tenotoxic than the other fluoroquinolones
examined.

32. The United Kingdom's Regulatory Authority issued a bulletin, published in
July 1995, stating that it had received 21 reports of tendon damage associated
with fluoroquinolone antibiotics. The Authority reported "elderly patients and
those treated concurrently with corticosteroid are at particular risk."

33. Defendants submitted their New Drug Application regarding Levaquin to the
FDA in 1995. Though they indicate that tendon disorders are associated with
fluoroquinolone use, Defendants failed to report that ofloxacin was more tendon
toxic than other currently marketed fluoroquinolones and failed to report that
the tendon toxicity was exacerbated in the elderly, and especially in those
taking corticosteroids.

34. The first epidemiological study to evaluate the relative risk of
fluoroquinolone-induced tendonitis was published in 1999 by
pharmacoepidimiologists and researchers at the Department of Epidemiology and
Biostatistics and Internal Medicine at Erasmus Medical Center in Rotterdam. Van
der Linden PD, Van de Lie J, Nab HW, Knok A, Stricker B H Ch, Achilles
tendonitis associated with fluoroquinolones, Br J Clin Pharmacol 1999; 48:
433-437.

35. Data analyzed in this retrospective cohort study from 41 general practices
in the Netherlands from 1995 and 1996 revealed that that ofloxacin had the
strongest association with Achilles tendonitis. The adjusted relative risk of
tendonitis to fluoroquinolones was 3.7, while Achilles tendonitis associated
with ofloxacin had a relative risk of 10.1. Upon information and belief,
Defendants knew of this study and had an obligation to inform the FDA of this
study by supplementing their New Drug Application.

36. A second epidemiological study published in 2002 by Van der Linden et al.
analyzed data from the IMS Health database in the United Kingdom which contained
general practice medical records on a source population of 1 to 2 million
inhabitants. Van der Linden, PD, Sturdenboom MCJM, Herings, RMC, Leufkens HGM,
Stricker BH Ch, Fluoroquinolones and risk of Achilles tendon disorders: case
control study, BMJ 2002; 324:1306-1307.

37. In this nested case control study, the authors again found that ofloxacin
was associated with an eleven fold increase in tendon disorders. More
specifically, the authors found that the relative risk of Achilles tendon
disorders following current use of fluoroquinolones was 1.9, but in patients
over 60 years of age, the relative risk was 3.2. However, in the elderly, the
relative risk was 11.5 for current use of ofloxacin, compared to 2.3 and 1.8 for
ciprofloxacin and norfloxacin respectively. In patients of 60 years and older,
concurrent use of corticosteroids and fluoroquinolones increased the risk to
6.2. Upon information and belief, Defendants knew of this study and had an
obligation to inform the FDA of this study by supplementing their New Drug
Application.

38. Soon thereafter, in 2003, Dr. Van der Linden published his final
epidemiological study, a larger population-based case control study that
analyzed cases of Achilles tendon rupture and fluoroquinolone use from 1988 to
1998. Stunningly, his report concludes that the relative risk of a tendon injury
in patients over 60 years old taking ofloxacin was 27.7 compared to
ciprofloxacin's 3.4. He also found that use of corticosteroids nearly doubled
the risk for tendon injury for patients over 60 years old.

39. Even Daiichi, the inventor of ofloxacin and Levaquin, published a 1997 rat
study that admitted that Levaquin and ofloxacin were the most toxic to tendons
of all the fluoroquinolones marketed in the United States. The study was
designed to not only better
understand the pathophysiological mechanism of fluoroquinolone- induced tendon
disorders, but also to compare the relative tendon toxicity of ten different
fluoroquinolones.

40. Although the exact mechanism of how fluoroquinolones cause tendon injury is
still being investigated, studies have suggested that fluoroquinolones can
degrade tendon cells by causing apoptosis, or a programmable cell death, and
therefore lose their integrity, and easily tear and/or rupture.

41. The outcome of Achilles tendon ruptures in persons over 60 - the population
most affected by this adverse reaction, is not favorable. Treatment may include
a corticosteroid to decrease inflammation - the very drug that, when combined
with a fluoroquinolone, can dramatically increase the risk of a tendon rupture.
In the event of a tendon rupture, the leg is often immobilized through a boot or
other casting for anywhere between six weeks to six months, and physical therapy
is ordered thereafter. Surgery is frequently not recommended in the elderly
population due to poor recovery rates. However, even with immobilization for
long periods of time and physical therapy, the Achilles tendons in the elderly
rarely fully recover.

C. THE FIRST U.S. TENDON WARNING

42. According to the U.S. consumer watchdog organization, Public Citizen, by
1996 there were over 130 reports of tendon injury from around the world over a
ten year period and 52 reports of tendon injury in the United States associated
with fluoroquinolone use.

43. As there was no mention of any fluoroquinolone-induced tendon injury on the
label, Public Citizen petitioned the FDA in 1996, based on the number of adverse
event reports world wide, to require that manufacturers of fluoroquinolones
revise their product label to alert physicians of this unusual adverse event.

44. The FDA responded by requiring the following warning on all fluoroquinolone
labels:
"Ruptures of the shoulder, hand, and Achilles tendons that required surgical
repair or resulted in prolonged disability have been reported with [the specific
drug name].[The specific drug name] should be discontinued if the patient
experiences pain, inflammation, or rupture of a tendon. Patients should rest and
refrain from exercise until the diagnosis of tendonitis or tendon rupture has
been confidently excluded. Tendon rupture can occur at any time during or after
therapy with [the specific drug name]."

45. By 1997, U.S. manufacturers of fluoroquinolones had modified their label.
However, the label was buried in a long list of potential adverse reactions; it
was not highlighted in any way, such as with bold lettering, or even a heading
titled "tendon injury." Moreover, no mention was made of the fact that age and
corticosteroid use tripled the risk of tendon injury. No letter to physicians
was disseminated, and Defendants did not highlight this unusual effect when
promoting Levaquin to doctors.

