Drugmakers Biogen Idec Inc. and Elan Corp. Plc. have warned doctors of significant liver injury, including markedly elevated serum hepatic enzymes and elevated total bilirubin, after taking the multiple sclerosis drug Tysabri. These adverse effects occurred as early as six days after the first dose of the drug. The combination of transaminase elevations and elevated bilirubin without evidence of obstruction is recognized as an important predictor of severe liver injury that may lead to death or the need for a liver transplant in some patients. Tysabri should be discontinued in people with jaundice or other evidence of significant liver injury.
The companies co-market the drug, with Biogen taking the lead in the U.S. The drug Tysabri is also used to treat people with Crohn's disease.
Claudine Homolash is a personal injury attorney in Philadelphia, PA, who focuses her practice representing individuals who have been injured by dangerous drugs and medical devices. Ms. Homolash was recently nominated for the National Multiple Sclerosis Society's 2008 MS Leadership Class and is familiar with the physical harm Tysabri may cause to certain individuals.
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Perspective of a Legal Specialist in Whistleblower Law and Pharmaceutical Injury
Thursday, February 28, 2008
Thursday, February 7, 2008
Riegel v. Medtronic -- Have You Lost the Right to Sue?
We represent multiple clients who have experienced unnecessary shocking due to Medtronic's faulty lead. One client, in particular, was shocked over thirty times.
What is more frightening is the fact that the Supreme Court recently held oral argument on whether federally approved medical devices are broadly shielded from product-liability lawsuits. If the Supreme Court agrees with this big business position, many people who are injured due to faulty medical devices will be left with no recourse. It seems that big business has bought the FDA since it recently admitted that it cannot keep up with advances in science! The report, from a subcommittee of the FDA's outside Science Board that included members and advisers from industry as well as academia, said the agency "cannot even keep up with the advances in science." An appendix to the report said the FDA conducted twice as many inspections of food facilities in 1973 as it did of all facilities -- including food, drugs and medical devices -- in 2006.
In Riegel v. Medtronic. The Riegel case was brought by a New York man, Charles Riegel, who was injured when a Medtronic catheter burst during a 1996 angioplasty procedure. Riegel, who died in 2004, asserted the catheter had design flaws and that labeling instructions for the device were misleading.
Allison Zieve, a Washington-based attorney representing Riegel, labored to convince the justices that federal law allowed Riegel to sue Medtronic over the device, which had received so-called premarket approval from the Food and Drug Administration.
"It is clear that Congress didn't want any additional requirements", Justice Antonin Scalia said, indicating he thinks Congress wanted the FDA to regulate medical devices without interference from state regulators or courts.
A majority of the Supreme Court appeared to support this view.
The BIGGER QUESTIONS - if the FDA has admitted that it can't protect the people and companies can avoid liability by having its products FDA-approved, what protections are afforded to the users of these products? What incentives do medical device companies have to protect the end user?
February 7, 2008 12:25 PM
What is more frightening is the fact that the Supreme Court recently held oral argument on whether federally approved medical devices are broadly shielded from product-liability lawsuits. If the Supreme Court agrees with this big business position, many people who are injured due to faulty medical devices will be left with no recourse. It seems that big business has bought the FDA since it recently admitted that it cannot keep up with advances in science! The report, from a subcommittee of the FDA's outside Science Board that included members and advisers from industry as well as academia, said the agency "cannot even keep up with the advances in science." An appendix to the report said the FDA conducted twice as many inspections of food facilities in 1973 as it did of all facilities -- including food, drugs and medical devices -- in 2006.
In Riegel v. Medtronic. The Riegel case was brought by a New York man, Charles Riegel, who was injured when a Medtronic catheter burst during a 1996 angioplasty procedure. Riegel, who died in 2004, asserted the catheter had design flaws and that labeling instructions for the device were misleading.
Allison Zieve, a Washington-based attorney representing Riegel, labored to convince the justices that federal law allowed Riegel to sue Medtronic over the device, which had received so-called premarket approval from the Food and Drug Administration.
