Many courts are eyeing this case because federal law has essentially left
users of generic drugs without much remedy when the drug they use proves defective.
[16] The SJC considered innovator liability to require such a modification given the certainty that
a user of a generic drug will rely on the label fashioned by the brand - name manufacturer and as state law shields failure to warn claims from generic manufacturers, leaving plaintiffs without recourse for their injuries.
Not exact matches
Many
of the new
user fee funds would come from new fees for
generic drug reviews and «biosimilars,» which aim to be
generic versions
of biologic
drugs.
The firm undertook an analysis
of data in the FDA's Adverse Event Reporting System related to the stomach disorder
drug, and «identified at least 106 cases
of tardive dyskinesia or other movement disorders reported among
users of Reglan or its
generic version, metoclopramide.»
Types
of medications (including the names
of generic and brand
drugs) that have been linked to Stevens - Johnson Syndrome: • Anticonvulsants • Antibiotics • Nonsteroidal anti-inflammatory drugs (OTC and prescription) • Drugs with sulfa • Barbiturates • COX - 2 inhibitors • Ibuprofen • Acetaminophens • Allopurinol • Carbamazepine • Phenytoin • Bextra, which Pfizer removed from the market in 2005 because of the SJS risk it posed to users • Children's Advil or Motrin • Tylenol • Aldactone • Septra • Advil • Motrin • Avelox • Prilosec • Neurontin • Coreg • Feldene • Athrotec • Ceclor • Dilantin • Vioxx • Relafen • Celebrex • Levaquin • Depakote • Zantac • Tegretol • Provigil • Zithromax • Trileptal • Zyloprin • Clinoril • Phenytek Dangerous Drugs Severe drug reactions cause tens of thousands of patient deaths in this country each
drugs) that have been linked to Stevens - Johnson Syndrome: • Anticonvulsants • Antibiotics • Nonsteroidal anti-inflammatory
drugs (OTC and prescription) • Drugs with sulfa • Barbiturates • COX - 2 inhibitors • Ibuprofen • Acetaminophens • Allopurinol • Carbamazepine • Phenytoin • Bextra, which Pfizer removed from the market in 2005 because of the SJS risk it posed to users • Children's Advil or Motrin • Tylenol • Aldactone • Septra • Advil • Motrin • Avelox • Prilosec • Neurontin • Coreg • Feldene • Athrotec • Ceclor • Dilantin • Vioxx • Relafen • Celebrex • Levaquin • Depakote • Zantac • Tegretol • Provigil • Zithromax • Trileptal • Zyloprin • Clinoril • Phenytek Dangerous Drugs Severe drug reactions cause tens of thousands of patient deaths in this country each
drugs (OTC and prescription) •
Drugs with sulfa • Barbiturates • COX - 2 inhibitors • Ibuprofen • Acetaminophens • Allopurinol • Carbamazepine • Phenytoin • Bextra, which Pfizer removed from the market in 2005 because of the SJS risk it posed to users • Children's Advil or Motrin • Tylenol • Aldactone • Septra • Advil • Motrin • Avelox • Prilosec • Neurontin • Coreg • Feldene • Athrotec • Ceclor • Dilantin • Vioxx • Relafen • Celebrex • Levaquin • Depakote • Zantac • Tegretol • Provigil • Zithromax • Trileptal • Zyloprin • Clinoril • Phenytek Dangerous Drugs Severe drug reactions cause tens of thousands of patient deaths in this country each
Drugs with sulfa • Barbiturates • COX - 2 inhibitors • Ibuprofen • Acetaminophens • Allopurinol • Carbamazepine • Phenytoin • Bextra, which Pfizer removed from the market in 2005 because
of the SJS risk it posed to
users • Children's Advil or Motrin • Tylenol • Aldactone • Septra • Advil • Motrin • Avelox • Prilosec • Neurontin • Coreg • Feldene • Athrotec • Ceclor • Dilantin • Vioxx • Relafen • Celebrex • Levaquin • Depakote • Zantac • Tegretol • Provigil • Zithromax • Trileptal • Zyloprin • Clinoril • Phenytek Dangerous
Drugs Severe drug reactions cause tens of thousands of patient deaths in this country each
Drugs Severe
drug reactions cause tens
of thousands
of patient deaths in this country each year.
Relevant to the matter considered by the SJC, the
Drug Price Competition and Patent Term Restoration Act, informally known as the «Hatch - Waxman Act» requires the «manufacturer of a generic drug [to] provide its users with a warning label that is identical to the label of the brand - name counterpart.&ra
Drug Price Competition and Patent Term Restoration Act, informally known as the «Hatch - Waxman Act» requires the «manufacturer
of a
generic drug [to] provide its users with a warning label that is identical to the label of the brand - name counterpart.&ra
drug [to] provide its
users with a warning label that is identical to the label
of the brand - name counterpart.»
With
generic drugs, it is not merely foreseeable but certain that the warning label provided by the brand - name manufacturer will be identical to the warning label provided by the
generic manufacturer, and moreover that it will be relied on, not only by
users of its own product, but also by
users of the
generic product.