Drug & Device News

Plaintiff Fails to Prove Fracture Caused by Fosomax

In the first case to go to a jury over whether Fosomax causes femur fractures, a New Jersey jury has found for the defense in Glynn v. Merck, Sharp & Dohme Corp., 11-cv-5304. Fosomax, the osteoperosis treatment drug marketed by Merck & Co. Inc., has been accused of exacerbating minor bone-related injuries by interfering with the normal healing process. Of the more than 4,000 plaintiffs in Fosomax suits, many claim femur or other bone injuries, while others complain of jaw problems. The federal jury that heard this first case unanimously concluded that the plaintiff had failed to prove that her femur injuries were of the unusual type that Fosomax is said to cause. Because they came to this conclusion, there was no need for them to move on to other questions raised in the case, including whether Merck gave adequate warnings to doctors of the potential for bone injuries with use of Foxomax. This case joins two others that have ended with defense verdicts for Merck; those others alleged that Fosomax caused jaw necrosis in the plaintiffs.

Vaccine Program Attorney Fees Awarded Despite Late Filing

n May 20, the U.S. Supreme Court affirmed a decision to award attorney fees to a woman whose claim for vaccine-related injuries was dismissed as untimely. The claimant, a doctor who received three Hepatitis-b shots in the period from September 1996 to April 1997, filed a claim in accordance with the National Childhood Vaccine Injury Act (NCVIA) of 1986 (42 U.S.C. ” 300aa-1 to 300aa-34). She asserted that soon after the third injection, she began to experience numbness in some of her extremities, and she sought medical assistance. No diagnosis could be made, however, until 2003, when the claimant's symptoms had worsened. That is when she was told she had Multiple Sclerosis (MS). In September 2004, the claimant learned that there is a known link between Hepatitis-b vaccines and the development of MS. She filed a claim for compensation from the National Vaccine Injury Compensation Program (the Program) in September 2005. The claim was ultimately denied, as the right to receive recovery through the Program is subject to a 36-month statute of imitations period. That period starts to run when a claimant first begins to experience symptoms, and not when she realizes that those symptoms might be vaccine-related.

When a claimant receives compensation through the Program, her reasonable attorney fees are paid as well, in accordance with the NCVIA. However, if she is not deemed eligible for compensation, attorney fees may (but need not be) paid, at the discretion of the court if “the petition was brought in good faith and there was a reasonable basis for the claim for which the petition was brought.” 42 U.S.C. ' 300aa-15(e). The en banc U.S. Court of Appeals for the Federal Circuit agreed with the claimant that she was eligible to receive attorney-fee compensation, but six of its judges dissented, and the government appealled.

The federal government argued before the Supreme Court that because the NCVIA sets a limitations period, a claim filed after the authorized period is, in effect, no claim at all; the claimant therefore should not be able to recover attorney fees. But the Supreme Court affirmed the Federal Circuit's determination that Dr. Cloer could recover attorney fees, explaining: “The Government asks us to adopt a different definition of the term 'filed' for a single subsection so that for fees purposes, and only for fees purposes, a petition filed out of time must be treated retroactively as though it was never filed in the first place. Nothing in the text or structure of the statute requires the unusual result the Government asks us to accept. ' That 'no petition may be filed for compensation' after the limitations period has run does not mean that a late petition was never filed at all.”

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Judge Intervenes to Help Young Lung Transplant Hopeful

On June 6, a U.S. District Court judge issued a' restraining order temporarily forbidding the enforcement in the case of 10-year-old Sarah Murnaghan of a rule that permits children under 12 years of age to receive donated lungs only from other children. Although young children can theoretically receive adult lung donations, they are currently placed at the end of the general nationwide lung transplant list, behind adults with less serious medical need. The rationale for this policy is that lung transplants are difficult to successfully perform, and successful transplants are more likely when the recipients are adults. Because there are more than 1,500 adults on the nationwide waiting list, young children on the list are not likely to see their turns come up.

The ruling in the Murnaghan case is raising ethical questions about the role of judges in making medical decisions, and about the rush to the courthouse the decision may encourage by desperate would-be transplant recipients unhappy with policies that adversely affect their personal chances for recovery.

