Dangerous Drugs: News About Lawyers, Lawsuits, & Drugs Like Fentanyl, Reglan, and Phospho-soda

Yaz Lawyers List Yaz Side Effects in Lawsuit

The following Yaz lawsuit was filed in the Southern District of Ohio in May of 2009:

39. Yasmin, (a predecessor to YAZ), known generically as drospirenone and ethinyl estradiol, is a combination birth control pill originally developed by Defendant BERLEX LABORATORIES, INC. and/or Defendant BERLEX, INC containing the hormones estrogen and progestin.

40. The estrogen is ethinyl estradiol and the progestin is drospirenone, (3 mg of drospirenone and 0.03 mg of ethinyl estradiol per tablet).

41. Combination birth control pills are referred to as combined hormonal oral contraceptives.

42. Yasmin was approved by the FDA in April, 2001.

43. In 2006, Bayer acquired Defendant BERLEX LABORATORIES, INC. and/or Defendant BERLEX, INC, and began marketing an almost identical drug, YAZ (which contains 3 mg of drospirenone and 0.02 mg of ethinyl estradiol per tablet).

44. The difference between YAZ/ Yasmin and other birth control pills on the market is that drospirenone has never before been marketed in the United States and is unlike other progestins available in the United States.

45. YAZ/ YASMIN's use of drospirenone, a diuretic, creates unique risks for compared to other oral contraceptives and is known to cause problems with the gallbladder that may require surgical intervention.

46. Defendants have been warned at least three times by the FDA; in 2003, 2008 and 2009, for misleading the public through the use of ads which overstate the efficacy of YAZ and/or its predecessor Yasmin, and minimize serious risks associated with the drug.

47. Defendants ignored the correlation between the use of YAZ and significantly increased risk of gallbladder complications despite the wealth of scientific information available.

48. Defendants knew or should have known about the correlation between the use of YAZ and significantly increased risk of gallbladder complications and still promoted, sold, advertised, and marketed the use of YAZ.

49. Defendants falsely and fraudulently represented to the medical and healthcare community, to Plaintiff, the FDA, and the public in general, that YAZ had been tested and was found to be safe and/or effective for its indicated use.

50. These false representations were made by Defendants with the intent of defrauding and deceiving Plaintiff, the public in general, and the medical and healthcare community in particular, and were made with the intent of inducing the public in general, and the medical and healthcare community in particular, to recommend, dispense and/or purchase YAZ for use as a contraceptive, all of which
evinced a callous, reckless, willful, depraved indifference to the health, safety and welfare of Plaintiff.

51. Defendants knew and were aware or should have been aware that YAZ had not been sufficiently tested, was defective in its design and testing, and/or that it lacked adequate and/or sufficient warnings.

52. Defendants knew or should have known that YAZ had a potential to, could, and would cause severe and grievous injury and death to the users of said product, and that it was inherently dangerous in a manner that exceeded any purported, inaccurate, and/or down-played warnings.

53. In representations to Plaintiff, her healthcare providers, and/or the FDA, Defendants also fraudulently concealed and intentionally omitted the following material information:

A. That YAZ is not as safe as other available contraceptives;

B. That the risks of adverse events with YAZ (drospirenone and ethinyl estradiol) was higher than those of other available contraceptives;

C. That the risks of adverse events with YAZ was not adequately tested and/or known by Defendants;

D. Plaintiff was put at risk of experiencing serious and dangerous side effects including, but not limited to, gallbladder complications, as well as other severe and personal injuries, physical pain, and mental anguish;

E. That patients needed to be monitored more regularly than normal while using YAZ ; and

F. That YAZ was designed, tested, manufactured, marketed, produced, distributed and advertised negligently, defectively, fraudulently and improperly.

54. Defendants were under a duty to disclose to Plaintiff and her physicians, hospitals, healthcare providers and/or the FDA the defective nature of YAZ.

55. Defendants had sole access to material facts concerning the defective nature of the product and its propensity to cause serious and dangerous side effects, and hence, cause damage to person who used YAZ, including Plaintiff.

56. Defendants made the misrepresentations and/or actively concealed information concerning the safety and efficacy of YAZ with the intention and specific desire that the medical, pharmaceutical and/or scientific communities, and users and/or consumers of the drug, including Plaintiff, would rely on such in selecting YAZ as a contraceptive.

57. Defendants made these misrepresentations and/or actively concealed information concerning the safety and efficacy of YAZ in their labeling, advertising, product inserts, promotional material or other marketing efforts.

58. The misrepresentations of and/or active concealment by Defendants were perpetuated directly and/or indirectly by Defendants, its sales representative, employees, distributors, agents and/or detail persons.

59. Defendants knew that Plaintiff, her healthcare providers, and/or the FDA had no way to determine the truth behind Defendants' concealment and omissions, and that these included material omissions of facts surrounding YAZ, as set forth herein.

