Drug & Device News

FDA Certification Does Not Shield Generic Drug Maker from Suit

Generic drug manufacturers are not insulated from lawsuits by a Food and Drug Administration (FDA) approval process that certifies such drugs as the “bioequivalent” of their brand-name predecessors, a federal judge in Philadelphia has ruled. In the 29-page decision rendered in In re Budeprion XL Marketing & Sales Litigation, U.S. District Judge Berle Schiller refused to dismiss a suit brought by consumers who were previously taking Wellbutrin, a brand-name antidepressant drug, and claim they experienced side effects upon switching to generic buproprion. The suit alleges that two manufacturers ' Teva Pharmaceuticals and Impax Laboratories ' became aware of the potential problem but failed to warn the public about differences between the name-brand and generic versions of the product that affected the release rate of the active ingredient. Schiller applied the U.S. Supreme Court's recent decision in Wyeth v. Levine, and concluded that generic drug manufacturers, like manufacturers of the previously approved name-brand drugs their products mimic, also have a continuing duty to issue warnings about any new hazards that arise after approval.

Suits Filed Against Pediatric Medication Manufacturer

Following reports that manufacturing problems possibly sent tainted medications into the stream of commerce, two class actions have been filed against a Pennsylvania manufacturing plant that produces the suspect products ' pediatric Motrin, Tylenol, Benadryl and Zyrtec ' for consumer health-care products manufacturer Johnson & Johnson. The suits, brought in the Northern District of Illinois and in the Eastern District of Pennsylvania, seek to force McNeil Consumer Healthcare to offer consumers cash back for the recalled products rather than coupons for new products. Donald Haviland Jr. of Philadelphia's Haviland Hughes, who represents the plaintiffs in the Pennsylvania suit, says of Johnson & Johnson: “It markets itself as a company that takes children's safety very seriously and that's why they can charge a premium price for the Tylenol. People [are] willing to pay the premium price because of that reputation for safety. Now they're being deceived. We want to make sure that value is offered.”

The FDA says the quality control division at McNeil had a pattern of lax oversight, and that it was slow to report problems to the agency. Some of these problems include unintended particles in medications and possible excess amounts of active ingredients.

Doctor Who Claimed MMR/Autism Link Barred from Practice in UK

The British doctor whose famous study warned parents and doctors that the MMR vaccine could cause bowel disease that could then lead to autism has been stripped of his medical license. The three-year investigation of Dr Andrew Wakefield ended in May with England's General Medical Council (GMC) finding him guilty of serious professional misconduct. The GMC said the doctor used invasive methods to conduct research on the 12 subjects of the study without obtaining the proper permission. He and his colleagues also failed to disclose that they received funding for the study that originated from a group of parents of autistic children who were interested in obtaining proof of a link between the MMR vaccine and their children's conditions. The GMC's decision does not concern the truth or falsity of the study's findings, which were published in Britain's prestigious medical journal The Lancet in 1998. That article and the study behind it prompted parents worldwide to refuse to allow their children to be vaccinated, leading to an upsurge in the number of measles cases.

Litigation in California Over Medical Marijuana Dispensary Ordinances

Although the State of California has legalized the sale of marijuana for medical purposes, the controversies over making the drug available to the public are far from over. Several cities all over the State have individually imposed restrictions on medical marijuana dispensaries, some of them so onerous that they interfere with business owners' and patients' rights, some say. In one recently filed lawsuit, the nation's largest medical marijuana organization, Americans for Safe Access, claimed that Los Angeles' ordinance prohibiting medical marijuana dispensaries from locating within 1,000 feet of schools, libraries, parks, churches and locations with other “sensitive uses” had gone too far by “effectively forcing plaintiffs, as well as the vast majority of medical marijuana collectives in the City, to close their doors.” In the wake of the law's passage, City prosecutors sent warning letters to more than 400 dispensary owners, saying they must shut down or face prosecution once the law goes into effect in June.

Use of Proton Pump Inhibitors May Increase Risk of Fracture

The U.S. Food and Drug Administration is advising consumers and health-care providers about a possible increased risk of fractures of the hip, wrist, and spine with high doses or long-term use of a class of medications called proton pump inhibitors. These medications, like Nexium, Prilosec and Prevacid, are available both by prescription and over the counter, and are used to reduce stomach acid. The product labeling will soon be changed to describe this possible increased risk. The FDA wants consumers and physicians to consider these new risks when deciding whether and how to use proton pump inhibitors in treating conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers and inflammation of the esophagus.

NJ Supreme Court to Decide if Discovery Rule Satisfied

The New Jersey Supreme Court has agreed to consider whether an appellate panel improperly dismissed as time-barred a product-liability suit against Johnson & Johnson over sutures alleged to have caused post-surgical injuries. Ethicon Inc., a J&J subsidiary in Somerville that made the Panacryl sutures, recalled one million of them in 2006, saying they could act as foreign bodies. In her petition for certification, which the Court granted on June 3, plaintiff Misti Blessing argued that she could not have known she had a cause of action because J&J concealed from the medical community mounting evidence of complications stemming from use of the sutures. Blessing also claimed that the Appellate Division, in affirming dismissal of her suit, flouted the discovery rule, which is designed to mitigate harsh results from strict application of the statute of limitations.

