Drug & Device News

Class Action Off-Label Drug Lawsuit Dismissed

A U.S. District Court judge sitting in Los Angeles dismissed an off-label drug promotion multi-district litigation on Dec. 17, 2008. The suit claimed that Amgen Inc., Da Vita Inc. and Fresenius Medical Care Holdings Inc. pushed doctors to use the anemia drugs Epogen and Aranesp to treat people with kidney disease, cancer and HIV even though the drugs are not approved for those uses. Judge Pillip Gutierrez ruled in In re Epogen & Aranesp Off-Label Mktg. and Sales Practices Litig., MDL08-1934 (ARG) (C.D. Calif.), that the seven plaintiff health-benefits plans could not sue the defendant drug companies using federal racketeering laws or state unfair business practices laws. The court determined the suit was barred because the Federal Food and Drug Administration has exclusive jurisdiction over enforcement of the rules against promoting off-label drug uses. “Allowing plaintiffs to proceed on a theory that defendants violated RICO by engaging in off-label promotion, without specific allegations that defendants made false or misleading statements, would, in effect, permit plaintiffs to use RICO as a vehicle to enforce the FDCA [Food, Drug and Cosmetic Act] and the regulations promulgated thereunder,” wrote the court. Justice Gutierrez did, however, leave it open for the plaintiffs to amend their suit to keep it alive, although it was not clear on what basis this could be done.

Following the dismissal, Amgen attorney Mark Cheffo, of Skadden Arps Slate Meagher & Flom in New York, said, “The judge is not letting insurers second-guess medical providers across the country. I think he also respected the FDA's role and was not going to allow judges and juries to make decisions around the United States that are inconsistent with the FDA.”

FTC Sues Pharmaceuticals Company for Antitrust
Violations

The Federal Trade Commission filed a lawsuit in December 2008 against Ovation Pharmaceuticals Inc., alleging that the company has obtained an illegal monopoly over the only two drugs available to treat premature babies with certain heart defects. The FTC claims in its suit, filed in Federal District Court in Minnesota, that the company in August 2005 purchased the rights to one of the two medications, Indocin. Five months later, it acquired the rights to the second medication, NeoProfen. Soon after this acquisition, the price of a vial of Indocin jumped from $36 per vial to $500 per vial. In a statement issued by the FTC, acting FTC Bureau of Competition Director David P. Wales said, “By acquiring its only competitor in the treatment of a serious heart condition affecting premature babies, Ovation has been able to charge dramatically higher prices for its drugs. While Ovation is profiting from its illegal acquisition, hospitals and ultimately consumers and American taxpayers are forced to pay millions of dollars a year more for these life-saving medications. The action taken today is intended to restore the lost competition and require Ovation to give up its unlawful profits.” The FTC claims the only alternative to the two medications for babies with the heart defect patent ductus arteriosus is surgery, which is expensive and dangerous. With surgery the only other option, medical caregivers and parents of affected babies are forced to pay the allegedly artificially inflated prices Ovation is charging for its medications. All the participating FTC commissioners voted to approve the complaint.

Commissioner Jon Leibowitz issued a separate concurring statement, in which he said, “Ovation's profiteering on the backs of critically ill premature babies is not only immoral, it is illegal. Ovation's behavior is a stark reminder of why America desperately needs health care reform and why vigorous antitrust enforcement is as relevant today as it was when the agency was created almost one hundred years ago in 1914.”

CA Narrows Definition of 'Primary Caregiver' for Medicinal Marijuana Use

The California Supreme Court has ruled unanimously that the term “primary caregiver,” as used in the state's medical-marijuana-dispensing law, the Compassionate Use Act of 1996, refers only to a very limited class of people. “The words the statute uses ' housing, health, safety ' imply a caretaking relationship directed at the core survival needs of a seriously ill patient, not just one single pharmaceutical need.” The statute thus does not shield from state prosecution growers of small amounts of marijuana who want to supply it to their ailing friends.

