Drug & Device News

No Injury, No Case

A federal district court has found that a woman who has a condition that could be a precursor to osteoporosis but who does not yet have a full-blown case of the disease has no case against a pharmaceuticals manufacturer for damage allegedly done to her when she used its birth-control product. In Colville v. Pharmacia & Upjohn Co. LLC, — F.Supp.2d —-, 2008 WL 2721194 (N.D.Fla. 7/10/08), the 35-year-old plaintiff produced evidence that she had developed osteopenia (loss of bone mineral density). She alleged that the condition was brought on by her use of the injectable birth-control drug known as Depo-Provera, and that the fact that she had osteopenia was a sign that she would probably eventually develop osteoporosis as well. She brought suit against Depo-Provera's manufacturers, who moved for summary judgment. The U.S. District Court for the Northern District of Florida granted the defendants' motion, in part because the plaintiff could not prove that she had suffered an injury, although considering her age and lack of family history for the condition, it was highly probable that her osteopenia was caused by her Depo-Provera use. Significant to the court, however, was the fact that neither plaintiff's nor defendants' experts testified that osteopenia is an actual injury; instead, it is a slow process in the bone that could lead to the injury of osteoporosis. In fact, two experts had stated it was even possible, now that plaintiff was no longer using the birth-control method, that her bones could re-strengthen themselves and her risks of future osteoporosis injury could decrease. As plaintiff failed to allege injury, the court felt compelled to dismiss the case.

California Supreme Court to Decide if Medical Marijuana Limits Stand

California's Supreme Court agreed Aug. 13 to hear an appeal of the recently decided People v. Kelly, B195624, in which a three-judge panel of the Los Angeles Second District Court of Appeal ruled unanimously that the California State Legislature violated the state's constitution when it passed legislation limiting the amount of medical marijuana a patient could possess. As passed by the voters, California's Proposition 215, also known as the Compassionate Use Act of 1996 (CUA), did not specifically limit the amount of marijuana a person could have, although it did limit the amount to that necessary for the patient's own personal medical needs. After California's legislature amended the law in 2003 to limit patients to a maximum of eight ounces of dried pot and six mature or 12 immature marijuana plants, the criminal defendant in Kelly ran afoul of the new limits. The appellate court threw out the conviction, stating that nothing in the voter-approved law permitted the legislature to amend it.

Hip Device Maker Suspends U.S. Sales Pending Surgeon Training

The Durom cup, a hip socket device used in hip replacement surgeries, has been the subject of recent complaints from surgeons and consumers in the United States who claim it has a high failure rate that may require follow-up surgery. In response, the manufacturer, Zimmer Holdings Inc., has temporarily pulled the product from the U.S. market, although it will continue to sell the Durom cup in other countries. The device will go back on the market, according to the company, after it has revised its instructions and surgical training methods so that American surgeons can learn the more reliable implantation techniques used by surgeons with high success rates in other countries. There are some differences between the Durom cups sold inside and outside the United States; it is unclear if these differences contributed to the dissimilar results for American and foreign surgeons.

A copy of the manufacturer's release is available at: http://zimmer.stage.biggs-gilmore.com/web/enUS/pdf/Durom_Backgrounder_on_Status_7-22-081.pdf (last accessed 8/14/08).

FDA Changes Rules for Advisory Committee Participation

The Food and Drug Administration (FDA) is imposing on advisory committee members stricter limits on financial conflicts of interest. FDA advisory committees are groups of experts in their fields formed to help the agency make decisions involving complex medical and scientific issues. According to the agency, 48 such committee meetings were held in 2007. Concerns have arisen in recent years because some of these committee members have had financial ties to the drug companies whose products are under investigation, perhaps because they own stock in those companies or have conducted scientific studies for them. The new rules create a bright-line limit of $50,000 in financial connections any committee member may have with a company affected by a committee decision. Even potential committee members with less than a $50,000 connection to a company may be barred from participation, although FDA officials may grant them a waiver if their expert advice is deemed essential to the question at hand. Any waivers the FDA grants will explain why the exempted adviser's expertise is essential and will describe the extent of that person's personal financial interest in the company. Waivers will all be posted on the FDA's Web site for public viewing in advance of the meeting in which the exempted adviser will participate.

Measles Cases Jump As More Skip Routine Vaccinations

The Centers for Disease Control and Prevention reports that from Jan. 1 of this year through July 31, more cases of measles were reported in the United States than in the same period in any year since 1996. The number of reported cases in the period was 131, with 15 measles sufferers requiring hospitalization. None of the 131 died. The agency's announcement, issued in its Mortality Weekly Report, largely blames the increase in measles cases on parents' decisions to forego childhood vaccinations for their children out of fears that they will contract autism.

To Limit Drug Maker Influence, Stanford Changes Policy

Seeking to limit the influence ' real or perceived ' of drug manufacturers over the medical profession, Stanford University announced on Aug. 26 that it will no longer permit drug companies to earmark which continuing medical education courses they will underwrite with funding. Critics of the former system worried that drug manufacturers that covered only the costs of classes promoting their products wielded undue influence over doctors' medical decisions. Stanford's new system will allow drug companies to contribute to a pool of educational funds, but those funds will be usable by the university for any class, even classes that promote a competitor's product, or no drug product at all.

