Drugs & Medical Devices
Get ready for the next wave of pharmaceutical litigation with HarrisMartin's Drugs & Medical Devices. This reporter will keep you one step ahead of drug and medical device litigation with in-depth investigations, guest commentaries and objective courtroom coverage on today's and tomorrow's hottest drugs and supplements.
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A New Jersey appellate panel has upheld an award of summary judgment to Johnson & Johnson and Ethicon Inc. in a hernia repair mesh action, finding the plaintiffs failed to prove that defendants manufactured the product at issue.
A federal appellate panel has refused to reinstate a $3 million verdict in a Paxil suicide case, explaining that a recent U.S. Supreme Court ruling clarifying the “clear evidence” standard in the context of whether the FDA would approve changes to a drug’s warning label does not affect the lower court’s decision.
A South Carolina federal judge has excluded the causation opinions of a plaintiff’s expert in an Invega gynecomastia case, ruling that his opinions are unsupported by any evidence in his report and fall outside of his expertise as a psychologist.
Issue #148, March 2020
50 Companies Express Concern About Court’s ‘Gatekeeping’ Function in Letter to Administrative Office of U.S. Courts
The chief legal officers of 50 companies have expressed concern that federal courts have not been fully executing or enforcing the “gatekeeping” obligation, instead allowing juries “a role in deciding whether an expert’s opinions have the requisite scientific support without first ensuring that the testimony is the product of reliable principles and methods and is reliably applied.”
The Food and Drug Administration says it is adding a boxed warning to asthma and allergy drug Singulair (montelukast) and generic equivalents regarding serious behavior and mood-related changes.
A Pennsylvania federal judge has refused to remand a pelvic mesh case, ruling that the joinder of a nondiverse supplier was fraudulent in light of a state judge’s previous ruling that the claims are preempted by federal law.
A Wisconsin federal judge has refused to dismiss misrepresentation claims in a Wright Medical Profemur hip replacement action, finding they were pled with the particularity required by Federal Rule of Civil Procedure 9(b).
A Minnesota federal magistrate judge has imposed discovery sanctions on Boston Scientific Corp. in a qui tam action accusing it of selling defective cardiac defibrillators, ruling that the company improperly failed to provide witness information in its Rule 26 disclosures until the final hours of discovery.
The Florida Supreme Court has adopted proposed amendments to standard jury instructions in civil cases, requiring a jury to consider state-of-the-art of scientific and technical knowledge and other circumstances that existed at the time of the product’s manufacture when deciding whether a product is defective.
A New York federal judge has dismissed a Covidien hernia repair mesh action, ruling that the plaintiff inadequately pled his claims for strict liability, negligence and breach of warranty because he failed to specify what warnings were provided and did not identify a safer alternative to the product he received.