60. The misrepresentations of and/or active concealment by Defendants constitute a continuing tort. Indeed, through Defendants' product inserts, Defendants continue to misrepresent the potential risks and serious side effects associated with the use of YAZ.

61. Moreover, Defendants had a post-sale duty to warn the medical, pharmaceutical and/or scientific communities, and users and/or consumers of the drug, including Plaintiff, about the potential risks and serious side effects associated with the use of YAZ in a timely manner, yet they failed to provide such warning.

Gadolinium Attorneys Give History of Nephrogenic Systemic Fibrosis In Gadolinium Lawsuit

This lawsuit was filed in February of 2009 and gives an excellent history of NSF:

26. This is a personal injury claim relating to Eric Jenkins' development of, and subsequent death from, Nephrogenic Systemic Fibrosis ("NSF"), also known as Nephrogenic Fibrosing Dermopathy ("NFD").

27. NSF/NFD develops only in patients with renal insufficiency, such as Eric Jenkins, who have been given an injection of a gadolinium-based contrast agent such as Magnevist, Omniscan, OptiMARK, and/or upon information and belief, MultiHance and/or ProHance.

28. NSF/NFD is predominantly characterized by discoloration, thickening, tightening, and swelling of the skin within weeks after receiving a gadolinium -based contrast injection such as Magnevist, Omiscan, OptiMARK and/or upon information and belief, MultiHance and/or ProHance.

29. These symptoms can occur weeks or months after a person is administered these dyes.

30. These fibrotic and edematous changes produce muscular weakness and inhibit flexion and extension of joints, resulting in painful and disfiguring contractures.

31. NSF/NFD often progresses to painful inhibition of the ability to use the arms, legs, hands, feet, and other joints.

32. The skin changes that begin as darkened patches or plaques progress to a "woody" texture, and are accompanied by burning, itching, or severe pain in the areas of involvement.

33. NSF/NFD also progresses to a fibrotic or scarring condition of other body organs such as the lungs, heart, liver, and musculature, and that can inhibit their ability to function properly and may lead to death.

34. NSF/NFD is a progressive disease for which there is no known cure.

35. NSF/NFD has been reported in medical literature since 2000.

36. It has always been the case that this clinical entity now known as NSF/NFD develops in patients with renal insufficiency, who have been given an injection of gadolinium-based contrast agent such as Omniscan, Magnevist, OptiMARK, MultiHance, and/or ProHance.

Yasmin Lawyers File Yasmin Lawsuit in California

This Yasmin lawsuit was filed in March of 2009 in the Northern District of California:

21. Yasmin, known generically as drospirenone and ethinyl estradiol, is a combination birth control pill containing the hormones estrogen and progestin and was approved by the FDA in April 2001. In the case of Yasmin, the estrogen is ethinyl estradiol and the progestin is drospirenone.

22. Yasmin is indicated for the prevention of pregnancy in women who elect to use an oral contraceptive.

23. Combination birth control pills are referred to as combined hormonal oral contraceptives.

24. The difference between Yasmin and other birth control pills on the market is that drospirenone has never before been marketed in the United States and is unlike other progestins available in the United States.

25. In April 2002, the British Medical Journal reported that the Dutch College of General Practitioners recommended that older second generation birth control pills be prescribed in lieu of Yasmin as a result of 40 cases of venous thrombosis among women taking Yasmin.

26. In February 2003, a paper entitled Thromboembolism associated with the newly contraceptive Yasmin was published in the British Medical Journal detailing a Netherlands Pharmacovigilance Centre report of five additional reports of thromboembolism where Yasmin was suspected as the cause, including two deaths.

27. Defendants have twice been warned by the FDA, in 2003 and 2008, for misleading the public through the use of television ads which overstate the efficacy of Yasmin and minimize serious risks associated with the drug.

28. The use of Yasmin has a prothrombotic effect resulting in thrombosis such as the pulmonary embolism suffered by Plaintiff.

29. Defendants failed or neglected to recognize the correlation between the use of Yasmin and increased thrombosis formation despite the wealth of scientific information available.

30. Upon information and belief, Defendants knew or should have known about the correlation between Yasmin use and a prothrombotic effect and still promoted, sold, advertised, and marketed the use of Yasmin.

31. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of Yasmin to Plaintiff herein, Plaintiff was prescribed with and ingested Yasmin, sustaining severe and permanent personal injuries, to wit: pulmonary embolism and all resulting damages, including the potential for future thrombembolic events.

Yaz Attorneys File Lawsuit Against Makers of Yaz and Yasmin

This lawsuit was filed in May of 2009, and explains some of the risks associated with taking Yaz or Yasmin.

15. YASMIN received FDA approval first in 2001. It is a combination of drospirenone, a progestin, and ethinyl estradiol, an estrogen.

16. YAZ received approval from the FDA in 2006 and is essentially the same as YASMIN, with the only difference being a slightly smaller amount of ethinyl estradiol.