No Injury, No Case

A federal district court has found that a woman who has a condition that could be a precursor to osteoporosis but who does not yet have a full-blown case of the disease has no case against a pharmaceuticals manufacturer for damage allegedly done to her when she used its birth-control product. In Colville v. Pharmacia & Upjohn Co. LLC, — F.Supp.2d —-, 2008 WL 2721194 (N.D.Fla. 7/10/08), the 35-year-old plaintiff produced evidence that she had developed osteopenia (loss of bone mineral density). She alleged that the condition was brought on by her use of the injectable birth-control drug known as Depo-Provera, and that the fact that she had osteopenia was a sign that she would probably eventually develop osteoporosis as well. She brought suit against Depo-Provera's manufacturers, who moved for summary judgment. The U.S. District Court for the Northern District of Florida granted the defendants' motion, in part because the plaintiff could not prove that she had suffered an injury, although considering her age and lack of family history for the condition, it was highly probable that her osteopenia was caused by her Depo-Provera use. Significant to the court, however, was the fact that neither plaintiff's nor defendants' experts testified that osteopenia is an actual injury; instead, it is a slow process in the bone that could lead to the injury of osteoporosis. In fact, two experts had stated it was even possible, now that plaintiff was no longer using the birth-control method, that her bones could re-strengthen themselves and her risks of future osteoporosis injury could decrease. As plaintiff failed to allege injury, the court felt compelled to dismiss the case.

California Supreme Court to Decide if Medical Marijuana Limits Stand

California's Supreme Court agreed Aug. 13 to hear an appeal of the recently decided People v. Kelly, B195624, in which a three-judge panel of the Los Angeles Second District Court of Appeal ruled unanimously that the California State Legislature violated the state's constitution when it passed legislation limiting the amount of medical marijuana a patient could possess. As passed by the voters, California's Proposition 215, also known as the Compassionate Use Act of 1996 (CUA), did not specifically limit the amount of marijuana a person could have, although it did limit the amount to that necessary for the patient's own personal medical needs. After California's legislature amended the law in 2003 to limit patients to a maximum of eight ounces of dried pot and six mature or 12 immature marijuana plants, the criminal defendant in Kelly ran afoul of the new limits. The appellate court threw out the conviction, stating that nothing in the voter-approved law permitted the legislature to amend it.

Hip Device Maker Suspends U.S. Sales Pending Surgeon Training

The Durom cup, a hip socket device used in hip replacement surgeries, has been the subject of recent complaints from surgeons and consumers in the United States who claim it has a high failure rate that may require follow-up surgery. In response, the manufacturer, Zimmer Holdings Inc., has temporarily pulled the product from the U.S. market, although it will continue to sell the Durom cup in other countries. The device will go back on the market, according to the company, after it has revised its instructions and surgical training methods so that American surgeons can learn the more reliable implantation techniques used by surgeons with high success rates in other countries. There are some differences between the Durom cups sold inside and outside the United States; it is unclear if these differences contributed to the dissimilar results for American and foreign surgeons.

A copy of the manufacturer's release is available at: http://zimmer.stage.biggs-gilmore.com/web/enUS/pdf/Durom_Backgrounder_on_Status_7-22-081.pdf (last accessed 8/14/08).

FDA Changes Rules for Advisory Committee Participation

The Food and Drug Administration (FDA) is imposing on advisory committee members stricter limits on financial conflicts of interest. FDA advisory committees are groups of experts in their fields formed to help the agency make decisions involving complex medical and scientific issues. According to the agency, 48 such committee meetings were held in 2007. Concerns have arisen in recent years because some of these committee members have had financial ties to the drug companies whose products are under investigation, perhaps because they own stock in those companies or have conducted scientific studies for them. The new rules create a bright-line limit of $50,000 in financial connections any committee member may have with a company affected by a committee decision. Even potential committee members with less than a $50,000 connection to a company may be barred from participation, although FDA officials may grant them a waiver if their expert advice is deemed essential to the question at hand. Any waivers the FDA grants will explain why the exempted adviser's expertise is essential and will describe the extent of that person's personal financial interest in the company. Waivers will all be posted on the FDA's Web site for public viewing in advance of the meeting in which the exempted adviser will participate.

Measles Cases Jump As More Skip Routine Vaccinations

The Centers for Disease Control and Prevention reports that from Jan. 1 of this year through July 31, more cases of measles were reported in the United States than in the same period in any year since 1996. The number of reported cases in the period was 131, with 15 measles sufferers requiring hospitalization. None of the 131 died. The agency's announcement, issued in its Mortality Weekly Report, largely blames the increase in measles cases on parents' decisions to forego childhood vaccinations for their children out of fears that they will contract autism.

To Limit Drug Maker Influence, Stanford Changes Policy

Seeking to limit the influence ' real or perceived ' of drug manufacturers over the medical profession, Stanford University announced on Aug. 26 that it will no longer permit drug companies to earmark which continuing medical education courses they will underwrite with funding. Critics of the former system worried that drug manufacturers that covered only the costs of classes promoting their products wielded undue influence over doctors' medical decisions. Stanford's new system will allow drug companies to contribute to a pool of educational funds, but those funds will be usable by the university for any class, even classes that promote a competitor's product, or no drug product at all.