"It is clear that Congress didn't want any additional requirements", Justice Antonin Scalia said, indicating he thinks Congress wanted the FDA to regulate medical devices without interference from state regulators or courts.
A majority of the Supreme Court appeared to support this view.
The BIGGER QUESTIONS - if the FDA has admitted that it can't protect the people and companies can avoid liability by having its products FDA-approved, what protections are afforded to the users of these products? What incentives do medical device companies have to protect the end user?
February 7, 2008 12:25 PM
PERSONAL INJURY LAWSUITS INITIATE CHANGE IN CHANTIX WARNINGS
(Feb. 1, 2008) The FDA announced a public health advisory about abnormal behavior, agitation, depressed mood, suicidal ideation, and actual suicidal behavior with Pfizer’s anti-smoking drug, Chantix. The FDA provided updated calculations reflecting the following:
- 491 cases of suicidal thinking or behavior, including 420 in the US. And of those, there were 39 suicides, including 34 in the US.
“We’ve become increasingly concerned as we see a number of cases that truly look like exposure to the drug and not other causes,” says Bob Rappaport, director of the FDA’s division of anesthesia, analgesia and rheumatology products, in a briefing this afternoon with reporters. As of now, he adds, “there’s no definitive evidence there’s a causal relationship” between Pfizer and the abnormal and suicidal behaviors. Although, the agency notes that “it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.”
The FDA started reviewing cases last November after national attention grew as a result of the case of Carter Albrecht. Albrecht was a guitarist and keyboardist with the band Edie Brickell & the New Bohemians. He died September 3, 2007 after being shot in the head by a neighbor as he tried to kick in his door.
Earlier that day, Albrecht had been having drinks with his girlfriend Ryann Rathbone at a local Dallas bar. After he become intoxicated, Rathbone drove Albrecht to their home where they both took their dose of Chantix. After that, Albrecht became incoherent and violent, breaking a glass and hitting Rathbone. When Rathbone left the house, Albrecht followed and she locked him out. He pounded on the door then went next door and began pounding on the neighbor’s door. The neighbor warned Albrecht to stop and fired a warning shot through the door, which hit Albrecht. Family and friends say that this type of violent behavior was atypical of Albrecht and believe that the use of Chantix caused the events.
Albrecht’s case is not so uncommon when compared to other normally calm people who have taken Chantix. Suits like Albrecht's initiate change and assist in protecting individuals who may have otherwise ingested this dangerous drug.
- 491 cases of suicidal thinking or behavior, including 420 in the US. And of those, there were 39 suicides, including 34 in the US.
“We’ve become increasingly concerned as we see a number of cases that truly look like exposure to the drug and not other causes,” says Bob Rappaport, director of the FDA’s division of anesthesia, analgesia and rheumatology products, in a briefing this afternoon with reporters. As of now, he adds, “there’s no definitive evidence there’s a causal relationship” between Pfizer and the abnormal and suicidal behaviors. Although, the agency notes that “it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.”
The FDA started reviewing cases last November after national attention grew as a result of the case of Carter Albrecht. Albrecht was a guitarist and keyboardist with the band Edie Brickell & the New Bohemians. He died September 3, 2007 after being shot in the head by a neighbor as he tried to kick in his door.
Earlier that day, Albrecht had been having drinks with his girlfriend Ryann Rathbone at a local Dallas bar. After he become intoxicated, Rathbone drove Albrecht to their home where they both took their dose of Chantix. After that, Albrecht became incoherent and violent, breaking a glass and hitting Rathbone. When Rathbone left the house, Albrecht followed and she locked him out. He pounded on the door then went next door and began pounding on the neighbor’s door. The neighbor warned Albrecht to stop and fired a warning shot through the door, which hit Albrecht. Family and friends say that this type of violent behavior was atypical of Albrecht and believe that the use of Chantix caused the events.
Albrecht’s case is not so uncommon when compared to other normally calm people who have taken Chantix. Suits like Albrecht's initiate change and assist in protecting individuals who may have otherwise ingested this dangerous drug.
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