Drug & Device News

Hospitals Lax in Safeguarding Nuclear Materials

In 2009, President Obama called for a worldwide effort to better secure nuclear materials. In response, the Government Accountability Office (GAO) conducted a study in 25 hospitals nationwide, and on March 14 the agency issued a report outlining problems that must be addressed in order to further the President's goal. See www.gao.gov/assets/590/589345.pdf. Among these is better securitization of radioactive materials located in hospitals. These types of radiological sources, although not usable in building a conventional nuclear bomb, could provide the raw material for building a “dirty bomb” that could potentially spread radioactive material around a city or any other vulnerable place. According to the report, “GAO found that NRC's security controls for hospitals and medical facilities do not prescribe the specific steps that must be taken to protect their radiological sources. GAO also found that medical facilities have implemented the controls in various ways. This has created a mix of security measures at the locations GAO visited that could leave some facilities more vulnerable than others.” At some of the medical facilities investigated hospital personnel spoke of discomfort at being placed in charge of security over radiological materials because they were not also given adequate training concerning how to carry out their duties. At one hospital, access to a room containing a blood irradiator was ostensibly secured by a combination lock system, but someone had written the combination on the outside door jamb, which was located in a heavily trafficked hallway. And at some hospitals, windows leading to rooms with radiological materials often were not secured beyond a conventional window lock. The GAO intends to conduct further studies that include more hospitals, and plans to issue a more comprehensive report by the end of this year.

Merck Prevails in One Case, Pays Large Fine in Another

In one of the first Fosomax cases to go to trial, a New Jersey Superior Court jury recently determined that a woman could not blame her development of osteonecrosis of the jaw (ONJ) on her use of the drug. With its win in Sessner v. Merck, ATL-L-3394-11, Merck & Co. has logged five victories and just one loss in the defense of those Fosomax cases claiming the osteoporosis drug causes jaw bone degeneration. The plaintiff in Sessner used the drug from 2002 to 2008, and claimed Merck failed to give adequate warnings of the effects Fosomax could have on users' jaws. The jury went against her, however, primarily because she could not prove causation, as she suffered other medical conditions that also could have caused her jaw issues. Christy Jones of Butler, Snow, O'Mara, Stevens & Cannada in Ridgeland, MS, who defended the suit, said in a news release: “Unfortunately, the plaintiff had medical conditions that can result in the development of jaw and dental problems in people, regardless of whether they were taking Fosamax. She had evidence of significant infections that required invasive dental procedures and had conditions that inhibit the body's ability to heal.”

On a lower note for the company, a Boston federal judge has ordered Merck to pay a criminal fine of $321.6 million for violating the Food, Drug and Cosmetic Act by introducing a misbranded drug into interstate commerce. The fine was imposed in March after Merck pleaded guilty in December 2011 to marketing its drug Vioxx for the treatment of rheumatoid arthritis, despite the product's lack of FDA approval for that purpose.

Putative Class Action Claims Pre-Empted by
Earlier-Filed Suit

A judge in Newark, NJ, applied the first-to-file rule to three putative class action suits against Bayer Health Care to throw them out, saying they were “overwhelmingly similar” to another suit filed earlier in California. The lawsuits (Worthington v. Bayer HealthCare, 11-cv-
2793; Rikos v. Bayer HealthCare, 11-cv-3017; and Yuncker v. Bayer HealthCare, 11-cv-3299) alleged the marketing campaigns for Bayer's digestive health products, Phillips Colon Health Probiotics + Fiber and Probiotics Caps, falsely claim that the products contain unique and especially beneficial strains of probiotic bacteria, when in fact no evidence of such superiority has been scientifically proven. These product claims, the plaintiffs said, were used to inflate the public's perception of the digestive health products, so that Bayer could charge premium prices for them. U.S. District Judge Esther Salas noted that the three cases were filed weeks after Stanley v. Bayer HealthCare, 11-cv-962, was filed in the Southern District of California, and that the claims and the relief sought in them not only “substantially overlap[ed]” with those in Stanley, but “in most instances, overlap[ed] with precision.”

FTC 'Pay for Delay' Suit Thrown Out

The U.S. Court of Appeals for the Eleventh Circuit has dismissed a Federal Trade Commission (FTC) suit against the manufacturer of the low- testosterone treatment product AndroGel. The suit claimed the company violated U.S. antitrust laws when it settled patent disputes with would-be generic makers of the product by compensating them in exchange for promises not to market their competing products until 2015. Charging unfair restraint of trade, the FTC alleged the AndroGel patent probably was not valid, so payments to its competitors unlawfully extended its monopoly. The court, however, refused to go there, stating, “What the FTC proposed is that we attempt to decide how some other court in some other case at some other time was likely to have resolved some other claim if it had been pursued to justice. If we did that we would be deciding a patent case within an antitrust case about the settlement of the patent case, a turducken task.” (A turducken is a dish composed of a chicken stuffed inside of a duck, which is then stuffed inside of a turkey and roasted.)

