Drug & Device News

Study: Testosterone Therapy Not As Innocuous As Previously Thought

A study published in the online journal PLOS One says that the dangers of testosterone boosters are being overlooked, just as their benefits are being oversold to doctors and men experiencing, perhaps, only the effects of normal aging. Finkle WD, Greenland S, Ridgeway GK, Adams JL, Frasco MA, et al. (2014) Increased Risk of Non-Fatal Myocardial Infarction Following Testosterone Therapy Prescription in Men. PLoS ONE 9(1): e85805. doi:10.1371/journal.pone.0085805. The article, which is available online without fee or subscription, states that in men over the age of 65 with no previous history of miocardial infarction (MI) the likelihood of experiencing MI in the 90 days following an initial prescription of testosterone therapy (TT) was double that of men who did not begin such therapy. In younger men with no previous history of MI, this increased risk was not observed. However, among the younger men who did have a history of cardiac disease (about 10% of these younger men), there was a two- to three-fold increase in the risk of MI during the 90 days following first prescription. These statistics, coupled with the fact that many men are prescribed TT even though they have not been medically tested to see if they actually do have low testosterone levels that warrant treatment, trouble the study's authors, who recommend that physicians discuss the increased risk of MI with their patients before prescribing testosterone therapy drugs.

Does Advertising Cancel Out Written Warnings?

The plaintiffs in an MDL seeking damages from drug makers McNeil-PPC and Johnson & Johnson for liver damage suffered after use of Tylenol are asking to depose the defendants concerning their marketing strategies over a 44-year period. Defendants oppose such discovery, arguing that the plaintiffs' theory “posits that failure-to-warn liability may be imposed despite entirely adequate warnings furnished with the product itself, because general statements in advertising that the product is 'safe' or 'doctor recommended' somehow nullifies the adequate warnings on the label, or excuses the consumer from reading those warning. This novel theory has no support in any relevant law.”

Vaginal-Mesh Defendant Wants Access to Medical Accounts

American Medical Systems Inc., a maker of vaginal mesh devices that faces more than 13,000 lawsuits, has joined ranks with another vaginal-mesh defendant in fighting to enforce subpoenas against a company that purchses medical accounts receivable. Medstar Funding LC and Medstar president Daniel Christensen have made motions to quash or modify the subpoenas issued by American Medical Systems (AMS) and C.R. Bard Inc. to third parties, if the result would be the revelation of the amounts MedStar pays to medical service providers.

AMS, however, insists that information that has already been disclosed by Medstar to third parties is no longer confidential commercial information. “AMS is entitled to this information, as the actual amounts paid to plaintiffs' medical providers are directly relevant to their damages claims, especially if this amount if dramatically less than as claimed in the providers' bills, or is the result of a non-arm's length, pre-surgery agreement between Medstar and the other parties,” AMS said.

While one trial issue would involve the costs incurred by plaintiffs for mesh-revision surgery, at least one case showed that a surgical center billed $24,000 and a surgeon $14,200, but the surgical center was paid $2,000 and the surgeon $2,500, AMS said. “Given this wide disparity in the amount that was billed versus the amount that was actually paid for a mesh revision surgery, and the corresponding difference in any potential damages claim, the information that Medstar seeks to conceal is directly relevant to AMS's rebuttal of plaintiff's damages claims,” AMS said.

The difference between the reduced rate paid for account receivables and the actual higher price MedStar receives upon “disposition of a receivable” is the gross profit realized by MedStar, and disclosure to buyers and sellers would “place MedStar in a serious disadvantage in a very competitive marketplace,” MedStar said in court papers.

Vaginal mesh is used to treat pelvic prolapse and urinary incontinence in women but has been blamed for complications including pain, infection and perforated organs. ' Amaris Elliott-Engle , The National Law Journal

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FDA Approves Opioid Overdose Injector for Use By Family Members

On April 3, the FDA approved the sale of Evzio (naloxone hydrochloride injection), a single-dose drug and delivery system to counteract opioid overdose, which, according to the FDA, is the most common cause of injury-induced death in the United States. It is meant to be carried in the purse or pocket or stored in the medicine cabinet and to be used by caregivers or family members of those known or suspected to be abusing prescription or illicit opioid drugs. Prior to Evzio's approval, naloxone had to be administered through a syringe by trained medical personnel, which often required a delay in treatment.

Those who expect they may need to use Evzio on someone who has overdosed are being advised to become familiar with how it works and is administered, by practicing with the training device included with the product. Further information can be found at http://1.usa.gov/1gWFCor.

