A New Jersey doctor has been charged with being a "moderator" in a lawsuit alleging the drug maker failed to adequately warn patients and doctors about the dangers of excessive use of Nexium and other heartburn medications.
Dr. David H. Johnson, 62, of Easton, has been charged with criminal charges and $2.2 million in damages after the alleged acts took place in February 2004.
Johann Johnson, the owner of Johnson & Johnson, was allegedly working under false and misleading company brochures and company promotional materials in an effort to warn patients about the side effects of Nexium and other heartburn medications.
The lawsuit alleges that Johnson & Johnson knew about the dangers of Nexium and other heartburn medications and failed to properly warn patients and doctors about the risks, including potential stomach bleeding, heart attack, and ulcers.
The suit also alleges that Johnson & Johnson's executives knew that Nexium and other heartburn medications were associated with increased heart attacks and strokes and should be avoided by patients and doctors and that Johnson & Johnson knew its sales representatives were exaggerating and not providing proper guidance.
The New Jersey Lawyer Review Board is investigating whether the conduct was a breach of professional conduct and has recommended that the matter be transferred to the U. S. Department of Justice.
Johnson & Johnson, which operates a "Biosimilar Drug Company" business that provides generic versions of the prescription drugs Nexium and other heartburn medications, also has admitted to selling Nexium over the Internet, according to an internal document unsealed today.
A Nexium marketing firm that was part of a "biosimilar drug company" operation sold Nexium to an online pharmacy and said the company provided accurate information about the drugs and was aware of the risks.
In addition to the Nexium claims, the lawsuit alleges that Johnson & Johnson also provided false or misleading information to doctors and other health care professionals.
A Nexium lawsuit also alleges that Johnson & Johnson knew or should have known that the risks were exaggerated and that it was misleading for patients and doctors to take the drugs and for them to take the risks.
Jointly owned by Johnson & Johnson, the company also has a "Biosimilar Drug Company" in operation and has more than 20 facilities and pharmacies in the state of New Jersey. It is the largest of these and has more than 100,000 employees worldwide.
The lawsuit alleges that Johnson & Johnson knew or should have known that Nexium and other heartburn medications were associated with increased heart attacks and strokes and that the drug's safety was at risk.
Johnson & Johnson also admitted to using the company's marketing materials to promote Nexium and other heartburn medications.
The lawsuit also alleges that the company knew or should have known that Nexium was associated with increased heart attacks and strokes and that the drug's safety was at risk.
Jointly owned by Johnson & Johnson, the company operates an "Biosimilar Drug Company" business that sells generic versions of prescription drugs and other non-prescription drugs, including Nexium, and sells its products through other drug manufacturers.
The lawsuit alleges that Johnson & Johnson's marketing and sales practices were deceptive and misleading.
Johnson & Johnson has admitted to the conduct that it was in breach of professional conduct.
The company also admitted to using false and misleading company brochures and promotional materials in an effort to promote Nexium and other heartburn medications and to provide for the "Biosimilar Drug Company" status and to provide for the "Biosimilar Drug Company" status.
The claims also allege that Johnson & Johnson's executives knew or should have known that Nexium and other heartburn medications were associated with increased heart attacks and strokes and that the company's sales representatives were exaggerating and not providing proper guidance.
The lawsuit also alleges that the company's sales representatives were deceptive and misleading in an effort to promote Nexium and other heartburn medications and to provide for the "Biosimilar Drug Company" status and to provide for the "Biosimilar Drug Company" status.
The plaintiffs allege that Johnson & Johnson failed to properly warn patients and doctors that the risks of Nexium and other heartburn medications were associated with increased heart attacks and that the drug's safety was at risk.
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This product is a Prescription Only Medicine (S4) and is sold by Healthylife Pharmacy, an independently owned and operated pharmacy business. This prescription product requires a valid Australian script.
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$35.95
Healthylife provides general product information such as nutritional information, country of origin and product packaging for your convenience. This information is intended as a guide only, including because products change from time to time. Please read product labels before consuming. For therapeutic goods, always read the label and follow the directions for use on pack. If you require specific information to assist with your purchasing decision, we recommend that you contact the manufacturer via the contact details on the packaging or email us at [email protected]. Product ratings and reviews are taken from various sources including Bazaarvoice. Healthylife does not represent or warrant the accuracy of any statements, claims or opinions made in product ratings and reviews.
Protein(s): 8.5mg, 40mgHealthylife contains the active ingredient esomeprazoleuminum salt. This is a prescription product (more than one prescription) and is dispensed by a pharmacy within a supply time of one. This item is sold by the manufacturer and is sold by the pharmacy. The manufacturer may have specific questions about the safety and efficacy of this medicine.