D. LEVAQUIN'S EARLY POST-MARKET EXPERIENCE

46. Levaquin was first introduced in Japan in 1993 and later introduced in the
United States in 1997.

47. As has previously been alleged and described, before Levaquin's market
launch in the United States, Defendants had knowledge that:
a. Levaquin would be as toxic as ofloxacin;
b. Ofloxacin was revealing itself as one of the most tenotoxic fluoroquinolones
on the market; and
c. The elderly, and especially those using corticosteroids, were at least three
times as likely to suffer a tendon injury.

48. Despite this unique knowledge, Defendants chose to use the same label that
the FDA required on all other fluoroquinolones. Accordingly, in 1997, most U.S.
physicians did not understand fluoroquinolone tendon toxicity, and were
completely ignorant of the elderly's exceptional vulnerability to this
antibiotic, especially those dependent on corticosteroids.

49. A look at Defendants' sales materials could explain why: the very group that
Levaquin was most toxic to was the very market Defendants were after.
Defendants' target market for Levaquin was the elderly – especially those with
upper respiratory infections who were likely to be chronic corticosteroid users.

50. More disturbing, Defendants' promotional campaign was themed on Levaquin's
excellent safety profile and failed to disclose the risks of tendon injury.

51. Defendants capitalized on Levaquin's early introduction into Japan and other
countries by using pre-U.S. prescription sales data to assert that Levaquin had
been prescribed frequently with few adverse events.

52. For example, one such advertisement boasted that Levaquin had "An
Outstanding Record of Safety" as "[o]ver 63,000,000 patients worldwide" had
taken the drug and only diarrhea and nausea had shown up as adverse effects,
albeit rarely.

53. Cleverly, the promotional literature only reported on adverse events in U.S.
clinical trials where only a very small sampling of patients took their drug,
and where many adverse events do not necessarily reveal themselves. So,
Defendants claimed "proven performance" on the 63,000,000 million people that
had used Levaquin outside the United States, but chose not to disclose the
adverse events that were being reported on this same population.

54. As Levaquin gained traction, its "Achilles heel" of heightened tenotoxicity
revealed itself.

55. Levaquin enjoyed immediate popularity in the Italian market. Introduced to
Italy in 1998, Levaquin became Italy's best selling fluoroquinolone, surpassing
Cipro, the major market leader, in just three years. Curiously, ofloxacin,
Defendant's previous fluoroquinolone, had the lowest market share, which was
consistent with Daiichi's plan to "cannibalize" ofloxacin in favor of Levaquin.

56. One of the first comparative studies that included post market experience
with Levaquin was from Italy. The authors analyzed Italian adverse event data
from 1999 to 2001 to help determine the relative toxicity of each marketed
fluoroquinolone antibiotic.

57. The Italian study was published in 2003 and revealed 1) the most frequently
reported serious reaction to fluoroquinolones were tendon disorders 2)
levofloxacin was the fluoroquinolone with the highest tendonitis reporting rate,
and 3) levofloxacin ranked first for tendonitis reports during the same period
in the World Health Organization's adverse event database, with 522 reports of
levofloxacin-induced tendon disorders and ruptures.

58. Not surprisingly, in March 2002, the Italian Health Ministry issued a Dear
Doctor letter to inform physicians of the risk of Levaquin tendon rupture.

59. France also reported a particularly large amount of tendon disorders soon
after Levaquin was first marketed to that country in September 2000. By June
2001, in just nine months, 333 adverse reactions had been reported, with tendon
disorder being the most frequently reported adverse event. Again, the adverse
event data supported the epidemiological evidence finding that tendon injuries
were more prominent in the elderly, especially when there had been
co-administration of corticosteroids.

60. France's regulatory authority published a Dear Doctor letter to highlight
this information in 2002.

61. Similarly, the Belgian regulatory authority received 161 reports of
Levaquin-induced tendon injury, including 68 reports of tendon rupture, in the
first two years of Levaquin's introduction to Belgium. Again, the average age of
patients with levofloxacin-associated tendinopathy was 69 years old and about
half were receiving concomitant corticosteroid treatment. As with other adverse
event data, the tendon injuries were reported to occur soon after Levaquin was
ingested. Belgium also noted, similar to Italy, that the number of tendon
disorders associated with levofloxacin was much higher than that of the other
quinolones. Not surprisingly, ofloxacin had the second highest reports of tendon
injury.

62. Recognizing that the number of tendon effects from Levaquin were far more
frequent that any of the older fluoroquinolones which had all been on the market
over the past ten years, the Belgium regulatory authority also disseminated a
Dear Doctor letter in 2002 highlighting their concerns about levofloxacin's
toxicity and suggesting that levofloxacin is only justified for the treatment of
community-acquired pneumonia in patients who are allergic to beta-lactams. The
agency stressed the elderly and people who used corticosteroids were
particularly at risk and encouraged doctors that if levofloxacin treatment was
necessary, to watch for tendon injury.

63. After nearly five years on the market in the United States, and following
the post-marketing data out of Europe, Defendants finally decided to update
their tendon warning.

E. LEVAQUIN'S SECOND TENDON WARNING

64. The pre-2002 Levaquin label bore the required tendon warning from its market
launch in 1997. It was the last of the warnings listed, with no header or any
other identification
to alert a practitioner to this unusual side effect. The warning was behind
gastrointestinal affects, hypersensitivity reactions, and even the rare event of
anaphylactic shock.

65. In 2002, Defendants embedded the following in the existing tendon warning:
"Post-marketing surveillance reports indicate that this risk may be increased in
patients receiving concomitant corticosteroids, especially in the elderly."

66. Through an international database managed by Daiichi, Defendants had access
to the post market surveillance data all over the world, and specifically
France, Belgium, Italy, and the United Kingdom.