17. YAZ and YASMIN are indicated for the prevention of pregnancy in women who elect to use an oral contraceptive.

18. Combination birth control pills are referred to as combined hormonal oral contraceptives.

19. The difference between YAZ and other birth control pills on the market is that drospirenone has never before been marketed in the United States and is unlike other progestins available in the United States.

20. In April 2002, the British Medical Journal reported that the Dutch College of General Practitioners recommended that older second generation birth control pills be prescribed in lieu of YASMIN as a result of 40 cases of venous thrombosis among women taking YAZ/YASMIN.

21. In February 2003, a paper entitled Thromboembolism associated with the new contraceptive YAZ/YASMIN was published in the British Medical Journal detailing a Netherlands Pharmacovigilance Centre report of additional reports of thromboembolism where YAZ/YASMIN was suspected as the cause, including two deaths.

22. Defendants have twice been warned by the FDA, in 2003 and 2008, for misleading the public through the use of television advertisements which overstate the efficacy of the drugs and minimize the serious risks associated with the drugs.

23. The use of YAZ/YASMIN has a prothrombotic effect resulting in the development of thromboses, such as pulmonary emboli and deep vein thrombosis.

24. Defendants failed to recognize the correlation between the use of YAZ/YASMIN and increased thrombosis formation despite the wealth of scientific information available.

25. Upon information and belief, Defendants knew or should have known about the correlation between YAZ/YASMIN use and a prothrombotic effect and still promoted, sold, advertised, and marketed the use of YAZ/YASMIN without sufficient warnings.

26. YAZ/YASMIN use of drospirenone, a diuretic, creates unique risks for compared to other oral contraceptives. These risks include heart arrhythmias, myocardial infarction, and other adverse cardiovascular events, including sudden death.

27. The diuretic in YAZ/YASMIN is also known to cause problems with the gallbladder; the problems sometimes require surgical intervention. The diuretic also causes kidney stone formation.

Gadolinium Lawyers Sue Makers of Omniscan and Magnevist, Alleging They Cause NSF

This Gadolinium lawsuit was filed in December of 2008 against the makers of a variety of MRI contrast dies that contain the paramagnetic metal Gadolinium:

47. Omniscan is an injectable paramagnetic contrast agent for magnetic resonance imaging and arteriography. It contains the metal gadolinium, which is highly toxic in its free state. Omniscan, the chemical name of which is gadolinium diethylenetriamine pentaacetic acid bismethylamide (gadodiamide), is represented by the GE Defendants to be safely and effectively indicated for intravenous administration to facilitate the visualization of lesions with abnormal
vascularity.

48. Omniscan is cleared from the body solely by glomerular filtration in the kidneys. As a result, it has a prolonged half-life in patients with renal insufficiency and who, therefore, are at increased risk for adverse health effects in connection with Omniscan administration.

49. Omniscan was originally developed by Salutar, Inc., which then conducted pre-clinical testing with Sterling Winthrop and Daiichi Pharmaceuticals. Salutar was subsequently acquired by Nycomed. In 1994, Nycomed acquired Sterling Winthrop's diagnostic imaging business.

50. In 1997, Nycomed acquired Amersham International plc, and the new company was named Amersham plc, which then held the rights to Omniscan.

51. In 2004, General Electric Company acquired Amersham plc and the rights to Omniscan. At the time of the acquisition, Amersham plc was the ultimate parent company of Amersham Health AS, which manufactured the Omniscan that was distributed and sold in the United States, and Amersham Health Inc., which distributed and sold Omniscan in the United States. In 2006, Amersham Health AS was renamed GE Healthcare AS, and Amersham Health, Inc. was renamed GE Healthcare Inc.

52. Defendants General Electric Company, GE Healthcare AS, and GE Healthcare, Inc. re corporate successors to Amersham plc and its related entities and, as such, are obligated for heir predecessor's liabilities. Amersham plc, either itself or by and through its subsidiaries, was ngaged in the business of designing, developing, manufacturing, testing, packaging, promoting, marketing, distributing, labeling,
and/or selling directly and indirectly through third parties or related entities, the drug Omniscan.

53. Magnevist is an injectable paramagnetic contrast agent used for magnetic resonance imaging and arteriography. It contains the metal gadolinium, which is highly toxic in its free state. Magnevist, the chemical name of which is gadopentetate dimeglumine, was represented by the Bayer Defendants to be safely and effectively indicated for intravenous administration to facilitate the visualization of cranial and spinal anatomy as well as tumors, lesions, and immediately adjacent areas. Magnevist was further represented by the Bayer Defendants to be superior to two of their competitors (Omniscan and Optimark) in its thermodynamic and conditional stability, its low volume of excess chelate and its ability to prevent the release of gadolinium.

