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Federal Appellate Court Applies Preemption In Reversing Verdict Against Pharmaceutical Company

March 9, 2021

The United States Court of Appeals for the Fourth Circuit (“Federal Appellate Court”) held in its published opinion dated January 6, 2020: “Boehringer [Boehringer Ingelheim Pharmaceuticals, Inc.] did not have “newly acquired information” regarding an optimal Pradaxa blood conce[...]

FDA Requests Manufacturers Of Ranitidine (Zantac) To Immediately Remove All Such Products From U.S. Market

April 3, 2020

On April 1, 2020, the FDA requested manufacturers of ranitidine (Zantaxc) to immediately withdraw all prescription and over-the-counter ranitidine products from the U.S. market due to a contaminant known as N-Nitrosodimethylamine (NDMA) found in the medicines. The FDA determined that NDMA in some ra[...]

FDA Strengthens Warning Regarding Clozapine And Untreated Constipation

March 7, 2020

In a January 28, 2020 Drug Safety Communication entitled “FDA strengthens warning that untreated constipation caused by schizophrenia medicine clozapine (Clozaril) can lead to serious bowel problems,” the FDA stated that it is “strengthening an existing warning that constipation ca[...]

Alabama Supreme Court Affirms Dismissal Of Untimely Drug Claim

November 12, 2019

The Supreme Court of Alabama (“Alabama Supreme Court”), in its decision released on September 27, 2019, affirmed the trial court’s dismissal of the plaintiffs’ amended complaint that alleged that the plaintiff husband developed demyelinating polyneuropathy as a result of bein[...]

Zantac OTC Recalled By Sanofi Due To Possible Contamination Concerns

October 22, 2019

Ranitidine is the active ingredient in Zantac®, which prevents or relieves heartburn by reducing the production of stomach acid. On October 18, 2019, Sanofi, which manufactures Zantac OTC, announced: “As a precautionary measure, Sanofi will conduct a voluntary recall of Zantac OTC (over-the-c[...]

$8 Billion Risperdal Punitive Damages Award

October 17, 2019

A Philadelphia jury awarded a Maryland man $1.75 million in compensatory damages (which was later reduced to $680,000) against Johnson & Johnson’s subsidiary unit, Janssen Pharmaceuticals Inc. (“Janssen”), in 2015 but the jury was not permitted at that time to consider awardin[...]

Maryland School Board Sues Pharmaceutical Company For Drug That Used To Cost $40 And Now Costs $40,000

July 23, 2019

The Washington County (Maryland) Board of Education has filed a lawsuit against pharmaceutical company Mallinckrodt ARD Inc. (“Mallinckrodt”), alleging that Mallinckrodt engaged in an unjust, unfair, and deceptive scheme and conspiracy along with its exclusive distributor, Express Script[...]

At Least 34,000 Deaths Associated With Biologic Drugs Since 2004

July 4, 2019

The Milwaukee Journal Sentinel conducted an analysis of data from the FDA and found “at least 34,000 reports to the U.S. Food and Drug Administration of people who died while using biologic drugs since 2004.” The analysis further found, “More than 1 million “adverse events” wer[...]

Drug Manufacturers Will Be Required To Disclose Drug Prices In TV Advertisements

May 26, 2019

The Secretary of the U.S. Department of Health and Human Services announced on May 8, 2019 a final rule from the Centers for Medicare & Medicaid Services (CMS) that will require direct-to-consumer television advertisements for prescription pharmaceuticals covered by Medicare or Medicaid to incl[...]

Maryland’s Opioid Operational Command Center Reports Increase In Opioid-Related Deaths In 2018

May 21, 2019

The Maryland Opioid Operational Command Center issued its “Opioid Operational Command Center Annual Report January 1, 2018 – December 31, 2018” on May 9, 2019, stating, “We have found that the rate of increase in the overall number of opioid-related fatalities has slowed for two [...]

FDA Warns About Aortic Tears/Ruptures Associated With Fluoroquinolone Antibiotics

February 5, 2019

The FDA issued a drug safety announcement on December 20, 2018 entitled, “FDA warns about increased risk of ruptures or tears in the aorta blood vessel with fluoroquinolone antibiotics in certain patients,” warning that fluoroquinolone antibiotics can increase the occurrence of rare but [...]

FDA Receives Over 100,000 Suspected Medication Error Reports Each Year

January 14, 2019

The FDA reports that it receives over 100,000 reports of suspected medication errors in the United States every year. A medication error is defined as any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare[...]

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