Food, Drug & Device Law

OVERVIEW

TEXAS BASED – GLOBALLY FOCUSED

In 1906, Congress chartered the Food and Drug Administration with a mission to promote the public health by ensuring that foods are safe, wholesome, sanitary, and properly labeled; drugs and devices are safe and effective; and cosmetics are safe and properly labeled. In the more than 100 years since its inception, FDA has exploded into an agency with more than 15,000 employees. It encompasses over 750 centers, divisions, and departments, 230 field offices, and 13 laboratories in 50 states and offices in 6 foreign countries. Today, FDA oversees licensing, registration, product approval and clearance, facility and product inspections, and civil and criminal enforcement of all aspects of the manufacture, distribution, marketing and sale of products ingested, applied or implanted into humans or animals. This regulatory landscape continues to grow with the introduction of new laws, regulations and guidance, amounting to thousands of pages every month.

Our team is equipped to match the complexity of these issues with a multidisciplinary approach. Our lawyers have broad experience handling FDA regulatory matters, transportation and import/export issues, civil and criminal enforcement, intellectual property, unfair competition, and product liability defense. The firm’s practice area leaders are available to answer any questions about Strasburger’s capabilities. To learn more about this practice area, please contact  Michael Walsh.

In 2016, Strasburger sponsored the Fourth Food Law Forum. The Forum was hosted in Dallas by Southern Methodist University and Michigan State University and provided quality educational programming featuring multiple panels comprised of food industry professionals, in-house lawyers, academicians and firm lawyers focused on cutting edge issues impacting the food industry. For complete details on our educational programs and information on upcoming FDA Law programs, please contact Emilie Strozier.

FARM TO TABLE – CONCEPT TO LABEL – DEMAND TO DISMISSAL

Food Manufacturing and Distribution. We counsel clients regarding implementation of the Food Safety Modernization Act (FSMA) and the rules implementing the law and related regulatory guidance concerning preventive controls, produce safety, foreign supplier verification, third-party auditors, sanitary transport and Mitigation Strategies to Protect Food Against Intentional Adulteration. We further counsel clients regarding facility and product licensing, registration, supplier and supply chain compliance, supplier verification, track and trace, and establishing and revising policies and procedures. We handle issues concerning labeling, claims substantiation, new dietary ingredients (NDI), packaging and food contact substances, and the changing landscape of foods and additives generally regarded as safe (GRAS). Our team is adept at addressing and responding to emerging and emergent product adulteration and labeling issues giving rise to product recalls.

Promotion and Advertising. Strasburger’s food and drug team provides counseling regarding traditional print, broadcast, and internet advertisements and promotional content, and concerning regulatory compliance for conduct and promotional activities related to tradeshows, educational programs, and sales representatives. Our experience extends from matters before the FDA to those where the FDA and FTC share jurisdiction over FDA-regulated product advertising and promotion. While our focus is compliance and anticipating and substantiating misbranding and potential false advertising claims, we bring our litigation expertise to bear in defending governmental, competitor and consumer false and deceptive advertising, Lanham Act and misbranding claims. We help clients address emerging new technology applications for product promotion, development, co-branding, and data privacy and security.

Civil Enforcement: We represent clients in a broad range of matters in this area from advising clients on negotiating with state and federal agencies, including FDA, FTC, USDA and CBP regarding inspections, product detention and product recalls to matters involving enforcement and administrative proceedings (483s), warning letters and injunctions.

Criminal Enforcement: We represent clients in this area advising clients from defense of companies and individuals facing criminal prosecution and complex cases involving white collar crimes, including fraud, “Park Doctrine” prosecutions, healthcare fraud, insurance fraud, official corruption, financial institutions fraud, and intellectual property rights violations—We have litigated cases at the federal level with U.S. Attorneys’ offices, the U.S. Department of Justice, U.S. Customs and Border Protection, FTC and FDA as well as with state law enforcement.

Transportation: New sanitary transportation and supply-chain regulations has required revising policies and procedures and operating procedures as well as supplier, vendor and broker agreements to address issues raised in current regulations.  We have the necessary transportation and FDA experience to counsel clients on how to manage these risks. Our experience in transportation/logistics law includes airlines, direct and indirect air cargo carriers, motor freight carriers (including the less than truckload, truckload, tank, dry bulk, drive-away, courier and private segments), air, ocean and inland freight forwarders, transportation brokers, customs brokers, railroads, warehouse operators, consolidators, third party and fourth party logistics providers, shippers, and insurers. We handle legal matters that are unique to the world of transportation and logistics, whether the problem involves surface, maritime, air or intermodal operations.