The question arose in a 2005 case against Roger Mentch, who claimed he was growing the 190 plants found in his home because he was providing marijuana to five people with various physical and psychological infirmities. He asserted that he counseled his clients as to proper usage of the drug, taught them how to grow it and occasionally drove them to medical appointments. Mentch lost his battle to prove his innocence by way of the primary caregiver defense after the trial court refused to allow Mentch to present evidence on the issue. The intermediate appellate court found that Mentch should have been allowed to assert the affirmative defense.

The State Supreme Court reversed, holding in People v. Mentch, 08 C.D.O.S. 14435, that medical marijuana primary caregivers are only those who consistently provided care to patients prior to deciding that medical marijuana use might be beneficial for them. “What is not permitted,” wrote the court, “is for an individual to establish an after-the-fact caregiving relationship in an effort to thereby immunize from prosecution previous cultivation or possession for sale.” The court went on to note that its decision should not put true primary caregivers in fear of prosecution: “The spouse or domestic partner caring for his or her ailing companion, the child caring for his or her ailing parent, the hospice nurse caring for his or her ailing patient each can point to the many ways in which they, medical marijuana aside, attend to and assume responsibility for the core survival needs of their dependents.”

Manufacturer Upgrades Warning on Cranial Implant Kits

In October 2008, Stryker's Craniomaxillofacial (CMF) business unit voluntarily recalled four lots of its Custom Cranial Implant Kits because there was some danger that they were not sterile. It took the FDA a two months after that recall to determine that the products in question posed an imminent hazard to health, meaning that this is a Class I recall. The company announced the FDA's finding on Dec. 23, 2008, and urged hospitals and physicians with the affected products ' those with catalogue numbers 54-00101, 54-00102, 54-00103 and 54-00104 ' to return them to the manufacturer. If the kits are used and are not, in fact, sterile, serious problems could ensue, including patient infection and long-term neurological deterioration. The company's notice can be found at: http://www.fda.gov/oc/po/firmrecalls/stryker12_08.html.

Class Action Off-Label Drug Lawsuit Dismissed

A U.S. District Court judge sitting in Los Angeles dismissed an off-label drug promotion multi-district litigation on Dec. 17, 2008. The suit claimed that Amgen Inc., Da Vita Inc. and Fresenius Medical Care Holdings Inc. pushed doctors to use the anemia drugs Epogen and Aranesp to treat people with kidney disease, cancer and HIV even though the drugs are not approved for those uses. Judge Pillip Gutierrez ruled in In re Epogen & Aranesp Off-Label Mktg. and Sales Practices Litig., MDL08-1934 (ARG) (C.D. Calif.), that the seven plaintiff health-benefits plans could not sue the defendant drug companies using federal racketeering laws or state unfair business practices laws. The court determined the suit was barred because the Federal Food and Drug Administration has exclusive jurisdiction over enforcement of the rules against promoting off-label drug uses. “Allowing plaintiffs to proceed on a theory that defendants violated RICO by engaging in off-label promotion, without specific allegations that defendants made false or misleading statements, would, in effect, permit plaintiffs to use RICO as a vehicle to enforce the FDCA [Food, Drug and Cosmetic Act] and the regulations promulgated thereunder,” wrote the court. Justice Gutierrez did, however, leave it open for the plaintiffs to amend their suit to keep it alive, although it was not clear on what basis this could be done.

Following the dismissal, Amgen attorney Mark Cheffo, of Skadden Arps Slate Meagher & Flom in New York, said, “The judge is not letting insurers second-guess medical providers across the country. I think he also respected the FDA's role and was not going to allow judges and juries to make decisions around the United States that are inconsistent with the FDA.”

