Drug & Device News

Ketek Label Change Reflects Evidence of Liver-Damage Risk

Just over a year ago, the FDA warned consumers and health care providers that Ketek' (telithromycin), an antibiotic often used to treat pneumonia and upper respiratory infections, had been implicated in three reported cases of liver toxicity. On Jan. 20, 2006, the agency stated it was 'continuing to evaluate the issue of liver problems in association with use of telithromycin in order to determine if labeling changes or other actions are warranted.' FDA Public Health Advisory, Ketek (telithromycin) Tablets, at: www.fda.gov/cder /drug/advisory/telithromycin.htm.

That labeling change was finally announced Feb. 12 of this year. The label changes include the removal of two of the three previously approved indications from the drugs label; Ketek is no longer approved for the treatment of acute bacterial sinusitis or acute bacterial exacerbations of chronic bronchitis. The medication will now also contain a 'boxed warning' on its label, the strongest form of FDA warning, stating that Ketek should not be used in patients with myasthenia gravis, a disease that causes muscle weakness. The announcement about the label changes can be accessed at: www.fda.gov/bbs/topics/NEWS/2007/NEW01561.html.

Attempt to Overturn No-Cause Verdict Fails in Vioxx Case

On March 5, New Jersey Superior Court Judge Carol Higbee denied a motion by a Vioxx' plaintiff in a suit against drug manufacturer Merck & Co. to overturn the jury verdict, precluding her from recovering anything but a nominal amount for the death of her brother. Plaintiff's decedent Brian Hermans began taking the painkiller in February 2001. He died of a heart attack in September 2002 at age 44, five months after Merck relabeled Vioxx to warn of potential problems. However, because of the number of cases awaiting trial in New Jersey (almost 15,200 of the 27,000 Vioxx suits filed nationally), plaintiff attorneys had pushed for group trials. The jury therefore was not given Hermans' medical history during the general liability phase of trial, which would have disclosed to them the fact that although Hermans died after adequate warnings were given, he began his use of Vioxx prior to the label change. New Jersey's product liability law requires a plaintiff to establish a failure to warn in order to recover compensatory or punitive damages on other counts.

Plaintiff's lawyer W. Mark Lanier, of the Lanier firm in Houston and New York, argued in his motion that the jury verdict was inconsistent, especially in view of the fact that the jury found Merck failed to provide adequate warning to co-plaintiff Frederick Humeston, 61, who suffered a heart attack but survived. Humeston's case is a retrial of New Jersey's first Vioxx case. His first trial ended in a no-cause verdict in 2005, but on March 12, an Atlantic City jury, finding Merck's failure to warn of the drug's cardiovascular risks substantially contributed to Humeston's heart attack, awarded him punitive damages of $27.5 million and compensatory damages of $18 million, and awarded his wife $2 million.

FDA warns of Possible Link Between RotaTeq and Intussusception

The FDA notified health care providers and consumers on Feb. 13 of 28 post-marketing reports of intussusception following administration of Rotavirus, Live, Oral, Pentavalent vaccine (trade name RotaTeq'), manufactured by Merck and Co. Inc. RotaTeq is administered to children to prevent rotavirus, the most common cause of severe diarrhea in that population.

The FDA reports that intussusception is a possibly life-threatening condition that occurs when the intestine gets blocked or twisted after one portion of the intestine telescopes into a nearby portion, and that it can occur spontaneously even in children who have not had the vaccine. Symptoms of intussusception include stomach pain, vomiting, diarrhea, blood in the stool or change in bowel movements, and these symptoms can occur even several weeks after vaccination. For further information, see: www.fda.gov/ cber/safety/phnrota021307.htm.

Vaccine Court Is Proper Forum

The New Jersey Superior Court, Appellate Division, has held in Rivard v. American Home Products Inc., L-08470-01. DDS No. 32-2-6729 (3/8/07), that where the defendant manufacturer of an oral polio vaccine began with a contaminant already in the strain and attempted to neutralize it, the contaminant was not something 'intentionally added' to the vaccine; therefore, plaintiffs' claim was subject to the National Childhood Vaccine Injury Act, 42 U.S.C.A. ” 300aa-1 to ' 34 (the Act), which generally requires plaintiffs in actions seeking damages in excess of $1000 for vaccine-related injuries or deaths to first bring suit against the U.S. Secretary of Health and Human Services in the federal court of claims (Vaccine Court).