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Plaintiff Fails to Prove Fracture Caused by Fosomax

In the first case to go to a jury over whether Fosomax causes femur fractures, a New Jersey jury has found for the defense in Glynn v. Merck, Sharp & Dohme Corp., 11-cv-5304. Fosomax, the osteoperosis treatment drug marketed by Merck & Co. Inc., has been accused of exacerbating minor bone-related injuries by interfering with the normal healing process. Of the more than 4,000 plaintiffs in Fosomax suits, many claim femur or other bone injuries, while others complain of jaw problems. The federal jury that heard this first case unanimously concluded that the plaintiff had failed to prove that her femur injuries were of the unusual type that Fosomax is said to cause. Because they came to this conclusion, there was no need for them to move on to other questions raised in the case, including whether Merck gave adequate warnings to doctors of the potential for bone injuries with use of Foxomax. This case joins two others that have ended with defense verdicts for Merck; those others alleged that Fosomax caused jaw necrosis in the plaintiffs.

Vaccine Program Attorney Fees Awarded Despite Late Filing

n May 20, the U.S. Supreme Court affirmed a decision to award attorney fees to a woman whose claim for vaccine-related injuries was dismissed as untimely. The claimant, a doctor who received three Hepatitis-b shots in the period from September 1996 to April 1997, filed a claim in accordance with the National Childhood Vaccine Injury Act (NCVIA) of 1986 (42 U.S.C. ” 300aa-1 to 300aa-34). She asserted that soon after the third injection, she began to experience numbness in some of her extremities, and she sought medical assistance. No diagnosis could be made, however, until 2003, when the claimant's symptoms had worsened. That is when she was told she had Multiple Sclerosis (MS). In September 2004, the claimant learned that there is a known link between Hepatitis-b vaccines and the development of MS. She filed a claim for compensation from the National Vaccine Injury Compensation Program (the Program) in September 2005. The claim was ultimately denied, as the right to receive recovery through the Program is subject to a 36-month statute of imitations period. That period starts to run when a claimant first begins to experience symptoms, and not when she realizes that those symptoms might be vaccine-related.

When a claimant receives compensation through the Program, her reasonable attorney fees are paid as well, in accordance with the NCVIA. However, if she is not deemed eligible for compensation, attorney fees may (but need not be) paid, at the discretion of the court if “the petition was brought in good faith and there was a reasonable basis for the claim for which the petition was brought.” 42 U.S.C. ' 300aa-15(e). The en banc U.S. Court of Appeals for the Federal Circuit agreed with the claimant that she was eligible to receive attorney-fee compensation, but six of its judges dissented, and the government appealled.

The federal government argued before the Supreme Court that because the NCVIA sets a limitations period, a claim filed after the authorized period is, in effect, no claim at all; the claimant therefore should not be able to recover attorney fees. But the Supreme Court affirmed the Federal Circuit's determination that Dr. Cloer could recover attorney fees, explaining: “The Government asks us to adopt a different definition of the term 'filed' for a single subsection so that for fees purposes, and only for fees purposes, a petition filed out of time must be treated retroactively as though it was never filed in the first place. Nothing in the text or structure of the statute requires the unusual result the Government asks us to accept. ' That 'no petition may be filed for compensation' after the limitations period has run does not mean that a late petition was never filed at all.”

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Judge Intervenes to Help Young Lung Transplant Hopeful

On June 6, a U.S. District Court judge issued a' restraining order temporarily forbidding the enforcement in the case of 10-year-old Sarah Murnaghan of a rule that permits children under 12 years of age to receive donated lungs only from other children. Although young children can theoretically receive adult lung donations, they are currently placed at the end of the general nationwide lung transplant list, behind adults with less serious medical need. The rationale for this policy is that lung transplants are difficult to successfully perform, and successful transplants are more likely when the recipients are adults. Because there are more than 1,500 adults on the nationwide waiting list, young children on the list are not likely to see their turns come up.

The ruling in the Murnaghan case is raising ethical questions about the role of judges in making medical decisions, and about the rush to the courthouse the decision may encourage by desperate would-be transplant recipients unhappy with policies that adversely affect their personal chances for recovery.

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