FDA Certification Does Not Shield Generic Drug Maker from Suit

Generic drug manufacturers are not insulated from lawsuits by a Food and Drug Administration (FDA) approval process that certifies such drugs as the “bioequivalent” of their brand-name predecessors, a federal judge in Philadelphia has ruled. In the 29-page decision rendered in In re Budeprion XL Marketing & Sales Litigation, U.S. District Judge Berle Schiller refused to dismiss a suit brought by consumers who were previously taking Wellbutrin, a brand-name antidepressant drug, and claim they experienced side effects upon switching to generic buproprion. The suit alleges that two manufacturers ' Teva Pharmaceuticals and Impax Laboratories ' became aware of the potential problem but failed to warn the public about differences between the name-brand and generic versions of the product that affected the release rate of the active ingredient. Schiller applied the U.S. Supreme Court's recent decision in Wyeth v. Levine, and concluded that generic drug manufacturers, like manufacturers of the previously approved name-brand drugs their products mimic, also have a continuing duty to issue warnings about any new hazards that arise after approval.

Suits Filed Against Pediatric Medication Manufacturer

Following reports that manufacturing problems possibly sent tainted medications into the stream of commerce, two class actions have been filed against a Pennsylvania manufacturing plant that produces the suspect products ' pediatric Motrin, Tylenol, Benadryl and Zyrtec ' for consumer health-care products manufacturer Johnson & Johnson. The suits, brought in the Northern District of Illinois and in the Eastern District of Pennsylvania, seek to force McNeil Consumer Healthcare to offer consumers cash back for the recalled products rather than coupons for new products. Donald Haviland Jr. of Philadelphia's Haviland Hughes, who represents the plaintiffs in the Pennsylvania suit, says of Johnson & Johnson: “It markets itself as a company that takes children's safety very seriously and that's why they can charge a premium price for the Tylenol. People [are] willing to pay the premium price because of that reputation for safety. Now they're being deceived. We want to make sure that value is offered.”

The FDA says the quality control division at McNeil had a pattern of lax oversight, and that it was slow to report problems to the agency. Some of these problems include unintended particles in medications and possible excess amounts of active ingredients.

Doctor Who Claimed MMR/Autism Link Barred from Practice in UK

The British doctor whose famous study warned parents and doctors that the MMR vaccine could cause bowel disease that could then lead to autism has been stripped of his medical license. The three-year investigation of Dr Andrew Wakefield ended in May with England's General Medical Council (GMC) finding him guilty of serious professional misconduct. The GMC said the doctor used invasive methods to conduct research on the 12 subjects of the study without obtaining the proper permission. He and his colleagues also failed to disclose that they received funding for the study that originated from a group of parents of autistic children who were interested in obtaining proof of a link between the MMR vaccine and their children's conditions. The GMC's decision does not concern the truth or falsity of the study's findings, which were published in Britain's prestigious medical journal The Lancet in 1998. That article and the study behind it prompted parents worldwide to refuse to allow their children to be vaccinated, leading to an upsurge in the number of measles cases.

Litigation in California Over Medical Marijuana Dispensary Ordinances

Although the State of California has legalized the sale of marijuana for medical purposes, the controversies over making the drug available to the public are far from over. Several cities all over the State have individually imposed restrictions on medical marijuana dispensaries, some of them so onerous that they interfere with business owners' and patients' rights, some say. In one recently filed lawsuit, the nation's largest medical marijuana organization, Americans for Safe Access, claimed that Los Angeles' ordinance prohibiting medical marijuana dispensaries from locating within 1,000 feet of schools, libraries, parks, churches and locations with other “sensitive uses” had gone too far by “effectively forcing plaintiffs, as well as the vast majority of medical marijuana collectives in the City, to close their doors.” In the wake of the law's passage, City prosecutors sent warning letters to more than 400 dispensary owners, saying they must shut down or face prosecution once the law goes into effect in June.

Use of Proton Pump Inhibitors May Increase Risk of Fracture

The U.S. Food and Drug Administration is advising consumers and health-care providers about a possible increased risk of fractures of the hip, wrist, and spine with high doses or long-term use of a class of medications called proton pump inhibitors. These medications, like Nexium, Prilosec and Prevacid, are available both by prescription and over the counter, and are used to reduce stomach acid. The product labeling will soon be changed to describe this possible increased risk. The FDA wants consumers and physicians to consider these new risks when deciding whether and how to use proton pump inhibitors in treating conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers and inflammation of the esophagus.

NJ Supreme Court to Decide if Discovery Rule Satisfied

The New Jersey Supreme Court has agreed to consider whether an appellate panel improperly dismissed as time-barred a product-liability suit against Johnson & Johnson over sutures alleged to have caused post-surgical injuries. Ethicon Inc., a J&J subsidiary in Somerville that made the Panacryl sutures, recalled one million of them in 2006, saying they could act as foreign bodies. In her petition for certification, which the Court granted on June 3, plaintiff Misti Blessing argued that she could not have known she had a cause of action because J&J concealed from the medical community mounting evidence of complications stemming from use of the sutures. Blessing also claimed that the Appellate Division, in affirming dismissal of her suit, flouted the discovery rule, which is designed to mitigate harsh results from strict application of the statute of limitations.