In Rivard, a child ingested an oral polio vaccine called Orimune from which she allegedly developed a brain tumor and died at seven years of age. Plaintiffs filed a complaint in state court against the manufacturer, alleging, among other things, negligence, strict liability, failure to warn, and fraud in the manufacture and testing of the vaccine ' specifically, that defendants failed to adequately test for and remove a monkey virus known as SV40 from the vaccine. The trial judge reasoned that SV40 'was not an ingredient in the vaccine,' that it 'served no purpose in the vaccine' and did not preserve, make more effective or aid the vaccine in distribution 'through the human body.' Instead, 'SV40 is a dangerous substance that could have been avoided in the manufacture of Orimune, had the defendants chosen to do so.' The court believed that defendants' actions satisfied the 'intentionally added contaminant' standard, which would take this case outside the realm of the Act.

The appellate court disagreed, finding that the trial court's interpretation did not comport with the ordinary meaning of 'intentionally adding' a contaminant or adulterant to the vaccine. Instead, it found that plaintiff's claim fairly implicated a constituent material of vaccines and, therefore, should be considered 'vaccine-related.' 'This is not a case where injuries were caused by exposure to a foreign substance purposefully introduced into the vaccine,' stated the court in dismissing those portions of the action seeking damages for the vaccine-related death.

Internet Drug Purchasers Get Wrong Medication

Some consumers who ordered medications over the Internet and thought they were receiving Ambien', Xanax', Lexapro' or Ativan', instead received counterfeit drugs allegedly containing haloperidol, an anti-psychotic drug usually prescribed to treat schizophrenia. Haloperidol can cause muscle spasms, muscle stiffness, agitation and sedation. The tainted shipments all were postmarked from Greece. For further information, see http://www.fda.gov/bbs/topics/ NEWS/2007/NEW01564.html.

In response to ongoing national concerns about this type of risk to consumers, Sen. Judd Gregg (R-NH) introduced legislation on Feb. 14 titled The Safe Internet Pharmacy Act of 2007. If passed, it would, among other things, require all Internet pharmacies dispensing prescription drugs to anyone in the United States to be licensed by the FDA. Each such pharmacy located outside the United States would have to designate an agent within these borders to accept service of process and would be required to list their places of business and names of pharmacists dispensing drugs. See press release at: http://gregg.senate. gov/public/index.cfm?FuseAction=PressRoom.PressReleases&ContentRecord_id=c5a0da76-802a-23ad-4719-67cd35ecc612.

Ketek Label Change Reflects Evidence of Liver-Damage Risk

Just over a year ago, the FDA warned consumers and health care providers that Ketek' (telithromycin), an antibiotic often used to treat pneumonia and upper respiratory infections, had been implicated in three reported cases of liver toxicity. On Jan. 20, 2006, the agency stated it was 'continuing to evaluate the issue of liver problems in association with use of telithromycin in order to determine if labeling changes or other actions are warranted.' FDA Public Health Advisory, Ketek (telithromycin) Tablets, at: www.fda.gov/cder /drug/advisory/telithromycin.htm.

That labeling change was finally announced Feb. 12 of this year. The label changes include the removal of two of the three previously approved indications from the drugs label; Ketek is no longer approved for the treatment of acute bacterial sinusitis or acute bacterial exacerbations of chronic bronchitis. The medication will now also contain a 'boxed warning' on its label, the strongest form of FDA warning, stating that Ketek should not be used in patients with myasthenia gravis, a disease that causes muscle weakness. The announcement about the label changes can be accessed at: www.fda.gov/bbs/topics/NEWS/2007/NEW01561.html.

Attempt to Overturn No-Cause Verdict Fails in Vioxx Case

On March 5, New Jersey Superior Court Judge Carol Higbee denied a motion by a Vioxx' plaintiff in a suit against drug manufacturer Merck & Co. to overturn the jury verdict, precluding her from recovering anything but a nominal amount for the death of her brother. Plaintiff's decedent Brian Hermans began taking the painkiller in February 2001. He died of a heart attack in September 2002 at age 44, five months after Merck relabeled Vioxx to warn of potential problems. However, because of the number of cases awaiting trial in New Jersey (almost 15,200 of the 27,000 Vioxx suits filed nationally), plaintiff attorneys had pushed for group trials. The jury therefore was not given Hermans' medical history during the general liability phase of trial, which would have disclosed to them the fact that although Hermans died after adequate warnings were given, he began his use of Vioxx prior to the label change. New Jersey's product liability law requires a plaintiff to establish a failure to warn in order to recover compensatory or punitive damages on other counts.

