Pharmacy Error Injury Lawyer Blog

Blood Pressure Medication Found in Allergy Medicine Bottles, Leads to Recall

June 11, 2014 | Lebowitz & Mzhen

Earlier in May of this year, an Indian-owned pharmaceutical company announced a voluntary recall of over 10,000 bottles of promethazine hydrochloride, a drug used to treat allergies. According to a report by Medical Daily, the recall was initiated when a 25-mg tablet of atenolol was found mixed in with the allergy medication. Atenolol is a medication used to treat high blood pressure. The recall affects those bottles with a September 2015 expiration date.

Potential side effects for atenolol are listed as constipation, memory loss, impotence, numbness, and diarrhea. There has not been any research done to determine what potential side effects may occur from taking the two medications together. However, out of an abundance of caution, the company decided to recall the bottles.

This recall is a Class-II recall, meaning that it “involves a potential health hazard situation where there is remote probability of adverse health consequences from the use of the product.” Evidently, this is the seventh recall that this particular pharmaceutical company has announced this year. Given their track record, the FDA is beginning to crack down on Indian pharmaceutical companies. In fact, the FDA has already placed a ban on the import of medication from two Indian pharmaceutical companies this year. Given this company’s track record for 2014, it may be next.

Drug Manufacturers Consent to Oversight by Federal Agency Following Increased Scrutiny

June 4, 2014 | Lebowitz & Mzhen

Following a meningitis outbreak that was linked to a faulty drug, several custom drug manufacturers have recently consented to voluntary oversight by the FDA. According to a report by AZ Central, the manufacturers of custom drugs exist in a bit of a legal loophole. These manufacturers often create specific drug “cocktails” designed to treat very specific conditions.

These “shadow” drug makers, as the article refers to them, came under scrutiny after an outbreak of meningitis was linked to 64 deaths and over 700 illnesses. Under current law, these manufacturers are not regulated by the federal government. However, in 2012, there were two citations issued for unsanitary conditions and a faulty injection.

These specialty drugs, which are prescribed by doctors and filled at regular pharmacies like CVS or Walgreens, are often combinations of other approved drugs. However, since the manufactures operated somewhere between the smaller state-regulated compounding manufacturers and the large-scale drug manufacturers regulated by the FDA, it is unclear who is in charge of making sure these facilities are up to par with the governing safety standards in place.

Drug Recall for a Generic Version of Claratin, 30,000 Packets

May 28, 2014 | Lebowitz & Mzhen

Earlier this month, Ranbaxy Laboratories initiated a voluntary drug recall of over 30,000 blister packs of one of the drugs it makes. The drug, which is a generic version of the popular allergy medication Claratin, is called loratadin and is a slow release pill with an added decongestant.

The FDA’s official title for the drugs is “Non-Drowsy 24 Hour Formula Allergy Relief and Nasal Decongestant, Pseudoephedrine Sulfate, USP 240 mg, Loratadine, USP, 10 mg, 5, 10, 15 count blister packs, OTC Only.”

According to a report by Business Insider, the recall affects drugs that were sold in the following five states: Rhode Island, Ohio, California, Pennsylvania, and Texas. Evidently, the expiration on the packaging indicates that it expires in September 2015. The defective drug was sold at the following pharmacies: Rite Aid, CVS, Discount Drug Mart, H-E-B, Kroger, Good Neighbor Pharmacy, and Sunmark.

Pharmacy Error Nearly Causes the Death of Another Young Boy

May 21, 2014 | Lebowitz & Mzhen

Earlier this year in Crystal Lake, Illinois, a five-year-old boy ended up taking a dangerous dose of an anti-psychotic drug when the pharmacy gave the drug to his mother under the auspice of a treatment for his allergies. According to a report by the local NBC affiliate, the young boy, Ali Ahmed, was in need of medication for his allergies, and a prescription was called in for him at the local Walgreen’s pharmacy.

When his mother went to pick up the prescription, she picked up what she thought to be the allergy medication that her son’s doctor had called in. However, the pharmacist gave her Halperidol instead, a dangerous anti-psychotic drug used primarily to treat adults with serious mental health issues.

Luckily, the boy’s parents only gave him a small dose of the wrong medication. After young Ali took the medication, he slept for two days straight. After waking, he had a small snack, and his neck began to flare. Emergency personnel were called, and eventually the flare went away. However, as soon as the neck flare went away, he began to act strangely and then fainted. His parents called the boy’s doctor, who told them to take him to the hospital immediately.

Air Force Claims Medication Errors on Base Presented Very Low Risk

May 14, 2014 | Lebowitz & Mzhen

Earlier this year in April, the Air Force released a report indicating that it had prescribed the wrong medication on an Air Force base in Kitty Hawk, North Carolina. Evidently, on April 29th, someone reported that their prescription was not properly filled; Tylenol was prescribed instead of Robaxin, a muscle relaxer.