FTC Sues Pharmaceuticals Company for Antitrust
Violations

The Federal Trade Commission filed a lawsuit in December 2008 against Ovation Pharmaceuticals Inc., alleging that the company has obtained an illegal monopoly over the only two drugs available to treat premature babies with certain heart defects. The FTC claims in its suit, filed in Federal District Court in Minnesota, that the company in August 2005 purchased the rights to one of the two medications, Indocin. Five months later, it acquired the rights to the second medication, NeoProfen. Soon after this acquisition, the price of a vial of Indocin jumped from $36 per vial to $500 per vial. In a statement issued by the FTC, acting FTC Bureau of Competition Director David P. Wales said, “By acquiring its only competitor in the treatment of a serious heart condition affecting premature babies, Ovation has been able to charge dramatically higher prices for its drugs. While Ovation is profiting from its illegal acquisition, hospitals and ultimately consumers and American taxpayers are forced to pay millions of dollars a year more for these life-saving medications. The action taken today is intended to restore the lost competition and require Ovation to give up its unlawful profits.” The FTC claims the only alternative to the two medications for babies with the heart defect patent ductus arteriosus is surgery, which is expensive and dangerous. With surgery the only other option, medical caregivers and parents of affected babies are forced to pay the allegedly artificially inflated prices Ovation is charging for its medications. All the participating FTC commissioners voted to approve the complaint.

Commissioner Jon Leibowitz issued a separate concurring statement, in which he said, “Ovation's profiteering on the backs of critically ill premature babies is not only immoral, it is illegal. Ovation's behavior is a stark reminder of why America desperately needs health care reform and why vigorous antitrust enforcement is as relevant today as it was when the agency was created almost one hundred years ago in 1914.”

CA Narrows Definition of 'Primary Caregiver' for Medicinal Marijuana Use

The California Supreme Court has ruled unanimously that the term “primary caregiver,” as used in the state's medical-marijuana-dispensing law, the Compassionate Use Act of 1996, refers only to a very limited class of people. “The words the statute uses ' housing, health, safety ' imply a caretaking relationship directed at the core survival needs of a seriously ill patient, not just one single pharmaceutical need.” The statute thus does not shield from state prosecution growers of small amounts of marijuana who want to supply it to their ailing friends.

The question arose in a 2005 case against Roger Mentch, who claimed he was growing the 190 plants found in his home because he was providing marijuana to five people with various physical and psychological infirmities. He asserted that he counseled his clients as to proper usage of the drug, taught them how to grow it and occasionally drove them to medical appointments. Mentch lost his battle to prove his innocence by way of the primary caregiver defense after the trial court refused to allow Mentch to present evidence on the issue. The intermediate appellate court found that Mentch should have been allowed to assert the affirmative defense.

The State Supreme Court reversed, holding in People v. Mentch , 08 C.D.O.S. 14435, that medical marijuana primary caregivers are only those who consistently provided care to patients prior to deciding that medical marijuana use might be beneficial for them. “What is not permitted,” wrote the court, “is for an individual to establish an after-the-fact caregiving relationship in an effort to thereby immunize from prosecution previous cultivation or possession for sale.” The court went on to note that its decision should not put true primary caregivers in fear of prosecution: “The spouse or domestic partner caring for his or her ailing companion, the child caring for his or her ailing parent, the hospice nurse caring for his or her ailing patient each can point to the many ways in which they, medical marijuana aside, attend to and assume responsibility for the core survival needs of their dependents.”

Manufacturer Upgrades Warning on Cranial Implant Kits

In October 2008, Stryker's Craniomaxillofacial (CMF) business unit voluntarily recalled four lots of its Custom Cranial Implant Kits because there was some danger that they were not sterile. It took the FDA a two months after that recall to determine that the products in question posed an imminent hazard to health, meaning that this is a Class I recall. The company announced the FDA's finding on Dec. 23, 2008, and urged hospitals and physicians with the affected products ' those with catalogue numbers 54-00101, 54-00102, 54-00103 and 54-00104 ' to return them to the manufacturer. If the kits are used and are not, in fact, sterile, serious problems could ensue, including patient infection and long-term neurological deterioration. The company's notice can be found at: http://www.fda.gov/oc/po/firmrecalls/stryker12_08.html.