Use
Do not take Nexium Esomeprazole (40mg) 30 Tablets x 2 Packs if you have or have ever had a stomach ulcer, perforation or bleeding problems. Take these as directed by your GP or your pharmacist. Do not take for more than 14 days unless directed by your doctor or pharmacist.
$29.95
Healthylife contains the active ingredient esomeprazole, which is a prescription product (more than one prescription) and is dispensed by a pharmacy within a supply time of one.
Protein(s): 9.5mg, 40mg$49.95
Drug information is provided by a pharmacist or doctor and may not cover all causes of this condition. For medicinal products for which they are not available or are not recommended, please check with your pharmacist or doctor. If you do not find medical information reliable by your evidence, consult your doctor or pharmacist.
Healthylife contains the active ingredient esomeprazole, which is a prescription product (more than one prescriptions) and is dispensed by a pharmacy within a supply time of one.
For medicinal products for which they are not available or are not recommended, check with your pharmacist or doctor. If you do not find medical information reliable by your evidence, contact your doctor or pharmacist.
$59.95
If you do not find medical information reliable by taking this medicine, contact the manufacturer via the contact details on the medication you are using.
Protein(s): 9.The U. S. Food and Drug Administration issued the following warning letters to consumers regarding the safety and efficacy of Nexium (esomeprazole magnesium) capsules:
The letter was not meant to be a complete warning or to serve as a substitute for a health care professional's advice.
The FDA has issued a letter to the maker of Nexium, Eli Lilly and Company, advising consumers that they should not purchase any of the capsules purchased from the manufacturer.
A review of Nexium’s marketing authorization process and product labeling indicates that the capsules contain the same active ingredients as the brand-name drug. The FDA’s letter is not intended to serve as a warning.
The FDA letter does not indicate whether other manufacturers of the esomeprazole capsules, or the generic equivalent, produce equivalent versions of the capsules. The FDA does not recommend using the generic version of Nexium or the brand-name version of esomeprazole magnesium, as a substitute for Nexium’s branded equivalent.
The FDA letter is not intended to be a substitute for a health care professional’s professional advice.
The FDA letter does not indicate whether other manufacturers of the capsules purchased from the manufacturer, or other related manufacturers of the capsules, produce or market other similar products.
This undeclared ingredient may interact with the following medications:
The Food and Drug Administration’s own website does not provide information on whether other manufacturers of the esomeprazole capsules, or other related manufacturers of the capsules, produce or market similar products, except for a small print warning that the esomeprazole capsules are not approved for use in the United States.
The FDA letter is not intended to be a warning, and consumers should not purchase any of the capsules purchased from the manufacturer, or any related manufacturer, unless they specifically state their purchase from the manufacturer, and unless, in the opinion of the FDA, the manufacturer or other related manufacturer states that they are not using the esomeprazole capsules.
Show More — 14 medicines approved for sale without requiring a prescriptionShow MoreFood and Drug Administration (FDA) approved Nexium (esomeprazole magnesium) capsules in May 2014 to treat gastroesophageal reflux disease (GERD) and acid reflux disease (“GERD”).
The FDA letter is not intended to serve as a warning.
General Product DescriptionNexium 24HR Once Daily Dosing Tablets provide lasting relief from frequent heartburn and acid reflux. They providelasting symptomatic relief of frequent heartburn, acid regurgitation and other symptoms associated with gastro-oesophageal reflux.
Key Features
Directions For UseAdults 18 years of age and over:Take 1 tablet daily for at least 7 days and up to 14 days. Swallow the tablet whole with water, with or without food. Do not crush or chew the tablet. Do not take for more than 14 days unless drected byt a doctor.Not intended for immediate relief. It may take a few days to achieve maximum results.
WarningsAlways read and follow the directions before use. If symptoms persist, disconinue use and consult your healthcare professional. Keep out of reach of children. Do not use if you are pregnant or breast feeding, or under the age of 18.
IngredientsEach tablet contains: Esomeprazole 20mg (as Magnesium Trihydrate).
Tablets 10sActive IngredientsNot intended for use in patients allergic to any other effective and used to treat mucosal symptoms (e.g. congestion, acid reflux) or a proton pump inhibitor (e.g. lansoprazole or propindolol, sucrose, or vendas containing proton pump inhibitors, such aspantoprazole or pantoprazole). Do not take if on an antacid at any time after prazosin or before first aid.Keep out of reach of childrenInform your doctor of any other medications you are taking and seek the help right away.
In case of use, avoid alcohol consumption while using the tablet and twoPDATED for adults and twofor children above 18 years old. Always read the label.
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