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Practice/Industry Group Overview
For more than 30 years, Porzio, Bromberg & Newman has represented major pharmaceutical and medical device manufacturers in many landmark cases. The firm is at the forefront of issues such as class action certification, the learned intermediary doctrine, protective orders for proprietary information, the exclusion of junk science, and the applicability of consumer fraud claims.
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Services Available
Pharmaceutical and Medical Device Mass Torts
Porzio, Bromberg & Newman litigates mass pharmaceutical and medical device product liability cases at the trial and appellate levels, in state and federal courts. The firm has the distinction of having acted as lead trial counsel in one of the few pharmaceutical personal injury and medical monitoring class actions tried before a jury. For a list of prescription pharmaceuticals and medical devices we have defended, see below.
Warning Labels
Porzio, Bromberg & Newman litigates warning claims for pharmaceutical and medical device manufacturers. We have successfully litigated the adequacy of warning labels for both over-the-counter and prescription drugs, and claims involving over-promotion in labeling, off-label uses, and product confusion due to inconspicuous or similar labeling.
Counseling
We counsel pharmaceutical manufacturers on issues related to bringing new prescription pharmaceutical drugs to market. We negotiate and prepare a broad range of agreements related to advertising, research and development, contract research organizations, clinical studies, and confidentiality. Porzio counsels on:
- The propriety of promotional and advertising materials, including physician, managed care and direct-to-consumer pieces
- Continuing medical education programs with consideration to FDA regulations
- The procurement of insurance and product liability issues, as well as general risk management initiatives
- FDA sampling regulations and assists with the implementation of compliant product sampling programs
- Regulatory issues, including revisions to product labels, and involuntary recalls due, for example, to post-marketing adverse events
- Direct-to-consumer advertising, revising product labels
- Involuntary recalls due to after-market discovered side-effects
Audit
Armed with knowledge, experience and insight, Porzio's audit teams can conduct your audit and produce a comprehensive report with recommendations that fit your business needs. Our lawyers are particularly well-suited to conduct your audit based upon their years of experience dealing with pharmaceutical and medical device clients in regulatory and product liability issues.
With the FDA and OIG devoting resources to inspections of marketing and sales practices, it is critical for pharmaceutical and medical device companies to demonstrate good corporate citizenship. A third-party Audit and Risk Evaluation Assessment, will be conducted under the protection of the attorney-client privilege by a Porzio team of lawyers and consultants.
Prescription Pharmaceuticals
- Anorectic drugs
- Diethylstilbestrol (DES)
- Diet drugs
- Intrauterine devices
- Hormone therapeutic
- Oral and implanted contraceptives
- Diphtheria, Pertussis, and Tetanus (DPT) vaccine
- Biologics
- Poliovirus vaccine
- Influenza vaccine
- Anticonvulsan
- Antimalarials
- Antidepressants
- Antipsychotics
- Anesthetic agents
- Non-steroidal anti-inflammatory drugs
- Tetracycline and other antibiotics
Medical Devices
- Electrosurgical generators
- Apnea monitors
- Ophthalmic and laboratory equipment
- Catheters
- Needles
- Sutures
- Latex gloves
- Medical implants
- Breast implants
- Heart valves
- Pacemakers
- Orthopedic prostheses
- Corneal tissue grafts
- Over the Counter (OTC)
- PPA
- Ephedra
Representative Cases
Extraordinary Results
- The firm demonstrates prominence in pharmaceutical litigation through its role in shaping the substantive law in this field. Consider these facts:
- Our briefing and legal argument before the New Jersey Supreme Court resulted in its adoption of the “learned intermediary” doctrine in this state
- We were intimately involved in developing the vaccine industry’s strategy to defeat plaintiffs’ efforts to impose market share liability
- The firm prevailed against plaintiffs’ attempts to eliminate the state-of-the-art defense in New Jersey for pharmaceutical manufacturers
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Clients:
Daiichi Pharmaceutical Corporation , ETHICON, Howmedica , Johnson & Johnson , Pfizer Inc. , Wyeth
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