Plaintiff's lawyer W. Mark Lanier, of the Lanier firm in Houston and New York, argued in his motion that the jury verdict was inconsistent, especially in view of the fact that the jury found Merck failed to provide adequate warning to co-plaintiff Frederick Humeston, 61, who suffered a heart attack but survived. Humeston's case is a retrial of New Jersey's first Vioxx case. His first trial ended in a no-cause verdict in 2005, but on March 12, an Atlantic City jury, finding Merck's failure to warn of the drug's cardiovascular risks substantially contributed to Humeston's heart attack, awarded him punitive damages of $27.5 million and compensatory damages of $18 million, and awarded his wife $2 million.

FDA warns of Possible Link Between RotaTeq and Intussusception

The FDA notified health care providers and consumers on Feb. 13 of 28 post-marketing reports of intussusception following administration of Rotavirus, Live, Oral, Pentavalent vaccine (trade name RotaTeq'), manufactured by Merck and Co. Inc. RotaTeq is administered to children to prevent rotavirus, the most common cause of severe diarrhea in that population.

The FDA reports that intussusception is a possibly life-threatening condition that occurs when the intestine gets blocked or twisted after one portion of the intestine telescopes into a nearby portion, and that it can occur spontaneously even in children who have not had the vaccine. Symptoms of intussusception include stomach pain, vomiting, diarrhea, blood in the stool or change in bowel movements, and these symptoms can occur even several weeks after vaccination. For further information, see: www.fda.gov/ cber/safety/phnrota021307.htm.

Vaccine Court Is Proper Forum

The New Jersey Superior Court, Appellate Division, has held in Rivard v. American Home Products Inc., L-08470-01. DDS No. 32-2-6729 (3/8/07), that where the defendant manufacturer of an oral polio vaccine began with a contaminant already in the strain and attempted to neutralize it, the contaminant was not something 'intentionally added' to the vaccine; therefore, plaintiffs' claim was subject to the National Childhood Vaccine Injury Act, 42 U.S.C.A. ” 300aa-1 to ' 34 (the Act), which generally requires plaintiffs in actions seeking damages in excess of $1000 for vaccine-related injuries or deaths to first bring suit against the U.S. Secretary of Health and Human Services in the federal court of claims (Vaccine Court).

In Rivard, a child ingested an oral polio vaccine called Orimune from which she allegedly developed a brain tumor and died at seven years of age. Plaintiffs filed a complaint in state court against the manufacturer, alleging, among other things, negligence, strict liability, failure to warn, and fraud in the manufacture and testing of the vaccine ' specifically, that defendants failed to adequately test for and remove a monkey virus known as SV40 from the vaccine. The trial judge reasoned that SV40 'was not an ingredient in the vaccine,' that it 'served no purpose in the vaccine' and did not preserve, make more effective or aid the vaccine in distribution 'through the human body.' Instead, 'SV40 is a dangerous substance that could have been avoided in the manufacture of Orimune, had the defendants chosen to do so.' The court believed that defendants' actions satisfied the 'intentionally added contaminant' standard, which would take this case outside the realm of the Act.

The appellate court disagreed, finding that the trial court's interpretation did not comport with the ordinary meaning of 'intentionally adding' a contaminant or adulterant to the vaccine. Instead, it found that plaintiff's claim fairly implicated a constituent material of vaccines and, therefore, should be considered 'vaccine-related.' 'This is not a case where injuries were caused by exposure to a foreign substance purposefully introduced into the vaccine,' stated the court in dismissing those portions of the action seeking damages for the vaccine-related death.

Internet Drug Purchasers Get Wrong Medication

Some consumers who ordered medications over the Internet and thought they were receiving Ambien', Xanax', Lexapro' or Ativan', instead received counterfeit drugs allegedly containing haloperidol, an anti-psychotic drug usually prescribed to treat schizophrenia. Haloperidol can cause muscle spasms, muscle stiffness, agitation and sedation. The tainted shipments all were postmarked from Greece. For further information, see http://www.fda.gov/bbs/topics/ NEWS/2007/NEW01564.html.

In response to ongoing national concerns about this type of risk to consumers, Sen. Judd Gregg (R-NH) introduced legislation on Feb. 14 titled The Safe Internet Pharmacy Act of 2007. If passed, it would, among other things, require all Internet pharmacies dispensing prescription drugs to anyone in the United States to be licensed by the FDA. Each such pharmacy located outside the United States would have to designate an agent within these borders to accept service of process and would be required to list their places of business and names of pharmacists dispensing drugs. See press release at: http://gregg.senate. gov/public/index.cfm?FuseAction=PressRoom.PressReleases&ContentRecord_id=c5a0da76-802a-23ad-4719-67cd35ecc612.