The Air Force immediately conducted an internal investigation and found that 1273 patients had been provided the incorrect medication at the Kitty Hawk base. Of those, the Air Force was able to contact 926 of the patients by telephone to let them know that they may have been proved the wrong medication. The remaining patients were sent a certified letter in the mail to let them know of the pharmacy’s error. Air Force records indicate that no one actually took the improperly prescribed drugs.

According to a report by the Dayton Daily News, the medication errors were due to a malfunction in an automated system that the Air Force pharmacy uses to fill prescriptions. Once the error was found, pharmacists and pharmacy techs began to fill all prescriptions by hand to ensure that patients received the correct medication.

Colorado Man Recovers Over $10 Million in Pharmaceutical Error Case

May 7, 2014 | Lebowitz & Mzhen

Physicians and nurses owe a duty to all of their patients to administer the proper medication and provide a certain basic level of medical care. Most of the time, physicians do the best job they can making sure that the sick are well cared for, but on occasion a lapse in judgment can result in serious consequences.

Bethel v. United States of America

In a recent case from Colorado, a man was granted a verdict in excess of $10 million after he suffered severe brain damage as a result of medication error. The facts of the case were as follows:

Bethel, the plaintiff in the lawsuit, was under the care of the Veterans Affairs Medical Center when he underwent general anesthesia. He was to be cared for by a doctor as well as by a first-year resident. The resident prepared Bethel for surgery, but in so doing administered a paralytic drug instead of a sedative drug. At this time, the doctor was away attending to another patient.

Pharmaceutical Company’s Failure to Warn Did Not Cause Plaintiff’s Injury, Court Rules

April 29, 2014 | Lebowitz & Mzhen

A federal district court dismissed a lawsuit against a pharmaceutical company for alleged failure to warn, holding that any defect in the drug’s label did not influence the prescribing doctor’s decision regarding the drug. Parkinson v. Novartis Pharmaceuticals Corp., No. 3:12-cv-02089, opinion (D. Ore., Mar. 20, 2014). In a claim for damages caused by a manufacturer’s failure to warn of a hazardous condition or risk, a plaintiff must prove that the failure to warn was a proximate cause of their injuries. The “learned intermediary doctrine” often applies in cases involving pharmaceutical drugs, meaning that the question is whether the failure to warn influenced the prescribing physician, not the plaintiff. The plaintiff must prove that the physician would not have prescribed the drug, or would have done so in a different manner, had the manufacturer provided adequate warnings.

The plaintiff was diagnosed with stage IIIB breast cancer in January 2003. She underwent chemotherapy for about six months and then voluntarily stopped receiving treatment. In May 2005, she underwent radiation therapy on her pelvis to treat pain caused by the cancer, which by then had spread. She also had surgery on her legs because of bone damage. Her physician began administering monthly infusions of Aredia, a bisphosphonate used to treat bone damage in cancer patients, in June of that year. Bisphosphonates have been associated with an increase risk of osteonecrosis of the jaw (ONJ), a condition in which the jaw bone weakens and, in some cases, dies. Dental surgery may aggravate the condition in cancer patients receiving bisphosphonates.

The plaintiff’s physician testified in his deposition that he was aware of the risks associated with ONJ, but felt that they were outweighed by the benefits of the drug for the plaintiff. He also testified that he continues to prescribe Aredia and other bisphosphonate drugs. After the plaintiff had been receiving monthly Aredia infusions for over a year, the doctor switched her to Zometa, another bisphosphonate, in September 2006. The plaintiff saw a dentist in December 2006, reportedly the first time in five years. She then began experiencing tooth and jaw aches, and was eventually diagnosed with bisphosphonate-related ONJ in January 2008.

Nationwide Lipitor Lawsuits Consolidated in One Court for Pretrial Proceedings

April 22, 2014 | Lebowitz & Mzhen

The Judicial Panel on Multidistrict Litigation (JPML) has consolidated lawsuits filed around the country against the pharmaceutical company Pfizer under the style In Re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices and Products Liability Litigation (No. II), No. MDL-2502. The cases involve allegations that the plaintiffs developed type 2 diabetes after taking the cholesterol-lowering drug marketed by Pfizer as Lipitor. As of April 15, 2014, the JPML has consolidated 464 claims in the U.S. District Court for the District of South Carolina. Consolidation is appropriate, according to federal statute, when multiple lawsuits involving common questions of fact are pending in multiple federal courts around the country, and a single court could efficiently handle various pretrial proceedings. 28 U.S.C. § 1407.

Atorvastatin, marketed under the brand name Lipitor, is part of the family of drugs known as statins, commonly used to reduce a patient’s cholesterol levels. Statins work by inhibiting an enzyme used by the liver to produce cholesterol. High cholesterol levels have been associated with an increased risk of heart disease, and statins have demonstrated the ability to prevent heart disease in high-risk patients. A paper published in the Lancet in February 2010 identified a slight risk of diabetes associated with statins, while a paper published in the January 2012 Archives of Internal Medicine found an increased risk of diabetes among postmenopausal women who take statins. These and other studies led to a series of lawsuits alleging that Lipitor caused plaintiffs to develop type 2 diabetes.