Study: Testosterone Therapy Not As Innocuous As Previously Thought

A study published in the online journal PLOS One says that the dangers of testosterone boosters are being overlooked, just as their benefits are being oversold to doctors and men experiencing, perhaps, only the effects of normal aging. Finkle WD, Greenland S, Ridgeway GK, Adams JL, Frasco MA, et al. (2014) Increased Risk of Non-Fatal Myocardial Infarction Following Testosterone Therapy Prescription in Men. PLoS ONE 9(1): e85805. doi:10.1371/journal.pone.0085805. The article, which is available online without fee or subscription, states that in men over the age of 65 with no previous history of miocardial infarction (MI) the likelihood of experiencing MI in the 90 days following an initial prescription of testosterone therapy (TT) was double that of men who did not begin such therapy. In younger men with no previous history of MI, this increased risk was not observed. However, among the younger men who did have a history of cardiac disease (about 10% of these younger men), there was a two- to three-fold increase in the risk of MI during the 90 days following first prescription. These statistics, coupled with the fact that many men are prescribed TT even though they have not been medically tested to see if they actually do have low testosterone levels that warrant treatment, trouble the study's authors, who recommend that physicians discuss the increased risk of MI with their patients before prescribing testosterone therapy drugs.

Does Advertising Cancel Out Written Warnings?

The plaintiffs in an MDL seeking damages from drug makers McNeil-PPC and Johnson & Johnson for liver damage suffered after use of Tylenol are asking to depose the defendants concerning their marketing strategies over a 44-year period. Defendants oppose such discovery, arguing that the plaintiffs' theory “posits that failure-to-warn liability may be imposed despite entirely adequate warnings furnished with the product itself, because general statements in advertising that the product is 'safe' or 'doctor recommended' somehow nullifies the adequate warnings on the label, or excuses the consumer from reading those warning. This novel theory has no support in any relevant law.”

Vaginal-Mesh Defendant Wants Access to Medical Accounts

American Medical Systems Inc., a maker of vaginal mesh devices that faces more than 13,000 lawsuits, has joined ranks with another vaginal-mesh defendant in fighting to enforce subpoenas against a company that purchses medical accounts receivable. Medstar Funding LC and Medstar president Daniel Christensen have made motions to quash or modify the subpoenas issued by American Medical Systems (AMS) and C.R. Bard Inc. to third parties, if the result would be the revelation of the amounts MedStar pays to medical service providers.

AMS, however, insists that information that has already been disclosed by Medstar to third parties is no longer confidential commercial information. “AMS is entitled to this information, as the actual amounts paid to plaintiffs' medical providers are directly relevant to their damages claims, especially if this amount if dramatically less than as claimed in the providers' bills, or is the result of a non-arm's length, pre-surgery agreement between Medstar and the other parties,” AMS said.

While one trial issue would involve the costs incurred by plaintiffs for mesh-revision surgery, at least one case showed that a surgical center billed $24,000 and a surgeon $14,200, but the surgical center was paid $2,000 and the surgeon $2,500, AMS said. “Given this wide disparity in the amount that was billed versus the amount that was actually paid for a mesh revision surgery, and the corresponding difference in any potential damages claim, the information that Medstar seeks to conceal is directly relevant to AMS's rebuttal of plaintiff's damages claims,” AMS said.

The difference between the reduced rate paid for account receivables and the actual higher price MedStar receives upon “disposition of a receivable” is the gross profit realized by MedStar, and disclosure to buyers and sellers would “place MedStar in a serious disadvantage in a very competitive marketplace,” MedStar said in court papers.

Vaginal mesh is used to treat pelvic prolapse and urinary incontinence in women but has been blamed for complications including pain, infection and perforated organs. ' Amaris Elliott-Engle , The National Law Journal

'

FDA Approves Opioid Overdose Injector for Use By Family Members

On April 3, the FDA approved the sale of Evzio (naloxone hydrochloride injection), a single-dose drug and delivery system to counteract opioid overdose, which, according to the FDA, is the most common cause of injury-induced death in the United States. It is meant to be carried in the purse or pocket or stored in the medicine cabinet and to be used by caregivers or family members of those known or suspected to be abusing prescription or illicit opioid drugs. Prior to Evzio's approval, naloxone had to be administered through a syringe by trained medical personnel, which often required a delay in treatment.

Those who expect they may need to use Evzio on someone who has overdosed are being advised to become familiar with how it works and is administered, by practicing with the training device included with the product. Further information can be found at http://1.usa.gov/1gWFCor.