54. Optimark is an injectable paramagnetic contrast agent used for magnetic resonance imaging and arteriography. It contains the metal gadolinium, which is highly toxic in its free state. Optimark, the chemical name of which is gadolinium diethylenetriamine pentaacetic acid bismethoxyethylamide (gadoversetamide), is represented by Defendant Mallinckrodt to be safely and effectively indicated for
intravenous administration to facilitate the visualization of lesions with abnormal vascularity.

55. Upon information and belief, ProHance is an injectable paramagnetic contrast agent for magnetic resonance imaging and arteriography. It contains the metal gadolinium, which is highly toxic in its free state. Upon information and belief, ProHance was represented by the Bracco Defendants to be safely and effectively indicated for intravenous administration to facilitate visualization of lesions with abnormal blood brain barrier or abnormal vascularity of the brain, spine, and associated tissues.

56. At all times relevant hereto, the Defendants knew, or should have known, about the significant health risk of their products' administration to patients with renal insufficiency, including, but not limited to, the risk of nephrogenic fibrosis in the skin and other body organs. At all times relevant hereto, Defendants knew, or should have known, that in its free state, gadolinium is highly toxic, harmful and dangerous to humans, and causes severe physical injury and knew, or should have known, of the need to prevent the gadolinium contained in its product from becoming free in the body of humans injected with Omniscan, Magnevist, OptiMark, and/or, upon information and belief, ProHance and/or MultiHance, through the use of, among other things, proper design, testing, and
manufacturing.

Gadolinium Lawyers File Nephrogenic Systemic Fibrosis (NSF) lawsuit

This lawsuit was filed in November of 2008 and alleges that Scott Smiley died after contracting NSF:

8. At all times relevant hereto, Defendants knew or should have known about the significant risk of gadolinium-based contrast agents administered to patients with renal insufficiency, including but not limited to the risk of NSF/NFD in the skin and other body organs.

9. NSF/NFD has been reported in medical literature for at least the last decade.

10. Prior to a decade ago, the group of symptoms now known as NSF/NFD had been variously described as scleromyxedema, scleroderma, or other connective tissue diseases. Regardless of the name ascribed to it, however, it has always been the case that this clinical entity now known as NSF/NFD develops only in patients with renal insufficiency who have been given an injection of gadolinium-type contrast agent.

11. NSF/NFD is predominantly characterized by discoloration, thickening, tightening, and swelling of the skin within days or weeks after receiving a gadolinium-based contrast injection. These fibrotic and edematous changes produce muscular weakness and inhibit flexion and extension of joints, resulting in contractures. NSF/NFD often progresses to painful inhibition of the ability to use the arms, legs, hands, feet, and other joints. The skin changes that begin as darkened patches or plaques progress to a "woody" texture and are accompanied by burning, itching, or severe pain in the areas of involvement. NSF/NFD also progresses to a fibrotic or scarring condition of other body organs such as the lungs, heart, liver, and musculature. This scarring can inhibit the ability of body organs to function properly and may lead to death. NSF/NFD is a progressive disease as to which there is no known cure.

12. NSF/NFD has been reported thus far only in people whose kidney function was compromised at the time of injection with gadolinium containing contrast solution.

13. NSF/NFD did not exist until gadolinium containing contrast solutions came into use for enhancing MRI and MRA scans.

14. At all times relevant hereto, Defendants and/or their corporate predecessors knew or should have known about the significant health risk of their gadolinium -based magnetic resonance contrast media being administered to patients with renal insufficiency, including but not limited to the risk of nephrogenic fibrosis in the skin and other body organs.

15. Defendants and/or their corporate predecessors consistently failed to warn consumers and/or their health care providers that NSF/NFD could result when their gadolinium-based magnetic resonance contrast media products were administered to patients with renal insufficiency.

16. During the years that Defendants and/or their corporate predecessors manufactured, marketed, and sold their respective gadolinium-based magnetic resonance contrast media products, there were numerous case reports, studies, assessments, papers, and other clinical data that have described and/or demonstrated NSF/NFD in connection with the use of certain gadolinium-based contrast agents, including Defendants' and/or their corporate predecessors'
gadolinium-based magnetic resonance contrast media products. Despite this, Defendants and/or their corporate predecessors repeatedly failed to adequately revise their package inserts, Material Safety Data Sheets, and other product-related literature, and to conduct appropriate post-marketing communications in order to convey adequate warnings.

17. Defendants and/or their corporate predecessors repeatedly and consistently failed to advise consumers and/or their health care providers of the causal relationship between their gadolinium-based magnetic resonance contrast media and NSF/NFD in patients with renal insufficiency.

18. Defendants and/or their corporate predecessors failed to take prompt, reasonable, and effective measures to alert the appropriate members of the health care community and its patients, including but not limited to renal patients, nephrologists and other physicians, radiologists, administrators, technicians, and hospital/radiology supply personnel, to the serious adverse health risks presented by administration of their gadolinium-based magnetic resonance contrast media.

