Medical devices manufacturers are braced for the overhaul of the EU Medical Devices Directives. New Regulations, which are closer to final adoption than ever (although not quite there yet), are expected to clarify the regulation of medical devices in Europe – at least once the delegated and implementing acts have been put in place.
As plaintiffs pursuing medical device and pharmaceutical product liability actions run into various dispositive legal defences to traditional tort claims, such as express and implied preemption, defence attorneys are seeing an increasing trend toward creative pleading in an effort to raise potential issues regarding the conduct of health care industry representatives who are either present in surgery or otherwise providing technical support to medical providers.
Who’s Who Legal brings together five leading experts to discuss issues facing life sciences lawyers and their clients today.
This year, our research identifies 314 standout regulatory law experts with a proven track record advising major clients in the life sciences sector. Those featured are highly skilled at providing advice and innovative solutions on matters ranging from product development, approval and manufacture to pricing, market safety and customs rules.
In this section, we highlight 218 transactional lawyers who have been selected for their outstanding work in the life sciences sector. Those included are the world’s leading experts when it comes to the corporate side of life sciences practices, and focus on a wide range of matters including mergers and acquisitions, IPOs, securities and venture capital transactions, outsourcing, and investment agreements and joint ventures.
Life sciences lawyers have had another busy year, reporting record-high levels of work across the board. For many life sciences and healthcare companies, 2017 was a particularly challenging year. Increased regulatory scrutiny, soaring R&D costs and heightened pricing pressures, coupled with the turbulent economic climate brought about by political changes, have led to fierce market competition. As a result, the legal community has experienced a surge in both contentious and non-contentious work in the sector, spurred on by the continued advancement of both major players and innovative start-ups. We spoke to some of the world’s most prominent practitioners in the life sciences space to examine some of the main trends affecting the market at the moment.
We are delighted to present WWL: Life Sciences 2018, which covers 1,047 lawyers from 420 firms worldwide.
Below we highlight the leading firms overall in our research this year. All but one of the firms below boast individual listings across multiple chapters, although most show one clear area of strength. Hogan Lovells stands out as the top firm in our research, with 39 listings in total and with particularly strong product liability and transactional practices at the heart of its offering. Sidley Austin, Bird & Bird and Covington & Burling all also perform well, with 33, 27 and 25 listings respectively.
Individual practice area charts can be found in the appropriate chapter analyses.
This chapter identifies 399 leading lights in the field of patent litigation from across 211 firms worldwide. Those included are well versed at handling patent disputes across a range of industry sectors, including pharmaceuticals, biotechnology and medical devices.
In this section we highlight 298 standout practitioners from 162 law firms with a proven track record defending product liability claims for major clients across the life sciences sector. Those included are widely recognised as the world’s foremost experts at handling mass tort claims, class actions suits and product recall actions.
As ever, our legal analysis seeks to identify which law firms and which lawyers are the most highly regarded practitioners both by region and by type of life sciences law. We have split our research into four practice areas: transactional, patent litigation, product liability and regulatory. Europe and the United States once again emerge as the regions with the greatest concentration of top life sciences lawyers. However, while smaller in volume, Australia, China and Japan’s leading law firms also demonstrate their depth of expertise in the area, with numerous individuals recommended across all areas.
Levels of activity within the life sciences market show no sign of abating, despite the economic uncertainty brought on by recent political events on both sides of the Atlantic. M&A and consolidation remains active and in regions where joined-up regulatory regimes are about to come into place, as in the European Union, regulatory and compliance law is robust. One of the reasons for such a buoyant market may be the successes that innovators have had recently, with several new biopharmaceutical products becoming available that seem likely to be lucrative regardless of the ups and downs of the market. This has culminated in a healthy year for life sciences, and for lawyers practising in all areas of the field.
The eighth edition of this ever-expanding publication features over 1,200 listings from 417 law firms across four distinct areas of research: patent litigation, regulatory, product liability defence and transactional.
In this analysis of the life sciences legal market, the following individuals and law firms stand out as the most highly regarded in our research process.
The life sciences industry is continuing to evolve in a time of economic uncertainty, demographic transformation and technological innovation. Governments are moving towards stricter regulatory regimes, and more austere pricing and reimbursement policies. The spiralling cost of R&D, along with technological innovations, continue to push life sciences companies into partnering transactions, as well as driving M&A deal activity. Meanwhile, the burgeoning biopharmaceutical industry is now faced with the emergence of game-changing biosimilars. It is a challenging time for life sciences companies and legal teams alike.
Click on the name of an expert below to view their profile. Experts shaded in blue have professional biographies in one or more practice areas.
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Nominees have been selected based upon comprehensive, independent survey work with both general counsel and private practice lawyers worldwide. Only specialists who have met independent international research criteria are listed.
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