67. By 2002, the adverse event data in all those countries consistently and
unequivocally revealed that the risk of tendon injury was nearly triple for
people over 60 as compared to people under 60. Additionally, Defendants had
knowledge of at least one epidemiological study confirming the age effects of
fluoroquinolone use. All data pointed to the fact that Levaquin was more tendon
toxic than all other fluoroquinolones.

68. Despite a wealth of information, Defendants chose not to warn their target
patient population - the elderly - with their 2002 warning. Instead, they muted
their additional tendon warning by flipping the confounders. Rather than warn
that the risk of tendon injury was increased (tripled) in the elderly, the
warning stated that that the risk was possibly increased in those using
corticosteroids. According to Defendants' warning, any elderly person not on
corticosteroids therefore had no additional risk of a tendon injury, and the
fact that the warning was so equivocal regarding corticosteroids diffused any
possible effect of warning physicians of the effect of age on the frequency and
severity and of this debilitating injury.

69. Nor did Defendants make any effort to highlight this new information to its
prescribing doctors - Defendants did not send any Dear Doctor letters regarding
the 2002 label change to any healthcare practitioners, as had been done in
Italy, Belgium, and France.

70. Accordingly, despite the 2002 label change, Levaquin prescriptions only
increased, and tendon injuries mounted.

F. DEFENDANTS THWART EFFORTS TO HIGHLIGHT LEVAQUIN'S INCREASED RISK OF
TENDON INJURY

71. Alarmed by the early post market experience with Levaquin, France, Belgium,
Italy, the United Kingdom and other European countries convened before the
European Agency for the Evaluation of Medicinal Products (EMEA) as early as
September 2001 to discuss a heightened warning for levofloxacin.

72. The EMEA proposal was that levofloxacin would be singled out as the most
tendon toxic of the fluoroquinolones with a warning that stated that
levofloxacin (marketed under the brand name Tavanic) was associated with a
greater frequency of tendinopathy and tendon rupture than other
fluoroquinolones.

73. Aventis Pharmaceutical was the manufacturer and distributor of levofloxacin
in Europe.

74. Under increasing pressure to agree to the proposed changes to the warning
label, Aventis conducted two epidemiological studies in Europe regarding the
relative tendon toxicity of levofloxacin. The first study used the United
Kingdom's General Practitioners Research Database of medical records from 1997
through 2001, and the second used Germany's Mediplus database of medical records
from 1998 to 2001.

75. Before releasing the results of the two epidemiology studies to the European
regulatory authorities, and ostensibly because of the results of the studies,
Aventis contracted
with Defendants, specifically Johnson & Johnson Pharmaceutical Research &
Development, to fund and co-author a study in the United States on tendon
rupture and fluoroquinolones.

76. Advocating that the U.S. study would be the largest epidemiological study to
date and therefore provide the most definitive evidence of the relative risk of
levofloxacin and tendon injury, and that the European studies to date were too
small from which to base a label change, Aventis convinced the European
regulatory authorities to forestall the proposed warning change until the
preliminary data from the U.S. study was released.

77. In or around April 2002, Aventis submitted the results of their two European
epidemiological studies to the United Kingdom's regulatory authority, the
Medicines and Healthcare Products Regulatory Agency (MHRA).

78. The epidemiology studies conducted by Aventis in Europe concluded that
levofloxacin was associated with a higher rate of tendon injury than all the
other fluoroquinolones compared. Ofloxacin, the fluoroquinolone indicted in
early epidemiological studies as the most teno-toxic, came in second.

79. An assessor at the MHRA concluded that the two epidemiological studies had
findings "supporting a signal generated by spontaneous reporting with respect to
an increased risk of tendinopathy with levofloxacin compared to other
fluoroquinolones."

80. Moreover, the assessor remarked "the finding that ofloxacin (the racemate)
is associated with an intermediate level of risk makes pharmacological sense,
suggesting that the L-rather than the D-isomer of ofloxacin is likely to be
responsible for tendon toxicity….given the consistency and plausibility of the
findings, a real difference is the most likely explanation."

81. By the time Aventis released the results of their epidemiological studies,
the preliminary results of the U.S. study was reportedly only six months away.
Accordingly, the European regulatory authorities agreed to wait before forcing a
label change.

82. The U.S. epidemiological study was funded and co-authored by Defendant
Johnson & Johnson Pharmaceutical Research & Development.

83. Unlike the healthcare databases in Europe which contain computerized medical
records, Johnson & Johnson PRD used data from the Ingenix Research database
which consisted of U.S. health insurance claims data from 1997 to 2001. The
study analyzed only Achilles tendon ruptures and sought to examine whether
fluoroquinolone exposure was a risk factor for this injury. It did not assess
the relative risk of Levaquin tendon toxicity, as had been requested by the
United Kingdom.

84. Under the guise of data validation, Defendant Johnson & Johnson PRD created
an algorithm that conveniently excluded nearly 70 percent of health claims for
elderly persons who suffered Achilles tendon rupture.

85. The algorithm used CPT procedure codes that only related to surgical repair
which thereby excluded all those Achilles tendon rupture cases where the patient
was casted or booted, as is the case in the elderly population.

86. By manipulating the data, Defendant Johnson & Johnson PRD was able to
exclude the very group that was most prone to tendon rupture.

87. Not surprisingly, the results of the U.S. epidemiological study – the study
upon which hinged regulatory action in Europe with ramifications to the U.S.
market – revealed for the first time that there was no increased risk of
Achilles tendon rupture associated with any
fluoroquinolone use. Neither the confounders of age nor corticosteroid use
altered these findings.