Yaz Lawsuit Filed In Illinois Discussed History of Yaz and Yasmin

The following Yaz lawsuit was filed in August of 2008 in the U.S. District Court for the Southern District of Illinois:

13. Yaz and Yasmin are birth control pills manufactured and marketed by 
Defendants. They are combination oral contraceptives, or "COCs," meaning that they
contain an estrogen component and a progestin component. Together, these steroidal
components work together in COCs to suppress ovulation, fertilization, and implantation and thus prevent pregnancy.

14. Yaz and Yasmin were approved by the Food and Drug Administration for marketing
in 2006 and 2001, respectively.

 15. The estrogen component in Yaz/ Yasmin is known generically as ethinyl estradiol. The progestin component is known as drospirenone. Yasmin contains 0.03 milligrams of ethinyl estradiol, and Yaz contains 0.02 milligrams of ethinyl estradiol. Both products contain 3 milligrams of drospirenone.

16. Yaz and Yasmin are different from other combined hormonal birth control pills in that they contain drospirenone, a progestin that is unlike other progestins available in the United States and was never before marketed in the United States prior to its use in Yaz/ Yasmin.

17. Shortly after the introduction of combined oral contraceptives in the 1960's, doctors and researchers found that women using birth control pills had a higher risk of blood clots, heart attacks, and strokes than women not using the pill. As a result, the various brands of birth control pills were reformulated to reduce the amounts of estrogen. As the amounts of estrogen levels reduced, so too did the risk of blood clots, heart attacks, and strokes.

18. During this time, new progestins were being developed, which became known as
"second generation" progestins (e.g. lovenorgestrel). These second generation progestins, when combined with the lower amounts of the estrogen, ethinyl estradiol, helped to reduce the risk of blood clots, heart attacks, and strokes and were considered safer for women.

19. During the 1990's, new "third generation" progestins were developed. Unfortunately, these "third generation" progestins (e.g. gestodene and desogestrel) have been associated with a greater risk of blood clots in the deep veins (deep vein thrombosis or "DVT") and lungs (Pulmonary Embolismsm or "PE"). As a result of this increased risk of blood clots, the FDA has required that products containing third generation progestins include a Warning of the potentially increased risk of thrombosis.

20. Yaz and Yasmin contain the same estrogen component, ethinyl estradiol which has been used in the lower dose birth control pills for decades.

21. However, drospirenone is a new type of progestin and is considered a "fourth generation" progestin. No other birth control pills contain drospirenone, except for a recently approved generic version of Yaz/ Yasmin marketed under the trade name Ocella.

22. Since drospirenone is new, there is insufficient data available to support its safe use, particularly compared with second generation progestins. In fact, studies performed prior to FDA approval indicate that drospirenone has certain effects that are different from those of traditional second generation progestins, and potentially more dangerous.

23. One possible mechanism of action is that drospirenone causes an increase in potassium levels in the blood, which can lead to a condition known as hyperkalemia if the potassium levels become too high. Hyperkalemia can cause heart rhythm disturbances, such as extrasystolies, pauses, or bradycardia. If left untreated, hyperkalemia can be fatal. If hyperkalemia disrupts the normal heart rhythms, the flow of blood through the heart can be slowed to the point that it permits blood clots to form. Blood clots in the heart can then lead to heart attacks, or the clots can break off and travel to the lungs where they can cause a pulmonary embolism, or can travel to the brain causing stroke.

24. During the brief time that Yaz/ Yasmin have been sold in the United States, hundreds of reports of injury and death have been submitted to the FDA in association with defendants' products.

25. In April 2002, the British Medical Journal reported that the Dutch College of General Practitioners recommended that older second generation birth control pills be prescribed in lieu of Yasmin as a result of 40 cases of venous thrombosis among women taking Yasmin.

26. In February 2003, a paper entitled ThromboEmbolismsm Associated with the New contraceptive Yasmin was published in the British Medical Journal detailing a Netherlands Pharmacovigilance Centre report of five additional reports of thrombo Embolismsm where Yasmin was suspected as the cause, including two deaths.

27. In fact, in less than a five-year period, from the first quarter of 2004 through the third quarter of 2008, over 50 reports of death among users of Yaz / Yasmin have been filed with the FDA.

28. These reports include deaths associated with cardiac arrhythmia, cardiac arrest, intracardiac thrombus, heart attack, and stroke in women in their child bearing years.

29. Some deaths reported occurred in women as young as 17 years old.

30. Significantly, reports of elevated potassium levels are frequently included among the symptoms of those suffering death while using Yaz/ Yasmin.

Gadolinium Lawsuit Filed For Plaintiff Who Contracted Nephrogenic Systemic Fibrosis

This Gadolinium lawsuit was filed in October of 2009 in New York.  This lawsuits gives a good background about Gadolinium and its association with Nephrogenic Systemic Fibrosis:

52. Gadolinium is cleared from the body by glomerular filtration in the kidneys. As a result, it has a prolonged half-life in patients with renal insufficiency and who, therefore, are at increased risk for adverse health effects in connection with gadolinium administration.

