Drug and Medical Device Lawsuits

New Warnings Issued Over GSK’s Shingrix Vaccine

warnings issued over Shingrix vaccineNew language has been added to leading shingles vaccine Shingrix over concerns that the injection may be responsible for an increased risk of a rare neurological autoimmune disease known as GBS, or Guillain-Barré Syndrome.

GBS occurs when the patient’s immune system attacks their nerve cells. It is diagnosed just 3,000 to 6,000 times a year and has been linked as a side effect of other vaccines as well, including the ...

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Report: Merck Failed to Warn Public on Propecia Suicide Risk

merck was aware of propecia suicide risk when changing label informationWhile crafting the language for the 2011 update to the label for its flagship hair loss drug Propecia, Merck was aware of a stunning number of reports of suicide among those taking the drug. Yet today, even though the FDA has records of over 700 reports of suicide or suicidal thoughts related to Propecia or its generics, Propecia’s label makes absolutely no mention of depression or ...

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Elmiron Eye Damage Cases Lead to Multidistrict Litigation Preparations

elmiron lawsuits leading to MDL prepWhen a 2018 study appeared to show a link between Janssen Pharmaceuticals’ bladder infection drug Elmiron and certain types of eye damage, researchers started reviewing the data they had at their own disposal. Elmiron had been in use for decades and had been prescribed to hundreds of thousands of people across the country.

One particularly exhaustive study was conducted by three Kaiser Permanente ophthalmologists in California. The doctors analyzed ...

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Flurry of Activity in Late December Could Spell a Long 2021 for Opioid Industry

justice department sues walmart as tennessee enforces drug dealer law against opioid manufacturersA ruling by the Tennessee Supreme Court makes it possible to sue opioid manufacturers under the state’s Drug Dealer Liability Act. The ruling clears the way for a lawsuit to proceed that had been filed on behalf of children that were born addicted to opioids. “If the Baby Doe plaintiffs prove their allegations at trial, a jury could reasonably conclude that ...

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Penumbra Jet 7 Xtra Flex Stroke Catheter Recalled

penumbra recalls catheterMedical device manufacturer Penumbra has issued an urgent voluntary recall of the Jet 7 Reperfusion Catheter with Xtra Flex Technology over reports of significant patient injuries, including death. The Jet 7 Xtra Flex catheter and the Jet 7Max configurations are included in the recall action, but the Jet 7 Reperfusion Catheter with Standard Tip is not.

In a release that corresponded with Penumbra’s recall, the Food and Drug Administration ...

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FDA Tracking: What Good is a Database if the Data is Inaccurate?

fda drug side effect database outdated and inaccurateA new report out of the Milwaukee Journal Sentinel calls attention to the fact that the FDA’s tracking of drug side effects; many of them dangerous, has been out of date, underreported, and inaccurate for upward of 60 years.

Created in 1960, the system was devised as a way of tracking adverse drug events once the products received their clearance and made it to market. Based largely ...

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