Imports/Exports. We counsel clients on the FSMA requirements for foreign supplier registration and verification requirements as well as third-party auditors and prior notice requirements.  We serve clients in Latin America, Europe, Canada, the Caribbean, Asia, and the Middle East—with a special focus on Latin America. We assist clients requiring all modes of transportation for the production, sales, and distribution of goods and services across borders. Our lawyers have extensive experience with the intricate laws and regulations associated with import and export regulation, maritime matters, border security and cross-border transportation, including the special regulatory regimes that apply to international transportation of hazardous materials, export of dual-use goods (having both military and civilian applications), and trade in goods for which NAFTA duty reductions are claimed.

Litigation and Dispute Resolution. New theories of liability are emerging and supplanting the traditional strict products liability doctrine for manufacturing defects, design defects and marketing defects (or failure to warn). State or federal enforcement often leads to “follow-on” litigation. Our experience and expertise is well suited to defending against sophisticated new approaches that often draw on state law-based claims paralleling federal requirements. Because we understand and participate in establishing the law for dealing with these theories, our lawyers are poised to counter new litigation threats intelligently and efficiently. Our team of litigators has appeared throughout the United States in state and federal courts and administrative agencies and have managed litigation for some of the world’s largest companies including convenience store operators, retail, and pharmaceutical and medical device manufacturers.

Litigation Management. Over the last ten years, our team has managed some of the largest litigation, and governmental proceedings in the country and has handled complex litigation for clients on national and regional bases. Our team of litigation management has been sought out for its efficiency, thoroughness and cost saving in formulating and implementing programs to manage litigation efficiently and cost-effectively using a number of project-focused strategies.

Brand Name Identification and Protection. Whether it involves trademark, copyright or Internet practice, we guard brand value by protecting clients’ intellectual property rights from infringement, misappropriation, dilution, and counterfeiting. We have experience with diverse products, including medical devices, packaging, patient monitoring systems, pharmaceuticals, products of genetic engineering. We prepare and prosecute patent applications, obtain copyright and trademark registrations, negotiate license agreements, counsel on mergers and acquisitions, and enforce intellectual property rights against infringers. We work in domestic markets, as well as in Central and South America, Canada, Asia and Europe.

Corporate Our corporate and securities attorneys represent clients in a broad range of matters, including merger, acquisition and divestiture transactions, private and public stock offerings, financial regulations, securities arbitration and defense, corporate reorganizations, and other business matters. Corporations, early stage companies, investors, brokers, and even non-profits rely on Strasburger to advise on everything from day-to-day compliance and reporting requirements to long-term business objectives.

EXPERIENCE

Representative matters handled by Strasburger’s food, drug, and device attorneys include the following:

FOOD, DRUG, DEVICE & BIOLOGICS COUNSELING

  • Food Safety Modernization Act (FSMA) advised client on contract revisions and updates for large national food distributor
  • Advised large national distributor on  new FSMA requirements and compliance issue
  • Coordinated national recall of misbranded food products and negotiated enforcement with FDA
  • Coordinated national recall of misbranded meat products and negotiated terms of recall and enforcement with USDA
  • Advised regional restaurant chain on licensing issues and State regulatory enforcement related to Texas Home Rule provisions
  • Advised large regional convenience store chain on federal menu labeling requirements
  • Product launch and labeling review and FDA compliance for cosmetic brand and compliance review regarding 510k issues
  • Product launch labeling review and FDA compliance for OTC products, and review of manufacturing and supply agreements
  • Resolved dispute between manufacturer and large national retailer over misbranding and labeling compliance issues Negotiated multiple copacking agreements for distributors and major retailer
  • Responded on behalf of manufacturer to FDA warning letter for medical device company
  • Advised on product distribution and California Prop 65 labeling concerns
  • Label review and auditing for food and dietary supplement manufacturer.
  • Labeling counsel for manufacturer regarding new dietary ingredients.
  • Created Social Media policies and procedures for online content for dietary supplement manufacturer.
  • Resolved non-compliance concerning Prior Notice of Imported Food.
  • Negotiate and resolved Texas Department of State Health Services enforcement and product detention for national dairy client.
  • Counsel medical device importer on CBP product detention and negotiation with FDA
  • Counseled device manufacturers on Sunshine Act compliance and CMS Open Payments program.
  • Counsel manufacturers on labeling content for OTC, cosmetic and dietary supplement products
  • Negotiation of supply chain agreements and policies and negotiation of terms.
  • Negotiated manufacturing agreements for food, dietary supplement, OTC and cosmetic manufacturers and marketers.
  • Involved in prosecution on numerous high profile cases involving adulterated and counterfeit drugs, medical devices, and claims involving unapproved drugs and fraudulent medical treatments.
  • Supervised prosecutions and investigation regarding drug products, drug/devices, cosmetics, dietary supplements and pet food.
  • Counseled on master vendor supply agreement for Contract Research Organization.
  • Established Compliance programs, including SOPs for OTC, compounding and dietary supplement manufacturers.
  • Resolved ligation docket of medical device cases in US and Mexico.
  • Negotiation California Prop 65 claims regarding alleged elevated heavy metal levels in food products.
  • Address compliance regarding FDA 483 issues in connection with laboratory facility.
  • Advise on acquisition of clinical trials company and establishment of risk factors for Private Placement.
  • Resolved federal enforcement and investigations concerning use of unapproved foreign manufactured drugs for medical facility.
  • Advise physicians on development and marketing of combination products, compounded products and dietary supplements.
  • Advise on acquisition of clinical trials company and establishment of risk factors for Private Placement.
  • Advise on sale of biologics company and negotiation of representations.
  • Advise food packaging manufacturer and importer on food contact substance requirements and regulations.