53. Neither Plaintiff, nor her prescribing physician, nor the performing radiologists or technicians were warned or cautioned by Defendants about the serious health risks presented by the administration of Omniscan, Magnevist, OptiMARK, MultiHance and/or ProHance.

54. Subsequent to being administered Omniscan, Magnevist, OptiMARK, MultiHance and/or ProHance, Plaintiff developed NSF/NFD, which was formally diagnosed, and progressed to widespread fibrosis in areas including, but not limited to, her arms, legs, and associated joints.

55. Nephrogenic Systemic Fibrosis (NSF), also known as Nephrogenic Fibrosing Dermopathy (NFD), has been reported in medical literature for at least the last decade.

56. Prior to a decade ago, the group of symptoms now known as NSF/NFD had been variously described as scleromyxedema, scleroderma, or other connective tissue diseases. Regardless of the name ascribed to it, however, it has always been the case that this clinical entity now known as NSF/NFD develops only in patients with renal insufficiency whom have been given an injection of gadolinium-type contrast agent such as Omniscan, Magnevist, OptiMARK, MultiHance and/or ProHance.

57. NSF/NFD is predominantly characterized by discoloration, thickening, tightening, and swelling of the skin within days or weeks after receiving an injection of a gadolinium based contrast agent. These fibrotic and edematous changes produce muscular weakness and inhibit flexion and extension of joints, resulting in contractures. NSF/NFD often progresses to painful inhibition of the ability to use the arms, legs, hands, feet, and other joints. The skin changes that begin as darkened patches or plaques progress to a “woody” texture and are accompanied by burning, itching, or severe pain in the areas of involvement. NSF/NFD also progresses to a fibrotic or scarring condition of other body organs such as the lungs, heart, liver, and musculature, and that can inhibit their ability to function properly and may lead to death. NSF/NFD is a progressive disease as to which there is no known cure.

58. The Defendants have consistently failed to warn consumers and/or their health care providers that NSF/NSD could result when the Omniscan, Magnevist, OptiMARK, MultiHance and/or ProHance is administered to patients with renal insufficiency.

59. As a direct and proximate result of being administered Omniscan, Magnevist, OptiMARK, MultiHance and/or ProHance, Plaintiff suffered serious, progressive, incurable, and inevitably fatal injuries.

60. Defendants knew or should have known that the administration of Omniscan, Magnevist, OptiMARK, MultiHance and/or ProHance to patients with renal insufficiency created an increased risk to those consumers of serious personal injury and even death.

61. Therefore, at the time Plaintiff was administered Omniscan, Magnevist, OptiMARK, MultiHance and/or ProHance, Defendants knew or should have known that the use of Omniscan, Magnevist, OptiMARK, MultiHance and/or ProHance created an increased risk of serious personal injury, or even death to consumers with renal insufficiency.

62. Despite the fact that Defendants knew or should have known of the serious health risks associated with the use of Omniscan, Magnevist, OptiMARK, MultiHance and/or ProHance, Defendants failed to warn Plaintiff and/or her health care providers of those serious risks.

63. Had Plaintiff and/or her health care providers known the risks of damages associated with Omniscan he would not have been administered Omniscan, Magnevist, OptiMARK, MultiHance and/or ProHance and would not have been afflicted with NSF/NFD.

64. As a direct and proximate result Plaintiff being administered Omniscan, Magnevist, OptiMARK, MultiHance and/or ProHance, she has suffered significant harm, conscious pain and suffering, physical injury and bodily impairment, including, but not limited to, suffering from NSF/NFD, which may have caused permanent effects, and which may continue in the future to cause her physical effects and damage which lead to her death.

65. Further, as a direct and proximate result of he being administered Omniscan, Magnevist, OptiMARK, MultiHance and/or ProHance, Plaintiff suffered significant mental anguish and emotional distress, physical limitations, pain, injury, damages, harm, and mental and emotional distress.

66. Plaintiffs also incurred medical expenses and other economic harm as a result of Plaintiff being administered Omniscan, Magnevist, OptiMARK, MultiHance and/or ProHance.

67. Despite reports of nephrogenic fibrotic changes and other data warranting caution and further evaluation, Omniscan, Magnevist, OptiMARK, MultiHance and/or ProHance was marketed and sold without appropriate clinical evaluation of the nephrotoxic effect of this drug on patients with renal insufficiency, without appropriate clinical evaluation of the propensity of this drug to produce nephrogenic fibrosis in humans, and without appropriate and effective warning with respect to either.

68. At all times relevant hereto, Defendants knew or should have known about the significant health risk of Omniscan, Magnevist, OptiMARK, MultiHance and/or ProHance administration to patients with renal insufficiency, including, but not limited to, the risk of nephrogenic fibrosis in the skin and other body organs.

