Drug & Device News

California's Attorney General Bill Lockyer filed suit against 39 pharmaceutical companies on Aug. 25 for allegedly defrauding California through a drug pricing scheme that forced the state's Medicaid program, known as Medi-Cal, to pay artificially inflated rates for medications. The losses to the state are estimated to be in the hundreds of millions of dollars, according to the Office of the Attorney General. “We're dragging these drug companies into the court of law because they're gouging the public on basic life necessities,” Lockyer said in an official release. “This may be a bitter pill for the drug companies to swallow, but the days of prescription pricing fraud are over. We're seeking immediate legal relief.”

In California, health care providers are reimbursed for drugs dispensed to Medi-Cal patients. The reimbursement rates are based on pricing data supplied by drug manufacturers. Lockyer's suit alleges that the drug makers manipulated the prices, resulting in inflated costs to the state's $34 billion Medi-Cal program, which provides essential health care to poor, elderly and disabled Californians. Among those being sued are pharmaceutical giants Abbott Laboratories, Amgen, Aventis Pharmaceuticals, Bristol-Myers, GlaxoSmithKline, Mylan Pharmaceuticals and SmithKline Beecham. The lawsuit was filed in U.S. District Court in Boston.

FDA Announces Program to Enhance Safe Use of Acne Medication

The FDA has approved a strengthened distribution program for isotretinoin (Accutane and its generics), aimed at preventing use of the drug during pregnancy. Women who are pregnant or who might become pregnant should not take the acne control drug because it carries a significant risk of birth defects if taken during pregnancy. The manufacturers are implementing a program that requires registration in the iPLEDGE database by doctors and patients, who will agree to accept specific responsibilities to prevent pregnancy before receiving authorization to prescribe or use the drug. Wholesalers and pharmacies must also comply with the manufacturers' program requirements in order to distribute and dispense the product.

Use of Internet Prescription Service Negates Local Pharmacist's Liability

The Court of Appeals of Michigan held in August that a plaintiff whose prescription was filled at her local pharmacy — where the pharmacy had previously filled her prescriptions for a drug that could have a harmful interaction with her newly prescribed drug – could not be held legally responsible for her adverse reaction to a drug combination because it was not aware that she was still using a drug that pharmacy records showed she had discontinued using 6 months earlier. Saukas v. Walker Street Pharmacy Inc., 2005 Mich. App. LEXIS 1847 (8/4/05).

The plaintiff experienced a drug-induced life-threatening rash after taking seizure medication Lamictal' in combination with Depakote', the effects of which she continues to suffer today. She sued defendant pharmacy, alleging that it was negligent for giving her such a large dose of Lamictal when it knew or should have known of a potentially serious interaction with the Depakote plaintiff was taking. The circuit court granted defendant's motion for summary judgment, finding that defendant owed plaintiff no duty under the circumstances. Plaintiff appealed.

The Michigan Court of Appeals had previously held in Stebbins v. Concord Drugs, 164 Mich. App. 204 (1987), that “a pharmacist has no duty to warn the patient of possible side effects of a prescribed medication where the prescription is proper on its face and neither the physician nor the manufacturer has required that any warning be given to the patient by the pharmacist.” The court here noted that while under the teachings of Baker v. Arbor Drugs Inc., 215 Mich. App. 198 (1996), a pharmacy can breach its duty by not following a drug interaction warning that the pharmacy's computer software generated, the pharmacy can be held liable only under peculiar circumstances, such as those in Baker in which the pharmacy specifically advertised its drug interaction system and thus voluntarily assumed a function it was not legally required to do. Defendant's legal duty in the present case was not as broad.

Plaintiff did not dispute that the pharmacy filled the prescription as her physician wrote it. Nor was she claiming that it failed to warn her of side effects. Instead, she claimed that defendant should have discovered that her usage of Depakote would interact harmfully with the Lamictal order she was submitting. But defendant had no reason to think that plaintiff was on Depakote. The pharmacy's record of her prescription for that drug indicated that she discontinued use of it 6 months earlier, and defendant had no way of knowing that she had ordered more from a mail-order source. Indeed, its drug interaction system indicated no red flags because there was no reason to assume that plaintiff was on Depakote. This case was therefore factually distinguishable from Baker, where a warning was missed.

Consumer Suit Against Drug Makers Thrown Out

A suit brought in federal district court alleging Pfizer Inc., Merck & Co. and several other drug manufacturers illegally attempted to control drug prices in the United States was dismissed Aug. 26 by Judge Joan N. Ericksen. The plaintiffs' claim that the companies' decision to limit amounts of product they would sell to Canadian entities in order that such products would not be re-imported to U.S. customers at prices lower than those in the United States failed, Ericksen said, because drug re-importation is currently illegal in the United States. Thus, the pharmaceutical companies could not be held liable because all they were doing was curtailing Americans' access to what are essentially illegal drugs.

FDA Clears Test That Helps Doctors Give Correct Drug Dosages

On Aug. 22, the FDA cleared for marketing a new blood test that will help doctors make personalized drug treatment decisions for some patients. The Invader UGT1A1 Molecular Assay detects variations in a gene that affects how certain drugs are broken down and cleared by the body. Doctors can use this information to help determine the right drug dosage for individual patients, and minimize harmful drug reactions. The Invader assay was studied in 66 patients receiving irinotecan therapy, a drug used in colorectal cancer treatment. The study showed that people with a certain type of genetic variation have a five times greater risk of experiencing irinotecan toxicity.