88. Indeed, when one includes the data that was excluded by the algorithm, the
result becomes consistent with the approximately eight other epidemiological
studies performed on the topic. See Seeger et al. Achilles Tendon Rupture and
its Associations with Fluoroquinolone Antibiotics and Other Potential Risk
Factors in a Managed Care Population, Pharmacoepidemiology and Drug Safety 2006;
15: 784-792 ("There was a stronger association with fluoroquinolone antibiotic
exposure among these "ruled-out" cases of ATR than among the decision rule
confirmed cases. This association was stronger with exposure close to the date
of the rupture and was more pronounced among the elderly.")

89. As a result of Defendants' misrepresentations in the U.S. Study, the MHRA
and the other European regulatory agencies chose not to revise the levofloxacin
label as they had previously recommended.

G. DEFENDANTS DOWNPLAY THE RISK OF LEVAQUIN TO PHYSICIANS

90. Consistent with their plan to downplay Levaquin's known risk of tendon
injury, Defendants made no attempts to educate physicians in the United States
about this unusual adverse event. Although Dear Doctor letters had been widely
disseminated throughout Europe advising of Levaquin's tendon toxicity and the
vulnerability of this adverse event to the elderly, Defendants did not so advise
the U.S. physicians.

91. Defendants plan was to hide behind the class warning and blame any tendon
injuries reported on the general pharmacological properties of a fluoroquinolone
antibiotic rather than on the L-isomer of the ofloxacin compound as the Aventis
studies suggested.

92. Promotional material designed and distributed by Defendants, and more
specifically, by Ortho-McNeil, consistently omits the risk of tendon injury on
materials left with physicians.

93. Accordingly, physicians continued to prescribe Levaquin believing it to have
the same safety profile as Cipro and unaware of the heightened affect of
Levaquin on the elderly population.

H. AN EXPLOSION OF TENDON INJURIES RESULTS IN THIRD LABEL CHANGE

94. A review of the events in the FDA Adverse Event database from 1997 through
2005, for Levaquin alone, showed 1,044 reports of tendon injuries, with 282
reports of tendon rupture. This six year figure for tendon affects associated
with Levaquin far surpassed the ten year history of tendon affects from 1985
through 1995 associated with all pre-Levaquin fluoroquinolones.

95. After Cipro went generic in 2003, Levaquin became the number one prescribed
fluoroquinolone in the United States. And when Zithromax, a highly popular
macrolide antibiotic, went generic after its patent expired in 2005, Levaquin
became the number one prescribed antibiotic in the world in 2006.

96. Corresponding with Levaquin's increased popularity, the number of adverse
events reported to the FDA reported soared. 143 tendon related injuries were
reported in 2006, and in just the first quarter 2007, 107 tendon related
injuries were reported where Levaquin was the primary suspect.

97. The Levaquin phenomenon did not go unnoticed by the Illinois Attorney
General. On May 18, 2005, the Attorney General submitted a petition to the FDA
requesting a black box warning on fluoroquinolones. The Attorney General
suggested that the black box was necessary
to highlight the seriousness of tendon injuries and that the risk is increased
in the elderly and in patients on corticosteroids.

98. The Attorney General also requested that the manufacturer issue a Dear
Doctor letter to inform the health care providers about this significant hazard
to health, as the tenotoxic affects of fluoroquinolones were not well known to
practicing physicians.

99. In the Petition, the Attorney General's office reviewed the literature and
stated that tendon injuries were not a rare complication of fluoroquinolone use.
The Petition complained that the current tendon warning was "buried in lists of
potential side effects which are both less frequent and less severe."

100. One year later, the same consumer watchdog organization that petitioned the
FDA in 1996 for a tendon warning, petitioned the FDA again saying the first
tendon warning did not go far enough. Citing the alarming increase in reports of
tendon injury, Public Citizen joined the Illinois Attorney General's petition
and urged that the FDA place a black box warning regarding the risk of
tendonitis and tendon rupture.

101. At the request of the FDA, in April 2007, the Levaquin label changed for a
third time with regard to tendon injuries. The new label is not a black box, but
it now states that indeed the elderly are at an increased risk of tendon injury,
and unequivocally states that the risk is increased with concomitant use of
corticosteroids, contrary to the results of Defendant's Ingenix study.

102. Upon information and belief, Defendants negotiated with the FDA and
insisted on a class warning to thereby minimize the heightened risk of tendon
injury with Levaquin.

103. The current class warning fails to alert physicians and prescribing health
care providers that Levaquin is more toxic to the tendons than the other
fluoroquinolones available in
the U.S. market. Health care providers have no warning that Levaquin is much
more tenotoxic than other drugs in the class and therefore will interpret the
relative risk of a Levaquin-induced tendon injury inappropriately.

104. Defendants, upon information and belief, have not advised physicians of the
2007 label change and therefore, it is not known when physicians might receive
this new information regarding the vulnerability of the elderly population to a
Levaquin-induced injury.

105. Defendants continue to market Levaquin as a first line therapy for the
common bronchitis and sinusitis infections, and for which many other, safer,
antibiotics are available.

V. SPECIFIC FACTUAL ALLEGATIONS

106. (deleted to protect the privacy of the Plaintiff)

VI. FIRST CAUSE OF ACTION STRICT LIABILITY

107. Plaintiff incorporates by reference of all other paragraphs of this
Complaint as if fully set forth herein and further alleges as follows:

108. At all relevant times hereto, Defendants were engaged in the development,
testing, manufacturing, marketing and sales of Levaquin. Defendants designed,
manufactured,
marketed, and sold Levaquin to medical professionals and their patients, knowing
it would be ingested for the treatment of infections.

109. Levaquin as designed, manufactured, marketed and sold by Defendants reached
Plaintiff without substantial change in its condition and was used by Plaintiff
in a reasonably foreseeable and intended manner.

110. Levaquin was "defective" and "unreasonably dangerous" when it entered the
stream of commerce and was received by Plaintiff, because it was dangerous to an
extent beyond that which would be contemplated by the ordinary consumer. At no
time did Plaintiff have reason to believe that Levaquin were in a condition not
suitable for their proper and intended use among patients.