The U.S. Food and Drug Administration requested in August 2011 that Pfizer change the Lipitor label to include warnings about the risk of type 2 diabetes. The company changed the label in February 2012, but allegedly did not include specific warnings about the diabetes risk. The plaintiff in Jennings v. Pfizer, No. 1:14-cv-00096, complaint at 2 (D. Md., Jan. 13, 2014), describes the revised Lipitor label as “extremely vague.” The complaint in Gaines v. Pfizer, No. 1:14-cv-00170, complaint (D. Md., Jan. 22, 2014), alleges that Pfizer did not issue any warnings about the possible connection between Lipitor and type 2 diabetes before making the requested changes to the drug label. It further claims that, while the new label “warns in the most obtuse terms” about the risk of elevated blood sugar, it makes no direct warning about diabetes risk. Id. at 5.

FDA Approves Prescription-Based Antidote for Overdose of Heroin, Other Opioids

April 15, 2014 | Lebowitz & Mzhen

The U.S. Food and Drug Administration (FDA) approved a “hand-held auto-injector” device for use with known or suspected opioid overdoses. Abuse of opioids, a group of drugs that includes many prescription painkillers, is becoming a serious problem in the U.S., and the FDA claims that opioid overdose has surpassed automobile accidents as the nation’s leading cause of injury deaths. The device, marketed under the brand name Evzio, delivers an injection of naloxone hydrochloride to counter or reverse the effects of opioid overdose. The FDA has stated that it hopes the availability of the device with a prescription will help prevent overdose deaths in emergency situations.

Opioid analgesics are a family of opiate-based drugs commonly used in prescription painkillers. They are derived from the same source as heroin and several other illegal narcotics. Common opioids include codeine, hydrocodone, morphine, and oxycodone. Opioids can be very addictive, so they are tightly controlled by the government. According to the Centers for Disease Control and Prevention (CDC), 16,651 people died of drug overdoses involving opioids in 2010, the most recent year for which statistics are available. This number accounts for about seventy-five percent of all drug overdose deaths that year. Many overdoses involve legally-obtained prescription painkillers. The total number presumably includes intentional and accidental overdoses, as well as dosage errors by a physician or pharmacist.

Evzio, as approved by the FDA, is a handheld device that injects naloxone hydrochloride, an “opioid antagonist” that is a common treatment for opioid overdose. Emergency responders often carry naloxone-containing products for use with suspected overdose victims. Since Evzio is only available with a prescription, it must be obtained in advance of any emergency situation. It is recommended for family members and caregivers of people using opioid painkillers in case of overdose. The device provides verbal instructions for use once it is turned on. A single dose of naloxone, according to the FDA, does not last as long as a typical opioid, so it cautions that the device is not a substitute for medical attention. What the device can do is delay further injury or death due to an overdose until medical attention is available.

FDA Proposes New Guidelines Regarding Off-Label Promotion of Drugs

April 8, 2014 | Lebowitz & Mzhen

The U.S. Food and Drug Administration (FDA) recently issued draft revisions of pharmaceutical industry guidelines regarding “off-label” promotion of drugs. “Off-label” refers to information about uses of a drug that have not been formally approved by the FDA and are not included in its approved labeling. The agency has treated off-label promotion as “misbranding,” which can carry both civil and criminal penalties under the Food, Drug, and Cosmetics Act (FDCA). The Second Circuit Court of Appeals struck down the conviction of a pharmaceutical sales representative for conspiring to introduce a misbranded drug into interstate commerce, finding that the off-label promotion rule violated his First Amendment right to free speech. United States v. Caronia, 703 F.3d 149 (2nd Cir. 2012). The FDA’s proposed revisions, published in the Federal Register at 79 FR 11793 (Mar. 3, 2014), seek to apply a narrower set of restrictions on off-label promotion.

The FDCA generally prohibits “misbranding” of an approved drug. In a “Guidance for Industry” document published in January 2009, the FDA addressed the distribution of medical literature and other scientific publications regarding off-label uses of approved drugs. The FDA has strict labeling requirements for all approved drugs, including risks of side effects and complications and instructions for use. Off-label marketing of a drug, the FDA stated in the guidance document, constitutes unlawful misbranding of a drug because the drug’s label does not include “adequate directions for use,” as required by the FDCA. 21 U.S.C. § 352(f), 21 C.F.R. § 201.100(c)(1).

The defendant in Caronia was charged with conspiracy to introduce a misbranded drug, and introducing a misbranded drug, into interstate commerce. 21 U.S.C. § 331(a). If a defendant had the “intent to defraud or mislead,” the offense carries a maximum penalty of three years in prison, a $10,000 fine, or both. 21 U.S.C. § 333(a)(2). The case involved Xyrem, a central nervous system depressant with only two FDA-approved uses. The drug contains GHB, a powerful depressant commonly known as the “date rape drug,” making it one that the FDA closely watches.