Category Archives: Medical Device

Keep Us Posted: FDA Updates Rules On Changes To Medical Devices

The U.S. Food and Drug Administration has updated its rules regarding how manufacturers of medical devices disclose manufacturing and design changes to previously approved medical devices. The focus of the FDA’s update is on annual reports for Class III devices which are subject to premarket approval. To read the rest of this blog entry, authored by Jesse D. Rutter of Goldberg Segalla, please visit Risky Business: Avoiding Product Liability, Commercial, and Other Litigation.

Continue Reading....

This Week’s Life Science Headlines

        Litigation

Continue Reading....

Pennsylvania Supreme Court Opens Door for Negligent Design Claims Against Pharmaceutical Manufacturers

In a decision with significant potential ramifications, the Pennsylvania Supreme Court has issued a ruling that pharmaceutical companies can be held liable for negligence in the design and marketing of drugs, regardless of claims that the drugs had been properly labeled and tested, as well as approved by the U.S. Food and Drug Administration. The ruling, announced January 22nd, upholds an intermediate appellate court decision against a Pfizer, Inc. subsidiary in a wrongful death action involving the diet drug Redux. In its 4-2 decision, the…

Continue Reading....

This Week’s Science Headlines

        Litigation

Continue Reading....

This Week’s Life Science Headlines

        Litigation

Continue Reading....

Claims Regarding Post-FDA Approval Problems Not Preempted

While Medical Device Amendments of 1976, 21 U.S.C. § 360k(a) provides protection to manufacturers for medical devices approved by the FDA, certain post-FDA approval activities may still give rise to claims.  In this recent case, the defendant St. Jude Medical, Inc. moved to dismiss the complaints against it for injuries allegedly resulting from St. Jude Riata leads on implantable cardiac defibrillators where the insulation failed and caused unnecessary shocks in the body.  The product was removed from the market in 2010, a warning letter was…

Continue Reading....

Drug Quality and Security Act

In October of 2012, a meningitis outbreak that caused the death of sixty-four people was traced to tainted steroids purchased from a Compounding Center in New England.  In response to this outbreak, last November President Barack Obama signed the Drug Quality and Security Act into law, which overhauls the FDA’s regulation of Compounding Pharmacies by establishing a system to trace the supply chain of prescription drugs. (See the bill here). Furthermore, under this bill, the FDA is given more authority to regulate and monitor…

Continue Reading....

This Week’s Life Science Headlines

        Litigation

Continue Reading....

PA Court Vacates $28 Million Verdict in Knee Replacement Case

A Pennsylvania Superior Court recently vacated a $27.6 million jury verdict against medical device manufacturer Zimmer Inc. (Zimmer), and marketing firm Public Communications, Inc. (PCI) in a case that involved Zimmer’s Gender Solutions Knee. The decision, which vacated the verdict on causation grounds, is available here. Zimmer’s Gender Solutions Knee is a knee replacement device specifically designed and manufactured for women. Zimmer hired PCI to produce a sales video featuring footage of patients who had received the Gender Solutions Knee. The plaintiff Margo Polett…

Continue Reading....

This Week’s Life Science Headlines

        Litigation

Regulatory Recalls

Continue Reading....