69. During the years that Defendants have manufactured, marketed, and sold Omniscan, Magnevist, OptiMARK, MultiHance and/or ProHance, there have been numerous case reports, studies, assessments, papers, and other clinical data that have described and/or demonstrated NSF/NFD in connection with the use of Omniscan, Magnevist, OptiMARK, MultiHance and/or ProHance. Despite this, Defendants have repeatedly failed to revise their package inserts, Material Safety Data Sheets, and other product-related literature, and to conduct appropriate post-marketing communications in order to convey adequate warnings.

70. In June 2006, and again in updated form in December 2006, the FDA issued Public Health Advisory Alerts concerning the development of serious, sometimes fatal, NSF/NFD following exposure to gadolinium-based contrast agents, including Omniscan, Magnevist, OptiMARK, MultiHance and/or ProHance.

71. The Defendants have repeatedly and consistently failed to advise consumers and/or their health care providers of the causal relationship between Omniscan, Magnevist, OptiMARK, MultiHance and/or ProHance and NSF/NFD in patients with renal insufficiency.

72. The Defendants have failed to take prompt, reasonable, and effective measures to alert the appropriate members of the health care community and its patients, including, but not limited to, renal patients, nephrologists and other physicians, radiologists, administrators, technicians, and hospital/radiology supply personnel, to the serious adverse health risks presented by administration of Omniscan, Magnevist, OptiMARK, MultiHance and/or ProHance.

CVS Sued for selling expired products

Just goes to show you that you should always check expiration dates – even if you buy from reputable vendors.

Connecticut Attorney General Richard Blumenthal said Monday that his office is suing a unit of CVS Caremark Corp. for allegedly selling expired over-the-counter drugs and other products in its stores in Connecticut.

In a statement, Mr. Blumenthal said investigators from his office found expired food, beverages and over-the-counter medications on sale in 20 or more CVS stores in Connecticut in the summers of 2008 and 2009.

The lawsuit was filed against CVS Pharmacy Inc. by Mr. Blumenthal's office in cooperation with Connecticut Department of Consumer Protection Commissioner Jerry Farrell Jr.

Source: CVS Accused of Selling Expired Products - WSJ.com

Premium Edge Cat Food Recalled

If you have a furry little friend who eats Premium Edge cat food, you’ll want to read this:

On September 23, Diamond Pet Foods issued a voluntary recall for Premium Edge Finicky Adult Cat and Premium Edge Hairball cat because they have the potential to produce Thiamine Deficiency. Today’s announcement provides additional information from the company’s posted announcement of September 23 when the initial recall information was provided.

Thiamine is essential for cats. Symptoms of deficiency displayed by an affected cat can be gastrointestinal or neurological in nature. At the first stage the cat may show decreased appetite, salivation, vomiting, and weight loss. Later, neurologic signs can develop, which may include ventriflexion (bending towards the floor) of the neck, wobbly walking, circling, falling, and seizures. These ultimately may result in the death of the animal if left untreated. If your cat has consumed the recalled product and has these symptoms, please contact your veterinarian.

The affected products were distributed in Maine, New Hampshire, Vermont, Massachusetts, Connecticut, Rhode Island, New Jersey, Maryland, Delaware, New York, Pennsylvania, Virginia, Alabama, Tennessee, North Carolina, South Carolina, Georgia, Florida.

The affected date codes were RAF0501A22X 18lb. (BB28NOV10), RAF0501A2X 6 lb. (BB28NOV10), RAF0802B12X 18lb (BB30FEB11), RAH0501A22X 18 lb. (BB28NOV10), RAH0501A2X 6lb. (BB28NOV10, BB30NOV10, BB08DEC10)

To date, 21 cases of thiamine deficiency in cats have been reported and confirmed by Diamond. The reports have been confined to the New York and Pennsylvania areas and none have been received since October 19.

Diamond has tested the product and found the cat foods were deficient in thiamine. Samples taken by the FDA indicated that there were additional lots with insufficient levels of thiamine. No other complaints have been reported on any other product manufactured by Diamond Pet Foods.

Consumers who have purchased the affected lots are urged to return it to the place of purchase for a full refund. Consumers with questions may contact the company at 1-800-977-8797, Monday-Friday, 8:00 am to 5:00 pm Central Time.

Source: Diamond Pet Foods Announces Recall of Premium Edge Adult Cat and Premium Edge Hairball Cat Food

Will there be a crackdown on pharmaceutical data mining?

I sure hope so.  Because the ability of pharmaceuticals to find out how often doctors prescribe which medications allows those pharmaceuticals to engage in all sorts of shenanigans, like finding doctors open to ghostwriting and pushing for off-label prescription use.

