Drug & Device News

Bill Seeks Greater Oversight of Some Devices

On Dec. 14, 2011, Senators Charles Grassley (R-IA), Richard Blumenthal (D-CT) and Herb Kohl (D-WI) introduced legislation in the U.S. Senate that would increase U.S. Food and Drug Administration (FDA) oversight of some medical implant products. If passed, the Medical Device Patient Safety Act would permit the FDA to better monitor the safety of implanted medical devices by requiring manufacturers to agree to collect post-market safety data as a condition of approval to market their devices to the public. While this type of data is currently required only of manufacturers of the highest-risk devices ' those that have been approved through the rigorous Pre-market Approval (PMA) process ' the new legislation would extend the agency's post-market surveillance powers to cover devices that have entered the market under the 510(k) system. (A device cleared under the 510(k) system must be shown to be substantially equivalent to a product already on the market, but it is not itself approved by the FDA as a safe product.) As part of their impetus for introducing the bill, its authors cited to concerns raised by the Government Accountability Office (GAO) when it placed the FDA on its “high risk list” (see www.gao.gov/highrisk/risks/safety-security/public_health.php), as well as to the case of the DePuy hip implant, which was recalled only after the FDA and the manufacturer learned through foreign registries that patients were experiencing problems with the device. If the bill becomes law, manufacturers failing to conduct required post-market monitoring of their product's safety could find their permission to sell rescinded.

Drug Manufacturer's Corporate Citizenship
Argument Fails

In a December 2011 opinion issued in the case of Brewer v. SmithKline Beecham Corp., U.S. District Judge Timothy J. Savage reiterated his March 2011 conclusion that GlaxoSmithKline is a citizen of Pennsylvania for purposes of federal diversity jurisdiction. The pharmaceuticals manufacturer argued that it was a citizen of Delaware because in October 2009 the Pennsylvania corporation, SmithKline Beecham Corp., converted into a Delaware LLC, GlaxoSmithKline LLC. The only member of the LLC is holding company GlaxoSmithKline Holdings (Americas) Inc. Citing to the U.S. Supreme Court's Hertz Corp. v. Friend “nerve center” test for corporate citizenship ' which says that a corporation's principal place of business should be determined by where the business is directed, controlled and coordinated ' Judge Savage concluded that the drug company's nerve center was not the holding company but the LLC. “Literally applying the Hertz 'nerve center' test, without analyzing the facts surrounding the operational decision-making, would exalt form over substance,” Judge Savage wrote. “Because LLC's pharmaceutical and consumer health care business is directed, controlled and coordinated from Philadelphia, and LLC is the primary and significant part of [GSK] Holdings' business, Holdings' 'nerve center' is in Pennsylvania where its principal place of business is located.”

Drug Company Execs Get Jail Time for Unauthorized Testing

Three former executives of pharmaceutical products manufacturer Synthes Inc. were sentenced to jail terms of up to nine months after pleading guilty to violating the Food Drug and Cosmetic Act (FDCA) by conducting unapproved medical experiments on human subjects. The three were held responsible as corporate officers. The charges stemmed from testing of the bone cement Norian XR on patients with spine fractures, although the FDA was not informed of this new use for a product approved only for use on human arms. Three of the approximately 200 spinal patients treated with the Norian XR died, although their deaths could not definitively be tied to the product's use. Nonetheless, although the applicable sentencing guidelines for the crimes committed ranged from zero to six months of incarceration, Judge Legrome D. Davis of the U.S. District Court for the Eastern District of Pennsylvania chose to impose longer sentences on some of the defendants. He explained that a Guidelines sentence “would not adequately address the unprecedented nature of the criminal conduct of [the defendants]. The scope of their scheme is without parallel, the risks created for an unsuspecting public were grave, and the scale of the deception of the Food and Drug Administration can only be characterized as extreme.”

Heart Defibrillator Leads Recalled

St. Jude Medical sent medical advisory letters to physicians on Nov. 28, 2011, informing them that the manufacturer's Riata defibrillator leads, which it no longer sells, are more prone to failure than was previously reported. The products (Riata (8F) Silicone Endocardial Defibrillation Leads (Models 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, and 1592), and the Riata ST (7Fr) Silicone Endocardial Defibrillation Leads (Models 7000, 7001, 7002, 7010, 7011, 7040, 7041, and 7042)) were pulled from the market in December 2010, but they are currently implanted in approximately 79,000 patients. When these leads become compromised, they might deliver a shock to a patient when they should not, or fail to do so when they should. The company does not recommend wholesale replacement of the leads, but has offered some practical guidance to physicians managing patients who are using the affected devices. That advice can be found at: http://investors.sjm.com/phoenix.zhtml?c=73836&p=irol-newsArticle&ID=1640339.

