Drug & Device News

Diagnostic Imaging Agent Pulled from Market

The FDA has issued a Public Health Advisory to inform health care providers the agency has requested the market withdrawal of the diagnostic imaging agent NeutroSpec (Technetium (99m TC) Fanolesomab) pending review of reported deaths and serious and life-threatening adverse events associated with use of the product. NeutroSpec, approved for marketing in July 2004, is a diagnostic imaging agent administered intravenously to help diagnose appendicitis in patients 5 years and older with possible appendicitis who lack its conventional signs and symptoms. News of these adverse events, including severe allergic reactions in certain patients shortly after being administered NeutroSpec, were reported to the FDA as part of the agency's post-market surveillance program. As all of the reactions occurred immediately after Neutro-Spec was administered, there is no indication that patients who already safely received the drug face any long-term risk.

Many 'Canadian' Imports Are Anything But

The FDA warned consumers and health care providers on Dec. 16 that an investigation it conducted in the summer of 2005, called “Bait and Switch,” revealed that many drugs supposedly imported from Canadian pharmacies by American consumers are not Canadian at all. The FDA conducted its operation over the course of a few days in August 2005 at JFK Airport in New York City, Miami International Airport, and Los Angeles International Airport. The agency examined all mail parcels suspected of containing pharmaceuticals sent from four countries — India, Israel, Costa Rica, and Vanuatu – that the FDA had previously noticed were sources of drugs apparently ordered from pharmacies alleged to be Canadian in origin. Out of nearly 4000 parcels examined, almost 1700 (about 43%) had been ordered from “Canadian” Internet pharmacies and were represented as being of Canadian origin. In fact, only 15% of the so-called “Canadian” drugs actually originated in Canada. The remainder came from 27 countries around the globe. A number of these products also were found to be counterfeit.

According to Dr. Andrew von Eschenbach, Acting FDA Commissioner, “These results make clear there are Internet sites that claim to be 'Canadian' that, in fact, are peddling drugs of dubious origin, safety, and efficacy. We believe that these 'bait and switch' tactics-offering patients one thing and then giving them something else are misleading to patients and potentially harmful to the public health.”

Proponents of a right to import pharmaceutical products argue that Americans are being unfairly forced to pay far greater prices for medications than citizens of other countries. Canadian pharmaceutical suppliers are widely considered to be the most reliable and safest sources for imported drug products. The FDA, however, has consistently fought the legalization of imported drugs, although it does not press for prosecution of individuals buying such products for their own use.

Hemodialysis Instrument Recalled

Baxter Healthcare Corporation of Deerfield, IL, has initiated a worldwide recall of its Meridian Hemodialysis Instrument because of reports of hemolysis (red blood cell destruction) that can result in kidney damage, anemia, and other serious health consequences. The hemolysis is caused by kinking in the blood tubing sets used with the Meridian. This has contributed to one death and one serious injury. The affected devices are all Meridian Instruments with model numbers 5M5576 and 5M5576R. There are over 2800 units currently in use, with approximately 2100 devices in the United States.

Users of the Meridian do not have to return the product to Baxter. The company is instructing users to route blood tubing through only one channel of the two channel clips mounted on the front of the Meridian to reduce the chances of kinking. This means that users should clamp the tubing in only one place, not two, to avoid causing hemolysis. (The original labeling for the device instructs users to route the blood tubing sets through both channels of the two-channel clips.) The firm also is instructing users to continuously verify by visual inspection that the tubing is not kinked.

DES Daughter Gets Day in Court

Eli Lilly & Co., former manufacturer of the anti-miscarriage drug Diethylstilbestrol (DES), recently lost its bid to have a case against it dismissed on the basis that it was brought outside the limitations period and that the plaintiff could not positively identify Eli Lilly as the manufacturer of the pills her mother ingested. Gassman v. Eli Lilly and Company, 2005 U.S. Dist. LEXIS 38112 (D.D.C. 12/29/05).

The plaintiff's mother, Lois Tholke, took DES beginning in 1968. DES is a synthetic estrogen that was developed and prescribed in the mid-20th century to prevent miscarriages and premature deliveries. It was pulled from the market in 1971 because of its links to a rare vaginal cancer in female children. Gassman is infertile because of cervical and uterine malformations she asserts were caused by DES.

Eli Lilly filed a motion for summary judgment on Dec. 1, 2004, arguing that all of Gassman's claims should be dismissed because they were barred by the District of Columbia's statute of limitations and because Gassman could not identify Eli Lilly as the manufacturer of the drug at issue in the case.

Gassman claimed that it was not until 2002, “at the earliest,” that she ever had any indication that her reproductive problems might be traced to her mother's use of DES. Under the “discovery rule” of the District of Columbia (the forum jurisdiction, and thus the supplier of the law on the procedural issue of a statute of limitations), a plaintiff can overcome the normal 3-year limitation period for filing her claim if she cannot discover the cause of injury because that cause is obscure. In such cases, the statute of limitations does not begin to run until the plaintiff knows (or by the exercise of reasonable diligence should know): “1) of the existence of the injury; 2) its cause in fact; and 3) of some evidence of wrongdoing.” Bussineau v. President of Directors of Georgetown Coll., 518 A2d 423 (D.C. 1986). Eli Lilly argued that Gassman was placed on inquiry notice in 1999 when she “acknowledged her awareness of her reproductive injuries and their cause.” At this point, defendant claimed, Gassman was under an obligation to investigate whether her injuries were the result of some wrongdoing.