LITIGATION

  • National coordinating counsel and MDL counsel to world’s largest owner of convenience stores in multiple MDL proceedings.
  • Regional trial counsel to the world’s largest generic drug manufacturer throughout Texas in pharmaceutical litigation, including products such as weight loss, gastrointestinal and epilepsy medications.
  • National Coordinating Counsel for a component parts manufacturer for an implanted orthopedic medical device.
  • Trial counsel in the Eastern District of Texas concerning cardiac medication.
  • Regional discovery counsel for a major medical device company in connection with threatened nationwide litigation concerning a medical device.
  • National counsel for a major hospital corporation in connection with allegations of healthcare facility fraud and conspiracy and abuse claims.
  • Texas trial counsel for a device manufacturer in cases involving claims of physical impairment due to allergic reaction.
  • Texas trial counsel for a foreign manufacturer and its affiliates in 91 state and federal cases alleging personal injuries from contaminated health supplements.
  • Trial counsel on behalf of a major device manufacturer in the breast implant litigation.
  • Prevented class-certification in a suit against a healthcare provider alleging exposure to viral contamination at a surgical facility.
  • Resolved docket of hepatitis “C” claims and suits against a national hospital corporation and related entities.
  • Serve as national counsel for a major hospital chain and related entities in connection with healthcare facility fraud and conspiracy and abuse claims.
  • Successfully settled price-fixing complaint by Texas Attorney General against multiple physicians.
  • Legal, investigational, and information management of potential AIDS exposure crisis for major hospital operation.
  • Legal, investigational and information management of potential infectious disease exposure crisis for multiple hospital organizations.
  • Class action defense counsel.
  • Defend manufacturer of prescription drug over manufacturing defect claims of arsenic contamination of product.
  • Texas trial counsel for generic drug manufacturer in pharmaceutical litigation for variety of prescription drugs.
  • Texas counsel for manufacturer of combination drug/device.

BLOG

gimp-supermarket-57196763

FDA Provides a Healthy Extension to Comment on Healthy

Written by Michael A. Walsh on December 30, 2016

In September 2016, the Food and Drug Administration (FDA) took a number of actions concerning the use of the term “Healthy” in the labeling of food products. The FDA published notice in the Federal Register on the use of the term, published a “Guidance for Industry: Use of the Term “Healthy” in the Labeling of Human Read More…


gimp-skin-care-41240063

Naturally FTC Rules

Written by Michael A. Walsh on December 22, 2016

FTC Finds “All Natural” and “100% Natural” Claims False and Misleading In April 2016, four companies[i] marketing skin care products online agreed to settle Federal Trade Commission (FTC) charges that the companies’ advertisements violated the Federal Trade FTC Act (the Act). According to the FTC complaints, claims that the products were “all natural” or “100% Read More…


gimp-customs-41189074

FDA Final Rule on the Submission of Import Data

Written by Michael A. Walsh on December 5, 2016

On November 29, 2016, the Food and Drug Administration (FDA) issued a Final Rule on the Submission of Import Data in the Automated Commercial Environment (ACE). The final rule specifies certain data that must be submitted when an FDA-regulated product is offered for import into the United States. The effective date of the rule is Read More…