111. Levaquin was used in the manner for which it was intended, that is, for
treatment of bacterial infections. This use resulted in injury to Plaintiff.

112. Plaintiff was not able to discover, nor could he have discovered through
the exercise of reasonable care, the defective nature of Levaquin. Further, in
no way could Plaintiff have known that Defendants had designed, developed, and
manufactured Levaquin in such a way as to increase the risk of harm or injury to
the recipients of Levaquin.

113. Levaquin is defective in design because of its propensity to cause tendon
ruptures and other serious tendon injuries.

114. Levaquin is unreasonably dangerous because it was sold to Plaintiff without
adequate warnings regarding, inter alia, the propensity of Levaquin to cause
serious tendon injuries; the post-marketing experience with Levaquin; the
increased risk of tendon injury in patients over the age of 60; the numbers of
tendon-related adverse events reported; and the
probability of suffering an acute tendon injury when ingesting corticosteroids
concomitantly with Levaquin or post-Levaquin use.

115. Defendants failed to develop and make available alternative products that
were designed in a safe or safer manner, even though such products were feasible
and marketable at the time Defendants sold Levaquin to Plaintiff.

116. Defendants had knowledge and information confirming the defective and
dangerous nature of Levaquin. Despite this knowledge and information, Defendants
failed to adequately and sufficiently warn Plaintiff and his physicians that
Levaquin causes serious tendon injuries including, without limitation, tendon
rupture.

117. As a direct and proximate result of Defendants' wrongful conduct, including
Levaquin's defective and dangerous design and inadequate warnings, Plaintiff has
sustained and will continue to sustain severe and debilitating injuries,
economic loss, and other damages including, but not limited to, cost of medical
care, rehabilitation, lost income, permanent instability and loss of balance,
immobility, and pain and suffering, for which he is entitled to compensatory and
equitable damages and declaratory relief in an amount to be proven at trial.

VII. SECOND CAUSE OF ACTION NEGLIGENCE

118. Plaintiff incorporates by reference of all other paragraphs of this
Complaint as if fully set forth herein and further alleges as follows:

119. At all relevant times, Defendants had a duty to exercise reasonable care in
the design, formulation, testing, manufacture, marketing, sale, and distribution
of Levaquin, including a duty to ensure that Levaquin did not pose a
significantly increased risk of bodily injury to its users.

120. Defendants had a duty to exercise reasonable care in the advertising and
sale of Levaquin, including a duty to warn Plaintiff and other consumers, of the
dangers associated with the consumption of Levaquin that were known or should
have been known to Defendants at the time of the sale of Levaquin to the
Plaintiff.

121. Defendants failed to exercise reasonable care in the design, testing,
manufacture, marketing, sale and distribution of Levaquin because Defendants
knew or should have known that Levaquin had a propensity to cause serious
injury, including tendon rupture and other serious tendon injuries.

122. Defendants failed to exercise ordinary care in the labeling of Levaquin and
failed to issue adequate pre-marketing or post-marketing warnings to prescribing
doctors and the general public regarding the risk of serious injury, including,
without limitation, tendon rupture.

123. Defendants knew or should have known that Plaintiff could foreseeably
suffer injury as a result of Defendants' failure to exercise ordinary care as
described above.

124. Defendants breached their duty of reasonable care to Plaintiff by failing
to exercise due care under the circumstances.

125. As a direct and proximate result of Defendants' acts and omissions,
including their failure to exercise ordinary care in the design, formulation,
testing, manufacture, sale, and distribution of Levaquin, Plaintiff ingested
Levaquin and suffered severe and debilitating injuries, economic loss, and other
damages, including but not limited to, cost of medical care, rehabilitation,
lost income, permanent instability and loss of balance, immobility, and pain and
suffering, for which they are entitled to compensatory and equitable damages and
declaratory relief in an amount to be proven at trial.

VIII. THIRD CAUSE OF ACTION BREACH OF IMPLIED WARRANTIES

126. Plaintiff incorporates by reference of all other paragraphs of this
Complaint as if fully set forth herein and further alleges as follows:

127. Defendants designed, formulated, tested, manufactured, marketed, sold, and
distributed Levaquin as has previously been alleged and described herein.

128. At the time Defendants marketed, sold and distributed Levaquin, Defendants
knew of the use for which Levaquin was intended and impliedly warranted that
Levaquin was merchantable, safe and fit for its intended purpose: namely that
Plaintiff could ingest Levaquin without the risk of serious injury.

129. Plaintiff, foreseeable users of Levaquin, and Plaintiffs' physician(s),
reasonably relied upon Defendants' judgment and implied warranties in purchasing
and consuming Levaquin as intended.

130. Levaquin was defective, unmerchantable, and unfit for ordinary use when
sold, and subjected Plaintiff to severe and permanent injuries.

131. Defendants breached their implied warranties because Levaquin was and
continues to be neither of merchantable quality nor safe for its intended use in
that Levaquin has the propensity to cause tendon rupture, other debilitating
tendon injuries, and bodily harm.

132. As a direct and proximate result of Defendants' breach of the implied
warranties of merchantability and fitness for its intended purpose, Plaintiff
ingested Levaquin and suffered severe and debilitating injuries, economic loss,
and other damages, including but not limited to, cost of medical care,
rehabilitation, lost income, permanent instability and loss of balance,
immobility, and pain and suffering, for which they are entitled to compensatory
and equitable damages in an amount to be proven at trial.

IX. FOURTH CAUSE OF ACTION BREACH OF EXPRESS WARRANTY

133. Plaintiff incorporates by reference of all other paragraphs of this
Complaint as if fully set forth herein and further alleges as follows:

134. Defendants through their marketing program, promotional activities, product
labeling, package inserts, and other written and verbal assurances expressly
warranted to physicians and consumers, including Plaintiff and/or his
physicians, that Levaquin had been shown by scientific study to be safe for its
intended use.