Gassman denied that her doctors ever informed her that her problems could be caused by DES exposure and stated she believed her fertility issues were the result of her husband's health problems. The court, in declining to dismiss on this ground, reasoned that, at this stage of the proceedings, it was required to believe the evidence of the non-movant and to draw all reasonable inferences in her favor. Doing so, it accepted that Gassman was unaware of DES litigation prior to 2002, that she believed that her infertility was due to a fertility problem her husband had, and that she never suspected that Eli Lilly was guilty of any wrongdoing.

Similarly, Eli Lilly's contention that the plaintiff could not recover because she could not positively identify it as the manufacturer of the particular drug Tholke took was inadequate. (At the time she was taking the pills, 75 companies were marketing DES, many of whom produced it in the form of the small white pills Tholke described.) To show that Eli Lilly was the manufacturer that made the pills Tholke took, plaintiff produced the affidavit of the current owner of the pharmacy where Tholke filled her prescriptions in 1968. This pharmacist stated that although he did not own the store in 1968, he knew the pharmacist there well, visited with him often and personally observed that “the sole and exclusive brand of DES in the store was the Eli Lilly Brand, from the late 60s through the time I actually bought the store” in 1975. This, along with Tholke's description of pills that matched those produced by Eli Lilly, were enough to create a triable question of fact for a jury. Therefore, the court denied the motion to dismiss.

More Guidant Device Failures

Since the FDA's last public notification of problems with Guidant implantable cardioverter defibrillator devices on Oct. 13, 2005, 35 more clinical failures have occurred, including five patient deaths. Health care providers should take these failures into account as they continue to follow the patients who have either the Contak Renewal' or Renewal' 2 devices. Guidant has also informed the agency of four additional clinical failures for the Ventak Prizm' 2DR device.

Kidney Failure Possible with Colonoscopy Prep

The New York Times reports that a study conducted by the Columbia College of Physicians and Surgeons has uncovered a potential problem with bowel-cleaning solutions made with sodium phosphate ingested by patients prior to undergoing colonoscopies; kidney failures can ensue in certain cases, sometimes requiring permanent dialysis. (Franklin, The New York Times 12/27/05.) The study was published in the November issue of the Journal of the American Society of Nephrology.

Diagnostic Imaging Agent Pulled from Market

The FDA has issued a Public Health Advisory to inform health care providers the agency has requested the market withdrawal of the diagnostic imaging agent NeutroSpec (Technetium (99m TC) Fanolesomab) pending review of reported deaths and serious and life-threatening adverse events associated with use of the product. NeutroSpec, approved for marketing in July 2004, is a diagnostic imaging agent administered intravenously to help diagnose appendicitis in patients 5 years and older with possible appendicitis who lack its conventional signs and symptoms. News of these adverse events, including severe allergic reactions in certain patients shortly after being administered NeutroSpec, were reported to the FDA as part of the agency's post-market surveillance program. As all of the reactions occurred immediately after Neutro-Spec was administered, there is no indication that patients who already safely received the drug face any long-term risk.

Many 'Canadian' Imports Are Anything But

The FDA warned consumers and health care providers on Dec. 16 that an investigation it conducted in the summer of 2005, called “Bait and Switch,” revealed that many drugs supposedly imported from Canadian pharmacies by American consumers are not Canadian at all. The FDA conducted its operation over the course of a few days in August 2005 at JFK Airport in New York City, Miami International Airport, and Los Angeles International Airport. The agency examined all mail parcels suspected of containing pharmaceuticals sent from four countries — India, Israel, Costa Rica, and Vanuatu – that the FDA had previously noticed were sources of drugs apparently ordered from pharmacies alleged to be Canadian in origin. Out of nearly 4000 parcels examined, almost 1700 (about 43%) had been ordered from “Canadian” Internet pharmacies and were represented as being of Canadian origin. In fact, only 15% of the so-called “Canadian” drugs actually originated in Canada. The remainder came from 27 countries around the globe. A number of these products also were found to be counterfeit.

According to Dr. Andrew von Eschenbach, Acting FDA Commissioner, “These results make clear there are Internet sites that claim to be 'Canadian' that, in fact, are peddling drugs of dubious origin, safety, and efficacy. We believe that these 'bait and switch' tactics-offering patients one thing and then giving them something else are misleading to patients and potentially harmful to the public health.”

Proponents of a right to import pharmaceutical products argue that Americans are being unfairly forced to pay far greater prices for medications than citizens of other countries. Canadian pharmaceutical suppliers are widely considered to be the most reliable and safest sources for imported drug products. The FDA, however, has consistently fought the legalization of imported drugs, although it does not press for prosecution of individuals buying such products for their own use.