gimp-formatted-md-with-medicine-molecule-16706310

Drug Law: Off-Label Use – a Paradigm Shift and a Moral Imperative

Written by Michael A. Walsh on November 21, 2016

On December 16, 2016, the State Bar of Texas will host a Webcast on the FDA and Off-Label Uses of Medical Products. Coincidentally in the wake of the 2016 presidential election, the Food and Drug Administration (FDA) is reevaluating its rules on how drug and device companies disseminate information. The change that the FDA is Read More…


gimp-formatted-menu-39411884

Will the Election Affect the Menu Labeling Rule Section of the ACA?

Written by Michael A. Walsh on November 10, 2016

The election is over and President-Elect Trump, the candidate who promised to repeal and replace the Patient Protection and Affordable Care Act a/k/a Obamacare (the ACA), will be sworn in on Friday, January 20, 2017. The ACA covers a number of issues that are not ordinarily associated with healthcare, including nutrition labeling of “standard” menu Read More…


NEWSLETTER

MEDIA

HONORS

TEXAS BASED – GLOBALLY FOCUSED

In 1906, Congress chartered the Food and Drug Administration with a mission to promote the public health by ensuring that foods are safe, wholesome, sanitary, and properly labeled; drugs and devices are safe and effective; and cosmetics are safe and properly labeled. In the more than 100 years since its inception, FDA has exploded into an agency with more than 15,000 employees. It encompasses over 750 centers, divisions, and departments, 230 field offices, and 13 laboratories in 50 states and offices in 6 foreign countries. Today, FDA oversees licensing, registration, product approval and clearance, facility and product inspections, and civil and criminal enforcement of all aspects of the manufacture, distribution, marketing and sale of products ingested, applied or implanted into humans or animals. This regulatory landscape continues to grow with the introduction of new laws, regulations and guidance, amounting to thousands of pages every month.

Our team is equipped to match the complexity of these issues with a multidisciplinary approach. Our lawyers have broad experience handling FDA regulatory matters, transportation and import/export issues, civil and criminal enforcement, intellectual property, unfair competition, and product liability defense. The firm’s practice area leaders are available to answer any questions about Strasburger’s capabilities. To learn more about this practice area, please contact  Michael Walsh.

In 2016, Strasburger sponsored the Fourth Food Law Forum. The Forum was hosted in Dallas by Southern Methodist University and Michigan State University and provided quality educational programming featuring multiple panels comprised of food industry professionals, in-house lawyers, academicians and firm lawyers focused on cutting edge issues impacting the food industry. For complete details on our educational programs and information on upcoming FDA Law programs, please contact Emilie Strozier.

FARM TO TABLE – CONCEPT TO LABEL – DEMAND TO DISMISSAL

Food Manufacturing and Distribution. We counsel clients regarding implementation of the Food Safety Modernization Act (FSMA) and the rules implementing the law and related regulatory guidance concerning preventive controls, produce safety, foreign supplier verification, third-party auditors, sanitary transport and Mitigation Strategies to Protect Food Against Intentional Adulteration. We further counsel clients regarding facility and product licensing, registration, supplier and supply chain compliance, supplier verification, track and trace, and establishing and revising policies and procedures. We handle issues concerning labeling, claims substantiation, new dietary ingredients (NDI), packaging and food contact substances, and the changing landscape of foods and additives generally regarded as safe (GRAS). Our team is adept at addressing and responding to emerging and emergent product adulteration and labeling issues giving rise to product recalls.

Promotion and Advertising. Strasburger’s food and drug team provides counseling regarding traditional print, broadcast, and internet advertisements and promotional content, and concerning regulatory compliance for conduct and promotional activities related to tradeshows, educational programs, and sales representatives. Our experience extends from matters before the FDA to those where the FDA and FTC share jurisdiction over FDA-regulated product advertising and promotion. While our focus is compliance and anticipating and substantiating misbranding and potential false advertising claims, we bring our litigation expertise to bear in defending governmental, competitor and consumer false and deceptive advertising, Lanham Act and misbranding claims. We help clients address emerging new technology applications for product promotion, development, co-branding, and data privacy and security.

Civil Enforcement: We represent clients in a broad range of matters in this area from advising clients on negotiating with state and federal agencies, including FDA, FTC, USDA and CBP regarding inspections, product detention and product recalls to matters involving enforcement and administrative proceedings (483s), warning letters and injunctions.