CA Attorney General Sues 39 Major Drug Companies

California's Attorney General Bill Lockyer filed suit against 39 pharmaceutical companies on Aug. 25 for allegedly defrauding California through a drug pricing scheme that forced the state's Medicaid program, known as Medi-Cal, to pay artificially inflated rates for medications. The losses to the state are estimated to be in the hundreds of millions of dollars, according to the Office of the Attorney General. “We're dragging these drug companies into the court of law because they're gouging the public on basic life necessities,” Lockyer said in an official release. “This may be a bitter pill for the drug companies to swallow, but the days of prescription pricing fraud are over. We're seeking immediate legal relief.”

In California, health care providers are reimbursed for drugs dispensed to Medi-Cal patients. The reimbursement rates are based on pricing data supplied by drug manufacturers. Lockyer's suit alleges that the drug makers manipulated the prices, resulting in inflated costs to the state's $34 billion Medi-Cal program, which provides essential health care to poor, elderly and disabled Californians. Among those being sued are pharmaceutical giants Abbott Laboratories, Amgen, Aventis Pharmaceuticals, Bristol-Myers, GlaxoSmithKline, Mylan Pharmaceuticals and SmithKline Beecham. The lawsuit was filed in U.S. District Court in Boston.

FDA Announces Program to Enhance Safe Use of Acne Medication

The FDA has approved a strengthened distribution program for isotretinoin (Accutane and its generics), aimed at preventing use of the drug during pregnancy. Women who are pregnant or who might become pregnant should not take the acne control drug because it carries a significant risk of birth defects if taken during pregnancy. The manufacturers are implementing a program that requires registration in the iPLEDGE database by doctors and patients, who will agree to accept specific responsibilities to prevent pregnancy before receiving authorization to prescribe or use the drug. Wholesalers and pharmacies must also comply with the manufacturers' program requirements in order to distribute and dispense the product.

Use of Internet Prescription Service Negates Local Pharmacist's Liability

The Court of Appeals of Michigan held in August that a plaintiff whose prescription was filled at her local pharmacy — where the pharmacy had previously filled her prescriptions for a drug that could have a harmful interaction with her newly prescribed drug – could not be held legally responsible for her adverse reaction to a drug combination because it was not aware that she was still using a drug that pharmacy records showed she had discontinued using 6 months earlier. Saukas v. Walker Street Pharmacy Inc., 2005 Mich. App. LEXIS 1847 (8/4/05).

The plaintiff experienced a drug-induced life-threatening rash after taking seizure medication Lamictal' in combination with Depakote', the effects of which she continues to suffer today. She sued defendant pharmacy, alleging that it was negligent for giving her such a large dose of Lamictal when it knew or should have known of a potentially serious interaction with the Depakote plaintiff was taking. The circuit court granted defendant's motion for summary judgment, finding that defendant owed plaintiff no duty under the circumstances. Plaintiff appealed.

The Michigan Court of Appeals had previously held in Stebbins v. Concord Drugs , 164 Mich. App. 204 (1987), that “a pharmacist has no duty to warn the patient of possible side effects of a prescribed medication where the prescription is proper on its face and neither the physician nor the manufacturer has required that any warning be given to the patient by the pharmacist.” The court here noted that while under the teachings of Baker v. Arbor Drugs Inc. , 215 Mich. App. 198 (1996), a pharmacy can breach its duty by not following a drug interaction warning that the pharmacy's computer software generated, the pharmacy can be held liable only under peculiar circumstances, such as those in Baker in which the pharmacy specifically advertised its drug interaction system and thus voluntarily assumed a function it was not legally required to do. Defendant's legal duty in the present case was not as broad.

Plaintiff did not dispute that the pharmacy filled the prescription as her physician wrote it. Nor was she claiming that it failed to warn her of side effects. Instead, she claimed that defendant should have discovered that her usage of Depakote would interact harmfully with the Lamictal order she was submitting. But defendant had no reason to think that plaintiff was on Depakote. The pharmacy's record of her prescription for that drug indicated that she discontinued use of it 6 months earlier, and defendant had no way of knowing that she had ordered more from a mail-order source. Indeed, its drug interaction system indicated no red flags because there was no reason to assume that plaintiff was on Depakote. This case was therefore factually distinguishable from Baker, where a warning was missed.

Consumer Suit Against Drug Makers Thrown Out

A suit brought in federal district court alleging Pfizer Inc., Merck & Co. and several other drug manufacturers illegally attempted to control drug prices in the United States was dismissed Aug. 26 by Judge Joan N. Ericksen. The plaintiffs' claim that the companies' decision to limit amounts of product they would sell to Canadian entities in order that such products would not be re-imported to U.S. customers at prices lower than those in the United States failed, Ericksen said, because drug re-importation is currently illegal in the United States. Thus, the pharmaceutical companies could not be held liable because all they were doing was curtailing Americans' access to what are essentially illegal drugs.