Washington Bureau - When your doctors writes you a prescription, that's just between you, your doctor, and maybe your health insurance company--right?
Wrong. As things stand now, the pharmaceutical companies that make those prescription drugs are also looking over the doctor's shoulder, keeping track of how many prescriptions for whose drugs the individual physician is writing.

And that data on the prescribing habits of thousands of doctors has become a powerful sales and marketing tool for the pharmaceutical industry, but also a source of growing concern among some elected officials, healthcare advocates and legal authorities.

Source: States, Consumer Advocates Challenge Rx Data Mining -- baltimoresun.com

Documents Available From Reglan (Metoclopramide) Lawsuits As of November of 2009

Lawsuits over the drug Reglan (Metoclopramide) fascinate me because of the unique nature of the disorders the drug can cause.  Reglan can cause movement disorders like tardive dyskinesia.  Individuals suffering from these disorders lose control of their facial muscles and their limbs.  It’s incredibly strange to me that temporary use of this drug can cause someone to permanently develop movement disorders.

Below you’ll find an assortment of documents filed in Reglan lawsuits from around the country.  If you’d like me to put you in touch with a Reglan lawyer, feel free to email me at justinian at justinian dot us, or use the form to the right.

• Report Filed In Reglan Lawsuit Alleges Reglan Warnings Were Inadequate
• Government Report Discusses Metoclopramide Side Effects
• California Reglan Lawsuit Discusses Side Effects of Reglan and Metoclopramide
• Expert Witness Discusses Reglan Risks in Texas Reglan Lawsuit
• FDA Document Discusses Movement Disorders Associated With Metoclopramide
• Metoclopramide Attorney Files Movement Disorder Lawsuit In West Virginia
• Expert Witness Report Filed In Lawsuit Regarding Adverse Reactions to Reglan
• Expert Witness In Metoclopramide Lawsuit Discusses Tardive Dyskinesia At Length
• Vermont Reglan Lawsuit Alleges That Reglan Label Is False and Misleading With Respect To Reglan
• Tardive Dyskinesia Lawyer Alleges Reglan Black Box Warning Should Have Come Sooner
• Georgia Reglan Lawsuit Alleges Wyeth and Schwarz Pharma Did Not Accurately Disclose Side Effects
• Oklahoma Reglan Lawyers File Movement Disorder Lawsuit Against Wyeth, and Generic Manufacturers
• Reglan Attorney Alleges that Reglan Manufacturers Knowingly Sell a Defective Product
• Movement Disorder Attorneys List Metoclopramide Side Effects In Reglan Lawsuit
• Metoclopramide Attorney Files Movement Disorder Lawsuit in Illinois
• Metoclopramide Lawyers Move For Summary Judgment In Reglan Lawsuit

FDA plans to speed reviews and visit China

I agree that visits to China should be at the top of the FDA priority list.  I’m not sure about increasing the speed of drug reviews, though, unless that speed increase comes from increased staff.  Asking existing staff to do more in less time is a recipe for another Vioxx disaster.

NEW YORK (Reuters) - The U.S. Food and Drug Administration is working to increase the speed of drug reviews and clean up problems in the division that oversees medical devices, the agency's commissioner said on Thursday.

Dr. Margaret Hamburg, speaking at the Reuters Health Summit in New York, also said visiting China to discuss the safety of imported products was a top priority for her in 2010.

Source: FDA head to speed reviews, visit China | Industry Summits | Reuters

More on the link between Meridia and cardiovascular events

As always, consult your doctor before you even think about taking yourself off a drug.

WASHINGTON -(Dow Jones)- The Food and Drug Administration Friday said it was conducting a safety review of the weight-loss drug Meridia, which is made by Abbott Laboratories (ABT).

The FDA siad it was reviewing preliminary data from a recent study that suggests patients using the drug have a higher number of cardiovascular events such as heart attacks and strokes compared to patients not on the drug.

Source: FDA Reviewing Safety Of Weight-Loss Drug Meridia

Second Fosamax Test Case Dismissed

There are many lawsuits pending against Merck over its drug Fosamax.  There is evidence that the drug causes necrosis of the jaw.  I’ve seen pictures of people with this disease, and they look like normal people with the jaw of a rotting corpse.  It’s a terrible, horrible disease.  At this time, I don’t know of any attorneys actively taking Fosamax cases.  One of the reasons why is that there haven’t been any trials against Merck yet.  When the first trial hits, the verdict in it will likely influence whether attorneys will pursue more Fosamax cases.

Wyeth and its new parent Pfizer are probably wishing they had more to be thankful for this week, after being hit with jury awards totaling $103 million over hormone drugs. But what started out as a tough week for Big Pharma got a little better late Monday, when Manhattan federal District Court Judge John Keenan dismissed the second of three bellwether cases facing Merck over its osteoporosis drug Fosamax just weeks before it was set for trial.

Source: Law.com - Merck Knocks Out Second Fosamax Test Case Before Trial