Criminal Enforcement: We represent clients in this area advising clients from defense of companies and individuals facing criminal prosecution and complex cases involving white collar crimes, including fraud, “Park Doctrine” prosecutions, healthcare fraud, insurance fraud, official corruption, financial institutions fraud, and intellectual property rights violations—We have litigated cases at the federal level with U.S. Attorneys’ offices, the U.S. Department of Justice, U.S. Customs and Border Protection, FTC and FDA as well as with state law enforcement.

Transportation: New sanitary transportation and supply-chain regulations has required revising policies and procedures and operating procedures as well as supplier, vendor and broker agreements to address issues raised in current regulations.  We have the necessary transportation and FDA experience to counsel clients on how to manage these risks. Our experience in transportation/logistics law includes airlines, direct and indirect air cargo carriers, motor freight carriers (including the less than truckload, truckload, tank, dry bulk, drive-away, courier and private segments), air, ocean and inland freight forwarders, transportation brokers, customs brokers, railroads, warehouse operators, consolidators, third party and fourth party logistics providers, shippers, and insurers. We handle legal matters that are unique to the world of transportation and logistics, whether the problem involves surface, maritime, air or intermodal operations.

Imports/Exports. We counsel clients on the FSMA requirements for foreign supplier registration and verification requirements as well as third-party auditors and prior notice requirements.  We serve clients in Latin America, Europe, Canada, the Caribbean, Asia, and the Middle East—with a special focus on Latin America. We assist clients requiring all modes of transportation for the production, sales, and distribution of goods and services across borders. Our lawyers have extensive experience with the intricate laws and regulations associated with import and export regulation, maritime matters, border security and cross-border transportation, including the special regulatory regimes that apply to international transportation of hazardous materials, export of dual-use goods (having both military and civilian applications), and trade in goods for which NAFTA duty reductions are claimed.

Litigation and Dispute Resolution. New theories of liability are emerging and supplanting the traditional strict products liability doctrine for manufacturing defects, design defects and marketing defects (or failure to warn). State or federal enforcement often leads to “follow-on” litigation. Our experience and expertise is well suited to defending against sophisticated new approaches that often draw on state law-based claims paralleling federal requirements. Because we understand and participate in establishing the law for dealing with these theories, our lawyers are poised to counter new litigation threats intelligently and efficiently. Our team of litigators has appeared throughout the United States in state and federal courts and administrative agencies and have managed litigation for some of the world’s largest companies including convenience store operators, retail, and pharmaceutical and medical device manufacturers.

Litigation Management. Over the last ten years, our team has managed some of the largest litigation, and governmental proceedings in the country and has handled complex litigation for clients on national and regional bases. Our team of litigation management has been sought out for its efficiency, thoroughness and cost saving in formulating and implementing programs to manage litigation efficiently and cost-effectively using a number of project-focused strategies.

Brand Name Identification and Protection. Whether it involves trademark, copyright or Internet practice, we guard brand value by protecting clients’ intellectual property rights from infringement, misappropriation, dilution, and counterfeiting. We have experience with diverse products, including medical devices, packaging, patient monitoring systems, pharmaceuticals, products of genetic engineering. We prepare and prosecute patent applications, obtain copyright and trademark registrations, negotiate license agreements, counsel on mergers and acquisitions, and enforce intellectual property rights against infringers. We work in domestic markets, as well as in Central and South America, Canada, Asia and Europe.

Corporate Our corporate and securities attorneys represent clients in a broad range of matters, including merger, acquisition and divestiture transactions, private and public stock offerings, financial regulations, securities arbitration and defense, corporate reorganizations, and other business matters. Corporations, early stage companies, investors, brokers, and even non-profits rely on Strasburger to advise on everything from day-to-day compliance and reporting requirements to long-term business objectives.

