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Pharma & Device Update


Pharma & Device Update

Pfizer settles lawsuit alleging Neurontin caused suicide of patient seeking off-label pain therapy.

Bloomberg News (5/17, Feeley) reported, “Pfizer Inc. agreed to settle a wrongful-death lawsuit alleging its Neurontin (gabapentin) epilepsy medicine caused…retired minister” Richard Smith to take his own life just two months into the regimen to treat chronic pain. Terms of the settlement were not disclosed. Bloomberg News noted that this is “the second settlement of claims that officials of a Pfizer unit knew the epilepsy drug posed a suicide risk and failed to disclose it to patients and doctors.” Currently, the pharmaceutical company “faces more than 1,000 lawsuits accusing it of illegally promoting Neurontin for unapproved uses and helping to cause some users’ suicides.” The settled case is Ruby Smith v. Pfizer Inc., 05-cv-11515-PBS, US District Court, Middle District of Tennessee (Nashville).

FDA widens J&J Recall investigation.

The Wall Street Journal (5/18, Rockoff) reports that the FDA has widened its investigation into the recall of some Johnson & Johnson children’s medicines and is inquiring into the manufacturing at J&J’s McNeil Consumer Healthcare, which makes a range of drugs, including Benadryl, St. Joseph aspirin, Motrin (ibuprofen), Tylenol (acetaminophen), and Zyrtec (cetirizine). FDA spokeswoman Elaine Gansz Bobo said, “We’re doing our due diligence.” A J&J spokeswoman said the unit “is conducting a comprehensive quality assessment across its manufacturing operations and continues to cooperate with the FDA.” (5/18, Kavilanz) adds that the “FDA on Monday declined to comment on how many other facilities it is targeting in the expanded probe.” The House Committee on Oversight and Government Reform also “has scheduled a hearing on May 27 to examine the recall,” and “invited Johnson & Johnson Chief Executive William Weldon to testify.”


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