Hemodialysis Instrument Recalled

Baxter Healthcare Corporation of Deerfield, IL, has initiated a worldwide recall of its Meridian Hemodialysis Instrument because of reports of hemolysis (red blood cell destruction) that can result in kidney damage, anemia, and other serious health consequences. The hemolysis is caused by kinking in the blood tubing sets used with the Meridian. This has contributed to one death and one serious injury. The affected devices are all Meridian Instruments with model numbers 5M5576 and 5M5576R. There are over 2800 units currently in use, with approximately 2100 devices in the United States.

Users of the Meridian do not have to return the product to Baxter. The company is instructing users to route blood tubing through only one channel of the two channel clips mounted on the front of the Meridian to reduce the chances of kinking. This means that users should clamp the tubing in only one place, not two, to avoid causing hemolysis. (The original labeling for the device instructs users to route the blood tubing sets through both channels of the two-channel clips.) The firm also is instructing users to continuously verify by visual inspection that the tubing is not kinked.

DES Daughter Gets Day in Court

Eli Lilly & Co., former manufacturer of the anti-miscarriage drug Diethylstilbestrol (DES), recently lost its bid to have a case against it dismissed on the basis that it was brought outside the limitations period and that the plaintiff could not positively identify Eli Lilly as the manufacturer of the pills her mother ingested. Gassman v. Eli Lilly and Company, 2005 U.S. Dist. LEXIS 38112 (D.D.C. 12/29/05).

The plaintiff's mother, Lois Tholke, took DES beginning in 1968. DES is a synthetic estrogen that was developed and prescribed in the mid-20th century to prevent miscarriages and premature deliveries. It was pulled from the market in 1971 because of its links to a rare vaginal cancer in female children. Gassman is infertile because of cervical and uterine malformations she asserts were caused by DES.

Eli Lilly filed a motion for summary judgment on Dec. 1, 2004, arguing that all of Gassman's claims should be dismissed because they were barred by the District of Columbia's statute of limitations and because Gassman could not identify Eli Lilly as the manufacturer of the drug at issue in the case.

Gassman claimed that it was not until 2002, “at the earliest,” that she ever had any indication that her reproductive problems might be traced to her mother's use of DES. Under the “discovery rule” of the District of Columbia (the forum jurisdiction, and thus the supplier of the law on the procedural issue of a statute of limitations), a plaintiff can overcome the normal 3-year limitation period for filing her claim if she cannot discover the cause of injury because that cause is obscure. In such cases, the statute of limitations does not begin to run until the plaintiff knows (or by the exercise of reasonable diligence should know): “1) of the existence of the injury; 2) its cause in fact; and 3) of some evidence of wrongdoing.” Bussineau v. President of Directors of Georgetown Coll. , 518 A2d 423 (D.C. 1986). Eli Lilly argued that Gassman was placed on inquiry notice in 1999 when she “acknowledged her awareness of her reproductive injuries and their cause.” At this point, defendant claimed, Gassman was under an obligation to investigate whether her injuries were the result of some wrongdoing.

Gassman denied that her doctors ever informed her that her problems could be caused by DES exposure and stated she believed her fertility issues were the result of her husband's health problems. The court, in declining to dismiss on this ground, reasoned that, at this stage of the proceedings, it was required to believe the evidence of the non-movant and to draw all reasonable inferences in her favor. Doing so, it accepted that Gassman was unaware of DES litigation prior to 2002, that she believed that her infertility was due to a fertility problem her husband had, and that she never suspected that Eli Lilly was guilty of any wrongdoing.

Similarly, Eli Lilly's contention that the plaintiff could not recover because she could not positively identify it as the manufacturer of the particular drug Tholke took was inadequate. (At the time she was taking the pills, 75 companies were marketing DES, many of whom produced it in the form of the small white pills Tholke described.) To show that Eli Lilly was the manufacturer that made the pills Tholke took, plaintiff produced the affidavit of the current owner of the pharmacy where Tholke filled her prescriptions in 1968. This pharmacist stated that although he did not own the store in 1968, he knew the pharmacist there well, visited with him often and personally observed that “the sole and exclusive brand of DES in the store was the Eli Lilly Brand, from the late 60s through the time I actually bought the store” in 1975. This, along with Tholke's description of pills that matched those produced by Eli Lilly, were enough to create a triable question of fact for a jury. Therefore, the court denied the motion to dismiss.

More Guidant Device Failures

Since the FDA's last public notification of problems with Guidant implantable cardioverter defibrillator devices on Oct. 13, 2005, 35 more clinical failures have occurred, including five patient deaths. Health care providers should take these failures into account as they continue to follow the patients who have either the Contak Renewal' or Renewal' 2 devices. Guidant has also informed the agency of four additional clinical failures for the Ventak Prizm' 2DR device.

Kidney Failure Possible with Colonoscopy Prep

The New York Times reports that a study conducted by the Columbia College of Physicians and Surgeons has uncovered a potential problem with bowel-cleaning solutions made with sodium phosphate ingested by patients prior to undergoing colonoscopies; kidney failures can ensue in certain cases, sometimes requiring permanent dialysis. (Franklin, The New York Times 12/27/05.) The study was published in the November issue of the Journal of the American Society of Nephrology.