Bill Seeks Greater Oversight of Some Devices

On Dec. 14, 2011, Senators Charles Grassley (R-IA), Richard Blumenthal (D-CT) and Herb Kohl (D-WI) introduced legislation in the U.S. Senate that would increase U.S. Food and Drug Administration (FDA) oversight of some medical implant products. If passed, the Medical Device Patient Safety Act would permit the FDA to better monitor the safety of implanted medical devices by requiring manufacturers to agree to collect post-market safety data as a condition of approval to market their devices to the public. While this type of data is currently required only of manufacturers of the highest-risk devices ' those that have been approved through the rigorous Pre-market Approval (PMA) process ' the new legislation would extend the agency's post-market surveillance powers to cover devices that have entered the market under the 510(k) system. (A device cleared under the 510(k) system must be shown to be substantially equivalent to a product already on the market, but it is not itself approved by the FDA as a safe product.) As part of their impetus for introducing the bill, its authors cited to concerns raised by the Government Accountability Office (GAO) when it placed the FDA on its “high risk list” (see www.gao.gov/highrisk/risks/safety-security/public_health.php), as well as to the case of the DePuy hip implant, which was recalled only after the FDA and the manufacturer learned through foreign registries that patients were experiencing problems with the device. If the bill becomes law, manufacturers failing to conduct required post-market monitoring of their product's safety could find their permission to sell rescinded.

Drug Manufacturer's Corporate Citizenship
Argument Fails

In a December 2011 opinion issued in the case of Brewer v. SmithKline Beecham Corp., U.S. District Judge Timothy J. Savage reiterated his March 2011 conclusion that GlaxoSmithKline is a citizen of Pennsylvania for purposes of federal diversity jurisdiction. The pharmaceuticals manufacturer argued that it was a citizen of Delaware because in October 2009 the Pennsylvania corporation, SmithKline Beecham Corp., converted into a Delaware LLC, GlaxoSmithKline LLC. The only member of the LLC is holding company GlaxoSmithKline Holdings (Americas) Inc. Citing to the U.S. Supreme Court's Hertz Corp. v. Friend “nerve center” test for corporate citizenship ' which says that a corporation's principal place of business should be determined by where the business is directed, controlled and coordinated ' Judge Savage concluded that the drug company's nerve center was not the holding company but the LLC. “Literally applying the Hertz 'nerve center' test, without analyzing the facts surrounding the operational decision-making, would exalt form over substance,” Judge Savage wrote. “Because LLC's pharmaceutical and consumer health care business is directed, controlled and coordinated from Philadelphia, and LLC is the primary and significant part of [GSK] Holdings' business, Holdings' 'nerve center' is in Pennsylvania where its principal place of business is located.”

Drug Company Execs Get Jail Time for Unauthorized Testing

Three former executives of pharmaceutical products manufacturer Synthes Inc. were sentenced to jail terms of up to nine months after pleading guilty to violating the Food Drug and Cosmetic Act (FDCA) by conducting unapproved medical experiments on human subjects. The three were held responsible as corporate officers. The charges stemmed from testing of the bone cement Norian XR on patients with spine fractures, although the FDA was not informed of this new use for a product approved only for use on human arms. Three of the approximately 200 spinal patients treated with the Norian XR died, although their deaths could not definitively be tied to the product's use. Nonetheless, although the applicable sentencing guidelines for the crimes committed ranged from zero to six months of incarceration, Judge Legrome D. Davis of the U.S. District Court for the Eastern District of Pennsylvania chose to impose longer sentences on some of the defendants. He explained that a Guidelines sentence “would not adequately address the unprecedented nature of the criminal conduct of [the defendants]. The scope of their scheme is without parallel, the risks created for an unsuspecting public were grave, and the scale of the deception of the Food and Drug Administration can only be characterized as extreme.”

Heart Defibrillator Leads Recalled

St. Jude Medical sent medical advisory letters to physicians on Nov. 28, 2011, informing them that the manufacturer's Riata defibrillator leads, which it no longer sells, are more prone to failure than was previously reported. The products (Riata (8F) Silicone Endocardial Defibrillation Leads (Models 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, and 1592), and the Riata ST (7Fr) Silicone Endocardial Defibrillation Leads (Models 7000, 7001, 7002, 7010, 7011, 7040, 7041, and 7042)) were pulled from the market in December 2010, but they are currently implanted in approximately 79,000 patients. When these leads become compromised, they might deliver a shock to a patient when they should not, or fail to do so when they should. The company does not recommend wholesale replacement of the leads, but has offered some practical guidance to physicians managing patients who are using the affected devices. That advice can be found at: http://investors.sjm.com/phoenix.zhtml?c=73836&p=irol-newsArticle&ID=1640339.