EXPERIENCE

Representative matters handled by Strasburger’s food, drug, and device attorneys include the following:

FOOD, DRUG, DEVICE & BIOLOGICS COUNSELING

  • Food Safety Modernization Act (FSMA) advised client on contract revisions and updates for large national food distributor
  • Advised large national distributor on  new FSMA requirements and compliance issue
  • Coordinated national recall of misbranded food products and negotiated enforcement with FDA
  • Coordinated national recall of misbranded meat products and negotiated terms of recall and enforcement with USDA
  • Advised regional restaurant chain on licensing issues and State regulatory enforcement related to Texas Home Rule provisions
  • Advised large regional convenience store chain on federal menu labeling requirements
  • Product launch and labeling review and FDA compliance for cosmetic brand and compliance review regarding 510k issues
  • Product launch labeling review and FDA compliance for OTC products, and review of manufacturing and supply agreements
  • Resolved dispute between manufacturer and large national retailer over misbranding and labeling compliance issues Negotiated multiple copacking agreements for distributors and major retailer
  • Responded on behalf of manufacturer to FDA warning letter for medical device company
  • Advised on product distribution and California Prop 65 labeling concerns
  • Label review and auditing for food and dietary supplement manufacturer.
  • Labeling counsel for manufacturer regarding new dietary ingredients.
  • Created Social Media policies and procedures for online content for dietary supplement manufacturer.
  • Resolved non-compliance concerning Prior Notice of Imported Food.
  • Negotiate and resolved Texas Department of State Health Services enforcement and product detention for national dairy client.
  • Counsel medical device importer on CBP product detention and negotiation with FDA
  • Counseled device manufacturers on Sunshine Act compliance and CMS Open Payments program.
  • Counsel manufacturers on labeling content for OTC, cosmetic and dietary supplement products
  • Negotiation of supply chain agreements and policies and negotiation of terms.
  • Negotiated manufacturing agreements for food, dietary supplement, OTC and cosmetic manufacturers and marketers.
  • Involved in prosecution on numerous high profile cases involving adulterated and counterfeit drugs, medical devices, and claims involving unapproved drugs and fraudulent medical treatments.
  • Supervised prosecutions and investigation regarding drug products, drug/devices, cosmetics, dietary supplements and pet food.
  • Counseled on master vendor supply agreement for Contract Research Organization.
  • Established Compliance programs, including SOPs for OTC, compounding and dietary supplement manufacturers.
  • Resolved ligation docket of medical device cases in US and Mexico.
  • Negotiation California Prop 65 claims regarding alleged elevated heavy metal levels in food products.
  • Address compliance regarding FDA 483 issues in connection with laboratory facility.
  • Advise on acquisition of clinical trials company and establishment of risk factors for Private Placement.
  • Resolved federal enforcement and investigations concerning use of unapproved foreign manufactured drugs for medical facility.
  • Advise physicians on development and marketing of combination products, compounded products and dietary supplements.
  • Advise on acquisition of clinical trials company and establishment of risk factors for Private Placement.
  • Advise on sale of biologics company and negotiation of representations.
  • Advise food packaging manufacturer and importer on food contact substance requirements and regulations.

LITIGATION

  • National coordinating counsel and MDL counsel to world’s largest owner of convenience stores in multiple MDL proceedings.
  • Regional trial counsel to the world’s largest generic drug manufacturer throughout Texas in pharmaceutical litigation, including products such as weight loss, gastrointestinal and epilepsy medications.
  • National Coordinating Counsel for a component parts manufacturer for an implanted orthopedic medical device.
  • Trial counsel in the Eastern District of Texas concerning cardiac medication.
  • Regional discovery counsel for a major medical device company in connection with threatened nationwide litigation concerning a medical device.
  • National counsel for a major hospital corporation in connection with allegations of healthcare facility fraud and conspiracy and abuse claims.
  • Texas trial counsel for a device manufacturer in cases involving claims of physical impairment due to allergic reaction.
  • Texas trial counsel for a foreign manufacturer and its affiliates in 91 state and federal cases alleging personal injuries from contaminated health supplements.
  • Trial counsel on behalf of a major device manufacturer in the breast implant litigation.
  • Prevented class-certification in a suit against a healthcare provider alleging exposure to viral contamination at a surgical facility.
  • Resolved docket of hepatitis “C” claims and suits against a national hospital corporation and related entities.
  • Serve as national counsel for a major hospital chain and related entities in connection with healthcare facility fraud and conspiracy and abuse claims.
  • Successfully settled price-fixing complaint by Texas Attorney General against multiple physicians.
  • Legal, investigational, and information management of potential AIDS exposure crisis for major hospital operation.
  • Legal, investigational and information management of potential infectious disease exposure crisis for multiple hospital organizations.
  • Class action defense counsel.
  • Defend manufacturer of prescription drug over manufacturing defect claims of arsenic contamination of product.
  • Texas trial counsel for generic drug manufacturer in pharmaceutical litigation for variety of prescription drugs.
  • Texas counsel for manufacturer of combination drug/device.
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