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Abbott Laboratories 35 articles

Boy awarded $15M in Depakote birth defects trial

A 10-year-old boy was awarded $15 million by an Illinois federal jury over claims that Abbott Laboratories’ did not adequately warn doctors that its anti-seizure and bipolar drug Depakote could cause severe birth defects, according to Law360. The jury deliberated nearly two full days, ultimately agreeing with attorneys for Stevie Gonzalez and his family that doctors who prescribed the drug to his mother, Christina Raquel, were not aware that there was at least a 10 percent chance that she could give birth to a baby with spina bifida or another major malformation. Raquel became pregnant with Gonzalez months after starting ... Read More

Testosterone Replacement Therapy trial requires Doc to reveal payments

A Boston-area doctor notorious for pushing testosterone replacement therapy to his patients for the past three decades was ordered to turn over his tax records indicating how much money he was paid by manufacturers of testosterone drugs. The order was made by U.S. District Judge Matthew F. Kennelly in the Northern District of Illinois regarding a multidistrict litigation (MDL) accusing testosterone replacement therapy manufacturers of promoting testosterone treatment for so-called Low T without revealing that use of the hormone can cause serious medical problems, including life threatening heart attacks, strokes and blood clots. AbbVie is in the hot seat for ... Read More

Testosterone replacement therapy makers can’t dodge trials

U.S. District Judge Matthew Kennelly dissed almost all the arguments AbbVie and Abbott Laboratories made for a summary judgment before the first of seven bellwether trials involving cardiovascular risks with the testosterone replacement treatment AndroGel begins, Law360 reported. The drug companies face more than 7,000 lawsuits in a sprawling multidistrict litigation (MDL) involving several different manufacturers of testosterone replacement therapies. As the maker of the top selling AndroGel, AbbVie will sit in the hot seat for all seven of the selected bellwethers. The first trial is set to begin in June. Plaintiffs suing AbbVie and other testosterone treatment manufacturers allege ... Read More

FDA wants Abbott to provide assurance regarding cybersecurity concerns with cardiac implants

The Food and Drug Administration (FDA) slapped Abbott Laboratories, the new owner of St. Jude Medical Inc., with a warning letter giving the company 15 days to explain how it corrected cybersecurity issues with some of its cardiac implant transmitter devices or face potential consequences. The cybersecurity issue was first raised in August 2016, when third-party investment firm Muddy Waters Capital LLC and MedSec Holdings issued a report detailing alleged “severe security vulnerabilities” in St. Jude Medical-brand implantable pacemakers, defibrillators and resynchronization devices. The devices in question are used to provide pacing for slow heart rhythms and electrical shock or pacing ... Read More

Abbott pulls Absorb BVS used in angioplasty procedures from European market due to safety risks

Abbott Laboratories is pulling its Absorb Bioresorbable Vascular Scaffold (BVS) and Absorb GT1 BVS from the European market, restricting use of the devices implanted in patients during angioplasty procedures after three-year study results released last fall revealed a significantly higher rate of target vessel heart attacks. The findings were confirmed in two-year trial results, which showed a significant increase in target lesion failure. Abbott said the BVS devices “will only be available for use in clinical registry setting at select sites/institutions.” Last month, the Food and Drug Administration (FDA) warned the public that a study showed patients who had the BVS were ... Read More

AndroGel makers try to shake testosterone side effects lawsuits

AbbVie Inc., and Abbott Laboratories are trying to wiggle their way out of a massive multidistrict litigation (MDL) over side effects allegedly caused by testosterone replacement therapies by arguing to an Illinois federal judge that plaintiffs have not shown that use of testosterone supplements increases the risk of heart attacks or strokes. Days earlier, the drug companies filed a separate summary judgment arguing that plaintiffs’ claims that they marketed testosterone treatments for unapproved uses was incorrect because Food and Drug Administration (FDA) officials had OK’d their marketing materials. The motions for summary judgment were filed just months before the companies ... Read More

French families sue Sanofi alleging epilepsy drug causes birth defects

A group of French families are suing Sanofi alleging the pharmaceutical company’s epilepsy drug Depakine caused birth defects. APESAC, the association assisting parents of children suffering from “foetal anti-convulsant syndrome,” raised concerns in 2014 about being slow to act on the drug’s harm to developing fetuses. APESAC claims the number of children affected since the anti-seizure drug hit the market in 1967 to be about 30,000. Depakine, which is sold in the U.S. by Abbott Laboratories under the brand name Depakote, contains the active ingredient sodium valproate. A Sanofi spokeswoman previously said that the company had become aware of the link ... Read More

Woman asks for new trial in case alleging birth defects with anti-seizure drug Depakote

A woman who claims the anti-seizure and migraine medication Depakote caused her child’s birth defects is asking the Sixth Court for a new trial after a lower court dismissed her case, arguing that the makers of the drug failed to warn of its risks to developing fetuses and that the lower court wrongfully let the drug’s makers “hide behind the FDA” by excluding crucial trial testimony. Pamela Rheinfrank’s lawsuit named Depakote makers Abbott Laboratories Inc. and AbbVie Inc. She argued to the Sixth Circuit that an opinion from a Missouri appeals court in a similar lawsuit found that there was ... Read More

Judge refuses to toss personal injury lawsuits waged against AndroGel maker Besins

Besins Healthcare sells enough of its testosterone replacement therapy in the United States that lawsuits alleging cardiovascular injuries with testosterone treatments will not be tossed out of a multidistrict litigation (MDL), an Illinois federal judge ruled. The lawsuits claim that Besins and other manufacturers of testosterone treatments invented a disease – Low T – and used fraudulent and aggressive marketing campaigns to lure men into asking their doctors for the treatment off-label despite knowing that use of the products put them at risk for heart attacks, strokes and life threatening blood clot conditions. Besins manufacturers the top selling testosterone treatment AndroGel in ... Read More

Wrongful death lawsuit involving AndroGel testosterone to remain in state court

A wrongful death lawsuit against AbbVie Inc. involving its top selling AndroGel testosterone treatment will remain in state court, a California federal judge ruled, rejecting the drug company’s bid to hold off on until the case can be transferred to a multidistrict litigation (MDL) in Illinois. Evelyn Calvillo filed her lawsuit against AbbVie and the California-based distributor McKesson Corp., in Orange County Superior Court in July, alleging her husband died after using the testosterone replacement therapy. AbbVie argued that Calvillo had included McKesson in the lawsuit only to anchor her suit in California and that McKesson was not a suitable ... Read More