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Miami 142 articles

Dietary supplement maker warned by FDA

Dietary supplement maker Morhaim Pharmalab Inc., was slapped with a Food and Drug Administration (FDA) warning letter for peddling dietary supplements that seriously violate federal laws. The FDA issued the warning letter following an inspection of the company’s Miami, Florida, manufacturing facility in September 2016. During the inspection, the FDA identified violations of Current Good Manufacturing Practice regulations that rendered the supplements adulterated under the Federal Food, Drug and Cosmetic act. The products were also found to be misbranded because they do not comply with the FDA’s labeling regulations. The agency accused the company of not following quality control regulations ... Read More

Whistleblower Gets $1 Million For Exposing Princess Cruise Oil Dumping

A whistleblower who reported illegal oil waste dumping from a Princess Cruise Lines ship that eventually exposed widespread oil dumping among other Princess ships received a $1 million award April 19. U.S. District Judge Patricia Seitz in Miami, who imposed a record $40 million criminal penalty on Princess and its parent company Carnival Corporation, awarded the $1 million payout to a British engineer who documented the Caribbean Princess using a “magic pipe” to illegally discharge oily wastewater off the coast of England in August 2013. Evidence provided by the newly hired ship engineer prompted inspections of the ship both in ... Read More

CDC urges doctors to look for seizures, epilepsy in babies born to Zika-infected moms

The Centers for Disease Control and Prevention (CDC) urged doctors to be aware of seizures and epilepsy in infants born to mothers infected with the Zika virus while pregnant, as cases of epilepsy caused by the virus can be misdiagnosed or underreported. Studies have confirmed that pregnant women infected with Zika are at an increased risk of having a fetus or delivering a baby with a brain abnormality such as microcephaly, or other neurological disorders. The CDC is hoping that by making doctors aware of epilepsy and seizure disorders in infants exposed to Zika in utero, reporting will be more ... Read More

Mazda, Mitsubishi Join Nissan In Seeking Compensation from Takata Over Airbag Recalls

Mazda and Mitsubishi have asked a federal judge to order airbag maker Takata to reimburse them for costs they incur from lawsuits over the faulty Takata-made airbag inflators, which have been consolidated in a multidistrict litigation (MDL) in Miami. Pointing to indemnification clauses in their contracts with Takata, the Japanese automakers claim the auto supplier is required to reimburse them for any financial losses they will suffer as a result of the defective airbags. “As a direct consequence of Takata’s design, development, production and sale to Mitsubishi of the alleged defective inflators at issue in this action, [Mitsubishi] has already ... Read More

Trucking company In Deadly Ohio Crash Had 65 Fatal Crashes in Last Two Years

A Missouri commercial truck driver who was killed Feb. 13 when he failed to stop for stalled traffic and collided with three other tractor-trailers on an Ohio highway worked for a commercial trucking company with a substantial record of violations and crashes. Theodore Stocker III was driving a tractor-trailer for Swift Transportation, a large trucking company headquartered in Phoenix, Arizona, along Interstate 70. About two miles inside Preble County, Ohio, Mr. Stocker’s truck slammed into the back of a flatbed trailer and two other semi-trucks. A fourth commercial semi-truck was also involved in the collision, but the vehicle sustained only ... Read More

E-Cigarette Fire Erupts Inside Lawyer’s Pants During Arson Trial

A Miami lawyer defending a man accused of arson abruptly ran out of the courtroom Feb. 8 just after he began closing arguments because his pants were on fire. Strangely, defense attorney Stephen Gutierrez, 28, was making an argument that his client’s car had spontaneously combusted when that very thing happened in his pants due to an e-cigarette in his front pocket, the Miami Herald reported. “He rushed out of the Miami courtroom, leaving spectators stunned. After jurors were ushered out, Gutierrez returned unharmed, with a singed pocket, and insisted it wasn’t a staged defense demonstration gone wrong,” the Miami ... Read More

Florida Dermatologist Settles Medicare Fraud, Kickback Complaints

A Florida federal judge has entered a judgement against a dermatologist and his medical practice, ordering them to pay more than $18 million for allegedly pocketing tens of millions of dollars from Medicare by ordering medically unnecessary biopsies, falsely diagnosing patients with cancer, performing unnecessary radiation treatments on patients, and illegally billing the government for those biopsies and radiation treatments. The allegations were originally made in two separate False Claims Act lawsuits filed in December 2013 and June 2014 by Dr. Theodore Schiff, a dermatologist who is the medical director and managing partner of Water’s Edge Dermatology LLC, a dermatology ... Read More

Florida Man Injured By Exploding Airbag Sues Takata, Honda

A Florida man filed a federal lawsuit against Japanese auto supplier Takata, Honda Motor Co., and related companies, alleging a defective airbag made by Takata and installed by Honda malfunctioned and caused him severe injuries. According to the Florida Record, Evelio Ruiz filed his complaint in a U.S. District Court in Miami Jan. 12. He claims the Takata airbag in his 2002 Honda Accord deployed with dangerous force in a collision he had in March 2015. Like many other motorists injured by the flawed airbags, Mr. Ruiz suffered from multiple lacerations to his neck. Such injuries occur when the airbag’s ... Read More

Baxter Healthcare To Pay $18M For Potentially Botching IV Solutions

Baxter Healthcare Corporation has agreed to pay the U.S. more than $18 million to resolve criminal and civil liabilities stemming from its failure to follow Good Manufacturing Practices when manufacturing sterile drug products at one of its U.S. manufacturing facilities. The settlement, announced by the U.S. Department of Justice Jan.12, includes a deferred prosecution agreement, penalties, and forfeiture totaling $16 million and a civil settlement resolving a whistleblower’s False Claims Act lawsuit totaling approximately $2.158 million. According to the court documents, the U.S. alleged that Baxter’s Marion, N.C., manufacturing facility introduced adulterated drugs into the U.S. market because it failed to ... Read More

Three Utility Workers Perish In Key Largo Trench

Three utility workers died Monday morning in a Key Largo, Fla., subdivision after being sent into an underground drainage trench to inspect a dip in a newly paved Key Largo road. The workers, identified as Elway Gray, 34, of Fort Lauderdale; Louis O’Keefe, 49, of Little Torch Key; and Robert Wilson, 24, of Summerland Key, were employed by D.N. Higgins, which had been contracted by Monroe County. According to the Keys Reporter, the men entered a 15-foot drainage hole to inspect the dip in the road when they were overcome by a mixture of hydrogen sulfide and methane gas. A ... Read More