135. Plaintiff, and/or his physicians, reasonably relied upon Defendants'
express warranties in purchasing consuming, and prescribing Levaquin.

136. Defendants breached their express warranties because Levaquin as
manufactured and sold by Defendants does not conform to these express
representations in that Levaquin has a propensity to cause tendon rupture, other
serious tendon injuries, and bodily harm.

137. As a direct and proximate result of Defendants' breach of their express
warranties, Plaintiff ingested Levaquin and suffered severe and debilitating
injuries, economic loss, and other damages, including but not limited to, cost
of medical care, rehabilitation, lost income, permanent instability and loss of
balance, immobility, and pain and suffering, for which they are entitled to
compensatory and equitable damages in an amount to be proven at trial.

X. FIFTH CAUSE OF ACTION FRAUD

138. Plaintiff incorporates by reference each and every paragraph of this
Complaint as if fully set forth herein and further allege as follows:

139. Defendants were under a duty and failed to discharge their duty to exercise
reasonable care to disclose to Plaintiff and his doctors the defective nature
and risks that
Levaquin can cause severe and permanent injuries, including, without limitation,
tendon ruptures, of which they had special knowledge not available to Plaintiff
or his doctors, and as to which they made affirmative representations in
violation of all applicable laws, and concealed material facts relating to the
defective nature and risks of Levaquin, which were peculiarly within its
knowledge, knowing that Plaintiff and his doctors would rely on the presumption
that no such facts exist.

140. Defendants knew that Levaquin can cause severe and permanent injuries,
including, without limitation, tendon ruptures; indeed, Defendants knew that
tendon injuries associated with Levaquin had occurred for years. Defendants had
actual knowledge at the time of sale of Levaquin to the Plaintiff that Levaquin
created a risk of serious bodily injury to its users, including, without
limitation, tendon injuries, based, in part, upon test results, studies, adverse
reaction reports, regulatory action in foreign countries, published reports, and
their own clinical trials and post-marketing surveillance of Levaquin and its
molecularly similar counterpart, ofloxacin.

141. At all times during the course of dealing between Defendants and Plaintiff,
Defendants knowingly and recklessly omitted and concealed information peculiarly
within their knowledge to the Plaintiff, his doctors, the scientific community
and to the general public - e.g., the dangers of Levaquin, including the special
risk of tendon injury and tendon ruptures, particularly to the elderly - knowing
that the scientific community, the general public, the Plaintiff and his
doctors, would rely on the presumption that the dangers did not exist.

142. Defendants actively concealed from the Plaintiff, his doctors, the
scientific community and the general public:
i. that their own test results, published studies, and/or clinical trials showed
a statistically high risk of serious tendon injuries associated with Levaquin
including, without limitation, tendon ruptures; and/or
ii. that Levaquin was not adequately tested for serious tendon injuries before
or after its introduction on the market; and/or
iii. that Levaquin was, in fact, unsafe as it posed a risk of injury which
outweighed any purported benefits.

143. Defendants misrepresented that Levaquin was safe and effective for its
intended uses by affirmative misrepresentation, and/or actively concealment and
omission of material facts regarding the safety and effectiveness of Levaquin,
and by their course of conscious or intentional conduct succeeded in selling and
marketing dangerous, defective, and ineffective antibiotics to be ingested by
Plaintiff. Defendants intentionally omitted, concealed and/or suppressed this
information from consumers, including Plaintiff and his doctors, in order to
avoid losses in sales to consumers and market share to its major competitors.

144. Moreover, Defendants engaged in an aggressive marketing strategy, which
included false representations regarding the safety profile and known adverse
side effects of Levaquin to create the impression and to convey to Plaintiff and
the general public that:
i. Levaquin had a favorable safety profile and was fit for human consumption;
ii. the benefits of taking Levaquin outweighed any associated risks; and
iii. the use of Levaquin was safe and had fewer adverse health and side effects
than were known or should have been known by Defendants at the time of these
representations.

145. The omissions, misrepresentations and concealment described in the
preceding paragraphs occurred, without limitation, in the Levaquin warning
labels, advertisements and promotional materials, in the Johnson & Johnson
funded or created scientific reports, and the failure to provide other special
notification of the dangers of Levaquin to the Plaintiff or his physicians, for
example, Dear Doctor letters. The Defendants' statements omitted, concealed, and
misrepresented the dangers of serious injury, including, but not limited to,
tendon ruptures, particularly to the elderly, to Plaintiff and his prescribing
doctors.

146. Defendants engaged in fraud by deliberately and affirmatively concealing
and failing to disclose adverse reactions of Levaquin to Plaintiff, his doctors,
the scientific community, and the general public, and by disseminating only
positive and misleading scientific data, and by concealing scientific data that
showed increased risk of tendon-related injury, to Plaintiff, his doctors, the
scientific community, and the general public.

147. Plaintiff ********and his physician(s) relied on the warning labels as they
appeared in the patient package insert at the time they prescribed or consumed
Levaquin. The applicable warnings concealed and omitted material facts relating
to the defective nature and risks of Levaquin. These dangers were peculiarly
within the Defendants' knowledge, and were omitted and concealed knowing that
Plaintiff and his doctors would rely on the presumption that no such facts
exist.

148. Defendants knew or should have known that their representations and
omissions regarding the safety of Levaquin were, in fact, false and/or
misleading, and actively made such representations and omissions with the
intent, design, and purpose that Plaintiff and others, including prescribing
physicians, rely on these representations leading to the prescription, purchase
and consumption of Levaquin.

149. At all times herein, Plaintiff and his physicians were unaware of the
dangers of Levaquin with respect to tendon ruptures, including the special risk
of tendon injury to the elderly, and were reasonably misled by the Defendants'
omission of information about this danger.