Hospitals Lax in Safeguarding Nuclear Materials

In 2009, President Obama called for a worldwide effort to better secure nuclear materials. In response, the Government Accountability Office (GAO) conducted a study in 25 hospitals nationwide, and on March 14 the agency issued a report outlining problems that must be addressed in order to further the President's goal. See www.gao.gov/assets/590/589345.pdf. Among these is better securitization of radioactive materials located in hospitals. These types of radiological sources, although not usable in building a conventional nuclear bomb, could provide the raw material for building a “dirty bomb” that could potentially spread radioactive material around a city or any other vulnerable place. According to the report, “GAO found that NRC's security controls for hospitals and medical facilities do not prescribe the specific steps that must be taken to protect their radiological sources. GAO also found that medical facilities have implemented the controls in various ways. This has created a mix of security measures at the locations GAO visited that could leave some facilities more vulnerable than others.” At some of the medical facilities investigated hospital personnel spoke of discomfort at being placed in charge of security over radiological materials because they were not also given adequate training concerning how to carry out their duties. At one hospital, access to a room containing a blood irradiator was ostensibly secured by a combination lock system, but someone had written the combination on the outside door jamb, which was located in a heavily trafficked hallway. And at some hospitals, windows leading to rooms with radiological materials often were not secured beyond a conventional window lock. The GAO intends to conduct further studies that include more hospitals, and plans to issue a more comprehensive report by the end of this year.

Merck Prevails in One Case, Pays Large Fine in Another

In one of the first Fosomax cases to go to trial, a New Jersey Superior Court jury recently determined that a woman could not blame her development of osteonecrosis of the jaw (ONJ) on her use of the drug. With its win in Sessner v. Merck, ATL-L-3394-11, Merck & Co. has logged five victories and just one loss in the defense of those Fosomax cases claiming the osteoporosis drug causes jaw bone degeneration. The plaintiff in Sessner used the drug from 2002 to 2008, and claimed Merck failed to give adequate warnings of the effects Fosomax could have on users' jaws. The jury went against her, however, primarily because she could not prove causation, as she suffered other medical conditions that also could have caused her jaw issues. Christy Jones of Butler, Snow, O'Mara, Stevens & Cannada in Ridgeland, MS, who defended the suit, said in a news release: “Unfortunately, the plaintiff had medical conditions that can result in the development of jaw and dental problems in people, regardless of whether they were taking Fosamax. She had evidence of significant infections that required invasive dental procedures and had conditions that inhibit the body's ability to heal.”

On a lower note for the company, a Boston federal judge has ordered Merck to pay a criminal fine of $321.6 million for violating the Food, Drug and Cosmetic Act by introducing a misbranded drug into interstate commerce. The fine was imposed in March after Merck pleaded guilty in December 2011 to marketing its drug Vioxx for the treatment of rheumatoid arthritis, despite the product's lack of FDA approval for that purpose.

Putative Class Action Claims Pre-Empted by
Earlier-Filed Suit

A judge in Newark, NJ, applied the first-to-file rule to three putative class action suits against Bayer Health Care to throw them out, saying they were “overwhelmingly similar” to another suit filed earlier in California. The lawsuits (Worthington v. Bayer HealthCare, 11-cv-
2793; Rikos v. Bayer HealthCare, 11-cv-3017; and Yuncker v. Bayer HealthCare, 11-cv-3299) alleged the marketing campaigns for Bayer's digestive health products, Phillips Colon Health Probiotics + Fiber and Probiotics Caps, falsely claim that the products contain unique and especially beneficial strains of probiotic bacteria, when in fact no evidence of such superiority has been scientifically proven. These product claims, the plaintiffs said, were used to inflate the public's perception of the digestive health products, so that Bayer could charge premium prices for them. U.S. District Judge Esther Salas noted that the three cases were filed weeks after Stanley v. Bayer HealthCare, 11-cv-962, was filed in the Southern District of California, and that the claims and the relief sought in them not only “substantially overlap[ed]” with those in Stanley, but “in most instances, overlap[ed] with precision.”

FTC 'Pay for Delay' Suit Thrown Out

The U.S. Court of Appeals for the Eleventh Circuit has dismissed a Federal Trade Commission (FTC) suit against the manufacturer of the low- testosterone treatment product AndroGel. The suit claimed the company violated U.S. antitrust laws when it settled patent disputes with would-be generic makers of the product by compensating them in exchange for promises not to market their competing products until 2015. Charging unfair restraint of trade, the FTC alleged the AndroGel patent probably was not valid, so payments to its competitors unlawfully extended its monopoly. The court, however, refused to go there, stating, “What the FTC proposed is that we attempt to decide how some other court in some other case at some other time was likely to have resolved some other claim if it had been pursued to justice. If we did that we would be deciding a patent case within an antitrust case about the settlement of the patent case, a turducken task.” (A turducken is a dish composed of a chicken stuffed inside of a duck, which is then stuffed inside of a turkey and roasted.)