150. At all times herein, Plaintiff and his physicians were unaware of the
falsity underlying Defendants' statements and reasonably believed Defendants'
false statements about the safety and efficacy of Levaquin to be true.

151. Plaintiff and his doctors could not have discovered Defendants' fraudulent
and misleading conduct at an earlier date through the exercise of reasonable
diligence because Defendants actively concealed their deceptive, misleading and
unlawful activities.

152. Plaintiff and his physicians did, and could be expected to, reasonably and
justifiably rely on Defendants' representations and omissions because Defendants
held themselves out as having expertise and specialized knowledge in the
pharmaceutical industry.

153. Plaintiff justifiably relied upon to his detriment and/or were induced by
Defendants' false statements and active concealment over the safety of Levaquin,
in part, because at no time did Plaintiff or his physicians have the knowledge
or expertise necessary to independently evaluate the safety of Levaquin.

154. Defendants' misrepresentations, concealment, suppression and omissions were
made willfully, wantonly, uniformly, deliberately, or recklessly, in order to
induce Plaintiff to purchase Levaquin and Plaintiff and his physicians did
reasonably and justifiably rely upon the material misrepresentations and
missions made by the Defendants about Levaquin when agreeing to purchase and/or
ingest Levaquin.

155. As a direct and proximate result of Defendants' false representations
and/or active concealment of material facts regarding the safety and efficacy of
Levaquin, Plaintiff ingested Levaquin and suffered severe and debilitating
injuries and economic loss, including but not limited to, cost of medical care,
rehabilitation, lost income, permanent instability and loss of balance,
immobility, and pain and suffering in an amount to be proven at trial.

XI. SIXTH CAUSE OF ACTION VIOLATION OF UNFAIR AND DECEPTIVE TRADE PRACTICES ACTS

156. Plaintiff incorporates by reference of each and every paragraph of this
Complaint as if fully set forth herein and further allege as follows:

157. Defendants have a statutory duty to refrain from unfair or deceptive acts
or trade practices in the design, development, manufacture, promotion, and sale
of Levaquin.

158. Had the Defendants not engaged in the deceptive conduct described above,
Plaintiff would not have purchased and/or paid for Levaquin, and would not have
incurred related medical costs.

159. Specifically, Plaintiff and his physician(s) were misled by the deceptive
conduct described above.

160. Defendants' deceptive, unconscionable, or fraudulent representations and
material omissions to
patients, physicians and consumers, including Plaintiff, constituted unfair and
deceptive acts and trade practices in violation of the state consumer protection
statutes listed below.

161. Defendants engaged in wrongful conduct while at the same time obtaining,
under false pretenses, substantial sums of money from Plaintiff for Levaquin
that they would not have paid had Defendants not engaged in unfair and deceptive
conduct.

162. Defendants' actions, as complained of herein, constitute unfair competition
or unfair, unconscionable, deceptive, or fraudulent acts or trade practices in
violation of state consumer protection statutes, as listed below:
i. Defendants have engaged in unfair competition or unfair or deceptive acts or
trade practices in violation of Minn. Stat. Ann. § 325D.13 and § 325D.44 et
seq.;
ii. Defendants have engaged in unfair competition or unfair or deceptive acts or
trade practices in violation of Pennsylvania's Unfair Trade Practices and
Consumer Protection Law (73 P.S. §§ 201-1 et seq.).

163. Plaintiff was injured by the cumulative and indivisible nature of
Defendants' conduct. The cumulative effect of Defendants' conduct directed at
patients, physicians and consumers was to create a demand for and sell Levaquin.
Each aspect of Defendants' conduct combined to artificially create sales of
Levaquin.

164. The medical community relied upon Defendants' misrepresentations and
omissions in determining which antibiotic to utilize.

165. By reason of the unlawful acts engaged in by Defendants, Plaintiff has
suffered ascertainable loss and damages.

166. As a direct and proximate result of Defendants' wrongful conduct, Plaintiff
was damaged by paying in whole or in part for Levaquin.

167. As a direct and proximate result of Defendants' violations of state
consumer protection statutes, Plaintiff has sustained economic losses and other
damages for which they are entitled to statutory and compensatory damages, and
declaratory relief, in an amount to be proven at trial.

XII. SEVENTH CAUSE OF ACTION VIOLATION OF MINNESOTA'S CONSUMER FRAUD ACT
MINN.STAT. § 325F.69

168. Plaintiff incorporates by reference each and every paragraph of this
Complaint as if fully set forth herein and further alleges as follows:

169. Defendants acted, used, and/or employed fraud, false pretense, false
promise, misrepresentation, misleading statements and/or deceptive practices,
concerning the safety, use, efficacy, and testing of Levaquin with the intent
that others, including Plaintiff, rely upon those false and deceptive acts in
determining whether to use Levaquin.

170. In its marketing, direct-to-consumer advertising, promotion, sale, and
distribution of Levaquin, Defendants knowingly, unfairly, and deceptively
promised and represented that Levaquin is a safe and effective antibiotic while
failing to disclose the known properties, ingredients, characteristics,
qualities and risks associated with Levaquin when the Defendants had actual
knowledge or should have known of the serious adverse health effects associated
with Levaquin, including but not limited to, tendon ruptures.

171. Defendants made such misrepresentations and omissions of material fact with
the intent, design, and purpose that consumers, including Plaintiff, rely on
such representations in choosing to purchase Levaquin.

172. As a direct and proximate result of Defendants' fraudulent sale and
marketing, Plaintiff ingested Levaquin, and suffered severe and debilitating
injuries and economic loss, including but not limited to, cost of medical care,
rehabilitation, lost income, permanent instability and loss of balance,
immobility, and pain and suffering.

XIII. EIGHTH CAUSE OF ACTION VIOLATION OF PENNSYLVANIA'S UNFAIR TRADE
PRACTICES AND CONSUMER PROTECTION LAW 73 P.S. § 201-1

173. Plaintiff incorporates by reference each and every paragraph of this
Complaint as if fully set forth herein and further alleges as follows:

174. Defendants knowingly misrepresented Levaquin as a safe and effective
antibiotic and knowingly made false statements and omissions of material fact
concerning the properties, ingredients, characteristics, qualities, benefits,
uses, efficacy, safety, and/or testing of Levaquin to the Plaintiff and the
general public.

175. In its labeling, marketing, direct-to-consumer advertising, promotion,
sale, and distribution of Levaquin, Defendants made untrue, deceptive, and/or
misleading material assertions, representations, and/or statements downplaying
risks associated with Levaquin and exaggerating the drug's safety to Plaintiff
and the general public when Defendants had actual knowledge of the serious,
adverse health effects associated with Levaquin including, but not limited to,
tendon ruptures.

176. Defendants intended to increase the sale and consumption of Levaquin by
falsely marketing Levaquin as safe and effective, and by concealing facts
regarding the dangerous properties of Levaquin, to thereby induce Plaintiff's
physicians to prescribe Levaquin and to ultimately cause Plaintiff to purchase
and consume Levaquin.

177. In purchasing and consuming Levaquin, Plaintiff reasonably relied upon
Defendants' false and misleading assertions and omissions of material fact that
Levaquin was safe and effective for the treatment their illness.

178. Defendants' actions as described herein constitute unlawful, unfair, and
deceptive trade practices within the meaning of Pennsylvania's Unfair Trade
Practices & Consumer Protection Law §§ 201-1, et seq.

179. As a direct and proximate result of Defendants' false statements as herein
alleged, Plaintiff ingested Levaquin and suffered severe and debilitating
injuries and economic loss, including but not limited to, cost of medical care,
rehabilitation, lost income, permanent instability and loss of balance,
immobility, and pain and suffering.

XIV. NINTH CAUSE OF ACTION VIOLATION OF MINNESOTA'S FALSE ADVERTISING ACT
MINN. STAT. § 325F.67

180. Plaintiff incorporates by reference each and every paragraph of this
Complaint as if fully set forth herein and further alleges as follows:

181. Defendants knowingly misrepresented Levaquin as a safe and effective
antibiotic and knowingly made false statements and omissions of material fact
concerning the properties, ingredients, characteristics, qualities, benefits,
uses, efficacy, safety, and/or testing of Levaquin to the Plaintiff and the
general public.

182. In its labeling, marketing, direct-to-consumer advertising, promotion,
sale, and distribution of Levaquin, Defendants made untrue, deceptive, and/or
misleading material assertions, representations, and/or statements downplaying
risks associated with Levaquin and exaggerating the drug's safety to Plaintiff
and the general public when Defendants had actual knowledge of the serious,
adverse health effects associated with Levaquin including, but not limited to,
tendon ruptures.

183. Defendants intended to increase the sale and consumption of Levaquin by
falsely marketing Levaquin as safe and effective, and by concealing facts
regarding the dangerous properties of Levaquin, to thereby induce Plaintiff's
physicians to prescribe Levaquin and to ultimately cause Plaintiff to purchase
and consume Levaquin.

184. In purchasing and consuming Levaquin, Plaintiff reasonably relied upon
Defendants' false and misleading assertions and omissions of material fact that
Levaquin was safe and effective for the treatment their illness.

185. Defendants' actions as described herein constitute unlawful, unfair, and
deceptive trade practices within the meaning of Minn. Stat § 325F.67.

186. As a direct and proximate result of Defendants' false statements as herein
alleged, Plaintiff ingested Levaquin and suffered severe and debilitating
injuries and economic loss, including but not limited to, cost of medical care,
rehabilitation, lost income, permanent instability and loss of balance,
immobility, and pain and suffering.

XV. TENTH CAUSE OF ACTION UNJUST ENRICHMENT

187. Plaintiff incorporates by reference of each and every paragraph of this
Complaint as if fully set forth herein and further allege as follows:

188. As the intended and expected result of their conscious wrongdoing,
Defendants have profited and benefited from the purchase and implementation of
Levaquin by Plaintiff.

189. Defendants have voluntarily accepted and retained those profits and
benefits, derived from Plaintiff, with full knowledge and awareness that, as a
result of Defendants' fraud and other conscious and intentional wrongdoing,
Plaintiff was not receiving a product of the quality, nature, or fitness that
had been represented by Defendants, or that Plaintiff, as a reasonable consumer,
expected to receive.

190. By virtue of the conscious wrongdoing alleged above, Defendants have been
unjustly enriched at the expense of Plaintiff, who is entitled in equity, and
hereby seek, the disgorgement and restitution of Defendants' wrongful profits,
revenues and benefits, to the
extent and in the amount deemed appropriate by the Court; and such other relief
as the Court deems just and proper to remedy Defendants' unjust enrichment.

WHEREFORE, Plaintiff prays for relief against Defendants, jointly and severally,
as follows:

1. Compensatory damages, in excess of the amount required for federal diversity
jurisdiction, and in an amount to fully compensate Plaintiffs for all of their
injuries and damages, both past and present;

2. Special damages, in excess of the amount required for federal diversity
jurisdiction and in an amount to fully compensate Plaintiffs for all of their
injuries and damages, both past and present, including but not limited to, past
and future medical expenses, costs for past and future rehabilitation and/or
home health care, lost income, permanent disability, including permanent
instability and loss of balance, and pain and suffering.

4. Double or triple damages as allowed by law;

5. Attorneys' fees, expenses, and costs of this action;

6. Pre-judgment and post-judgment interest in the maximum amount allowed by law;
and

7. Such further relief as this Court deems necessary, just, and proper.

JURY DEMAND

Plaintiff demands a trial by jury of all claims asserted in this Complaint.

Respectfully submitted,
ATTORNEYS FOR PLAINTIFF
Dated: April 8, 2009
 




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